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Gastric Bypass Surgery Alternatives Nearing Market
SAN DIEGO — A number of experimental treatments for obesity are being developed as alternatives to Roux-en-Y surgery or gastric banding.
Devices that are placed endoscopically or surgically may someday fill a gap between low-risk, low-effectiveness diet/exercise strategies and the higher-risk procedures, Dr. Jeffrey S. Brooks said at a symposium on obesity sponsored by the American Society of Bariatric Physicians.
Only 2% of obese patients undergo Roux-en-Y surgery or gastric banding. Rates of death after open procedures are 2% within a month of surgery and 5% within 1 year (JAMA 2005;294:1903–6). Laparoscopic procedures lower the overall reported mortality rate for Roux-en-Y and gastric banding procedures to 1% or less, he noted.
Alternative devices being investigated include gastric balloons (to fill stomach space and give the sensation of satiety with less food) and gastric stimulation devices (to stimulate quicker gastric emptying).
“At least one of these will hit the streets in 2–3 years,” said Dr. Brooks, a gastroenterologist and chief scientific officer of a company that is developing one of the balloons.
The saline-filled Bioenterics intragastric balloon (BIB) and the air-filled Heliosphere intragastric balloon are in use in some European and South American countries, Mexico, and Canada, he said.
Approximately 2,500 BIBs have been placed in patients in Italy, and studies have ranged from 30 to a few hundred patients.
The BIB contributes to an average weight loss of 15 kg and a five-point decrease in body mass index (BMI) after 6 months, data suggest.
The balloon initially causes severe nausea, but the rate of balloon removal in the first few postoperative days is less than 3%, Dr. Brooks said. Overall rates of removal due to intolerance range from 3% to 9%.
The BIB deflates prematurely in up to 29% of cases, depending on the study. Intestinal obstruction has occurred in 0.3%–5% of patients, and 3% of patients have suffered gastric perforations. The device is contraindicated in patients who have previously had gastric surgery, because they are at highest risk for perforation.
Although supposedly adjustable to fit the patient's size requirements, the BIB is “quite difficult” and not practical to adjust, Dr. Brooks said.
The Heliosphere balloon is relatively easy to put in but very difficult to take out, he said. This double-walled polymer balloon is covered with silicone. Placed endoscopically, it gets inflated with 650–750 mL of air. Like the BIB, it is used for 6 months as an adjunct to diet and exercise.
The removal rate for intolerance is around 6%, and approximately 2% of the devices deflate prematurely, preliminary data suggest.
A third endoscopically placed balloon currently being developed by Dr. Brooks' company, Spatz-FGIA Inc., is expected to be adjustable, he said. Studies in animals so far show no migration or gastric perforations.
Two other companies (Satiety Inc. and Fulfillium Inc.) have filed patents for gastric balloons, but it's unclear if and when they will start clinical studies.
Two kinds of gastric stimulators are in development: one by Transneuronix Inc., which provides continuous stimulation, and one by Metacure, which provides intermittent stimulation when food is ingested.
Impressive European results with gastric stimulation have not been matched by early U.S. data, he noted. A randomized trial of the Transneuronix device in 190 patients in 2004 found that 27% in the stimulator group and 16% in the control group had lost at least 20% of excess weight 1 year later.
“I think it will work for some patients,” Dr. Brooks commented.
SAN DIEGO — A number of experimental treatments for obesity are being developed as alternatives to Roux-en-Y surgery or gastric banding.
Devices that are placed endoscopically or surgically may someday fill a gap between low-risk, low-effectiveness diet/exercise strategies and the higher-risk procedures, Dr. Jeffrey S. Brooks said at a symposium on obesity sponsored by the American Society of Bariatric Physicians.
Only 2% of obese patients undergo Roux-en-Y surgery or gastric banding. Rates of death after open procedures are 2% within a month of surgery and 5% within 1 year (JAMA 2005;294:1903–6). Laparoscopic procedures lower the overall reported mortality rate for Roux-en-Y and gastric banding procedures to 1% or less, he noted.
Alternative devices being investigated include gastric balloons (to fill stomach space and give the sensation of satiety with less food) and gastric stimulation devices (to stimulate quicker gastric emptying).
“At least one of these will hit the streets in 2–3 years,” said Dr. Brooks, a gastroenterologist and chief scientific officer of a company that is developing one of the balloons.
The saline-filled Bioenterics intragastric balloon (BIB) and the air-filled Heliosphere intragastric balloon are in use in some European and South American countries, Mexico, and Canada, he said.
Approximately 2,500 BIBs have been placed in patients in Italy, and studies have ranged from 30 to a few hundred patients.
The BIB contributes to an average weight loss of 15 kg and a five-point decrease in body mass index (BMI) after 6 months, data suggest.
The balloon initially causes severe nausea, but the rate of balloon removal in the first few postoperative days is less than 3%, Dr. Brooks said. Overall rates of removal due to intolerance range from 3% to 9%.
The BIB deflates prematurely in up to 29% of cases, depending on the study. Intestinal obstruction has occurred in 0.3%–5% of patients, and 3% of patients have suffered gastric perforations. The device is contraindicated in patients who have previously had gastric surgery, because they are at highest risk for perforation.
Although supposedly adjustable to fit the patient's size requirements, the BIB is “quite difficult” and not practical to adjust, Dr. Brooks said.
The Heliosphere balloon is relatively easy to put in but very difficult to take out, he said. This double-walled polymer balloon is covered with silicone. Placed endoscopically, it gets inflated with 650–750 mL of air. Like the BIB, it is used for 6 months as an adjunct to diet and exercise.
The removal rate for intolerance is around 6%, and approximately 2% of the devices deflate prematurely, preliminary data suggest.
A third endoscopically placed balloon currently being developed by Dr. Brooks' company, Spatz-FGIA Inc., is expected to be adjustable, he said. Studies in animals so far show no migration or gastric perforations.
Two other companies (Satiety Inc. and Fulfillium Inc.) have filed patents for gastric balloons, but it's unclear if and when they will start clinical studies.
Two kinds of gastric stimulators are in development: one by Transneuronix Inc., which provides continuous stimulation, and one by Metacure, which provides intermittent stimulation when food is ingested.
Impressive European results with gastric stimulation have not been matched by early U.S. data, he noted. A randomized trial of the Transneuronix device in 190 patients in 2004 found that 27% in the stimulator group and 16% in the control group had lost at least 20% of excess weight 1 year later.
“I think it will work for some patients,” Dr. Brooks commented.
SAN DIEGO — A number of experimental treatments for obesity are being developed as alternatives to Roux-en-Y surgery or gastric banding.
Devices that are placed endoscopically or surgically may someday fill a gap between low-risk, low-effectiveness diet/exercise strategies and the higher-risk procedures, Dr. Jeffrey S. Brooks said at a symposium on obesity sponsored by the American Society of Bariatric Physicians.
Only 2% of obese patients undergo Roux-en-Y surgery or gastric banding. Rates of death after open procedures are 2% within a month of surgery and 5% within 1 year (JAMA 2005;294:1903–6). Laparoscopic procedures lower the overall reported mortality rate for Roux-en-Y and gastric banding procedures to 1% or less, he noted.
Alternative devices being investigated include gastric balloons (to fill stomach space and give the sensation of satiety with less food) and gastric stimulation devices (to stimulate quicker gastric emptying).
“At least one of these will hit the streets in 2–3 years,” said Dr. Brooks, a gastroenterologist and chief scientific officer of a company that is developing one of the balloons.
The saline-filled Bioenterics intragastric balloon (BIB) and the air-filled Heliosphere intragastric balloon are in use in some European and South American countries, Mexico, and Canada, he said.
Approximately 2,500 BIBs have been placed in patients in Italy, and studies have ranged from 30 to a few hundred patients.
The BIB contributes to an average weight loss of 15 kg and a five-point decrease in body mass index (BMI) after 6 months, data suggest.
The balloon initially causes severe nausea, but the rate of balloon removal in the first few postoperative days is less than 3%, Dr. Brooks said. Overall rates of removal due to intolerance range from 3% to 9%.
The BIB deflates prematurely in up to 29% of cases, depending on the study. Intestinal obstruction has occurred in 0.3%–5% of patients, and 3% of patients have suffered gastric perforations. The device is contraindicated in patients who have previously had gastric surgery, because they are at highest risk for perforation.
Although supposedly adjustable to fit the patient's size requirements, the BIB is “quite difficult” and not practical to adjust, Dr. Brooks said.
The Heliosphere balloon is relatively easy to put in but very difficult to take out, he said. This double-walled polymer balloon is covered with silicone. Placed endoscopically, it gets inflated with 650–750 mL of air. Like the BIB, it is used for 6 months as an adjunct to diet and exercise.
The removal rate for intolerance is around 6%, and approximately 2% of the devices deflate prematurely, preliminary data suggest.
A third endoscopically placed balloon currently being developed by Dr. Brooks' company, Spatz-FGIA Inc., is expected to be adjustable, he said. Studies in animals so far show no migration or gastric perforations.
Two other companies (Satiety Inc. and Fulfillium Inc.) have filed patents for gastric balloons, but it's unclear if and when they will start clinical studies.
Two kinds of gastric stimulators are in development: one by Transneuronix Inc., which provides continuous stimulation, and one by Metacure, which provides intermittent stimulation when food is ingested.
Impressive European results with gastric stimulation have not been matched by early U.S. data, he noted. A randomized trial of the Transneuronix device in 190 patients in 2004 found that 27% in the stimulator group and 16% in the control group had lost at least 20% of excess weight 1 year later.
“I think it will work for some patients,” Dr. Brooks commented.
Consider Key Gender Differences When Treating Depression
SAN FRANCISCO — Recognizing some important differences between women and men can help in treating depressed women, Dr. Holly A. Swartz said at Perspectives on Women's Health sponsored by OB.GYN. NEWS.
When treating women with depression, physicians should increase their attention to psychosocial stressors, work on strengthening social support, and treat comorbid anxiety or phobic symptoms. Psychotherapy may be especially helpful, said Dr. Swartz.
In the selection of pharmacotherapy, a selective serotonin reuptake inhibitor (SSRI) would be the first choice for younger women or postmenopausal women on hormone therapy, while a tricyclic antidepressant may be more effective in men and older women not taking hormones, said Dr. Swartz of the University of Pittsburgh.
“Atypical” depression with somatic symptoms and fatigue, sleep disturbance, and overeating or carbohydrate craving is more common in women than in men, who are more likely to have typical vegetative symptoms and low appetite when depressed. Comorbid anxiety also is more common in depressed women than in depressed men.
Interactions between an individual's underlying biology or genetics and events in the external environment play important roles in the causes and manifestations of depression.
It is theorized that women evolved to be more focused on affiliative behaviors, child rearing, and maintenance of social bonds, compared with men. It is believed that, in general, a disruption in interpersonal relationships is more stressful to women than to men, while a threat to social status is more upsetting to men than to women.
“In treating depression in women, you need to attend to the interpersonal context,” Dr. Swartz said.
Depression-specific psychotherapies can be as helpful as medication for depressed women and may have more lasting effects, she added.
Women are nearly twice as likely as men to develop major depression—21% vs. 13%, data suggest (Arch. Gen. Psychiatry 1995;52:1048). Approximately one in five women will have major depression at some point in their lifetimes.
Among people who develop major depression, 59% also will be diagnosed with an anxiety disorder, and in 86% of cases, the anxiety disorder precedes the depression. Depressed patients with comorbid anxiety are more likely to be severely suicidal and are less likely to respond to therapy, be it medication or psychotherapy. The risk for recurrent depression is higher in patients with untreated anxiety.
“If you're not paying attention to the anxiety, you're not doing the patient a service,” Dr. Swartz said.
