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Poor Surgical Outcomes for Safety-Net Hospitals
NEW YORK - Hospital resources, and not necessarily patient characteristics, may be causing safety-net hospitals to deliver inferior surgical outcomes at increased cost in elective surgical procedures, according to a new study.
"Analysis of Medicare Hospital Compare data revealed that safety-net hospitals perform worse on Surgical Care Improvement Project (SCIP) measures and have less efficient emergency departments throughput," first author Dr. Richard S. Hoehn from the University of Cincinnati, Ohio, said by email. "This last category indicates that these hospitals have insufficient staffing and/or resources to handle their patient burden."
"Safety-net hospitals care for a vulnerable population and maintain an open door to all patients, regardless of their ability to pay. Our study of nine major surgical procedures at academic medical centers in the United States found that hospitals with the highest safety net burden have the most patients of low socioeconomic status, extreme severity of illness, and in need of urgent surgery," Dr. Hoehn said.
"These hospitals also had the worst mortality and readmission rates and highest costs for most procedures. After controlling for patient age, race, severity of illness, and socioeconomic status, safety-net hospitals still had worse outcomes. Their inferior mortality and readmission rates were somewhat reduced, but the increased costs observed at these centers persisted, implying that other characteristics intrinsic to safety-net hospitals are associated with increased costs," he added.
Dr. Hoehn and colleagues analyzed outcomes for nine surgical procedures at 231 hospitals in the University HealthSystem Consortium over a four-year period ending in 2012, accounting for more than 12.6 million patient encounters. They sorted the hospitals into high safety-net burden (HBH) versus hospitals with low (LBH) or medium (MBH) safety-net burden.
They found the HBHs overall to have the most patients likely to be young, black, have the lowest socioeconomic status, and have the highest severity of illness and the highest cost for surgical care (p<0.01 for all). They also had the highest proportion of patient-emergent cases and the longest lengths of stay (p<0.01 for all).
After the researchers adjusted for patient characteristics and hospital volume, the HBHs still had higher odds ratios of mortality for three procedures (OR, 1.81 to 2.08, p<0.05), readmission for two procedures (OR, 1.19 to 1.30, p<0.05), and the highest cost of care for seven procedures (risk ratios, 1.23 to 1.35, p<0.05).
Postoperative mortality was worse for colectomy, esophagectomy, pancreaticoduodenectomy, and ventral hernia repair. Readmission odds were higher for coronary artery bypass, colectomy, kidney transplant, and ventral hernia repair.
"[W]hen assessing markers of emergency department throughput, HBHs were inferior to LBHs in all measures, including time from arrival to evaluation, admission decision time, times from arrival to departure for discharged and admitted patients, time for pain medicine administration to patients with long-bone fractures, and patients who left without being seen (p <= 0.002 for all)," the researchers write in JAMA Surgery, online October 14.
In an accompanying editorial, Dr. Larry R. Kaiser of Temple University School of Medicine, Philadelphia, and colleagues note, "At best, emergency department throughput as a surrogate for staffing adequacy and systems efficiency is an indirect estimate of these important hospital factors. Deficiencies in documentation and coding may or may not be influenced by overall hospital performance but could have a significant influence on expected rates of death and complications."
Dr. Kaiser said by email, "Physicians and surgeons should be very careful in drawing substantive conclusions from the study because of factors we don't know about these patients. Let the message be greater resources should be provided to those hospitals bearing the burden of caring for this underserved population of patients who, if anything, are more complex than commercially insured patients with similar problems."
"It's important to acknowledge that this study is not trying to criticize safety-net hospitals," Dr. Hoehn emphasized. "We are trying to highlight the unique situation these providers face, and also show that current policy changes that financially penalize these hospitals may adversely impact surgical care and further exacerbate the disparities in health care that already exist in our country. Safety-net hospitals in America have always been important institutions that train doctors and care for indigent patients, and our goal is to find a way to preserve this model in the face of changing healthcare policy."
Dr. Hoehn continued, "There are two options to improve the care at these centers: either close these hospitals and send their patients elsewhere or invest in initiatives that will allow these hospitals to improve not only their outcomes but also their efficiency. To do this, we must better understand their needs."
Dr. Kaiser said, "Continued scrutiny of outcomes with transparency and sharing of data with all those involved in the care of patients will result in continued quality improvement. Participation in [universal health care] that allows institutions to benchmark their data with similar institutions will tend to push those who need improvement to continue to improve."
"There must be a concerted effort among all involved in caring for patients at an institution to continue to improve quality. The designation of a chief quality officer working in concert with the chief medical officer also is critically important in working toward improved quality. But all of this depends on accurate recording and reporting of quality metrics," he concluded.
NEW YORK - Hospital resources, and not necessarily patient characteristics, may be causing safety-net hospitals to deliver inferior surgical outcomes at increased cost in elective surgical procedures, according to a new study.
"Analysis of Medicare Hospital Compare data revealed that safety-net hospitals perform worse on Surgical Care Improvement Project (SCIP) measures and have less efficient emergency departments throughput," first author Dr. Richard S. Hoehn from the University of Cincinnati, Ohio, said by email. "This last category indicates that these hospitals have insufficient staffing and/or resources to handle their patient burden."
"Safety-net hospitals care for a vulnerable population and maintain an open door to all patients, regardless of their ability to pay. Our study of nine major surgical procedures at academic medical centers in the United States found that hospitals with the highest safety net burden have the most patients of low socioeconomic status, extreme severity of illness, and in need of urgent surgery," Dr. Hoehn said.
"These hospitals also had the worst mortality and readmission rates and highest costs for most procedures. After controlling for patient age, race, severity of illness, and socioeconomic status, safety-net hospitals still had worse outcomes. Their inferior mortality and readmission rates were somewhat reduced, but the increased costs observed at these centers persisted, implying that other characteristics intrinsic to safety-net hospitals are associated with increased costs," he added.
Dr. Hoehn and colleagues analyzed outcomes for nine surgical procedures at 231 hospitals in the University HealthSystem Consortium over a four-year period ending in 2012, accounting for more than 12.6 million patient encounters. They sorted the hospitals into high safety-net burden (HBH) versus hospitals with low (LBH) or medium (MBH) safety-net burden.
They found the HBHs overall to have the most patients likely to be young, black, have the lowest socioeconomic status, and have the highest severity of illness and the highest cost for surgical care (p<0.01 for all). They also had the highest proportion of patient-emergent cases and the longest lengths of stay (p<0.01 for all).
After the researchers adjusted for patient characteristics and hospital volume, the HBHs still had higher odds ratios of mortality for three procedures (OR, 1.81 to 2.08, p<0.05), readmission for two procedures (OR, 1.19 to 1.30, p<0.05), and the highest cost of care for seven procedures (risk ratios, 1.23 to 1.35, p<0.05).
Postoperative mortality was worse for colectomy, esophagectomy, pancreaticoduodenectomy, and ventral hernia repair. Readmission odds were higher for coronary artery bypass, colectomy, kidney transplant, and ventral hernia repair.
"[W]hen assessing markers of emergency department throughput, HBHs were inferior to LBHs in all measures, including time from arrival to evaluation, admission decision time, times from arrival to departure for discharged and admitted patients, time for pain medicine administration to patients with long-bone fractures, and patients who left without being seen (p <= 0.002 for all)," the researchers write in JAMA Surgery, online October 14.
In an accompanying editorial, Dr. Larry R. Kaiser of Temple University School of Medicine, Philadelphia, and colleagues note, "At best, emergency department throughput as a surrogate for staffing adequacy and systems efficiency is an indirect estimate of these important hospital factors. Deficiencies in documentation and coding may or may not be influenced by overall hospital performance but could have a significant influence on expected rates of death and complications."
Dr. Kaiser said by email, "Physicians and surgeons should be very careful in drawing substantive conclusions from the study because of factors we don't know about these patients. Let the message be greater resources should be provided to those hospitals bearing the burden of caring for this underserved population of patients who, if anything, are more complex than commercially insured patients with similar problems."
"It's important to acknowledge that this study is not trying to criticize safety-net hospitals," Dr. Hoehn emphasized. "We are trying to highlight the unique situation these providers face, and also show that current policy changes that financially penalize these hospitals may adversely impact surgical care and further exacerbate the disparities in health care that already exist in our country. Safety-net hospitals in America have always been important institutions that train doctors and care for indigent patients, and our goal is to find a way to preserve this model in the face of changing healthcare policy."
Dr. Hoehn continued, "There are two options to improve the care at these centers: either close these hospitals and send their patients elsewhere or invest in initiatives that will allow these hospitals to improve not only their outcomes but also their efficiency. To do this, we must better understand their needs."
Dr. Kaiser said, "Continued scrutiny of outcomes with transparency and sharing of data with all those involved in the care of patients will result in continued quality improvement. Participation in [universal health care] that allows institutions to benchmark their data with similar institutions will tend to push those who need improvement to continue to improve."
"There must be a concerted effort among all involved in caring for patients at an institution to continue to improve quality. The designation of a chief quality officer working in concert with the chief medical officer also is critically important in working toward improved quality. But all of this depends on accurate recording and reporting of quality metrics," he concluded.
NEW YORK - Hospital resources, and not necessarily patient characteristics, may be causing safety-net hospitals to deliver inferior surgical outcomes at increased cost in elective surgical procedures, according to a new study.
"Analysis of Medicare Hospital Compare data revealed that safety-net hospitals perform worse on Surgical Care Improvement Project (SCIP) measures and have less efficient emergency departments throughput," first author Dr. Richard S. Hoehn from the University of Cincinnati, Ohio, said by email. "This last category indicates that these hospitals have insufficient staffing and/or resources to handle their patient burden."
"Safety-net hospitals care for a vulnerable population and maintain an open door to all patients, regardless of their ability to pay. Our study of nine major surgical procedures at academic medical centers in the United States found that hospitals with the highest safety net burden have the most patients of low socioeconomic status, extreme severity of illness, and in need of urgent surgery," Dr. Hoehn said.
"These hospitals also had the worst mortality and readmission rates and highest costs for most procedures. After controlling for patient age, race, severity of illness, and socioeconomic status, safety-net hospitals still had worse outcomes. Their inferior mortality and readmission rates were somewhat reduced, but the increased costs observed at these centers persisted, implying that other characteristics intrinsic to safety-net hospitals are associated with increased costs," he added.
Dr. Hoehn and colleagues analyzed outcomes for nine surgical procedures at 231 hospitals in the University HealthSystem Consortium over a four-year period ending in 2012, accounting for more than 12.6 million patient encounters. They sorted the hospitals into high safety-net burden (HBH) versus hospitals with low (LBH) or medium (MBH) safety-net burden.
They found the HBHs overall to have the most patients likely to be young, black, have the lowest socioeconomic status, and have the highest severity of illness and the highest cost for surgical care (p<0.01 for all). They also had the highest proportion of patient-emergent cases and the longest lengths of stay (p<0.01 for all).
After the researchers adjusted for patient characteristics and hospital volume, the HBHs still had higher odds ratios of mortality for three procedures (OR, 1.81 to 2.08, p<0.05), readmission for two procedures (OR, 1.19 to 1.30, p<0.05), and the highest cost of care for seven procedures (risk ratios, 1.23 to 1.35, p<0.05).
Postoperative mortality was worse for colectomy, esophagectomy, pancreaticoduodenectomy, and ventral hernia repair. Readmission odds were higher for coronary artery bypass, colectomy, kidney transplant, and ventral hernia repair.
"[W]hen assessing markers of emergency department throughput, HBHs were inferior to LBHs in all measures, including time from arrival to evaluation, admission decision time, times from arrival to departure for discharged and admitted patients, time for pain medicine administration to patients with long-bone fractures, and patients who left without being seen (p <= 0.002 for all)," the researchers write in JAMA Surgery, online October 14.
In an accompanying editorial, Dr. Larry R. Kaiser of Temple University School of Medicine, Philadelphia, and colleagues note, "At best, emergency department throughput as a surrogate for staffing adequacy and systems efficiency is an indirect estimate of these important hospital factors. Deficiencies in documentation and coding may or may not be influenced by overall hospital performance but could have a significant influence on expected rates of death and complications."
Dr. Kaiser said by email, "Physicians and surgeons should be very careful in drawing substantive conclusions from the study because of factors we don't know about these patients. Let the message be greater resources should be provided to those hospitals bearing the burden of caring for this underserved population of patients who, if anything, are more complex than commercially insured patients with similar problems."
"It's important to acknowledge that this study is not trying to criticize safety-net hospitals," Dr. Hoehn emphasized. "We are trying to highlight the unique situation these providers face, and also show that current policy changes that financially penalize these hospitals may adversely impact surgical care and further exacerbate the disparities in health care that already exist in our country. Safety-net hospitals in America have always been important institutions that train doctors and care for indigent patients, and our goal is to find a way to preserve this model in the face of changing healthcare policy."
Dr. Hoehn continued, "There are two options to improve the care at these centers: either close these hospitals and send their patients elsewhere or invest in initiatives that will allow these hospitals to improve not only their outcomes but also their efficiency. To do this, we must better understand their needs."
Dr. Kaiser said, "Continued scrutiny of outcomes with transparency and sharing of data with all those involved in the care of patients will result in continued quality improvement. Participation in [universal health care] that allows institutions to benchmark their data with similar institutions will tend to push those who need improvement to continue to improve."
"There must be a concerted effort among all involved in caring for patients at an institution to continue to improve quality. The designation of a chief quality officer working in concert with the chief medical officer also is critically important in working toward improved quality. But all of this depends on accurate recording and reporting of quality metrics," he concluded.
Dementia Most Costly Terminal Disease, Study Says
Families may spend almost twice as much caring for dementia patients at the end of life than they might if their loved one suffered from a different disease, a U.S. study suggests.
Costs paid by Medicare, the U.S. health insurance program for the elderly, were similar over the final five years of life for patients with dementia, heart disease, cancer and other conditions, according to the study published in the Annals of Internal Medicine.
But the average out-of-pocket costs absorbed by families of dementia patients totaled $61,522 over those five years, far greater than the typical tab of $34,068 for patients without dementia.
