New Syncope Statement Features Cardiac Diagnostic Flowchart

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A new scientific statement from the cardiology community on the evaluation of syncope could either win nods of acceptance or raise eyebrows with its support for echocardiograms and stress tests and its caution against tilt table testing.

The American Heart Association/American College of Cardiology Foundation Scientific Statement on the Evaluation of Syncope—the first such statement on syncope issued by the organizations—reiterates some well-established findings, chiefly that most cases of the often-vexing problem have a cardiovascular cause.

It emphasizes the importance of promptly ruling out structural heart disease and ischemia, as well as less common causes associated with sudden death.

The statement lays out a diminished role, however, for tilt table testing, saying that “serious questions about the sensitivity, specificity, diagnostic yield, and day-to-day reproducibility of tilt table testing exist.”

Tilt table testing has traditionally been used as an aid in establishing the diagnosis of neurocardiogenic syncope, and according to lead author Dr. S. Adam Strickberger, “Some … may feel the tilt table test was devalued” in the new statement.

“But in general, I think there are a lot fewer tilt table tests ordered by electrophysiologists today … and it's fair to say there is a smaller role for the tests than there would have been 10–15 years ago,” Dr. Strickberger said in an interview.

The 11-page statement, which the AHA and ACC Foundation issued in collaboration with the Heart Rhythm Society and which was endorsed by the American Autonomic Society, was published last month (J. Am. Coll. Cardiol. 2006;47:473–84).

Although the document does not offer guidelines per se, it features a simple flowchart for the “diagnostic approach” to patients with syncope as well as comments on the role of various tests.

Its creation was driven by the recognition that syncope “can herald life-threatening diseases” and that “there are patients who are not managed appropriately,” said Dr. Strickberger, director of arrhythmia research and professor of medicine at Georgetown University, Washington. “We wanted a practical document.”

Most important, the statement says, the evaluation of syncope should include a front-line assessment for structural heart disease and ischemia. Less common causes that are associated with sudden death, including Wolff-Parkinson-White syndrome and inherited cardiac ion channel abnormalities, should be excluded early.

“The primary purpose of the evaluation … is to determine whether the patient is at increased risk for death,” the statement says.

In most patients, the cause of syncope can be determined “with great accuracy” from a careful history, physical exam, and ECG. Echocardiograms, exercise tests, and ischemic evaluations fall on the next tier.

The statement says that “an echocardiogram is a helpful screening test if the history, physical examination, and ECG do not provide a diagnosis or if underlying heart disease is suspected.”

“Most of the people on the writing group have a fairly low threshold for the echocardiogram and stress test, which may represent some shift (in thinking),” Dr. Strickberger said.

The statement includes a section on the elderly, mentioning that up to 30% of falls in this population may be due to syncope, and that orthostatic hypotension is the cause of falls in up to a third of elderly patients.

Carotid sinus hypersensitivity is an underrecognized cause of syncope in the elderly, the statement says, and “neurally mediated causes remain a frequent mechanism of syncope in the elderly and may be underestimated because of an atypical presentation.”

The statement futhermore states that “particular emphasis (in the elderly) should be given to the impact of polypharmacy, orthostatic intolerance, autonomic dysfunction, and carotid sinus hypersensitivity.”

The greatest challenges with syncope evaluation can lie with the patient, of any age, who has a normal general work-up and cardiac examination.

Here, Dr. Strickberger said, the key lies in determining the “malignancy” of the episode and adjusting the intensity of the evaluation accordingly.

Episodes that occur with little or no warning and that result in a significant injury may warrant other tests such as electrophysiologic testing—which has a low yield and is not routinely recommended—and the tilt table test, he said.

In general, though, the tilt table test provides little information, the statement says.

In patients with no evidence of ischemia and a structurally normal heart, “the pretest probability that the diagnosis is neurocardiogenic syncope is high, so heads-up tilt table testing contributes little to establishing the diagnosis,” according to the statement.

In a patient with an otherwise normal evaluation, the statement explains, “the most likely diagnosis” after a negative tilt table test “is still neurocardiogenic syncope.”

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A new scientific statement from the cardiology community on the evaluation of syncope could either win nods of acceptance or raise eyebrows with its support for echocardiograms and stress tests and its caution against tilt table testing.

The American Heart Association/American College of Cardiology Foundation Scientific Statement on the Evaluation of Syncope—the first such statement on syncope issued by the organizations—reiterates some well-established findings, chiefly that most cases of the often-vexing problem have a cardiovascular cause.

It emphasizes the importance of promptly ruling out structural heart disease and ischemia, as well as less common causes associated with sudden death.

The statement lays out a diminished role, however, for tilt table testing, saying that “serious questions about the sensitivity, specificity, diagnostic yield, and day-to-day reproducibility of tilt table testing exist.”

Tilt table testing has traditionally been used as an aid in establishing the diagnosis of neurocardiogenic syncope, and according to lead author Dr. S. Adam Strickberger, “Some … may feel the tilt table test was devalued” in the new statement.

“But in general, I think there are a lot fewer tilt table tests ordered by electrophysiologists today … and it's fair to say there is a smaller role for the tests than there would have been 10–15 years ago,” Dr. Strickberger said in an interview.

The 11-page statement, which the AHA and ACC Foundation issued in collaboration with the Heart Rhythm Society and which was endorsed by the American Autonomic Society, was published last month (J. Am. Coll. Cardiol. 2006;47:473–84).

Although the document does not offer guidelines per se, it features a simple flowchart for the “diagnostic approach” to patients with syncope as well as comments on the role of various tests.

Its creation was driven by the recognition that syncope “can herald life-threatening diseases” and that “there are patients who are not managed appropriately,” said Dr. Strickberger, director of arrhythmia research and professor of medicine at Georgetown University, Washington. “We wanted a practical document.”

Most important, the statement says, the evaluation of syncope should include a front-line assessment for structural heart disease and ischemia. Less common causes that are associated with sudden death, including Wolff-Parkinson-White syndrome and inherited cardiac ion channel abnormalities, should be excluded early.

“The primary purpose of the evaluation … is to determine whether the patient is at increased risk for death,” the statement says.

In most patients, the cause of syncope can be determined “with great accuracy” from a careful history, physical exam, and ECG. Echocardiograms, exercise tests, and ischemic evaluations fall on the next tier.

The statement says that “an echocardiogram is a helpful screening test if the history, physical examination, and ECG do not provide a diagnosis or if underlying heart disease is suspected.”

“Most of the people on the writing group have a fairly low threshold for the echocardiogram and stress test, which may represent some shift (in thinking),” Dr. Strickberger said.

The statement includes a section on the elderly, mentioning that up to 30% of falls in this population may be due to syncope, and that orthostatic hypotension is the cause of falls in up to a third of elderly patients.

Carotid sinus hypersensitivity is an underrecognized cause of syncope in the elderly, the statement says, and “neurally mediated causes remain a frequent mechanism of syncope in the elderly and may be underestimated because of an atypical presentation.”

The statement futhermore states that “particular emphasis (in the elderly) should be given to the impact of polypharmacy, orthostatic intolerance, autonomic dysfunction, and carotid sinus hypersensitivity.”

The greatest challenges with syncope evaluation can lie with the patient, of any age, who has a normal general work-up and cardiac examination.

Here, Dr. Strickberger said, the key lies in determining the “malignancy” of the episode and adjusting the intensity of the evaluation accordingly.

Episodes that occur with little or no warning and that result in a significant injury may warrant other tests such as electrophysiologic testing—which has a low yield and is not routinely recommended—and the tilt table test, he said.

In general, though, the tilt table test provides little information, the statement says.

In patients with no evidence of ischemia and a structurally normal heart, “the pretest probability that the diagnosis is neurocardiogenic syncope is high, so heads-up tilt table testing contributes little to establishing the diagnosis,” according to the statement.

In a patient with an otherwise normal evaluation, the statement explains, “the most likely diagnosis” after a negative tilt table test “is still neurocardiogenic syncope.”

A new scientific statement from the cardiology community on the evaluation of syncope could either win nods of acceptance or raise eyebrows with its support for echocardiograms and stress tests and its caution against tilt table testing.

The American Heart Association/American College of Cardiology Foundation Scientific Statement on the Evaluation of Syncope—the first such statement on syncope issued by the organizations—reiterates some well-established findings, chiefly that most cases of the often-vexing problem have a cardiovascular cause.

It emphasizes the importance of promptly ruling out structural heart disease and ischemia, as well as less common causes associated with sudden death.

The statement lays out a diminished role, however, for tilt table testing, saying that “serious questions about the sensitivity, specificity, diagnostic yield, and day-to-day reproducibility of tilt table testing exist.”

Tilt table testing has traditionally been used as an aid in establishing the diagnosis of neurocardiogenic syncope, and according to lead author Dr. S. Adam Strickberger, “Some … may feel the tilt table test was devalued” in the new statement.

“But in general, I think there are a lot fewer tilt table tests ordered by electrophysiologists today … and it's fair to say there is a smaller role for the tests than there would have been 10–15 years ago,” Dr. Strickberger said in an interview.

The 11-page statement, which the AHA and ACC Foundation issued in collaboration with the Heart Rhythm Society and which was endorsed by the American Autonomic Society, was published last month (J. Am. Coll. Cardiol. 2006;47:473–84).

Although the document does not offer guidelines per se, it features a simple flowchart for the “diagnostic approach” to patients with syncope as well as comments on the role of various tests.

Its creation was driven by the recognition that syncope “can herald life-threatening diseases” and that “there are patients who are not managed appropriately,” said Dr. Strickberger, director of arrhythmia research and professor of medicine at Georgetown University, Washington. “We wanted a practical document.”

Most important, the statement says, the evaluation of syncope should include a front-line assessment for structural heart disease and ischemia. Less common causes that are associated with sudden death, including Wolff-Parkinson-White syndrome and inherited cardiac ion channel abnormalities, should be excluded early.

“The primary purpose of the evaluation … is to determine whether the patient is at increased risk for death,” the statement says.

In most patients, the cause of syncope can be determined “with great accuracy” from a careful history, physical exam, and ECG. Echocardiograms, exercise tests, and ischemic evaluations fall on the next tier.

The statement says that “an echocardiogram is a helpful screening test if the history, physical examination, and ECG do not provide a diagnosis or if underlying heart disease is suspected.”

“Most of the people on the writing group have a fairly low threshold for the echocardiogram and stress test, which may represent some shift (in thinking),” Dr. Strickberger said.

The statement includes a section on the elderly, mentioning that up to 30% of falls in this population may be due to syncope, and that orthostatic hypotension is the cause of falls in up to a third of elderly patients.

Carotid sinus hypersensitivity is an underrecognized cause of syncope in the elderly, the statement says, and “neurally mediated causes remain a frequent mechanism of syncope in the elderly and may be underestimated because of an atypical presentation.”

The statement futhermore states that “particular emphasis (in the elderly) should be given to the impact of polypharmacy, orthostatic intolerance, autonomic dysfunction, and carotid sinus hypersensitivity.”

