Reuters Health

NEW YORK (Reuters Health) - The "vast majority" of elderly patients admitted with small bowel obstruction (SBO) are hospitalized for more than two days, and the diagnosis alone should allow appropriate Medicare coverage, according to a new study.

In a paper online July 1 in Annals of Surgery, Dr. Zara Cooper, of Brigham and Women's Hospital, Boston, and colleagues noted that their study was prompted by the Two-Midnight Rule established by the Centers for Medicare & Medicaid Services (CMS) in 2013.

The authors explained that if a physician expects a patient to need a hospital stay that crosses two midnights and thus admits the patient, related costs may be covered. However, shorter stays are deemed as observational and can raise the possibility of non-reimbursement for hospitals.

For example, if someone is admitted as an inpatient, but discharged in less than two days, payment will be made only if it can be documented that a longer stay was reasonably expected and unforeseen circumstances led to the shorter stay. Hospital stays that are incorrectly classified or have improperly documented changes in admission status will not be paid.

However, Dr. Cooper told Reuters Health by email, "Older patients with SBO, a very common diagnosis, should be presumed to be admitted for more than two midnights and hospitals should not get penalized."

She and her colleagues pointed out that SBO accounts for about 15% of surgical admissions to U.S. hospitals and more than $1 billion in annual hospital charges. However, diagnosis requires surgeons to observe patients to determine if surgery is warranted.

Thus, the authors wrote, "It is critically important for surgeons to correctly assign admission status for patients with SBO to ensure that hospitals are reimbursed appropriately, and patients are not unduly burdened."

The investigators examined data on 855 older patients admitted with SBO from 2006 and 2013. Of these, 816 (95%) stayed for two midnights or longer. This was true of all patients aged 85 years or older (n=108, approximately 13%).

The only significant difference in clinical characteristics was the presence of inflammatory bowel disease. Of five such patients, only one stayed for less than two midnights.

"Based on our study and others," the investigators wrote, "we propose that hospital admission for SBO in elderly patients is sufficient justification for the reasonable expectation" of the required length of stay for reimbursement.

This also may be true of other conditions. Dr. Cooper concluded, "More studies like this are needed in surgical patients to better understand the impact of CMS admission guidelines. The rule may not make sense in certain populations, leading to heavy and unfair penalties for hospitals."

The authors reported no disclosures.

NEW YORK (Reuters Health) - The "vast majority" of elderly patients admitted with small bowel obstruction (SBO) are hospitalized for more than two days, and the diagnosis alone should allow appropriate Medicare coverage, according to a new study.

In a paper online July 1 in Annals of Surgery, Dr. Zara Cooper, of Brigham and Women's Hospital, Boston, and colleagues noted that their study was prompted by the Two-Midnight Rule established by the Centers for Medicare & Medicaid Services (CMS) in 2013.

The authors explained that if a physician expects a patient to need a hospital stay that crosses two midnights and thus admits the patient, related costs may be covered. However, shorter stays are deemed as observational and can raise the possibility of non-reimbursement for hospitals.

For example, if someone is admitted as an inpatient, but discharged in less than two days, payment will be made only if it can be documented that a longer stay was reasonably expected and unforeseen circumstances led to the shorter stay. Hospital stays that are incorrectly classified or have improperly documented changes in admission status will not be paid.

However, Dr. Cooper told Reuters Health by email, "Older patients with SBO, a very common diagnosis, should be presumed to be admitted for more than two midnights and hospitals should not get penalized."

She and her colleagues pointed out that SBO accounts for about 15% of surgical admissions to U.S. hospitals and more than $1 billion in annual hospital charges. However, diagnosis requires surgeons to observe patients to determine if surgery is warranted.

Thus, the authors wrote, "It is critically important for surgeons to correctly assign admission status for patients with SBO to ensure that hospitals are reimbursed appropriately, and patients are not unduly burdened."

