Reuters Health

(Reuters Health) - The proportion of older Americans taking at least five medications or supplements went up in a recent study.

The increase in people using multiple medications - known as polypharmacy - paralleled an increase in the number of older Americans at risk for major drug interactions, researchers found.

"That's a concern from a public health standpoint, because it's getting worse," said Dima Qato, the study's lead author from the University of Illinois at Chicago.

Qato and her colleagues previously reported that polypharmacy is common among older Americans. More than half were taking prescription and nonprescription medications between 2005 and 2006.

There have been a lot of changes in U.S. regulations and the pharmacy market since that time, however. Some of those changes include new and less expensive generic drugs and the implementation of Medicare Part D, which is the prescription component of the government-run health insurance program for the elderly or disabled.

To evaluate the change in polypharmacy over time, the researchers compared the 2005-2006 results to data collected from 2010-2011.

Participants in the study were between the ages of 62 and 85 and were living at home. The researchers interviewed 2,351 people in 2005-2006 and 2,206 in 2010-2011.

Overall, about 67 percent were taking five or more medications or supplements in 2010-2011, up from about 53 percent in 2005-2006.

Use of cholesterol-lowering statins rose from about 34 percent to about 46 percent, the researchers reported in JAMA Internal Medicine. The proportion of people taking blood-thinning medications also increased, from about 33 percent to 43 percent, and use of omega-3 fish oil pills rose from about 5 percent to about 19 percent.

Along with the increase in polypharmacy, the researchers found the risk of major drug interactions nearly doubled, going from about 8 percent to about 15 percent.

"I think we have to keep in mind that while it's important to improve access to medications, we need to make sure they're used safely," said Qato.

On one hand, the new results can be seen as positive, said Dr. Michael Steinman, a gerontologist at the University of California, San Francisco.

We're treating more people with medications that could potentially help them," he said. "But when people have four or five chronic conditions, medications quickly balloon to a large number."

It's important to ensure clear communication between everyone involved in a patient's care, including the patient, said Steinman, who wrote an editorial accompanying the new study.

"You can get rid of problems and excess medications by talking with your doctors," he said.

A separate study reported in the same issue of the journal found that nearly 42 percent of adults did not tell their doctors about the use of complementary or alternative medicine, which includes - among other things - supplements, herbs, homeopathy, special diets and acupuncture.

Many patients said they didn't tell their doctors about these alternative medicines because they weren't asked or because their doctors didn't need to know that information, write Judy Juo and Pamela Jo Johnson, of the University of Minnesota in Minneapolis.

"If a person is talking with their doctor about the medications they're using, they should be talking about all the medications they're using," said Steinman.

(Reuters Health) - The proportion of older Americans taking at least five medications or supplements went up in a recent study.

The increase in people using multiple medications - known as polypharmacy - paralleled an increase in the number of older Americans at risk for major drug interactions, researchers found.

"That's a concern from a public health standpoint, because it's getting worse," said Dima Qato, the study's lead author from the University of Illinois at Chicago.

Qato and her colleagues previously reported that polypharmacy is common among older Americans. More than half were taking prescription and nonprescription medications between 2005 and 2006.

There have been a lot of changes in U.S. regulations and the pharmacy market since that time, however. Some of those changes include new and less expensive generic drugs and the implementation of Medicare Part D, which is the prescription component of the government-run health insurance program for the elderly or disabled.

To evaluate the change in polypharmacy over time, the researchers compared the 2005-2006 results to data collected from 2010-2011.

Participants in the study were between the ages of 62 and 85 and were living at home. The researchers interviewed 2,351 people in 2005-2006 and 2,206 in 2010-2011.

Overall, about 67 percent were taking five or more medications or supplements in 2010-2011, up from about 53 percent in 2005-2006.

Use of cholesterol-lowering statins rose from about 34 percent to about 46 percent, the researchers reported in JAMA Internal Medicine. The proportion of people taking blood-thinning medications also increased, from about 33 percent to 43 percent, and use of omega-3 fish oil pills rose from about 5 percent to about 19 percent.

Along with the increase in polypharmacy, the researchers found the risk of major drug interactions nearly doubled, going from about 8 percent to about 15 percent.

"I think we have to keep in mind that while it's important to improve access to medications, we need to make sure they're used safely," said Qato.

On one hand, the new results can be seen as positive, said Dr. Michael Steinman, a gerontologist at the University of California, San Francisco.

We're treating more people with medications that could potentially help them," he said. "But when people have four or five chronic conditions, medications quickly balloon to a large number."

It's important to ensure clear communication between everyone involved in a patient's care, including the patient, said Steinman, who wrote an editorial accompanying the new study.

"You can get rid of problems and excess medications by talking with your doctors," he said.

A separate study reported in the same issue of the journal found that nearly 42 percent of adults did not tell their doctors about the use of complementary or alternative medicine, which includes - among other things - supplements, herbs, homeopathy, special diets and acupuncture.

Many patients said they didn't tell their doctors about these alternative medicines because they weren't asked or because their doctors didn't need to know that information, write Judy Juo and Pamela Jo Johnson, of the University of Minnesota in Minneapolis.

"If a person is talking with their doctor about the medications they're using, they should be talking about all the medications they're using," said Steinman.

(Reuters Health) - The proportion of older Americans taking at least five medications or supplements went up in a recent study.

The increase in people using multiple medications - known as polypharmacy - paralleled an increase in the number of older Americans at risk for major drug interactions, researchers found.

"That's a concern from a public health standpoint, because it's getting worse," said Dima Qato, the study's lead author from the University of Illinois at Chicago.

Qato and her colleagues previously reported that polypharmacy is common among older Americans. More than half were taking prescription and nonprescription medications between 2005 and 2006.

There have been a lot of changes in U.S. regulations and the pharmacy market since that time, however. Some of those changes include new and less expensive generic drugs and the implementation of Medicare Part D, which is the prescription component of the government-run health insurance program for the elderly or disabled.

To evaluate the change in polypharmacy over time, the researchers compared the 2005-2006 results to data collected from 2010-2011.

Participants in the study were between the ages of 62 and 85 and were living at home. The researchers interviewed 2,351 people in 2005-2006 and 2,206 in 2010-2011.

Overall, about 67 percent were taking five or more medications or supplements in 2010-2011, up from about 53 percent in 2005-2006.

Use of cholesterol-lowering statins rose from about 34 percent to about 46 percent, the researchers reported in JAMA Internal Medicine. The proportion of people taking blood-thinning medications also increased, from about 33 percent to 43 percent, and use of omega-3 fish oil pills rose from about 5 percent to about 19 percent.

Along with the increase in polypharmacy, the researchers found the risk of major drug interactions nearly doubled, going from about 8 percent to about 15 percent.

"I think we have to keep in mind that while it's important to improve access to medications, we need to make sure they're used safely," said Qato.

On one hand, the new results can be seen as positive, said Dr. Michael Steinman, a gerontologist at the University of California, San Francisco.

We're treating more people with medications that could potentially help them," he said. "But when people have four or five chronic conditions, medications quickly balloon to a large number."

It's important to ensure clear communication between everyone involved in a patient's care, including the patient, said Steinman, who wrote an editorial accompanying the new study.

"You can get rid of problems and excess medications by talking with your doctors," he said.

A separate study reported in the same issue of the journal found that nearly 42 percent of adults did not tell their doctors about the use of complementary or alternative medicine, which includes - among other things - supplements, herbs, homeopathy, special diets and acupuncture.

Many patients said they didn't tell their doctors about these alternative medicines because they weren't asked or because their doctors didn't need to know that information, write Judy Juo and Pamela Jo Johnson, of the University of Minnesota in Minneapolis.

"If a person is talking with their doctor about the medications they're using, they should be talking about all the medications they're using," said Steinman.

NEW YORK (Reuters Health) - In the absence of a congenital anomaly, the main cause of inferior vena cava (IVC) thrombosis is the presence of an unretrieved IVC filter, researchers report.

"Since IVC filter thrombosis is the main etiology for IVC thrombosis, physicians may want to ensure the absolute need for the filter before its placement," Dr. Mohamad Alkhouli from University of Rochester Medical Center, New York told Reuters Health by email. "A tracking system should be instituted to follow up with these patients, and the implanted IVC filter should be pulled out as soon as is safe and reasonable."

IVC thrombosis accompanies lower extremity deep vein thrombosis (DVT) in 4% or more of patients, leading to post-thrombotic syndrome (PTS) in up to 90% of patients, disabling venous claudication in 45%, pulmonary embolism in 30%, and venous ulceration in 15%, according to Dr. Alkhouli and colleagues, who reviewed the diagnosis and management of IVC thrombosis in a report online March 9th in JACC: Cardiovascular Interventions.

IVC filter placement rates are 25 times higher in the U.S. than in Europe, and late filter thrombosis has been reported in up to a third of patients, yet retrieval rates are consistently low.

Presenting symptoms of IVC thrombosis include leg heaviness, pain, swelling, and cramping, often preceded by nonspecific back and abdominal/pelvic pain. Because of the ambiguous symptoms and insidious onset, IVC thrombosis often goes undiagnosed until clot migration or embolization into the lungs and renal veins results in dyspnea and oliguria.

Lower extremity duplex ultrasound can be used to screen for IVC thrombosis, but appropriately timed CT and MRI are essential for diagnosis and assessment of the extent of thrombosis.

Once IVC thrombosis is diagnosed, the mainstay of treatment is anticoagulation, although specific guidelines are lacking.

In observational studies, thrombus removal with pharmacomechanical catheter directed thrombolysis (PMCT) has reduced the incidence of PTS and improved quality of life, but whether this is as safe as standard anticoagulation remains unclear.

While acute thrombosis may be amenable to PMCT and catheter-directed thrombolysis (CDT), the presence of a fibrotic component in patients who present late may require balloon venoplasty with or without stenting.

The available treatments work best when IVC thrombosis is recognized early, Dr. Alkhouli said.

Dr. Michael Jaff from Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, who wrote an editorial related to this report, told Reuters Health by email, "Limit placement of IVC filters to only absolute indications, and retrieve them as soon as possible."

Dr. Jaff explained, "There are three basic questions I ask myself when considering catheter-based intervention for IVC thrombosis: (1) How long has the patient had symptoms/signs suggestive of this, and how severe are they? (2) What is my estimation of bleeding risk? (3) Do I have an interventionist with skill and experience available to perform the intervention?"

He continued, "Regarding question 1, shorter duration of symptoms and more severe symptoms and signs prompt me to aggressively consider catheter-based intervention. Regarding question 2, if there is significant bleeding risk (for example, inflammatory bowel disease as the underlying culprit for the IVC thrombosis), I am reluctant to consider catheter-based intervention.Regarding question 3, don't consider this if your colleague has little experience performing this procedure or managing the complications of the procedure."

