Reuters Health

NEW YORK - The American College of Physicians (ACP) has issued a baker's dozen of recommendations intended to guide the effective use of telemedicine in primary care settings.

"The recommendations balance the potential benefits and expanded use of telemedicine with the importance of maintaining the patient-physician relationship and patient safety," Hilary Daniel from American College of Physicians, Washington, DC, said by email.

Telemedicine, the use of technology to deliver health care services at a distance, began mainly in rural communities and federal health programs, but now is used in a variety of medical specialties and subspecialties.

Daniel and colleagues on the ACP Health and Public Policy Committee detail pragmatic recommendations on the use of telemedicine in the primary care setting, physician considerations for those who use telemedicine in their practices, and policy recommendations on the practice and reimbursement of telemedicine in their September 8 Annals of Internal Medicine online position paper.

While ACP "supports the expanded role of telemedicine as a method of health care delivery that may enhance patient-physician collaborations," it also recommends that direct-to-patient telemedicine services should be used only as an intermittent alternative to a patient's primary care physician when necessary to meet the patient's immediate care

needs.

These services should take place within the context of a valid patient-physician relationship. Physicians who use telemedicine have an obligation to establish such a relationship based on the standard of care required for an in-person visit or consult with another physician who has such a relationship with the patient.

Physicians should take care to see that financially disadvantaged populations also have access to telemedicine services, where appropriate, as well as ensure that these services comply with federal and state security and privacy regulations while meeting the same standards of practice as if the physician were seeing the patient in person.

ACP supports efforts to reimburse telemedicine communications and telehealth services and supports processes to obtain medical licenses and hospital privileges necessary to support telemedicine across state lines.

The committee also endorses the use of federal funds to support the broadband infrastructure and to establish an evidence base on the safety, efficacy, and cost of telemedicine technologies.

"Telemedicine can be an effective and beneficial tool for physicians and patients to enhance a patient's care," Daniel concluded. "Physicians can take away from this report a greater understanding of the regulatory and payment issues surrounding telemedicine and evaluate how telemedicine may be useful for their patients and practice and augment the care they already provide."

In a related editorial, Dr. David A. Asch, from the University of Pennsylvania's Center for Health Care Innovation, Philadelphia, addressed the hidden economics of telemedicine. He said by email, "I think it is a trap to think that the only promise of telemedicine is the opportunity to do something remotely that used to happen face to face. The real opportunities will come from doing health care in a different way because of this remote technology."

"An important question is, 'If there are so many opportunities from telemedicine, why doesn't more of it happen?'" Dr. Asch said. "I think there are a lot of reasons for that but one important reason is that insurers, in particular, worry that if they make telemedicine payments easy, then they will open up the floodgates of demand."

Dr. Laura Markwick, from Wegmans School of Nursing, St. John Fisher College, Rochester, New York, said by email, "I would like to apply these to all health care providers and not just physicians. Of note, they do mention that they recommend a relationship already be established with the patient, which I do not feel is an absolute must. When we did our telemedicine program, we did not have a previous in-person relationship established and we were able to provide high-quality care that improved access for the patients."

"All health care providers should be reimbursed for telemedicine care, at levels similar to what is reimbursed currently," Dr. Markwick said. "This should be a covered service from the person's insurance, depending upon the care needed. If it is just someone who does not feel like making it to an appointment but otherwise could with little difficulty (social issues included in this decision), then perhaps the patient should contribute toward this reimbursement."

Dr. Manish N. Shah, from the University of Wisconsin School of Medicine and Public Health, Madison, said by email, "It is important to know that the U.S. is behind the rest of the world when it comes to telemedicine. In Canada, the Ontario Telemedicine Network has existed for years. In the UK, telemedicine has been also available."

"Reimbursement for telemedicine is a complex issue, particularly because the entire provider payment system is changing," Dr. Shah said. "However, without funding, telemedicine will not be made available to patients despite increasing evidence showing that patients want to use it, that care can be effectively delivered via telemedicine, and that telemedicine is cost effective."

The authors reported no external funding or disclosures.

NEW YORK - The American College of Physicians (ACP) has issued a baker's dozen of recommendations intended to guide the effective use of telemedicine in primary care settings.

"The recommendations balance the potential benefits and expanded use of telemedicine with the importance of maintaining the patient-physician relationship and patient safety," Hilary Daniel from American College of Physicians, Washington, DC, said by email.

Telemedicine, the use of technology to deliver health care services at a distance, began mainly in rural communities and federal health programs, but now is used in a variety of medical specialties and subspecialties.

Daniel and colleagues on the ACP Health and Public Policy Committee detail pragmatic recommendations on the use of telemedicine in the primary care setting, physician considerations for those who use telemedicine in their practices, and policy recommendations on the practice and reimbursement of telemedicine in their September 8 Annals of Internal Medicine online position paper.

While ACP "supports the expanded role of telemedicine as a method of health care delivery that may enhance patient-physician collaborations," it also recommends that direct-to-patient telemedicine services should be used only as an intermittent alternative to a patient's primary care physician when necessary to meet the patient's immediate care

needs.

These services should take place within the context of a valid patient-physician relationship. Physicians who use telemedicine have an obligation to establish such a relationship based on the standard of care required for an in-person visit or consult with another physician who has such a relationship with the patient.

Physicians should take care to see that financially disadvantaged populations also have access to telemedicine services, where appropriate, as well as ensure that these services comply with federal and state security and privacy regulations while meeting the same standards of practice as if the physician were seeing the patient in person.

ACP supports efforts to reimburse telemedicine communications and telehealth services and supports processes to obtain medical licenses and hospital privileges necessary to support telemedicine across state lines.

The committee also endorses the use of federal funds to support the broadband infrastructure and to establish an evidence base on the safety, efficacy, and cost of telemedicine technologies.

"Telemedicine can be an effective and beneficial tool for physicians and patients to enhance a patient's care," Daniel concluded. "Physicians can take away from this report a greater understanding of the regulatory and payment issues surrounding telemedicine and evaluate how telemedicine may be useful for their patients and practice and augment the care they already provide."

In a related editorial, Dr. David A. Asch, from the University of Pennsylvania's Center for Health Care Innovation, Philadelphia, addressed the hidden economics of telemedicine. He said by email, "I think it is a trap to think that the only promise of telemedicine is the opportunity to do something remotely that used to happen face to face. The real opportunities will come from doing health care in a different way because of this remote technology."

"An important question is, 'If there are so many opportunities from telemedicine, why doesn't more of it happen?'" Dr. Asch said. "I think there are a lot of reasons for that but one important reason is that insurers, in particular, worry that if they make telemedicine payments easy, then they will open up the floodgates of demand."

Dr. Laura Markwick, from Wegmans School of Nursing, St. John Fisher College, Rochester, New York, said by email, "I would like to apply these to all health care providers and not just physicians. Of note, they do mention that they recommend a relationship already be established with the patient, which I do not feel is an absolute must. When we did our telemedicine program, we did not have a previous in-person relationship established and we were able to provide high-quality care that improved access for the patients."

"All health care providers should be reimbursed for telemedicine care, at levels similar to what is reimbursed currently," Dr. Markwick said. "This should be a covered service from the person's insurance, depending upon the care needed. If it is just someone who does not feel like making it to an appointment but otherwise could with little difficulty (social issues included in this decision), then perhaps the patient should contribute toward this reimbursement."

Dr. Manish N. Shah, from the University of Wisconsin School of Medicine and Public Health, Madison, said by email, "It is important to know that the U.S. is behind the rest of the world when it comes to telemedicine. In Canada, the Ontario Telemedicine Network has existed for years. In the UK, telemedicine has been also available."

"Reimbursement for telemedicine is a complex issue, particularly because the entire provider payment system is changing," Dr. Shah said. "However, without funding, telemedicine will not be made available to patients despite increasing evidence showing that patients want to use it, that care can be effectively delivered via telemedicine, and that telemedicine is cost effective."

The authors reported no external funding or disclosures.

NEW YORK - The American College of Physicians (ACP) has issued a baker's dozen of recommendations intended to guide the effective use of telemedicine in primary care settings.

"The recommendations balance the potential benefits and expanded use of telemedicine with the importance of maintaining the patient-physician relationship and patient safety," Hilary Daniel from American College of Physicians, Washington, DC, said by email.

Telemedicine, the use of technology to deliver health care services at a distance, began mainly in rural communities and federal health programs, but now is used in a variety of medical specialties and subspecialties.

Daniel and colleagues on the ACP Health and Public Policy Committee detail pragmatic recommendations on the use of telemedicine in the primary care setting, physician considerations for those who use telemedicine in their practices, and policy recommendations on the practice and reimbursement of telemedicine in their September 8 Annals of Internal Medicine online position paper.

While ACP "supports the expanded role of telemedicine as a method of health care delivery that may enhance patient-physician collaborations," it also recommends that direct-to-patient telemedicine services should be used only as an intermittent alternative to a patient's primary care physician when necessary to meet the patient's immediate care

needs.

These services should take place within the context of a valid patient-physician relationship. Physicians who use telemedicine have an obligation to establish such a relationship based on the standard of care required for an in-person visit or consult with another physician who has such a relationship with the patient.

Physicians should take care to see that financially disadvantaged populations also have access to telemedicine services, where appropriate, as well as ensure that these services comply with federal and state security and privacy regulations while meeting the same standards of practice as if the physician were seeing the patient in person.

ACP supports efforts to reimburse telemedicine communications and telehealth services and supports processes to obtain medical licenses and hospital privileges necessary to support telemedicine across state lines.

The committee also endorses the use of federal funds to support the broadband infrastructure and to establish an evidence base on the safety, efficacy, and cost of telemedicine technologies.

"Telemedicine can be an effective and beneficial tool for physicians and patients to enhance a patient's care," Daniel concluded. "Physicians can take away from this report a greater understanding of the regulatory and payment issues surrounding telemedicine and evaluate how telemedicine may be useful for their patients and practice and augment the care they already provide."

In a related editorial, Dr. David A. Asch, from the University of Pennsylvania's Center for Health Care Innovation, Philadelphia, addressed the hidden economics of telemedicine. He said by email, "I think it is a trap to think that the only promise of telemedicine is the opportunity to do something remotely that used to happen face to face. The real opportunities will come from doing health care in a different way because of this remote technology."

"An important question is, 'If there are so many opportunities from telemedicine, why doesn't more of it happen?'" Dr. Asch said. "I think there are a lot of reasons for that but one important reason is that insurers, in particular, worry that if they make telemedicine payments easy, then they will open up the floodgates of demand."

Dr. Laura Markwick, from Wegmans School of Nursing, St. John Fisher College, Rochester, New York, said by email, "I would like to apply these to all health care providers and not just physicians. Of note, they do mention that they recommend a relationship already be established with the patient, which I do not feel is an absolute must. When we did our telemedicine program, we did not have a previous in-person relationship established and we were able to provide high-quality care that improved access for the patients."

"All health care providers should be reimbursed for telemedicine care, at levels similar to what is reimbursed currently," Dr. Markwick said. "This should be a covered service from the person's insurance, depending upon the care needed. If it is just someone who does not feel like making it to an appointment but otherwise could with little difficulty (social issues included in this decision), then perhaps the patient should contribute toward this reimbursement."