The greatest challenges with syncope evaluation can lie with the patient, of any age, who has a normal general work-up and cardiac examination.

Here, Dr. Strickberger said, the key lies in determining the “malignancy” of the episode and adjusting the intensity of the evaluation accordingly.

Episodes that occur with little or no warning and that result in a significant injury may warrant other tests such as electrophysiologic testing—which has a low yield and is not routinely recommended—and the tilt table test, he said.

In general, though, the tilt table test provides little information, the statement says.

In patients with no evidence of ischemia and a structurally normal heart, “the pretest probability that the diagnosis is neurocardiogenic syncope is high, so heads-up tilt table testing contributes little to establishing the diagnosis,” according to the statement.

In a patient with an otherwise normal evaluation, the statement explains, “the most likely diagnosis” after a negative tilt table test “is still neurocardiogenic syncope.”

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Parkinson's Mutant Gene Proving to Be Common

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Neurologists for the first time have reason to be optimistic about the potential usefulness of genetic testing for Parkinson's disease, following two reports that a specific mutation in the LRRK2 gene is relatively common in patients with Parkinson's disease, according to Dr. Zbigniew Wszolek, professor of neurology at the Mayo Clinic in Jacksonville, Fla.

Specifically, the LRRK2 G2019S mutation occurs in 13%–41% of cases in North African Arab and Ashkenazi Jewish patients, according to the two reports. Dr. Wszolek cautioned that uncertainties about the precise penetrance of the mutation mean that “the counseling [for asymptomatic patients] needs to be cautious.”

LRRK2 (leucine-rich repeat kinase 2) is the most recent gene to be implicated in Parkinson's disease, and the G2019S mutation is the first genetic mutation that appears to be relatively common. The mutation has been linked with autosomal dominant forms of Parkinson's disease.

Reports published in the past year or so on patients primarily of European ancestry—including three reports published last year (CLINICAL NEUROLOGY NEWS, March 2005, p. 24)—have shown that the G2019S mutation explained up to 2% of cases of sporadic Parkinson's and 5%–7% of familial cases. The latest reports, which were published as letters to the editor in the New England Journal of Medicine, described a much higher frequency of the G2019S mutation among North African Arabs and Ashkenazi Jews.

Researchers at the Beth Israel Medical Center, New York, detected the G2019S mutation in 22 of 120 (18%) Ashkenazi Jewish patients with Parkinson's disease and only 4 of 317 (1%) Ashkenazi Jewish patients without the disease.

When there was a familial pattern, 30% (11 of 37 patients) carried the mutation. In the absence of a family history, 13% (11 of 83) had the mutation, reported Laurie J. Ozelius, Ph.D., of Albert Einstein College of Medicine, New York, and associates (N. Engl. J. Med. 2006;354:424–5).

In the other letter, Suzanne Lesage, Ph.D., and colleagues from the French Parkinson's Disease Genetics Study Group described how they looked for the G2019S mutation in 104 North African Arabs with Parkinson's disease and 151 healthy Arab controls, and found the frequency to be 37% in familial cases and, “more unexpectedly,” 41% in sporadic cases (N. Engl. J. Med. 2006;354:422–3).

Matthew Farrer, Ph.D., of the Morris K. Udall Parkinson's Disease Research Center of Excellence at the Mayo Clinic in Jacksonville, cautioned against putting too much weight on such “convenience sample” reports because they are based on patients who present to the clinic and fall short in terms of epidemiologic rigor. That said, the reports are receiving growing appreciation among experts for showing an interesting pattern of frequency of the mutation in idiopathic or sporadic cases of Parkinson's disease, he said. Frequencies are low in Northern Europe and North America (1%–3%), are higher in Southern Europe (about 10% in southern Spain, for example), and explode in North Africa (as high as 41%).

Moreover, the mutation is associated with the same haplotype in different populations, which indicates the existence of a common ancestor.

More research needs to be done on the precise penetrance of the mutation for testing and counseling to be more meaningful. Penetrance in carriers at this point is known to be age dependent, increasing from approximately 20% at age 50 to 90% at age 80 and up, Dr. Wszolek said.

Overall, “we can educate as much as we can on the current status of the gene. But the management of the disease doesn't change,” Dr. Wszolek said. “We can tell patients that the disease related to this gene is generally well-managed, and the medications are well tolerated.” A test for the mutation is not yet commercially available.

The clinical phenotype of both homozygous and heterozygous carriers of the G2019S mutation (clusters of homozygotes have been identified) largely mirrors that of typical late-onset, levodopa-responsive, idiopathic Parkinson's disease, Dr. Farrer said. Still, the phenotype varies, even within families, he said.

The most striking variability, though, concerns the neuropathologic features of the disease, he said.

Most cases of LRRK2 Parkinsonism show the Lewy body disease that is consistent with a postmortem definitive diagnosis of Parkinson's disease. Some cases have tau-positive neurofibrillary tangles without Lewy bodies. Such multiple pathologic expressions have occurred within families as well.

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Neurologists for the first time have reason to be optimistic about the potential usefulness of genetic testing for Parkinson's disease, following two reports that a specific mutation in the LRRK2 gene is relatively common in patients with Parkinson's disease, according to Dr. Zbigniew Wszolek, professor of neurology at the Mayo Clinic in Jacksonville, Fla.

Specifically, the LRRK2 G2019S mutation occurs in 13%–41% of cases in North African Arab and Ashkenazi Jewish patients, according to the two reports. Dr. Wszolek cautioned that uncertainties about the precise penetrance of the mutation mean that “the counseling [for asymptomatic patients] needs to be cautious.”

LRRK2 (leucine-rich repeat kinase 2) is the most recent gene to be implicated in Parkinson's disease, and the G2019S mutation is the first genetic mutation that appears to be relatively common. The mutation has been linked with autosomal dominant forms of Parkinson's disease.

Reports published in the past year or so on patients primarily of European ancestry—including three reports published last year (CLINICAL NEUROLOGY NEWS, March 2005, p. 24)—have shown that the G2019S mutation explained up to 2% of cases of sporadic Parkinson's and 5%–7% of familial cases. The latest reports, which were published as letters to the editor in the New England Journal of Medicine, described a much higher frequency of the G2019S mutation among North African Arabs and Ashkenazi Jews.

Researchers at the Beth Israel Medical Center, New York, detected the G2019S mutation in 22 of 120 (18%) Ashkenazi Jewish patients with Parkinson's disease and only 4 of 317 (1%) Ashkenazi Jewish patients without the disease.

When there was a familial pattern, 30% (11 of 37 patients) carried the mutation. In the absence of a family history, 13% (11 of 83) had the mutation, reported Laurie J. Ozelius, Ph.D., of Albert Einstein College of Medicine, New York, and associates (N. Engl. J. Med. 2006;354:424–5).

In the other letter, Suzanne Lesage, Ph.D., and colleagues from the French Parkinson's Disease Genetics Study Group described how they looked for the G2019S mutation in 104 North African Arabs with Parkinson's disease and 151 healthy Arab controls, and found the frequency to be 37% in familial cases and, “more unexpectedly,” 41% in sporadic cases (N. Engl. J. Med. 2006;354:422–3).

Matthew Farrer, Ph.D., of the Morris K. Udall Parkinson's Disease Research Center of Excellence at the Mayo Clinic in Jacksonville, cautioned against putting too much weight on such “convenience sample” reports because they are based on patients who present to the clinic and fall short in terms of epidemiologic rigor. That said, the reports are receiving growing appreciation among experts for showing an interesting pattern of frequency of the mutation in idiopathic or sporadic cases of Parkinson's disease, he said. Frequencies are low in Northern Europe and North America (1%–3%), are higher in Southern Europe (about 10% in southern Spain, for example), and explode in North Africa (as high as 41%).

Moreover, the mutation is associated with the same haplotype in different populations, which indicates the existence of a common ancestor.

More research needs to be done on the precise penetrance of the mutation for testing and counseling to be more meaningful. Penetrance in carriers at this point is known to be age dependent, increasing from approximately 20% at age 50 to 90% at age 80 and up, Dr. Wszolek said.

Overall, “we can educate as much as we can on the current status of the gene. But the management of the disease doesn't change,” Dr. Wszolek said. “We can tell patients that the disease related to this gene is generally well-managed, and the medications are well tolerated.” A test for the mutation is not yet commercially available.

The clinical phenotype of both homozygous and heterozygous carriers of the G2019S mutation (clusters of homozygotes have been identified) largely mirrors that of typical late-onset, levodopa-responsive, idiopathic Parkinson's disease, Dr. Farrer said. Still, the phenotype varies, even within families, he said.

The most striking variability, though, concerns the neuropathologic features of the disease, he said.

Most cases of LRRK2 Parkinsonism show the Lewy body disease that is consistent with a postmortem definitive diagnosis of Parkinson's disease. Some cases have tau-positive neurofibrillary tangles without Lewy bodies. Such multiple pathologic expressions have occurred within families as well.

Neurologists for the first time have reason to be optimistic about the potential usefulness of genetic testing for Parkinson's disease, following two reports that a specific mutation in the LRRK2 gene is relatively common in patients with Parkinson's disease, according to Dr. Zbigniew Wszolek, professor of neurology at the Mayo Clinic in Jacksonville, Fla.

Specifically, the LRRK2 G2019S mutation occurs in 13%–41% of cases in North African Arab and Ashkenazi Jewish patients, according to the two reports. Dr. Wszolek cautioned that uncertainties about the precise penetrance of the mutation mean that “the counseling [for asymptomatic patients] needs to be cautious.”

LRRK2 (leucine-rich repeat kinase 2) is the most recent gene to be implicated in Parkinson's disease, and the G2019S mutation is the first genetic mutation that appears to be relatively common. The mutation has been linked with autosomal dominant forms of Parkinson's disease.

Reports published in the past year or so on patients primarily of European ancestry—including three reports published last year (CLINICAL NEUROLOGY NEWS, March 2005, p. 24)—have shown that the G2019S mutation explained up to 2% of cases of sporadic Parkinson's and 5%–7% of familial cases. The latest reports, which were published as letters to the editor in the New England Journal of Medicine, described a much higher frequency of the G2019S mutation among North African Arabs and Ashkenazi Jews.

Researchers at the Beth Israel Medical Center, New York, detected the G2019S mutation in 22 of 120 (18%) Ashkenazi Jewish patients with Parkinson's disease and only 4 of 317 (1%) Ashkenazi Jewish patients without the disease.

When there was a familial pattern, 30% (11 of 37 patients) carried the mutation. In the absence of a family history, 13% (11 of 83) had the mutation, reported Laurie J. Ozelius, Ph.D., of Albert Einstein College of Medicine, New York, and associates (N. Engl. J. Med. 2006;354:424–5).

In the other letter, Suzanne Lesage, Ph.D., and colleagues from the French Parkinson's Disease Genetics Study Group described how they looked for the G2019S mutation in 104 North African Arabs with Parkinson's disease and 151 healthy Arab controls, and found the frequency to be 37% in familial cases and, “more unexpectedly,” 41% in sporadic cases (N. Engl. J. Med. 2006;354:422–3).