The investigators examined data on 855 older patients admitted with SBO from 2006 and 2013. Of these, 816 (95%) stayed for two midnights or longer. This was true of all patients aged 85 years or older (n=108, approximately 13%).

The only significant difference in clinical characteristics was the presence of inflammatory bowel disease. Of five such patients, only one stayed for less than two midnights.

"Based on our study and others," the investigators wrote, "we propose that hospital admission for SBO in elderly patients is sufficient justification for the reasonable expectation" of the required length of stay for reimbursement.

This also may be true of other conditions. Dr. Cooper concluded, "More studies like this are needed in surgical patients to better understand the impact of CMS admission guidelines. The rule may not make sense in certain populations, leading to heavy and unfair penalties for hospitals."

The authors reported no disclosures.

NEW YORK (Reuters Health) - The "vast majority" of elderly patients admitted with small bowel obstruction (SBO) are hospitalized for more than two days, and the diagnosis alone should allow appropriate Medicare coverage, according to a new study.

In a paper online July 1 in Annals of Surgery, Dr. Zara Cooper, of Brigham and Women's Hospital, Boston, and colleagues noted that their study was prompted by the Two-Midnight Rule established by the Centers for Medicare & Medicaid Services (CMS) in 2013.

The authors explained that if a physician expects a patient to need a hospital stay that crosses two midnights and thus admits the patient, related costs may be covered. However, shorter stays are deemed as observational and can raise the possibility of non-reimbursement for hospitals.

For example, if someone is admitted as an inpatient, but discharged in less than two days, payment will be made only if it can be documented that a longer stay was reasonably expected and unforeseen circumstances led to the shorter stay. Hospital stays that are incorrectly classified or have improperly documented changes in admission status will not be paid.

However, Dr. Cooper told Reuters Health by email, "Older patients with SBO, a very common diagnosis, should be presumed to be admitted for more than two midnights and hospitals should not get penalized."

She and her colleagues pointed out that SBO accounts for about 15% of surgical admissions to U.S. hospitals and more than $1 billion in annual hospital charges. However, diagnosis requires surgeons to observe patients to determine if surgery is warranted.

Thus, the authors wrote, "It is critically important for surgeons to correctly assign admission status for patients with SBO to ensure that hospitals are reimbursed appropriately, and patients are not unduly burdened."

The investigators examined data on 855 older patients admitted with SBO from 2006 and 2013. Of these, 816 (95%) stayed for two midnights or longer. This was true of all patients aged 85 years or older (n=108, approximately 13%).

The only significant difference in clinical characteristics was the presence of inflammatory bowel disease. Of five such patients, only one stayed for less than two midnights.

"Based on our study and others," the investigators wrote, "we propose that hospital admission for SBO in elderly patients is sufficient justification for the reasonable expectation" of the required length of stay for reimbursement.

This also may be true of other conditions. Dr. Cooper concluded, "More studies like this are needed in surgical patients to better understand the impact of CMS admission guidelines. The rule may not make sense in certain populations, leading to heavy and unfair penalties for hospitals."

The authors reported no disclosures.

NEW YORK (Reuters Health) - In certain circumstances one widely used test for vitamin D intoxication, the Diasorin radioimmunoassay, may not be entirely reliable, according to two case studies by U.S. and Irish investigators.

"Our study," Dr. Michael A. Levine told Reuters Health by email, "highlights the continuing challenge that we face when using current assay technologies to measure vitamin D metabolites." The patients involved "developed vitamin D toxicity from inadvertent overdosage using standard over-the-counter preparations of vitamin D."

In a June 22 online paper in the Journal of Clinical Endocrinology & Metabolism, Dr. Levine, of the University of Pennsylvania, Philadelphia, and colleagues note that vitamin D intoxication is characterized by elevated serum 25-hydroxyvitamin D (25(OH)D) and suppressed serum 1,25-dihydroxvitamin D (1,25(OH)2D).