Dr. Manish N. Shah, from the University of Wisconsin School of Medicine and Public Health, Madison, said by email, "It is important to know that the U.S. is behind the rest of the world when it comes to telemedicine. In Canada, the Ontario Telemedicine Network has existed for years. In the UK, telemedicine has been also available."

"Reimbursement for telemedicine is a complex issue, particularly because the entire provider payment system is changing," Dr. Shah said. "However, without funding, telemedicine will not be made available to patients despite increasing evidence showing that patients want to use it, that care can be effectively delivered via telemedicine, and that telemedicine is cost effective."

The authors reported no external funding or disclosures.

NEW YORK - Coating on endovascular devices is associated with embolization and microvascular occlusion leading to purpura or livedo racemosa, according to a new report.

Dr. Alina Bridges, of the Department of Dermatology at Mayo Clinic in Rochester, Minnesota, said by email that the study was conducted "to make clinicians and pathologists aware of this underrecognized phenomenon of iatrogenic hydrophilic polymer gel embolization that can involve the skin and present with purpura."

The phenomenon "has distinctive microscopic morphology and potential for internal organ involvement," she added.

Endovascular devices commonly are coated with hydrophilic polymer gels to improve maneuverability and prevent vasospasm. However, there are reports of the coating embolizing, resulting

in severe reactions such as stroke, pulmonary infarction, and death.

Dr. Bridges and colleagues presented a case study of eight patients with livedo racemosa and purpura after an endovascular procedure. The patients had punch biopsies obtained with hematoxylin-eosin-stained sections.

The study subjects were between 58 and 81 years old, most were men and most had previous endovascular procedures and multiple comorbidities, according to an article online August 11 in the Journal of the American Academy of Dermatology.

In all but one patient, the cutaneous lesions were unilateral and all but two were asymptomatic. Six patients presented with livedo racemosa and two with purpura.

All cases demonstrated pauci-inflammatory occlusion in the mid-dermal and small superficial vessels. Likewise, histopathologic evidence was consistent with previously reported cases of emboli secondary to hydrophilic gel polymer.

There was no evidence of embolic sequela to the organs in three patients. However, one patient died of unknown reasons and four patients experienced postoperative complications including spinal cord ischemia, acute kidney injury, and cerebral infarction. In all cases, the cutaneous manifestations resolved without intervention.

The authors say they suspect the incidence of this type of embolization is underrecognized, especially with the common use of hydrophilic polymer gel coatings.

"This report highlights the importance of awareness of this rare iatrogenic complication and the importance of investigating a patient's clinical history to determine if there had been recent exposure to an intravascular device with a hydrophilic coating," Dr. Bridges said.

"While the use of polymer-coated devices offers several advantages, clinicians must be aware of their potential complications, including stroke, myocardial and pulmonary infarction, gangrene, and/or death," she said.

The authors reported no funding or conflicts of interest.

NEW YORK - Coating on endovascular devices is associated with embolization and microvascular occlusion leading to purpura or livedo racemosa, according to a new report.

Dr. Alina Bridges, of the Department of Dermatology at Mayo Clinic in Rochester, Minnesota, said by email that the study was conducted "to make clinicians and pathologists aware of this underrecognized phenomenon of iatrogenic hydrophilic polymer gel embolization that can involve the skin and present with purpura."

The phenomenon "has distinctive microscopic morphology and potential for internal organ involvement," she added.

Endovascular devices commonly are coated with hydrophilic polymer gels to improve maneuverability and prevent vasospasm. However, there are reports of the coating embolizing, resulting

in severe reactions such as stroke, pulmonary infarction, and death.

Dr. Bridges and colleagues presented a case study of eight patients with livedo racemosa and purpura after an endovascular procedure. The patients had punch biopsies obtained with hematoxylin-eosin-stained sections.

The study subjects were between 58 and 81 years old, most were men and most had previous endovascular procedures and multiple comorbidities, according to an article online August 11 in the Journal of the American Academy of Dermatology.

In all but one patient, the cutaneous lesions were unilateral and all but two were asymptomatic. Six patients presented with livedo racemosa and two with purpura.

All cases demonstrated pauci-inflammatory occlusion in the mid-dermal and small superficial vessels. Likewise, histopathologic evidence was consistent with previously reported cases of emboli secondary to hydrophilic gel polymer.

There was no evidence of embolic sequela to the organs in three patients. However, one patient died of unknown reasons and four patients experienced postoperative complications including spinal cord ischemia, acute kidney injury, and cerebral infarction. In all cases, the cutaneous manifestations resolved without intervention.

The authors say they suspect the incidence of this type of embolization is underrecognized, especially with the common use of hydrophilic polymer gel coatings.

"This report highlights the importance of awareness of this rare iatrogenic complication and the importance of investigating a patient's clinical history to determine if there had been recent exposure to an intravascular device with a hydrophilic coating," Dr. Bridges said.

"While the use of polymer-coated devices offers several advantages, clinicians must be aware of their potential complications, including stroke, myocardial and pulmonary infarction, gangrene, and/or death," she said.

The authors reported no funding or conflicts of interest.

NEW YORK - Coating on endovascular devices is associated with embolization and microvascular occlusion leading to purpura or livedo racemosa, according to a new report.

Dr. Alina Bridges, of the Department of Dermatology at Mayo Clinic in Rochester, Minnesota, said by email that the study was conducted "to make clinicians and pathologists aware of this underrecognized phenomenon of iatrogenic hydrophilic polymer gel embolization that can involve the skin and present with purpura."

The phenomenon "has distinctive microscopic morphology and potential for internal organ involvement," she added.

Endovascular devices commonly are coated with hydrophilic polymer gels to improve maneuverability and prevent vasospasm. However, there are reports of the coating embolizing, resulting

in severe reactions such as stroke, pulmonary infarction, and death.

Dr. Bridges and colleagues presented a case study of eight patients with livedo racemosa and purpura after an endovascular procedure. The patients had punch biopsies obtained with hematoxylin-eosin-stained sections.

The study subjects were between 58 and 81 years old, most were men and most had previous endovascular procedures and multiple comorbidities, according to an article online August 11 in the Journal of the American Academy of Dermatology.

In all but one patient, the cutaneous lesions were unilateral and all but two were asymptomatic. Six patients presented with livedo racemosa and two with purpura.

All cases demonstrated pauci-inflammatory occlusion in the mid-dermal and small superficial vessels. Likewise, histopathologic evidence was consistent with previously reported cases of emboli secondary to hydrophilic gel polymer.

There was no evidence of embolic sequela to the organs in three patients. However, one patient died of unknown reasons and four patients experienced postoperative complications including spinal cord ischemia, acute kidney injury, and cerebral infarction. In all cases, the cutaneous manifestations resolved without intervention.

The authors say they suspect the incidence of this type of embolization is underrecognized, especially with the common use of hydrophilic polymer gel coatings.

"This report highlights the importance of awareness of this rare iatrogenic complication and the importance of investigating a patient's clinical history to determine if there had been recent exposure to an intravascular device with a hydrophilic coating," Dr. Bridges said.

"While the use of polymer-coated devices offers several advantages, clinicians must be aware of their potential complications, including stroke, myocardial and pulmonary infarction, gangrene, and/or death," she said.

The authors reported no funding or conflicts of interest.

Too little sleep, or poor-quality sleep, may be linked to early markers of heart disease in asymptomatic healthy adults, a new study from South Korea suggests.

More than 47,000 men and women completed a sleep questionnaire and underwent assessments of coronary artery calcium and plaque as well as brachial-ankle pulse wave velocity (PWV).

Participants' average sleep duration was 6.4 hours per night, and about 84 percent said their sleep quality was "good," according to Dr. Chan-Won Kim of Kangbuk Samsung Hospital of Sungkyunkwan University School of Medicine in Seoul, South Korea and colleagues.

The researchers considered those who got five hours or less per night to be "short" sleepers, and those who got nine or more hours to be "long" sleepers.

Short sleepers had 50% more coronary artery calcium than those who slept for seven hours per night, according to the results in Arteriosclerosis, Thrombosis and Vascular Biology. Long sleepers had 70% more calcium than those who slept seven hours.

Those who reported poor sleep quality also tended to have more coronary calcium and more arterial stiffness.

In a 2013 study, people who tended to get less than six hours of sleep nightly were more likely to have high blood pressure, high cholesterol, diabetes and to be obese.

"Adults with poor sleep quality have stiffer arteries than those who sleep seven hours a day or had good sleep quality," co-lead author Dr. Yoosoo Chang of the Center for Cohort Studies at Kangbuk Samsung Hospital said in a statement accompanying the study. "Overall, we saw the lowest levels of vascular disease in adults sleeping seven hours a day and reporting good sleep quality."

Short sleepers were more likely than others to be older, have depression, type 2 diabetes or to be smokers.

"The associations of too short or too long sleep duration and of poor sleep quality with early indicators of heart disease, such as coronary calcium and arterial stiffness, provides strong support to the increasing body of evidence that links inadequate sleep with an increased risk of heart attacks," Kim said by email.

"It is still not clear if inadequate sleep is the cause or the consequence of ill health," but good sleep hygiene, including avoiding electronic media at bedtime, should be part of a healthy lifestyle, Kim said.

"For doctors, it can be helpful to evaluate sleep duration and sleep quality when assessing the health status of their patients," Kim said.

Too little sleep, or poor-quality sleep, may be linked to early markers of heart disease in asymptomatic healthy adults, a new study from South Korea suggests.

More than 47,000 men and women completed a sleep questionnaire and underwent assessments of coronary artery calcium and plaque as well as brachial-ankle pulse wave velocity (PWV).

Participants' average sleep duration was 6.4 hours per night, and about 84 percent said their sleep quality was "good," according to Dr. Chan-Won Kim of Kangbuk Samsung Hospital of Sungkyunkwan University School of Medicine in Seoul, South Korea and colleagues.

The researchers considered those who got five hours or less per night to be "short" sleepers, and those who got nine or more hours to be "long" sleepers.

Short sleepers had 50% more coronary artery calcium than those who slept for seven hours per night, according to the results in Arteriosclerosis, Thrombosis and Vascular Biology. Long sleepers had 70% more calcium than those who slept seven hours.

Those who reported poor sleep quality also tended to have more coronary calcium and more arterial stiffness.

In a 2013 study, people who tended to get less than six hours of sleep nightly were more likely to have high blood pressure, high cholesterol, diabetes and to be obese.

"Adults with poor sleep quality have stiffer arteries than those who sleep seven hours a day or had good sleep quality," co-lead author Dr. Yoosoo Chang of the Center for Cohort Studies at Kangbuk Samsung Hospital said in a statement accompanying the study. "Overall, we saw the lowest levels of vascular disease in adults sleeping seven hours a day and reporting good sleep quality."

Short sleepers were more likely than others to be older, have depression, type 2 diabetes or to be smokers.

"The associations of too short or too long sleep duration and of poor sleep quality with early indicators of heart disease, such as coronary calcium and arterial stiffness, provides strong support to the increasing body of evidence that links inadequate sleep with an increased risk of heart attacks," Kim said by email.