Matthew Farrer, Ph.D., of the Morris K. Udall Parkinson's Disease Research Center of Excellence at the Mayo Clinic in Jacksonville, cautioned against putting too much weight on such “convenience sample” reports because they are based on patients who present to the clinic and fall short in terms of epidemiologic rigor. That said, the reports are receiving growing appreciation among experts for showing an interesting pattern of frequency of the mutation in idiopathic or sporadic cases of Parkinson's disease, he said. Frequencies are low in Northern Europe and North America (1%–3%), are higher in Southern Europe (about 10% in southern Spain, for example), and explode in North Africa (as high as 41%).

Moreover, the mutation is associated with the same haplotype in different populations, which indicates the existence of a common ancestor.

More research needs to be done on the precise penetrance of the mutation for testing and counseling to be more meaningful. Penetrance in carriers at this point is known to be age dependent, increasing from approximately 20% at age 50 to 90% at age 80 and up, Dr. Wszolek said.

Overall, “we can educate as much as we can on the current status of the gene. But the management of the disease doesn't change,” Dr. Wszolek said. “We can tell patients that the disease related to this gene is generally well-managed, and the medications are well tolerated.” A test for the mutation is not yet commercially available.

The clinical phenotype of both homozygous and heterozygous carriers of the G2019S mutation (clusters of homozygotes have been identified) largely mirrors that of typical late-onset, levodopa-responsive, idiopathic Parkinson's disease, Dr. Farrer said. Still, the phenotype varies, even within families, he said.

The most striking variability, though, concerns the neuropathologic features of the disease, he said.

Most cases of LRRK2 Parkinsonism show the Lewy body disease that is consistent with a postmortem definitive diagnosis of Parkinson's disease. Some cases have tau-positive neurofibrillary tangles without Lewy bodies. Such multiple pathologic expressions have occurred within families as well.

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FDA Approves Fetal Heart Monitor; ACOG Balks

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A fetal heart monitor that provides an analysis of the fetal ECG during labor has won Food and Drug Administration approval almost 4 years after it was originally rejected for use in the United States.

The American College of Obstetricians and Gynecologists is standing firm, however, in its refusal to endorse the STAN S31 fetal heart monitoring system “until it's proved efficacious” in everyday clinical use.

The device, which is used in 22 countries, is now labeled for use in the United States as an adjunct to standard electronic fetal monitoring (EFM) for determining “whether obstetric intervention is warranted when there is increased risk of developing metabolic acidosis.” Physicians who use the device, the labeling says, must be certified and credentialed in its use.

The new system monitors the fetal ECG and heart rate via a scalp electrode, automatically identifying and analyzing T-wave and ST-segment changes, which reflect myocardial ability to respond to hypoxia. When the STAN system was first reviewed in 2002, members of the FDA's Obstetrics and Gynecology Devices Panel agreed that findings from a randomized Swedish trial of almost 5,000 women in labor demonstrated its safety and effectiveness.

Among women who were monitored with both the STAN monitor and conventional monitoring, as opposed to conventional monitoring alone, metabolic acidosis was reduced by 54%, and operative deliveries for nonreassuring fetal heart rate were reduced by 19%. Moderate and severe neonatal encephalopathy were also significantly reduced.

The panel recommended nonapproval, however, citing concern about differences between Sweden and the United States in labor management and medical terminology. The FDA asked the manufacturer to conduct bridging studies to show that U.S. clinicians could learn the STAN system.

Last June, satisfied with the results of the two bridging studies, the panel unanimously recommended approval. Panelists voiced hope that the device could decrease its false-positive rate and thus reduce the rate of unnecessary cesarean sections. But at the same time they expressed concern that it could do the opposite and increase the cesarean section rate.

Dr. Gary D.V. Hankins, who chairs ACOG's Committee on Obstetric Practice, said he and others on the committee share this concern. For ACOG to endorse use of the device, it has to know “if it does indeed prevent injury without inordinately increasing operative delivery” once it is used in U.S. institutions. “Other technologies that were going to 'get rid of the neurologically impaired baby' haven't delivered on their promises,” said Dr. Hankins of the University of Texas, Galveston. “It's a responsible position to be conservative and not endorse any technology until it's proved efficacious—that is, it provides something that's worth the cost.”

Dr. Julia Carey-Corrado, the FDA's clinical reviewer of the device application, said the FDA is requiring the manufacturer to submit annual reports that address a specified list of adverse events, including rates of perinatal death, neonatal encephalopathy, acidemia, and acidosis; the rate of device malfunction; the number of monitors sold; the number of institutions using the monitors; the proportion of patients monitored with STAN as opposed to standard EFM; and the number of physicians credentialed.

“The reports [will provide for] a more systematic, intense review” than normally occurs through the FDA's standard adverse event reporting requirements, Dr. Carey-Corrado said.

“The approval is unique in that we have been very explicit [in our conditions],” she said. “And having a denominator [on the extent of the device's use] will allow us to interpret the significance of outcomes.”

The FDA will not, however, require the manufacturer to submit data on operative delivery rates, which is something its advisory panel recommended in June.

According to Colin Pollard, chief of the FDA's ob.gyn. devices branch, the agency decided not to require collection of these data, largely because it felt the issue of operative delivery rates had been addressed in the pivotal study.

In the pivotal Swedish randomized trial, the rate of operative delivery decreased significantly with the use of the STAN system. The rate of cesarean section for fetal distress was not significantly lower when all enrollees were included (the intent-to-treat analysis), but it was significantly lower when only those with adequate recordings were included.

Under the FDA's requirement for training, clinicians must be certified based on a written test and credentialed based on an oral exam that is administered after successful completion of at least five “practice cases,” according to Dr. Carey-Corrado.

Physician certification is something the FDA's advisory panel called for in June, and the FDA deliberately structured its training requirement to resemble the training that was required of clinicians in the U.S. bridging studies, she said.

 

 

Dr. Hankins questioned how such a requirement could be enforced and said that training is ultimately “under local purview.” When asked about enforcement, the FDA's Mr. Pollard acknowledged the validity of the question and said that the agency's authority “does not extend beyond the labeling.”

The STAN S31 system is indicated for use in patients with planned vaginal delivery, greater than 36 weeks of gestation, a singleton fetus, vertex presentation, and ruptured amniotic membranes. Simon Grant, CEO of Neoventa, the monitor's Swedish manufacturer, said the company intends to partner with a U.S. company to introduce the device to the U.S. market this year.

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A fetal heart monitor that provides an analysis of the fetal ECG during labor has won Food and Drug Administration approval almost 4 years after it was originally rejected for use in the United States.

The American College of Obstetricians and Gynecologists is standing firm, however, in its refusal to endorse the STAN S31 fetal heart monitoring system “until it's proved efficacious” in everyday clinical use.

The device, which is used in 22 countries, is now labeled for use in the United States as an adjunct to standard electronic fetal monitoring (EFM) for determining “whether obstetric intervention is warranted when there is increased risk of developing metabolic acidosis.” Physicians who use the device, the labeling says, must be certified and credentialed in its use.

The new system monitors the fetal ECG and heart rate via a scalp electrode, automatically identifying and analyzing T-wave and ST-segment changes, which reflect myocardial ability to respond to hypoxia. When the STAN system was first reviewed in 2002, members of the FDA's Obstetrics and Gynecology Devices Panel agreed that findings from a randomized Swedish trial of almost 5,000 women in labor demonstrated its safety and effectiveness.

Among women who were monitored with both the STAN monitor and conventional monitoring, as opposed to conventional monitoring alone, metabolic acidosis was reduced by 54%, and operative deliveries for nonreassuring fetal heart rate were reduced by 19%. Moderate and severe neonatal encephalopathy were also significantly reduced.

The panel recommended nonapproval, however, citing concern about differences between Sweden and the United States in labor management and medical terminology. The FDA asked the manufacturer to conduct bridging studies to show that U.S. clinicians could learn the STAN system.

Last June, satisfied with the results of the two bridging studies, the panel unanimously recommended approval. Panelists voiced hope that the device could decrease its false-positive rate and thus reduce the rate of unnecessary cesarean sections. But at the same time they expressed concern that it could do the opposite and increase the cesarean section rate.

Dr. Gary D.V. Hankins, who chairs ACOG's Committee on Obstetric Practice, said he and others on the committee share this concern. For ACOG to endorse use of the device, it has to know “if it does indeed prevent injury without inordinately increasing operative delivery” once it is used in U.S. institutions. “Other technologies that were going to 'get rid of the neurologically impaired baby' haven't delivered on their promises,” said Dr. Hankins of the University of Texas, Galveston. “It's a responsible position to be conservative and not endorse any technology until it's proved efficacious—that is, it provides something that's worth the cost.”

Dr. Julia Carey-Corrado, the FDA's clinical reviewer of the device application, said the FDA is requiring the manufacturer to submit annual reports that address a specified list of adverse events, including rates of perinatal death, neonatal encephalopathy, acidemia, and acidosis; the rate of device malfunction; the number of monitors sold; the number of institutions using the monitors; the proportion of patients monitored with STAN as opposed to standard EFM; and the number of physicians credentialed.

“The reports [will provide for] a more systematic, intense review” than normally occurs through the FDA's standard adverse event reporting requirements, Dr. Carey-Corrado said.

“The approval is unique in that we have been very explicit [in our conditions],” she said. “And having a denominator [on the extent of the device's use] will allow us to interpret the significance of outcomes.”

The FDA will not, however, require the manufacturer to submit data on operative delivery rates, which is something its advisory panel recommended in June.

According to Colin Pollard, chief of the FDA's ob.gyn. devices branch, the agency decided not to require collection of these data, largely because it felt the issue of operative delivery rates had been addressed in the pivotal study.

In the pivotal Swedish randomized trial, the rate of operative delivery decreased significantly with the use of the STAN system. The rate of cesarean section for fetal distress was not significantly lower when all enrollees were included (the intent-to-treat analysis), but it was significantly lower when only those with adequate recordings were included.

Under the FDA's requirement for training, clinicians must be certified based on a written test and credentialed based on an oral exam that is administered after successful completion of at least five “practice cases,” according to Dr. Carey-Corrado.

Physician certification is something the FDA's advisory panel called for in June, and the FDA deliberately structured its training requirement to resemble the training that was required of clinicians in the U.S. bridging studies, she said.

 

 

Dr. Hankins questioned how such a requirement could be enforced and said that training is ultimately “under local purview.” When asked about enforcement, the FDA's Mr. Pollard acknowledged the validity of the question and said that the agency's authority “does not extend beyond the labeling.”

The STAN S31 system is indicated for use in patients with planned vaginal delivery, greater than 36 weeks of gestation, a singleton fetus, vertex presentation, and ruptured amniotic membranes. Simon Grant, CEO of Neoventa, the monitor's Swedish manufacturer, said the company intends to partner with a U.S. company to introduce the device to the U.S. market this year.