"Many costs related to daily care for patients with dementia are not covered by health insurance, and these care needs, including everything from supervision to bathing and feeding, may span several years," lead author Dr. Amy Kelley of the Icahn School of Medicine at Mount Sinai in New York said by email.
To assess the financial toll dementia takes on families, Dr. Kelley and colleagues analyzed Medicare spending and out-of-pocket costs for about 1,700 people aged 70 and older who died between 2005 and 2010.
Over the five years prior to each patient's date of death, the average total cost, including what Medicare covered as well as what families paid, was about $287,000 for dementia patients. That compares with roughly $175,000 for heart disease, $173,000 for cancer, and $197,000 for people who died of other causes.
Families caring for dementia patients also spent a greater proportion of their wealth than families helping loved ones with other conditions. The financial burden as a proportion of wealth was even more pronounced for patients who were black, had less than a high school education, or were unmarried or widowed women.
Shortcomings of the study include the possibility that insurance payments may have been underestimated as well as the lack of data on wages family members may have lost while caring for their loved ones, the authors acknowledge.
In addition, researchers measured only the probability of dementia and not whether the patients actually had dementia, the authors note. Few death certificates for patients with dementia will list that as the primary cause; instead, they report the problem that actually caused the patient to die, such as pneumonia.
Even so, the study findings highlight a financial burden posed by end-of-life care for elderly dementia patients that care reverberate through multiple generations, noted Carol Levine, director of the Families and Health Care Project at the United Hospital Fund, an independent policy group in New York City.
"There is a cascading effect: the financial drain for the older person's care means fewer resources not only for the caregiver but also for the younger generation's education and future prospects," Levine, who wasn't involved in the study, said by email.
"The immediate need for assistance is so compelling that future needs are often disregarded," Levine added. "The impact is greatest on families with the fewest resources to start with."
Many families also run into financial trouble because they mistakenly believe Medicare will pay for long term care services, said Dr. Mark Lachs, an expert in aging and finances at Weill Cornell Medical College in New York who wasn't involved in the study.
Families may consider long term care insurance to cover this gap in Medicare benefits, Dr. Lachs said by email.
Policy changes that might pay family members to be dementia caregivers would also help ease the financial strain, Dr. Lachs added.
Families may spend almost twice as much caring for dementia patients at the end of life than they might if their loved one suffered from a different disease, a U.S. study suggests.
Costs paid by Medicare, the U.S. health insurance program for the elderly, were similar over the final five years of life for patients with dementia, heart disease, cancer and other conditions, according to the study published in the Annals of Internal Medicine.
But the average out-of-pocket costs absorbed by families of dementia patients totaled $61,522 over those five years, far greater than the typical tab of $34,068 for patients without dementia.
"Many costs related to daily care for patients with dementia are not covered by health insurance, and these care needs, including everything from supervision to bathing and feeding, may span several years," lead author Dr. Amy Kelley of the Icahn School of Medicine at Mount Sinai in New York said by email.
To assess the financial toll dementia takes on families, Dr. Kelley and colleagues analyzed Medicare spending and out-of-pocket costs for about 1,700 people aged 70 and older who died between 2005 and 2010.
Over the five years prior to each patient's date of death, the average total cost, including what Medicare covered as well as what families paid, was about $287,000 for dementia patients. That compares with roughly $175,000 for heart disease, $173,000 for cancer, and $197,000 for people who died of other causes.
Families caring for dementia patients also spent a greater proportion of their wealth than families helping loved ones with other conditions. The financial burden as a proportion of wealth was even more pronounced for patients who were black, had less than a high school education, or were unmarried or widowed women.
Shortcomings of the study include the possibility that insurance payments may have been underestimated as well as the lack of data on wages family members may have lost while caring for their loved ones, the authors acknowledge.
In addition, researchers measured only the probability of dementia and not whether the patients actually had dementia, the authors note. Few death certificates for patients with dementia will list that as the primary cause; instead, they report the problem that actually caused the patient to die, such as pneumonia.
Even so, the study findings highlight a financial burden posed by end-of-life care for elderly dementia patients that care reverberate through multiple generations, noted Carol Levine, director of the Families and Health Care Project at the United Hospital Fund, an independent policy group in New York City.
"There is a cascading effect: the financial drain for the older person's care means fewer resources not only for the caregiver but also for the younger generation's education and future prospects," Levine, who wasn't involved in the study, said by email.
"The immediate need for assistance is so compelling that future needs are often disregarded," Levine added. "The impact is greatest on families with the fewest resources to start with."
Many families also run into financial trouble because they mistakenly believe Medicare will pay for long term care services, said Dr. Mark Lachs, an expert in aging and finances at Weill Cornell Medical College in New York who wasn't involved in the study.
Families may consider long term care insurance to cover this gap in Medicare benefits, Dr. Lachs said by email.
Policy changes that might pay family members to be dementia caregivers would also help ease the financial strain, Dr. Lachs added.
Families may spend almost twice as much caring for dementia patients at the end of life than they might if their loved one suffered from a different disease, a U.S. study suggests.
Costs paid by Medicare, the U.S. health insurance program for the elderly, were similar over the final five years of life for patients with dementia, heart disease, cancer and other conditions, according to the study published in the Annals of Internal Medicine.
But the average out-of-pocket costs absorbed by families of dementia patients totaled $61,522 over those five years, far greater than the typical tab of $34,068 for patients without dementia.
"Many costs related to daily care for patients with dementia are not covered by health insurance, and these care needs, including everything from supervision to bathing and feeding, may span several years," lead author Dr. Amy Kelley of the Icahn School of Medicine at Mount Sinai in New York said by email.
To assess the financial toll dementia takes on families, Dr. Kelley and colleagues analyzed Medicare spending and out-of-pocket costs for about 1,700 people aged 70 and older who died between 2005 and 2010.
Over the five years prior to each patient's date of death, the average total cost, including what Medicare covered as well as what families paid, was about $287,000 for dementia patients. That compares with roughly $175,000 for heart disease, $173,000 for cancer, and $197,000 for people who died of other causes.
Families caring for dementia patients also spent a greater proportion of their wealth than families helping loved ones with other conditions. The financial burden as a proportion of wealth was even more pronounced for patients who were black, had less than a high school education, or were unmarried or widowed women.
Shortcomings of the study include the possibility that insurance payments may have been underestimated as well as the lack of data on wages family members may have lost while caring for their loved ones, the authors acknowledge.
In addition, researchers measured only the probability of dementia and not whether the patients actually had dementia, the authors note. Few death certificates for patients with dementia will list that as the primary cause; instead, they report the problem that actually caused the patient to die, such as pneumonia.
Even so, the study findings highlight a financial burden posed by end-of-life care for elderly dementia patients that care reverberate through multiple generations, noted Carol Levine, director of the Families and Health Care Project at the United Hospital Fund, an independent policy group in New York City.
"There is a cascading effect: the financial drain for the older person's care means fewer resources not only for the caregiver but also for the younger generation's education and future prospects," Levine, who wasn't involved in the study, said by email.
"The immediate need for assistance is so compelling that future needs are often disregarded," Levine added. "The impact is greatest on families with the fewest resources to start with."
Many families also run into financial trouble because they mistakenly believe Medicare will pay for long term care services, said Dr. Mark Lachs, an expert in aging and finances at Weill Cornell Medical College in New York who wasn't involved in the study.
Families may consider long term care insurance to cover this gap in Medicare benefits, Dr. Lachs said by email.
Policy changes that might pay family members to be dementia caregivers would also help ease the financial strain, Dr. Lachs added.
Younger Type 2 Diabetics Face Greater Mortality Risks
NEW YORK - People with type 2 diabetes are 15 percent more likely to die from any cause and 14 percent more likely to die from a cardiovascular cause than non-diabetics at any given time, according to data from several Swedish registries.
The rates are significantly lower than previous estimates. Fifteen years ago, research was suggesting that having diabetes doubled the risk of premature death.
But the new study also found that the risk was dramatically elevated among people whose type 2 diabetes appeared by age 54. The worse their glycemic control and the more evidence of renal problems, the higher the risk.
In contrast, by age 75, type 2 diabetes posed little additional risk for people with good control and no kidney issues, according to the results.
"The overall increased risk of 15 percent among type 2 diabetics in general is a very low figure that has not been found in earlier type 2 diabetes studies," coauthor Dr. Marcus Lind of Uddevalla Hospital said in a telephone interview.
"The other thing that was interesting is that when we looked at patients with good glycemic control and no renal complications, if they were 75 years age, they had a lower risk than those in the general population. That hasn't been shown before," he said.
"What we are seeing is, if you are younger, aggressive management makes a difference," said Dr. Robert Ratner, chief scientific and medical officer of the American Diabetes Association, who was not involved in the research. At age 75, "you don't have to worry about it as much."
The study, published in the October 29 New England Journal of Medicine, is the largest to date to look at premature death in general - and death from cardiovascular causes in particular - among people with type 2 diabetes.
It compared more than 435,000 diabetics who were followed for a mean of 4.6 years with more than 2 million matched controls who were tracked for a mean of 4.8 years. The diabetics had had glucose problems for an average of 5.7 years.
In terms of actual death rates, cardiovascular mortality during the study period was 7.9 percent for diabetics versus 6.1 percent for controls (adjusted hazard ratio, 1.14; 95 percent confidence interval: 1.13-1.15). The respective rates for death from any cause were 17.7 percent and 14.5 percent (aHR, 1.15; 95 percent CI: 1.14-1.16).
For patients under age 55 with glycated hemoglobin levels below 7.0 percent, the risk of death from any cause nearly doubled (aHR, 1.92; 95 percent CI: 1.75-2.11).
"Those who are younger than 55, those who have target glycemic control and no signs of any renal complications, they had a clearly-elevated risk," said Dr. Lind.
But for people over 75, the hazard was actually 5 percent lower than it was for people without diabetes (aHR, 0.95; 95 percent CI: 0.94-0.96).
When the research team factored in people with normoalbuminuria, the risks were slightly mitigated.
Heart attack was the most common cause of death among diabetics.
When glycated hemoglobin levels were at 9.7 percent and higher for people below age 55, the hazard of death from any cause more than quadrupled. The hazard of death from cardiovascular causes rose more than five-fold.
Once again, the danger was far less extreme for people over 75, the researchers found.
"Excess mortality in type 2 diabetes was substantially higher with worsening glycemic control, severe renal complications, impaired renal function, and younger age," they concluded.
Renal function is a key element, Dr. Ratner said.
The study "reinforces the importance of early aggressive management of diabetes in order to prevent premature death and the fact is that the prevention of renal disease is probably the most potent thing we can do to reduce cardiovascular events," he said.
Dr. Lind said the risk may appear lower in the elderly because older people with diabetes are more likely to be getting aggressive treatment for their high blood pressure and high lipid levels, therapy that other people who also have hypertension and high cholesterol levels might not be receiving.
"I think that's the reason the rates are a bit lower" for seniors, he said.
Dr. Ratner said he believes the data for older diabetics simply reflects the fact that "you're seeing the survival cohort. They've made it past the difficult time."
We're all going to die, he said. "The issue is when does it happen? With diabetes, it's happening years ahead of time - in their 50s and early 60s, more so than when they reach 75. The younger you are, the greater that risk. That's when aggressive therapy should be given."
NEW YORK - People with type 2 diabetes are 15 percent more likely to die from any cause and 14 percent more likely to die from a cardiovascular cause than non-diabetics at any given time, according to data from several Swedish registries.
The rates are significantly lower than previous estimates. Fifteen years ago, research was suggesting that having diabetes doubled the risk of premature death.
But the new study also found that the risk was dramatically elevated among people whose type 2 diabetes appeared by age 54. The worse their glycemic control and the more evidence of renal problems, the higher the risk.
In contrast, by age 75, type 2 diabetes posed little additional risk for people with good control and no kidney issues, according to the results.
"The overall increased risk of 15 percent among type 2 diabetics in general is a very low figure that has not been found in earlier type 2 diabetes studies," coauthor Dr. Marcus Lind of Uddevalla Hospital said in a telephone interview.
"The other thing that was interesting is that when we looked at patients with good glycemic control and no renal complications, if they were 75 years age, they had a lower risk than those in the general population. That hasn't been shown before," he said.
"What we are seeing is, if you are younger, aggressive management makes a difference," said Dr. Robert Ratner, chief scientific and medical officer of the American Diabetes Association, who was not involved in the research. At age 75, "you don't have to worry about it as much."
The study, published in the October 29 New England Journal of Medicine, is the largest to date to look at premature death in general - and death from cardiovascular causes in particular - among people with type 2 diabetes.
It compared more than 435,000 diabetics who were followed for a mean of 4.6 years with more than 2 million matched controls who were tracked for a mean of 4.8 years. The diabetics had had glucose problems for an average of 5.7 years.
In terms of actual death rates, cardiovascular mortality during the study period was 7.9 percent for diabetics versus 6.1 percent for controls (adjusted hazard ratio, 1.14; 95 percent confidence interval: 1.13-1.15). The respective rates for death from any cause were 17.7 percent and 14.5 percent (aHR, 1.15; 95 percent CI: 1.14-1.16).
For patients under age 55 with glycated hemoglobin levels below 7.0 percent, the risk of death from any cause nearly doubled (aHR, 1.92; 95 percent CI: 1.75-2.11).
"Those who are younger than 55, those who have target glycemic control and no signs of any renal complications, they had a clearly-elevated risk," said Dr. Lind.
But for people over 75, the hazard was actually 5 percent lower than it was for people without diabetes (aHR, 0.95; 95 percent CI: 0.94-0.96).
When the research team factored in people with normoalbuminuria, the risks were slightly mitigated.
Heart attack was the most common cause of death among diabetics.
When glycated hemoglobin levels were at 9.7 percent and higher for people below age 55, the hazard of death from any cause more than quadrupled. The hazard of death from cardiovascular causes rose more than five-fold.
Once again, the danger was far less extreme for people over 75, the researchers found.