"It is still not clear if inadequate sleep is the cause or the consequence of ill health," but good sleep hygiene, including avoiding electronic media at bedtime, should be part of a healthy lifestyle, Kim said.

"For doctors, it can be helpful to evaluate sleep duration and sleep quality when assessing the health status of their patients," Kim said.

Too little sleep, or poor-quality sleep, may be linked to early markers of heart disease in asymptomatic healthy adults, a new study from South Korea suggests.

More than 47,000 men and women completed a sleep questionnaire and underwent assessments of coronary artery calcium and plaque as well as brachial-ankle pulse wave velocity (PWV).

Participants' average sleep duration was 6.4 hours per night, and about 84 percent said their sleep quality was "good," according to Dr. Chan-Won Kim of Kangbuk Samsung Hospital of Sungkyunkwan University School of Medicine in Seoul, South Korea and colleagues.

The researchers considered those who got five hours or less per night to be "short" sleepers, and those who got nine or more hours to be "long" sleepers.

Short sleepers had 50% more coronary artery calcium than those who slept for seven hours per night, according to the results in Arteriosclerosis, Thrombosis and Vascular Biology. Long sleepers had 70% more calcium than those who slept seven hours.

Those who reported poor sleep quality also tended to have more coronary calcium and more arterial stiffness.

In a 2013 study, people who tended to get less than six hours of sleep nightly were more likely to have high blood pressure, high cholesterol, diabetes and to be obese.

"Adults with poor sleep quality have stiffer arteries than those who sleep seven hours a day or had good sleep quality," co-lead author Dr. Yoosoo Chang of the Center for Cohort Studies at Kangbuk Samsung Hospital said in a statement accompanying the study. "Overall, we saw the lowest levels of vascular disease in adults sleeping seven hours a day and reporting good sleep quality."

Short sleepers were more likely than others to be older, have depression, type 2 diabetes or to be smokers.

"The associations of too short or too long sleep duration and of poor sleep quality with early indicators of heart disease, such as coronary calcium and arterial stiffness, provides strong support to the increasing body of evidence that links inadequate sleep with an increased risk of heart attacks," Kim said by email.

"It is still not clear if inadequate sleep is the cause or the consequence of ill health," but good sleep hygiene, including avoiding electronic media at bedtime, should be part of a healthy lifestyle, Kim said.

"For doctors, it can be helpful to evaluate sleep duration and sleep quality when assessing the health status of their patients," Kim said.

NEW YORK—Smokers who switch to e-cigarettes - even if only some of the time - may dramatically reduce their exposure to air pollutants including carbon monoxide and acrolein, a British study suggests.

Researchers gave e-cigarettes to 40 smokers who said they wanted to quit. After four weeks, the 16 participants using only e-cigarettes had about an 80% drop in exposure both to carbon monoxide and to acrolein, a harmful breakdown product that is also in some e-cigarettes' vapor. Acrolein is known to irritate exposed tissues and can destroy cilia.

The 17 participants who swapped some regular cigarettes for the electronic version had a 52% decline in carbon monoxide exposure and a 60% decline for acrolein, according to a report online September 3 in Cancer Prevention Research.

To get the most benefit from switching to e-cigarettes, smokers need to completely give up traditional cigarettes, lead study author Dr. Hayden McRobbie, of the Wolfson Institute of Preventive Medicine at Queen Mary University of London, said by email.

"Smokers may get some encouragement from the finding that there is some potential health benefit as soon as they start the process," Dr. McRobbie said.

While tobacco control advocates fear that e-cigarettes may give rise to a new generation of nicotine addicts who eventually transition to conventional cigarettes, the current study adds to a small but growing body of evidence suggesting the devices might benefit the health of people who already smoke.

An international analysis of published research by the Cochrane Review in December concluded the devices could help smokers quit but said much of the existing research on e-cigarettes was thin.

Even though the current study points to another potential benefit of e-cigarettes, more evidence is still needed from longer and larger trials before scientists can draw firm conclusions about any safety advantages, Dr. Nancy Rigotti, director of tobacco research at Massachusetts General Hospital in Boston, said by email.

"It is exactly the type of incremental, careful work that is needed but it is not yet a definitive study," Rigotti, who wasn't involved in the study, said.

Study participants were typically in their 40s and had attempted to quit at least twice before joining the trial. All of them were offered the same type of e-cigarette and encouraged to completely abandon traditional cigarettes.

Researchers measured carbon monoxide in participants' breath one week before switching to e-cigarettes, on the day they switched, and again four weeks later. They followed the same schedule for testing urine for exposure to acrolein.

A limitation of the study, the authors acknowledged, is that it only included people with a desire to quit smoking, making it possible the results would be different for smokers with no intention of quitting. It's also possible that the specific model of e-cigarette used in the study might not be representative of other devices.

Still, the findings suggest smokers should be told e-cigarettes may curb their exposure to toxic chemicals, Dr. Riccardo Polosa, head of the tobacco research center at the University of Catania in Italy, said by email.

"This study adds to the evidence that e-cigarettes are much less harmful compared to conventional cigarettes," said Polosa, who wasn't involved in the study.

NEW YORK—Smokers who switch to e-cigarettes - even if only some of the time - may dramatically reduce their exposure to air pollutants including carbon monoxide and acrolein, a British study suggests.

Researchers gave e-cigarettes to 40 smokers who said they wanted to quit. After four weeks, the 16 participants using only e-cigarettes had about an 80% drop in exposure both to carbon monoxide and to acrolein, a harmful breakdown product that is also in some e-cigarettes' vapor. Acrolein is known to irritate exposed tissues and can destroy cilia.

The 17 participants who swapped some regular cigarettes for the electronic version had a 52% decline in carbon monoxide exposure and a 60% decline for acrolein, according to a report online September 3 in Cancer Prevention Research.

To get the most benefit from switching to e-cigarettes, smokers need to completely give up traditional cigarettes, lead study author Dr. Hayden McRobbie, of the Wolfson Institute of Preventive Medicine at Queen Mary University of London, said by email.

"Smokers may get some encouragement from the finding that there is some potential health benefit as soon as they start the process," Dr. McRobbie said.

While tobacco control advocates fear that e-cigarettes may give rise to a new generation of nicotine addicts who eventually transition to conventional cigarettes, the current study adds to a small but growing body of evidence suggesting the devices might benefit the health of people who already smoke.

An international analysis of published research by the Cochrane Review in December concluded the devices could help smokers quit but said much of the existing research on e-cigarettes was thin.

Even though the current study points to another potential benefit of e-cigarettes, more evidence is still needed from longer and larger trials before scientists can draw firm conclusions about any safety advantages, Dr. Nancy Rigotti, director of tobacco research at Massachusetts General Hospital in Boston, said by email.

"It is exactly the type of incremental, careful work that is needed but it is not yet a definitive study," Rigotti, who wasn't involved in the study, said.

Study participants were typically in their 40s and had attempted to quit at least twice before joining the trial. All of them were offered the same type of e-cigarette and encouraged to completely abandon traditional cigarettes.

Researchers measured carbon monoxide in participants' breath one week before switching to e-cigarettes, on the day they switched, and again four weeks later. They followed the same schedule for testing urine for exposure to acrolein.

A limitation of the study, the authors acknowledged, is that it only included people with a desire to quit smoking, making it possible the results would be different for smokers with no intention of quitting. It's also possible that the specific model of e-cigarette used in the study might not be representative of other devices.

Still, the findings suggest smokers should be told e-cigarettes may curb their exposure to toxic chemicals, Dr. Riccardo Polosa, head of the tobacco research center at the University of Catania in Italy, said by email.

"This study adds to the evidence that e-cigarettes are much less harmful compared to conventional cigarettes," said Polosa, who wasn't involved in the study.

NEW YORK—Smokers who switch to e-cigarettes - even if only some of the time - may dramatically reduce their exposure to air pollutants including carbon monoxide and acrolein, a British study suggests.

Researchers gave e-cigarettes to 40 smokers who said they wanted to quit. After four weeks, the 16 participants using only e-cigarettes had about an 80% drop in exposure both to carbon monoxide and to acrolein, a harmful breakdown product that is also in some e-cigarettes' vapor. Acrolein is known to irritate exposed tissues and can destroy cilia.

The 17 participants who swapped some regular cigarettes for the electronic version had a 52% decline in carbon monoxide exposure and a 60% decline for acrolein, according to a report online September 3 in Cancer Prevention Research.

To get the most benefit from switching to e-cigarettes, smokers need to completely give up traditional cigarettes, lead study author Dr. Hayden McRobbie, of the Wolfson Institute of Preventive Medicine at Queen Mary University of London, said by email.

"Smokers may get some encouragement from the finding that there is some potential health benefit as soon as they start the process," Dr. McRobbie said.

While tobacco control advocates fear that e-cigarettes may give rise to a new generation of nicotine addicts who eventually transition to conventional cigarettes, the current study adds to a small but growing body of evidence suggesting the devices might benefit the health of people who already smoke.

An international analysis of published research by the Cochrane Review in December concluded the devices could help smokers quit but said much of the existing research on e-cigarettes was thin.

Even though the current study points to another potential benefit of e-cigarettes, more evidence is still needed from longer and larger trials before scientists can draw firm conclusions about any safety advantages, Dr. Nancy Rigotti, director of tobacco research at Massachusetts General Hospital in Boston, said by email.

"It is exactly the type of incremental, careful work that is needed but it is not yet a definitive study," Rigotti, who wasn't involved in the study, said.

Study participants were typically in their 40s and had attempted to quit at least twice before joining the trial. All of them were offered the same type of e-cigarette and encouraged to completely abandon traditional cigarettes.

Researchers measured carbon monoxide in participants' breath one week before switching to e-cigarettes, on the day they switched, and again four weeks later. They followed the same schedule for testing urine for exposure to acrolein.

A limitation of the study, the authors acknowledged, is that it only included people with a desire to quit smoking, making it possible the results would be different for smokers with no intention of quitting. It's also possible that the specific model of e-cigarette used in the study might not be representative of other devices.

Still, the findings suggest smokers should be told e-cigarettes may curb their exposure to toxic chemicals, Dr. Riccardo Polosa, head of the tobacco research center at the University of Catania in Italy, said by email.

"This study adds to the evidence that e-cigarettes are much less harmful compared to conventional cigarettes," said Polosa, who wasn't involved in the study.

NEW YORK — An experimental, highly sensitive troponin test cannot predict when type 2 diabetics with stable ischemic heart disease will benefit from prompt coronary revascularization, but it can show which patients are more likely to die from myocardial infarction, stroke, or other cardiovascular cases, according to a new study.

Because the troponin test measures damage to heart muscle, the outcome "suggests there's ongoing injury to patients with stable heart disease and diabetes. It has a strong association with death, heart attack, stroke, heart failure," the chief author, Dr. Brendan Everett, director of inpatient general cardiology at Brigham and Women's Hospital in Boston, told Reuters Health in a telephone interview.

But when it comes to heading off a higher risk, "we need to do more research to understand where it's coming from and what therapies might be appropriate. So it does not appear in this population that opening the coronary arteries offers any long-term benefit with respect to death or heart attack," he said.