A fetal heart monitor that provides an analysis of the fetal ECG during labor has won Food and Drug Administration approval almost 4 years after it was originally rejected for use in the United States.

The American College of Obstetricians and Gynecologists is standing firm, however, in its refusal to endorse the STAN S31 fetal heart monitoring system “until it's proved efficacious” in everyday clinical use.

The device, which is used in 22 countries, is now labeled for use in the United States as an adjunct to standard electronic fetal monitoring (EFM) for determining “whether obstetric intervention is warranted when there is increased risk of developing metabolic acidosis.” Physicians who use the device, the labeling says, must be certified and credentialed in its use.

The new system monitors the fetal ECG and heart rate via a scalp electrode, automatically identifying and analyzing T-wave and ST-segment changes, which reflect myocardial ability to respond to hypoxia. When the STAN system was first reviewed in 2002, members of the FDA's Obstetrics and Gynecology Devices Panel agreed that findings from a randomized Swedish trial of almost 5,000 women in labor demonstrated its safety and effectiveness.

Among women who were monitored with both the STAN monitor and conventional monitoring, as opposed to conventional monitoring alone, metabolic acidosis was reduced by 54%, and operative deliveries for nonreassuring fetal heart rate were reduced by 19%. Moderate and severe neonatal encephalopathy were also significantly reduced.

The panel recommended nonapproval, however, citing concern about differences between Sweden and the United States in labor management and medical terminology. The FDA asked the manufacturer to conduct bridging studies to show that U.S. clinicians could learn the STAN system.

Last June, satisfied with the results of the two bridging studies, the panel unanimously recommended approval. Panelists voiced hope that the device could decrease its false-positive rate and thus reduce the rate of unnecessary cesarean sections. But at the same time they expressed concern that it could do the opposite and increase the cesarean section rate.

Dr. Gary D.V. Hankins, who chairs ACOG's Committee on Obstetric Practice, said he and others on the committee share this concern. For ACOG to endorse use of the device, it has to know “if it does indeed prevent injury without inordinately increasing operative delivery” once it is used in U.S. institutions. “Other technologies that were going to 'get rid of the neurologically impaired baby' haven't delivered on their promises,” said Dr. Hankins of the University of Texas, Galveston. “It's a responsible position to be conservative and not endorse any technology until it's proved efficacious—that is, it provides something that's worth the cost.”

Dr. Julia Carey-Corrado, the FDA's clinical reviewer of the device application, said the FDA is requiring the manufacturer to submit annual reports that address a specified list of adverse events, including rates of perinatal death, neonatal encephalopathy, acidemia, and acidosis; the rate of device malfunction; the number of monitors sold; the number of institutions using the monitors; the proportion of patients monitored with STAN as opposed to standard EFM; and the number of physicians credentialed.

“The reports [will provide for] a more systematic, intense review” than normally occurs through the FDA's standard adverse event reporting requirements, Dr. Carey-Corrado said.

“The approval is unique in that we have been very explicit [in our conditions],” she said. “And having a denominator [on the extent of the device's use] will allow us to interpret the significance of outcomes.”

The FDA will not, however, require the manufacturer to submit data on operative delivery rates, which is something its advisory panel recommended in June.

According to Colin Pollard, chief of the FDA's ob.gyn. devices branch, the agency decided not to require collection of these data, largely because it felt the issue of operative delivery rates had been addressed in the pivotal study.

In the pivotal Swedish randomized trial, the rate of operative delivery decreased significantly with the use of the STAN system. The rate of cesarean section for fetal distress was not significantly lower when all enrollees were included (the intent-to-treat analysis), but it was significantly lower when only those with adequate recordings were included.

Under the FDA's requirement for training, clinicians must be certified based on a written test and credentialed based on an oral exam that is administered after successful completion of at least five “practice cases,” according to Dr. Carey-Corrado.

Physician certification is something the FDA's advisory panel called for in June, and the FDA deliberately structured its training requirement to resemble the training that was required of clinicians in the U.S. bridging studies, she said.

 

 

Dr. Hankins questioned how such a requirement could be enforced and said that training is ultimately “under local purview.” When asked about enforcement, the FDA's Mr. Pollard acknowledged the validity of the question and said that the agency's authority “does not extend beyond the labeling.”

The STAN S31 system is indicated for use in patients with planned vaginal delivery, greater than 36 weeks of gestation, a singleton fetus, vertex presentation, and ruptured amniotic membranes. Simon Grant, CEO of Neoventa, the monitor's Swedish manufacturer, said the company intends to partner with a U.S. company to introduce the device to the U.S. market this year.

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Success of Electronic Medical Records Varies With Cardiology Practice Size

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WASHINGTON — The introduction of a customized electronic medical record system in a multisite practice of heart specialists enhanced efficiency and the quality of care that the patients received, said Dr. Vince Bufalino in a presentation at the Heart IT Summit.

Dr. Bufalino, who came to the summit from the 55-physician multisite Midwest Heart Specialists practice in suburban Chicago, reported on a host of improved outcomes that the practice has documented since it developed an electronic medical record (EMR) system in 1997.

He detailed improvements in the numbers of patients achieving LDL-cholesterol goals, significant increases in the numbers of coronary artery disease and heart failure patients taking recommended drugs, and more. He also said his practice's customized EMR system “has made us more efficient” and “it practices the way we practice.”

The summit, which was sponsored by the American Heart Association, American Stroke Association, the Agency for Healthcare Research and Quality in coordination with the Office of the National Coordinator for Health Information Technology, was devised to “develop a road map” for using IT to improve the quality of care for patients with cardiovascular disease and stroke. Each organization went home with a list of potential strategies developed by break-out groups focusing on clinical practice, research, and patients.

However, Robert Miller, Ph.D., who reported on electronic happenings in solo and small group practices, said that of 14 primary care practices he and his associates studied, only 2 had extensively used their electronic medical record systems to improve chronic and preventive care.

Dr. Miller, of the University of California at San Francisco, said that practice support services and performance incentives that are tied to quality improvement are “musts” for increasing the “value for all” of EMRs in smaller practices.

Overall, the physicians in his study saw a mean revenue gain from EMRs of $33,000 per full-time provider per year after an average “pay-back time” of 2.5 years. Almost all of that gain came from increased coding levels and efficiency-related gains—results that are a good value for many practices but not for payers or even patients, he said.

The differences between the large IT leaders and the small- to medium-sized practices that are attempting to build electronic systems—or still rejecting them—were the cruxes of the summit.

“We all know the quality benefits of the EMR” from the larger practices, “but how do we actually roll it out on a larger scale?” said Dr. Rose Marie Robertson, chief science officer of the American Heart Association.

The problem is that little is known about how off-the-shelf systems work in everyday practice and about what nontechnical factors—such as organizational factors—are needed to sustain electronic systems, she and other physicians at the meeting said.

The physicians recommended developing interoperable systems, standardized clinical no-menclature and decision support tools, fiscal and nonfiscal incentives for using EMRs, and sharing best practices.

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WASHINGTON — The introduction of a customized electronic medical record system in a multisite practice of heart specialists enhanced efficiency and the quality of care that the patients received, said Dr. Vince Bufalino in a presentation at the Heart IT Summit.

Dr. Bufalino, who came to the summit from the 55-physician multisite Midwest Heart Specialists practice in suburban Chicago, reported on a host of improved outcomes that the practice has documented since it developed an electronic medical record (EMR) system in 1997.

He detailed improvements in the numbers of patients achieving LDL-cholesterol goals, significant increases in the numbers of coronary artery disease and heart failure patients taking recommended drugs, and more. He also said his practice's customized EMR system “has made us more efficient” and “it practices the way we practice.”

The summit, which was sponsored by the American Heart Association, American Stroke Association, the Agency for Healthcare Research and Quality in coordination with the Office of the National Coordinator for Health Information Technology, was devised to “develop a road map” for using IT to improve the quality of care for patients with cardiovascular disease and stroke. Each organization went home with a list of potential strategies developed by break-out groups focusing on clinical practice, research, and patients.

However, Robert Miller, Ph.D., who reported on electronic happenings in solo and small group practices, said that of 14 primary care practices he and his associates studied, only 2 had extensively used their electronic medical record systems to improve chronic and preventive care.

Dr. Miller, of the University of California at San Francisco, said that practice support services and performance incentives that are tied to quality improvement are “musts” for increasing the “value for all” of EMRs in smaller practices.

Overall, the physicians in his study saw a mean revenue gain from EMRs of $33,000 per full-time provider per year after an average “pay-back time” of 2.5 years. Almost all of that gain came from increased coding levels and efficiency-related gains—results that are a good value for many practices but not for payers or even patients, he said.

The differences between the large IT leaders and the small- to medium-sized practices that are attempting to build electronic systems—or still rejecting them—were the cruxes of the summit.

“We all know the quality benefits of the EMR” from the larger practices, “but how do we actually roll it out on a larger scale?” said Dr. Rose Marie Robertson, chief science officer of the American Heart Association.

The problem is that little is known about how off-the-shelf systems work in everyday practice and about what nontechnical factors—such as organizational factors—are needed to sustain electronic systems, she and other physicians at the meeting said.

The physicians recommended developing interoperable systems, standardized clinical no-menclature and decision support tools, fiscal and nonfiscal incentives for using EMRs, and sharing best practices.

WASHINGTON — The introduction of a customized electronic medical record system in a multisite practice of heart specialists enhanced efficiency and the quality of care that the patients received, said Dr. Vince Bufalino in a presentation at the Heart IT Summit.

Dr. Bufalino, who came to the summit from the 55-physician multisite Midwest Heart Specialists practice in suburban Chicago, reported on a host of improved outcomes that the practice has documented since it developed an electronic medical record (EMR) system in 1997.

He detailed improvements in the numbers of patients achieving LDL-cholesterol goals, significant increases in the numbers of coronary artery disease and heart failure patients taking recommended drugs, and more. He also said his practice's customized EMR system “has made us more efficient” and “it practices the way we practice.”

The summit, which was sponsored by the American Heart Association, American Stroke Association, the Agency for Healthcare Research and Quality in coordination with the Office of the National Coordinator for Health Information Technology, was devised to “develop a road map” for using IT to improve the quality of care for patients with cardiovascular disease and stroke. Each organization went home with a list of potential strategies developed by break-out groups focusing on clinical practice, research, and patients.

However, Robert Miller, Ph.D., who reported on electronic happenings in solo and small group practices, said that of 14 primary care practices he and his associates studied, only 2 had extensively used their electronic medical record systems to improve chronic and preventive care.

Dr. Miller, of the University of California at San Francisco, said that practice support services and performance incentives that are tied to quality improvement are “musts” for increasing the “value for all” of EMRs in smaller practices.

Overall, the physicians in his study saw a mean revenue gain from EMRs of $33,000 per full-time provider per year after an average “pay-back time” of 2.5 years. Almost all of that gain came from increased coding levels and efficiency-related gains—results that are a good value for many practices but not for payers or even patients, he said.