The team used both the Diasorin radioimmunaossay test (RIA) and liquid chromatography and tandem mass spectrometry (LC-MS/MS) to evaluate samples from two retrospectively identified patients with hypercalcemia. One was a 15-year-old male with a two-week history of postprandial vomiting, abdominal pain and polyuria. The other, a 17-year old female, had a history of weight loss.

Both had elevated serum 1,25(OH)2D by RIA, but normal serum 1,25(OH)2D concentrations by LC-MS/MS. To help explain these surprising findings the team conducted further in vitro experiments on serum samples from a random set of inpatients and outpatients.

The team noted that concentrations of 25(OH)D2 or 25(OH)D3 increased as expected based on the amount of vitamin D metabolite added to pooled serum samples or artificial serum matrix in all experiments.

The addition of 100 ng/mL of 25(OH)D3 to pooled patient serum resulted in a median increase of 114% in measured 1,25(OH)D2 via RIA and a 21% increase via LC-MS/MS. At 700 ng/mL, the increase was 349% with RIA and 117% with LC-MS/MS.

Thus, wrote the researchers, "We recommend measurement of serum 24,25(OH)2D and use of LC-MS/MS, which appears less susceptible to this interference, to reassess serum levels of 1,25(OH)2D when the clinical scenario is confusing."

Summing up, Dr. Levine said, "Assessment of plasma levels of the most active vitamin D metabolite, 1,25(OH)2D, using a common laboratory immunoassay pointed away from nutritional vitamin D intoxication and suggested other more worrisome diagnoses. Repeating the testing with a mass spectrometer assay confirmed the clinical diagnosis of vitamin D intoxication."

He concluded, "Clinicians must remember that laboratory tests are not 100% reliable, and they must continue to rely upon their clinical judgment when confronted with test results that do not make sense."

Diasorin did not respond to a request for comment.

The authors reported no financial disclosures or competing interests.

NEW YORK (Reuters Health) - In certain circumstances one widely used test for vitamin D intoxication, the Diasorin radioimmunoassay, may not be entirely reliable, according to two case studies by U.S. and Irish investigators.

"Our study," Dr. Michael A. Levine told Reuters Health by email, "highlights the continuing challenge that we face when using current assay technologies to measure vitamin D metabolites." The patients involved "developed vitamin D toxicity from inadvertent overdosage using standard over-the-counter preparations of vitamin D."

In a June 22 online paper in the Journal of Clinical Endocrinology & Metabolism, Dr. Levine, of the University of Pennsylvania, Philadelphia, and colleagues note that vitamin D intoxication is characterized by elevated serum 25-hydroxyvitamin D (25(OH)D) and suppressed serum 1,25-dihydroxvitamin D (1,25(OH)2D).

The team used both the Diasorin radioimmunaossay test (RIA) and liquid chromatography and tandem mass spectrometry (LC-MS/MS) to evaluate samples from two retrospectively identified patients with hypercalcemia. One was a 15-year-old male with a two-week history of postprandial vomiting, abdominal pain and polyuria. The other, a 17-year old female, had a history of weight loss.

Both had elevated serum 1,25(OH)2D by RIA, but normal serum 1,25(OH)2D concentrations by LC-MS/MS. To help explain these surprising findings the team conducted further in vitro experiments on serum samples from a random set of inpatients and outpatients.

The team noted that concentrations of 25(OH)D2 or 25(OH)D3 increased as expected based on the amount of vitamin D metabolite added to pooled serum samples or artificial serum matrix in all experiments.

The addition of 100 ng/mL of 25(OH)D3 to pooled patient serum resulted in a median increase of 114% in measured 1,25(OH)D2 via RIA and a 21% increase via LC-MS/MS. At 700 ng/mL, the increase was 349% with RIA and 117% with LC-MS/MS.

Thus, wrote the researchers, "We recommend measurement of serum 24,25(OH)2D and use of LC-MS/MS, which appears less susceptible to this interference, to reassess serum levels of 1,25(OH)2D when the clinical scenario is confusing."