"Excess mortality in type 2 diabetes was substantially higher with worsening glycemic control, severe renal complications, impaired renal function, and younger age," they concluded.
Renal function is a key element, Dr. Ratner said.
The study "reinforces the importance of early aggressive management of diabetes in order to prevent premature death and the fact is that the prevention of renal disease is probably the most potent thing we can do to reduce cardiovascular events," he said.
Dr. Lind said the risk may appear lower in the elderly because older people with diabetes are more likely to be getting aggressive treatment for their high blood pressure and high lipid levels, therapy that other people who also have hypertension and high cholesterol levels might not be receiving.
"I think that's the reason the rates are a bit lower" for seniors, he said.
Dr. Ratner said he believes the data for older diabetics simply reflects the fact that "you're seeing the survival cohort. They've made it past the difficult time."
We're all going to die, he said. "The issue is when does it happen? With diabetes, it's happening years ahead of time - in their 50s and early 60s, more so than when they reach 75. The younger you are, the greater that risk. That's when aggressive therapy should be given."
NEW YORK - People with type 2 diabetes are 15 percent more likely to die from any cause and 14 percent more likely to die from a cardiovascular cause than non-diabetics at any given time, according to data from several Swedish registries.
The rates are significantly lower than previous estimates. Fifteen years ago, research was suggesting that having diabetes doubled the risk of premature death.
But the new study also found that the risk was dramatically elevated among people whose type 2 diabetes appeared by age 54. The worse their glycemic control and the more evidence of renal problems, the higher the risk.
In contrast, by age 75, type 2 diabetes posed little additional risk for people with good control and no kidney issues, according to the results.
"The overall increased risk of 15 percent among type 2 diabetics in general is a very low figure that has not been found in earlier type 2 diabetes studies," coauthor Dr. Marcus Lind of Uddevalla Hospital said in a telephone interview.
"The other thing that was interesting is that when we looked at patients with good glycemic control and no renal complications, if they were 75 years age, they had a lower risk than those in the general population. That hasn't been shown before," he said.
"What we are seeing is, if you are younger, aggressive management makes a difference," said Dr. Robert Ratner, chief scientific and medical officer of the American Diabetes Association, who was not involved in the research. At age 75, "you don't have to worry about it as much."
The study, published in the October 29 New England Journal of Medicine, is the largest to date to look at premature death in general - and death from cardiovascular causes in particular - among people with type 2 diabetes.
It compared more than 435,000 diabetics who were followed for a mean of 4.6 years with more than 2 million matched controls who were tracked for a mean of 4.8 years. The diabetics had had glucose problems for an average of 5.7 years.
In terms of actual death rates, cardiovascular mortality during the study period was 7.9 percent for diabetics versus 6.1 percent for controls (adjusted hazard ratio, 1.14; 95 percent confidence interval: 1.13-1.15). The respective rates for death from any cause were 17.7 percent and 14.5 percent (aHR, 1.15; 95 percent CI: 1.14-1.16).
For patients under age 55 with glycated hemoglobin levels below 7.0 percent, the risk of death from any cause nearly doubled (aHR, 1.92; 95 percent CI: 1.75-2.11).
"Those who are younger than 55, those who have target glycemic control and no signs of any renal complications, they had a clearly-elevated risk," said Dr. Lind.
But for people over 75, the hazard was actually 5 percent lower than it was for people without diabetes (aHR, 0.95; 95 percent CI: 0.94-0.96).
When the research team factored in people with normoalbuminuria, the risks were slightly mitigated.
Heart attack was the most common cause of death among diabetics.
When glycated hemoglobin levels were at 9.7 percent and higher for people below age 55, the hazard of death from any cause more than quadrupled. The hazard of death from cardiovascular causes rose more than five-fold.
Once again, the danger was far less extreme for people over 75, the researchers found.
"Excess mortality in type 2 diabetes was substantially higher with worsening glycemic control, severe renal complications, impaired renal function, and younger age," they concluded.
Renal function is a key element, Dr. Ratner said.
The study "reinforces the importance of early aggressive management of diabetes in order to prevent premature death and the fact is that the prevention of renal disease is probably the most potent thing we can do to reduce cardiovascular events," he said.
Dr. Lind said the risk may appear lower in the elderly because older people with diabetes are more likely to be getting aggressive treatment for their high blood pressure and high lipid levels, therapy that other people who also have hypertension and high cholesterol levels might not be receiving.
"I think that's the reason the rates are a bit lower" for seniors, he said.
Dr. Ratner said he believes the data for older diabetics simply reflects the fact that "you're seeing the survival cohort. They've made it past the difficult time."
We're all going to die, he said. "The issue is when does it happen? With diabetes, it's happening years ahead of time - in their 50s and early 60s, more so than when they reach 75. The younger you are, the greater that risk. That's when aggressive therapy should be given."
Drug Treatment Key to Fewer Hospitalizations for Schizophrenic Patients
NEW YORK - Initiation of antipsychotic or antidepressant drug treatment is linked to a reduction in hospitalizations for patients with schizophrenia, according to a new study.
"Use of sulpiride, mirtazapine, venlafaxine, and clozapine-aripiprazole and clozapine amisulpride combinations were associated with fewer subsequent admission-days in patients with schizophrenia," Dr. Rudolf N. Cardinal of the Behavioral and Clinical Neuroscience Institute, University of Cambridge, UK, said by email.
"These studies are correlative and do not prove causation," he cautioned.
Dr. Cardinal and colleagues analyzed eight years' of admission records at a secondary mental health care institution in Cambridgeshire. The analysis included nearly 1,500 patients with a diagnosis of schizophrenia and a median follow-up of five years.
In mirror-image analysis covering two years before and after therapy initiation, the researchers found treatment with amisulpride, aripiprazole, clozapine, fluoxetine, mirtazapine, olanzapine, quetiapine, and sulpiride was associated with fewer subsequent admissions in one year.
The association persisted in a "more stringent" two-year analysis for aripiprazole, clozapine, and sulpiride.
Using regression analysis, the researchers found a continued reduction in admissions with sulpiride and mirtazapine (estimated mean change, -20.4 and -11.6 days/year, respectively).
Treatment with clozapine-aripiprazole and clozapine-amisulpride combinations as well as venlafaxine was associated with significantly fewer hospitalized days (-17.7, -13.8, and -12.3 days/year, respectively).
Overall, the mean admission rate was 26.8 days/year.
"This analysis focused on patients with more severe disease, in that they had at least one hospital admission in the pre-drug period," the researchers note in the article online October 21 in NPJ Schizophrenia.
"Larger correlative studies are required to corroborate these effects, followed by randomized controlled trials if appropriate," Dr. Cardinal said. "We are all very keen that these are not misrepresented as causal-grade findings."
The authors reported no funding. One coauthor reported receiving research funding from Genus Pharmaceuticals and consulting fees from Roche/Genentech.
NEW YORK - Initiation of antipsychotic or antidepressant drug treatment is linked to a reduction in hospitalizations for patients with schizophrenia, according to a new study.
"Use of sulpiride, mirtazapine, venlafaxine, and clozapine-aripiprazole and clozapine amisulpride combinations were associated with fewer subsequent admission-days in patients with schizophrenia," Dr. Rudolf N. Cardinal of the Behavioral and Clinical Neuroscience Institute, University of Cambridge, UK, said by email.
"These studies are correlative and do not prove causation," he cautioned.
Dr. Cardinal and colleagues analyzed eight years' of admission records at a secondary mental health care institution in Cambridgeshire. The analysis included nearly 1,500 patients with a diagnosis of schizophrenia and a median follow-up of five years.
In mirror-image analysis covering two years before and after therapy initiation, the researchers found treatment with amisulpride, aripiprazole, clozapine, fluoxetine, mirtazapine, olanzapine, quetiapine, and sulpiride was associated with fewer subsequent admissions in one year.
The association persisted in a "more stringent" two-year analysis for aripiprazole, clozapine, and sulpiride.
Using regression analysis, the researchers found a continued reduction in admissions with sulpiride and mirtazapine (estimated mean change, -20.4 and -11.6 days/year, respectively).
Treatment with clozapine-aripiprazole and clozapine-amisulpride combinations as well as venlafaxine was associated with significantly fewer hospitalized days (-17.7, -13.8, and -12.3 days/year, respectively).
Overall, the mean admission rate was 26.8 days/year.
"This analysis focused on patients with more severe disease, in that they had at least one hospital admission in the pre-drug period," the researchers note in the article online October 21 in NPJ Schizophrenia.
"Larger correlative studies are required to corroborate these effects, followed by randomized controlled trials if appropriate," Dr. Cardinal said. "We are all very keen that these are not misrepresented as causal-grade findings."
The authors reported no funding. One coauthor reported receiving research funding from Genus Pharmaceuticals and consulting fees from Roche/Genentech.
NEW YORK - Initiation of antipsychotic or antidepressant drug treatment is linked to a reduction in hospitalizations for patients with schizophrenia, according to a new study.
"Use of sulpiride, mirtazapine, venlafaxine, and clozapine-aripiprazole and clozapine amisulpride combinations were associated with fewer subsequent admission-days in patients with schizophrenia," Dr. Rudolf N. Cardinal of the Behavioral and Clinical Neuroscience Institute, University of Cambridge, UK, said by email.
"These studies are correlative and do not prove causation," he cautioned.
Dr. Cardinal and colleagues analyzed eight years' of admission records at a secondary mental health care institution in Cambridgeshire. The analysis included nearly 1,500 patients with a diagnosis of schizophrenia and a median follow-up of five years.
In mirror-image analysis covering two years before and after therapy initiation, the researchers found treatment with amisulpride, aripiprazole, clozapine, fluoxetine, mirtazapine, olanzapine, quetiapine, and sulpiride was associated with fewer subsequent admissions in one year.
The association persisted in a "more stringent" two-year analysis for aripiprazole, clozapine, and sulpiride.
Using regression analysis, the researchers found a continued reduction in admissions with sulpiride and mirtazapine (estimated mean change, -20.4 and -11.6 days/year, respectively).
Treatment with clozapine-aripiprazole and clozapine-amisulpride combinations as well as venlafaxine was associated with significantly fewer hospitalized days (-17.7, -13.8, and -12.3 days/year, respectively).
Overall, the mean admission rate was 26.8 days/year.
"This analysis focused on patients with more severe disease, in that they had at least one hospital admission in the pre-drug period," the researchers note in the article online October 21 in NPJ Schizophrenia.
"Larger correlative studies are required to corroborate these effects, followed by randomized controlled trials if appropriate," Dr. Cardinal said. "We are all very keen that these are not misrepresented as causal-grade findings."
The authors reported no funding. One coauthor reported receiving research funding from Genus Pharmaceuticals and consulting fees from Roche/Genentech.
Younger AF Patients at Higher Risk of Dementia
NEW YORK - Atrial fibrillation (AF) is associated with an increased risk of dementia, especially in younger individuals, according to results from the Rotterdam Study.
"When we started this study, we hypothesized that the hazard of atrial fibrillation would be higher with longer exposure, but to find such a strong exposure-time association in younger participants was striking," said Dr. Frank J. Wolters from Erasmus Medical Center in Rotterdam, the Netherlands.
"It emphasizes that prevention of dementia doesn't start when people report to their physician with mild memory complaints, but years, if not decades before, by identifying those at risk and optimizing preventive strategies," he said by email.
An earlier report from the Rotterdam Study showed that AF is more prevalent in people with dementia, but the cross-sectional design did not allow conclusions regarding a causal relationship.
Dr. Wolters's team investigated the association between AF and dementia during a follow up of 20 years of nearly 6,200 participants in the Rotterdam Study.
About 5% of the participants had AF at baseline, and 15.3% of these individuals developed dementia during more than 81,000 person-years of follow-up.
Another 11.7% developed AF later, and 15.0% developed dementia during more than 79,000 person-years, the researchers report in JAMA Neurology, online September 21.
People who had AF at the start of the study had a 34% increased risk of dementia (compared with those who did not have prevalent AF), and people who developed AF during follow-up had a 23% increased risk of dementia (compared with those who did not have incident AF).
The association between AF and dementia was strongest in persons younger than the median age (67 years), and in these younger participants, the risk of dementia was higher with increasing duration of AF.
"As we found atrial fibrillation to increase the risk of dementia independent of clinical stroke, either chronic hypoperfusion or more acutely silent infarcts or perhaps cortical microinfarcts could account for the increased risk of dementia," Dr. Wolters said.
"A few observational studies have suggested beneficialeffect of treatment of atrial fibrillation on the risk of dementia, but more evidence on treatment efficacy is sorely needed. This includes insight into whether optimal treatment consists of anticoagulation, heart rhythm, or rate control," he noted.
"With regard to treatment of atrial fibrillation, until further evidence on efficacy becomes available, it is worth realizing that optimal adherence to current guidelines may contribute to prevention of cognitive decline in addition to prevention of stroke," Dr. Wolters added. "Although we found the strongest associations between atrial fibrillation and dementia for younger people, the need to determine treatment efficacy is just as profound in the elderly."
Dr. Sanjay Dixit, director of cardiac electrophysiology at Philadelphia VA Medical Center in Pennsylvania, said by email, "Although the association between AF and dementia has been shown, it's difficult to establish cause and effect. As I point out in my previous review, obstructive sleep apnea (OSA) is considered to be a major contributor to the development of neurocognitive decline and dementia. OSA is very common in the AF population and many consider this to be (a) risk factor in the development of AF. So the question remains whether AF is the cause of dementia or other co-morbidities such as OSA that frequently co-exist in the AF population."
"Look for AF in patients with dementia and also caution patients with AF of the possibility of developing this condition in the future," Dr. Dixit advised. "Since catheter ablation therapy has been shown to have better outcomes for long-term control of AF than drugs, physicians should discuss this with patients and consider referring them to cardiac electrophysiologists early in the course of the disease."
Dr. T. Jared Bunch, director of heart rhythm services for Intermountain Healthcare, Murray, Utah, said by email, "It is great to see another confirmatory study that found essentially the same thing we did 5 years ago. These data in aggregate make the likelihood of the association much more compelling."