The differences between the large IT leaders and the small- to medium-sized practices that are attempting to build electronic systems—or still rejecting them—were the cruxes of the summit.

“We all know the quality benefits of the EMR” from the larger practices, “but how do we actually roll it out on a larger scale?” said Dr. Rose Marie Robertson, chief science officer of the American Heart Association.

The problem is that little is known about how off-the-shelf systems work in everyday practice and about what nontechnical factors—such as organizational factors—are needed to sustain electronic systems, she and other physicians at the meeting said.

The physicians recommended developing interoperable systems, standardized clinical no-menclature and decision support tools, fiscal and nonfiscal incentives for using EMRs, and sharing best practices.

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EMR Success Varies With Size of Cardiology Practice

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WASHINGTON — The introduction of a customized electronic medical record system in a multisite practice of heart specialists enhanced efficiency and the quality of care that the patients received, said Dr. Vince Bufalino in a presentation at the Heart IT Summit.

Dr. Bufalino, who came to the summit from the 55-physician multisite Midwest Heart Specialists practice in suburban Chicago, reported on a host of improved outcomes that the practice has documented since it developed an electronic medical record (EMR) system in 1997.

He detailed improvements in the numbers of patients achieving LDL cholesterol goals and the numbers of coronary artery disease and heart failure patients taking recommended drugs, and more. In addition, he said, the customized EMR system “has made us more efficient” and “it practices the way we practice.”

The summit, sponsored by the American Heart Association, American Stroke Association, the Agency for Healthcare Research and Quality in coordination with the Office of the National Coordinator for Health Information Technology, was devised to “develop a road map” for using IT to improve the quality of care for patients with cardiovascular disease and stroke. Each organization went home with a list of potential strategies developed by break-out groups focusing on clinical practice, research, and patients.

However, Robert Miller, Ph.D., who reported on electronic happenings in solo and small group practices, said of the 14 primary care practices he and his associates studied, only 2 had extensively used their electronic medical record systems to improve chronic and preventive care.

Dr. Miller, of the University of California, San Francisco, said practice support services and performance incentives that are tied to quality improvement are “musts” for increasing the “value for all” of EMRs in smaller practices. Overall, the physicians in his study saw substantial revenue gains from EMRs: an average of $33,000 per full-time provider per year after an average “pay-back time” of 2.5 years. Almost all of that gain came from increased coding levels and efficiency-related gains—results that are a good value for many practices but “not a good value for payers” or even patients, he said.

The differences between the large IT leaders and the small- to medium-sized practices that are attempting to build electronic systems—or still rejecting them—were the cruxes of the summit.

“We all know the quality benefits of the EMR” from the larger practices, “But how do we actually roll it out on a larger scale?” said Dr. Rose Marie Robertson, chief science officer of the American Heart Association. The problem is that little is known about how off-the-shelf systems are working in everyday practice and about what nontechnical factors, such as organizational and human factors, are necessary to sustain electronic systems, she and other physicians at the meeting said.

Suggested strategies included improving and standardizing decision support tools, developing fiscal and nonfiscal incentives for using EMRs, sharing best practices, and collaborating on developing standardized clinical nomenclature and interoperable systems.

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WASHINGTON — The introduction of a customized electronic medical record system in a multisite practice of heart specialists enhanced efficiency and the quality of care that the patients received, said Dr. Vince Bufalino in a presentation at the Heart IT Summit.

Dr. Bufalino, who came to the summit from the 55-physician multisite Midwest Heart Specialists practice in suburban Chicago, reported on a host of improved outcomes that the practice has documented since it developed an electronic medical record (EMR) system in 1997.

He detailed improvements in the numbers of patients achieving LDL cholesterol goals and the numbers of coronary artery disease and heart failure patients taking recommended drugs, and more. In addition, he said, the customized EMR system “has made us more efficient” and “it practices the way we practice.”

The summit, sponsored by the American Heart Association, American Stroke Association, the Agency for Healthcare Research and Quality in coordination with the Office of the National Coordinator for Health Information Technology, was devised to “develop a road map” for using IT to improve the quality of care for patients with cardiovascular disease and stroke. Each organization went home with a list of potential strategies developed by break-out groups focusing on clinical practice, research, and patients.

However, Robert Miller, Ph.D., who reported on electronic happenings in solo and small group practices, said of the 14 primary care practices he and his associates studied, only 2 had extensively used their electronic medical record systems to improve chronic and preventive care.

Dr. Miller, of the University of California, San Francisco, said practice support services and performance incentives that are tied to quality improvement are “musts” for increasing the “value for all” of EMRs in smaller practices. Overall, the physicians in his study saw substantial revenue gains from EMRs: an average of $33,000 per full-time provider per year after an average “pay-back time” of 2.5 years. Almost all of that gain came from increased coding levels and efficiency-related gains—results that are a good value for many practices but “not a good value for payers” or even patients, he said.

The differences between the large IT leaders and the small- to medium-sized practices that are attempting to build electronic systems—or still rejecting them—were the cruxes of the summit.

“We all know the quality benefits of the EMR” from the larger practices, “But how do we actually roll it out on a larger scale?” said Dr. Rose Marie Robertson, chief science officer of the American Heart Association. The problem is that little is known about how off-the-shelf systems are working in everyday practice and about what nontechnical factors, such as organizational and human factors, are necessary to sustain electronic systems, she and other physicians at the meeting said.

Suggested strategies included improving and standardizing decision support tools, developing fiscal and nonfiscal incentives for using EMRs, sharing best practices, and collaborating on developing standardized clinical nomenclature and interoperable systems.

WASHINGTON — The introduction of a customized electronic medical record system in a multisite practice of heart specialists enhanced efficiency and the quality of care that the patients received, said Dr. Vince Bufalino in a presentation at the Heart IT Summit.

Dr. Bufalino, who came to the summit from the 55-physician multisite Midwest Heart Specialists practice in suburban Chicago, reported on a host of improved outcomes that the practice has documented since it developed an electronic medical record (EMR) system in 1997.

He detailed improvements in the numbers of patients achieving LDL cholesterol goals and the numbers of coronary artery disease and heart failure patients taking recommended drugs, and more. In addition, he said, the customized EMR system “has made us more efficient” and “it practices the way we practice.”

The summit, sponsored by the American Heart Association, American Stroke Association, the Agency for Healthcare Research and Quality in coordination with the Office of the National Coordinator for Health Information Technology, was devised to “develop a road map” for using IT to improve the quality of care for patients with cardiovascular disease and stroke. Each organization went home with a list of potential strategies developed by break-out groups focusing on clinical practice, research, and patients.

However, Robert Miller, Ph.D., who reported on electronic happenings in solo and small group practices, said of the 14 primary care practices he and his associates studied, only 2 had extensively used their electronic medical record systems to improve chronic and preventive care.

Dr. Miller, of the University of California, San Francisco, said practice support services and performance incentives that are tied to quality improvement are “musts” for increasing the “value for all” of EMRs in smaller practices. Overall, the physicians in his study saw substantial revenue gains from EMRs: an average of $33,000 per full-time provider per year after an average “pay-back time” of 2.5 years. Almost all of that gain came from increased coding levels and efficiency-related gains—results that are a good value for many practices but “not a good value for payers” or even patients, he said.

The differences between the large IT leaders and the small- to medium-sized practices that are attempting to build electronic systems—or still rejecting them—were the cruxes of the summit.

“We all know the quality benefits of the EMR” from the larger practices, “But how do we actually roll it out on a larger scale?” said Dr. Rose Marie Robertson, chief science officer of the American Heart Association. The problem is that little is known about how off-the-shelf systems are working in everyday practice and about what nontechnical factors, such as organizational and human factors, are necessary to sustain electronic systems, she and other physicians at the meeting said.

Suggested strategies included improving and standardizing decision support tools, developing fiscal and nonfiscal incentives for using EMRs, sharing best practices, and collaborating on developing standardized clinical nomenclature and interoperable systems.

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Limited Mobility Impairs More Than One in Four Adult Diabetics

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Limited Mobility Impairs More Than One in Four Adult Diabetics

Adults with diagnosed diabetes were significantly more likely to have limited mobility than were those without the disease (27% vs. 16%), according to preliminary findings from an analysis of data from the National Health and Nutrition Examination Survey, 1999–2002.

Adults with lower extremity disease (LED) faced similarly increased risks: Twenty-six percent of those with the disease had mobility limitation, compared with 15% of those without LED, the Centers for Disease Control and Prevention reported.

LED was defined as the presence of peripheral arterial disease, peripheral neuropathy, a self-report of foot/leg ulcers, or a technician-observed toe or foot lesion or amputation.

The prevalence of limited mobility among adults with both diagnosed diabetes and LED was greater than that among adults with only one of the conditions, and almost three times greater—39%—than the prevalence among adults with neither condition.

The risk of limited mobility in patients with diagnosed diabetes or LED was “additive overall,” with “no statistically significant interaction between diabetes status and LED status,” the investigators reported (MMWR 2005:54;1183–6).

The findings likely underestimate the prevalence of mobility limitation because almost a quarter of patients who participated in the survey were excluded from the study due to missing data. Such patients were older and more likely to have diagnosed diabetes, the investigators noted.

Patients with limited mobility most frequently reported that their limitations were related to an inability to walk a quarter mile or up 10 steps without resting.

Among those with both diabetes and LED, 33% reported such difficulties. Significantly fewer—6%—said they had difficulty walking from one room to another on the same level (the most severe form of mobility limitation analyzed).

“As the U.S. population ages and the prevalence of diabetes increases, LED and its health consequences, including chronic ulcers in feet or legs, amputations, and mobility limitations, will become increasing public health concerns,” the CDC researchers said.

The analysis covered approximately 4,700 noninstitutionalized adults aged 40 and over who participated in the National Health and Nutrition Examination Survey, an ongoing, cross-sectional survey in which data are collected through in-person interviews and medical examinations. (Approximately 6,000 adults participated, but more than 1,300 were excluded from the analysis.)

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Adults with diagnosed diabetes were significantly more likely to have limited mobility than were those without the disease (27% vs. 16%), according to preliminary findings from an analysis of data from the National Health and Nutrition Examination Survey, 1999–2002.

Adults with lower extremity disease (LED) faced similarly increased risks: Twenty-six percent of those with the disease had mobility limitation, compared with 15% of those without LED, the Centers for Disease Control and Prevention reported.

LED was defined as the presence of peripheral arterial disease, peripheral neuropathy, a self-report of foot/leg ulcers, or a technician-observed toe or foot lesion or amputation.

The prevalence of limited mobility among adults with both diagnosed diabetes and LED was greater than that among adults with only one of the conditions, and almost three times greater—39%—than the prevalence among adults with neither condition.

The risk of limited mobility in patients with diagnosed diabetes or LED was “additive overall,” with “no statistically significant interaction between diabetes status and LED status,” the investigators reported (MMWR 2005:54;1183–6).

The findings likely underestimate the prevalence of mobility limitation because almost a quarter of patients who participated in the survey were excluded from the study due to missing data. Such patients were older and more likely to have diagnosed diabetes, the investigators noted.