"It tells you this is not the type of disease status that can be managed by bypass or stenting," said Dr. David Zhao, chairman of cardiology at Wake Forest Baptist Medical Center in Winston-Salem, North Carolina. He was not involved in the research.

"From the patient's standpoint, it is disappointing," Dr. Zhao said. "But from a science standpoint, it all comes together nicely. These patients tend to have more small-vessel microvascular disease and the constant elevation of troponin indicates that there is more severe microvascular disease and more endomyocardial injury. I think it gives us the opportunity to look at more intensified medical management in this group of patients."

The study was an offshoot of the BARI 2D trial, conducted at 49 sites in six countries. It found that aggressive revascularization didn't reduce the risk of death or cardiovascular outcomes compared to intensive medical therapy alone in type 2 diabetics with stable heart disease.

In the new research, the team went back and used a highly sensitive troponin test sold in Europe but not available in the United States to see "if it could be used in stable patients to identify those who would benefit from having their coronary arteries opened with either angioplasty and stenting or bypass surgery," Dr. Everett said.

"There aren't many studies addressing that question and luckily BARI 2D had samples that were stored and available to us after the completion of the trial," he said. "What we did find was that there's clearly a group of patients that are at very high risk for death, heart attack, heart failure, and stroke."

The researchers found 27.1% of patients with a troponin T level of 14.0 ng/L or higher died from cardiovascular cause, or had a heart attack or stroke, compared to 12.9% of patients whose levels were lower, they reported online August 12 in the New England Journal of Medicine.

Adjusting for various factors, the risk of reaching one of those primary endpoints after five years was 85% greater with the higher troponin levels (P<0.001).

The risks for reaching individual components of the composite endpoint were also higher. Unadjusted five-year rates for patients with higher versus lower troponin levels were, respectively, 10.9% versus 3.5% for cardiovascular death, 18.7% versus 9.2% for myocardial infarction, 4.4% versus 2.3% for stroke, and 25.7% versus 11.1% for heart failure.

The Everett team also found that among the 897 volunteers whose levels had been at 14 or above, receiving a prompt intervention did not reduce their likelihood of reaching a primary endpoint compared to the 2,277 with normal concentrations.

The five-year rates of heart attack, stroke, or death from any cardiovascular cause were 26.5% in the revascularization group and 27.6% with medical therapy alone.

"We need to figure out how to better treat them, because fixing their coronary arteries doesn't seem to be giving them the benefit we thought it would, or hoped it would," said Dr. Everett. "For the time being, this is not a test that should be routinely used on stable patients."

The researchers also looked at how troponin levels changed over time.

"Despite aggressive medical therapy for type 2 diabetes and stable ischemic heart disease, the median troponin T concentration increased over one year of follow-up, and no significant reductions in troponin T concentrations were observed in patients who underwent coronary revascularization," the researchers said.

"If this type of patient has elevated troponin, I would be more aggressive in medical management, including statins, smoking cessation, and lifestyle changes," said Dr. Zhao of Wake Forest. "I think the next step would be to ideally run a clinical trial and see if, in patients with elevated troponin levels, intensified medical management reduces the number of events as compared to standard therapy.

NEW YORK — An experimental, highly sensitive troponin test cannot predict when type 2 diabetics with stable ischemic heart disease will benefit from prompt coronary revascularization, but it can show which patients are more likely to die from myocardial infarction, stroke, or other cardiovascular cases, according to a new study.

Because the troponin test measures damage to heart muscle, the outcome "suggests there's ongoing injury to patients with stable heart disease and diabetes. It has a strong association with death, heart attack, stroke, heart failure," the chief author, Dr. Brendan Everett, director of inpatient general cardiology at Brigham and Women's Hospital in Boston, told Reuters Health in a telephone interview.

But when it comes to heading off a higher risk, "we need to do more research to understand where it's coming from and what therapies might be appropriate. So it does not appear in this population that opening the coronary arteries offers any long-term benefit with respect to death or heart attack," he said.

"It tells you this is not the type of disease status that can be managed by bypass or stenting," said Dr. David Zhao, chairman of cardiology at Wake Forest Baptist Medical Center in Winston-Salem, North Carolina. He was not involved in the research.

"From the patient's standpoint, it is disappointing," Dr. Zhao said. "But from a science standpoint, it all comes together nicely. These patients tend to have more small-vessel microvascular disease and the constant elevation of troponin indicates that there is more severe microvascular disease and more endomyocardial injury. I think it gives us the opportunity to look at more intensified medical management in this group of patients."

The study was an offshoot of the BARI 2D trial, conducted at 49 sites in six countries. It found that aggressive revascularization didn't reduce the risk of death or cardiovascular outcomes compared to intensive medical therapy alone in type 2 diabetics with stable heart disease.

In the new research, the team went back and used a highly sensitive troponin test sold in Europe but not available in the United States to see "if it could be used in stable patients to identify those who would benefit from having their coronary arteries opened with either angioplasty and stenting or bypass surgery," Dr. Everett said.

"There aren't many studies addressing that question and luckily BARI 2D had samples that were stored and available to us after the completion of the trial," he said. "What we did find was that there's clearly a group of patients that are at very high risk for death, heart attack, heart failure, and stroke."

The researchers found 27.1% of patients with a troponin T level of 14.0 ng/L or higher died from cardiovascular cause, or had a heart attack or stroke, compared to 12.9% of patients whose levels were lower, they reported online August 12 in the New England Journal of Medicine.

Adjusting for various factors, the risk of reaching one of those primary endpoints after five years was 85% greater with the higher troponin levels (P<0.001).

The risks for reaching individual components of the composite endpoint were also higher. Unadjusted five-year rates for patients with higher versus lower troponin levels were, respectively, 10.9% versus 3.5% for cardiovascular death, 18.7% versus 9.2% for myocardial infarction, 4.4% versus 2.3% for stroke, and 25.7% versus 11.1% for heart failure.

The Everett team also found that among the 897 volunteers whose levels had been at 14 or above, receiving a prompt intervention did not reduce their likelihood of reaching a primary endpoint compared to the 2,277 with normal concentrations.

The five-year rates of heart attack, stroke, or death from any cardiovascular cause were 26.5% in the revascularization group and 27.6% with medical therapy alone.

"We need to figure out how to better treat them, because fixing their coronary arteries doesn't seem to be giving them the benefit we thought it would, or hoped it would," said Dr. Everett. "For the time being, this is not a test that should be routinely used on stable patients."

The researchers also looked at how troponin levels changed over time.

"Despite aggressive medical therapy for type 2 diabetes and stable ischemic heart disease, the median troponin T concentration increased over one year of follow-up, and no significant reductions in troponin T concentrations were observed in patients who underwent coronary revascularization," the researchers said.

"If this type of patient has elevated troponin, I would be more aggressive in medical management, including statins, smoking cessation, and lifestyle changes," said Dr. Zhao of Wake Forest. "I think the next step would be to ideally run a clinical trial and see if, in patients with elevated troponin levels, intensified medical management reduces the number of events as compared to standard therapy.

NEW YORK — An experimental, highly sensitive troponin test cannot predict when type 2 diabetics with stable ischemic heart disease will benefit from prompt coronary revascularization, but it can show which patients are more likely to die from myocardial infarction, stroke, or other cardiovascular cases, according to a new study.

Because the troponin test measures damage to heart muscle, the outcome "suggests there's ongoing injury to patients with stable heart disease and diabetes. It has a strong association with death, heart attack, stroke, heart failure," the chief author, Dr. Brendan Everett, director of inpatient general cardiology at Brigham and Women's Hospital in Boston, told Reuters Health in a telephone interview.

But when it comes to heading off a higher risk, "we need to do more research to understand where it's coming from and what therapies might be appropriate. So it does not appear in this population that opening the coronary arteries offers any long-term benefit with respect to death or heart attack," he said.

"It tells you this is not the type of disease status that can be managed by bypass or stenting," said Dr. David Zhao, chairman of cardiology at Wake Forest Baptist Medical Center in Winston-Salem, North Carolina. He was not involved in the research.

"From the patient's standpoint, it is disappointing," Dr. Zhao said. "But from a science standpoint, it all comes together nicely. These patients tend to have more small-vessel microvascular disease and the constant elevation of troponin indicates that there is more severe microvascular disease and more endomyocardial injury. I think it gives us the opportunity to look at more intensified medical management in this group of patients."

The study was an offshoot of the BARI 2D trial, conducted at 49 sites in six countries. It found that aggressive revascularization didn't reduce the risk of death or cardiovascular outcomes compared to intensive medical therapy alone in type 2 diabetics with stable heart disease.

In the new research, the team went back and used a highly sensitive troponin test sold in Europe but not available in the United States to see "if it could be used in stable patients to identify those who would benefit from having their coronary arteries opened with either angioplasty and stenting or bypass surgery," Dr. Everett said.

"There aren't many studies addressing that question and luckily BARI 2D had samples that were stored and available to us after the completion of the trial," he said. "What we did find was that there's clearly a group of patients that are at very high risk for death, heart attack, heart failure, and stroke."

The researchers found 27.1% of patients with a troponin T level of 14.0 ng/L or higher died from cardiovascular cause, or had a heart attack or stroke, compared to 12.9% of patients whose levels were lower, they reported online August 12 in the New England Journal of Medicine.

Adjusting for various factors, the risk of reaching one of those primary endpoints after five years was 85% greater with the higher troponin levels (P<0.001).

The risks for reaching individual components of the composite endpoint were also higher. Unadjusted five-year rates for patients with higher versus lower troponin levels were, respectively, 10.9% versus 3.5% for cardiovascular death, 18.7% versus 9.2% for myocardial infarction, 4.4% versus 2.3% for stroke, and 25.7% versus 11.1% for heart failure.

The Everett team also found that among the 897 volunteers whose levels had been at 14 or above, receiving a prompt intervention did not reduce their likelihood of reaching a primary endpoint compared to the 2,277 with normal concentrations.

The five-year rates of heart attack, stroke, or death from any cardiovascular cause were 26.5% in the revascularization group and 27.6% with medical therapy alone.

"We need to figure out how to better treat them, because fixing their coronary arteries doesn't seem to be giving them the benefit we thought it would, or hoped it would," said Dr. Everett. "For the time being, this is not a test that should be routinely used on stable patients."

The researchers also looked at how troponin levels changed over time.

"Despite aggressive medical therapy for type 2 diabetes and stable ischemic heart disease, the median troponin T concentration increased over one year of follow-up, and no significant reductions in troponin T concentrations were observed in patients who underwent coronary revascularization," the researchers said.

"If this type of patient has elevated troponin, I would be more aggressive in medical management, including statins, smoking cessation, and lifestyle changes," said Dr. Zhao of Wake Forest. "I think the next step would be to ideally run a clinical trial and see if, in patients with elevated troponin levels, intensified medical management reduces the number of events as compared to standard therapy.

(Reuters Health) - A decades old Medicare rule requiring a three-day hospital stay before patients can transfer to skilled nursing facilities may needlessly prolong hospitalizations, a study suggests.

Researchers compared the average time patients were hospitalized between 2006 and 2010 in privately administered Medicare Advantage health plans that either stuck to this rule or allowed people to transfer to skilled nursing facilities sooner.