People with high-anxiety levels typically are very somatically preoccupied, either with hyperalgesia (increased sensitivity to pain) or increased attention to sensations. When you treat highly anxious patients with antidepressants, “in practical terms, they'll get every side effect in the book, and then some,” she said.
High anxiety levels also may cause these patients to avoid treatment altogether.
Considering that depressed women often have comorbid anxiety, it's advisable to acknowledge their high degree of sensitivity and explain that this is hard-wired behavior that probably was adaptive at some point but has gone awry. Help them anticipate side effects to treatment, and assure them that side effects are transient and that they will reach a point where the treatment is tolerable.
Start with a low dose of an antidepressant and increase the dosage slowly, but forewarn the patient that she probably will need a high dose to achieve full remission. “It's typically a long process. I like to tell my patients about this up front,” she said.
Physicians who are not comfortable prescribing tricyclics might consider such dual agonists as venlafaxine or duloxetine, which have receptor effects similar to those of older tricyclics, she said.
Dr. Swartz is a consultant for Novartis and a speaker for Bristol-Myers Squibb Co. and Pfizer Inc. and has given continuing medical education presentations for Astra Zeneca. All these companies make psychotropic medications.
OB.GYN. NEWS is published by the International Medical News Group, a division of Elsevier.
A disruption in interpersonal relationships is more stressful to women than to men. DR. SWARTZ
SAN FRANCISCO — Recognizing some important differences between women and men can help in treating depressed women, Dr. Holly A. Swartz said at Perspectives on Women's Health sponsored by OB.GYN. NEWS.
When treating women with depression, physicians should increase their attention to psychosocial stressors, work on strengthening social support, and treat comorbid anxiety or phobic symptoms. Psychotherapy may be especially helpful, said Dr. Swartz.
In the selection of pharmacotherapy, a selective serotonin reuptake inhibitor (SSRI) would be the first choice for younger women or postmenopausal women on hormone therapy, while a tricyclic antidepressant may be more effective in men and older women not taking hormones, said Dr. Swartz of the University of Pittsburgh.
“Atypical” depression with somatic symptoms and fatigue, sleep disturbance, and overeating or carbohydrate craving is more common in women than in men, who are more likely to have typical vegetative symptoms and low appetite when depressed. Comorbid anxiety also is more common in depressed women than in depressed men.
Interactions between an individual's underlying biology or genetics and events in the external environment play important roles in the causes and manifestations of depression.
It is theorized that women evolved to be more focused on affiliative behaviors, child rearing, and maintenance of social bonds, compared with men. It is believed that, in general, a disruption in interpersonal relationships is more stressful to women than to men, while a threat to social status is more upsetting to men than to women.
“In treating depression in women, you need to attend to the interpersonal context,” Dr. Swartz said.
Depression-specific psychotherapies can be as helpful as medication for depressed women and may have more lasting effects, she added.
Women are nearly twice as likely as men to develop major depression—21% vs. 13%, data suggest (Arch. Gen. Psychiatry 1995;52:1048). Approximately one in five women will have major depression at some point in their lifetimes.
Among people who develop major depression, 59% also will be diagnosed with an anxiety disorder, and in 86% of cases, the anxiety disorder precedes the depression. Depressed patients with comorbid anxiety are more likely to be severely suicidal and are less likely to respond to therapy, be it medication or psychotherapy. The risk for recurrent depression is higher in patients with untreated anxiety.
“If you're not paying attention to the anxiety, you're not doing the patient a service,” Dr. Swartz said.
People with high-anxiety levels typically are very somatically preoccupied, either with hyperalgesia (increased sensitivity to pain) or increased attention to sensations. When you treat highly anxious patients with antidepressants, “in practical terms, they'll get every side effect in the book, and then some,” she said.
High anxiety levels also may cause these patients to avoid treatment altogether.
Considering that depressed women often have comorbid anxiety, it's advisable to acknowledge their high degree of sensitivity and explain that this is hard-wired behavior that probably was adaptive at some point but has gone awry. Help them anticipate side effects to treatment, and assure them that side effects are transient and that they will reach a point where the treatment is tolerable.
Start with a low dose of an antidepressant and increase the dosage slowly, but forewarn the patient that she probably will need a high dose to achieve full remission. “It's typically a long process. I like to tell my patients about this up front,” she said.
Physicians who are not comfortable prescribing tricyclics might consider such dual agonists as venlafaxine or duloxetine, which have receptor effects similar to those of older tricyclics, she said.
Dr. Swartz is a consultant for Novartis and a speaker for Bristol-Myers Squibb Co. and Pfizer Inc. and has given continuing medical education presentations for Astra Zeneca. All these companies make psychotropic medications.
OB.GYN. NEWS is published by the International Medical News Group, a division of Elsevier.
A disruption in interpersonal relationships is more stressful to women than to men. DR. SWARTZ
SAN FRANCISCO — Recognizing some important differences between women and men can help in treating depressed women, Dr. Holly A. Swartz said at Perspectives on Women's Health sponsored by OB.GYN. NEWS.
When treating women with depression, physicians should increase their attention to psychosocial stressors, work on strengthening social support, and treat comorbid anxiety or phobic symptoms. Psychotherapy may be especially helpful, said Dr. Swartz.
In the selection of pharmacotherapy, a selective serotonin reuptake inhibitor (SSRI) would be the first choice for younger women or postmenopausal women on hormone therapy, while a tricyclic antidepressant may be more effective in men and older women not taking hormones, said Dr. Swartz of the University of Pittsburgh.
“Atypical” depression with somatic symptoms and fatigue, sleep disturbance, and overeating or carbohydrate craving is more common in women than in men, who are more likely to have typical vegetative symptoms and low appetite when depressed. Comorbid anxiety also is more common in depressed women than in depressed men.
Interactions between an individual's underlying biology or genetics and events in the external environment play important roles in the causes and manifestations of depression.
It is theorized that women evolved to be more focused on affiliative behaviors, child rearing, and maintenance of social bonds, compared with men. It is believed that, in general, a disruption in interpersonal relationships is more stressful to women than to men, while a threat to social status is more upsetting to men than to women.
“In treating depression in women, you need to attend to the interpersonal context,” Dr. Swartz said.
Depression-specific psychotherapies can be as helpful as medication for depressed women and may have more lasting effects, she added.
Women are nearly twice as likely as men to develop major depression—21% vs. 13%, data suggest (Arch. Gen. Psychiatry 1995;52:1048). Approximately one in five women will have major depression at some point in their lifetimes.
Among people who develop major depression, 59% also will be diagnosed with an anxiety disorder, and in 86% of cases, the anxiety disorder precedes the depression. Depressed patients with comorbid anxiety are more likely to be severely suicidal and are less likely to respond to therapy, be it medication or psychotherapy. The risk for recurrent depression is higher in patients with untreated anxiety.
“If you're not paying attention to the anxiety, you're not doing the patient a service,” Dr. Swartz said.
People with high-anxiety levels typically are very somatically preoccupied, either with hyperalgesia (increased sensitivity to pain) or increased attention to sensations. When you treat highly anxious patients with antidepressants, “in practical terms, they'll get every side effect in the book, and then some,” she said.
High anxiety levels also may cause these patients to avoid treatment altogether.
Considering that depressed women often have comorbid anxiety, it's advisable to acknowledge their high degree of sensitivity and explain that this is hard-wired behavior that probably was adaptive at some point but has gone awry. Help them anticipate side effects to treatment, and assure them that side effects are transient and that they will reach a point where the treatment is tolerable.
Start with a low dose of an antidepressant and increase the dosage slowly, but forewarn the patient that she probably will need a high dose to achieve full remission. “It's typically a long process. I like to tell my patients about this up front,” she said.
Physicians who are not comfortable prescribing tricyclics might consider such dual agonists as venlafaxine or duloxetine, which have receptor effects similar to those of older tricyclics, she said.
Dr. Swartz is a consultant for Novartis and a speaker for Bristol-Myers Squibb Co. and Pfizer Inc. and has given continuing medical education presentations for Astra Zeneca. All these companies make psychotropic medications.
OB.GYN. NEWS is published by the International Medical News Group, a division of Elsevier.
A disruption in interpersonal relationships is more stressful to women than to men. DR. SWARTZ
Little Support for Adding T3 to T4 Therapy for Hypothyroidism
SAN FRANCISCO — The scientific evidence does not support adding T3 therapy to T4 therapy for patients with hypothyroidism, but some patients insist on it, according to Dr. Hossein Gharib.
Most patients do well on T4 therapy alone, but some complain of fatigue, low energy, weight gain, or depressed mood despite adequate thyroid hormone replacement on T4 therapy. They may read on the Internet that some patients with hypothyroidism or their treating psychiatrists report mood improvements after adding T3 to therapy, he said at Perspectives in Women's Health sponsored by OB.GYN. NEWS.
In humans, 20% of T3 is secreted by the thyroid gland. Standard treatment for hypothyroid disease replaces only T4. “There is a feeling among physicians that when symptoms persist despite normal T4 and TSH levels, we should switch to T4 plus T3 therapy,” said Dr. Gharib, professor of medicine at the Mayo Medical School, Rochester, Minn.
Data from thyroid clinics and endocrinology practices, however, do not show any physiologic benefit from adding T3 to therapy, he said. “There are several good studies in the last 5 years that have looked at this, and none of them support a physiologic response,” he said.
Adding T3 to therapy increases the cost of care and requires additional monitoring of hormone levels. If the patient insists on trying it, and thyroid hormone levels are in normal ranges, Dr. Gharib documents the conversation and adds T3 to therapy. When adding T3, he added, the dose of T4 should be lowered by about 20%.
Conventional treatment for hypothyroidism calls for individualized dosing of T4 therapy (based on body size and hormone levels) to reach a target TSH level of 0.3–3.0 mIU/L.
Ask patients who complain about symptoms of hypothyroidism after years of successful T4 therapy about several possible changes in their habits that may be responsible, Dr. Gharib suggested.
The patient may have become less adherent to therapy, or a pharmacist may have convinced the patient to switch to less expensive generic T4 therapy. Alternatively, the patient may be taking one of an increasing number of drugs that necessitate a boost in T4 dosage. Calcium and ferrous sulfate are common inhibitors of T4 absorption. “Take these two agents at different schedules than thyroxine,” he advised.
Dr. Gharib indicated no association with the companies that make the treatments he discussed. OB.GYN. NEWS is published by the International Medical News Group, a division of Elsevier.
SAN FRANCISCO — The scientific evidence does not support adding T3 therapy to T4 therapy for patients with hypothyroidism, but some patients insist on it, according to Dr. Hossein Gharib.
Most patients do well on T4 therapy alone, but some complain of fatigue, low energy, weight gain, or depressed mood despite adequate thyroid hormone replacement on T4 therapy. They may read on the Internet that some patients with hypothyroidism or their treating psychiatrists report mood improvements after adding T3 to therapy, he said at Perspectives in Women's Health sponsored by OB.GYN. NEWS.
In humans, 20% of T3 is secreted by the thyroid gland. Standard treatment for hypothyroid disease replaces only T4. “There is a feeling among physicians that when symptoms persist despite normal T4 and TSH levels, we should switch to T4 plus T3 therapy,” said Dr. Gharib, professor of medicine at the Mayo Medical School, Rochester, Minn.
Data from thyroid clinics and endocrinology practices, however, do not show any physiologic benefit from adding T3 to therapy, he said. “There are several good studies in the last 5 years that have looked at this, and none of them support a physiologic response,” he said.
Adding T3 to therapy increases the cost of care and requires additional monitoring of hormone levels. If the patient insists on trying it, and thyroid hormone levels are in normal ranges, Dr. Gharib documents the conversation and adds T3 to therapy. When adding T3, he added, the dose of T4 should be lowered by about 20%.