Dr. Xiao-Qiang Li from Second Affiliated Hospital of Soochow University in Suzhou, China, who recently described the experience with CDT combined with manual aspiration thrombectomy for acute inferior vena cava filter thrombosis, told Reuters Health by email, "As you see, no consensuses have been reached."

"For a new patient with acute DVT, if he or she has no contraindications for thrombolysis, especially with a life expectancy more than one year, we prefer to perform catheter-based interventions, including catheter-directed thrombolysis, pharmacomechanical thrombolysis, ultrasound-assisted catheter-directed thrombolysis and subsequent percutaneous transluminal angioplasty and stenting,"Dr. Li said."But, of note, anticoagulation is the basic treatment whatever catheter-based interventions are adopted."

NEW YORK (Reuters Health) - In the absence of a congenital anomaly, the main cause of inferior vena cava (IVC) thrombosis is the presence of an unretrieved IVC filter, researchers report.

"Since IVC filter thrombosis is the main etiology for IVC thrombosis, physicians may want to ensure the absolute need for the filter before its placement," Dr. Mohamad Alkhouli from University of Rochester Medical Center, New York told Reuters Health by email. "A tracking system should be instituted to follow up with these patients, and the implanted IVC filter should be pulled out as soon as is safe and reasonable."

IVC thrombosis accompanies lower extremity deep vein thrombosis (DVT) in 4% or more of patients, leading to post-thrombotic syndrome (PTS) in up to 90% of patients, disabling venous claudication in 45%, pulmonary embolism in 30%, and venous ulceration in 15%, according to Dr. Alkhouli and colleagues, who reviewed the diagnosis and management of IVC thrombosis in a report online March 9th in JACC: Cardiovascular Interventions.

IVC filter placement rates are 25 times higher in the U.S. than in Europe, and late filter thrombosis has been reported in up to a third of patients, yet retrieval rates are consistently low.

Presenting symptoms of IVC thrombosis include leg heaviness, pain, swelling, and cramping, often preceded by nonspecific back and abdominal/pelvic pain. Because of the ambiguous symptoms and insidious onset, IVC thrombosis often goes undiagnosed until clot migration or embolization into the lungs and renal veins results in dyspnea and oliguria.

Lower extremity duplex ultrasound can be used to screen for IVC thrombosis, but appropriately timed CT and MRI are essential for diagnosis and assessment of the extent of thrombosis.

Once IVC thrombosis is diagnosed, the mainstay of treatment is anticoagulation, although specific guidelines are lacking.

In observational studies, thrombus removal with pharmacomechanical catheter directed thrombolysis (PMCT) has reduced the incidence of PTS and improved quality of life, but whether this is as safe as standard anticoagulation remains unclear.

While acute thrombosis may be amenable to PMCT and catheter-directed thrombolysis (CDT), the presence of a fibrotic component in patients who present late may require balloon venoplasty with or without stenting.

The available treatments work best when IVC thrombosis is recognized early, Dr. Alkhouli said.

Dr. Michael Jaff from Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, who wrote an editorial related to this report, told Reuters Health by email, "Limit placement of IVC filters to only absolute indications, and retrieve them as soon as possible."

Dr. Jaff explained, "There are three basic questions I ask myself when considering catheter-based intervention for IVC thrombosis: (1) How long has the patient had symptoms/signs suggestive of this, and how severe are they? (2) What is my estimation of bleeding risk? (3) Do I have an interventionist with skill and experience available to perform the intervention?"

He continued, "Regarding question 1, shorter duration of symptoms and more severe symptoms and signs prompt me to aggressively consider catheter-based intervention. Regarding question 2, if there is significant bleeding risk (for example, inflammatory bowel disease as the underlying culprit for the IVC thrombosis), I am reluctant to consider catheter-based intervention.Regarding question 3, don't consider this if your colleague has little experience performing this procedure or managing the complications of the procedure."

Dr. Xiao-Qiang Li from Second Affiliated Hospital of Soochow University in Suzhou, China, who recently described the experience with CDT combined with manual aspiration thrombectomy for acute inferior vena cava filter thrombosis, told Reuters Health by email, "As you see, no consensuses have been reached."

"For a new patient with acute DVT, if he or she has no contraindications for thrombolysis, especially with a life expectancy more than one year, we prefer to perform catheter-based interventions, including catheter-directed thrombolysis, pharmacomechanical thrombolysis, ultrasound-assisted catheter-directed thrombolysis and subsequent percutaneous transluminal angioplasty and stenting,"Dr. Li said."But, of note, anticoagulation is the basic treatment whatever catheter-based interventions are adopted."

NEW YORK (Reuters Health) - In the absence of a congenital anomaly, the main cause of inferior vena cava (IVC) thrombosis is the presence of an unretrieved IVC filter, researchers report.

"Since IVC filter thrombosis is the main etiology for IVC thrombosis, physicians may want to ensure the absolute need for the filter before its placement," Dr. Mohamad Alkhouli from University of Rochester Medical Center, New York told Reuters Health by email. "A tracking system should be instituted to follow up with these patients, and the implanted IVC filter should be pulled out as soon as is safe and reasonable."

IVC thrombosis accompanies lower extremity deep vein thrombosis (DVT) in 4% or more of patients, leading to post-thrombotic syndrome (PTS) in up to 90% of patients, disabling venous claudication in 45%, pulmonary embolism in 30%, and venous ulceration in 15%, according to Dr. Alkhouli and colleagues, who reviewed the diagnosis and management of IVC thrombosis in a report online March 9th in JACC: Cardiovascular Interventions.

IVC filter placement rates are 25 times higher in the U.S. than in Europe, and late filter thrombosis has been reported in up to a third of patients, yet retrieval rates are consistently low.

Presenting symptoms of IVC thrombosis include leg heaviness, pain, swelling, and cramping, often preceded by nonspecific back and abdominal/pelvic pain. Because of the ambiguous symptoms and insidious onset, IVC thrombosis often goes undiagnosed until clot migration or embolization into the lungs and renal veins results in dyspnea and oliguria.

Lower extremity duplex ultrasound can be used to screen for IVC thrombosis, but appropriately timed CT and MRI are essential for diagnosis and assessment of the extent of thrombosis.

Once IVC thrombosis is diagnosed, the mainstay of treatment is anticoagulation, although specific guidelines are lacking.

In observational studies, thrombus removal with pharmacomechanical catheter directed thrombolysis (PMCT) has reduced the incidence of PTS and improved quality of life, but whether this is as safe as standard anticoagulation remains unclear.

While acute thrombosis may be amenable to PMCT and catheter-directed thrombolysis (CDT), the presence of a fibrotic component in patients who present late may require balloon venoplasty with or without stenting.

The available treatments work best when IVC thrombosis is recognized early, Dr. Alkhouli said.

Dr. Michael Jaff from Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, who wrote an editorial related to this report, told Reuters Health by email, "Limit placement of IVC filters to only absolute indications, and retrieve them as soon as possible."

Dr. Jaff explained, "There are three basic questions I ask myself when considering catheter-based intervention for IVC thrombosis: (1) How long has the patient had symptoms/signs suggestive of this, and how severe are they? (2) What is my estimation of bleeding risk? (3) Do I have an interventionist with skill and experience available to perform the intervention?"

He continued, "Regarding question 1, shorter duration of symptoms and more severe symptoms and signs prompt me to aggressively consider catheter-based intervention. Regarding question 2, if there is significant bleeding risk (for example, inflammatory bowel disease as the underlying culprit for the IVC thrombosis), I am reluctant to consider catheter-based intervention.Regarding question 3, don't consider this if your colleague has little experience performing this procedure or managing the complications of the procedure."

Dr. Xiao-Qiang Li from Second Affiliated Hospital of Soochow University in Suzhou, China, who recently described the experience with CDT combined with manual aspiration thrombectomy for acute inferior vena cava filter thrombosis, told Reuters Health by email, "As you see, no consensuses have been reached."

"For a new patient with acute DVT, if he or she has no contraindications for thrombolysis, especially with a life expectancy more than one year, we prefer to perform catheter-based interventions, including catheter-directed thrombolysis, pharmacomechanical thrombolysis, ultrasound-assisted catheter-directed thrombolysis and subsequent percutaneous transluminal angioplasty and stenting,"Dr. Li said."But, of note, anticoagulation is the basic treatment whatever catheter-based interventions are adopted."

NEW YORK (Reuters Health) - U.S. hospitals save money when they use the novel oral anticoagulant rivaroxaban instead of warfarin to treat patients with venous thromboembolism (VTE), a new analysis finds.

"These days it's important to consider the cost of new drugs to the health system," Dr. Steven Deitelzweig from Ochsner Health System in New Orleans, Louisiana, noted in an interview with Reuters Health.

"This retrospective observational analysis had an ample number of patients, they had very good clinical outcomes with rivaroxaban, and we also demonstrated that those clinical outcomes could be achieved with a notable reduction in the all-important utilization side of healthcare," he said.

It's estimated that VTE affects more than 900,000 Americans each year, at a cost to the healthcare system between $13 and $27 billion.

Dr. Deitelzweig and his colleagues did an economic analysis of rivaroxaban versus low-molecular-weight heparin (LMWH)/warfarin for VTE in the hospital setting.

Using Truven MarketScan Hospital Drug Database, they identified more than 2,400 older adults hospitalized for primary VTE between 2012 and 2013. They created two groups of 1,223 patients each. Each group included 751 pulmonary embolism (PE) patients and 472 deep vein thrombosis (DVT) patients.

According to the analysis, total hospitalization costs - including room rate, laboratory tests, inpatient procedures, pharmacy costs and all other inpatient services - were significantly lower and length of stay was significantly shorter for patients treated with rivaroxaban rather than LMWH/warfarin.

Patients receiving rivaroxaban spent an average of 1.5 fewer days in the hospital than their peers on LMWH/warfarin (3.7 versus 5.2 days, p<0.001).

"This finding is consistent with the length of stay reduction found in the EINSTEIN VTE clinical trials," the researchers note in their poster presented March 7 at the Society of Hospital Medicine annual meeting in San Diego, California.

"Length of stay is one metric that we track quite closely and care about. Even one day less in a hospital is a significant cost savings and allows hospitals that are very busy to take care of the next patient, as appropriate," Dr. Deitelzweig told Reuters Health.

The rivaroxaban group had an adjusted average cost savings of $1,888 per admission compared with the LMWH/warfarin group ($8,387 versus $10,275; p<0.001), the study found.

Limitations of the study include the fact that patient medical history was limited to the patient's current admission. Outpatient treatment prior to admission, particularly whether they had received either rivaroxaban or LMWH/warfarin prior to admission was unknown. And despite propensity score matching and further statistical modeling, there remains the potential for unmeasured confounders, they note.

The study was funded by Janssen Scientific Affairs, LLC. Janssen Pharmaceuticals markets rivaroxaban under the trade name Xarelto. Four authors are employees of Janssen Research and Development, LLC.