"What is interesting in our subsequent work is the patients more sensitive to poor warfarin management (low times in therapeutic range) were at the highest relative risk of dementia compared to older patients," Dr. Bunch explained. "Now we all need to start to unravel the mechanisms behind it and find avenues of preventative treatment. The choice and manner of anticoagulant treatment is one and allowing faster heart rates is another."
Dr. Shih-An Chen and Dr. Tzu-Fan Chao from Taipei Veterans General Hospital, Taipei, Taiwan, who recently reported on the independent association between AF and dementia, struck a more cautious note.
"Only when a lower risk of dementia can be achieved by AF ablation in the prospective and randomized trial can we conclude that AF is the direct cause of dementia," they said in a joint email. "It should also be noted that the development of dementia is multifactorial, and AF only represents one of them."
NEW YORK - Atrial fibrillation (AF) is associated with an increased risk of dementia, especially in younger individuals, according to results from the Rotterdam Study.
"When we started this study, we hypothesized that the hazard of atrial fibrillation would be higher with longer exposure, but to find such a strong exposure-time association in younger participants was striking," said Dr. Frank J. Wolters from Erasmus Medical Center in Rotterdam, the Netherlands.
"It emphasizes that prevention of dementia doesn't start when people report to their physician with mild memory complaints, but years, if not decades before, by identifying those at risk and optimizing preventive strategies," he said by email.
An earlier report from the Rotterdam Study showed that AF is more prevalent in people with dementia, but the cross-sectional design did not allow conclusions regarding a causal relationship.
Dr. Wolters's team investigated the association between AF and dementia during a follow up of 20 years of nearly 6,200 participants in the Rotterdam Study.
About 5% of the participants had AF at baseline, and 15.3% of these individuals developed dementia during more than 81,000 person-years of follow-up.
Another 11.7% developed AF later, and 15.0% developed dementia during more than 79,000 person-years, the researchers report in JAMA Neurology, online September 21.
People who had AF at the start of the study had a 34% increased risk of dementia (compared with those who did not have prevalent AF), and people who developed AF during follow-up had a 23% increased risk of dementia (compared with those who did not have incident AF).
The association between AF and dementia was strongest in persons younger than the median age (67 years), and in these younger participants, the risk of dementia was higher with increasing duration of AF.
"As we found atrial fibrillation to increase the risk of dementia independent of clinical stroke, either chronic hypoperfusion or more acutely silent infarcts or perhaps cortical microinfarcts could account for the increased risk of dementia," Dr. Wolters said.
"A few observational studies have suggested beneficialeffect of treatment of atrial fibrillation on the risk of dementia, but more evidence on treatment efficacy is sorely needed. This includes insight into whether optimal treatment consists of anticoagulation, heart rhythm, or rate control," he noted.
"With regard to treatment of atrial fibrillation, until further evidence on efficacy becomes available, it is worth realizing that optimal adherence to current guidelines may contribute to prevention of cognitive decline in addition to prevention of stroke," Dr. Wolters added. "Although we found the strongest associations between atrial fibrillation and dementia for younger people, the need to determine treatment efficacy is just as profound in the elderly."
Dr. Sanjay Dixit, director of cardiac electrophysiology at Philadelphia VA Medical Center in Pennsylvania, said by email, "Although the association between AF and dementia has been shown, it's difficult to establish cause and effect. As I point out in my previous review, obstructive sleep apnea (OSA) is considered to be a major contributor to the development of neurocognitive decline and dementia. OSA is very common in the AF population and many consider this to be (a) risk factor in the development of AF. So the question remains whether AF is the cause of dementia or other co-morbidities such as OSA that frequently co-exist in the AF population."
"Look for AF in patients with dementia and also caution patients with AF of the possibility of developing this condition in the future," Dr. Dixit advised. "Since catheter ablation therapy has been shown to have better outcomes for long-term control of AF than drugs, physicians should discuss this with patients and consider referring them to cardiac electrophysiologists early in the course of the disease."
Dr. T. Jared Bunch, director of heart rhythm services for Intermountain Healthcare, Murray, Utah, said by email, "It is great to see another confirmatory study that found essentially the same thing we did 5 years ago. These data in aggregate make the likelihood of the association much more compelling."
"What is interesting in our subsequent work is the patients more sensitive to poor warfarin management (low times in therapeutic range) were at the highest relative risk of dementia compared to older patients," Dr. Bunch explained. "Now we all need to start to unravel the mechanisms behind it and find avenues of preventative treatment. The choice and manner of anticoagulant treatment is one and allowing faster heart rates is another."
Dr. Shih-An Chen and Dr. Tzu-Fan Chao from Taipei Veterans General Hospital, Taipei, Taiwan, who recently reported on the independent association between AF and dementia, struck a more cautious note.
"Only when a lower risk of dementia can be achieved by AF ablation in the prospective and randomized trial can we conclude that AF is the direct cause of dementia," they said in a joint email. "It should also be noted that the development of dementia is multifactorial, and AF only represents one of them."
NEW YORK - Atrial fibrillation (AF) is associated with an increased risk of dementia, especially in younger individuals, according to results from the Rotterdam Study.
"When we started this study, we hypothesized that the hazard of atrial fibrillation would be higher with longer exposure, but to find such a strong exposure-time association in younger participants was striking," said Dr. Frank J. Wolters from Erasmus Medical Center in Rotterdam, the Netherlands.
"It emphasizes that prevention of dementia doesn't start when people report to their physician with mild memory complaints, but years, if not decades before, by identifying those at risk and optimizing preventive strategies," he said by email.
An earlier report from the Rotterdam Study showed that AF is more prevalent in people with dementia, but the cross-sectional design did not allow conclusions regarding a causal relationship.
Dr. Wolters's team investigated the association between AF and dementia during a follow up of 20 years of nearly 6,200 participants in the Rotterdam Study.
About 5% of the participants had AF at baseline, and 15.3% of these individuals developed dementia during more than 81,000 person-years of follow-up.
Another 11.7% developed AF later, and 15.0% developed dementia during more than 79,000 person-years, the researchers report in JAMA Neurology, online September 21.
People who had AF at the start of the study had a 34% increased risk of dementia (compared with those who did not have prevalent AF), and people who developed AF during follow-up had a 23% increased risk of dementia (compared with those who did not have incident AF).
The association between AF and dementia was strongest in persons younger than the median age (67 years), and in these younger participants, the risk of dementia was higher with increasing duration of AF.
"As we found atrial fibrillation to increase the risk of dementia independent of clinical stroke, either chronic hypoperfusion or more acutely silent infarcts or perhaps cortical microinfarcts could account for the increased risk of dementia," Dr. Wolters said.
"A few observational studies have suggested beneficialeffect of treatment of atrial fibrillation on the risk of dementia, but more evidence on treatment efficacy is sorely needed. This includes insight into whether optimal treatment consists of anticoagulation, heart rhythm, or rate control," he noted.
"With regard to treatment of atrial fibrillation, until further evidence on efficacy becomes available, it is worth realizing that optimal adherence to current guidelines may contribute to prevention of cognitive decline in addition to prevention of stroke," Dr. Wolters added. "Although we found the strongest associations between atrial fibrillation and dementia for younger people, the need to determine treatment efficacy is just as profound in the elderly."
Dr. Sanjay Dixit, director of cardiac electrophysiology at Philadelphia VA Medical Center in Pennsylvania, said by email, "Although the association between AF and dementia has been shown, it's difficult to establish cause and effect. As I point out in my previous review, obstructive sleep apnea (OSA) is considered to be a major contributor to the development of neurocognitive decline and dementia. OSA is very common in the AF population and many consider this to be (a) risk factor in the development of AF. So the question remains whether AF is the cause of dementia or other co-morbidities such as OSA that frequently co-exist in the AF population."
"Look for AF in patients with dementia and also caution patients with AF of the possibility of developing this condition in the future," Dr. Dixit advised. "Since catheter ablation therapy has been shown to have better outcomes for long-term control of AF than drugs, physicians should discuss this with patients and consider referring them to cardiac electrophysiologists early in the course of the disease."
Dr. T. Jared Bunch, director of heart rhythm services for Intermountain Healthcare, Murray, Utah, said by email, "It is great to see another confirmatory study that found essentially the same thing we did 5 years ago. These data in aggregate make the likelihood of the association much more compelling."
"What is interesting in our subsequent work is the patients more sensitive to poor warfarin management (low times in therapeutic range) were at the highest relative risk of dementia compared to older patients," Dr. Bunch explained. "Now we all need to start to unravel the mechanisms behind it and find avenues of preventative treatment. The choice and manner of anticoagulant treatment is one and allowing faster heart rates is another."
Dr. Shih-An Chen and Dr. Tzu-Fan Chao from Taipei Veterans General Hospital, Taipei, Taiwan, who recently reported on the independent association between AF and dementia, struck a more cautious note.
"Only when a lower risk of dementia can be achieved by AF ablation in the prospective and randomized trial can we conclude that AF is the direct cause of dementia," they said in a joint email. "It should also be noted that the development of dementia is multifactorial, and AF only represents one of them."
Risk of Diabetes in Ex-Smokers Decreases
While smoking is linked to an increased risk of developing diabetes, this risk appears to drop over the long term once cigarette use stops, a review of evidence suggests.
Researchers analyzed data on almost 5.9 million people in 88 previous studies examining the connection between smoking, second-hand smoke exposure and diabetes. They estimated that roughly 28 million type 2 diabetes cases worldwide - or about 11.7 percent of cases in men and 2.4 percent in women - could be attributed to active smoking.
The more cigarettes smokers consumed, the more their odds of getting diabetes increased.
If they quit, ex-smokers initially faced an even higher risk of diabetes, but as more years pass without cigarette use their odds of getting the disease gradually diminished, the analysis found.
"The diabetes risk remains high in the recent quitters," said lead study author An Pan, of Huazhong University of Science and Technology in China. Weight gain linked to smoking cessation may be at least partly to blame for the heightened diabetes risk in those first months after giving up cigarettes, Pan added.
"However, the diabetes risk is reduced substantially after five years," Pan said by email. "The long-term benefits - including benefits for other diseases like cancer and heart disease - clearly outweigh the short-term higher risk."
Worldwide, nearly one in 10 adults had diabetes in 2014, and the disease will be the seventh leading cause of death by 2030, according to the World Health Organization.
Most of these people have type 2 diabetes, which is associated with obesity and aging and happens when the body can't properly use or make enough of the hormone insulin to convert blood sugar into energy. Left untreated, diabetes can lead to nerve damage, amputations, blindness, heart disease and strokes.
Plenty of research has established a connection between smoking and diabetes, although the reason is still unclear.
For the current analysis, Pan and colleges focused on exploring the link between the amount and type of smoke exposure and diabetes risk, as well as the potential for this risk to diminish with smoking cessation.
Overall, the pooled data from all the studies showed the risk of diabetes was 37 percent higher for smokers than non-smokers, the study team reports in The Lancet Diabetes and Endocrinology.
Exactly how smoking might lead to diabetes isn't firmly established, but it's possible smoking might cause inflammation, which in turn boosts the risk for diabetes, Dr. Abbas Dehghan, of Erasmus University Medical Center in Rotterdam, The Netherlands.
"The more one smokes, the more chronic inflammation there will be, and the higher the risk of diabetes will be," Dehghan, who wasn't involved in the study, said by email.
Occasional smokers were 21 percent more likely to have diabetes than people who never picked up the habit, while the increased risk was 57 percent for heavy smokers.
People exposed to second-hand smoke were 22 percent more likely to develop diabetes than people who never smoked, the study also found.
If smokers quit, their risk of diabetes over the next five years was 54 percent higher than for people who never smoked. After that, the increased risk dropped to 18 percent over the following five-year period. Remaining abstinent for a decade or more, however, reduced the extra risk to 11 percent.
While the connection between smoking and diabetes is nowhere near as strong as the link between cigarettes and lung cancer, the findings still suggest that doctors should add diabetes to the list of risks they warn smokers about, Amy Taylor of the University of Bristol in the U.K. and colleagues note in an accompanying editorial.
The short-term increase in diabetes risk after quitting shouldn't deter smokers' cessation efforts, they argue. Instead, smokers should remember that cigarettes are tied to lower weight and cessation can lead some people to eat or drink more, leading to weight gain.
While smoking is linked to an increased risk of developing diabetes, this risk appears to drop over the long term once cigarette use stops, a review of evidence suggests.
Researchers analyzed data on almost 5.9 million people in 88 previous studies examining the connection between smoking, second-hand smoke exposure and diabetes. They estimated that roughly 28 million type 2 diabetes cases worldwide - or about 11.7 percent of cases in men and 2.4 percent in women - could be attributed to active smoking.
The more cigarettes smokers consumed, the more their odds of getting diabetes increased.
If they quit, ex-smokers initially faced an even higher risk of diabetes, but as more years pass without cigarette use their odds of getting the disease gradually diminished, the analysis found.
"The diabetes risk remains high in the recent quitters," said lead study author An Pan, of Huazhong University of Science and Technology in China. Weight gain linked to smoking cessation may be at least partly to blame for the heightened diabetes risk in those first months after giving up cigarettes, Pan added.
"However, the diabetes risk is reduced substantially after five years," Pan said by email. "The long-term benefits - including benefits for other diseases like cancer and heart disease - clearly outweigh the short-term higher risk."
Worldwide, nearly one in 10 adults had diabetes in 2014, and the disease will be the seventh leading cause of death by 2030, according to the World Health Organization.
Most of these people have type 2 diabetes, which is associated with obesity and aging and happens when the body can't properly use or make enough of the hormone insulin to convert blood sugar into energy. Left untreated, diabetes can lead to nerve damage, amputations, blindness, heart disease and strokes.
Plenty of research has established a connection between smoking and diabetes, although the reason is still unclear.
For the current analysis, Pan and colleges focused on exploring the link between the amount and type of smoke exposure and diabetes risk, as well as the potential for this risk to diminish with smoking cessation.