Summing up, Dr. Levine said, "Assessment of plasma levels of the most active vitamin D metabolite, 1,25(OH)2D, using a common laboratory immunoassay pointed away from nutritional vitamin D intoxication and suggested other more worrisome diagnoses. Repeating the testing with a mass spectrometer assay confirmed the clinical diagnosis of vitamin D intoxication."

He concluded, "Clinicians must remember that laboratory tests are not 100% reliable, and they must continue to rely upon their clinical judgment when confronted with test results that do not make sense."

Diasorin did not respond to a request for comment.

The authors reported no financial disclosures or competing interests.

NEW YORK (Reuters Health) - In certain circumstances one widely used test for vitamin D intoxication, the Diasorin radioimmunoassay, may not be entirely reliable, according to two case studies by U.S. and Irish investigators.

"Our study," Dr. Michael A. Levine told Reuters Health by email, "highlights the continuing challenge that we face when using current assay technologies to measure vitamin D metabolites." The patients involved "developed vitamin D toxicity from inadvertent overdosage using standard over-the-counter preparations of vitamin D."

In a June 22 online paper in the Journal of Clinical Endocrinology & Metabolism, Dr. Levine, of the University of Pennsylvania, Philadelphia, and colleagues note that vitamin D intoxication is characterized by elevated serum 25-hydroxyvitamin D (25(OH)D) and suppressed serum 1,25-dihydroxvitamin D (1,25(OH)2D).

The team used both the Diasorin radioimmunaossay test (RIA) and liquid chromatography and tandem mass spectrometry (LC-MS/MS) to evaluate samples from two retrospectively identified patients with hypercalcemia. One was a 15-year-old male with a two-week history of postprandial vomiting, abdominal pain and polyuria. The other, a 17-year old female, had a history of weight loss.

Both had elevated serum 1,25(OH)2D by RIA, but normal serum 1,25(OH)2D concentrations by LC-MS/MS. To help explain these surprising findings the team conducted further in vitro experiments on serum samples from a random set of inpatients and outpatients.

The team noted that concentrations of 25(OH)D2 or 25(OH)D3 increased as expected based on the amount of vitamin D metabolite added to pooled serum samples or artificial serum matrix in all experiments.

The addition of 100 ng/mL of 25(OH)D3 to pooled patient serum resulted in a median increase of 114% in measured 1,25(OH)D2 via RIA and a 21% increase via LC-MS/MS. At 700 ng/mL, the increase was 349% with RIA and 117% with LC-MS/MS.

Thus, wrote the researchers, "We recommend measurement of serum 24,25(OH)2D and use of LC-MS/MS, which appears less susceptible to this interference, to reassess serum levels of 1,25(OH)2D when the clinical scenario is confusing."

Summing up, Dr. Levine said, "Assessment of plasma levels of the most active vitamin D metabolite, 1,25(OH)2D, using a common laboratory immunoassay pointed away from nutritional vitamin D intoxication and suggested other more worrisome diagnoses. Repeating the testing with a mass spectrometer assay confirmed the clinical diagnosis of vitamin D intoxication."

He concluded, "Clinicians must remember that laboratory tests are not 100% reliable, and they must continue to rely upon their clinical judgment when confronted with test results that do not make sense."

Diasorin did not respond to a request for comment.

The authors reported no financial disclosures or competing interests.

Young adult cancer survivors will continue to have high hospitalization rates over time, a Canadian study shows.

In five-year cancer survivors diagnosed between ages 20 and 44, hospitalization rates were elevated for at least 20 years, compared to rates in age- and sex-matched controls, according to Dr. Nancy N. Baxter at St. Michael's Hospital in Toronto and colleagues.

For all malignancies except melanoma and testicular cancer, the adjusted relative rate (ARR) of hospitalizations was significantly higher among survivors than controls.