NEW YORK (Reuters Health) - U.S. hospitals save money when they use the novel oral anticoagulant rivaroxaban instead of warfarin to treat patients with venous thromboembolism (VTE), a new analysis finds.

"These days it's important to consider the cost of new drugs to the health system," Dr. Steven Deitelzweig from Ochsner Health System in New Orleans, Louisiana, noted in an interview with Reuters Health.

"This retrospective observational analysis had an ample number of patients, they had very good clinical outcomes with rivaroxaban, and we also demonstrated that those clinical outcomes could be achieved with a notable reduction in the all-important utilization side of healthcare," he said.

It's estimated that VTE affects more than 900,000 Americans each year, at a cost to the healthcare system between $13 and $27 billion.

Dr. Deitelzweig and his colleagues did an economic analysis of rivaroxaban versus low-molecular-weight heparin (LMWH)/warfarin for VTE in the hospital setting.

Using Truven MarketScan Hospital Drug Database, they identified more than 2,400 older adults hospitalized for primary VTE between 2012 and 2013. They created two groups of 1,223 patients each. Each group included 751 pulmonary embolism (PE) patients and 472 deep vein thrombosis (DVT) patients.

According to the analysis, total hospitalization costs - including room rate, laboratory tests, inpatient procedures, pharmacy costs and all other inpatient services - were significantly lower and length of stay was significantly shorter for patients treated with rivaroxaban rather than LMWH/warfarin.

Patients receiving rivaroxaban spent an average of 1.5 fewer days in the hospital than their peers on LMWH/warfarin (3.7 versus 5.2 days, p<0.001).

"This finding is consistent with the length of stay reduction found in the EINSTEIN VTE clinical trials," the researchers note in their poster presented March 7 at the Society of Hospital Medicine annual meeting in San Diego, California.

"Length of stay is one metric that we track quite closely and care about. Even one day less in a hospital is a significant cost savings and allows hospitals that are very busy to take care of the next patient, as appropriate," Dr. Deitelzweig told Reuters Health.

The rivaroxaban group had an adjusted average cost savings of $1,888 per admission compared with the LMWH/warfarin group ($8,387 versus $10,275; p<0.001), the study found.

Limitations of the study include the fact that patient medical history was limited to the patient's current admission. Outpatient treatment prior to admission, particularly whether they had received either rivaroxaban or LMWH/warfarin prior to admission was unknown. And despite propensity score matching and further statistical modeling, there remains the potential for unmeasured confounders, they note.

The study was funded by Janssen Scientific Affairs, LLC. Janssen Pharmaceuticals markets rivaroxaban under the trade name Xarelto. Four authors are employees of Janssen Research and Development, LLC.

NEW YORK (Reuters Health) - U.S. hospitals save money when they use the novel oral anticoagulant rivaroxaban instead of warfarin to treat patients with venous thromboembolism (VTE), a new analysis finds.

"These days it's important to consider the cost of new drugs to the health system," Dr. Steven Deitelzweig from Ochsner Health System in New Orleans, Louisiana, noted in an interview with Reuters Health.

"This retrospective observational analysis had an ample number of patients, they had very good clinical outcomes with rivaroxaban, and we also demonstrated that those clinical outcomes could be achieved with a notable reduction in the all-important utilization side of healthcare," he said.

It's estimated that VTE affects more than 900,000 Americans each year, at a cost to the healthcare system between $13 and $27 billion.

Dr. Deitelzweig and his colleagues did an economic analysis of rivaroxaban versus low-molecular-weight heparin (LMWH)/warfarin for VTE in the hospital setting.

Using Truven MarketScan Hospital Drug Database, they identified more than 2,400 older adults hospitalized for primary VTE between 2012 and 2013. They created two groups of 1,223 patients each. Each group included 751 pulmonary embolism (PE) patients and 472 deep vein thrombosis (DVT) patients.

According to the analysis, total hospitalization costs - including room rate, laboratory tests, inpatient procedures, pharmacy costs and all other inpatient services - were significantly lower and length of stay was significantly shorter for patients treated with rivaroxaban rather than LMWH/warfarin.

Patients receiving rivaroxaban spent an average of 1.5 fewer days in the hospital than their peers on LMWH/warfarin (3.7 versus 5.2 days, p<0.001).

"This finding is consistent with the length of stay reduction found in the EINSTEIN VTE clinical trials," the researchers note in their poster presented March 7 at the Society of Hospital Medicine annual meeting in San Diego, California.

"Length of stay is one metric that we track quite closely and care about. Even one day less in a hospital is a significant cost savings and allows hospitals that are very busy to take care of the next patient, as appropriate," Dr. Deitelzweig told Reuters Health.

The rivaroxaban group had an adjusted average cost savings of $1,888 per admission compared with the LMWH/warfarin group ($8,387 versus $10,275; p<0.001), the study found.

Limitations of the study include the fact that patient medical history was limited to the patient's current admission. Outpatient treatment prior to admission, particularly whether they had received either rivaroxaban or LMWH/warfarin prior to admission was unknown. And despite propensity score matching and further statistical modeling, there remains the potential for unmeasured confounders, they note.

The study was funded by Janssen Scientific Affairs, LLC. Janssen Pharmaceuticals markets rivaroxaban under the trade name Xarelto. Four authors are employees of Janssen Research and Development, LLC.

(Reuters Health) - For people with Alzheimer's disease, having gum disease is tied to faster cognitive decline, according to a new study.

"What we have shown is that regardless of the severity of dementia (within this mild to moderate impaired group) that patients with more severe gum disease are declining more rapidly," said senior author Clive Holmes of the University of Southampton in the UK.

In other studies, Holmes and his coauthors have found that conditions such as chest infections, urinary tract infections, rheumatoid arthritis and diabetes are associated with faster disease progression in Alzheimer's, he said.

"We hadn't previously looked at gum disease because MDs tendto leave this in the hands of dentists but it is an important common low grade chronic infection," Holmes told Reuters Health by email.

The researchers observed 60 people with mild to moderate Alzheimer's disease living at home for six months. The participants did not smoke, had not been treated for gum disease within the previous six months, and had at least 10 teeth.

At the start, each participant completed a cognitive assessment, gave a blood sample, was examined by a dental hygienist and their main caregiver was interviewed to provide a medical and dental history. The same tests and interviews were repeated six months later.

Of the 60 people in the study, 22 had moderate to severe gum disease at the beginning of the study. By six months later, one participant had died, three had withdrawn from the study and three were lost to follow-up.

Cognitive score declined more for those who had periodontitis to begin with than for those who did not, the researchers reported February 24 in PLoS One.

According to one theory, cognitive impairment leads to adverse oral health due to inattention to routine oral hygiene and care, said Dr. James M. Noble of the Taub Institute for Research on Alzheimer's Disease and the Aging Brain at Columbia University Medical Center in New York City, who was not part of the new study.

"The second, and the one I'm most intrigued by, is whether or not periodontal disease has an influence on cognitive outcomes of aging, either as an independent risk factor for (new-onset) cognitive impairment including Alzheimer's disease, or more rapid decline once (Alzheimer's disease) has been diagnosed, as was suggested by this study," Noble told Reuters Health by email.

Gum disease may cause chronic low-grade inflammation in the rest of the body, and inflammation is associated with changes in the brain, he said.

"It is known that gum disease is associated with increased markers of inflammation," Holmes said.

But the new study indicates a connection between gum disease and cognitive decline, not necessarily that one causes the other, he said. Further studies need to assess whether treatingthe gum disease would also slow cognitive decline.

"Periodontitis has been associated with heart disease and stroke among other conditions," Noble said. Based on this and other studies, "it seems to be good advice to brush and floss," Noble said.

(Reuters Health) - For people with Alzheimer's disease, having gum disease is tied to faster cognitive decline, according to a new study.

"What we have shown is that regardless of the severity of dementia (within this mild to moderate impaired group) that patients with more severe gum disease are declining more rapidly," said senior author Clive Holmes of the University of Southampton in the UK.

In other studies, Holmes and his coauthors have found that conditions such as chest infections, urinary tract infections, rheumatoid arthritis and diabetes are associated with faster disease progression in Alzheimer's, he said.

"We hadn't previously looked at gum disease because MDs tendto leave this in the hands of dentists but it is an important common low grade chronic infection," Holmes told Reuters Health by email.

The researchers observed 60 people with mild to moderate Alzheimer's disease living at home for six months. The participants did not smoke, had not been treated for gum disease within the previous six months, and had at least 10 teeth.

At the start, each participant completed a cognitive assessment, gave a blood sample, was examined by a dental hygienist and their main caregiver was interviewed to provide a medical and dental history. The same tests and interviews were repeated six months later.

Of the 60 people in the study, 22 had moderate to severe gum disease at the beginning of the study. By six months later, one participant had died, three had withdrawn from the study and three were lost to follow-up.

Cognitive score declined more for those who had periodontitis to begin with than for those who did not, the researchers reported February 24 in PLoS One.

According to one theory, cognitive impairment leads to adverse oral health due to inattention to routine oral hygiene and care, said Dr. James M. Noble of the Taub Institute for Research on Alzheimer's Disease and the Aging Brain at Columbia University Medical Center in New York City, who was not part of the new study.

"The second, and the one I'm most intrigued by, is whether or not periodontal disease has an influence on cognitive outcomes of aging, either as an independent risk factor for (new-onset) cognitive impairment including Alzheimer's disease, or more rapid decline once (Alzheimer's disease) has been diagnosed, as was suggested by this study," Noble told Reuters Health by email.

Gum disease may cause chronic low-grade inflammation in the rest of the body, and inflammation is associated with changes in the brain, he said.

"It is known that gum disease is associated with increased markers of inflammation," Holmes said.

But the new study indicates a connection between gum disease and cognitive decline, not necessarily that one causes the other, he said. Further studies need to assess whether treatingthe gum disease would also slow cognitive decline.

"Periodontitis has been associated with heart disease and stroke among other conditions," Noble said. Based on this and other studies, "it seems to be good advice to brush and floss," Noble said.

(Reuters Health) - For people with Alzheimer's disease, having gum disease is tied to faster cognitive decline, according to a new study.

"What we have shown is that regardless of the severity of dementia (within this mild to moderate impaired group) that patients with more severe gum disease are declining more rapidly," said senior author Clive Holmes of the University of Southampton in the UK.

In other studies, Holmes and his coauthors have found that conditions such as chest infections, urinary tract infections, rheumatoid arthritis and diabetes are associated with faster disease progression in Alzheimer's, he said.

"We hadn't previously looked at gum disease because MDs tendto leave this in the hands of dentists but it is an important common low grade chronic infection," Holmes told Reuters Health by email.