Patients with limited mobility most frequently reported that their limitations were related to an inability to walk a quarter mile or up 10 steps without resting.

Among those with both diabetes and LED, 33% reported such difficulties. Significantly fewer—6%—said they had difficulty walking from one room to another on the same level (the most severe form of mobility limitation analyzed).

“As the U.S. population ages and the prevalence of diabetes increases, LED and its health consequences, including chronic ulcers in feet or legs, amputations, and mobility limitations, will become increasing public health concerns,” the CDC researchers said.

The analysis covered approximately 4,700 noninstitutionalized adults aged 40 and over who participated in the National Health and Nutrition Examination Survey, an ongoing, cross-sectional survey in which data are collected through in-person interviews and medical examinations. (Approximately 6,000 adults participated, but more than 1,300 were excluded from the analysis.)

Adults with diagnosed diabetes were significantly more likely to have limited mobility than were those without the disease (27% vs. 16%), according to preliminary findings from an analysis of data from the National Health and Nutrition Examination Survey, 1999–2002.

Adults with lower extremity disease (LED) faced similarly increased risks: Twenty-six percent of those with the disease had mobility limitation, compared with 15% of those without LED, the Centers for Disease Control and Prevention reported.

LED was defined as the presence of peripheral arterial disease, peripheral neuropathy, a self-report of foot/leg ulcers, or a technician-observed toe or foot lesion or amputation.

The prevalence of limited mobility among adults with both diagnosed diabetes and LED was greater than that among adults with only one of the conditions, and almost three times greater—39%—than the prevalence among adults with neither condition.

The risk of limited mobility in patients with diagnosed diabetes or LED was “additive overall,” with “no statistically significant interaction between diabetes status and LED status,” the investigators reported (MMWR 2005:54;1183–6).

The findings likely underestimate the prevalence of mobility limitation because almost a quarter of patients who participated in the survey were excluded from the study due to missing data. Such patients were older and more likely to have diagnosed diabetes, the investigators noted.

Patients with limited mobility most frequently reported that their limitations were related to an inability to walk a quarter mile or up 10 steps without resting.

Among those with both diabetes and LED, 33% reported such difficulties. Significantly fewer—6%—said they had difficulty walking from one room to another on the same level (the most severe form of mobility limitation analyzed).

“As the U.S. population ages and the prevalence of diabetes increases, LED and its health consequences, including chronic ulcers in feet or legs, amputations, and mobility limitations, will become increasing public health concerns,” the CDC researchers said.

The analysis covered approximately 4,700 noninstitutionalized adults aged 40 and over who participated in the National Health and Nutrition Examination Survey, an ongoing, cross-sectional survey in which data are collected through in-person interviews and medical examinations. (Approximately 6,000 adults participated, but more than 1,300 were excluded from the analysis.)

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Dental Care for Diabetics Falls Short in Most States

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Most states have not yet reached national targets set for dental health care in patients with diabetes, or have not made significant improvements in the past 5 years—a finding that “underscore(s) the need to increase awareness and support for oral health care among adults with diabetes,” according to the Centers for Disease Control and Prevention.

Only seven states thus far have reached the national health objective for 2010 of increasing to at least 71% the proportion of people with diabetes who have annual dental examinations. And only four states and the District of Columbia made significant improvements between 1999 and 2004 (MMWR 2005:54:1181–3).

Adults with diabetes have both a higher prevalence of periodontal disease and more severe forms of the disease. And periodontal disease has been associated with development of glucose intolerance and poor glycemic control among adults with diabetes, the CDCsaid.

The CDC analyzed data from the state-based telephone surveys that were conducted in 1999 and 2004 as part of the Behavioral Risk Factor Surveillance System.

Participants in the telephone survey were asked how long it had been since they last visited a dentist or a dental clinic for any reason.

The participants who identified themselves as dentate and diabetic and who provided information about their dental visit history—approximately 21,000 respondents—were included in the data analysis.

Nationally, a median of 67% reported in the 2004 survey that they had a dental visit during the preceding 12 months—up just 1% from 66% in 1999.

Age-adjusted estimates for 2004 exceeded 71% in Kansas, Minnesota, Nebraska, Pennsylvania, Rhode Island, Utah, and Wisconsin. Significant increases over 1999 were seen in Arizona, the District of Columbia, Kansas, Minnesota, and Ohio.

The District of Columbia made the biggest strides, increasing its estimated percentage of dental patients to 71% in 2004 from just 37%—the lowest percentage in any state—in 1999.

Diabetes education programs should emphasize dental care for all people with the disease, “with emphasis on non-Hispanic blacks, persons with lower education and income, and those who lack health insurance,” the CDC stated. These groups were least likely to report dental visits.

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Most states have not yet reached national targets set for dental health care in patients with diabetes, or have not made significant improvements in the past 5 years—a finding that “underscore(s) the need to increase awareness and support for oral health care among adults with diabetes,” according to the Centers for Disease Control and Prevention.

Only seven states thus far have reached the national health objective for 2010 of increasing to at least 71% the proportion of people with diabetes who have annual dental examinations. And only four states and the District of Columbia made significant improvements between 1999 and 2004 (MMWR 2005:54:1181–3).

Adults with diabetes have both a higher prevalence of periodontal disease and more severe forms of the disease. And periodontal disease has been associated with development of glucose intolerance and poor glycemic control among adults with diabetes, the CDCsaid.

The CDC analyzed data from the state-based telephone surveys that were conducted in 1999 and 2004 as part of the Behavioral Risk Factor Surveillance System.

Participants in the telephone survey were asked how long it had been since they last visited a dentist or a dental clinic for any reason.

The participants who identified themselves as dentate and diabetic and who provided information about their dental visit history—approximately 21,000 respondents—were included in the data analysis.

Nationally, a median of 67% reported in the 2004 survey that they had a dental visit during the preceding 12 months—up just 1% from 66% in 1999.

Age-adjusted estimates for 2004 exceeded 71% in Kansas, Minnesota, Nebraska, Pennsylvania, Rhode Island, Utah, and Wisconsin. Significant increases over 1999 were seen in Arizona, the District of Columbia, Kansas, Minnesota, and Ohio.

The District of Columbia made the biggest strides, increasing its estimated percentage of dental patients to 71% in 2004 from just 37%—the lowest percentage in any state—in 1999.

Diabetes education programs should emphasize dental care for all people with the disease, “with emphasis on non-Hispanic blacks, persons with lower education and income, and those who lack health insurance,” the CDC stated. These groups were least likely to report dental visits.

Most states have not yet reached national targets set for dental health care in patients with diabetes, or have not made significant improvements in the past 5 years—a finding that “underscore(s) the need to increase awareness and support for oral health care among adults with diabetes,” according to the Centers for Disease Control and Prevention.

Only seven states thus far have reached the national health objective for 2010 of increasing to at least 71% the proportion of people with diabetes who have annual dental examinations. And only four states and the District of Columbia made significant improvements between 1999 and 2004 (MMWR 2005:54:1181–3).

Adults with diabetes have both a higher prevalence of periodontal disease and more severe forms of the disease. And periodontal disease has been associated with development of glucose intolerance and poor glycemic control among adults with diabetes, the CDCsaid.

The CDC analyzed data from the state-based telephone surveys that were conducted in 1999 and 2004 as part of the Behavioral Risk Factor Surveillance System.

Participants in the telephone survey were asked how long it had been since they last visited a dentist or a dental clinic for any reason.

The participants who identified themselves as dentate and diabetic and who provided information about their dental visit history—approximately 21,000 respondents—were included in the data analysis.

Nationally, a median of 67% reported in the 2004 survey that they had a dental visit during the preceding 12 months—up just 1% from 66% in 1999.

Age-adjusted estimates for 2004 exceeded 71% in Kansas, Minnesota, Nebraska, Pennsylvania, Rhode Island, Utah, and Wisconsin. Significant increases over 1999 were seen in Arizona, the District of Columbia, Kansas, Minnesota, and Ohio.

The District of Columbia made the biggest strides, increasing its estimated percentage of dental patients to 71% in 2004 from just 37%—the lowest percentage in any state—in 1999.

Diabetes education programs should emphasize dental care for all people with the disease, “with emphasis on non-Hispanic blacks, persons with lower education and income, and those who lack health insurance,” the CDC stated. These groups were least likely to report dental visits.

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Neuroimaging Sorts Out Eclampsialike Conditions

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Neuroradiologic studies can provide valuable diagnostic information in women who present during pregnancy or the puerperium with apparent eclampsia or similar neurologic manifestations, British investigators have reported.

A host of less common neurologic conditions and manifestations may mimic or resemble eclampsia and, because signs and symptoms are often nonspecific, it can be difficult to differentiate these conditions “on clinical grounds alone,” they said in a recently published pictorial review.

“Neuroimaging in a clearly defined case of eclampsia may not be necessary but, if there is focal neurology or deterioration in neurological status, imaging should be performed,” said Dr. R. Dineen of the department of neuroradiology at Queen's Medical Centre in Nottingham, England, and his associates.

Without it, the diagnosis of various conditions—from intracranial hemorrhage and other cerebrovascular conditions, to intracranial tumors and various pituitary and metabolic conditions—may be delayed as women are mistakenly treated for eclampsia, they said.

In women with true eclampsia, the most frequent abnormality detected on cranial MRI is high-signal change on T2-weighted and FLAIR images. Lesions are commonly seen in both deep and subcortical white matter, often with a posterior circulation distribution, and within the basal ganglia.

Lesions also occur within the pons and brainstem, and correspond to low-attenuation areas on CT scanning.

The majority of lesions are reversible but some may progress to infarction, the investigators said.

Several “overlap syndromes”—postpartum cerebral angiopathy, hypertensive encephalopathy, and reversible posterior leukoencephalopathy syndrome—may show neuroimaging features that are similar to or indistinguishable from those of eclampsia, the authors said (Clin. Radiol. 2005;60:1156–70).

Neuroimaging features are more distinct with other neurologic emergencies, such as the cerebrovascular disorders that can occur in pregnancy or the puerperal period: arterial ischemia and infarction, intracranial hemorrhage, venoocclusive disease, and vasculitis.

The mainstay for investigating ruptured intracranial aneurysms—the most common cause of subarachnoid hemorrhage and a cause of intracerebral hemorrhage—is CT with either CT angiography or conventional angiography. Magnetic resonance angiography, however, can be used to assess aneurysms without the need for ionizing radiation or contrast media.

Just as the risk of ruptured intracranial aneurysms increases for women who are pregnant or in the puerperal period, compared with nonpregnant women, the risk of intracranial venoocclusive disease is particularly increased around the puerperal period. Intracranial venoocclusive disease also can occur in women with pre-eclampsia.

Women with the condition present with headache, confusion, decreased consciousness level, papilledema, sei-zures, and often, focal deficits.

CT scanning shows hyperdensity in the venous sinuses, cortical veins, or deep cerebral veins. When venous infarction develops, areas of low attenuation are seen.