Overall, the pooled data from all the studies showed the risk of diabetes was 37 percent higher for smokers than non-smokers, the study team reports in The Lancet Diabetes and Endocrinology.
Exactly how smoking might lead to diabetes isn't firmly established, but it's possible smoking might cause inflammation, which in turn boosts the risk for diabetes, Dr. Abbas Dehghan, of Erasmus University Medical Center in Rotterdam, The Netherlands.
"The more one smokes, the more chronic inflammation there will be, and the higher the risk of diabetes will be," Dehghan, who wasn't involved in the study, said by email.
Occasional smokers were 21 percent more likely to have diabetes than people who never picked up the habit, while the increased risk was 57 percent for heavy smokers.
People exposed to second-hand smoke were 22 percent more likely to develop diabetes than people who never smoked, the study also found.
If smokers quit, their risk of diabetes over the next five years was 54 percent higher than for people who never smoked. After that, the increased risk dropped to 18 percent over the following five-year period. Remaining abstinent for a decade or more, however, reduced the extra risk to 11 percent.
While the connection between smoking and diabetes is nowhere near as strong as the link between cigarettes and lung cancer, the findings still suggest that doctors should add diabetes to the list of risks they warn smokers about, Amy Taylor of the University of Bristol in the U.K. and colleagues note in an accompanying editorial.
The short-term increase in diabetes risk after quitting shouldn't deter smokers' cessation efforts, they argue. Instead, smokers should remember that cigarettes are tied to lower weight and cessation can lead some people to eat or drink more, leading to weight gain.
While smoking is linked to an increased risk of developing diabetes, this risk appears to drop over the long term once cigarette use stops, a review of evidence suggests.
Researchers analyzed data on almost 5.9 million people in 88 previous studies examining the connection between smoking, second-hand smoke exposure and diabetes. They estimated that roughly 28 million type 2 diabetes cases worldwide - or about 11.7 percent of cases in men and 2.4 percent in women - could be attributed to active smoking.
The more cigarettes smokers consumed, the more their odds of getting diabetes increased.
If they quit, ex-smokers initially faced an even higher risk of diabetes, but as more years pass without cigarette use their odds of getting the disease gradually diminished, the analysis found.
"The diabetes risk remains high in the recent quitters," said lead study author An Pan, of Huazhong University of Science and Technology in China. Weight gain linked to smoking cessation may be at least partly to blame for the heightened diabetes risk in those first months after giving up cigarettes, Pan added.
"However, the diabetes risk is reduced substantially after five years," Pan said by email. "The long-term benefits - including benefits for other diseases like cancer and heart disease - clearly outweigh the short-term higher risk."
Worldwide, nearly one in 10 adults had diabetes in 2014, and the disease will be the seventh leading cause of death by 2030, according to the World Health Organization.
Most of these people have type 2 diabetes, which is associated with obesity and aging and happens when the body can't properly use or make enough of the hormone insulin to convert blood sugar into energy. Left untreated, diabetes can lead to nerve damage, amputations, blindness, heart disease and strokes.
Plenty of research has established a connection between smoking and diabetes, although the reason is still unclear.
For the current analysis, Pan and colleges focused on exploring the link between the amount and type of smoke exposure and diabetes risk, as well as the potential for this risk to diminish with smoking cessation.
Overall, the pooled data from all the studies showed the risk of diabetes was 37 percent higher for smokers than non-smokers, the study team reports in The Lancet Diabetes and Endocrinology.
Exactly how smoking might lead to diabetes isn't firmly established, but it's possible smoking might cause inflammation, which in turn boosts the risk for diabetes, Dr. Abbas Dehghan, of Erasmus University Medical Center in Rotterdam, The Netherlands.
"The more one smokes, the more chronic inflammation there will be, and the higher the risk of diabetes will be," Dehghan, who wasn't involved in the study, said by email.
Occasional smokers were 21 percent more likely to have diabetes than people who never picked up the habit, while the increased risk was 57 percent for heavy smokers.
People exposed to second-hand smoke were 22 percent more likely to develop diabetes than people who never smoked, the study also found.
If smokers quit, their risk of diabetes over the next five years was 54 percent higher than for people who never smoked. After that, the increased risk dropped to 18 percent over the following five-year period. Remaining abstinent for a decade or more, however, reduced the extra risk to 11 percent.
While the connection between smoking and diabetes is nowhere near as strong as the link between cigarettes and lung cancer, the findings still suggest that doctors should add diabetes to the list of risks they warn smokers about, Amy Taylor of the University of Bristol in the U.K. and colleagues note in an accompanying editorial.
The short-term increase in diabetes risk after quitting shouldn't deter smokers' cessation efforts, they argue. Instead, smokers should remember that cigarettes are tied to lower weight and cessation can lead some people to eat or drink more, leading to weight gain.
Beta-Blockers Increase Mortality in Hypertensive Patients
NEW YORK - Perioperative beta-blocker use in patients with hypertension is associated with increased cardiovascular complications and mortality after noncardiac surgery, researchers from Denmark report.
"The consistency of the findings of increased risks associated with beta-blockers across numerous subgroups was an important finding," Dr. Mads Emil Jorgensen from Gentofte Hospital in Hellerup said by email. "It supports our concern that in a low-risk population, beta-blocker-associated risks may outweigh the advantages of the treatment, in a wide range of low-risk patients."
Several studies have shown that perioperative beta-blocker use may benefit patients at high cardiac risk, but may increase mortality in others. Guidelines from the United States and Europe support continuing beta-blocker use perioperatively in patients already using being treated with them, but literature support for these recommendations is sparse.
Dr. Jorgensen's team used data from Statistics Denmark to investigate whether perioperative beta-blocker use is associated with an increased risk of major adverse cardiovascular events (MACEs) and all-cause mortality in the 30 days after noncardiac surgery in hypertensive patients free of cardiac, renal, and liver disease.
Among 14,644 patients treated with beta-blockers and 40,676 patients treated with other antihypertensives, the incidence of 30-day MACEs was significantly higher among those taking beta-blockers than among those taking other antihypertensives (1.32% vs. 0.84%, p<0.001).
Thirty-day all-cause mortality was also significantly higher in the beta-blocker group than in the other antihypertensives group (1.93% vs. 1.32%, p<0.001), the researchers report in JAMA Internal Medicine, online Oct. 5.
With the exception of combinations that included beta-blockers and two other antihypertensive drugs, all regimens that included a beta-blocker were associated with significantly increased risks of MACE and all-cause mortality, compared with regimens of renin-angiotensin system inhibitors and thiazides.
Results were comparable in subgroup analyses of diabetics versus nondiabetics and patients with low risk versus elevated risk.
The elevated risks were especially notable among patients at least 70 years old (number needed to harm, NNH, 140), men (NNH, 142), and patients undergoing acute surgery (NNH, 97).
"This study, among others, presents the case that the beneficial effects of beta-blockers might be subgroup dependent and that beta-blockers may not be the safe haven that previous perioperative guidelines have suggested," Dr. Jorgensen concluded. "More studies are needed to further the understanding of patient subgroups at risk, preferably in the setting of a randomized trial."
"The use of beta-blockers in 1 out of 4 patients with uncomplicated hypertension was higher than expected, as beta-blockers are no longer first-line drugs for treating hypertension," Dr. Jorgensen noted. "The high prevalence of beta-blocker use in this patient group underlines the clinical importance of these findings."
"Although we cannot conclude on whether the therapy should be changed prior to surgery, clinicians might want to pay special attention to these otherwise low-risk patients in the perioperative setting," he said.
"It is important to keep in mind that our population consisted of hypertensive patients without cardiac, renal or liver disease; thus not all patients with hypertension receiving a beta-blocker are expected to be at increased risk," Dr. Jorgensen cautioned. "Several conditions may necessitate and fully justify the use of beta-blockers, such as congestive heart failure or recent myocardial infarction, as demonstrated in a previous study from our research group."
Dr. Mark L. Friedell from the University of Missouri Kansas City School of Medicine in Kansas City coauthored one of the earlier reports that called into question the safety of perioperative beta-blocker use in low-risk patients. He said by email, "I was surprised at the higher mortality of patients with no cardiac risk factors. But, when taking the POISE trial into consideration, it makes sense that patients with no risk factors might be the ones most harmed by hypotension/stroke since there was no counter balance of cardiac protection such as that given to the patients with 3-4 cardiac risk factors."
His conclusion: "Patients with no or 1-2 cardiac risk factors do not need to be started on a beta-blocker perioperatively to try to mitigate cardiac risk."
"I think patients with perioperative hypertension and tachycardia could probably still be treated with short-acting beta-blockers," Dr. Friedell said. "If starting a beta-blocker in preparation for surgery (3-4 cardiac risk factors), do it at least a week in advance."
Dr. Elisabetta Patorno from Harvard Medical School in Boston recently coauthored a report of patterns of beta-blocker initiation in patients undergoing noncardiac surgery.
"These findings are just one piece of information and it is important not to overreact to only one study," she cautioned in an email. "These findings should be considered in addition to other available research, recommendations from professional societies like the American Heart Association, and patient specific considerations, when deciding regarding the perioperative management of patients with hypertension."
"Doctors should also balance these findings in light of the possible problems associated with this study," Dr. Patorno said. "Beta-blockers are not typically a first-line treatment for hypertension, so it is conceivable that the study participants treated with beta-blockers may have had a longer history and greater severity of hypertension compared with the patients treated with other antihypertensive therapy (the comparison group used in this study). This suggests the groups may be inherently different, with the implication that the underlying differential severity of hypertension and not the specific treatment may be responsible for the post-surgical increased risk of cardiovascular events and mortality observed among patients treated with beta-blocker therapy."
"Finally," she said, "as this study focuses on chronic antihypertensive users only, the question of whether there is real benefit or harm associated with initiating beta-blocker therapy prior to surgery remains unanswered."
Dr. Hermann Blessberger from Johannes Kepler University Linz School of Medicine, Linz, Austria, who has coauthored several papers regarding perioperative beta-blocker use, offered similar comments.
"We learned from our meta-analysis that dosage of beta-blockers (heart rate titrated), time point of start of beta-blockers before surgery (at least 2 weeks prior to surgery to allow the circulatory system to accommodate) as well as type of beta-blocker (issue with metoprolol metabolism - blood level may be heavily increased in poor metabolizers) are crucial," he said. "Except for the type of beta-blocker (mainly metoprolol and atenolol) this information could not be provided in this article as we can read in the discussion section but may be important."
"If a patient suffers from arterial hypertension, do not use a beta-blocker for initial treatment unless a beta-blocker seems desirable for another condition (rhythm disturbances, coronary heart disease, hyperthyroidism, etc.)," he advised.
NEW YORK - Perioperative beta-blocker use in patients with hypertension is associated with increased cardiovascular complications and mortality after noncardiac surgery, researchers from Denmark report.
"The consistency of the findings of increased risks associated with beta-blockers across numerous subgroups was an important finding," Dr. Mads Emil Jorgensen from Gentofte Hospital in Hellerup said by email. "It supports our concern that in a low-risk population, beta-blocker-associated risks may outweigh the advantages of the treatment, in a wide range of low-risk patients."
Several studies have shown that perioperative beta-blocker use may benefit patients at high cardiac risk, but may increase mortality in others. Guidelines from the United States and Europe support continuing beta-blocker use perioperatively in patients already using being treated with them, but literature support for these recommendations is sparse.
Dr. Jorgensen's team used data from Statistics Denmark to investigate whether perioperative beta-blocker use is associated with an increased risk of major adverse cardiovascular events (MACEs) and all-cause mortality in the 30 days after noncardiac surgery in hypertensive patients free of cardiac, renal, and liver disease.
Among 14,644 patients treated with beta-blockers and 40,676 patients treated with other antihypertensives, the incidence of 30-day MACEs was significantly higher among those taking beta-blockers than among those taking other antihypertensives (1.32% vs. 0.84%, p<0.001).
Thirty-day all-cause mortality was also significantly higher in the beta-blocker group than in the other antihypertensives group (1.93% vs. 1.32%, p<0.001), the researchers report in JAMA Internal Medicine, online Oct. 5.
With the exception of combinations that included beta-blockers and two other antihypertensive drugs, all regimens that included a beta-blocker were associated with significantly increased risks of MACE and all-cause mortality, compared with regimens of renin-angiotensin system inhibitors and thiazides.
Results were comparable in subgroup analyses of diabetics versus nondiabetics and patients with low risk versus elevated risk.
The elevated risks were especially notable among patients at least 70 years old (number needed to harm, NNH, 140), men (NNH, 142), and patients undergoing acute surgery (NNH, 97).
"This study, among others, presents the case that the beneficial effects of beta-blockers might be subgroup dependent and that beta-blockers may not be the safe haven that previous perioperative guidelines have suggested," Dr. Jorgensen concluded. "More studies are needed to further the understanding of patient subgroups at risk, preferably in the setting of a randomized trial."
"The use of beta-blockers in 1 out of 4 patients with uncomplicated hypertension was higher than expected, as beta-blockers are no longer first-line drugs for treating hypertension," Dr. Jorgensen noted. "The high prevalence of beta-blocker use in this patient group underlines the clinical importance of these findings."
"Although we cannot conclude on whether the therapy should be changed prior to surgery, clinicians might want to pay special attention to these otherwise low-risk patients in the perioperative setting," he said.
"It is important to keep in mind that our population consisted of hypertensive patients without cardiac, renal or liver disease; thus not all patients with hypertension receiving a beta-blocker are expected to be at increased risk," Dr. Jorgensen cautioned. "Several conditions may necessitate and fully justify the use of beta-blockers, such as congestive heart failure or recent myocardial infarction, as demonstrated in a previous study from our research group."
Dr. Mark L. Friedell from the University of Missouri Kansas City School of Medicine in Kansas City coauthored one of the earlier reports that called into question the safety of perioperative beta-blocker use in low-risk patients. He said by email, "I was surprised at the higher mortality of patients with no cardiac risk factors. But, when taking the POISE trial into consideration, it makes sense that patients with no risk factors might be the ones most harmed by hypotension/stroke since there was no counter balance of cardiac protection such as that given to the patients with 3-4 cardiac risk factors."