Lengths of hospital stays increased with the rule in place and declined when it was waived, the study found.

"The three-day stay rule may inappropriately lengthen the time spent in a hospital for patients who could be transferred to a skilled nursing facility earlier," senior author Dr. Amal Trivedi, a health policy researcher at Brown University in Providence, Rhode Island, said by email.

This minimum-stay rule dates back to the 1960s, when patients typically remained in the hospital for nearly two weeks, and three days was the minimum time needed to evaluate them and plan their post-hospital care, Trivedi and colleagues note in the journal Health Affairs for August.

Since then, typical stays have shortened, and skilled nursing facilities have become an increasingly common treatment setting for patients with complex medical problems who no longer require acute inpatient care.

To see how the three-day minimum stay requirement might impact hospitalization, researchers compared the typical number of hospital days for nearly 141,000 patients in 14 Medicare Advantage plans that upheld the rule and for nearly 117,000 people in 14 similar plans that waived it.

The people enrolled in plans that waived the rule were typically younger, poorer and less likely to be white.

For plans that waived the rule, 23.5% of hospitalized patients were admitted to skilled nursing facilities in the year before the rule was eliminated, compared with 25.7% in the year after it went away.

Plans that kept the rule saw a similar gain, from 22.8% to 26.3%.

But the average length of hospital stays for patients in plans that waived the three-day rule declined from 6.9 days to 6.7 days, compared with an increase from 6.1 days to 6.6 days in plans that kept the requirement in place.

Overall, the average reduction in hospital stays was 0.7 days with the rule elimination, translating into approximately $1,500 in savings for every admission that ended with a transfer to a skilled nursing facility, the researchers estimated.

One limitation of the study, however, is that it looked at hospital days over the entire year, rather then the number of days for each stay, the researchers acknowledge. It's also possible that the cost savings wouldn't be the same for people with traditional fee-for-service Medicare or other plans unlike the ones in the study.

Even so, as hospital stays become shorter and patients with complicated illnesses are treated in other settings, it makes sense to revisit whether the three days is the right cutoff to identify people who can appropriately transfer to a skilled nursing facility, said David Grabowski, a health policy researcher at Harvard Medical School in Boston.

Certain patients may also benefit from leaving the hospital sooner, because longer stays can increase their risk of infections and make it less likely that they get out of bed for physical activity that can aid recovery, Grabowski, who wasn't involved in the study, said by email.

"Some individuals with short hospital stays may be inappropriately excluded from skilled nursing facility care under the current system," he said. "Moreover, this rule has led to some unintended consequences like the growth in observational stays."

"There really aren't many benefits to staying beyond medical necessity," Grabowski added.

(Reuters Health) - A decades old Medicare rule requiring a three-day hospital stay before patients can transfer to skilled nursing facilities may needlessly prolong hospitalizations, a study suggests.

Researchers compared the average time patients were hospitalized between 2006 and 2010 in privately administered Medicare Advantage health plans that either stuck to this rule or allowed people to transfer to skilled nursing facilities sooner.

Lengths of hospital stays increased with the rule in place and declined when it was waived, the study found.

"The three-day stay rule may inappropriately lengthen the time spent in a hospital for patients who could be transferred to a skilled nursing facility earlier," senior author Dr. Amal Trivedi, a health policy researcher at Brown University in Providence, Rhode Island, said by email.

This minimum-stay rule dates back to the 1960s, when patients typically remained in the hospital for nearly two weeks, and three days was the minimum time needed to evaluate them and plan their post-hospital care, Trivedi and colleagues note in the journal Health Affairs for August.

Since then, typical stays have shortened, and skilled nursing facilities have become an increasingly common treatment setting for patients with complex medical problems who no longer require acute inpatient care.

To see how the three-day minimum stay requirement might impact hospitalization, researchers compared the typical number of hospital days for nearly 141,000 patients in 14 Medicare Advantage plans that upheld the rule and for nearly 117,000 people in 14 similar plans that waived it.

The people enrolled in plans that waived the rule were typically younger, poorer and less likely to be white.

For plans that waived the rule, 23.5% of hospitalized patients were admitted to skilled nursing facilities in the year before the rule was eliminated, compared with 25.7% in the year after it went away.

Plans that kept the rule saw a similar gain, from 22.8% to 26.3%.

But the average length of hospital stays for patients in plans that waived the three-day rule declined from 6.9 days to 6.7 days, compared with an increase from 6.1 days to 6.6 days in plans that kept the requirement in place.

Overall, the average reduction in hospital stays was 0.7 days with the rule elimination, translating into approximately $1,500 in savings for every admission that ended with a transfer to a skilled nursing facility, the researchers estimated.

One limitation of the study, however, is that it looked at hospital days over the entire year, rather then the number of days for each stay, the researchers acknowledge. It's also possible that the cost savings wouldn't be the same for people with traditional fee-for-service Medicare or other plans unlike the ones in the study.

Even so, as hospital stays become shorter and patients with complicated illnesses are treated in other settings, it makes sense to revisit whether the three days is the right cutoff to identify people who can appropriately transfer to a skilled nursing facility, said David Grabowski, a health policy researcher at Harvard Medical School in Boston.

Certain patients may also benefit from leaving the hospital sooner, because longer stays can increase their risk of infections and make it less likely that they get out of bed for physical activity that can aid recovery, Grabowski, who wasn't involved in the study, said by email.

"Some individuals with short hospital stays may be inappropriately excluded from skilled nursing facility care under the current system," he said. "Moreover, this rule has led to some unintended consequences like the growth in observational stays."

"There really aren't many benefits to staying beyond medical necessity," Grabowski added.

(Reuters Health) - A decades old Medicare rule requiring a three-day hospital stay before patients can transfer to skilled nursing facilities may needlessly prolong hospitalizations, a study suggests.

Researchers compared the average time patients were hospitalized between 2006 and 2010 in privately administered Medicare Advantage health plans that either stuck to this rule or allowed people to transfer to skilled nursing facilities sooner.

Lengths of hospital stays increased with the rule in place and declined when it was waived, the study found.

"The three-day stay rule may inappropriately lengthen the time spent in a hospital for patients who could be transferred to a skilled nursing facility earlier," senior author Dr. Amal Trivedi, a health policy researcher at Brown University in Providence, Rhode Island, said by email.

This minimum-stay rule dates back to the 1960s, when patients typically remained in the hospital for nearly two weeks, and three days was the minimum time needed to evaluate them and plan their post-hospital care, Trivedi and colleagues note in the journal Health Affairs for August.

Since then, typical stays have shortened, and skilled nursing facilities have become an increasingly common treatment setting for patients with complex medical problems who no longer require acute inpatient care.

To see how the three-day minimum stay requirement might impact hospitalization, researchers compared the typical number of hospital days for nearly 141,000 patients in 14 Medicare Advantage plans that upheld the rule and for nearly 117,000 people in 14 similar plans that waived it.

The people enrolled in plans that waived the rule were typically younger, poorer and less likely to be white.

For plans that waived the rule, 23.5% of hospitalized patients were admitted to skilled nursing facilities in the year before the rule was eliminated, compared with 25.7% in the year after it went away.

Plans that kept the rule saw a similar gain, from 22.8% to 26.3%.

But the average length of hospital stays for patients in plans that waived the three-day rule declined from 6.9 days to 6.7 days, compared with an increase from 6.1 days to 6.6 days in plans that kept the requirement in place.

Overall, the average reduction in hospital stays was 0.7 days with the rule elimination, translating into approximately $1,500 in savings for every admission that ended with a transfer to a skilled nursing facility, the researchers estimated.

One limitation of the study, however, is that it looked at hospital days over the entire year, rather then the number of days for each stay, the researchers acknowledge. It's also possible that the cost savings wouldn't be the same for people with traditional fee-for-service Medicare or other plans unlike the ones in the study.

Even so, as hospital stays become shorter and patients with complicated illnesses are treated in other settings, it makes sense to revisit whether the three days is the right cutoff to identify people who can appropriately transfer to a skilled nursing facility, said David Grabowski, a health policy researcher at Harvard Medical School in Boston.

Certain patients may also benefit from leaving the hospital sooner, because longer stays can increase their risk of infections and make it less likely that they get out of bed for physical activity that can aid recovery, Grabowski, who wasn't involved in the study, said by email.

"Some individuals with short hospital stays may be inappropriately excluded from skilled nursing facility care under the current system," he said. "Moreover, this rule has led to some unintended consequences like the growth in observational stays."

"There really aren't many benefits to staying beyond medical necessity," Grabowski added.

NEW YORK - In-hospital mortality and bleeding rates after catheter-directed thrombolysis (CDT) of lower extremity proximal deep vein thrombosis are lower in institutions that perform more procedures than in those with fewer procedures, according to a new study.

"As utilization of CDT continues to increase, we propose that institutions follow a standardized CDT protocol that includes careful patient selection as well as patient monitoring," Dr. Riyaz Bashir from Temple University School of Medicine in Philadelphia, Pennsylvania, told Reuters Health by email. "In addition, establishment of centers of excellence in treating venous thromboembolic disease may provide the necessary framework within which bleeding risk to the patient can be minimized."

CDT is increasingly favored over anticoagulation for patients with lower extremity proximal deep vein thrombosis (LE-DVT), but it has been associated with increased bleeding rates and procedure-related complications, Dr. Bashir and colleagues note in Circulation, online July 21.

In light of literature implicating institutional volume as a significant factor in patient outcomes, the team used the Nationwide Inpatient Sample database to investigate the relationship between annual institutional procedure volume and adverse in-hospital patient outcomes in patients receiving CDT for acute proximal LE-DVT.

Just over half the 3,649 procedures were performed at high-volume centers (six or more procedures per year), with the remainder (43%) done at low-volume centers (less than six procedures per year).

In a propensity-matched comparison of 1,310 patients from each group, in-hospital mortality was significantly lower at high-volume centers than at low-volume centers (0.6% vs. 1.5%, p=0.04), the researchers found.

Intracranial hemorrhage rates tended to be lower at high-volume centers (0.4% vs. 1.0%, p=0.07), while inferior vena cava filter placement rates were significantly higher at high-volume centers (37.0% vs. 32.8%; p=0.03).

Institutional volume did not influence blood transfusion, GI bleeding, or pulmonary embolism rates or hospital length of stay. Median hospital charges were higher at high-volume centers ($75,870) than at low-volume centers ($65,500).

At low-volume centers, outcomes tended to be worse for CDT plus anticoagulation than for anticoagulation alone, whereas outcomes were similar for CDT plus anticoagulation and for anticoagulation alone at high-volume centers.

On multiple regression analysis, there was a significant inverse relationship between institutional volume and in-hospital mortality.

"Our observation that the major safety outcomes (death and intracranial hemorrhage) were not significantly different between patients undergoing CDT as compared to patients undergoing anticoagulation therapy alone at high volume centers suggests that these complications can be minimized," Dr. Bashir concluded. "Patients with leg DVT - especially young patients - should feel comfortable considering clot removal, particularly at a high volume center, as a viable option to prevent post-thrombotic syndrome."