The researchers observed 60 people with mild to moderate Alzheimer's disease living at home for six months. The participants did not smoke, had not been treated for gum disease within the previous six months, and had at least 10 teeth.

At the start, each participant completed a cognitive assessment, gave a blood sample, was examined by a dental hygienist and their main caregiver was interviewed to provide a medical and dental history. The same tests and interviews were repeated six months later.

Of the 60 people in the study, 22 had moderate to severe gum disease at the beginning of the study. By six months later, one participant had died, three had withdrawn from the study and three were lost to follow-up.

Cognitive score declined more for those who had periodontitis to begin with than for those who did not, the researchers reported February 24 in PLoS One.

According to one theory, cognitive impairment leads to adverse oral health due to inattention to routine oral hygiene and care, said Dr. James M. Noble of the Taub Institute for Research on Alzheimer's Disease and the Aging Brain at Columbia University Medical Center in New York City, who was not part of the new study.

"The second, and the one I'm most intrigued by, is whether or not periodontal disease has an influence on cognitive outcomes of aging, either as an independent risk factor for (new-onset) cognitive impairment including Alzheimer's disease, or more rapid decline once (Alzheimer's disease) has been diagnosed, as was suggested by this study," Noble told Reuters Health by email.

Gum disease may cause chronic low-grade inflammation in the rest of the body, and inflammation is associated with changes in the brain, he said.

"It is known that gum disease is associated with increased markers of inflammation," Holmes said.

But the new study indicates a connection between gum disease and cognitive decline, not necessarily that one causes the other, he said. Further studies need to assess whether treatingthe gum disease would also slow cognitive decline.

"Periodontitis has been associated with heart disease and stroke among other conditions," Noble said. Based on this and other studies, "it seems to be good advice to brush and floss," Noble said.

(Reuters Health) - Kids who live in a stress-free environment may grow up to be adults with a lower risk of heart attacks than their peers who experience social, emotional or financial difficulties during childhood, a Finnish study suggests.

Researchers assessed psychosocial factors in 311 kids at age 12 and 18. Then, at age 28, they looked for coronary artery calcification.

The adults who had high psychosocial wellbeing as kids were 15% less likely to have calcium deposits clogging their arteries as adults, the study found.

"This study suggests that childhood psychosocial factors may have long-term consequences on cardiovascular health," lead study author Dr. Markus Juonala of the University of Turku in Finland said by email.

To understand the connection between how kids feel growing up and how their arteries look decades later, Juonala and colleagues analyzed data gathered from 1980 to 2008 as part of the Cardiovascular Risk in Young Finns Study.

Among other things, this study measured psychosocial wellbeing by looking at family income and education levels, parents' job status, parents' mental health and history of smoking or substance abuse, parents' weight and exercise habits, stressful events such as divorce, death or moves, as well as the child's level of aggressive or anti-social behaviors and ability to interact with other people.

In addition, researchers analyzed results from computed tomography (CT) scans assessing coronary artery calcification. Overall, 55 participants, or about 18%, had at least some calcification in their arteries, researchers report in JAMA Pediatrics, March 14.

Among this group with calcification, 28 participants had low levels of buildup, 20 had moderate amounts of calcium and 7 had substantial deposits, the study found.

Even after accounting for adult circumstances like psychosocial factors and risk factors for heart disease like obesity, smoking, hypertension and elevated cholesterol, the research team still found well-being during childhood was associated with reduced coronary artery calcification in adulthood.

The study is observational and doesn't prove childhood stress causes clogged arteries or heart attacks, only that the two things are related, the authors note.

It's possible, however, that stress during childhood might trigger changes in metabolic functioning and inflammation that later contribute to calcium deposits in the arteries, the researchers point out.

It's also possible that happier kids may develop healthier habits like better diets and more rigorous exercise routines that help keep arteries unclogged and lower their risk of heart disease later in life.

"The take-home message for parents is to understand that stress in childhood may have many adverse effects and that they should help their children avoid stress," said Dr. Stephen Daniels, a researcher at the University of Colorado School of Medicine and pediatrician-in-chief at Children's Hospital Colorado.

Parents may not always be able to eliminate stress, however, particularly the stress that can come from environmental factors like lower socioeconomic status, Daniels, who wasn't involved in the study, added by email.

When children grow up with stress, they can still take charge of their health as adults to lower their risk of heart disease, Daniels noted.

"For an adult who had a stressful childhood, the best approach is to be aware of their cardiovascular risk status and to reduce their risk by improving diet and physical activity and avoiding cigarette smoking," Daniels added. "Where risk factors exist, such as high blood pressure, they should be appropriately treated."

(Reuters Health) - Kids who live in a stress-free environment may grow up to be adults with a lower risk of heart attacks than their peers who experience social, emotional or financial difficulties during childhood, a Finnish study suggests.

Researchers assessed psychosocial factors in 311 kids at age 12 and 18. Then, at age 28, they looked for coronary artery calcification.

The adults who had high psychosocial wellbeing as kids were 15% less likely to have calcium deposits clogging their arteries as adults, the study found.

"This study suggests that childhood psychosocial factors may have long-term consequences on cardiovascular health," lead study author Dr. Markus Juonala of the University of Turku in Finland said by email.

To understand the connection between how kids feel growing up and how their arteries look decades later, Juonala and colleagues analyzed data gathered from 1980 to 2008 as part of the Cardiovascular Risk in Young Finns Study.

Among other things, this study measured psychosocial wellbeing by looking at family income and education levels, parents' job status, parents' mental health and history of smoking or substance abuse, parents' weight and exercise habits, stressful events such as divorce, death or moves, as well as the child's level of aggressive or anti-social behaviors and ability to interact with other people.

In addition, researchers analyzed results from computed tomography (CT) scans assessing coronary artery calcification. Overall, 55 participants, or about 18%, had at least some calcification in their arteries, researchers report in JAMA Pediatrics, March 14.

Among this group with calcification, 28 participants had low levels of buildup, 20 had moderate amounts of calcium and 7 had substantial deposits, the study found.

Even after accounting for adult circumstances like psychosocial factors and risk factors for heart disease like obesity, smoking, hypertension and elevated cholesterol, the research team still found well-being during childhood was associated with reduced coronary artery calcification in adulthood.

The study is observational and doesn't prove childhood stress causes clogged arteries or heart attacks, only that the two things are related, the authors note.

It's possible, however, that stress during childhood might trigger changes in metabolic functioning and inflammation that later contribute to calcium deposits in the arteries, the researchers point out.

It's also possible that happier kids may develop healthier habits like better diets and more rigorous exercise routines that help keep arteries unclogged and lower their risk of heart disease later in life.

"The take-home message for parents is to understand that stress in childhood may have many adverse effects and that they should help their children avoid stress," said Dr. Stephen Daniels, a researcher at the University of Colorado School of Medicine and pediatrician-in-chief at Children's Hospital Colorado.

Parents may not always be able to eliminate stress, however, particularly the stress that can come from environmental factors like lower socioeconomic status, Daniels, who wasn't involved in the study, added by email.

When children grow up with stress, they can still take charge of their health as adults to lower their risk of heart disease, Daniels noted.

"For an adult who had a stressful childhood, the best approach is to be aware of their cardiovascular risk status and to reduce their risk by improving diet and physical activity and avoiding cigarette smoking," Daniels added. "Where risk factors exist, such as high blood pressure, they should be appropriately treated."

(Reuters Health) - Kids who live in a stress-free environment may grow up to be adults with a lower risk of heart attacks than their peers who experience social, emotional or financial difficulties during childhood, a Finnish study suggests.

Researchers assessed psychosocial factors in 311 kids at age 12 and 18. Then, at age 28, they looked for coronary artery calcification.

The adults who had high psychosocial wellbeing as kids were 15% less likely to have calcium deposits clogging their arteries as adults, the study found.

"This study suggests that childhood psychosocial factors may have long-term consequences on cardiovascular health," lead study author Dr. Markus Juonala of the University of Turku in Finland said by email.

To understand the connection between how kids feel growing up and how their arteries look decades later, Juonala and colleagues analyzed data gathered from 1980 to 2008 as part of the Cardiovascular Risk in Young Finns Study.

Among other things, this study measured psychosocial wellbeing by looking at family income and education levels, parents' job status, parents' mental health and history of smoking or substance abuse, parents' weight and exercise habits, stressful events such as divorce, death or moves, as well as the child's level of aggressive or anti-social behaviors and ability to interact with other people.

In addition, researchers analyzed results from computed tomography (CT) scans assessing coronary artery calcification. Overall, 55 participants, or about 18%, had at least some calcification in their arteries, researchers report in JAMA Pediatrics, March 14.

Among this group with calcification, 28 participants had low levels of buildup, 20 had moderate amounts of calcium and 7 had substantial deposits, the study found.

Even after accounting for adult circumstances like psychosocial factors and risk factors for heart disease like obesity, smoking, hypertension and elevated cholesterol, the research team still found well-being during childhood was associated with reduced coronary artery calcification in adulthood.

The study is observational and doesn't prove childhood stress causes clogged arteries or heart attacks, only that the two things are related, the authors note.

It's possible, however, that stress during childhood might trigger changes in metabolic functioning and inflammation that later contribute to calcium deposits in the arteries, the researchers point out.

It's also possible that happier kids may develop healthier habits like better diets and more rigorous exercise routines that help keep arteries unclogged and lower their risk of heart disease later in life.

"The take-home message for parents is to understand that stress in childhood may have many adverse effects and that they should help their children avoid stress," said Dr. Stephen Daniels, a researcher at the University of Colorado School of Medicine and pediatrician-in-chief at Children's Hospital Colorado.

Parents may not always be able to eliminate stress, however, particularly the stress that can come from environmental factors like lower socioeconomic status, Daniels, who wasn't involved in the study, added by email.

When children grow up with stress, they can still take charge of their health as adults to lower their risk of heart disease, Daniels noted.

"For an adult who had a stressful childhood, the best approach is to be aware of their cardiovascular risk status and to reduce their risk by improving diet and physical activity and avoiding cigarette smoking," Daniels added. "Where risk factors exist, such as high blood pressure, they should be appropriately treated."

NEW YORK (Reuters Health) - Use of the marker procalcitonin to guide antibacterial therapy in the critically ill is associated with shorter treatment and reduced mortality, according to Dutch researchers.

As Dr. Evelien de Jong told Reuters Health by email, "Antibiotic overconsumption is one of the largest threats to medicine in the near future. Our study is the largest randomized controlled trial of antibiotic reduction in intensive care units (ICUs) and will, hopefully, contribute to a more individualized antibiotic duration per patient and an overall reduction of antibiotic use."

In a February 29 online paper in the Lancet Infectious Diseases, Dr. de Jong, of VU University Medical Center, Amsterdam, and colleagues noted that a "drop in procalcitonin concentration might help (clinicians) to discontinue antibiotic use in a more timely fashion" than reliance on biomarkers such as C-reactive protein.