His conclusion: "Patients with no or 1-2 cardiac risk factors do not need to be started on a beta-blocker perioperatively to try to mitigate cardiac risk."
"I think patients with perioperative hypertension and tachycardia could probably still be treated with short-acting beta-blockers," Dr. Friedell said. "If starting a beta-blocker in preparation for surgery (3-4 cardiac risk factors), do it at least a week in advance."
Dr. Elisabetta Patorno from Harvard Medical School in Boston recently coauthored a report of patterns of beta-blocker initiation in patients undergoing noncardiac surgery.
"These findings are just one piece of information and it is important not to overreact to only one study," she cautioned in an email. "These findings should be considered in addition to other available research, recommendations from professional societies like the American Heart Association, and patient specific considerations, when deciding regarding the perioperative management of patients with hypertension."
"Doctors should also balance these findings in light of the possible problems associated with this study," Dr. Patorno said. "Beta-blockers are not typically a first-line treatment for hypertension, so it is conceivable that the study participants treated with beta-blockers may have had a longer history and greater severity of hypertension compared with the patients treated with other antihypertensive therapy (the comparison group used in this study). This suggests the groups may be inherently different, with the implication that the underlying differential severity of hypertension and not the specific treatment may be responsible for the post-surgical increased risk of cardiovascular events and mortality observed among patients treated with beta-blocker therapy."
"Finally," she said, "as this study focuses on chronic antihypertensive users only, the question of whether there is real benefit or harm associated with initiating beta-blocker therapy prior to surgery remains unanswered."
Dr. Hermann Blessberger from Johannes Kepler University Linz School of Medicine, Linz, Austria, who has coauthored several papers regarding perioperative beta-blocker use, offered similar comments.
"We learned from our meta-analysis that dosage of beta-blockers (heart rate titrated), time point of start of beta-blockers before surgery (at least 2 weeks prior to surgery to allow the circulatory system to accommodate) as well as type of beta-blocker (issue with metoprolol metabolism - blood level may be heavily increased in poor metabolizers) are crucial," he said. "Except for the type of beta-blocker (mainly metoprolol and atenolol) this information could not be provided in this article as we can read in the discussion section but may be important."
"If a patient suffers from arterial hypertension, do not use a beta-blocker for initial treatment unless a beta-blocker seems desirable for another condition (rhythm disturbances, coronary heart disease, hyperthyroidism, etc.)," he advised.
NEW YORK - Perioperative beta-blocker use in patients with hypertension is associated with increased cardiovascular complications and mortality after noncardiac surgery, researchers from Denmark report.
"The consistency of the findings of increased risks associated with beta-blockers across numerous subgroups was an important finding," Dr. Mads Emil Jorgensen from Gentofte Hospital in Hellerup said by email. "It supports our concern that in a low-risk population, beta-blocker-associated risks may outweigh the advantages of the treatment, in a wide range of low-risk patients."
Several studies have shown that perioperative beta-blocker use may benefit patients at high cardiac risk, but may increase mortality in others. Guidelines from the United States and Europe support continuing beta-blocker use perioperatively in patients already using being treated with them, but literature support for these recommendations is sparse.
Dr. Jorgensen's team used data from Statistics Denmark to investigate whether perioperative beta-blocker use is associated with an increased risk of major adverse cardiovascular events (MACEs) and all-cause mortality in the 30 days after noncardiac surgery in hypertensive patients free of cardiac, renal, and liver disease.
Among 14,644 patients treated with beta-blockers and 40,676 patients treated with other antihypertensives, the incidence of 30-day MACEs was significantly higher among those taking beta-blockers than among those taking other antihypertensives (1.32% vs. 0.84%, p<0.001).
Thirty-day all-cause mortality was also significantly higher in the beta-blocker group than in the other antihypertensives group (1.93% vs. 1.32%, p<0.001), the researchers report in JAMA Internal Medicine, online Oct. 5.
With the exception of combinations that included beta-blockers and two other antihypertensive drugs, all regimens that included a beta-blocker were associated with significantly increased risks of MACE and all-cause mortality, compared with regimens of renin-angiotensin system inhibitors and thiazides.
Results were comparable in subgroup analyses of diabetics versus nondiabetics and patients with low risk versus elevated risk.
The elevated risks were especially notable among patients at least 70 years old (number needed to harm, NNH, 140), men (NNH, 142), and patients undergoing acute surgery (NNH, 97).
"This study, among others, presents the case that the beneficial effects of beta-blockers might be subgroup dependent and that beta-blockers may not be the safe haven that previous perioperative guidelines have suggested," Dr. Jorgensen concluded. "More studies are needed to further the understanding of patient subgroups at risk, preferably in the setting of a randomized trial."
"The use of beta-blockers in 1 out of 4 patients with uncomplicated hypertension was higher than expected, as beta-blockers are no longer first-line drugs for treating hypertension," Dr. Jorgensen noted. "The high prevalence of beta-blocker use in this patient group underlines the clinical importance of these findings."
"Although we cannot conclude on whether the therapy should be changed prior to surgery, clinicians might want to pay special attention to these otherwise low-risk patients in the perioperative setting," he said.
"It is important to keep in mind that our population consisted of hypertensive patients without cardiac, renal or liver disease; thus not all patients with hypertension receiving a beta-blocker are expected to be at increased risk," Dr. Jorgensen cautioned. "Several conditions may necessitate and fully justify the use of beta-blockers, such as congestive heart failure or recent myocardial infarction, as demonstrated in a previous study from our research group."
Dr. Mark L. Friedell from the University of Missouri Kansas City School of Medicine in Kansas City coauthored one of the earlier reports that called into question the safety of perioperative beta-blocker use in low-risk patients. He said by email, "I was surprised at the higher mortality of patients with no cardiac risk factors. But, when taking the POISE trial into consideration, it makes sense that patients with no risk factors might be the ones most harmed by hypotension/stroke since there was no counter balance of cardiac protection such as that given to the patients with 3-4 cardiac risk factors."
His conclusion: "Patients with no or 1-2 cardiac risk factors do not need to be started on a beta-blocker perioperatively to try to mitigate cardiac risk."
"I think patients with perioperative hypertension and tachycardia could probably still be treated with short-acting beta-blockers," Dr. Friedell said. "If starting a beta-blocker in preparation for surgery (3-4 cardiac risk factors), do it at least a week in advance."
Dr. Elisabetta Patorno from Harvard Medical School in Boston recently coauthored a report of patterns of beta-blocker initiation in patients undergoing noncardiac surgery.
"These findings are just one piece of information and it is important not to overreact to only one study," she cautioned in an email. "These findings should be considered in addition to other available research, recommendations from professional societies like the American Heart Association, and patient specific considerations, when deciding regarding the perioperative management of patients with hypertension."
"Doctors should also balance these findings in light of the possible problems associated with this study," Dr. Patorno said. "Beta-blockers are not typically a first-line treatment for hypertension, so it is conceivable that the study participants treated with beta-blockers may have had a longer history and greater severity of hypertension compared with the patients treated with other antihypertensive therapy (the comparison group used in this study). This suggests the groups may be inherently different, with the implication that the underlying differential severity of hypertension and not the specific treatment may be responsible for the post-surgical increased risk of cardiovascular events and mortality observed among patients treated with beta-blocker therapy."
"Finally," she said, "as this study focuses on chronic antihypertensive users only, the question of whether there is real benefit or harm associated with initiating beta-blocker therapy prior to surgery remains unanswered."
Dr. Hermann Blessberger from Johannes Kepler University Linz School of Medicine, Linz, Austria, who has coauthored several papers regarding perioperative beta-blocker use, offered similar comments.
"We learned from our meta-analysis that dosage of beta-blockers (heart rate titrated), time point of start of beta-blockers before surgery (at least 2 weeks prior to surgery to allow the circulatory system to accommodate) as well as type of beta-blocker (issue with metoprolol metabolism - blood level may be heavily increased in poor metabolizers) are crucial," he said. "Except for the type of beta-blocker (mainly metoprolol and atenolol) this information could not be provided in this article as we can read in the discussion section but may be important."
"If a patient suffers from arterial hypertension, do not use a beta-blocker for initial treatment unless a beta-blocker seems desirable for another condition (rhythm disturbances, coronary heart disease, hyperthyroidism, etc.)," he advised.
New Studies Find RIPC Ineffective
NEW YORK - The theory that heart surgery can be made safer by periodically cutting off blood flow to an arm has been called into serious question.
Two large randomized studies, published online by the New England Journal of Medicine and presented on Oct. 5 at the European Society of Intensive Care Medicine Congress in Berlin, show that the technique, known as remote ischemic preconditioning (RIPC), made no difference in terms of the risk of death, heart attack, or kidney failure after surgery.
"The conclusions from both trials are definitive: remote ischemic preconditioning is ineffective in adults undergoing on-pump cardiac surgery," wrote Dr. Michael Zaugg and Dr. Eliana Lucchinetti of the University of Alberta in Edmonton, Canada, in a Journal editorial.
But the chief author of one of the studies, Dr. Patrick Meybohm of University Hospital Frankfurt in Germany, said research on the technique will likely continue because propofol was used as an anesthetic, which may have muted the effect, and patients who were excluded because of recent heart attack or severe liver or kidney disease might benefit.
"Other RIPC protocols (e.g., involving lower-limb RIPC, a longer duration of ischemia, or more cycles) may still be protective. Thus future studies should focus on these confounders," he said by email.
Evidence supporting the technique has been mixed, although tests that have looked at serum cardiac and renal biomarkers have suggested that cutting off flow to an extremity during on-pump surgery might offer better outcomes.
"The underlying hypothesis is that RIPC may attenuate organ injury by releasing various molecules such as damage-associated molecular patterns, adenosin, etc. etc., and that the body's own mediators may then induce natural defenses such as bioenergetic down-regulation and temporary cell-cycle arrest," Meybohm said. "These defenses, once engaged, can then protect the organs during subsequent inflammatory or ischemic stress."
The two studies, known as ERICCA and the RIPHeart, both included a sham group so the surgeons would not know which of the unconscious patients were getting their arm circulation cut off by a blood pressure cuff during the operation. Virtually all the patients were sedated with intravenous propofol.
ERICCA, the larger of the two, was conducted in the UK at 30 cardiac surgery centers on people undergoing coronary artery bypass graft surgery with or without valve replacement.
In the active treatment group, the blood was cut off from the arm for five minutes and restored for five minutes. The cycle was repeated three more times. In the control group, the inflation valve was left open.
Ultimately, 26.5% of the 801 patients in the test group died from cardiovascular causes, experienced a myocardial infarction, required coronary revascularization or experienced a stroke 12 months after randomization. The rate was 27.7% for the 811 in the control group (p=0.58).
There were no significant differences for those individual measures, nor on secondary measures such as the rate of acute kidney injury, troponin levels, length of stay in the ICU, or amount of time spent in the hospital.
The research team, led by Dr. Derek Hausenloy of University College in London, did not find any evidence that preconditioning produced serious side effects.
The RIPHeart study, conducted at 14 German hospitals by Dr. Meybohm and colleagues, randomized 1,403 patients and used a composite endpoint of death, heart attack, stroke, or acute renal failure up to the time of hospital discharge or a maximum of 14 days. A secondary analysis followed the volunteers for three months.
To disguise which patients were receiving preconditioning and which were not, cuffs were placed on each patient's arm and on a dummy arm, both covered by surgical drapes. Only one cuff was inflated.
Again, the endpoint rates in the two groups were the same - 14.3% with preconditioning and 14.6% with sham preconditioning. Analyzing the individual elements of the composite endpoint also show no advantage either way.
No significant differences were seen "in the level of troponin release, the duration of mechanical ventilation, the length of stay in the intensive care unit or the hospital, new onset of atrial fibrillation, and the incidence of postoperative delirium," the team concluded.
"In addition, no significant differences between treatment groups were found at the 30-day and 90-day follow-up," they wrote.
They also saw no adverse events. In their editorial, Drs. Zaugg and Lucchinetti speculated that the technique might be risky in patients with highly unstable coronary plaques because there was a small, albeit nonsignificant, increase in deaths from cardiovascular causes in one of the two studies.
Dr. Meybohm said he didn't think that speculation was warranted.
"Current data do not strongly support the hypothesis that RIPC may do more harm than good," he said. "There are preliminary results from about two-three studies, but there are also nearly a hundred studies demonstrating reduced biomarkers of organ ischemia/reperfusion injury, and positive/neutral effects."
The ERICCA study was funded by the Efficacy and Evaluation Program and the British Heart Foundation; the RIPHeart study was funded by the German Research Foundation.
NEW YORK - The theory that heart surgery can be made safer by periodically cutting off blood flow to an arm has been called into serious question.
Two large randomized studies, published online by the New England Journal of Medicine and presented on Oct. 5 at the European Society of Intensive Care Medicine Congress in Berlin, show that the technique, known as remote ischemic preconditioning (RIPC), made no difference in terms of the risk of death, heart attack, or kidney failure after surgery.
"The conclusions from both trials are definitive: remote ischemic preconditioning is ineffective in adults undergoing on-pump cardiac surgery," wrote Dr. Michael Zaugg and Dr. Eliana Lucchinetti of the University of Alberta in Edmonton, Canada, in a Journal editorial.
But the chief author of one of the studies, Dr. Patrick Meybohm of University Hospital Frankfurt in Germany, said research on the technique will likely continue because propofol was used as an anesthetic, which may have muted the effect, and patients who were excluded because of recent heart attack or severe liver or kidney disease might benefit.
"Other RIPC protocols (e.g., involving lower-limb RIPC, a longer duration of ischemia, or more cycles) may still be protective. Thus future studies should focus on these confounders," he said by email.
Evidence supporting the technique has been mixed, although tests that have looked at serum cardiac and renal biomarkers have suggested that cutting off flow to an extremity during on-pump surgery might offer better outcomes.