Conventional treatment for hypothyroidism calls for individualized dosing of T4 therapy (based on body size and hormone levels) to reach a target TSH level of 0.3–3.0 mIU/L.
Ask patients who complain about symptoms of hypothyroidism after years of successful T4 therapy about several possible changes in their habits that may be responsible, Dr. Gharib suggested.
The patient may have become less adherent to therapy, or a pharmacist may have convinced the patient to switch to less expensive generic T4 therapy. Alternatively, the patient may be taking one of an increasing number of drugs that necessitate a boost in T4 dosage. Calcium and ferrous sulfate are common inhibitors of T4 absorption. “Take these two agents at different schedules than thyroxine,” he advised.
Dr. Gharib indicated no association with the companies that make the treatments he discussed. OB.GYN. NEWS is published by the International Medical News Group, a division of Elsevier.
SAN FRANCISCO — The scientific evidence does not support adding T3 therapy to T4 therapy for patients with hypothyroidism, but some patients insist on it, according to Dr. Hossein Gharib.
Most patients do well on T4 therapy alone, but some complain of fatigue, low energy, weight gain, or depressed mood despite adequate thyroid hormone replacement on T4 therapy. They may read on the Internet that some patients with hypothyroidism or their treating psychiatrists report mood improvements after adding T3 to therapy, he said at Perspectives in Women's Health sponsored by OB.GYN. NEWS.
In humans, 20% of T3 is secreted by the thyroid gland. Standard treatment for hypothyroid disease replaces only T4. “There is a feeling among physicians that when symptoms persist despite normal T4 and TSH levels, we should switch to T4 plus T3 therapy,” said Dr. Gharib, professor of medicine at the Mayo Medical School, Rochester, Minn.
Data from thyroid clinics and endocrinology practices, however, do not show any physiologic benefit from adding T3 to therapy, he said. “There are several good studies in the last 5 years that have looked at this, and none of them support a physiologic response,” he said.
Adding T3 to therapy increases the cost of care and requires additional monitoring of hormone levels. If the patient insists on trying it, and thyroid hormone levels are in normal ranges, Dr. Gharib documents the conversation and adds T3 to therapy. When adding T3, he added, the dose of T4 should be lowered by about 20%.
Conventional treatment for hypothyroidism calls for individualized dosing of T4 therapy (based on body size and hormone levels) to reach a target TSH level of 0.3–3.0 mIU/L.
Ask patients who complain about symptoms of hypothyroidism after years of successful T4 therapy about several possible changes in their habits that may be responsible, Dr. Gharib suggested.
The patient may have become less adherent to therapy, or a pharmacist may have convinced the patient to switch to less expensive generic T4 therapy. Alternatively, the patient may be taking one of an increasing number of drugs that necessitate a boost in T4 dosage. Calcium and ferrous sulfate are common inhibitors of T4 absorption. “Take these two agents at different schedules than thyroxine,” he advised.
Dr. Gharib indicated no association with the companies that make the treatments he discussed. OB.GYN. NEWS is published by the International Medical News Group, a division of Elsevier.
Hyperthyroidism in Elderly Can Be Hard to Spot : Biochemical tests can help make the diagnosis, and the first step in that process is to order a serum TSH.
SAN FRANCISCO — Hyperthyroid disease can be deceptively symptom free or mildly symptomatic, especially in the elderly, Dr. Hossein Gharib said at Perspectives in Women's Health sponsored by OB.GYN. NEWS.
Common symptoms of hypermetabolism include warm, moist skin, fine hair, physically stimulated or nervous mannerisms, possibly a goiter present on palpitation, and perhaps symptoms such as eye asymmetry, a typical hyperthyroid “stare,” and lid retraction.
Elderly patients with hyperthyroidism, however, may complain instead about lethargy, fatigue, or depression. They also have cardiac disease, or atrial fibrillation.
“It is easy to miss the diagnosis [in elderly patients],” said Dr. Gharib, professor of medicine at the Mayo Clinic in Rochester, Minn.
Biochemical tests make the diagnosis. The first step is to order a serum TSH; if it's low, especially if less than 0.1 mIU/L, the patient has hyperthyroidism until proven otherwise, he said.
Next, order total T4 and free T4 fractions; if these are high and the TSH is low, that confirms the diagnosis of hyperthyroidism.
For high suspicion of hyperthyroidism in a patient, test both the TSH and thyroid hormone levels at the same time, he added.
Finally, conduct a radioiodine uptake test, which will differentiate between Graves' disease (which accounts for 70%–80% of hyperthyroidism and requires treatment) and thyroiditis (which is less common and usually subsides spontaneously), Dr. Gharib said.
For most hyperthyroid adults, radioiodine therapy is the treatment of choice. Follow up within 2 months or sooner. Patients will become hypothyroid sooner or later and will require lifelong thyroxine therapy.
For pregnant women who have hyperthyroidism, the antithyroid thionamides are the first choice in treatment. Follow total T4 and free T4 levels in patients on medical therapy and aim for high-normal levels, Dr. Gharib advised. Antithyroid drugs are safe during breast-feeding.
Surgery is a treatment option starting in the second trimester if there's an experienced surgeon in your area. However, surgery for benign thyroid disease is rare enough that finding an experienced surgeon can be difficult, he said. Surgery typically is reserved for toxic nodular goiters, large symptomatic goiters, children with hyperthyroidism, or pregnant patients.
An estimated 0.5%–1% of adults have hyperthyroidism, which is more common in women.
Dr. Gharib has no association with the companies that make the treatments he discussed. OB.GYN. NEWS is published by the International Medical News Group, a division of Elsevier.
SAN FRANCISCO — Hyperthyroid disease can be deceptively symptom free or mildly symptomatic, especially in the elderly, Dr. Hossein Gharib said at Perspectives in Women's Health sponsored by OB.GYN. NEWS.
Common symptoms of hypermetabolism include warm, moist skin, fine hair, physically stimulated or nervous mannerisms, possibly a goiter present on palpitation, and perhaps symptoms such as eye asymmetry, a typical hyperthyroid “stare,” and lid retraction.
Elderly patients with hyperthyroidism, however, may complain instead about lethargy, fatigue, or depression. They also have cardiac disease, or atrial fibrillation.
“It is easy to miss the diagnosis [in elderly patients],” said Dr. Gharib, professor of medicine at the Mayo Clinic in Rochester, Minn.
Biochemical tests make the diagnosis. The first step is to order a serum TSH; if it's low, especially if less than 0.1 mIU/L, the patient has hyperthyroidism until proven otherwise, he said.
Next, order total T4 and free T4 fractions; if these are high and the TSH is low, that confirms the diagnosis of hyperthyroidism.
For high suspicion of hyperthyroidism in a patient, test both the TSH and thyroid hormone levels at the same time, he added.
Finally, conduct a radioiodine uptake test, which will differentiate between Graves' disease (which accounts for 70%–80% of hyperthyroidism and requires treatment) and thyroiditis (which is less common and usually subsides spontaneously), Dr. Gharib said.
For most hyperthyroid adults, radioiodine therapy is the treatment of choice. Follow up within 2 months or sooner. Patients will become hypothyroid sooner or later and will require lifelong thyroxine therapy.
For pregnant women who have hyperthyroidism, the antithyroid thionamides are the first choice in treatment. Follow total T4 and free T4 levels in patients on medical therapy and aim for high-normal levels, Dr. Gharib advised. Antithyroid drugs are safe during breast-feeding.
Surgery is a treatment option starting in the second trimester if there's an experienced surgeon in your area. However, surgery for benign thyroid disease is rare enough that finding an experienced surgeon can be difficult, he said. Surgery typically is reserved for toxic nodular goiters, large symptomatic goiters, children with hyperthyroidism, or pregnant patients.
An estimated 0.5%–1% of adults have hyperthyroidism, which is more common in women.
Dr. Gharib has no association with the companies that make the treatments he discussed. OB.GYN. NEWS is published by the International Medical News Group, a division of Elsevier.
SAN FRANCISCO — Hyperthyroid disease can be deceptively symptom free or mildly symptomatic, especially in the elderly, Dr. Hossein Gharib said at Perspectives in Women's Health sponsored by OB.GYN. NEWS.
Common symptoms of hypermetabolism include warm, moist skin, fine hair, physically stimulated or nervous mannerisms, possibly a goiter present on palpitation, and perhaps symptoms such as eye asymmetry, a typical hyperthyroid “stare,” and lid retraction.
Elderly patients with hyperthyroidism, however, may complain instead about lethargy, fatigue, or depression. They also have cardiac disease, or atrial fibrillation.
“It is easy to miss the diagnosis [in elderly patients],” said Dr. Gharib, professor of medicine at the Mayo Clinic in Rochester, Minn.
Biochemical tests make the diagnosis. The first step is to order a serum TSH; if it's low, especially if less than 0.1 mIU/L, the patient has hyperthyroidism until proven otherwise, he said.
Next, order total T4 and free T4 fractions; if these are high and the TSH is low, that confirms the diagnosis of hyperthyroidism.
For high suspicion of hyperthyroidism in a patient, test both the TSH and thyroid hormone levels at the same time, he added.
Finally, conduct a radioiodine uptake test, which will differentiate between Graves' disease (which accounts for 70%–80% of hyperthyroidism and requires treatment) and thyroiditis (which is less common and usually subsides spontaneously), Dr. Gharib said.
For most hyperthyroid adults, radioiodine therapy is the treatment of choice. Follow up within 2 months or sooner. Patients will become hypothyroid sooner or later and will require lifelong thyroxine therapy.
For pregnant women who have hyperthyroidism, the antithyroid thionamides are the first choice in treatment. Follow total T4 and free T4 levels in patients on medical therapy and aim for high-normal levels, Dr. Gharib advised. Antithyroid drugs are safe during breast-feeding.
Surgery is a treatment option starting in the second trimester if there's an experienced surgeon in your area. However, surgery for benign thyroid disease is rare enough that finding an experienced surgeon can be difficult, he said. Surgery typically is reserved for toxic nodular goiters, large symptomatic goiters, children with hyperthyroidism, or pregnant patients.
An estimated 0.5%–1% of adults have hyperthyroidism, which is more common in women.
Dr. Gharib has no association with the companies that make the treatments he discussed. OB.GYN. NEWS is published by the International Medical News Group, a division of Elsevier.
Noncardiac Surgery May Not Require Cardiac Tests : Preoperative testing may result in worse outcomes than no testing.
SAN FRANCISCO — New guidelines for perioperative evaluation and management of cardiac patients undergoing noncardiac surgery are expected to be released in the spring, and they are likely to shift the emphasis from preoperative risk stratification to optimizing medical therapy in order to reduce perioperative complications, Dr. Gabriel Gregoratos said at a meeting sponsored by the California chapter of the American College of Cardiology.
New data have come along to challenge the current guidelines, published by the college and the American Heart Association in 2002, regarding preoperative cardiac testing, preoperative revascularization procedures, and the use of perioperative β-blockers in low-risk patients, said Dr. Gregoratos, professor of medicine at the University of California, San Francisco.
The current guidelines call for those at intermediate risk for perioperative cardiac events to undergo noninvasive assessment of the severity of cardiac ischemia, proceeding to cardiac surgery if the severity is significant. Predictors of intermediate risk in patients with coronary disease include mild angina, a prior MI, compensated or prior heart failure, or diabetes mellitus. Preoperative noninvasive testing also is appropriate, the guidelines say, in patients with poor functional capacity or who are undergoing a high-risk surgery.
Several recent studies, however, suggest that patients who underwent preoperative noninvasive testing to evaluate myocardial ischemia fared worse than those who were not tested, Dr. Gregoratos said at the meeting, also sponsored by the university. One randomized study of 1,476 intermediate-risk patients undergoing vascular surgery found a 2.3% rate of cardiac death or nonfatal MI within 30 days in tested patients, compared with a 1.8% rate in nontested patients (J. Am. Coll. Cardiol. 2006;48:964–9).