Patterns of venous infarction on MRI “do not conform to the contours expected from an arterial occlusion,” the investigators noted.

T2-weighted images show high-signal change involving the white matter with absent flow void in the related cortical vein or dural venous sinus.

Precautions should be taken to limit fetal exposure to ionizing radiation, however, “fetal exposure to ionizing radiation from CT of the maternal head is extremely low, and the risk to the fetus is likely to be considerably less than the risk to both the fetus and mother from an acute neurological condition,” the investigators wrote in their report.

An internal carotid catheter angiogram shows a giant intracavernous aneurysm at the underside of the C4 segment. ©Elsevier, Clinical Radiology, Vol. 60, R. Dineen, “Imaging of acute neurological conditions in pregnancy and puerperium,” 1156 - 1170, 2005. Reprinted with permission from The Royal College of Radiologists

A CT scan shows hemorrhagic venous infarction in the left temporal lobe.

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Neuroradiologic studies can provide valuable diagnostic information in women who present during pregnancy or the puerperium with apparent eclampsia or similar neurologic manifestations, British investigators have reported.

A host of less common neurologic conditions and manifestations may mimic or resemble eclampsia and, because signs and symptoms are often nonspecific, it can be difficult to differentiate these conditions “on clinical grounds alone,” they said in a recently published pictorial review.

“Neuroimaging in a clearly defined case of eclampsia may not be necessary but, if there is focal neurology or deterioration in neurological status, imaging should be performed,” said Dr. R. Dineen of the department of neuroradiology at Queen's Medical Centre in Nottingham, England, and his associates.

Without it, the diagnosis of various conditions—from intracranial hemorrhage and other cerebrovascular conditions, to intracranial tumors and various pituitary and metabolic conditions—may be delayed as women are mistakenly treated for eclampsia, they said.

In women with true eclampsia, the most frequent abnormality detected on cranial MRI is high-signal change on T2-weighted and FLAIR images. Lesions are commonly seen in both deep and subcortical white matter, often with a posterior circulation distribution, and within the basal ganglia.

Lesions also occur within the pons and brainstem, and correspond to low-attenuation areas on CT scanning.

The majority of lesions are reversible but some may progress to infarction, the investigators said.

Several “overlap syndromes”—postpartum cerebral angiopathy, hypertensive encephalopathy, and reversible posterior leukoencephalopathy syndrome—may show neuroimaging features that are similar to or indistinguishable from those of eclampsia, the authors said (Clin. Radiol. 2005;60:1156–70).

Neuroimaging features are more distinct with other neurologic emergencies, such as the cerebrovascular disorders that can occur in pregnancy or the puerperal period: arterial ischemia and infarction, intracranial hemorrhage, venoocclusive disease, and vasculitis.

The mainstay for investigating ruptured intracranial aneurysms—the most common cause of subarachnoid hemorrhage and a cause of intracerebral hemorrhage—is CT with either CT angiography or conventional angiography. Magnetic resonance angiography, however, can be used to assess aneurysms without the need for ionizing radiation or contrast media.

Just as the risk of ruptured intracranial aneurysms increases for women who are pregnant or in the puerperal period, compared with nonpregnant women, the risk of intracranial venoocclusive disease is particularly increased around the puerperal period. Intracranial venoocclusive disease also can occur in women with pre-eclampsia.

Women with the condition present with headache, confusion, decreased consciousness level, papilledema, sei-zures, and often, focal deficits.

CT scanning shows hyperdensity in the venous sinuses, cortical veins, or deep cerebral veins. When venous infarction develops, areas of low attenuation are seen.

Patterns of venous infarction on MRI “do not conform to the contours expected from an arterial occlusion,” the investigators noted.

T2-weighted images show high-signal change involving the white matter with absent flow void in the related cortical vein or dural venous sinus.

Precautions should be taken to limit fetal exposure to ionizing radiation, however, “fetal exposure to ionizing radiation from CT of the maternal head is extremely low, and the risk to the fetus is likely to be considerably less than the risk to both the fetus and mother from an acute neurological condition,” the investigators wrote in their report.

An internal carotid catheter angiogram shows a giant intracavernous aneurysm at the underside of the C4 segment. ©Elsevier, Clinical Radiology, Vol. 60, R. Dineen, “Imaging of acute neurological conditions in pregnancy and puerperium,” 1156 - 1170, 2005. Reprinted with permission from The Royal College of Radiologists

A CT scan shows hemorrhagic venous infarction in the left temporal lobe.

Neuroradiologic studies can provide valuable diagnostic information in women who present during pregnancy or the puerperium with apparent eclampsia or similar neurologic manifestations, British investigators have reported.

A host of less common neurologic conditions and manifestations may mimic or resemble eclampsia and, because signs and symptoms are often nonspecific, it can be difficult to differentiate these conditions “on clinical grounds alone,” they said in a recently published pictorial review.

“Neuroimaging in a clearly defined case of eclampsia may not be necessary but, if there is focal neurology or deterioration in neurological status, imaging should be performed,” said Dr. R. Dineen of the department of neuroradiology at Queen's Medical Centre in Nottingham, England, and his associates.

Without it, the diagnosis of various conditions—from intracranial hemorrhage and other cerebrovascular conditions, to intracranial tumors and various pituitary and metabolic conditions—may be delayed as women are mistakenly treated for eclampsia, they said.

In women with true eclampsia, the most frequent abnormality detected on cranial MRI is high-signal change on T2-weighted and FLAIR images. Lesions are commonly seen in both deep and subcortical white matter, often with a posterior circulation distribution, and within the basal ganglia.

Lesions also occur within the pons and brainstem, and correspond to low-attenuation areas on CT scanning.

The majority of lesions are reversible but some may progress to infarction, the investigators said.

Several “overlap syndromes”—postpartum cerebral angiopathy, hypertensive encephalopathy, and reversible posterior leukoencephalopathy syndrome—may show neuroimaging features that are similar to or indistinguishable from those of eclampsia, the authors said (Clin. Radiol. 2005;60:1156–70).

Neuroimaging features are more distinct with other neurologic emergencies, such as the cerebrovascular disorders that can occur in pregnancy or the puerperal period: arterial ischemia and infarction, intracranial hemorrhage, venoocclusive disease, and vasculitis.

The mainstay for investigating ruptured intracranial aneurysms—the most common cause of subarachnoid hemorrhage and a cause of intracerebral hemorrhage—is CT with either CT angiography or conventional angiography. Magnetic resonance angiography, however, can be used to assess aneurysms without the need for ionizing radiation or contrast media.

Just as the risk of ruptured intracranial aneurysms increases for women who are pregnant or in the puerperal period, compared with nonpregnant women, the risk of intracranial venoocclusive disease is particularly increased around the puerperal period. Intracranial venoocclusive disease also can occur in women with pre-eclampsia.

Women with the condition present with headache, confusion, decreased consciousness level, papilledema, sei-zures, and often, focal deficits.

CT scanning shows hyperdensity in the venous sinuses, cortical veins, or deep cerebral veins. When venous infarction develops, areas of low attenuation are seen.

Patterns of venous infarction on MRI “do not conform to the contours expected from an arterial occlusion,” the investigators noted.

T2-weighted images show high-signal change involving the white matter with absent flow void in the related cortical vein or dural venous sinus.

Precautions should be taken to limit fetal exposure to ionizing radiation, however, “fetal exposure to ionizing radiation from CT of the maternal head is extremely low, and the risk to the fetus is likely to be considerably less than the risk to both the fetus and mother from an acute neurological condition,” the investigators wrote in their report.

An internal carotid catheter angiogram shows a giant intracavernous aneurysm at the underside of the C4 segment. ©Elsevier, Clinical Radiology, Vol. 60, R. Dineen, “Imaging of acute neurological conditions in pregnancy and puerperium,” 1156 - 1170, 2005. Reprinted with permission from The Royal College of Radiologists

A CT scan shows hemorrhagic venous infarction in the left temporal lobe.

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Neuroimaging Sorts Out Eclampsia-Like Conditions

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Neuroradiologic studies can provide valuable diagnostic information in women who present during pregnancy or the puerperium with apparent eclampsia or similar neurologic manifestations, British investigators have reported.

A host of less common neurologic conditions and manifestations may mimic or resemble eclampsia and, because signs and symptoms are often nonspecific, it can be difficult to differentiate these conditions “on clinical grounds alone,” they said in a recently published pictorial review.

“Neuroimaging in a clearly defined case of eclampsia may not be necessary but, if there is focal neurology or deterioration in neurological status, imaging should be performed,” said Dr. R. Dineen of the department of neuroradiology at Queen's Medical Centre in Nottingham, England, and his associates.

Without it, the diagnosis of various conditions—from intracranial hemorrhage and other cerebrovascular conditions, to intracranial tumors and various pituitary and metabolic conditions—may be delayed as women are mistakenly treated for eclampsia, they said.

In women with true eclampsia, the most frequent abnormality detected on cranial MRI is high-signal change on T2-weighted and FLAIR images. Lesions are commonly seen in both deep and subcortical white matter, often with a posterior circulation distribution, and within the basal ganglia.

Lesions also occur within the pons and brainstem, and correspond to low-attenuation areas on CT scanning. The majority of lesions are reversible but some may progress to infarction, they said.

Several “overlap syndromes”—postpartum cerebral angiopathy, hypertensive encephalopathy, and reversible posterior leukoencephalopathy syndrome—may show neuroimaging features that are similar to or indistinguishable from those of eclampsia, they said (Clin. Radiol. 2005;60:1156-70).

Neuroimaging features are more distinct with other neurologic emergencies, such as the cerebrovascular disorders that can occur in pregnancy or the puerperal period: arterial ischemia and infarction, intracranial hemorrhage, venoocclusive disease, and vasculitis.

The mainstay for investigating ruptured intracranial aneurysms—the most common cause of subarachnoid hemorrhage and a cause of intracerebral hemorrhage—is CT with either CT angiography or conventional angiography. Magnetic resonance angiography, however, can be used to assess aneurysms without the need for ionizing radiation or contrast media.

Just as the risk of ruptured intracranial aneurysms increases for women who are pregnant or in the puerperal period, compared with nonpregnant women, the risk of intracranial venoocclusive disease is particularly increased around the puerperal period. Intracranial venoocclusive disease also can occur in women with preeclampsia.

Women with the condition present with headache, confusion, decreased consciousness level, papilledema, seizures, and often, focal deficits.

CT scanning shows hyperdensity in the venous sinuses, cortical veins, or deep cerebral veins. When venous infarction develops, areas of low attenuation are seen. Patterns of venous infarction on MRI “do not conform to the contours expected from an arterial occlusion,” the investigators note. T2-weighted images show high-signal change involving the white matter with absent flow void in the related cortical vein or dural venous sinus.

Precautions should be taken to limit fetal exposure to ionizing radiation, but “fetal exposure to ionizing radiation from CT of the maternal head is extremely low, and the risk to the fetus is likely to be considerably less than the risk to both the fetus and mother from an acute neurological condition,” the investigators reported.