"Late effects and complications of cancer treatments are experienced by many survivors for the rest of their lives," Dr. Baxter told Reuters Health via e-mail. The patients in this population-based study were treated from 1992-1999. "Therapies have changed, she said. "In some cases there may be fewer late effects, but in others, they may be worse."

The study cohort included 20,275 survivors of young adult cancers who were recurrence-free for at least five years, and 101,344 controls. The authors observed survivors for a median of 9.93 years (range 0-16 years), according to their report online July 13 in the Journal of Clinical Oncology. During this period, 34.3% had at least one hospitalization,

vs. 27.3% for controls. The rate per 100 person-years was similar between male and female survivors.

Overall, the ARR of hospitalization in survivors compared with controls was 1.51. At all-time periods, survivors were more likely to be hospitalized than controls. The rate of hospitalization (per 100-person years) among survivors was 0.22 during years 5 to 8, 9 to11, and 12 to14. It decreased significantly during years 15 to 17 and 18 to 20, falling to 0.17 and 0.15, respectively (P<0.0001). Among controls, the hospitalization rate was relatively constant during all time periods, ranging from 0.13 at 5 to 8 years to 0.12 at years 18 to 20.

The ARR of hospitalizations in survivors compared with controls was also relatively constant during for the first three3 time periods: 1.67, 1.55, and 1.57 at years 5 to 8, 9 to

11, and 12 to 14, respectively. It decreased to 1.36 at 15 to 17 years and 1.22 at years 18 to 20. Those who survived gastrointestinal, urologic, colorectal, or brain cancers, or leukemia or lymphoma, had an ARR of hospitalization at least twice that of controls.

"We only looked at hospital admissions, not visits to the family doctor or medical conditions and disabilities that didn't require inpatient care," Dr. Baxter said, explaining that this likely underestimated the long-term impact of intense treatments that include surgery, chemotherapy, radiation, and hormonal therapy.

"Understanding the late effects of cancer treatment will help us design better treatments, counsel patients, and improve symptom management."

Young adult cancer survivors will continue to have high hospitalization rates over time, a Canadian study shows.

In five-year cancer survivors diagnosed between ages 20 and 44, hospitalization rates were elevated for at least 20 years, compared to rates in age- and sex-matched controls, according to Dr. Nancy N. Baxter at St. Michael's Hospital in Toronto and colleagues.

For all malignancies except melanoma and testicular cancer, the adjusted relative rate (ARR) of hospitalizations was significantly higher among survivors than controls.

"Late effects and complications of cancer treatments are experienced by many survivors for the rest of their lives," Dr. Baxter told Reuters Health via e-mail. The patients in this population-based study were treated from 1992-1999. "Therapies have changed, she said. "In some cases there may be fewer late effects, but in others, they may be worse."

The study cohort included 20,275 survivors of young adult cancers who were recurrence-free for at least five years, and 101,344 controls. The authors observed survivors for a median of 9.93 years (range 0-16 years), according to their report online July 13 in the Journal of Clinical Oncology. During this period, 34.3% had at least one hospitalization,

vs. 27.3% for controls. The rate per 100 person-years was similar between male and female survivors.

Overall, the ARR of hospitalization in survivors compared with controls was 1.51. At all-time periods, survivors were more likely to be hospitalized than controls. The rate of hospitalization (per 100-person years) among survivors was 0.22 during years 5 to 8, 9 to11, and 12 to14. It decreased significantly during years 15 to 17 and 18 to 20, falling to 0.17 and 0.15, respectively (P<0.0001). Among controls, the hospitalization rate was relatively constant during all time periods, ranging from 0.13 at 5 to 8 years to 0.12 at years 18 to 20.

The ARR of hospitalizations in survivors compared with controls was also relatively constant during for the first three3 time periods: 1.67, 1.55, and 1.57 at years 5 to 8, 9 to

11, and 12 to 14, respectively. It decreased to 1.36 at 15 to 17 years and 1.22 at years 18 to 20. Those who survived gastrointestinal, urologic, colorectal, or brain cancers, or leukemia or lymphoma, had an ARR of hospitalization at least twice that of controls.