To investigate, the researchers studied 1,575 ICU patients who received antibiotics and were randomized to procalcitonin-guided antibiotic discontinuation or standard of care. Fifteen were excluded from the procalcitonin group and 14 were excluded from the standard care group.

"In the procalcitonin-guided group, a non-binding advice to discontinue antibiotics was provided if procalcitonin concentration had decreased by 80% or more of its peak value or to 0.5 ug/L or lower," the authors reported.

In all, 538 (71%) of 761 patients in the procalcitonin-guided group and 457 (58%) of 785 patients in the standard-of-care group completed their antibiotic treatment in the ICU.

Median consumption of antibiotics was 7.5 daily defined doses in the procalcitonin group, significantly less than the 9.3 daily defined doses in the standard-of-care group, for a mean group absolute difference of 2.69 (p<0.0001).

Median duration of treatment was also significantly shorter in the procalcitonin-guided group (five versus seven days), for a mean group absolute difference of 1.22 (p<0.0001).

Mortality at 28 days was also significantly less than in the standard-of-care group. This was 20% versus 27% in intention-to-treat analysis. At one year, corresponding per protocol proportions were 36% and 43%.

Overall, the researchers concluded, "Procalcitonin concentrations might help physicians in deciding whether or not the presumed infection is truly bacterial, leading to more adequate diagnosis and treatment, the cornerstones of antibiotic stewardship."

Commenting by email, Dr. Philipp Schuetz, coauthor of an accompanying editorial, told Reuters Health, "This well-done and large landmark trial proves that procalcitonin-guided care reduces unnecessary antibiotic courses in critical care patients with assumed or proven infection and thereby improves patient outcomes, namely overall survival."

Dr. Schuetz, of the University of Basel, Switzerland, concluded, "We should now adapt our guidelines and start to (adopt) more widespread use of procalcitonin protocols in clinical practice to slow emergence of bacterial resistance and improve sepsis care."

NEW YORK (Reuters Health) - Use of the marker procalcitonin to guide antibacterial therapy in the critically ill is associated with shorter treatment and reduced mortality, according to Dutch researchers.

As Dr. Evelien de Jong told Reuters Health by email, "Antibiotic overconsumption is one of the largest threats to medicine in the near future. Our study is the largest randomized controlled trial of antibiotic reduction in intensive care units (ICUs) and will, hopefully, contribute to a more individualized antibiotic duration per patient and an overall reduction of antibiotic use."

In a February 29 online paper in the Lancet Infectious Diseases, Dr. de Jong, of VU University Medical Center, Amsterdam, and colleagues noted that a "drop in procalcitonin concentration might help (clinicians) to discontinue antibiotic use in a more timely fashion" than reliance on biomarkers such as C-reactive protein.

To investigate, the researchers studied 1,575 ICU patients who received antibiotics and were randomized to procalcitonin-guided antibiotic discontinuation or standard of care. Fifteen were excluded from the procalcitonin group and 14 were excluded from the standard care group.

"In the procalcitonin-guided group, a non-binding advice to discontinue antibiotics was provided if procalcitonin concentration had decreased by 80% or more of its peak value or to 0.5 ug/L or lower," the authors reported.

In all, 538 (71%) of 761 patients in the procalcitonin-guided group and 457 (58%) of 785 patients in the standard-of-care group completed their antibiotic treatment in the ICU.

Median consumption of antibiotics was 7.5 daily defined doses in the procalcitonin group, significantly less than the 9.3 daily defined doses in the standard-of-care group, for a mean group absolute difference of 2.69 (p<0.0001).

Median duration of treatment was also significantly shorter in the procalcitonin-guided group (five versus seven days), for a mean group absolute difference of 1.22 (p<0.0001).

Mortality at 28 days was also significantly less than in the standard-of-care group. This was 20% versus 27% in intention-to-treat analysis. At one year, corresponding per protocol proportions were 36% and 43%.

Overall, the researchers concluded, "Procalcitonin concentrations might help physicians in deciding whether or not the presumed infection is truly bacterial, leading to more adequate diagnosis and treatment, the cornerstones of antibiotic stewardship."

Commenting by email, Dr. Philipp Schuetz, coauthor of an accompanying editorial, told Reuters Health, "This well-done and large landmark trial proves that procalcitonin-guided care reduces unnecessary antibiotic courses in critical care patients with assumed or proven infection and thereby improves patient outcomes, namely overall survival."

Dr. Schuetz, of the University of Basel, Switzerland, concluded, "We should now adapt our guidelines and start to (adopt) more widespread use of procalcitonin protocols in clinical practice to slow emergence of bacterial resistance and improve sepsis care."

NEW YORK (Reuters Health) - Use of the marker procalcitonin to guide antibacterial therapy in the critically ill is associated with shorter treatment and reduced mortality, according to Dutch researchers.

As Dr. Evelien de Jong told Reuters Health by email, "Antibiotic overconsumption is one of the largest threats to medicine in the near future. Our study is the largest randomized controlled trial of antibiotic reduction in intensive care units (ICUs) and will, hopefully, contribute to a more individualized antibiotic duration per patient and an overall reduction of antibiotic use."

In a February 29 online paper in the Lancet Infectious Diseases, Dr. de Jong, of VU University Medical Center, Amsterdam, and colleagues noted that a "drop in procalcitonin concentration might help (clinicians) to discontinue antibiotic use in a more timely fashion" than reliance on biomarkers such as C-reactive protein.

To investigate, the researchers studied 1,575 ICU patients who received antibiotics and were randomized to procalcitonin-guided antibiotic discontinuation or standard of care. Fifteen were excluded from the procalcitonin group and 14 were excluded from the standard care group.

"In the procalcitonin-guided group, a non-binding advice to discontinue antibiotics was provided if procalcitonin concentration had decreased by 80% or more of its peak value or to 0.5 ug/L or lower," the authors reported.

In all, 538 (71%) of 761 patients in the procalcitonin-guided group and 457 (58%) of 785 patients in the standard-of-care group completed their antibiotic treatment in the ICU.

Median consumption of antibiotics was 7.5 daily defined doses in the procalcitonin group, significantly less than the 9.3 daily defined doses in the standard-of-care group, for a mean group absolute difference of 2.69 (p<0.0001).

Median duration of treatment was also significantly shorter in the procalcitonin-guided group (five versus seven days), for a mean group absolute difference of 1.22 (p<0.0001).

Mortality at 28 days was also significantly less than in the standard-of-care group. This was 20% versus 27% in intention-to-treat analysis. At one year, corresponding per protocol proportions were 36% and 43%.

Overall, the researchers concluded, "Procalcitonin concentrations might help physicians in deciding whether or not the presumed infection is truly bacterial, leading to more adequate diagnosis and treatment, the cornerstones of antibiotic stewardship."

Commenting by email, Dr. Philipp Schuetz, coauthor of an accompanying editorial, told Reuters Health, "This well-done and large landmark trial proves that procalcitonin-guided care reduces unnecessary antibiotic courses in critical care patients with assumed or proven infection and thereby improves patient outcomes, namely overall survival."

Dr. Schuetz, of the University of Basel, Switzerland, concluded, "We should now adapt our guidelines and start to (adopt) more widespread use of procalcitonin protocols in clinical practice to slow emergence of bacterial resistance and improve sepsis care."

NEW YORK (Reuters Health) - Certain older patients on warfarin therapy are at greater risk than others for traumatic intracranial bleeding, Veterans Affairs researchers have reported.

In their study of elderly adults receiving warfarin for atrial fibrillation (AF), five factors - dementia, anemia, depression, anticonvulsant use, and labile international normalized ratio - each made patients more vulnerable to traumatic intracranial bleeding.

"Advanced age is a powerful risk factor for thromboembolic stroke in patients with AF, and oral anticoagulation reduces this risk by almost two-thirds in patients at risk," the authors wrote. "However, up to half of the eligible older adults with AF are not treated with anticoagulant therapy due to health care professionals' concerns about potential treatment-related harms."

The research team reviewed medical and administrative data for 31,951 U.S. veterans with AF. Patients were 75 or older andwere newly referred to an anticoagulation clinic for warfarin therapy. Most had comorbidities, including hypertension (82.5%), coronary artery disease (42.6%) and diabetes (33.8%).

During the 11-year study period, 2002 through 2012, the incidence rate of hospitalization for traumatic intracranial bleeding was 4.80 per 1,000 person-years. The incidence rates for any intracranial bleeding and ischemic stroke were 14.58 and 13.44, respectively, per 1,000 person-years, the researchers reported online March 9 in JAMA Cardiology.

After adjusting for age, sex, race/ethnicity, and common comorbidities, significant predictors for traumatic intracranial bleeding were dementia (hazard ratio 1.76, p<0.01), anemia (HR 1.23, p<0.05), depression (HR 1.30, p<0.05), anticonvulsant use (HR 1.35, p<0.05), and labile international normalized ratio (HR 1.33, p<0.05).

"The differential risk between traumatic intracranial bleeding and ischemic stroke for those on warfarin therapy was lower than in prior studies, although the rate of ischemic stroke in our population was still considerable," senior author Dr. John Dodson, director of the Geriatric Cardiology Program at New York University School of Medicine, New York City, told Reuters Health by email.

"Of note, the most commonly used stroke risk score, CHA2S2-VASc, does a poor job of predicting risk for traumatic intracranial bleeding," he added. "Therefore, the risk factors appear to be distinct."

"For the practicing clinician, I think our findings underscore the need for a personalized approach to patients, potentially incorporating the risk factors we identified for traumatic intracranial bleeding in conversations around the risk versus benefit of warfarin therapy," Dr. Dodson said.

Dr. Dodson further noted that several oral anticoagulants have been approved in recent years that don't require the dose adjustment and monitoring needed with warfarin. "When we began this study, these drugs were very new and we therefore did not have a sufficient length of observation to generate a large enough sample of patients taking these medications."

"There are also implantable devices that have recently been approved that exclude the left atrial appendage, which is where most cerebroembolic phenomena originate from the circulation. We cannot comment on the relative harms of either of these strategies compared with warfarin in our data set," he acknowledged."

The final option would be to not treat - that is, taking a conservative approach with no medications or procedure - in a patient at particularly high risk for treatment-related harms, if this is concordant with the patient's own preferences," he concluded.

Dr. Vivek Reddy, director of Cardiac Arrhythmia Services at the Mount Sinai Health System and professor of medicine at the Icahn School of Medicine at Mount Sinai in New York City, also noted that clinicians have alternatives to warfarin. "We now have new oral anticoagulants (dabigatran, rivaroxaban, apixaban and edoxaban), but since they are also anticoagulants, it is unknown if the risk of traumatic bleeding would be lower in these patients," he told Reuters Health by email.