NEW YORK - In-hospital mortality and bleeding rates after catheter-directed thrombolysis (CDT) of lower extremity proximal deep vein thrombosis are lower in institutions that perform more procedures than in those with fewer procedures, according to a new study.

"As utilization of CDT continues to increase, we propose that institutions follow a standardized CDT protocol that includes careful patient selection as well as patient monitoring," Dr. Riyaz Bashir from Temple University School of Medicine in Philadelphia, Pennsylvania, told Reuters Health by email. "In addition, establishment of centers of excellence in treating venous thromboembolic disease may provide the necessary framework within which bleeding risk to the patient can be minimized."

CDT is increasingly favored over anticoagulation for patients with lower extremity proximal deep vein thrombosis (LE-DVT), but it has been associated with increased bleeding rates and procedure-related complications, Dr. Bashir and colleagues note in Circulation, online July 21.

In light of literature implicating institutional volume as a significant factor in patient outcomes, the team used the Nationwide Inpatient Sample database to investigate the relationship between annual institutional procedure volume and adverse in-hospital patient outcomes in patients receiving CDT for acute proximal LE-DVT.

Just over half the 3,649 procedures were performed at high-volume centers (six or more procedures per year), with the remainder (43%) done at low-volume centers (less than six procedures per year).

In a propensity-matched comparison of 1,310 patients from each group, in-hospital mortality was significantly lower at high-volume centers than at low-volume centers (0.6% vs. 1.5%, p=0.04), the researchers found.

Intracranial hemorrhage rates tended to be lower at high-volume centers (0.4% vs. 1.0%, p=0.07), while inferior vena cava filter placement rates were significantly higher at high-volume centers (37.0% vs. 32.8%; p=0.03).

Institutional volume did not influence blood transfusion, GI bleeding, or pulmonary embolism rates or hospital length of stay. Median hospital charges were higher at high-volume centers ($75,870) than at low-volume centers ($65,500).

At low-volume centers, outcomes tended to be worse for CDT plus anticoagulation than for anticoagulation alone, whereas outcomes were similar for CDT plus anticoagulation and for anticoagulation alone at high-volume centers.

On multiple regression analysis, there was a significant inverse relationship between institutional volume and in-hospital mortality.

"Our observation that the major safety outcomes (death and intracranial hemorrhage) were not significantly different between patients undergoing CDT as compared to patients undergoing anticoagulation therapy alone at high volume centers suggests that these complications can be minimized," Dr. Bashir concluded. "Patients with leg DVT - especially young patients - should feel comfortable considering clot removal, particularly at a high volume center, as a viable option to prevent post-thrombotic syndrome."

NEW YORK - In-hospital mortality and bleeding rates after catheter-directed thrombolysis (CDT) of lower extremity proximal deep vein thrombosis are lower in institutions that perform more procedures than in those with fewer procedures, according to a new study.

"As utilization of CDT continues to increase, we propose that institutions follow a standardized CDT protocol that includes careful patient selection as well as patient monitoring," Dr. Riyaz Bashir from Temple University School of Medicine in Philadelphia, Pennsylvania, told Reuters Health by email. "In addition, establishment of centers of excellence in treating venous thromboembolic disease may provide the necessary framework within which bleeding risk to the patient can be minimized."

CDT is increasingly favored over anticoagulation for patients with lower extremity proximal deep vein thrombosis (LE-DVT), but it has been associated with increased bleeding rates and procedure-related complications, Dr. Bashir and colleagues note in Circulation, online July 21.

In light of literature implicating institutional volume as a significant factor in patient outcomes, the team used the Nationwide Inpatient Sample database to investigate the relationship between annual institutional procedure volume and adverse in-hospital patient outcomes in patients receiving CDT for acute proximal LE-DVT.

Just over half the 3,649 procedures were performed at high-volume centers (six or more procedures per year), with the remainder (43%) done at low-volume centers (less than six procedures per year).

In a propensity-matched comparison of 1,310 patients from each group, in-hospital mortality was significantly lower at high-volume centers than at low-volume centers (0.6% vs. 1.5%, p=0.04), the researchers found.

Intracranial hemorrhage rates tended to be lower at high-volume centers (0.4% vs. 1.0%, p=0.07), while inferior vena cava filter placement rates were significantly higher at high-volume centers (37.0% vs. 32.8%; p=0.03).

Institutional volume did not influence blood transfusion, GI bleeding, or pulmonary embolism rates or hospital length of stay. Median hospital charges were higher at high-volume centers ($75,870) than at low-volume centers ($65,500).

At low-volume centers, outcomes tended to be worse for CDT plus anticoagulation than for anticoagulation alone, whereas outcomes were similar for CDT plus anticoagulation and for anticoagulation alone at high-volume centers.

On multiple regression analysis, there was a significant inverse relationship between institutional volume and in-hospital mortality.

"Our observation that the major safety outcomes (death and intracranial hemorrhage) were not significantly different between patients undergoing CDT as compared to patients undergoing anticoagulation therapy alone at high volume centers suggests that these complications can be minimized," Dr. Bashir concluded. "Patients with leg DVT - especially young patients - should feel comfortable considering clot removal, particularly at a high volume center, as a viable option to prevent post-thrombotic syndrome."

NEW YORK - Inflammation may contribute to impaired cerebral vasoregulation in type 2 diabetes, research suggests.

In a two-year study, participants with type 2 diabetes experienced diminished regional and global vasoreactivity in the brain, as well as a decline in cognitive function and the ability to perform daily tasks.

Higher blood levels of inflammatory markers were correlated with decreases in cerebral vasoreactivity and vasodilation in the diabetic subjects, but not in controls.

"Normal blood flow regulation allows the brain to redistribute blood to areas of the brain that have increased activity while performing certain tasks," senior author Dr. Vera Novak, of Beth Israel Deaconess Medical Center in Boston, said in a news release. "People with type 2 diabetes have impaired blood flow regulation. Our results suggest that diabetes and high blood sugar impose a chronic negative effect on cognitive and decision-making skills."

The study's final analysis involved 40 people, average age 69, including 19 with diabetes and 21 controls. The diabetes patients had been treated for the disease an average of 13 years. Smokers were excluded.

The researchers administered a number of cognition and memory tests, magnetic resonance imaging (MRI) scans and blood tests at the beginning of the study and at 24 months.

At the two-year visit, the diabetics had lower global gray matter volume, lower composite scores on learning and memory, lower regional and global cerebral vasoreactivity, and worse glycemic control, compared to baseline.

Among the diabetics, impaired cerebral vasoreactivity at baseline correlated with worse performance of daily activities. In addition, worsening vasodilation correlated with greater decreases in executive function, independent of age, education, and other factors.

"Higher serum soluble intercellular and vascular adhesion molecules, higher cortisol, and higher C-reactive protein levels at baseline were associated with greater decreases in cerebral vasoreactivity and vasodilation only in the (diabetes) group, independent of diabetes control and 24-hour blood pressure," the researchers wrote online July 8 in Neurology.

"Inflammation may further impair cerebral vasoregulation, which consequently accelerates decline in executive function and daily activities performance in older people with (diabetes)," they said.

"Early detection and monitoring of blood flow regulation may be an important predictor of accelerated changes in cognitive and decision-making skills," Dr. Novak said in the news release. She called for additional studies in a greater number of people and for a longer duration.

"We are currently starting a Phase 2-3 clinical trial to see if intranasal insulin could prevent/slow down cognitive decline," she told Reuters Health by email.

She also noted that while no specific treatment exists to prevent cognitive decline, healthy life styles help people to have less decline.

Large clinical trials have shown that even strict control of blood sugar does not prevent cognitive decline. The high fluctuation in blood glucose that occurs with diabetes damages the nerves of the brain, she said.

The study was funded by the National Institute on Aging, American Diabetes Association, Harvard Clinical and Translational Science Center and National Center for Research Resources.

NEW YORK - Inflammation may contribute to impaired cerebral vasoregulation in type 2 diabetes, research suggests.

In a two-year study, participants with type 2 diabetes experienced diminished regional and global vasoreactivity in the brain, as well as a decline in cognitive function and the ability to perform daily tasks.

Higher blood levels of inflammatory markers were correlated with decreases in cerebral vasoreactivity and vasodilation in the diabetic subjects, but not in controls.

"Normal blood flow regulation allows the brain to redistribute blood to areas of the brain that have increased activity while performing certain tasks," senior author Dr. Vera Novak, of Beth Israel Deaconess Medical Center in Boston, said in a news release. "People with type 2 diabetes have impaired blood flow regulation. Our results suggest that diabetes and high blood sugar impose a chronic negative effect on cognitive and decision-making skills."

The study's final analysis involved 40 people, average age 69, including 19 with diabetes and 21 controls. The diabetes patients had been treated for the disease an average of 13 years. Smokers were excluded.

The researchers administered a number of cognition and memory tests, magnetic resonance imaging (MRI) scans and blood tests at the beginning of the study and at 24 months.

At the two-year visit, the diabetics had lower global gray matter volume, lower composite scores on learning and memory, lower regional and global cerebral vasoreactivity, and worse glycemic control, compared to baseline.

Among the diabetics, impaired cerebral vasoreactivity at baseline correlated with worse performance of daily activities. In addition, worsening vasodilation correlated with greater decreases in executive function, independent of age, education, and other factors.

"Higher serum soluble intercellular and vascular adhesion molecules, higher cortisol, and higher C-reactive protein levels at baseline were associated with greater decreases in cerebral vasoreactivity and vasodilation only in the (diabetes) group, independent of diabetes control and 24-hour blood pressure," the researchers wrote online July 8 in Neurology.

"Inflammation may further impair cerebral vasoregulation, which consequently accelerates decline in executive function and daily activities performance in older people with (diabetes)," they said.

"Early detection and monitoring of blood flow regulation may be an important predictor of accelerated changes in cognitive and decision-making skills," Dr. Novak said in the news release. She called for additional studies in a greater number of people and for a longer duration.

"We are currently starting a Phase 2-3 clinical trial to see if intranasal insulin could prevent/slow down cognitive decline," she told Reuters Health by email.

She also noted that while no specific treatment exists to prevent cognitive decline, healthy life styles help people to have less decline.

Large clinical trials have shown that even strict control of blood sugar does not prevent cognitive decline. The high fluctuation in blood glucose that occurs with diabetes damages the nerves of the brain, she said.

The study was funded by the National Institute on Aging, American Diabetes Association, Harvard Clinical and Translational Science Center and National Center for Research Resources.

NEW YORK - Inflammation may contribute to impaired cerebral vasoregulation in type 2 diabetes, research suggests.

In a two-year study, participants with type 2 diabetes experienced diminished regional and global vasoreactivity in the brain, as well as a decline in cognitive function and the ability to perform daily tasks.

Higher blood levels of inflammatory markers were correlated with decreases in cerebral vasoreactivity and vasodilation in the diabetic subjects, but not in controls.

"Normal blood flow regulation allows the brain to redistribute blood to areas of the brain that have increased activity while performing certain tasks," senior author Dr. Vera Novak, of Beth Israel Deaconess Medical Center in Boston, said in a news release. "People with type 2 diabetes have impaired blood flow regulation. Our results suggest that diabetes and high blood sugar impose a chronic negative effect on cognitive and decision-making skills."