The difference between groups was not statistically significant, but “we have to consider why this is happening,” he said. “I would suggest that when we submit patients to preoperative testing and then some of them go to revascularization, we are not giving them any benefit, and we may be doing them harm.”
Preoperative testing delayed the noncardiac surgery by 3 weeks.
Other data have shown equivocal results on the potential benefit of preoperative coronary artery bypass grafting or percutaneous coronary intervention when performed simply to reduce the risk of complications from noncardiac surgery.
A major randomized study of 510 cardiac patients undergoing elective vascular surgery found no difference in survival at 6 years in those who did or didn't get preoperative revascularization to reduce perioperative risk (N. Engl. J. Med. 2004;351:2795–804). A trend suggested higher mortality in the first year after surgery for patients who were revascularized.
The guidelines already state that the decision to revascularize patients in preparation for noncardiac surgery is appropriate only in a very small subgroup of very high-risk patients. “I suspect that the revised guideline will be even stronger than this statement,” Dr. Gregoratos said.
The reductions in perioperative MI or death in cardiac patients given β-blockers around noncardiac surgery seem to benefit mainly patients at high risk for an ischemic event, he said. For patients with a Revised Cardiac Risk Index score of 0, 1 of every 208 patients given perioperative β-blockers will be harmed, a large retrospective study suggests (N. Engl. J. Med. 2005;353:349–61).
In addition, simply giving β-blockers is not enough to benefit intermediate-risk patients. Tight heart rate control is the key. “Patients have to be physiologically β-blocked,” he emphasized.
SAN FRANCISCO — New guidelines for perioperative evaluation and management of cardiac patients undergoing noncardiac surgery are expected to be released in the spring, and they are likely to shift the emphasis from preoperative risk stratification to optimizing medical therapy in order to reduce perioperative complications, Dr. Gabriel Gregoratos said at a meeting sponsored by the California chapter of the American College of Cardiology.
New data have come along to challenge the current guidelines, published by the college and the American Heart Association in 2002, regarding preoperative cardiac testing, preoperative revascularization procedures, and the use of perioperative β-blockers in low-risk patients, said Dr. Gregoratos, professor of medicine at the University of California, San Francisco.
The current guidelines call for those at intermediate risk for perioperative cardiac events to undergo noninvasive assessment of the severity of cardiac ischemia, proceeding to cardiac surgery if the severity is significant. Predictors of intermediate risk in patients with coronary disease include mild angina, a prior MI, compensated or prior heart failure, or diabetes mellitus. Preoperative noninvasive testing also is appropriate, the guidelines say, in patients with poor functional capacity or who are undergoing a high-risk surgery.
Several recent studies, however, suggest that patients who underwent preoperative noninvasive testing to evaluate myocardial ischemia fared worse than those who were not tested, Dr. Gregoratos said at the meeting, also sponsored by the university. One randomized study of 1,476 intermediate-risk patients undergoing vascular surgery found a 2.3% rate of cardiac death or nonfatal MI within 30 days in tested patients, compared with a 1.8% rate in nontested patients (J. Am. Coll. Cardiol. 2006;48:964–9).
The difference between groups was not statistically significant, but “we have to consider why this is happening,” he said. “I would suggest that when we submit patients to preoperative testing and then some of them go to revascularization, we are not giving them any benefit, and we may be doing them harm.”
Preoperative testing delayed the noncardiac surgery by 3 weeks.
Other data have shown equivocal results on the potential benefit of preoperative coronary artery bypass grafting or percutaneous coronary intervention when performed simply to reduce the risk of complications from noncardiac surgery.
A major randomized study of 510 cardiac patients undergoing elective vascular surgery found no difference in survival at 6 years in those who did or didn't get preoperative revascularization to reduce perioperative risk (N. Engl. J. Med. 2004;351:2795–804). A trend suggested higher mortality in the first year after surgery for patients who were revascularized.
The guidelines already state that the decision to revascularize patients in preparation for noncardiac surgery is appropriate only in a very small subgroup of very high-risk patients. “I suspect that the revised guideline will be even stronger than this statement,” Dr. Gregoratos said.
The reductions in perioperative MI or death in cardiac patients given β-blockers around noncardiac surgery seem to benefit mainly patients at high risk for an ischemic event, he said. For patients with a Revised Cardiac Risk Index score of 0, 1 of every 208 patients given perioperative β-blockers will be harmed, a large retrospective study suggests (N. Engl. J. Med. 2005;353:349–61).
In addition, simply giving β-blockers is not enough to benefit intermediate-risk patients. Tight heart rate control is the key. “Patients have to be physiologically β-blocked,” he emphasized.
SAN FRANCISCO — New guidelines for perioperative evaluation and management of cardiac patients undergoing noncardiac surgery are expected to be released in the spring, and they are likely to shift the emphasis from preoperative risk stratification to optimizing medical therapy in order to reduce perioperative complications, Dr. Gabriel Gregoratos said at a meeting sponsored by the California chapter of the American College of Cardiology.
New data have come along to challenge the current guidelines, published by the college and the American Heart Association in 2002, regarding preoperative cardiac testing, preoperative revascularization procedures, and the use of perioperative β-blockers in low-risk patients, said Dr. Gregoratos, professor of medicine at the University of California, San Francisco.
The current guidelines call for those at intermediate risk for perioperative cardiac events to undergo noninvasive assessment of the severity of cardiac ischemia, proceeding to cardiac surgery if the severity is significant. Predictors of intermediate risk in patients with coronary disease include mild angina, a prior MI, compensated or prior heart failure, or diabetes mellitus. Preoperative noninvasive testing also is appropriate, the guidelines say, in patients with poor functional capacity or who are undergoing a high-risk surgery.
Several recent studies, however, suggest that patients who underwent preoperative noninvasive testing to evaluate myocardial ischemia fared worse than those who were not tested, Dr. Gregoratos said at the meeting, also sponsored by the university. One randomized study of 1,476 intermediate-risk patients undergoing vascular surgery found a 2.3% rate of cardiac death or nonfatal MI within 30 days in tested patients, compared with a 1.8% rate in nontested patients (J. Am. Coll. Cardiol. 2006;48:964–9).
The difference between groups was not statistically significant, but “we have to consider why this is happening,” he said. “I would suggest that when we submit patients to preoperative testing and then some of them go to revascularization, we are not giving them any benefit, and we may be doing them harm.”
Preoperative testing delayed the noncardiac surgery by 3 weeks.
Other data have shown equivocal results on the potential benefit of preoperative coronary artery bypass grafting or percutaneous coronary intervention when performed simply to reduce the risk of complications from noncardiac surgery.
A major randomized study of 510 cardiac patients undergoing elective vascular surgery found no difference in survival at 6 years in those who did or didn't get preoperative revascularization to reduce perioperative risk (N. Engl. J. Med. 2004;351:2795–804). A trend suggested higher mortality in the first year after surgery for patients who were revascularized.
The guidelines already state that the decision to revascularize patients in preparation for noncardiac surgery is appropriate only in a very small subgroup of very high-risk patients. “I suspect that the revised guideline will be even stronger than this statement,” Dr. Gregoratos said.
The reductions in perioperative MI or death in cardiac patients given β-blockers around noncardiac surgery seem to benefit mainly patients at high risk for an ischemic event, he said. For patients with a Revised Cardiac Risk Index score of 0, 1 of every 208 patients given perioperative β-blockers will be harmed, a large retrospective study suggests (N. Engl. J. Med. 2005;353:349–61).
In addition, simply giving β-blockers is not enough to benefit intermediate-risk patients. Tight heart rate control is the key. “Patients have to be physiologically β-blocked,” he emphasized.
Imaging Methods Offer Options Beyond Echocardiography
SAN FRANCISCO — Echocardiography provides adequate imaging for most cardiac patients, but when more information is needed, clinicians choose from three imaging methods that bring different strengths and weaknesses.
Of the three options—CT scans, nuclear medicine, or cardiovascular magnetic resonance (CMR) imaging—the one that probably provides the most information and holds the greatest potential for future applications is CMR, Dr. Matthias G. Friedrich said at a meeting sponsored by the California chapter of the American College of Cardiology.
“If I had to pick one,” it would be CMR, said Dr. Friedrich, director of the Stephenson Cardiovascular Magnetic Resonance Centre at the Libin Cardiovascular Institute of Alberta, Canada. He reported having no financial affiliation with companies that make the technologies that he discussed.
Dr. Friedrich weighed the advantages and disadvantages of each modality:
P CT. A CT scan provides excellent imaging of cardiovascular structures but is less helpful for assessing function or metabolism.
The spatial accuracy of CT scans is unbeaten for describing morphology. They are fast and relatively easy to perform. “You push a button, and you wait for a couple of seconds. Then you wait for a couple of minutes to have the automatic CT rendering done. You get nice images,” he said at the meeting, also sponsored by the University of California, San Francisco.
On the downside, 1 in every 1,000 patients undergoing CT scans will develop cancer from the radiation, he said. CT is not very good for tissue characterization or functional assessment, and not good at all for imaging blood flow. CT can visualize and quantify calcium, but calcium plaques generally provide little prognostic value. The technology is approaching the peak of its capabilities.
“It does not have a huge future potential,” he added.
P Nuclear medicine. Although very good at assessing metabolism, nuclear medicine is only so-so for imaging structures and is not very good at assessing function.
Its strengths are very specific metabolic information and strong prognostic value. A solid body of data shows that the extent of an ischemic lesion or perfusion deficit on nuclear imaging predicts the patient's prognosis.
Disadvantages of the approach include poor spatial resolution, radiation exposure, cost, poor assessment of flow, and uncertain availability of the tracer for PET scanning.
Some newer applications of nuclear cardiology may be more exciting, Dr. Friedrich said. Animal studies suggest that accumulation of a tracer may correlate with the activity of a plaque. Nuclear medicine may allow visualization of matrix metalloproteinases, an important component of plaque stability, or visualization of apoptosis. To overcome the poor spatial resolution, studies are underway to fuse CT and nuclear images to overlay anatomic images with metabolic details.
P CMR. Although not as good as nuclear medicine for assessing metabolism—“not yet, at least,” he said—CMR provides good structural images and is very good for assessing function.
It is noninvasive, safe, and versatile. It is especially good at tissue characterization but also good for assessing function and flow. “It has the largest future potential because we have not started to exploit all the options in molecular imaging” with CMR, he said.
CMR is complex to perform, however, and it is costly because both image acquisition and evaluation take too long under current protocols.
“We're working on getting evaluations done in a few minutes” instead of the typical half-hour, he said.
Experimental uses of CMR suggest that it could allow clinicians to assess cardiac pathophysiology directly instead of surrogate markers, Dr. Friedrich said.
Recent, unpublished studies in animals report that CMR visualized ischemia-induced intracellular edema, which showed up before the irreversible injury of acute infarction.
Dr. Friedrich and his associates now are studying CMR for triage of emergency department patients with suspected acute coronary syndrome who don't have troponin levels or echocardiography results that warrant sending them straight to the catheterization lab.
“According to the guidelines, you have to wait a couple of hours and repeat the troponin. If you are unlucky, this was an infarct, and during those 4, 6, or 10 hours you have lost most of the myocardium you could have salvaged,” he said.
Under their CMR protocol, intracellular edema can be identified quickly, and those patients are sent to the cath lab within minutes of intake. Patients with negative results in the multistep protocol are being sent home before ordering a second troponin test.