An internal carotid catheter angiogram shows a giant intracavernous aneurysm at the underside of the C4 segment.

A CT shows high density in the left transverse sinus and hemorrhagic venous infarction in the left temporal lobe. ©Elsevier, Clinical Radiology, Vol. 60, R. Dineen, “Imaging of acute neurological conditions in pregnancy and puerperium,” 1156 - 1170, 2005, Reprinted with permission from The Royal College of Radiologists

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Neuroradiologic studies can provide valuable diagnostic information in women who present during pregnancy or the puerperium with apparent eclampsia or similar neurologic manifestations, British investigators have reported.

A host of less common neurologic conditions and manifestations may mimic or resemble eclampsia and, because signs and symptoms are often nonspecific, it can be difficult to differentiate these conditions “on clinical grounds alone,” they said in a recently published pictorial review.

“Neuroimaging in a clearly defined case of eclampsia may not be necessary but, if there is focal neurology or deterioration in neurological status, imaging should be performed,” said Dr. R. Dineen of the department of neuroradiology at Queen's Medical Centre in Nottingham, England, and his associates.

Without it, the diagnosis of various conditions—from intracranial hemorrhage and other cerebrovascular conditions, to intracranial tumors and various pituitary and metabolic conditions—may be delayed as women are mistakenly treated for eclampsia, they said.

In women with true eclampsia, the most frequent abnormality detected on cranial MRI is high-signal change on T2-weighted and FLAIR images. Lesions are commonly seen in both deep and subcortical white matter, often with a posterior circulation distribution, and within the basal ganglia.

Lesions also occur within the pons and brainstem, and correspond to low-attenuation areas on CT scanning. The majority of lesions are reversible but some may progress to infarction, they said.

Several “overlap syndromes”—postpartum cerebral angiopathy, hypertensive encephalopathy, and reversible posterior leukoencephalopathy syndrome—may show neuroimaging features that are similar to or indistinguishable from those of eclampsia, they said (Clin. Radiol. 2005;60:1156-70).

Neuroimaging features are more distinct with other neurologic emergencies, such as the cerebrovascular disorders that can occur in pregnancy or the puerperal period: arterial ischemia and infarction, intracranial hemorrhage, venoocclusive disease, and vasculitis.

The mainstay for investigating ruptured intracranial aneurysms—the most common cause of subarachnoid hemorrhage and a cause of intracerebral hemorrhage—is CT with either CT angiography or conventional angiography. Magnetic resonance angiography, however, can be used to assess aneurysms without the need for ionizing radiation or contrast media.

Just as the risk of ruptured intracranial aneurysms increases for women who are pregnant or in the puerperal period, compared with nonpregnant women, the risk of intracranial venoocclusive disease is particularly increased around the puerperal period. Intracranial venoocclusive disease also can occur in women with preeclampsia.

Women with the condition present with headache, confusion, decreased consciousness level, papilledema, seizures, and often, focal deficits.

CT scanning shows hyperdensity in the venous sinuses, cortical veins, or deep cerebral veins. When venous infarction develops, areas of low attenuation are seen. Patterns of venous infarction on MRI “do not conform to the contours expected from an arterial occlusion,” the investigators note. T2-weighted images show high-signal change involving the white matter with absent flow void in the related cortical vein or dural venous sinus.

Precautions should be taken to limit fetal exposure to ionizing radiation, but “fetal exposure to ionizing radiation from CT of the maternal head is extremely low, and the risk to the fetus is likely to be considerably less than the risk to both the fetus and mother from an acute neurological condition,” the investigators reported.

An internal carotid catheter angiogram shows a giant intracavernous aneurysm at the underside of the C4 segment.

A CT shows high density in the left transverse sinus and hemorrhagic venous infarction in the left temporal lobe. ©Elsevier, Clinical Radiology, Vol. 60, R. Dineen, “Imaging of acute neurological conditions in pregnancy and puerperium,” 1156 - 1170, 2005, Reprinted with permission from The Royal College of Radiologists

Neuroradiologic studies can provide valuable diagnostic information in women who present during pregnancy or the puerperium with apparent eclampsia or similar neurologic manifestations, British investigators have reported.

A host of less common neurologic conditions and manifestations may mimic or resemble eclampsia and, because signs and symptoms are often nonspecific, it can be difficult to differentiate these conditions “on clinical grounds alone,” they said in a recently published pictorial review.

“Neuroimaging in a clearly defined case of eclampsia may not be necessary but, if there is focal neurology or deterioration in neurological status, imaging should be performed,” said Dr. R. Dineen of the department of neuroradiology at Queen's Medical Centre in Nottingham, England, and his associates.

Without it, the diagnosis of various conditions—from intracranial hemorrhage and other cerebrovascular conditions, to intracranial tumors and various pituitary and metabolic conditions—may be delayed as women are mistakenly treated for eclampsia, they said.

In women with true eclampsia, the most frequent abnormality detected on cranial MRI is high-signal change on T2-weighted and FLAIR images. Lesions are commonly seen in both deep and subcortical white matter, often with a posterior circulation distribution, and within the basal ganglia.

Lesions also occur within the pons and brainstem, and correspond to low-attenuation areas on CT scanning. The majority of lesions are reversible but some may progress to infarction, they said.

Several “overlap syndromes”—postpartum cerebral angiopathy, hypertensive encephalopathy, and reversible posterior leukoencephalopathy syndrome—may show neuroimaging features that are similar to or indistinguishable from those of eclampsia, they said (Clin. Radiol. 2005;60:1156-70).

Neuroimaging features are more distinct with other neurologic emergencies, such as the cerebrovascular disorders that can occur in pregnancy or the puerperal period: arterial ischemia and infarction, intracranial hemorrhage, venoocclusive disease, and vasculitis.

The mainstay for investigating ruptured intracranial aneurysms—the most common cause of subarachnoid hemorrhage and a cause of intracerebral hemorrhage—is CT with either CT angiography or conventional angiography. Magnetic resonance angiography, however, can be used to assess aneurysms without the need for ionizing radiation or contrast media.

Just as the risk of ruptured intracranial aneurysms increases for women who are pregnant or in the puerperal period, compared with nonpregnant women, the risk of intracranial venoocclusive disease is particularly increased around the puerperal period. Intracranial venoocclusive disease also can occur in women with preeclampsia.

Women with the condition present with headache, confusion, decreased consciousness level, papilledema, seizures, and often, focal deficits.

CT scanning shows hyperdensity in the venous sinuses, cortical veins, or deep cerebral veins. When venous infarction develops, areas of low attenuation are seen. Patterns of venous infarction on MRI “do not conform to the contours expected from an arterial occlusion,” the investigators note. T2-weighted images show high-signal change involving the white matter with absent flow void in the related cortical vein or dural venous sinus.

Precautions should be taken to limit fetal exposure to ionizing radiation, but “fetal exposure to ionizing radiation from CT of the maternal head is extremely low, and the risk to the fetus is likely to be considerably less than the risk to both the fetus and mother from an acute neurological condition,” the investigators reported.

An internal carotid catheter angiogram shows a giant intracavernous aneurysm at the underside of the C4 segment.

A CT shows high density in the left transverse sinus and hemorrhagic venous infarction in the left temporal lobe. ©Elsevier, Clinical Radiology, Vol. 60, R. Dineen, “Imaging of acute neurological conditions in pregnancy and puerperium,” 1156 - 1170, 2005, Reprinted with permission from The Royal College of Radiologists

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Statins to Prevent Melanoma? No Clear Answer Yet

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The jury is still out, but for now there is no clear evidence that statins or fibrates can decrease the risk of melanoma, according to a new review of studies conducted by The Cochrane Collaboration.

Investigators for the international organization, which conducts systematic reviews and issues evidence-based conclusions about medical practice, identified 16 qualifying randomized controlled trials (7 on statins, 9 on fibrates), 13 of which provided data on incident melanomas. Investigators also requested unpublished melanoma outcomes data from study authors.

There were 66 reported melanomas in patients receiving the experimental drug and 86 in patients receiving placebo and other control therapies in the trials, which included more than 62,000 patients, according to the Cochrane review.

The outcomes data “[do] not exclude the possibility that these drugs prevent melanoma,” since there was a 10% and 42% reduction in melanoma for patients taking statins and fibrates, respectively, the investigators say in the review, which was led by Dr. Robert Dellavalle of Denver Veterans Affairs Medical Center.

The results were not statistically significant, however, and trials of cancer and statins should continue in order to further address suggestions raised by case-control, in vitro, and animal model studies.

The trials included in the review all involved random allocation of study participants, the use of statins or fibrates in isolation in the studies' experimental groups, and the administration of therapy for at least 4 years.

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The jury is still out, but for now there is no clear evidence that statins or fibrates can decrease the risk of melanoma, according to a new review of studies conducted by The Cochrane Collaboration.

Investigators for the international organization, which conducts systematic reviews and issues evidence-based conclusions about medical practice, identified 16 qualifying randomized controlled trials (7 on statins, 9 on fibrates), 13 of which provided data on incident melanomas. Investigators also requested unpublished melanoma outcomes data from study authors.

There were 66 reported melanomas in patients receiving the experimental drug and 86 in patients receiving placebo and other control therapies in the trials, which included more than 62,000 patients, according to the Cochrane review.

The outcomes data “[do] not exclude the possibility that these drugs prevent melanoma,” since there was a 10% and 42% reduction in melanoma for patients taking statins and fibrates, respectively, the investigators say in the review, which was led by Dr. Robert Dellavalle of Denver Veterans Affairs Medical Center.

The results were not statistically significant, however, and trials of cancer and statins should continue in order to further address suggestions raised by case-control, in vitro, and animal model studies.

The trials included in the review all involved random allocation of study participants, the use of statins or fibrates in isolation in the studies' experimental groups, and the administration of therapy for at least 4 years.

The jury is still out, but for now there is no clear evidence that statins or fibrates can decrease the risk of melanoma, according to a new review of studies conducted by The Cochrane Collaboration.

Investigators for the international organization, which conducts systematic reviews and issues evidence-based conclusions about medical practice, identified 16 qualifying randomized controlled trials (7 on statins, 9 on fibrates), 13 of which provided data on incident melanomas. Investigators also requested unpublished melanoma outcomes data from study authors.

There were 66 reported melanomas in patients receiving the experimental drug and 86 in patients receiving placebo and other control therapies in the trials, which included more than 62,000 patients, according to the Cochrane review.

The outcomes data “[do] not exclude the possibility that these drugs prevent melanoma,” since there was a 10% and 42% reduction in melanoma for patients taking statins and fibrates, respectively, the investigators say in the review, which was led by Dr. Robert Dellavalle of Denver Veterans Affairs Medical Center.

The results were not statistically significant, however, and trials of cancer and statins should continue in order to further address suggestions raised by case-control, in vitro, and animal model studies.

The trials included in the review all involved random allocation of study participants, the use of statins or fibrates in isolation in the studies' experimental groups, and the administration of therapy for at least 4 years.

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