"The underlying hypothesis is that RIPC may attenuate organ injury by releasing various molecules such as damage-associated molecular patterns, adenosin, etc. etc., and that the body's own mediators may then induce natural defenses such as bioenergetic down-regulation and temporary cell-cycle arrest," Meybohm said. "These defenses, once engaged, can then protect the organs during subsequent inflammatory or ischemic stress."
The two studies, known as ERICCA and the RIPHeart, both included a sham group so the surgeons would not know which of the unconscious patients were getting their arm circulation cut off by a blood pressure cuff during the operation. Virtually all the patients were sedated with intravenous propofol.
ERICCA, the larger of the two, was conducted in the UK at 30 cardiac surgery centers on people undergoing coronary artery bypass graft surgery with or without valve replacement.
In the active treatment group, the blood was cut off from the arm for five minutes and restored for five minutes. The cycle was repeated three more times. In the control group, the inflation valve was left open.
Ultimately, 26.5% of the 801 patients in the test group died from cardiovascular causes, experienced a myocardial infarction, required coronary revascularization or experienced a stroke 12 months after randomization. The rate was 27.7% for the 811 in the control group (p=0.58).
There were no significant differences for those individual measures, nor on secondary measures such as the rate of acute kidney injury, troponin levels, length of stay in the ICU, or amount of time spent in the hospital.
The research team, led by Dr. Derek Hausenloy of University College in London, did not find any evidence that preconditioning produced serious side effects.
The RIPHeart study, conducted at 14 German hospitals by Dr. Meybohm and colleagues, randomized 1,403 patients and used a composite endpoint of death, heart attack, stroke, or acute renal failure up to the time of hospital discharge or a maximum of 14 days. A secondary analysis followed the volunteers for three months.
To disguise which patients were receiving preconditioning and which were not, cuffs were placed on each patient's arm and on a dummy arm, both covered by surgical drapes. Only one cuff was inflated.
Again, the endpoint rates in the two groups were the same - 14.3% with preconditioning and 14.6% with sham preconditioning. Analyzing the individual elements of the composite endpoint also show no advantage either way.
No significant differences were seen "in the level of troponin release, the duration of mechanical ventilation, the length of stay in the intensive care unit or the hospital, new onset of atrial fibrillation, and the incidence of postoperative delirium," the team concluded.
"In addition, no significant differences between treatment groups were found at the 30-day and 90-day follow-up," they wrote.
They also saw no adverse events. In their editorial, Drs. Zaugg and Lucchinetti speculated that the technique might be risky in patients with highly unstable coronary plaques because there was a small, albeit nonsignificant, increase in deaths from cardiovascular causes in one of the two studies.
Dr. Meybohm said he didn't think that speculation was warranted.
"Current data do not strongly support the hypothesis that RIPC may do more harm than good," he said. "There are preliminary results from about two-three studies, but there are also nearly a hundred studies demonstrating reduced biomarkers of organ ischemia/reperfusion injury, and positive/neutral effects."
The ERICCA study was funded by the Efficacy and Evaluation Program and the British Heart Foundation; the RIPHeart study was funded by the German Research Foundation.
NEW YORK - The theory that heart surgery can be made safer by periodically cutting off blood flow to an arm has been called into serious question.
Two large randomized studies, published online by the New England Journal of Medicine and presented on Oct. 5 at the European Society of Intensive Care Medicine Congress in Berlin, show that the technique, known as remote ischemic preconditioning (RIPC), made no difference in terms of the risk of death, heart attack, or kidney failure after surgery.
"The conclusions from both trials are definitive: remote ischemic preconditioning is ineffective in adults undergoing on-pump cardiac surgery," wrote Dr. Michael Zaugg and Dr. Eliana Lucchinetti of the University of Alberta in Edmonton, Canada, in a Journal editorial.
But the chief author of one of the studies, Dr. Patrick Meybohm of University Hospital Frankfurt in Germany, said research on the technique will likely continue because propofol was used as an anesthetic, which may have muted the effect, and patients who were excluded because of recent heart attack or severe liver or kidney disease might benefit.
"Other RIPC protocols (e.g., involving lower-limb RIPC, a longer duration of ischemia, or more cycles) may still be protective. Thus future studies should focus on these confounders," he said by email.
Evidence supporting the technique has been mixed, although tests that have looked at serum cardiac and renal biomarkers have suggested that cutting off flow to an extremity during on-pump surgery might offer better outcomes.
"The underlying hypothesis is that RIPC may attenuate organ injury by releasing various molecules such as damage-associated molecular patterns, adenosin, etc. etc., and that the body's own mediators may then induce natural defenses such as bioenergetic down-regulation and temporary cell-cycle arrest," Meybohm said. "These defenses, once engaged, can then protect the organs during subsequent inflammatory or ischemic stress."
The two studies, known as ERICCA and the RIPHeart, both included a sham group so the surgeons would not know which of the unconscious patients were getting their arm circulation cut off by a blood pressure cuff during the operation. Virtually all the patients were sedated with intravenous propofol.
ERICCA, the larger of the two, was conducted in the UK at 30 cardiac surgery centers on people undergoing coronary artery bypass graft surgery with or without valve replacement.
In the active treatment group, the blood was cut off from the arm for five minutes and restored for five minutes. The cycle was repeated three more times. In the control group, the inflation valve was left open.
Ultimately, 26.5% of the 801 patients in the test group died from cardiovascular causes, experienced a myocardial infarction, required coronary revascularization or experienced a stroke 12 months after randomization. The rate was 27.7% for the 811 in the control group (p=0.58).
There were no significant differences for those individual measures, nor on secondary measures such as the rate of acute kidney injury, troponin levels, length of stay in the ICU, or amount of time spent in the hospital.
The research team, led by Dr. Derek Hausenloy of University College in London, did not find any evidence that preconditioning produced serious side effects.
The RIPHeart study, conducted at 14 German hospitals by Dr. Meybohm and colleagues, randomized 1,403 patients and used a composite endpoint of death, heart attack, stroke, or acute renal failure up to the time of hospital discharge or a maximum of 14 days. A secondary analysis followed the volunteers for three months.
To disguise which patients were receiving preconditioning and which were not, cuffs were placed on each patient's arm and on a dummy arm, both covered by surgical drapes. Only one cuff was inflated.
Again, the endpoint rates in the two groups were the same - 14.3% with preconditioning and 14.6% with sham preconditioning. Analyzing the individual elements of the composite endpoint also show no advantage either way.
No significant differences were seen "in the level of troponin release, the duration of mechanical ventilation, the length of stay in the intensive care unit or the hospital, new onset of atrial fibrillation, and the incidence of postoperative delirium," the team concluded.
"In addition, no significant differences between treatment groups were found at the 30-day and 90-day follow-up," they wrote.
They also saw no adverse events. In their editorial, Drs. Zaugg and Lucchinetti speculated that the technique might be risky in patients with highly unstable coronary plaques because there was a small, albeit nonsignificant, increase in deaths from cardiovascular causes in one of the two studies.
Dr. Meybohm said he didn't think that speculation was warranted.
"Current data do not strongly support the hypothesis that RIPC may do more harm than good," he said. "There are preliminary results from about two-three studies, but there are also nearly a hundred studies demonstrating reduced biomarkers of organ ischemia/reperfusion injury, and positive/neutral effects."
The ERICCA study was funded by the Efficacy and Evaluation Program and the British Heart Foundation; the RIPHeart study was funded by the German Research Foundation.
Lymphedema Patients Benefit from Pneumatic Compression Devices
NEW YORK - Patients with lymphedema may reduce their risk of cellulitis, as well as the number of outpatient visits, by using an advanced pneumatic compression device (APCD), according to a new study.
"Our study demonstrates, for the first time, that receipt of an advanced pneumatic compression device is associated with significant improvements in key clinical endpoints for lymphedema patients, both for those with cancer and those without," Dr. Pinar Karaca-Mandic of the University of Minnesota School of Public Health in Minneapolis said by email.
"This finding has important implications for the patients who suffer from the disease, especially for those who have high rates of cellulitis. These devices serve as a viable self-management option and can reduce the need for more intensive outpatient care in rehabilitative settings," she added.
Advanced devices have more garment chambers and greater adjustability than earlier devices, the researchers wrote.
Dr. Karaca-Mandic and colleagues used a commercial insurance claims database to compare outcomes for 12 months before and 12 months after APCD purchase (Flexitouch System, Tactile Medical) by 718 patients (374 with cancer) between 2008 and 2012.
Lymphedema-related outcomes had either primary or secondary diagnosis codes.
The patients' mean age was 54.2, 84.8% were female, and 71.6% were non-Hispanic white. Just over half (52.2%) had hypertension, and breast cancer (39.6%) was the predominant disease in the cancer group.
As reported online October 7 in JAMA Dermatology, the adjusted rate of cellulitis diagnoses fell from 21.1% before APCD use to 4.5% afterward (p<0.001), a 79% decline. The noncancer group had a 75% decline, from 28.8% to 7.3% (p<0.001).
The noncancer group also had a 54% decline in adjusted rate of hospitalizations, from 7.0% to 3.2% (p=0.02), the authors reported.
Both groups had declines in receipt of manual therapy, from an adjusted rate of 35.6% before APCD use to 24.9% afterward for cancer patients (p<0.001) and from 32.3% to 21.2% for noncancer patients (p<0.001).
The adjusted rate of outpatient visits fell from 58.6% to 41.4% in the cancer cohort and from 52.6% to 31.4% in the noncancer group (p<0.001 for both).
Total costs per patient, excluding medical equipment, declined from $2597 to $1642 for cancer patients (p=0.002) and from $2937 to $1883 (p=0.007) for noncancer patients.
"While our findings are based upon the outcomes from one specific device, it is possible other such devices may also reduce patient burden. This warrants explorations in future studies. In addition, our study was not designed to assess the long term effectiveness of the device. That should be studied in future work," Dr. Karaca-Mandic explained.
Also, she pointed out, her team didn't look at nonmonetary expenses such as productivity loss and caretaker costs. "To the extent that device use improves physical functioning and lowers such costs as well, the impact is likely much larger than we can measure," she added.
Dr. Peter J. Franks, of the Center for Research and Implementation of Clinical Practice in London, UK, said by email, "We have these devices that appear to work. The problem is that the evidence on efficacy and cost effectiveness is so poor. The article gave some retrospective observational data that implied that the incidence of infection (cellulitis) was reduced. This is important, as infections lead to further deterioration of the lymphatic system, making the situation worse for the patient and increasing the risk of further infections."
"It is hard to say how generalizable the results are to other devices, though fundamentally they all work in similar ways," said Dr. Franks, who coauthored an accompanying editorial. "I think that this is an important step in how we consider the use of medical devices."
Cynthia Shechter, an occupational therapist in New York City who is a lymphedema specialist for cancer patients, said by email, "When looking for the right device, look for a pump that contains multiple chambers, operates on a short thirty-second cycle time, and applies graduated compression."
"The body operates on a pressure gradient system, so it is imperative to obtain a gradient or graduated compression pump. Pressure at the feet or hand is greater than the thigh or shoulder," she added.
"Clinicians practicing in the treatment of lymphedema need to be open-minded regarding less traditional treatment options for this insidious condition, including the use of traditional and advanced pneumatic compression devices," Shechter said.
"This study indicates that use of an APCD reduces the necessity for therapy. However, rehabilitation therapy for primary and secondary lymphedema, at least a short course of
treatment, is important, especially in order to ensure patients are adequately educated in lymphedema care, management, and precautions," she said.
"There should be a follow-up study performed to discuss a patient's ability to sustain use of the APCD versus a traditional pneumatic pump, and the long-term success in both preventing infection and in reduction of therapy visits," Shechter said.
Tactile Medical partially supported this research and employs one coauthor as chief medical officer. Dr. Karaca-Mandic, Dr. Franks, and his coauthor reported consulting for the company.
NEW YORK - Patients with lymphedema may reduce their risk of cellulitis, as well as the number of outpatient visits, by using an advanced pneumatic compression device (APCD), according to a new study.
"Our study demonstrates, for the first time, that receipt of an advanced pneumatic compression device is associated with significant improvements in key clinical endpoints for lymphedema patients, both for those with cancer and those without," Dr. Pinar Karaca-Mandic of the University of Minnesota School of Public Health in Minneapolis said by email.
"This finding has important implications for the patients who suffer from the disease, especially for those who have high rates of cellulitis. These devices serve as a viable self-management option and can reduce the need for more intensive outpatient care in rehabilitative settings," she added.
Advanced devices have more garment chambers and greater adjustability than earlier devices, the researchers wrote.
Dr. Karaca-Mandic and colleagues used a commercial insurance claims database to compare outcomes for 12 months before and 12 months after APCD purchase (Flexitouch System, Tactile Medical) by 718 patients (374 with cancer) between 2008 and 2012.
Lymphedema-related outcomes had either primary or secondary diagnosis codes.
The patients' mean age was 54.2, 84.8% were female, and 71.6% were non-Hispanic white. Just over half (52.2%) had hypertension, and breast cancer (39.6%) was the predominant disease in the cancer group.
As reported online October 7 in JAMA Dermatology, the adjusted rate of cellulitis diagnoses fell from 21.1% before APCD use to 4.5% afterward (p<0.001), a 79% decline. The noncancer group had a 75% decline, from 28.8% to 7.3% (p<0.001).
The noncancer group also had a 54% decline in adjusted rate of hospitalizations, from 7.0% to 3.2% (p=0.02), the authors reported.
Both groups had declines in receipt of manual therapy, from an adjusted rate of 35.6% before APCD use to 24.9% afterward for cancer patients (p<0.001) and from 32.3% to 21.2% for noncancer patients (p<0.001).
The adjusted rate of outpatient visits fell from 58.6% to 41.4% in the cancer cohort and from 52.6% to 31.4% in the noncancer group (p<0.001 for both).
Total costs per patient, excluding medical equipment, declined from $2597 to $1642 for cancer patients (p=0.002) and from $2937 to $1883 (p=0.007) for noncancer patients.
"While our findings are based upon the outcomes from one specific device, it is possible other such devices may also reduce patient burden. This warrants explorations in future studies. In addition, our study was not designed to assess the long term effectiveness of the device. That should be studied in future work," Dr. Karaca-Mandic explained.