“This is just one example where tissue characterization, without using a contrast agent, can be very, very helpful in a daily clinical setting,” he said. He estimated that the hospital would save $1 million Canadian dollars per year from the earlier discharges and avoidance of extra exercise stress tests.
Cardiovascular magnetic resonance produced these functional (left) and structural images (right); arrows show infarcted areas. Photos courtesy Dr. Matthias G. Friedrich
SAN FRANCISCO — Echocardiography provides adequate imaging for most cardiac patients, but when more information is needed, clinicians choose from three imaging methods that bring different strengths and weaknesses.
Of the three options—CT scans, nuclear medicine, or cardiovascular magnetic resonance (CMR) imaging—the one that probably provides the most information and holds the greatest potential for future applications is CMR, Dr. Matthias G. Friedrich said at a meeting sponsored by the California chapter of the American College of Cardiology.
“If I had to pick one,” it would be CMR, said Dr. Friedrich, director of the Stephenson Cardiovascular Magnetic Resonance Centre at the Libin Cardiovascular Institute of Alberta, Canada. He reported having no financial affiliation with companies that make the technologies that he discussed.
Dr. Friedrich weighed the advantages and disadvantages of each modality:
P CT. A CT scan provides excellent imaging of cardiovascular structures but is less helpful for assessing function or metabolism.
The spatial accuracy of CT scans is unbeaten for describing morphology. They are fast and relatively easy to perform. “You push a button, and you wait for a couple of seconds. Then you wait for a couple of minutes to have the automatic CT rendering done. You get nice images,” he said at the meeting, also sponsored by the University of California, San Francisco.
On the downside, 1 in every 1,000 patients undergoing CT scans will develop cancer from the radiation, he said. CT is not very good for tissue characterization or functional assessment, and not good at all for imaging blood flow. CT can visualize and quantify calcium, but calcium plaques generally provide little prognostic value. The technology is approaching the peak of its capabilities.
“It does not have a huge future potential,” he added.
P Nuclear medicine. Although very good at assessing metabolism, nuclear medicine is only so-so for imaging structures and is not very good at assessing function.
Its strengths are very specific metabolic information and strong prognostic value. A solid body of data shows that the extent of an ischemic lesion or perfusion deficit on nuclear imaging predicts the patient's prognosis.
Disadvantages of the approach include poor spatial resolution, radiation exposure, cost, poor assessment of flow, and uncertain availability of the tracer for PET scanning.
Some newer applications of nuclear cardiology may be more exciting, Dr. Friedrich said. Animal studies suggest that accumulation of a tracer may correlate with the activity of a plaque. Nuclear medicine may allow visualization of matrix metalloproteinases, an important component of plaque stability, or visualization of apoptosis. To overcome the poor spatial resolution, studies are underway to fuse CT and nuclear images to overlay anatomic images with metabolic details.
P CMR. Although not as good as nuclear medicine for assessing metabolism—“not yet, at least,” he said—CMR provides good structural images and is very good for assessing function.
It is noninvasive, safe, and versatile. It is especially good at tissue characterization but also good for assessing function and flow. “It has the largest future potential because we have not started to exploit all the options in molecular imaging” with CMR, he said.
CMR is complex to perform, however, and it is costly because both image acquisition and evaluation take too long under current protocols.
“We're working on getting evaluations done in a few minutes” instead of the typical half-hour, he said.
Experimental uses of CMR suggest that it could allow clinicians to assess cardiac pathophysiology directly instead of surrogate markers, Dr. Friedrich said.
Recent, unpublished studies in animals report that CMR visualized ischemia-induced intracellular edema, which showed up before the irreversible injury of acute infarction.
Dr. Friedrich and his associates now are studying CMR for triage of emergency department patients with suspected acute coronary syndrome who don't have troponin levels or echocardiography results that warrant sending them straight to the catheterization lab.
“According to the guidelines, you have to wait a couple of hours and repeat the troponin. If you are unlucky, this was an infarct, and during those 4, 6, or 10 hours you have lost most of the myocardium you could have salvaged,” he said.
Under their CMR protocol, intracellular edema can be identified quickly, and those patients are sent to the cath lab within minutes of intake. Patients with negative results in the multistep protocol are being sent home before ordering a second troponin test.
“This is just one example where tissue characterization, without using a contrast agent, can be very, very helpful in a daily clinical setting,” he said. He estimated that the hospital would save $1 million Canadian dollars per year from the earlier discharges and avoidance of extra exercise stress tests.
Cardiovascular magnetic resonance produced these functional (left) and structural images (right); arrows show infarcted areas. Photos courtesy Dr. Matthias G. Friedrich
SAN FRANCISCO — Echocardiography provides adequate imaging for most cardiac patients, but when more information is needed, clinicians choose from three imaging methods that bring different strengths and weaknesses.
Of the three options—CT scans, nuclear medicine, or cardiovascular magnetic resonance (CMR) imaging—the one that probably provides the most information and holds the greatest potential for future applications is CMR, Dr. Matthias G. Friedrich said at a meeting sponsored by the California chapter of the American College of Cardiology.
“If I had to pick one,” it would be CMR, said Dr. Friedrich, director of the Stephenson Cardiovascular Magnetic Resonance Centre at the Libin Cardiovascular Institute of Alberta, Canada. He reported having no financial affiliation with companies that make the technologies that he discussed.
Dr. Friedrich weighed the advantages and disadvantages of each modality:
P CT. A CT scan provides excellent imaging of cardiovascular structures but is less helpful for assessing function or metabolism.
The spatial accuracy of CT scans is unbeaten for describing morphology. They are fast and relatively easy to perform. “You push a button, and you wait for a couple of seconds. Then you wait for a couple of minutes to have the automatic CT rendering done. You get nice images,” he said at the meeting, also sponsored by the University of California, San Francisco.
On the downside, 1 in every 1,000 patients undergoing CT scans will develop cancer from the radiation, he said. CT is not very good for tissue characterization or functional assessment, and not good at all for imaging blood flow. CT can visualize and quantify calcium, but calcium plaques generally provide little prognostic value. The technology is approaching the peak of its capabilities.
“It does not have a huge future potential,” he added.
P Nuclear medicine. Although very good at assessing metabolism, nuclear medicine is only so-so for imaging structures and is not very good at assessing function.
Its strengths are very specific metabolic information and strong prognostic value. A solid body of data shows that the extent of an ischemic lesion or perfusion deficit on nuclear imaging predicts the patient's prognosis.
Disadvantages of the approach include poor spatial resolution, radiation exposure, cost, poor assessment of flow, and uncertain availability of the tracer for PET scanning.
Some newer applications of nuclear cardiology may be more exciting, Dr. Friedrich said. Animal studies suggest that accumulation of a tracer may correlate with the activity of a plaque. Nuclear medicine may allow visualization of matrix metalloproteinases, an important component of plaque stability, or visualization of apoptosis. To overcome the poor spatial resolution, studies are underway to fuse CT and nuclear images to overlay anatomic images with metabolic details.
P CMR. Although not as good as nuclear medicine for assessing metabolism—“not yet, at least,” he said—CMR provides good structural images and is very good for assessing function.
It is noninvasive, safe, and versatile. It is especially good at tissue characterization but also good for assessing function and flow. “It has the largest future potential because we have not started to exploit all the options in molecular imaging” with CMR, he said.
CMR is complex to perform, however, and it is costly because both image acquisition and evaluation take too long under current protocols.
“We're working on getting evaluations done in a few minutes” instead of the typical half-hour, he said.
Experimental uses of CMR suggest that it could allow clinicians to assess cardiac pathophysiology directly instead of surrogate markers, Dr. Friedrich said.
Recent, unpublished studies in animals report that CMR visualized ischemia-induced intracellular edema, which showed up before the irreversible injury of acute infarction.
Dr. Friedrich and his associates now are studying CMR for triage of emergency department patients with suspected acute coronary syndrome who don't have troponin levels or echocardiography results that warrant sending them straight to the catheterization lab.
“According to the guidelines, you have to wait a couple of hours and repeat the troponin. If you are unlucky, this was an infarct, and during those 4, 6, or 10 hours you have lost most of the myocardium you could have salvaged,” he said.
Under their CMR protocol, intracellular edema can be identified quickly, and those patients are sent to the cath lab within minutes of intake. Patients with negative results in the multistep protocol are being sent home before ordering a second troponin test.
“This is just one example where tissue characterization, without using a contrast agent, can be very, very helpful in a daily clinical setting,” he said. He estimated that the hospital would save $1 million Canadian dollars per year from the earlier discharges and avoidance of extra exercise stress tests.
Cardiovascular magnetic resonance produced these functional (left) and structural images (right); arrows show infarcted areas. Photos courtesy Dr. Matthias G. Friedrich
New Obesity Group to Tackle Policy Challenges
SAN DIEGO — The recent merger of two obesity associations to create the Obesity Society is expected to consolidate efforts to influence government programs and funding for the obesity epidemic, Richard M. Downey, J.D., said at a symposium on obesity sponsored by the American Society of Bariatric Physicians.
Mr. Downey is a staff member for the North American Association for the Study of Obesity, which has been renamed the Obesity Society. In December 2006, the association completed a merger with the American Obesity Association, where Mr. Downey previously was executive director.
He highlighted some of the successes and continuing struggles in the effort to increase government attention to obesity.
Although the Department of Health and Human Services (DHHS) Healthy People 2010 report prominently listed obesity as a leading health indicator, little has been done on the DHHS level to address the problem, he said. Although the stated goal was to decrease the prevalence of obesity in adults and adolescents by 10% by 2010, the prevalence is on track to increase 10% by then—the only leading health indicator moving in the opposite direction of the goal. Today, about 60% of U.S. adults are overweight or obese.
The new Obesity Society will push for creation of a National Institute of Obesity Research, he said. The National Institutes of Health (NIH) spends around $450 million per year on obesity research, but spends 6 times that amount on diabetes, 10 times that amount on cardiovascular disease, and 15 times that amount on HIV and AIDS research, he added.
“A few years ago, obesity got the same amount of research funding as anthrax, which was responsible for five deaths,” he noted.
The NIH did develop a 4-year plan for research on obesity, but NIH research funding for obesity is grant driven, without an initial commitment of government funding as applied to other problems such as HIV or bioterrorism, he added.
In activities by other federal agencies, the Food and Drug Administration posts links to resources for tackling obesity (www.fda.gov/loseweight/obesity_info.htm
On the positive side, 18 states receive funding from the Centers for Disease Control and Prevention to address pediatric obesity. In addition, the Centers for Medicare and Medicaid Services in 2004 deleted language from its policies that said obesity is not a disease, and in 2005 expanded coverage for bariatric surgery for obesity at Centers of Excellence. Prior to those actions, insurers were abandoning coverage of bariatric surgery, Mr. Downey said.
His and others' efforts to get obesity medications included in Medicare drug benefits have been unsuccessful, and Medicare still does not cover physician counseling for weight loss. “We will continue to lobby for these,” he said. Mr. Downey has been an adviser to Eli Lilly & Co. and to Amylin Pharmaceuticals Inc., which make obesity drugs.
Actions by other federal agencies sometimes conflict with efforts to decrease obesity, he noted. Some of the $35 million allocated to agricultural subsidies go to programs to increase food consumption. In 2006, Congress appropriated $1.3 billion to subsidize the cost of high-definition television converter boxes. The amount of TV viewing correlates with excess weight, studies have shown.
The Obesity Society is likely to demand better evaluation of obesity prevention programs, Mr. Downey said. The lack of coordination and evaluation of programs to prevent childhood obesity makes it impossible to learn from experience and difficult to replicate successes, a recent Institute of Medicine report suggests.
SAN DIEGO — The recent merger of two obesity associations to create the Obesity Society is expected to consolidate efforts to influence government programs and funding for the obesity epidemic, Richard M. Downey, J.D., said at a symposium on obesity sponsored by the American Society of Bariatric Physicians.