"We only looked at hospital admissions, not visits to the family doctor or medical conditions and disabilities that didn't require inpatient care," Dr. Baxter said, explaining that this likely underestimated the long-term impact of intense treatments that include surgery, chemotherapy, radiation, and hormonal therapy.

"Understanding the late effects of cancer treatment will help us design better treatments, counsel patients, and improve symptom management."

Young adult cancer survivors will continue to have high hospitalization rates over time, a Canadian study shows.

In five-year cancer survivors diagnosed between ages 20 and 44, hospitalization rates were elevated for at least 20 years, compared to rates in age- and sex-matched controls, according to Dr. Nancy N. Baxter at St. Michael's Hospital in Toronto and colleagues.

For all malignancies except melanoma and testicular cancer, the adjusted relative rate (ARR) of hospitalizations was significantly higher among survivors than controls.

"Late effects and complications of cancer treatments are experienced by many survivors for the rest of their lives," Dr. Baxter told Reuters Health via e-mail. The patients in this population-based study were treated from 1992-1999. "Therapies have changed, she said. "In some cases there may be fewer late effects, but in others, they may be worse."

The study cohort included 20,275 survivors of young adult cancers who were recurrence-free for at least five years, and 101,344 controls. The authors observed survivors for a median of 9.93 years (range 0-16 years), according to their report online July 13 in the Journal of Clinical Oncology. During this period, 34.3% had at least one hospitalization,

vs. 27.3% for controls. The rate per 100 person-years was similar between male and female survivors.

Overall, the ARR of hospitalization in survivors compared with controls was 1.51. At all-time periods, survivors were more likely to be hospitalized than controls. The rate of hospitalization (per 100-person years) among survivors was 0.22 during years 5 to 8, 9 to11, and 12 to14. It decreased significantly during years 15 to 17 and 18 to 20, falling to 0.17 and 0.15, respectively (P<0.0001). Among controls, the hospitalization rate was relatively constant during all time periods, ranging from 0.13 at 5 to 8 years to 0.12 at years 18 to 20.

The ARR of hospitalizations in survivors compared with controls was also relatively constant during for the first three3 time periods: 1.67, 1.55, and 1.57 at years 5 to 8, 9 to

11, and 12 to 14, respectively. It decreased to 1.36 at 15 to 17 years and 1.22 at years 18 to 20. Those who survived gastrointestinal, urologic, colorectal, or brain cancers, or leukemia or lymphoma, had an ARR of hospitalization at least twice that of controls.

"We only looked at hospital admissions, not visits to the family doctor or medical conditions and disabilities that didn't require inpatient care," Dr. Baxter said, explaining that this likely underestimated the long-term impact of intense treatments that include surgery, chemotherapy, radiation, and hormonal therapy.

"Understanding the late effects of cancer treatment will help us design better treatments, counsel patients, and improve symptom management."

(Reuters Health) - Not all U.S. stroke patients eligible for thrombolytic therapy actually receive it - and the odds of getting this therapy may depend on where they live, a large study finds.

Dr. James Burke of the University of Michigan and the VA Ann Arbor Health System and colleagues examined 844,241 hospital admissions for ischemic stroke from 2007 to 2010 among U.S. patients insured by Medicare.

They sorted patients into 3,436 different hospital service areas based on home postal code to assess regional variation in thrombolysis treatment rates.

Patients were 78 years old on average. About 57% were women, and most were white. The majority had hypertension and many also had diabetes, high cholesterol or arrhythmia.

Overall, just 3.9% of these patients received thrombolysis, the researchers report online June 2 in the journal Stroke. The treatment wasn't given at all in 20% of regions, and it was more likely to occur in places with higher population density.

In the 20 regions with the highest rates of thrombolysis, roughly 10% to 14% of patients received the treatment.