Of the mechanical left atrial appendage closure device, Dr. Reddy, who was not involved in the study, stated, "the data is quite compelling for patients that are not good candidates for oral anticoagulation - and the elderly population seems to be a population that would particularly benefit."

Dr. Reddy also pointed out, as did the authors, that the findings may not be applicable to women because 98% of those studied were men. He also observed that "virtually all (participants) were Caucasian, so it's not known if there would be differences for other ethnicities."

The National Institutes of Health and a number of other organizations supported this research. One coauthor reported disclosures.

NEW YORK (Reuters Health) - Certain older patients on warfarin therapy are at greater risk than others for traumatic intracranial bleeding, Veterans Affairs researchers have reported.

In their study of elderly adults receiving warfarin for atrial fibrillation (AF), five factors - dementia, anemia, depression, anticonvulsant use, and labile international normalized ratio - each made patients more vulnerable to traumatic intracranial bleeding.

"Advanced age is a powerful risk factor for thromboembolic stroke in patients with AF, and oral anticoagulation reduces this risk by almost two-thirds in patients at risk," the authors wrote. "However, up to half of the eligible older adults with AF are not treated with anticoagulant therapy due to health care professionals' concerns about potential treatment-related harms."

The research team reviewed medical and administrative data for 31,951 U.S. veterans with AF. Patients were 75 or older andwere newly referred to an anticoagulation clinic for warfarin therapy. Most had comorbidities, including hypertension (82.5%), coronary artery disease (42.6%) and diabetes (33.8%).

During the 11-year study period, 2002 through 2012, the incidence rate of hospitalization for traumatic intracranial bleeding was 4.80 per 1,000 person-years. The incidence rates for any intracranial bleeding and ischemic stroke were 14.58 and 13.44, respectively, per 1,000 person-years, the researchers reported online March 9 in JAMA Cardiology.

After adjusting for age, sex, race/ethnicity, and common comorbidities, significant predictors for traumatic intracranial bleeding were dementia (hazard ratio 1.76, p<0.01), anemia (HR 1.23, p<0.05), depression (HR 1.30, p<0.05), anticonvulsant use (HR 1.35, p<0.05), and labile international normalized ratio (HR 1.33, p<0.05).

"The differential risk between traumatic intracranial bleeding and ischemic stroke for those on warfarin therapy was lower than in prior studies, although the rate of ischemic stroke in our population was still considerable," senior author Dr. John Dodson, director of the Geriatric Cardiology Program at New York University School of Medicine, New York City, told Reuters Health by email.

"Of note, the most commonly used stroke risk score, CHA2S2-VASc, does a poor job of predicting risk for traumatic intracranial bleeding," he added. "Therefore, the risk factors appear to be distinct."

"For the practicing clinician, I think our findings underscore the need for a personalized approach to patients, potentially incorporating the risk factors we identified for traumatic intracranial bleeding in conversations around the risk versus benefit of warfarin therapy," Dr. Dodson said.

Dr. Dodson further noted that several oral anticoagulants have been approved in recent years that don't require the dose adjustment and monitoring needed with warfarin. "When we began this study, these drugs were very new and we therefore did not have a sufficient length of observation to generate a large enough sample of patients taking these medications."

"There are also implantable devices that have recently been approved that exclude the left atrial appendage, which is where most cerebroembolic phenomena originate from the circulation. We cannot comment on the relative harms of either of these strategies compared with warfarin in our data set," he acknowledged."

The final option would be to not treat - that is, taking a conservative approach with no medications or procedure - in a patient at particularly high risk for treatment-related harms, if this is concordant with the patient's own preferences," he concluded.

Dr. Vivek Reddy, director of Cardiac Arrhythmia Services at the Mount Sinai Health System and professor of medicine at the Icahn School of Medicine at Mount Sinai in New York City, also noted that clinicians have alternatives to warfarin. "We now have new oral anticoagulants (dabigatran, rivaroxaban, apixaban and edoxaban), but since they are also anticoagulants, it is unknown if the risk of traumatic bleeding would be lower in these patients," he told Reuters Health by email.

Of the mechanical left atrial appendage closure device, Dr. Reddy, who was not involved in the study, stated, "the data is quite compelling for patients that are not good candidates for oral anticoagulation - and the elderly population seems to be a population that would particularly benefit."

Dr. Reddy also pointed out, as did the authors, that the findings may not be applicable to women because 98% of those studied were men. He also observed that "virtually all (participants) were Caucasian, so it's not known if there would be differences for other ethnicities."

The National Institutes of Health and a number of other organizations supported this research. One coauthor reported disclosures.

NEW YORK (Reuters Health) - Certain older patients on warfarin therapy are at greater risk than others for traumatic intracranial bleeding, Veterans Affairs researchers have reported.

In their study of elderly adults receiving warfarin for atrial fibrillation (AF), five factors - dementia, anemia, depression, anticonvulsant use, and labile international normalized ratio - each made patients more vulnerable to traumatic intracranial bleeding.

"Advanced age is a powerful risk factor for thromboembolic stroke in patients with AF, and oral anticoagulation reduces this risk by almost two-thirds in patients at risk," the authors wrote. "However, up to half of the eligible older adults with AF are not treated with anticoagulant therapy due to health care professionals' concerns about potential treatment-related harms."

The research team reviewed medical and administrative data for 31,951 U.S. veterans with AF. Patients were 75 or older andwere newly referred to an anticoagulation clinic for warfarin therapy. Most had comorbidities, including hypertension (82.5%), coronary artery disease (42.6%) and diabetes (33.8%).

During the 11-year study period, 2002 through 2012, the incidence rate of hospitalization for traumatic intracranial bleeding was 4.80 per 1,000 person-years. The incidence rates for any intracranial bleeding and ischemic stroke were 14.58 and 13.44, respectively, per 1,000 person-years, the researchers reported online March 9 in JAMA Cardiology.

After adjusting for age, sex, race/ethnicity, and common comorbidities, significant predictors for traumatic intracranial bleeding were dementia (hazard ratio 1.76, p<0.01), anemia (HR 1.23, p<0.05), depression (HR 1.30, p<0.05), anticonvulsant use (HR 1.35, p<0.05), and labile international normalized ratio (HR 1.33, p<0.05).

"The differential risk between traumatic intracranial bleeding and ischemic stroke for those on warfarin therapy was lower than in prior studies, although the rate of ischemic stroke in our population was still considerable," senior author Dr. John Dodson, director of the Geriatric Cardiology Program at New York University School of Medicine, New York City, told Reuters Health by email.

"Of note, the most commonly used stroke risk score, CHA2S2-VASc, does a poor job of predicting risk for traumatic intracranial bleeding," he added. "Therefore, the risk factors appear to be distinct."

"For the practicing clinician, I think our findings underscore the need for a personalized approach to patients, potentially incorporating the risk factors we identified for traumatic intracranial bleeding in conversations around the risk versus benefit of warfarin therapy," Dr. Dodson said.

Dr. Dodson further noted that several oral anticoagulants have been approved in recent years that don't require the dose adjustment and monitoring needed with warfarin. "When we began this study, these drugs were very new and we therefore did not have a sufficient length of observation to generate a large enough sample of patients taking these medications."

"There are also implantable devices that have recently been approved that exclude the left atrial appendage, which is where most cerebroembolic phenomena originate from the circulation. We cannot comment on the relative harms of either of these strategies compared with warfarin in our data set," he acknowledged."

The final option would be to not treat - that is, taking a conservative approach with no medications or procedure - in a patient at particularly high risk for treatment-related harms, if this is concordant with the patient's own preferences," he concluded.

Dr. Vivek Reddy, director of Cardiac Arrhythmia Services at the Mount Sinai Health System and professor of medicine at the Icahn School of Medicine at Mount Sinai in New York City, also noted that clinicians have alternatives to warfarin. "We now have new oral anticoagulants (dabigatran, rivaroxaban, apixaban and edoxaban), but since they are also anticoagulants, it is unknown if the risk of traumatic bleeding would be lower in these patients," he told Reuters Health by email.

Of the mechanical left atrial appendage closure device, Dr. Reddy, who was not involved in the study, stated, "the data is quite compelling for patients that are not good candidates for oral anticoagulation - and the elderly population seems to be a population that would particularly benefit."

Dr. Reddy also pointed out, as did the authors, that the findings may not be applicable to women because 98% of those studied were men. He also observed that "virtually all (participants) were Caucasian, so it's not known if there would be differences for other ethnicities."

The National Institutes of Health and a number of other organizations supported this research. One coauthor reported disclosures.

NEW YORK (Reuters Health) - Receiving the seasonal flu vaccine while in the hospital does not increase surgical patients' health care utilization or their likelihood of being evaluated for infection after discharge, according to a new retrospective cohort study.

The Advisory Committee on Immunization Practices recommends that hospitalized patients who are eligible for the flu vaccine receive it before discharge, but rates of vaccination remain low in surgical patients, Dr. Sara Tartof of Kaiser Permanente Southern California in Pasadena and her colleagues note in their report, published online March 14 in the Annals of Internal Medicine.

This could be due to surgeons' concerns that adverse effects of influenza vaccine such as myalgia or fever could be attributed to surgical complications, or could complicate post-surgical care, they add.

"When we searched in the literature, we really just couldn't find any data that really speak to this question," Dr. Tartof told Reuters Health in a telephone interview.

She and her colleagues looked at Kaiser Permanente Southern California patients aged six months or older who had inpatient surgery between September 2010 and March 2013. Of the 42,777 surgeries in their analysis, 6,420 included seasonal flu vaccination during hospitalization.

The researchers found no differences between the vaccinated and unvaccinated groups in the risk of inpatient visits,emergency department visits, post-discharge fever, or clinical evaluation for infection. There was a marginal increase in the risk of outpatient visits (relative risk 1.05, p=0.032).

"We feel that the benefits of vaccination outweigh this risk," Dr. Tartof said. "For high-risk patients, this is a health care contact, this is an opportunity to vaccinate, and we don't want to miss those."

Many patients in the study who were vaccinated against the flu received the shot when they were discharged, the researcher noted. "This may be a more comfortable time for patients and for their clinicians to vaccinate," she said.

Dr. Tartof and her colleagues are now planning to repeat the study in a larger population of nonsurgical inpatients, including children.

The Centers for Disease Control and Prevention funded this research. Five coauthors reported disclosures.

NEW YORK (Reuters Health) - Receiving the seasonal flu vaccine while in the hospital does not increase surgical patients' health care utilization or their likelihood of being evaluated for infection after discharge, according to a new retrospective cohort study.

The Advisory Committee on Immunization Practices recommends that hospitalized patients who are eligible for the flu vaccine receive it before discharge, but rates of vaccination remain low in surgical patients, Dr. Sara Tartof of Kaiser Permanente Southern California in Pasadena and her colleagues note in their report, published online March 14 in the Annals of Internal Medicine.