Mr. Downey is a staff member for the North American Association for the Study of Obesity, which has been renamed the Obesity Society. In December 2006, the association completed a merger with the American Obesity Association, where Mr. Downey previously was executive director.
He highlighted some of the successes and continuing struggles in the effort to increase government attention to obesity.
Although the Department of Health and Human Services (DHHS) Healthy People 2010 report prominently listed obesity as a leading health indicator, little has been done on the DHHS level to address the problem, he said. Although the stated goal was to decrease the prevalence of obesity in adults and adolescents by 10% by 2010, the prevalence is on track to increase 10% by then—the only leading health indicator moving in the opposite direction of the goal. Today, about 60% of U.S. adults are overweight or obese.
The new Obesity Society will push for creation of a National Institute of Obesity Research, he said. The National Institutes of Health (NIH) spends around $450 million per year on obesity research, but spends 6 times that amount on diabetes, 10 times that amount on cardiovascular disease, and 15 times that amount on HIV and AIDS research, he added.
“A few years ago, obesity got the same amount of research funding as anthrax, which was responsible for five deaths,” he noted.
The NIH did develop a 4-year plan for research on obesity, but NIH research funding for obesity is grant driven, without an initial commitment of government funding as applied to other problems such as HIV or bioterrorism, he added.
In activities by other federal agencies, the Food and Drug Administration posts links to resources for tackling obesity (www.fda.gov/loseweight/obesity_info.htm
On the positive side, 18 states receive funding from the Centers for Disease Control and Prevention to address pediatric obesity. In addition, the Centers for Medicare and Medicaid Services in 2004 deleted language from its policies that said obesity is not a disease, and in 2005 expanded coverage for bariatric surgery for obesity at Centers of Excellence. Prior to those actions, insurers were abandoning coverage of bariatric surgery, Mr. Downey said.
His and others' efforts to get obesity medications included in Medicare drug benefits have been unsuccessful, and Medicare still does not cover physician counseling for weight loss. “We will continue to lobby for these,” he said. Mr. Downey has been an adviser to Eli Lilly & Co. and to Amylin Pharmaceuticals Inc., which make obesity drugs.
Actions by other federal agencies sometimes conflict with efforts to decrease obesity, he noted. Some of the $35 million allocated to agricultural subsidies go to programs to increase food consumption. In 2006, Congress appropriated $1.3 billion to subsidize the cost of high-definition television converter boxes. The amount of TV viewing correlates with excess weight, studies have shown.
The Obesity Society is likely to demand better evaluation of obesity prevention programs, Mr. Downey said. The lack of coordination and evaluation of programs to prevent childhood obesity makes it impossible to learn from experience and difficult to replicate successes, a recent Institute of Medicine report suggests.
SAN DIEGO — The recent merger of two obesity associations to create the Obesity Society is expected to consolidate efforts to influence government programs and funding for the obesity epidemic, Richard M. Downey, J.D., said at a symposium on obesity sponsored by the American Society of Bariatric Physicians.
Mr. Downey is a staff member for the North American Association for the Study of Obesity, which has been renamed the Obesity Society. In December 2006, the association completed a merger with the American Obesity Association, where Mr. Downey previously was executive director.
He highlighted some of the successes and continuing struggles in the effort to increase government attention to obesity.
Although the Department of Health and Human Services (DHHS) Healthy People 2010 report prominently listed obesity as a leading health indicator, little has been done on the DHHS level to address the problem, he said. Although the stated goal was to decrease the prevalence of obesity in adults and adolescents by 10% by 2010, the prevalence is on track to increase 10% by then—the only leading health indicator moving in the opposite direction of the goal. Today, about 60% of U.S. adults are overweight or obese.
The new Obesity Society will push for creation of a National Institute of Obesity Research, he said. The National Institutes of Health (NIH) spends around $450 million per year on obesity research, but spends 6 times that amount on diabetes, 10 times that amount on cardiovascular disease, and 15 times that amount on HIV and AIDS research, he added.
“A few years ago, obesity got the same amount of research funding as anthrax, which was responsible for five deaths,” he noted.
The NIH did develop a 4-year plan for research on obesity, but NIH research funding for obesity is grant driven, without an initial commitment of government funding as applied to other problems such as HIV or bioterrorism, he added.
In activities by other federal agencies, the Food and Drug Administration posts links to resources for tackling obesity (www.fda.gov/loseweight/obesity_info.htm
On the positive side, 18 states receive funding from the Centers for Disease Control and Prevention to address pediatric obesity. In addition, the Centers for Medicare and Medicaid Services in 2004 deleted language from its policies that said obesity is not a disease, and in 2005 expanded coverage for bariatric surgery for obesity at Centers of Excellence. Prior to those actions, insurers were abandoning coverage of bariatric surgery, Mr. Downey said.
His and others' efforts to get obesity medications included in Medicare drug benefits have been unsuccessful, and Medicare still does not cover physician counseling for weight loss. “We will continue to lobby for these,” he said. Mr. Downey has been an adviser to Eli Lilly & Co. and to Amylin Pharmaceuticals Inc., which make obesity drugs.
Actions by other federal agencies sometimes conflict with efforts to decrease obesity, he noted. Some of the $35 million allocated to agricultural subsidies go to programs to increase food consumption. In 2006, Congress appropriated $1.3 billion to subsidize the cost of high-definition television converter boxes. The amount of TV viewing correlates with excess weight, studies have shown.
The Obesity Society is likely to demand better evaluation of obesity prevention programs, Mr. Downey said. The lack of coordination and evaluation of programs to prevent childhood obesity makes it impossible to learn from experience and difficult to replicate successes, a recent Institute of Medicine report suggests.
Low Carb Beats Low Fat for Lipids and Weight Loss
SAN DIEGO — People on very-low-carbohydrate diets who consumed three times as much daily saturated fat as people on high-carbohydrate, low-fat diets, lost more weight and had twice the reduction in saturated fat levels compared with the latter, according to a report on a small study presented at a symposium on obesity sponsored by the American Society of Bariatric Physicians.
“If you still believe that you are what you eat, [you are] wrong. You are what you save when you eat,” because the level of carbohydrate intake dictates how the body makes use of dietary fatty acids, Dr. Stephen D. Phinney said.
Total circulating saturated fats decreased by 57% over the 12-week study on the low-carbohydrate diet and by 24% on the low-fat diet, he reported.
The unpublished data came from a recent randomized study of 40 patients that was led by Jeff S. Volek, Ph.D., of the University of Connecticut, Storrs, with Dr. Phinney and associates.
Two groups of 20 patients (10 men and 10 women in each) with triglyceride levels above 150 mg/dL and low HDL-cholesterol levels (less than 40 mg/dL in men or less than 50 mg/dL in women) were put on either a low-carbohydrate, ketogenic diet or on a low-fat, high-carbohydrate diet.
All of the patients consumed about 1,500 calories per day. The low-carbohydrate diet contained more protein than the low-fat diet (28% of calories vs. 20%, respectively), more total fat (59% vs. 24%), and more saturated fat (37 g/day vs. 12 g/day).
Although people tend to assume that the low-carbohydrate diet “would be dangerous with all that fat,” said Dr. Phinney of Elk Grove, Calif., and a professor of medicine, emeritus, University of California, Davis, patients in the low-carbohydrate group lost more weight than did those on the low-fat diet (10 kg vs. 5 kg) and more fat (6 kg vs. 4 kg).
In addition, those on the low-carbohydrate diet also lost more abdominal fat (828 g), compared with those in the low-fat diet group (526 g).
Besides fat loss, water loss accounted for most of the weight loss, he said.
The study results suggested benefits in lipid levels, Dr. Phinney reported. Triglyceride levels decreased by 51% on the low-carbohydrate diet and by 19% on the low-fat diet. HDL-cholesterol levels increased by 13% on the low-carbohydrate diet and remained essentially unchanged on the low-fat diet.
There were no significant differences between groups in LDL-cholesterol levels, although LDL-cholesterol particle size increased by 3% in the low-carbohydrate group and did not change in the low-fat group. This may be significant because smaller, denser LDL particles increase cardiovascular risk, said Dr. Phinney.
Saturated fats as a percentage of triglycerides decreased by 12% in the low-carbohydrate group and by 5% in the low-fat group.
Fatty acids esterified to cholesterol ester decreased by 10% in the low-carbohydrate group and by 5% in the low-fat group.
“So it's a uniform decrease in both compartments of circulating lipids,” he said.
Dietary saturated fatty acids seem to be of much less concern when consumed during a carbohydrate-restricted diet, Dr. Phinney explained.
“The human machinery [seems to be] well equipped to handle this kind of diet,” he said.
He also reviewed separate data showing that serum cholesterol levels tend to decrease during weight loss of up to 10% of body weight in people on low-carbohydrate diets.
Total cholesterol and LDL-cholesterol levels then rise transiently as weight loss approaches 20% of baseline body weight, but lipid levels stabilize (with decreases in LDL cholesterol and increases in HDL) when the patient switches to a maintenance diet.
“If you look at cholesterol during weight loss, this can be alarming, but it's pre-owned” cholesterol that was stored in fat cells and is secreted into plasma during weight loss on low-carbohydrate diets, he explained. Return to a maintenance diet should stabilize lipid levels, he noted.
SAN DIEGO — People on very-low-carbohydrate diets who consumed three times as much daily saturated fat as people on high-carbohydrate, low-fat diets, lost more weight and had twice the reduction in saturated fat levels compared with the latter, according to a report on a small study presented at a symposium on obesity sponsored by the American Society of Bariatric Physicians.
“If you still believe that you are what you eat, [you are] wrong. You are what you save when you eat,” because the level of carbohydrate intake dictates how the body makes use of dietary fatty acids, Dr. Stephen D. Phinney said.
Total circulating saturated fats decreased by 57% over the 12-week study on the low-carbohydrate diet and by 24% on the low-fat diet, he reported.
The unpublished data came from a recent randomized study of 40 patients that was led by Jeff S. Volek, Ph.D., of the University of Connecticut, Storrs, with Dr. Phinney and associates.
Two groups of 20 patients (10 men and 10 women in each) with triglyceride levels above 150 mg/dL and low HDL-cholesterol levels (less than 40 mg/dL in men or less than 50 mg/dL in women) were put on either a low-carbohydrate, ketogenic diet or on a low-fat, high-carbohydrate diet.
All of the patients consumed about 1,500 calories per day. The low-carbohydrate diet contained more protein than the low-fat diet (28% of calories vs. 20%, respectively), more total fat (59% vs. 24%), and more saturated fat (37 g/day vs. 12 g/day).
Although people tend to assume that the low-carbohydrate diet “would be dangerous with all that fat,” said Dr. Phinney of Elk Grove, Calif., and a professor of medicine, emeritus, University of California, Davis, patients in the low-carbohydrate group lost more weight than did those on the low-fat diet (10 kg vs. 5 kg) and more fat (6 kg vs. 4 kg).
In addition, those on the low-carbohydrate diet also lost more abdominal fat (828 g), compared with those in the low-fat diet group (526 g).
Besides fat loss, water loss accounted for most of the weight loss, he said.
The study results suggested benefits in lipid levels, Dr. Phinney reported. Triglyceride levels decreased by 51% on the low-carbohydrate diet and by 19% on the low-fat diet. HDL-cholesterol levels increased by 13% on the low-carbohydrate diet and remained essentially unchanged on the low-fat diet.
There were no significant differences between groups in LDL-cholesterol levels, although LDL-cholesterol particle size increased by 3% in the low-carbohydrate group and did not change in the low-fat group. This may be significant because smaller, denser LDL particles increase cardiovascular risk, said Dr. Phinney.