The study's final analysis involved 40 people, average age 69, including 19 with diabetes and 21 controls. The diabetes patients had been treated for the disease an average of 13 years. Smokers were excluded.

The researchers administered a number of cognition and memory tests, magnetic resonance imaging (MRI) scans and blood tests at the beginning of the study and at 24 months.

At the two-year visit, the diabetics had lower global gray matter volume, lower composite scores on learning and memory, lower regional and global cerebral vasoreactivity, and worse glycemic control, compared to baseline.

Among the diabetics, impaired cerebral vasoreactivity at baseline correlated with worse performance of daily activities. In addition, worsening vasodilation correlated with greater decreases in executive function, independent of age, education, and other factors.

"Higher serum soluble intercellular and vascular adhesion molecules, higher cortisol, and higher C-reactive protein levels at baseline were associated with greater decreases in cerebral vasoreactivity and vasodilation only in the (diabetes) group, independent of diabetes control and 24-hour blood pressure," the researchers wrote online July 8 in Neurology.

"Inflammation may further impair cerebral vasoregulation, which consequently accelerates decline in executive function and daily activities performance in older people with (diabetes)," they said.

"Early detection and monitoring of blood flow regulation may be an important predictor of accelerated changes in cognitive and decision-making skills," Dr. Novak said in the news release. She called for additional studies in a greater number of people and for a longer duration.

"We are currently starting a Phase 2-3 clinical trial to see if intranasal insulin could prevent/slow down cognitive decline," she told Reuters Health by email.

She also noted that while no specific treatment exists to prevent cognitive decline, healthy life styles help people to have less decline.

Large clinical trials have shown that even strict control of blood sugar does not prevent cognitive decline. The high fluctuation in blood glucose that occurs with diabetes damages the nerves of the brain, she said.

The study was funded by the National Institute on Aging, American Diabetes Association, Harvard Clinical and Translational Science Center and National Center for Research Resources.

NEW YORK - Compared with dual antiplatelet therapy (DAPT), triple therapy increases the risk of major bleeding without altering the rates of myocardial infarction (MI), stroke, or death in older patients with acute MI and atrial fibrillation (AF), according to a registry study.

"These data suggest that the risk-benefit ratio of triple therapy in older patients with myocardial infarction and atrial fibrillation should be carefully considered," Dr. Connie N. Hess, from Duke Clinical Research Institute, Duke University, Durham, North Carolina, told Reuters Health by email. "However, these results need to be confirmed with prospective studies; a number of ongoing randomized clinical trials may help to provide insight."

Therapeutic decisions for older patients with acute MI and AF are challenging, not least because they have been excluded from or underrepresented in clinical trials.

Dr. Hess's team linked data from the ACTION Registry Get With The Guidelines and Medicare administrative claims to compare outcomes with DAPT or triple therapy (DAPT plus warfarin) in 4959 patients age 65 and older with acute MI and AF who underwent coronary stenting.

More patients were discharged on DAPT (72.4%) than on triple therapy (27.6%), the researchers report in the August 11 issue of the Journal of the American College of Cardiology (JACC), available online now.

The primary effectiveness outcome, major adverse cardiac events (MACE, including death or readmission for MI or stroke) at two years, did not differ in incidence between triple therapy (32.6%) and DAPT (32.7%), and there were no significant differences in the incidences of the individual MACE components.

In contrast, the cumulative incidence of bleeding requiring hospitalization within two years of discharge was significantly higher for patients on triple therapy (17.6%) than for patients on DAPT (11.0%; p<0.0001), and this difference persisted after adjustment for case-mix, treatment, and hospital features.

Triple therapy was also associated with a 2.04-fold higher risk of intracranial hemorrhage, compared with DAPT.

The association of triple therapy with MACE and bleeding outcomes was similar for patients older and younger than 75, for men and women, for patients with low and high predicted stroke risk, for patients with shorter versus longer duration of AF, for patients treated with drug-eluting versus bare-metal stents, and for patients presenting with non-ST-segment elevation MI versus ST-segment elevation MI.

"Until we have data from prospective studies to define optimal antithrombotic use in older patients with myocardial infarction and atrial fibrillation, providers should be especially mindful of an individual's bleeding risk when deciding to prescribe triple therapy," Dr. Hess concluded.

Dr. John C. Messenger, from the University of Colorado School of Medicine, Aurora, cowrote an editorial related to this report. He told Reuters Health by email, "We should ideally look to minimize duration of triple therapy, keeping it as short as possible. We also need to enroll patients in trials designed to evaluate double therapy without the use of aspirin."

"With the change in guidelines recommending oral anticoagulation for patients with atrial fibrillation at lower risk for ischemic stroke, the negative impact of bleeding related to the use of triple therapy may far outweigh the benefit of reduction of ischemic stroke," Dr. Messenger said. "We obviously need further study on this topic."

Dr. Andrea Rubboli, from Ospedale Maggiore, Bologna, Italy, has researched how best to treat these patients. He told Reuters Health by email, "Given that I practice in Europe, where current guidelines recommend triple therapy for these patients, what I found most surprising is the relatively small proportion of AF patients treated with (percutaneous coronary intervention) PCI who were discharged on triple therapy. Conversely, it was not surprising that DAPT was comparable to triple therapy in terms of MACE and superior in terms of bleeding because this has been previously reported and the several limitations of this kind of analysis (especially the lack of information on the therapy really ongoing at the time of event) may account for that."

"Triple therapy confirmed to be the best treatment for these patients," Dr. Rubboli concluded. "While not reducing MACE versus DAPT, it is indeed significantly more effective in reducing the most feared and devastating complication of AF, that is, stroke. Given the increased risk of bleeding, however, great care should be put in monitoring such therapy."

Dr. Nikolaus Sarafoff, from Ludwig-Maximilians University, Munich, Germany, told Reuters Health by email, "In my opinion, one major limitation of the study is that only 7.7% of patients in the DAPT group were on oral anticoagulation (OAC) at randomization as compared to 62.1% in the triple arm. This shows clearly that physicians felt that patients in the DAPT arm had no real indication for OAC (even before the myocardial infarction with PCI occurred) and this makes the comparison of the two groups very difficult."

"The indication for triple therapy and the optimal antithrombotic treatment should be taken carefully, weighing the bleeding and the ischemic risk of the patient," Dr. Sarafoff concluded. "Several options to reduce bleeding complications in this high-risk population exist, such as omitting aspirin, shortening the duration of therapy. The results of the present study cannot supplant current guidelines that state clearly that patients with atrial fibrillation and a CHA2DS2-VASc Score 2 are in need of OAC no matter whether concomitant antiplatelet therapy is needed."

The American College of Cardiology Foundation's National Cardiovascular Data Registry supported this study. Three coauthors reported relevant relationships.

NEW YORK - Compared with dual antiplatelet therapy (DAPT), triple therapy increases the risk of major bleeding without altering the rates of myocardial infarction (MI), stroke, or death in older patients with acute MI and atrial fibrillation (AF), according to a registry study.

"These data suggest that the risk-benefit ratio of triple therapy in older patients with myocardial infarction and atrial fibrillation should be carefully considered," Dr. Connie N. Hess, from Duke Clinical Research Institute, Duke University, Durham, North Carolina, told Reuters Health by email. "However, these results need to be confirmed with prospective studies; a number of ongoing randomized clinical trials may help to provide insight."

Therapeutic decisions for older patients with acute MI and AF are challenging, not least because they have been excluded from or underrepresented in clinical trials.

Dr. Hess's team linked data from the ACTION Registry Get With The Guidelines and Medicare administrative claims to compare outcomes with DAPT or triple therapy (DAPT plus warfarin) in 4959 patients age 65 and older with acute MI and AF who underwent coronary stenting.

More patients were discharged on DAPT (72.4%) than on triple therapy (27.6%), the researchers report in the August 11 issue of the Journal of the American College of Cardiology (JACC), available online now.

The primary effectiveness outcome, major adverse cardiac events (MACE, including death or readmission for MI or stroke) at two years, did not differ in incidence between triple therapy (32.6%) and DAPT (32.7%), and there were no significant differences in the incidences of the individual MACE components.

In contrast, the cumulative incidence of bleeding requiring hospitalization within two years of discharge was significantly higher for patients on triple therapy (17.6%) than for patients on DAPT (11.0%; p<0.0001), and this difference persisted after adjustment for case-mix, treatment, and hospital features.

Triple therapy was also associated with a 2.04-fold higher risk of intracranial hemorrhage, compared with DAPT.

The association of triple therapy with MACE and bleeding outcomes was similar for patients older and younger than 75, for men and women, for patients with low and high predicted stroke risk, for patients with shorter versus longer duration of AF, for patients treated with drug-eluting versus bare-metal stents, and for patients presenting with non-ST-segment elevation MI versus ST-segment elevation MI.

"Until we have data from prospective studies to define optimal antithrombotic use in older patients with myocardial infarction and atrial fibrillation, providers should be especially mindful of an individual's bleeding risk when deciding to prescribe triple therapy," Dr. Hess concluded.

Dr. John C. Messenger, from the University of Colorado School of Medicine, Aurora, cowrote an editorial related to this report. He told Reuters Health by email, "We should ideally look to minimize duration of triple therapy, keeping it as short as possible. We also need to enroll patients in trials designed to evaluate double therapy without the use of aspirin."

"With the change in guidelines recommending oral anticoagulation for patients with atrial fibrillation at lower risk for ischemic stroke, the negative impact of bleeding related to the use of triple therapy may far outweigh the benefit of reduction of ischemic stroke," Dr. Messenger said. "We obviously need further study on this topic."

Dr. Andrea Rubboli, from Ospedale Maggiore, Bologna, Italy, has researched how best to treat these patients. He told Reuters Health by email, "Given that I practice in Europe, where current guidelines recommend triple therapy for these patients, what I found most surprising is the relatively small proportion of AF patients treated with (percutaneous coronary intervention) PCI who were discharged on triple therapy. Conversely, it was not surprising that DAPT was comparable to triple therapy in terms of MACE and superior in terms of bleeding because this has been previously reported and the several limitations of this kind of analysis (especially the lack of information on the therapy really ongoing at the time of event) may account for that."

"Triple therapy confirmed to be the best treatment for these patients," Dr. Rubboli concluded. "While not reducing MACE versus DAPT, it is indeed significantly more effective in reducing the most feared and devastating complication of AF, that is, stroke. Given the increased risk of bleeding, however, great care should be put in monitoring such therapy."

Dr. Nikolaus Sarafoff, from Ludwig-Maximilians University, Munich, Germany, told Reuters Health by email, "In my opinion, one major limitation of the study is that only 7.7% of patients in the DAPT group were on oral anticoagulation (OAC) at randomization as compared to 62.1% in the triple arm. This shows clearly that physicians felt that patients in the DAPT arm had no real indication for OAC (even before the myocardial infarction with PCI occurred) and this makes the comparison of the two groups very difficult."