This could be due to surgeons' concerns that adverse effects of influenza vaccine such as myalgia or fever could be attributed to surgical complications, or could complicate post-surgical care, they add.

"When we searched in the literature, we really just couldn't find any data that really speak to this question," Dr. Tartof told Reuters Health in a telephone interview.

She and her colleagues looked at Kaiser Permanente Southern California patients aged six months or older who had inpatient surgery between September 2010 and March 2013. Of the 42,777 surgeries in their analysis, 6,420 included seasonal flu vaccination during hospitalization.

The researchers found no differences between the vaccinated and unvaccinated groups in the risk of inpatient visits,emergency department visits, post-discharge fever, or clinical evaluation for infection. There was a marginal increase in the risk of outpatient visits (relative risk 1.05, p=0.032).

"We feel that the benefits of vaccination outweigh this risk," Dr. Tartof said. "For high-risk patients, this is a health care contact, this is an opportunity to vaccinate, and we don't want to miss those."

Many patients in the study who were vaccinated against the flu received the shot when they were discharged, the researcher noted. "This may be a more comfortable time for patients and for their clinicians to vaccinate," she said.

Dr. Tartof and her colleagues are now planning to repeat the study in a larger population of nonsurgical inpatients, including children.

The Centers for Disease Control and Prevention funded this research. Five coauthors reported disclosures.

NEW YORK (Reuters Health) - Receiving the seasonal flu vaccine while in the hospital does not increase surgical patients' health care utilization or their likelihood of being evaluated for infection after discharge, according to a new retrospective cohort study.

The Advisory Committee on Immunization Practices recommends that hospitalized patients who are eligible for the flu vaccine receive it before discharge, but rates of vaccination remain low in surgical patients, Dr. Sara Tartof of Kaiser Permanente Southern California in Pasadena and her colleagues note in their report, published online March 14 in the Annals of Internal Medicine.

This could be due to surgeons' concerns that adverse effects of influenza vaccine such as myalgia or fever could be attributed to surgical complications, or could complicate post-surgical care, they add.

"When we searched in the literature, we really just couldn't find any data that really speak to this question," Dr. Tartof told Reuters Health in a telephone interview.

She and her colleagues looked at Kaiser Permanente Southern California patients aged six months or older who had inpatient surgery between September 2010 and March 2013. Of the 42,777 surgeries in their analysis, 6,420 included seasonal flu vaccination during hospitalization.

The researchers found no differences between the vaccinated and unvaccinated groups in the risk of inpatient visits,emergency department visits, post-discharge fever, or clinical evaluation for infection. There was a marginal increase in the risk of outpatient visits (relative risk 1.05, p=0.032).

"We feel that the benefits of vaccination outweigh this risk," Dr. Tartof said. "For high-risk patients, this is a health care contact, this is an opportunity to vaccinate, and we don't want to miss those."

Many patients in the study who were vaccinated against the flu received the shot when they were discharged, the researcher noted. "This may be a more comfortable time for patients and for their clinicians to vaccinate," she said.

Dr. Tartof and her colleagues are now planning to repeat the study in a larger population of nonsurgical inpatients, including children.

The Centers for Disease Control and Prevention funded this research. Five coauthors reported disclosures.

NEW YORK (Reuters Health) - The Sepsis Definitions Task Force, using expanded quantitative information, has updated its definitions for sepsis and septic shock and the clinical criteria underlying them.

Two reports and one summary communication published in JAMA February 23 detail the processes used to reach the consensus

definitions that have remained largely unchanged for more than two decades.

"The new definitions and clinical criteria of sepsis and septic shock are aimed to help clinicians at the bedside recognize these deadly syndromes and start therapy promptly," Dr. Christopher W. Seymour, from the University of Pittsburgh School of Medicine in Pennsylvania, told Reuters Health by email.

"After two years of deliberations and research, we were surprised to uncover the broad differences in how clinicians approach sepsis, and variety of criteria used in septic shock trials in the past decade. This mandated a re-examination of the criteria, strong efforts to speak a common language, and generate simple, easy to use criteria," Dr. Seymour said.

Dr. Seymour and colleagues recommended elimination of the terms sepsis syndrome, septicemia, and severe sepsis and settled on the definition of sepsis as "life-threatening organ dysfunction due to a dysregulated host response to infection."

They explored several sets of clinical criteria and their predictive validity for hospital mortality, including the Sequential Organ Function Assessment (SOFA), Logistic Organ Dysfunction System (LODS), systemic inflammatory response syndrome (SIRS), and a simplified qSOFA model that included Glasgow Coma Scale (GCS) score of 13 or less, systolic blood pressure of 100 mm Hg or less, and respiratory rate of 22/min or more (1 point each; score range, 0-3).

For intensive care unit encounters with suspected infection, SOFA came out on top, whereas for encounters with suspected infection outside of the ICU, qSOFA offered the best predictive validity for in-hospital mortality.

"Sepsis has no gold standard for diagnosis," Dr. Seymour said. "Given its complex pathophysiology and our evolving knowledge base, the current definition and criteria for sepsis represent a first step. Our field will need to continue to embark on improvements in the practicality, validity, and scientific rationale for sepsis definitions/criteria in future iterations."

He added,"We also hope that physicians recognize that, for the first time, these criteria derive from new data analyses in real patients. More than 700,000 encounters in 170 hospitals were studied to evaluate existing and new sepsis criteria."

Dr. Manu Shankar-Hari, from Guy's and St. Thomas' NHS Foundation Trust, London, UK, and colleagues reviewed 44 studies of septic shock involving 166,479 patients and used a Delphi process to arrive at the new consensus definition: "septic shock is defined as a subset of sepsis in which underlying circulatory, cellular, and metabolic abnormalities are associated with a greater risk of mortality than sepsis alone."

Dr. Shankar-Hari told Reuters Health by email, "The proposed definition for septic shock is a paradigm shift in illness concept. We wanted to provide consistency in diagnosing septic shock. The epidemiology of this illness as we measure currently is messy."

After examining six possible sets of clinical criteria, the group identified two criteria that proved most consistent with the proposed septic shock definition: hypotension requiring use of vasopressors to maintain mean blood pressure of 65 mm Hg or greater and having a serum lactate level greater than 2 mmol/L persisting after adequate fluid resuscitation.

In their summary report, Dr. Clifford S. Deutschman, from Hofstra-Northwell School of Medicine, Feinstein Institute for Medical Research, New Hyde Park, New York, and colleagues on the Task Force write, "The proposed criteria should aid diagnostic categorization once initial assessment and immediate management are completed. qSOFA or SOFA may at some point be used as entry criteria for clinical trials."

"Greater clarity and consistency will also facilitate research and more accurate coding," they add.

Dr. Edward Abraham, from Wake Forest School of Medicine, Winston Salem, North Carolina, who wrote an editorial related to these reports, told Reuters Health by email, "While the new definitions advance the field, particularly from an epidemiologic viewpoint and potentially in helping to identify the economic impact associated with sepsis and septic shock, they are only of limited help in defining care for an individual patient or in designing clinical trials to examine new therapies for sepsis."

"As noted in the editorial, more discriminatory definitions, based on specific cellular and genomic alterations, are necessary to truly affect care for individual patients and to assist in the development of novel therapeutic approaches to sepsis and septic shock," he said.

A number of organizations supported this research and a number of coauthors reported disclosures.

NEW YORK (Reuters Health) - The Sepsis Definitions Task Force, using expanded quantitative information, has updated its definitions for sepsis and septic shock and the clinical criteria underlying them.

Two reports and one summary communication published in JAMA February 23 detail the processes used to reach the consensus

definitions that have remained largely unchanged for more than two decades.

"The new definitions and clinical criteria of sepsis and septic shock are aimed to help clinicians at the bedside recognize these deadly syndromes and start therapy promptly," Dr. Christopher W. Seymour, from the University of Pittsburgh School of Medicine in Pennsylvania, told Reuters Health by email.

"After two years of deliberations and research, we were surprised to uncover the broad differences in how clinicians approach sepsis, and variety of criteria used in septic shock trials in the past decade. This mandated a re-examination of the criteria, strong efforts to speak a common language, and generate simple, easy to use criteria," Dr. Seymour said.

Dr. Seymour and colleagues recommended elimination of the terms sepsis syndrome, septicemia, and severe sepsis and settled on the definition of sepsis as "life-threatening organ dysfunction due to a dysregulated host response to infection."

They explored several sets of clinical criteria and their predictive validity for hospital mortality, including the Sequential Organ Function Assessment (SOFA), Logistic Organ Dysfunction System (LODS), systemic inflammatory response syndrome (SIRS), and a simplified qSOFA model that included Glasgow Coma Scale (GCS) score of 13 or less, systolic blood pressure of 100 mm Hg or less, and respiratory rate of 22/min or more (1 point each; score range, 0-3).

For intensive care unit encounters with suspected infection, SOFA came out on top, whereas for encounters with suspected infection outside of the ICU, qSOFA offered the best predictive validity for in-hospital mortality.

"Sepsis has no gold standard for diagnosis," Dr. Seymour said. "Given its complex pathophysiology and our evolving knowledge base, the current definition and criteria for sepsis represent a first step. Our field will need to continue to embark on improvements in the practicality, validity, and scientific rationale for sepsis definitions/criteria in future iterations."

He added,"We also hope that physicians recognize that, for the first time, these criteria derive from new data analyses in real patients. More than 700,000 encounters in 170 hospitals were studied to evaluate existing and new sepsis criteria."

Dr. Manu Shankar-Hari, from Guy's and St. Thomas' NHS Foundation Trust, London, UK, and colleagues reviewed 44 studies of septic shock involving 166,479 patients and used a Delphi process to arrive at the new consensus definition: "septic shock is defined as a subset of sepsis in which underlying circulatory, cellular, and metabolic abnormalities are associated with a greater risk of mortality than sepsis alone."

Dr. Shankar-Hari told Reuters Health by email, "The proposed definition for septic shock is a paradigm shift in illness concept. We wanted to provide consistency in diagnosing septic shock. The epidemiology of this illness as we measure currently is messy."

After examining six possible sets of clinical criteria, the group identified two criteria that proved most consistent with the proposed septic shock definition: hypotension requiring use of vasopressors to maintain mean blood pressure of 65 mm Hg or greater and having a serum lactate level greater than 2 mmol/L persisting after adequate fluid resuscitation.

In their summary report, Dr. Clifford S. Deutschman, from Hofstra-Northwell School of Medicine, Feinstein Institute for Medical Research, New Hyde Park, New York, and colleagues on the Task Force write, "The proposed criteria should aid diagnostic categorization once initial assessment and immediate management are completed. qSOFA or SOFA may at some point be used as entry criteria for clinical trials."

"Greater clarity and consistency will also facilitate research and more accurate coding," they add.