Saturated fats as a percentage of triglycerides decreased by 12% in the low-carbohydrate group and by 5% in the low-fat group.
Fatty acids esterified to cholesterol ester decreased by 10% in the low-carbohydrate group and by 5% in the low-fat group.
“So it's a uniform decrease in both compartments of circulating lipids,” he said.
Dietary saturated fatty acids seem to be of much less concern when consumed during a carbohydrate-restricted diet, Dr. Phinney explained.
“The human machinery [seems to be] well equipped to handle this kind of diet,” he said.
He also reviewed separate data showing that serum cholesterol levels tend to decrease during weight loss of up to 10% of body weight in people on low-carbohydrate diets.
Total cholesterol and LDL-cholesterol levels then rise transiently as weight loss approaches 20% of baseline body weight, but lipid levels stabilize (with decreases in LDL cholesterol and increases in HDL) when the patient switches to a maintenance diet.
“If you look at cholesterol during weight loss, this can be alarming, but it's pre-owned” cholesterol that was stored in fat cells and is secreted into plasma during weight loss on low-carbohydrate diets, he explained. Return to a maintenance diet should stabilize lipid levels, he noted.
SAN DIEGO — People on very-low-carbohydrate diets who consumed three times as much daily saturated fat as people on high-carbohydrate, low-fat diets, lost more weight and had twice the reduction in saturated fat levels compared with the latter, according to a report on a small study presented at a symposium on obesity sponsored by the American Society of Bariatric Physicians.
“If you still believe that you are what you eat, [you are] wrong. You are what you save when you eat,” because the level of carbohydrate intake dictates how the body makes use of dietary fatty acids, Dr. Stephen D. Phinney said.
Total circulating saturated fats decreased by 57% over the 12-week study on the low-carbohydrate diet and by 24% on the low-fat diet, he reported.
The unpublished data came from a recent randomized study of 40 patients that was led by Jeff S. Volek, Ph.D., of the University of Connecticut, Storrs, with Dr. Phinney and associates.
Two groups of 20 patients (10 men and 10 women in each) with triglyceride levels above 150 mg/dL and low HDL-cholesterol levels (less than 40 mg/dL in men or less than 50 mg/dL in women) were put on either a low-carbohydrate, ketogenic diet or on a low-fat, high-carbohydrate diet.
All of the patients consumed about 1,500 calories per day. The low-carbohydrate diet contained more protein than the low-fat diet (28% of calories vs. 20%, respectively), more total fat (59% vs. 24%), and more saturated fat (37 g/day vs. 12 g/day).
Although people tend to assume that the low-carbohydrate diet “would be dangerous with all that fat,” said Dr. Phinney of Elk Grove, Calif., and a professor of medicine, emeritus, University of California, Davis, patients in the low-carbohydrate group lost more weight than did those on the low-fat diet (10 kg vs. 5 kg) and more fat (6 kg vs. 4 kg).
In addition, those on the low-carbohydrate diet also lost more abdominal fat (828 g), compared with those in the low-fat diet group (526 g).
Besides fat loss, water loss accounted for most of the weight loss, he said.
The study results suggested benefits in lipid levels, Dr. Phinney reported. Triglyceride levels decreased by 51% on the low-carbohydrate diet and by 19% on the low-fat diet. HDL-cholesterol levels increased by 13% on the low-carbohydrate diet and remained essentially unchanged on the low-fat diet.
There were no significant differences between groups in LDL-cholesterol levels, although LDL-cholesterol particle size increased by 3% in the low-carbohydrate group and did not change in the low-fat group. This may be significant because smaller, denser LDL particles increase cardiovascular risk, said Dr. Phinney.
Saturated fats as a percentage of triglycerides decreased by 12% in the low-carbohydrate group and by 5% in the low-fat group.
Fatty acids esterified to cholesterol ester decreased by 10% in the low-carbohydrate group and by 5% in the low-fat group.
“So it's a uniform decrease in both compartments of circulating lipids,” he said.
Dietary saturated fatty acids seem to be of much less concern when consumed during a carbohydrate-restricted diet, Dr. Phinney explained.
“The human machinery [seems to be] well equipped to handle this kind of diet,” he said.
He also reviewed separate data showing that serum cholesterol levels tend to decrease during weight loss of up to 10% of body weight in people on low-carbohydrate diets.
Total cholesterol and LDL-cholesterol levels then rise transiently as weight loss approaches 20% of baseline body weight, but lipid levels stabilize (with decreases in LDL cholesterol and increases in HDL) when the patient switches to a maintenance diet.
“If you look at cholesterol during weight loss, this can be alarming, but it's pre-owned” cholesterol that was stored in fat cells and is secreted into plasma during weight loss on low-carbohydrate diets, he explained. Return to a maintenance diet should stabilize lipid levels, he noted.
Immune Modulation Helps Some HF Patients
SEATTLE — Immune modulation therapy for patients with chronic heart failure did not reduce deaths or hospitalizations but was helpful in two subsets of patients in a 2,426-patient trial, Dr. Guillermo Torre-Amione reported.
Prespecified subgroup analyses found fewer deaths or hospitalizations with Celacade immune modulation therapy than with placebo in patients with New York Heart Association (NYHA) class II heart failure and in patients with class III-IV heart failure but no history of MI, he said at the annual meeting of the Heart Failure Society of America.
The randomized, double-blind, placebo-controlled Advanced Chronic Heart Failure Clinical Assessment of Immune Modulation Therapy (ACCLAIM) trial showed that the Celacade technology was safe and well tolerated and “helpful in heart failure from nonischemic etiology, and in patients with ischemic etiology who have not yet reached more advanced disease stages,” said Dr. Torre-Amione, medical director at the Methodist DeBakey Heart Center, Houston, and his associates.
Dr. Torre-Amione has received honoraria and research funding from Vasogen Inc., which funded the trial and owns the experimental Celacade technology.
Celacade therapy targets the chronic inflammation associated with cardiovascular disease. Samples of whole blood taken from patients randomized to Celacade therapy were subjected to oxidative stress and returned to patients via intramuscular injection. The oxidative stress induces cell apoptosis and triggers other reactions that increase production of anti-inflammatory cytokines and regulatory T cells that help reduce chronic inflammation, the investigators said.
Outpatient treatment with the 10-mL blood samples took place on days 1, 2, and 14, then every 30 days for 22 weeks or longer during June 2003-November 2005. All patients were on standard medications for heart failure, as tolerated. The mean follow-up in the study was 10 months.
There was no significant difference at 600 days between the Celacade and placebo groups in the primary combined end point of death from any cause or hospitalization for cardiovascular reasons. Quality-of-life scores were significantly better in the Celacade group than in placebo patients in preplanned analyses of secondary end points. The number of serious adverse events was similar between groups, as was the number of patients with more than one serious adverse event.
Among 900 patients with no prior MI, however, there were 26% fewer deaths or cardiovascular hospitalizations with Celacade compared with placebo, and patients fared better on secondary end points with Celacade as well, Dr. Torre-Amione said.
Among 700 patients with NYHA class II heart failure, there were 29% fewer deaths or cardiovascular hospitalizations with Celacade compared with placebo.
In a separate analysis of a combined group of 1,300 patients (about half of all patients in the study) with either class II heart failure or class III-IV but no history of MI, there were 165 deaths or heart failure hospitalizations in the Celacade group, compared with 226 in the placebo group, a highly statistically significant difference. In addition, the Celacade group had fewer mean days in the hospital for heart failure or for any cause, he said.
The study took place in 177 centers in North America, Europe, and Israel. Patients predominantly were white males and had a mean age of 64 years. All had a baseline ejection fraction of 30% or less and prior hospitalization (or outpatient treatment with IV medication) for heart failure within the previous 12 months. Sixty-two percent of patients had a history of MI.
SEATTLE — Immune modulation therapy for patients with chronic heart failure did not reduce deaths or hospitalizations but was helpful in two subsets of patients in a 2,426-patient trial, Dr. Guillermo Torre-Amione reported.
Prespecified subgroup analyses found fewer deaths or hospitalizations with Celacade immune modulation therapy than with placebo in patients with New York Heart Association (NYHA) class II heart failure and in patients with class III-IV heart failure but no history of MI, he said at the annual meeting of the Heart Failure Society of America.
The randomized, double-blind, placebo-controlled Advanced Chronic Heart Failure Clinical Assessment of Immune Modulation Therapy (ACCLAIM) trial showed that the Celacade technology was safe and well tolerated and “helpful in heart failure from nonischemic etiology, and in patients with ischemic etiology who have not yet reached more advanced disease stages,” said Dr. Torre-Amione, medical director at the Methodist DeBakey Heart Center, Houston, and his associates.
Dr. Torre-Amione has received honoraria and research funding from Vasogen Inc., which funded the trial and owns the experimental Celacade technology.
Celacade therapy targets the chronic inflammation associated with cardiovascular disease. Samples of whole blood taken from patients randomized to Celacade therapy were subjected to oxidative stress and returned to patients via intramuscular injection. The oxidative stress induces cell apoptosis and triggers other reactions that increase production of anti-inflammatory cytokines and regulatory T cells that help reduce chronic inflammation, the investigators said.
Outpatient treatment with the 10-mL blood samples took place on days 1, 2, and 14, then every 30 days for 22 weeks or longer during June 2003-November 2005. All patients were on standard medications for heart failure, as tolerated. The mean follow-up in the study was 10 months.
There was no significant difference at 600 days between the Celacade and placebo groups in the primary combined end point of death from any cause or hospitalization for cardiovascular reasons. Quality-of-life scores were significantly better in the Celacade group than in placebo patients in preplanned analyses of secondary end points. The number of serious adverse events was similar between groups, as was the number of patients with more than one serious adverse event.
Among 900 patients with no prior MI, however, there were 26% fewer deaths or cardiovascular hospitalizations with Celacade compared with placebo, and patients fared better on secondary end points with Celacade as well, Dr. Torre-Amione said.
Among 700 patients with NYHA class II heart failure, there were 29% fewer deaths or cardiovascular hospitalizations with Celacade compared with placebo.
In a separate analysis of a combined group of 1,300 patients (about half of all patients in the study) with either class II heart failure or class III-IV but no history of MI, there were 165 deaths or heart failure hospitalizations in the Celacade group, compared with 226 in the placebo group, a highly statistically significant difference. In addition, the Celacade group had fewer mean days in the hospital for heart failure or for any cause, he said.
The study took place in 177 centers in North America, Europe, and Israel. Patients predominantly were white males and had a mean age of 64 years. All had a baseline ejection fraction of 30% or less and prior hospitalization (or outpatient treatment with IV medication) for heart failure within the previous 12 months. Sixty-two percent of patients had a history of MI.
SEATTLE — Immune modulation therapy for patients with chronic heart failure did not reduce deaths or hospitalizations but was helpful in two subsets of patients in a 2,426-patient trial, Dr. Guillermo Torre-Amione reported.
Prespecified subgroup analyses found fewer deaths or hospitalizations with Celacade immune modulation therapy than with placebo in patients with New York Heart Association (NYHA) class II heart failure and in patients with class III-IV heart failure but no history of MI, he said at the annual meeting of the Heart Failure Society of America.
The randomized, double-blind, placebo-controlled Advanced Chronic Heart Failure Clinical Assessment of Immune Modulation Therapy (ACCLAIM) trial showed that the Celacade technology was safe and well tolerated and “helpful in heart failure from nonischemic etiology, and in patients with ischemic etiology who have not yet reached more advanced disease stages,” said Dr. Torre-Amione, medical director at the Methodist DeBakey Heart Center, Houston, and his associates.
Dr. Torre-Amione has received honoraria and research funding from Vasogen Inc., which funded the trial and owns the experimental Celacade technology.