After accounting for the number of strokes in each region, the proportion of patients receiving thrombolysis ranged from 2.2% in the bottom fifth of regions to 5.9% in the top fifth.

Older patients, women and minorities were less likely to receive the treatment. Regions with the lowest proportion of college graduates also had a smaller percentage of people treated with thrombolysis.

Not every patient with stroke should receive thrombolysis. One study in Cincinnati estimated that about 6% of stroke patients would be eligible, but the new findings of higher rates in the highest-performing regions suggest that more patients could benefit if they could be transported more quickly to hospitals where thrombolysis is available, the authors say.

By boosting use of the treatment in regions where it's least likely to happen up to the level in places where the therapy is most common, researchers estimated that an additional 92,847 stroke patients might get thrombolysis, averting disability for 8,078 of them.

"Prompt recognition and reaction to warning signs and effective emergency service systems can minimize delays in pre-hospital dispatch, assessment and transport, and ultimately increase the number of stroke patients reaching the hospital and being prepared for thrombolytic therapy within the 4.5-hour time window," Dr. Maurizio Paciaroni, a stroke specialist at the University of Perugia in Italy who wasn't involved in the study, said by email.

"For a variety of reasons, only a minority of patients get to the hospital within the first couple hours of a stroke," Burke said by email. Patients might not recognize symptoms or call 911 soon enough, and even when they do seek help quickly they might not end up at a hospital that's equipped to provide thrombolysis, he added.

The best outcomes are for patients who receive thrombolysis within the first hour after the blood vessel becomes blocked, said Dr. Brian Silver, director of the Comprehensive Stroke Center at Rhode Island Hospital and researcher at Brown University.

"When patients don't receive this treatment, they are up to 50% less likely to have a better outcome," Silver, who wasn't involved with the study, said by email. "This means, for some, residual speech difficulties, paralysis, vision loss, cognitive impairment and depression."

Globally, 15 million people suffer strokes each year; five million of them die and another five million are left permanently disabled, according to the World Health Organization.

(Reuters Health) - Not all U.S. stroke patients eligible for thrombolytic therapy actually receive it - and the odds of getting this therapy may depend on where they live, a large study finds.

Dr. James Burke of the University of Michigan and the VA Ann Arbor Health System and colleagues examined 844,241 hospital admissions for ischemic stroke from 2007 to 2010 among U.S. patients insured by Medicare.

They sorted patients into 3,436 different hospital service areas based on home postal code to assess regional variation in thrombolysis treatment rates.

Patients were 78 years old on average. About 57% were women, and most were white. The majority had hypertension and many also had diabetes, high cholesterol or arrhythmia.

Overall, just 3.9% of these patients received thrombolysis, the researchers report online June 2 in the journal Stroke. The treatment wasn't given at all in 20% of regions, and it was more likely to occur in places with higher population density.

In the 20 regions with the highest rates of thrombolysis, roughly 10% to 14% of patients received the treatment.

After accounting for the number of strokes in each region, the proportion of patients receiving thrombolysis ranged from 2.2% in the bottom fifth of regions to 5.9% in the top fifth.

Older patients, women and minorities were less likely to receive the treatment. Regions with the lowest proportion of college graduates also had a smaller percentage of people treated with thrombolysis.

Not every patient with stroke should receive thrombolysis. One study in Cincinnati estimated that about 6% of stroke patients would be eligible, but the new findings of higher rates in the highest-performing regions suggest that more patients could benefit if they could be transported more quickly to hospitals where thrombolysis is available, the authors say.

By boosting use of the treatment in regions where it's least likely to happen up to the level in places where the therapy is most common, researchers estimated that an additional 92,847 stroke patients might get thrombolysis, averting disability for 8,078 of them.