"The indication for triple therapy and the optimal antithrombotic treatment should be taken carefully, weighing the bleeding and the ischemic risk of the patient," Dr. Sarafoff concluded. "Several options to reduce bleeding complications in this high-risk population exist, such as omitting aspirin, shortening the duration of therapy. The results of the present study cannot supplant current guidelines that state clearly that patients with atrial fibrillation and a CHA2DS2-VASc Score 2 are in need of OAC no matter whether concomitant antiplatelet therapy is needed."

The American College of Cardiology Foundation's National Cardiovascular Data Registry supported this study. Three coauthors reported relevant relationships.

NEW YORK - Compared with dual antiplatelet therapy (DAPT), triple therapy increases the risk of major bleeding without altering the rates of myocardial infarction (MI), stroke, or death in older patients with acute MI and atrial fibrillation (AF), according to a registry study.

"These data suggest that the risk-benefit ratio of triple therapy in older patients with myocardial infarction and atrial fibrillation should be carefully considered," Dr. Connie N. Hess, from Duke Clinical Research Institute, Duke University, Durham, North Carolina, told Reuters Health by email. "However, these results need to be confirmed with prospective studies; a number of ongoing randomized clinical trials may help to provide insight."

Therapeutic decisions for older patients with acute MI and AF are challenging, not least because they have been excluded from or underrepresented in clinical trials.

Dr. Hess's team linked data from the ACTION Registry Get With The Guidelines and Medicare administrative claims to compare outcomes with DAPT or triple therapy (DAPT plus warfarin) in 4959 patients age 65 and older with acute MI and AF who underwent coronary stenting.

More patients were discharged on DAPT (72.4%) than on triple therapy (27.6%), the researchers report in the August 11 issue of the Journal of the American College of Cardiology (JACC), available online now.

The primary effectiveness outcome, major adverse cardiac events (MACE, including death or readmission for MI or stroke) at two years, did not differ in incidence between triple therapy (32.6%) and DAPT (32.7%), and there were no significant differences in the incidences of the individual MACE components.

In contrast, the cumulative incidence of bleeding requiring hospitalization within two years of discharge was significantly higher for patients on triple therapy (17.6%) than for patients on DAPT (11.0%; p<0.0001), and this difference persisted after adjustment for case-mix, treatment, and hospital features.

Triple therapy was also associated with a 2.04-fold higher risk of intracranial hemorrhage, compared with DAPT.

The association of triple therapy with MACE and bleeding outcomes was similar for patients older and younger than 75, for men and women, for patients with low and high predicted stroke risk, for patients with shorter versus longer duration of AF, for patients treated with drug-eluting versus bare-metal stents, and for patients presenting with non-ST-segment elevation MI versus ST-segment elevation MI.

"Until we have data from prospective studies to define optimal antithrombotic use in older patients with myocardial infarction and atrial fibrillation, providers should be especially mindful of an individual's bleeding risk when deciding to prescribe triple therapy," Dr. Hess concluded.

Dr. John C. Messenger, from the University of Colorado School of Medicine, Aurora, cowrote an editorial related to this report. He told Reuters Health by email, "We should ideally look to minimize duration of triple therapy, keeping it as short as possible. We also need to enroll patients in trials designed to evaluate double therapy without the use of aspirin."

"With the change in guidelines recommending oral anticoagulation for patients with atrial fibrillation at lower risk for ischemic stroke, the negative impact of bleeding related to the use of triple therapy may far outweigh the benefit of reduction of ischemic stroke," Dr. Messenger said. "We obviously need further study on this topic."

Dr. Andrea Rubboli, from Ospedale Maggiore, Bologna, Italy, has researched how best to treat these patients. He told Reuters Health by email, "Given that I practice in Europe, where current guidelines recommend triple therapy for these patients, what I found most surprising is the relatively small proportion of AF patients treated with (percutaneous coronary intervention) PCI who were discharged on triple therapy. Conversely, it was not surprising that DAPT was comparable to triple therapy in terms of MACE and superior in terms of bleeding because this has been previously reported and the several limitations of this kind of analysis (especially the lack of information on the therapy really ongoing at the time of event) may account for that."

"Triple therapy confirmed to be the best treatment for these patients," Dr. Rubboli concluded. "While not reducing MACE versus DAPT, it is indeed significantly more effective in reducing the most feared and devastating complication of AF, that is, stroke. Given the increased risk of bleeding, however, great care should be put in monitoring such therapy."

Dr. Nikolaus Sarafoff, from Ludwig-Maximilians University, Munich, Germany, told Reuters Health by email, "In my opinion, one major limitation of the study is that only 7.7% of patients in the DAPT group were on oral anticoagulation (OAC) at randomization as compared to 62.1% in the triple arm. This shows clearly that physicians felt that patients in the DAPT arm had no real indication for OAC (even before the myocardial infarction with PCI occurred) and this makes the comparison of the two groups very difficult."

"The indication for triple therapy and the optimal antithrombotic treatment should be taken carefully, weighing the bleeding and the ischemic risk of the patient," Dr. Sarafoff concluded. "Several options to reduce bleeding complications in this high-risk population exist, such as omitting aspirin, shortening the duration of therapy. The results of the present study cannot supplant current guidelines that state clearly that patients with atrial fibrillation and a CHA2DS2-VASc Score 2 are in need of OAC no matter whether concomitant antiplatelet therapy is needed."

The American College of Cardiology Foundation's National Cardiovascular Data Registry supported this study. Three coauthors reported relevant relationships.

NEW YORK - In the early months of anticoagulant treatment, patients with nonvalvular atrial fibrillation (nvAF) have similar rates of bleeding and arterial clots with dabigatran, rivaroxaban and vitamin K antagonists (VKA) like warfarin, researchers from France report.

Large randomized trials have shown the newer non-VKA oral anticoagulants (NOAC) to have superior safety and efficacy relative to warfarin, but subsequent observational studies have yielded conflicting results.

Dr. Géric Maura from National Health Insurance (CNAMTS) in Paris and colleagues used the French National Health Insurance information system to assess the bleeding and arterial thrombotic risks of dabigatran and rivaroxaban, each compared with VKA, during the first few months of therapy in 32,807 newly treated patients with nvAF.

There was no significant difference in bleeding between VKA- and dabigatran- or rivaroxaban-treated patients on propensity-matched analysis, regardless of whether patients were treated with low or high doses of each NOAC, the researchers report in Circulation, online July 21.

The composite outcome comprising hospitalization for bleeding and death occurred with similar frequency in the different treatment groups.

Among the secondary endpoints, there were no significant differences between treatments in arterial thromboembolic events or in the composite outcome comprising stroke, systemic embolism and death.

"Although our overall results are reassuring in relation to initiation of NOAC in nvAF patients in France with no marked excess thromboembolic or bleeding risk, they also suggest that particular caution is required when initiating NOAC," the researchers conclude. "But on the basis of this study comparing NOAC to VKA, NOAC cannot be considered to be safer than VKA during the early phase of treatment. On the contrary, the clinical implications of our results are that physicians must be just as cautious when initiating NOAC as when initiating VKA, particularly in view of the absence of an antidote and objective monitoring of the extent of anticoagulation."

"Similar analyses should be extended to other NOAC such as apixaban and observational studies should now focus on NOAC head-to-head comparison in a non-inferiority design," they suggest.

The study had no commercial funding and the authors reported no conflicts of interest.

Dr. Maura did not respond to a request for comment.

NEW YORK - In the early months of anticoagulant treatment, patients with nonvalvular atrial fibrillation (nvAF) have similar rates of bleeding and arterial clots with dabigatran, rivaroxaban and vitamin K antagonists (VKA) like warfarin, researchers from France report.

Large randomized trials have shown the newer non-VKA oral anticoagulants (NOAC) to have superior safety and efficacy relative to warfarin, but subsequent observational studies have yielded conflicting results.

Dr. Géric Maura from National Health Insurance (CNAMTS) in Paris and colleagues used the French National Health Insurance information system to assess the bleeding and arterial thrombotic risks of dabigatran and rivaroxaban, each compared with VKA, during the first few months of therapy in 32,807 newly treated patients with nvAF.

There was no significant difference in bleeding between VKA- and dabigatran- or rivaroxaban-treated patients on propensity-matched analysis, regardless of whether patients were treated with low or high doses of each NOAC, the researchers report in Circulation, online July 21.

The composite outcome comprising hospitalization for bleeding and death occurred with similar frequency in the different treatment groups.

Among the secondary endpoints, there were no significant differences between treatments in arterial thromboembolic events or in the composite outcome comprising stroke, systemic embolism and death.

"Although our overall results are reassuring in relation to initiation of NOAC in nvAF patients in France with no marked excess thromboembolic or bleeding risk, they also suggest that particular caution is required when initiating NOAC," the researchers conclude. "But on the basis of this study comparing NOAC to VKA, NOAC cannot be considered to be safer than VKA during the early phase of treatment. On the contrary, the clinical implications of our results are that physicians must be just as cautious when initiating NOAC as when initiating VKA, particularly in view of the absence of an antidote and objective monitoring of the extent of anticoagulation."

"Similar analyses should be extended to other NOAC such as apixaban and observational studies should now focus on NOAC head-to-head comparison in a non-inferiority design," they suggest.

The study had no commercial funding and the authors reported no conflicts of interest.

Dr. Maura did not respond to a request for comment.

NEW YORK - In the early months of anticoagulant treatment, patients with nonvalvular atrial fibrillation (nvAF) have similar rates of bleeding and arterial clots with dabigatran, rivaroxaban and vitamin K antagonists (VKA) like warfarin, researchers from France report.

Large randomized trials have shown the newer non-VKA oral anticoagulants (NOAC) to have superior safety and efficacy relative to warfarin, but subsequent observational studies have yielded conflicting results.

Dr. Géric Maura from National Health Insurance (CNAMTS) in Paris and colleagues used the French National Health Insurance information system to assess the bleeding and arterial thrombotic risks of dabigatran and rivaroxaban, each compared with VKA, during the first few months of therapy in 32,807 newly treated patients with nvAF.

There was no significant difference in bleeding between VKA- and dabigatran- or rivaroxaban-treated patients on propensity-matched analysis, regardless of whether patients were treated with low or high doses of each NOAC, the researchers report in Circulation, online July 21.

The composite outcome comprising hospitalization for bleeding and death occurred with similar frequency in the different treatment groups.

Among the secondary endpoints, there were no significant differences between treatments in arterial thromboembolic events or in the composite outcome comprising stroke, systemic embolism and death.

"Although our overall results are reassuring in relation to initiation of NOAC in nvAF patients in France with no marked excess thromboembolic or bleeding risk, they also suggest that particular caution is required when initiating NOAC," the researchers conclude. "But on the basis of this study comparing NOAC to VKA, NOAC cannot be considered to be safer than VKA during the early phase of treatment. On the contrary, the clinical implications of our results are that physicians must be just as cautious when initiating NOAC as when initiating VKA, particularly in view of the absence of an antidote and objective monitoring of the extent of anticoagulation."

"Similar analyses should be extended to other NOAC such as apixaban and observational studies should now focus on NOAC head-to-head comparison in a non-inferiority design," they suggest.

The study had no commercial funding and the authors reported no conflicts of interest.

Dr. Maura did not respond to a request for comment.