Also, she pointed out, her team didn't look at nonmonetary expenses such as productivity loss and caretaker costs. "To the extent that device use improves physical functioning and lowers such costs as well, the impact is likely much larger than we can measure," she added.
Dr. Peter J. Franks, of the Center for Research and Implementation of Clinical Practice in London, UK, said by email, "We have these devices that appear to work. The problem is that the evidence on efficacy and cost effectiveness is so poor. The article gave some retrospective observational data that implied that the incidence of infection (cellulitis) was reduced. This is important, as infections lead to further deterioration of the lymphatic system, making the situation worse for the patient and increasing the risk of further infections."
"It is hard to say how generalizable the results are to other devices, though fundamentally they all work in similar ways," said Dr. Franks, who coauthored an accompanying editorial. "I think that this is an important step in how we consider the use of medical devices."
Cynthia Shechter, an occupational therapist in New York City who is a lymphedema specialist for cancer patients, said by email, "When looking for the right device, look for a pump that contains multiple chambers, operates on a short thirty-second cycle time, and applies graduated compression."
"The body operates on a pressure gradient system, so it is imperative to obtain a gradient or graduated compression pump. Pressure at the feet or hand is greater than the thigh or shoulder," she added.
"Clinicians practicing in the treatment of lymphedema need to be open-minded regarding less traditional treatment options for this insidious condition, including the use of traditional and advanced pneumatic compression devices," Shechter said.
"This study indicates that use of an APCD reduces the necessity for therapy. However, rehabilitation therapy for primary and secondary lymphedema, at least a short course of
treatment, is important, especially in order to ensure patients are adequately educated in lymphedema care, management, and precautions," she said.
"There should be a follow-up study performed to discuss a patient's ability to sustain use of the APCD versus a traditional pneumatic pump, and the long-term success in both preventing infection and in reduction of therapy visits," Shechter said.
Tactile Medical partially supported this research and employs one coauthor as chief medical officer. Dr. Karaca-Mandic, Dr. Franks, and his coauthor reported consulting for the company.
NEW YORK - Patients with lymphedema may reduce their risk of cellulitis, as well as the number of outpatient visits, by using an advanced pneumatic compression device (APCD), according to a new study.
"Our study demonstrates, for the first time, that receipt of an advanced pneumatic compression device is associated with significant improvements in key clinical endpoints for lymphedema patients, both for those with cancer and those without," Dr. Pinar Karaca-Mandic of the University of Minnesota School of Public Health in Minneapolis said by email.
"This finding has important implications for the patients who suffer from the disease, especially for those who have high rates of cellulitis. These devices serve as a viable self-management option and can reduce the need for more intensive outpatient care in rehabilitative settings," she added.
Advanced devices have more garment chambers and greater adjustability than earlier devices, the researchers wrote.
Dr. Karaca-Mandic and colleagues used a commercial insurance claims database to compare outcomes for 12 months before and 12 months after APCD purchase (Flexitouch System, Tactile Medical) by 718 patients (374 with cancer) between 2008 and 2012.
Lymphedema-related outcomes had either primary or secondary diagnosis codes.
The patients' mean age was 54.2, 84.8% were female, and 71.6% were non-Hispanic white. Just over half (52.2%) had hypertension, and breast cancer (39.6%) was the predominant disease in the cancer group.
As reported online October 7 in JAMA Dermatology, the adjusted rate of cellulitis diagnoses fell from 21.1% before APCD use to 4.5% afterward (p<0.001), a 79% decline. The noncancer group had a 75% decline, from 28.8% to 7.3% (p<0.001).
The noncancer group also had a 54% decline in adjusted rate of hospitalizations, from 7.0% to 3.2% (p=0.02), the authors reported.
Both groups had declines in receipt of manual therapy, from an adjusted rate of 35.6% before APCD use to 24.9% afterward for cancer patients (p<0.001) and from 32.3% to 21.2% for noncancer patients (p<0.001).
The adjusted rate of outpatient visits fell from 58.6% to 41.4% in the cancer cohort and from 52.6% to 31.4% in the noncancer group (p<0.001 for both).
Total costs per patient, excluding medical equipment, declined from $2597 to $1642 for cancer patients (p=0.002) and from $2937 to $1883 (p=0.007) for noncancer patients.
"While our findings are based upon the outcomes from one specific device, it is possible other such devices may also reduce patient burden. This warrants explorations in future studies. In addition, our study was not designed to assess the long term effectiveness of the device. That should be studied in future work," Dr. Karaca-Mandic explained.
Also, she pointed out, her team didn't look at nonmonetary expenses such as productivity loss and caretaker costs. "To the extent that device use improves physical functioning and lowers such costs as well, the impact is likely much larger than we can measure," she added.
Dr. Peter J. Franks, of the Center for Research and Implementation of Clinical Practice in London, UK, said by email, "We have these devices that appear to work. The problem is that the evidence on efficacy and cost effectiveness is so poor. The article gave some retrospective observational data that implied that the incidence of infection (cellulitis) was reduced. This is important, as infections lead to further deterioration of the lymphatic system, making the situation worse for the patient and increasing the risk of further infections."
"It is hard to say how generalizable the results are to other devices, though fundamentally they all work in similar ways," said Dr. Franks, who coauthored an accompanying editorial. "I think that this is an important step in how we consider the use of medical devices."
Cynthia Shechter, an occupational therapist in New York City who is a lymphedema specialist for cancer patients, said by email, "When looking for the right device, look for a pump that contains multiple chambers, operates on a short thirty-second cycle time, and applies graduated compression."
"The body operates on a pressure gradient system, so it is imperative to obtain a gradient or graduated compression pump. Pressure at the feet or hand is greater than the thigh or shoulder," she added.
"Clinicians practicing in the treatment of lymphedema need to be open-minded regarding less traditional treatment options for this insidious condition, including the use of traditional and advanced pneumatic compression devices," Shechter said.
"This study indicates that use of an APCD reduces the necessity for therapy. However, rehabilitation therapy for primary and secondary lymphedema, at least a short course of
treatment, is important, especially in order to ensure patients are adequately educated in lymphedema care, management, and precautions," she said.
"There should be a follow-up study performed to discuss a patient's ability to sustain use of the APCD versus a traditional pneumatic pump, and the long-term success in both preventing infection and in reduction of therapy visits," Shechter said.
Tactile Medical partially supported this research and employs one coauthor as chief medical officer. Dr. Karaca-Mandic, Dr. Franks, and his coauthor reported consulting for the company.
Prognostic Disclosures Benefit Cancer Patients
When doctors discuss prognosis with advanced cancer patients, those patients have more realistic views of their life expectancy and don't seem to experience a decrease in emotional wellbeing, according to a new study.
"That the vast majority of cancer patients who are dying say that they want to know their prognosis seems surprisingly courageous," said senior author Holly G. Prigerson of Weill Cornell Medical College in New York City.
Every patient needs to know their prognosis, including life expectancy, and expected outcomes of treatment; for example, they should know that chemotherapy cannot cure incurable cancer, Prigerson said.
"Providers often are reluctant to communicate grim news, as anyone would be," she said.
The study included 590 patients with advanced, metastatic cancer who had been treated with at least one round of palliative chemotherapy, which is meant to improve comfort rather than to cure.
Researchers asked the patients whether their oncologist had ever given them a prognosis with a life expectancy estimate, then asked the patients to estimate their own life expectancy and to complete assessments of emotional distress, whether they had advance directives and their end-of-life care preferences.
The patients also described their relationship with their doctors.
Half of the patients survived for less than six months after the study began.
About 70 percent wanted to be told their life expectancy, but only about 18 percent recalled having this discussion with their oncologist.
Half of the patients were willing to estimate their own life expectancy, and those who remembered having a prognosis conversation with their doctor estimated a life expectancy closer to their actual survival than those who did not.
Less than 10 percent of those who remembered having a conversation with their doctor made estimates that were more than five years longer than their actual survival. That compares with 35 percent of those who did not remember having the conversation who overestimated their life expectancy by more than five years.
Remembering a prognostic discussion with a doctor decreased patient estimated life expectancy by about 17 months, when the researchers accounted for other factors, according to the results in the Journal of Clinical Oncology.
Talking to a doctor about life expectancy was not tied to worse doctor-patient relationship, more sadness or higher anxiety, the surveys found.
"It is encouraging that the patients who reported a prognostic disclosure by their oncologist were more realistic in their life-expectancy estimate, more likely to complete a [Do Not Resuscitate] order and to want comfort care," Prigerson said by email.
"There was no emotional fallout that damaged their relationship with their oncologist - as reported by the patient," she said.
Often these conversations should happen, but they do not, for a multitude of reasons, she said. The patient may not be ready to hear bad news, some patients may reject information they are given because they believe a miracle may happen, and other reasons, she said.
"Some patients are not able to hear and process poor prognoses and more harm than good can be done by forcing the situation," Prigerson said. "However, we have found that over 90 percent of patients benefit from prognostic disclosures and it is a minority of patients for religious or personal or social reasons that do not benefit."
When doctors discuss prognosis with advanced cancer patients, those patients have more realistic views of their life expectancy and don't seem to experience a decrease in emotional wellbeing, according to a new study.
"That the vast majority of cancer patients who are dying say that they want to know their prognosis seems surprisingly courageous," said senior author Holly G. Prigerson of Weill Cornell Medical College in New York City.
Every patient needs to know their prognosis, including life expectancy, and expected outcomes of treatment; for example, they should know that chemotherapy cannot cure incurable cancer, Prigerson said.
"Providers often are reluctant to communicate grim news, as anyone would be," she said.
The study included 590 patients with advanced, metastatic cancer who had been treated with at least one round of palliative chemotherapy, which is meant to improve comfort rather than to cure.
Researchers asked the patients whether their oncologist had ever given them a prognosis with a life expectancy estimate, then asked the patients to estimate their own life expectancy and to complete assessments of emotional distress, whether they had advance directives and their end-of-life care preferences.
The patients also described their relationship with their doctors.
Half of the patients survived for less than six months after the study began.
About 70 percent wanted to be told their life expectancy, but only about 18 percent recalled having this discussion with their oncologist.
Half of the patients were willing to estimate their own life expectancy, and those who remembered having a prognosis conversation with their doctor estimated a life expectancy closer to their actual survival than those who did not.
Less than 10 percent of those who remembered having a conversation with their doctor made estimates that were more than five years longer than their actual survival. That compares with 35 percent of those who did not remember having the conversation who overestimated their life expectancy by more than five years.
Remembering a prognostic discussion with a doctor decreased patient estimated life expectancy by about 17 months, when the researchers accounted for other factors, according to the results in the Journal of Clinical Oncology.
Talking to a doctor about life expectancy was not tied to worse doctor-patient relationship, more sadness or higher anxiety, the surveys found.
"It is encouraging that the patients who reported a prognostic disclosure by their oncologist were more realistic in their life-expectancy estimate, more likely to complete a [Do Not Resuscitate] order and to want comfort care," Prigerson said by email.
"There was no emotional fallout that damaged their relationship with their oncologist - as reported by the patient," she said.
Often these conversations should happen, but they do not, for a multitude of reasons, she said. The patient may not be ready to hear bad news, some patients may reject information they are given because they believe a miracle may happen, and other reasons, she said.
"Some patients are not able to hear and process poor prognoses and more harm than good can be done by forcing the situation," Prigerson said. "However, we have found that over 90 percent of patients benefit from prognostic disclosures and it is a minority of patients for religious or personal or social reasons that do not benefit."
When doctors discuss prognosis with advanced cancer patients, those patients have more realistic views of their life expectancy and don't seem to experience a decrease in emotional wellbeing, according to a new study.
"That the vast majority of cancer patients who are dying say that they want to know their prognosis seems surprisingly courageous," said senior author Holly G. Prigerson of Weill Cornell Medical College in New York City.
Every patient needs to know their prognosis, including life expectancy, and expected outcomes of treatment; for example, they should know that chemotherapy cannot cure incurable cancer, Prigerson said.
"Providers often are reluctant to communicate grim news, as anyone would be," she said.
The study included 590 patients with advanced, metastatic cancer who had been treated with at least one round of palliative chemotherapy, which is meant to improve comfort rather than to cure.
Researchers asked the patients whether their oncologist had ever given them a prognosis with a life expectancy estimate, then asked the patients to estimate their own life expectancy and to complete assessments of emotional distress, whether they had advance directives and their end-of-life care preferences.
The patients also described their relationship with their doctors.
Half of the patients survived for less than six months after the study began.
About 70 percent wanted to be told their life expectancy, but only about 18 percent recalled having this discussion with their oncologist.
Half of the patients were willing to estimate their own life expectancy, and those who remembered having a prognosis conversation with their doctor estimated a life expectancy closer to their actual survival than those who did not.
Less than 10 percent of those who remembered having a conversation with their doctor made estimates that were more than five years longer than their actual survival. That compares with 35 percent of those who did not remember having the conversation who overestimated their life expectancy by more than five years.
Remembering a prognostic discussion with a doctor decreased patient estimated life expectancy by about 17 months, when the researchers accounted for other factors, according to the results in the Journal of Clinical Oncology.
Talking to a doctor about life expectancy was not tied to worse doctor-patient relationship, more sadness or higher anxiety, the surveys found.
"It is encouraging that the patients who reported a prognostic disclosure by their oncologist were more realistic in their life-expectancy estimate, more likely to complete a [Do Not Resuscitate] order and to want comfort care," Prigerson said by email.
"There was no emotional fallout that damaged their relationship with their oncologist - as reported by the patient," she said.
Often these conversations should happen, but they do not, for a multitude of reasons, she said. The patient may not be ready to hear bad news, some patients may reject information they are given because they believe a miracle may happen, and other reasons, she said.
"Some patients are not able to hear and process poor prognoses and more harm than good can be done by forcing the situation," Prigerson said. "However, we have found that over 90 percent of patients benefit from prognostic disclosures and it is a minority of patients for religious or personal or social reasons that do not benefit."