Dr. Edward Abraham, from Wake Forest School of Medicine, Winston Salem, North Carolina, who wrote an editorial related to these reports, told Reuters Health by email, "While the new definitions advance the field, particularly from an epidemiologic viewpoint and potentially in helping to identify the economic impact associated with sepsis and septic shock, they are only of limited help in defining care for an individual patient or in designing clinical trials to examine new therapies for sepsis."

"As noted in the editorial, more discriminatory definitions, based on specific cellular and genomic alterations, are necessary to truly affect care for individual patients and to assist in the development of novel therapeutic approaches to sepsis and septic shock," he said.

A number of organizations supported this research and a number of coauthors reported disclosures.

NEW YORK (Reuters Health) - The Sepsis Definitions Task Force, using expanded quantitative information, has updated its definitions for sepsis and septic shock and the clinical criteria underlying them.

Two reports and one summary communication published in JAMA February 23 detail the processes used to reach the consensus

definitions that have remained largely unchanged for more than two decades.

"The new definitions and clinical criteria of sepsis and septic shock are aimed to help clinicians at the bedside recognize these deadly syndromes and start therapy promptly," Dr. Christopher W. Seymour, from the University of Pittsburgh School of Medicine in Pennsylvania, told Reuters Health by email.

"After two years of deliberations and research, we were surprised to uncover the broad differences in how clinicians approach sepsis, and variety of criteria used in septic shock trials in the past decade. This mandated a re-examination of the criteria, strong efforts to speak a common language, and generate simple, easy to use criteria," Dr. Seymour said.

Dr. Seymour and colleagues recommended elimination of the terms sepsis syndrome, septicemia, and severe sepsis and settled on the definition of sepsis as "life-threatening organ dysfunction due to a dysregulated host response to infection."

They explored several sets of clinical criteria and their predictive validity for hospital mortality, including the Sequential Organ Function Assessment (SOFA), Logistic Organ Dysfunction System (LODS), systemic inflammatory response syndrome (SIRS), and a simplified qSOFA model that included Glasgow Coma Scale (GCS) score of 13 or less, systolic blood pressure of 100 mm Hg or less, and respiratory rate of 22/min or more (1 point each; score range, 0-3).

For intensive care unit encounters with suspected infection, SOFA came out on top, whereas for encounters with suspected infection outside of the ICU, qSOFA offered the best predictive validity for in-hospital mortality.

"Sepsis has no gold standard for diagnosis," Dr. Seymour said. "Given its complex pathophysiology and our evolving knowledge base, the current definition and criteria for sepsis represent a first step. Our field will need to continue to embark on improvements in the practicality, validity, and scientific rationale for sepsis definitions/criteria in future iterations."

He added,"We also hope that physicians recognize that, for the first time, these criteria derive from new data analyses in real patients. More than 700,000 encounters in 170 hospitals were studied to evaluate existing and new sepsis criteria."

Dr. Manu Shankar-Hari, from Guy's and St. Thomas' NHS Foundation Trust, London, UK, and colleagues reviewed 44 studies of septic shock involving 166,479 patients and used a Delphi process to arrive at the new consensus definition: "septic shock is defined as a subset of sepsis in which underlying circulatory, cellular, and metabolic abnormalities are associated with a greater risk of mortality than sepsis alone."

Dr. Shankar-Hari told Reuters Health by email, "The proposed definition for septic shock is a paradigm shift in illness concept. We wanted to provide consistency in diagnosing septic shock. The epidemiology of this illness as we measure currently is messy."

After examining six possible sets of clinical criteria, the group identified two criteria that proved most consistent with the proposed septic shock definition: hypotension requiring use of vasopressors to maintain mean blood pressure of 65 mm Hg or greater and having a serum lactate level greater than 2 mmol/L persisting after adequate fluid resuscitation.

In their summary report, Dr. Clifford S. Deutschman, from Hofstra-Northwell School of Medicine, Feinstein Institute for Medical Research, New Hyde Park, New York, and colleagues on the Task Force write, "The proposed criteria should aid diagnostic categorization once initial assessment and immediate management are completed. qSOFA or SOFA may at some point be used as entry criteria for clinical trials."

"Greater clarity and consistency will also facilitate research and more accurate coding," they add.

Dr. Edward Abraham, from Wake Forest School of Medicine, Winston Salem, North Carolina, who wrote an editorial related to these reports, told Reuters Health by email, "While the new definitions advance the field, particularly from an epidemiologic viewpoint and potentially in helping to identify the economic impact associated with sepsis and septic shock, they are only of limited help in defining care for an individual patient or in designing clinical trials to examine new therapies for sepsis."

"As noted in the editorial, more discriminatory definitions, based on specific cellular and genomic alterations, are necessary to truly affect care for individual patients and to assist in the development of novel therapeutic approaches to sepsis and septic shock," he said.

A number of organizations supported this research and a number of coauthors reported disclosures.

NEW YORK (Reuters Health) - Cardiac resynchronization therapy (CRT) in patients with heart failure (HF) without left bundle branch block (LBBB) may not help and might even harm, according to an international group of investigators.

As Dr. Yitschak Biton told Reuters Health by email, "Our findings suggest that patients without LBBB electrocardiogram (ECG) morphology are not likely to benefit from CRT implantation and a subgroup of patients with short QRS duration might even be at higher risk for mortality."

In a January 28 online paper in Circulation: Heart Failure, Dr. Biton, of the University of Rochester Medical Center, New York, and colleagues note that the efficacy of CRT is well established in patients with both mild and moderate to severe HF symptoms. However, data on non-LBBB patients "are more limited and conflicting."

To investigate, the team examined data on 537 such patients with mild HF taking part in a larger study. At seven years, the cumulative probability of HF hospitalization or death was 45% in those randomized to an implantable cardioverter-defibrillator (ICD) and 56% in those given CRT with a defibrillator (CRT-D).

Multivariable-adjusted subgroup analysis by QRS duration showed that patients from the lower quartile (134 ms or less) had a 2.4-fold greater risk of HF hospitalization or death with CRT-D versus those with ICD-only therapy.

However, the effect of CRT-D in patients from the upper quartiles group (QRS greater than 134 ms) was neutral (hazard ratio 0.97).

In a further analysis based on PR interval, patients with prolonged QRS (more than 134 ms) and prolonged PR (at least 230 ms) were protected with CRT-D (HR 0.31). The association was neutral with prolonged QRS and shorter PR.

"Overall," the researchers conclude, "patients with mild HF but without left bundle branch block morphology did not derive clinical benefit with CRT-D during long-term follow-up. Relatively shorter QRS was associated with a significantly increased risk with CRT-D relative to implantable cardioverter-defibrillator only."

"This information should be taken into account when CRT therapy is considered in this subgroup of patients," Dr. Biton told Reuters Health.

Boston Scientific Corporation funded the clinical trial this research is based on. Five coauthors reported disclosures.

NEW YORK (Reuters Health) - Cardiac resynchronization therapy (CRT) in patients with heart failure (HF) without left bundle branch block (LBBB) may not help and might even harm, according to an international group of investigators.

As Dr. Yitschak Biton told Reuters Health by email, "Our findings suggest that patients without LBBB electrocardiogram (ECG) morphology are not likely to benefit from CRT implantation and a subgroup of patients with short QRS duration might even be at higher risk for mortality."

In a January 28 online paper in Circulation: Heart Failure, Dr. Biton, of the University of Rochester Medical Center, New York, and colleagues note that the efficacy of CRT is well established in patients with both mild and moderate to severe HF symptoms. However, data on non-LBBB patients "are more limited and conflicting."

To investigate, the team examined data on 537 such patients with mild HF taking part in a larger study. At seven years, the cumulative probability of HF hospitalization or death was 45% in those randomized to an implantable cardioverter-defibrillator (ICD) and 56% in those given CRT with a defibrillator (CRT-D).

Multivariable-adjusted subgroup analysis by QRS duration showed that patients from the lower quartile (134 ms or less) had a 2.4-fold greater risk of HF hospitalization or death with CRT-D versus those with ICD-only therapy.

However, the effect of CRT-D in patients from the upper quartiles group (QRS greater than 134 ms) was neutral (hazard ratio 0.97).

In a further analysis based on PR interval, patients with prolonged QRS (more than 134 ms) and prolonged PR (at least 230 ms) were protected with CRT-D (HR 0.31). The association was neutral with prolonged QRS and shorter PR.

"Overall," the researchers conclude, "patients with mild HF but without left bundle branch block morphology did not derive clinical benefit with CRT-D during long-term follow-up. Relatively shorter QRS was associated with a significantly increased risk with CRT-D relative to implantable cardioverter-defibrillator only."

"This information should be taken into account when CRT therapy is considered in this subgroup of patients," Dr. Biton told Reuters Health.

Boston Scientific Corporation funded the clinical trial this research is based on. Five coauthors reported disclosures.

NEW YORK (Reuters Health) - Cardiac resynchronization therapy (CRT) in patients with heart failure (HF) without left bundle branch block (LBBB) may not help and might even harm, according to an international group of investigators.

As Dr. Yitschak Biton told Reuters Health by email, "Our findings suggest that patients without LBBB electrocardiogram (ECG) morphology are not likely to benefit from CRT implantation and a subgroup of patients with short QRS duration might even be at higher risk for mortality."

In a January 28 online paper in Circulation: Heart Failure, Dr. Biton, of the University of Rochester Medical Center, New York, and colleagues note that the efficacy of CRT is well established in patients with both mild and moderate to severe HF symptoms. However, data on non-LBBB patients "are more limited and conflicting."

To investigate, the team examined data on 537 such patients with mild HF taking part in a larger study. At seven years, the cumulative probability of HF hospitalization or death was 45% in those randomized to an implantable cardioverter-defibrillator (ICD) and 56% in those given CRT with a defibrillator (CRT-D).

Multivariable-adjusted subgroup analysis by QRS duration showed that patients from the lower quartile (134 ms or less) had a 2.4-fold greater risk of HF hospitalization or death with CRT-D versus those with ICD-only therapy.

However, the effect of CRT-D in patients from the upper quartiles group (QRS greater than 134 ms) was neutral (hazard ratio 0.97).

In a further analysis based on PR interval, patients with prolonged QRS (more than 134 ms) and prolonged PR (at least 230 ms) were protected with CRT-D (HR 0.31). The association was neutral with prolonged QRS and shorter PR.

"Overall," the researchers conclude, "patients with mild HF but without left bundle branch block morphology did not derive clinical benefit with CRT-D during long-term follow-up. Relatively shorter QRS was associated with a significantly increased risk with CRT-D relative to implantable cardioverter-defibrillator only."

"This information should be taken into account when CRT therapy is considered in this subgroup of patients," Dr. Biton told Reuters Health.

Boston Scientific Corporation funded the clinical trial this research is based on. Five coauthors reported disclosures.