Celacade therapy targets the chronic inflammation associated with cardiovascular disease. Samples of whole blood taken from patients randomized to Celacade therapy were subjected to oxidative stress and returned to patients via intramuscular injection. The oxidative stress induces cell apoptosis and triggers other reactions that increase production of anti-inflammatory cytokines and regulatory T cells that help reduce chronic inflammation, the investigators said.
Outpatient treatment with the 10-mL blood samples took place on days 1, 2, and 14, then every 30 days for 22 weeks or longer during June 2003-November 2005. All patients were on standard medications for heart failure, as tolerated. The mean follow-up in the study was 10 months.
There was no significant difference at 600 days between the Celacade and placebo groups in the primary combined end point of death from any cause or hospitalization for cardiovascular reasons. Quality-of-life scores were significantly better in the Celacade group than in placebo patients in preplanned analyses of secondary end points. The number of serious adverse events was similar between groups, as was the number of patients with more than one serious adverse event.
Among 900 patients with no prior MI, however, there were 26% fewer deaths or cardiovascular hospitalizations with Celacade compared with placebo, and patients fared better on secondary end points with Celacade as well, Dr. Torre-Amione said.
Among 700 patients with NYHA class II heart failure, there were 29% fewer deaths or cardiovascular hospitalizations with Celacade compared with placebo.
In a separate analysis of a combined group of 1,300 patients (about half of all patients in the study) with either class II heart failure or class III-IV but no history of MI, there were 165 deaths or heart failure hospitalizations in the Celacade group, compared with 226 in the placebo group, a highly statistically significant difference. In addition, the Celacade group had fewer mean days in the hospital for heart failure or for any cause, he said.
The study took place in 177 centers in North America, Europe, and Israel. Patients predominantly were white males and had a mean age of 64 years. All had a baseline ejection fraction of 30% or less and prior hospitalization (or outpatient treatment with IV medication) for heart failure within the previous 12 months. Sixty-two percent of patients had a history of MI.
Young Patient With Chest Pain? Suspect Cocaine
SAN FRANCISCO — Consider cocaine use when diagnosing chest pain, especially in young patients, Dr. Priscilla Hsue said at a meeting sponsored by the California chapter of the American College of Cardiology.
In 2004, 2 million Americans were cocaine users, and cocaine was the most frequently used illicit drug among patients seeking care in emergency departments. Yet one study found that only 13% of patients who presented with chest pain to an emergency department were assessed for cocaine use.
“I was covering the cardiology service a couple of weeks ago, and almost every day 50% of our admissions were for some kind of side effect from cocaine,” said Dr. Hsue of San Francisco General Hospital. “This is something we see so often.”
About 6% of patients with cocaine-associated chest pain seen in emergency departments develop MI. Patients with cocaine-related chest pain, unstable angina, or MI tend to be younger than 40 years old, male, and cigarette smokers who have no other risk factors for coronary artery disease. Chronic and first-time cocaine users have the same risk for MI. Symptoms can appear within minutes or hours after exposure to any dose of cocaine via any route—smoking, snorting, or ingesting.
Cocaine increases the risk of MI 24-fold within 1 hour of use, with the risk decreasing over time after that. The overall likelihood of MI is seven times higher in chronic cocaine users compared with nonusers. Combining cocaine with alcohol use increases the risk of sudden death by more than 20 times compared with nonusers, studies suggest.
Cocaine use increases the risk for MI in three ways: by increasing the heart rate and blood pressure in a setting of limited oxygen supply; by vasoconstriction (which is a danger especially in patients who smoke cigarettes or who have preexisting cardiovascular disease), and by promoting inflammation (possibly due to increases in C-reactive protein and platelet levels), she said at the meeting, also sponsored by the University of California, San Francisco.
Ischemic chest discomfort from cocaine use can be indistinguishable from unstable angina or non-ST-segment elevation MI due to coronary atherosclerosis.
If cocaine use is suspected or known in a patient with chest pain who has ECG changes, treat with oral nitroglycerin and a calcium antagonist, in accordance with 2002 guidelines from the ACC and American Heart Association. If ST-segment elevations persist, perform coronary arteriography immediately. Give thrombolytic therapy if a thrombus is detected, and consider it if catheterization is not available, the guidelines state.
Those class I recommendations are backed by evidence for or general agreement about their effectiveness and usefulness. The guidelines include several class IIa recommendations based on conflicting evidence or opinions that tend to favor efficacy. These include giving β–blockers for patients with hypertension or sinus tachycardia, and giving intravenous calcium antagonists if the ECG changes suggest ischemia (J. Am. Coll. Cardiol. 2002;40:366–74).
Thrombolytic therapy is controversial because of case reports of complications. There is no way to clinically differentiate cocaine-related MI from non-cocaine-related MI, and 50%–80% of cocaine users with chest pain have abnormal ECG results that can persist for weeks, complicating the diagnosis.
On the other hand, many clinicians believe that β-blockers should not be given to patients with cocaine-induced chest pain, but this view is based on a study of normotensive patients with no prior cocaine use, she noted. The evidence for use of calcium channel blockers likewise comes from a few studies of patients not representative of cocaine users.
“These studies were small, and it's hard to base conclusions on them,” Dr. Hsue commented.
Symptoms can appear within minutes or hours after exposure to any dose of cocaine via any route. DR. HSUE
SAN FRANCISCO — Consider cocaine use when diagnosing chest pain, especially in young patients, Dr. Priscilla Hsue said at a meeting sponsored by the California chapter of the American College of Cardiology.
In 2004, 2 million Americans were cocaine users, and cocaine was the most frequently used illicit drug among patients seeking care in emergency departments. Yet one study found that only 13% of patients who presented with chest pain to an emergency department were assessed for cocaine use.
“I was covering the cardiology service a couple of weeks ago, and almost every day 50% of our admissions were for some kind of side effect from cocaine,” said Dr. Hsue of San Francisco General Hospital. “This is something we see so often.”
About 6% of patients with cocaine-associated chest pain seen in emergency departments develop MI. Patients with cocaine-related chest pain, unstable angina, or MI tend to be younger than 40 years old, male, and cigarette smokers who have no other risk factors for coronary artery disease. Chronic and first-time cocaine users have the same risk for MI. Symptoms can appear within minutes or hours after exposure to any dose of cocaine via any route—smoking, snorting, or ingesting.
Cocaine increases the risk of MI 24-fold within 1 hour of use, with the risk decreasing over time after that. The overall likelihood of MI is seven times higher in chronic cocaine users compared with nonusers. Combining cocaine with alcohol use increases the risk of sudden death by more than 20 times compared with nonusers, studies suggest.
Cocaine use increases the risk for MI in three ways: by increasing the heart rate and blood pressure in a setting of limited oxygen supply; by vasoconstriction (which is a danger especially in patients who smoke cigarettes or who have preexisting cardiovascular disease), and by promoting inflammation (possibly due to increases in C-reactive protein and platelet levels), she said at the meeting, also sponsored by the University of California, San Francisco.
Ischemic chest discomfort from cocaine use can be indistinguishable from unstable angina or non-ST-segment elevation MI due to coronary atherosclerosis.
If cocaine use is suspected or known in a patient with chest pain who has ECG changes, treat with oral nitroglycerin and a calcium antagonist, in accordance with 2002 guidelines from the ACC and American Heart Association. If ST-segment elevations persist, perform coronary arteriography immediately. Give thrombolytic therapy if a thrombus is detected, and consider it if catheterization is not available, the guidelines state.
Those class I recommendations are backed by evidence for or general agreement about their effectiveness and usefulness. The guidelines include several class IIa recommendations based on conflicting evidence or opinions that tend to favor efficacy. These include giving β–blockers for patients with hypertension or sinus tachycardia, and giving intravenous calcium antagonists if the ECG changes suggest ischemia (J. Am. Coll. Cardiol. 2002;40:366–74).
Thrombolytic therapy is controversial because of case reports of complications. There is no way to clinically differentiate cocaine-related MI from non-cocaine-related MI, and 50%–80% of cocaine users with chest pain have abnormal ECG results that can persist for weeks, complicating the diagnosis.
On the other hand, many clinicians believe that β-blockers should not be given to patients with cocaine-induced chest pain, but this view is based on a study of normotensive patients with no prior cocaine use, she noted. The evidence for use of calcium channel blockers likewise comes from a few studies of patients not representative of cocaine users.
“These studies were small, and it's hard to base conclusions on them,” Dr. Hsue commented.
Symptoms can appear within minutes or hours after exposure to any dose of cocaine via any route. DR. HSUE
SAN FRANCISCO — Consider cocaine use when diagnosing chest pain, especially in young patients, Dr. Priscilla Hsue said at a meeting sponsored by the California chapter of the American College of Cardiology.
In 2004, 2 million Americans were cocaine users, and cocaine was the most frequently used illicit drug among patients seeking care in emergency departments. Yet one study found that only 13% of patients who presented with chest pain to an emergency department were assessed for cocaine use.
“I was covering the cardiology service a couple of weeks ago, and almost every day 50% of our admissions were for some kind of side effect from cocaine,” said Dr. Hsue of San Francisco General Hospital. “This is something we see so often.”
About 6% of patients with cocaine-associated chest pain seen in emergency departments develop MI. Patients with cocaine-related chest pain, unstable angina, or MI tend to be younger than 40 years old, male, and cigarette smokers who have no other risk factors for coronary artery disease. Chronic and first-time cocaine users have the same risk for MI. Symptoms can appear within minutes or hours after exposure to any dose of cocaine via any route—smoking, snorting, or ingesting.
Cocaine increases the risk of MI 24-fold within 1 hour of use, with the risk decreasing over time after that. The overall likelihood of MI is seven times higher in chronic cocaine users compared with nonusers. Combining cocaine with alcohol use increases the risk of sudden death by more than 20 times compared with nonusers, studies suggest.
Cocaine use increases the risk for MI in three ways: by increasing the heart rate and blood pressure in a setting of limited oxygen supply; by vasoconstriction (which is a danger especially in patients who smoke cigarettes or who have preexisting cardiovascular disease), and by promoting inflammation (possibly due to increases in C-reactive protein and platelet levels), she said at the meeting, also sponsored by the University of California, San Francisco.
Ischemic chest discomfort from cocaine use can be indistinguishable from unstable angina or non-ST-segment elevation MI due to coronary atherosclerosis.
If cocaine use is suspected or known in a patient with chest pain who has ECG changes, treat with oral nitroglycerin and a calcium antagonist, in accordance with 2002 guidelines from the ACC and American Heart Association. If ST-segment elevations persist, perform coronary arteriography immediately. Give thrombolytic therapy if a thrombus is detected, and consider it if catheterization is not available, the guidelines state.
Those class I recommendations are backed by evidence for or general agreement about their effectiveness and usefulness. The guidelines include several class IIa recommendations based on conflicting evidence or opinions that tend to favor efficacy. These include giving β–blockers for patients with hypertension or sinus tachycardia, and giving intravenous calcium antagonists if the ECG changes suggest ischemia (J. Am. Coll. Cardiol. 2002;40:366–74).
Thrombolytic therapy is controversial because of case reports of complications. There is no way to clinically differentiate cocaine-related MI from non-cocaine-related MI, and 50%–80% of cocaine users with chest pain have abnormal ECG results that can persist for weeks, complicating the diagnosis.
On the other hand, many clinicians believe that β-blockers should not be given to patients with cocaine-induced chest pain, but this view is based on a study of normotensive patients with no prior cocaine use, she noted. The evidence for use of calcium channel blockers likewise comes from a few studies of patients not representative of cocaine users.
“These studies were small, and it's hard to base conclusions on them,” Dr. Hsue commented.
Symptoms can appear within minutes or hours after exposure to any dose of cocaine via any route. DR. HSUE