"Prompt recognition and reaction to warning signs and effective emergency service systems can minimize delays in pre-hospital dispatch, assessment and transport, and ultimately increase the number of stroke patients reaching the hospital and being prepared for thrombolytic therapy within the 4.5-hour time window," Dr. Maurizio Paciaroni, a stroke specialist at the University of Perugia in Italy who wasn't involved in the study, said by email.

"For a variety of reasons, only a minority of patients get to the hospital within the first couple hours of a stroke," Burke said by email. Patients might not recognize symptoms or call 911 soon enough, and even when they do seek help quickly they might not end up at a hospital that's equipped to provide thrombolysis, he added.

The best outcomes are for patients who receive thrombolysis within the first hour after the blood vessel becomes blocked, said Dr. Brian Silver, director of the Comprehensive Stroke Center at Rhode Island Hospital and researcher at Brown University.

"When patients don't receive this treatment, they are up to 50% less likely to have a better outcome," Silver, who wasn't involved with the study, said by email. "This means, for some, residual speech difficulties, paralysis, vision loss, cognitive impairment and depression."

Globally, 15 million people suffer strokes each year; five million of them die and another five million are left permanently disabled, according to the World Health Organization.

(Reuters Health) - Not all U.S. stroke patients eligible for thrombolytic therapy actually receive it - and the odds of getting this therapy may depend on where they live, a large study finds.

Dr. James Burke of the University of Michigan and the VA Ann Arbor Health System and colleagues examined 844,241 hospital admissions for ischemic stroke from 2007 to 2010 among U.S. patients insured by Medicare.

They sorted patients into 3,436 different hospital service areas based on home postal code to assess regional variation in thrombolysis treatment rates.

Patients were 78 years old on average. About 57% were women, and most were white. The majority had hypertension and many also had diabetes, high cholesterol or arrhythmia.

Overall, just 3.9% of these patients received thrombolysis, the researchers report online June 2 in the journal Stroke. The treatment wasn't given at all in 20% of regions, and it was more likely to occur in places with higher population density.

In the 20 regions with the highest rates of thrombolysis, roughly 10% to 14% of patients received the treatment.

After accounting for the number of strokes in each region, the proportion of patients receiving thrombolysis ranged from 2.2% in the bottom fifth of regions to 5.9% in the top fifth.

Older patients, women and minorities were less likely to receive the treatment. Regions with the lowest proportion of college graduates also had a smaller percentage of people treated with thrombolysis.

Not every patient with stroke should receive thrombolysis. One study in Cincinnati estimated that about 6% of stroke patients would be eligible, but the new findings of higher rates in the highest-performing regions suggest that more patients could benefit if they could be transported more quickly to hospitals where thrombolysis is available, the authors say.

By boosting use of the treatment in regions where it's least likely to happen up to the level in places where the therapy is most common, researchers estimated that an additional 92,847 stroke patients might get thrombolysis, averting disability for 8,078 of them.

"Prompt recognition and reaction to warning signs and effective emergency service systems can minimize delays in pre-hospital dispatch, assessment and transport, and ultimately increase the number of stroke patients reaching the hospital and being prepared for thrombolytic therapy within the 4.5-hour time window," Dr. Maurizio Paciaroni, a stroke specialist at the University of Perugia in Italy who wasn't involved in the study, said by email.

"For a variety of reasons, only a minority of patients get to the hospital within the first couple hours of a stroke," Burke said by email. Patients might not recognize symptoms or call 911 soon enough, and even when they do seek help quickly they might not end up at a hospital that's equipped to provide thrombolysis, he added.

The best outcomes are for patients who receive thrombolysis within the first hour after the blood vessel becomes blocked, said Dr. Brian Silver, director of the Comprehensive Stroke Center at Rhode Island Hospital and researcher at Brown University.

"When patients don't receive this treatment, they are up to 50% less likely to have a better outcome," Silver, who wasn't involved with the study, said by email. "This means, for some, residual speech difficulties, paralysis, vision loss, cognitive impairment and depression."

Globally, 15 million people suffer strokes each year; five million of them die and another five million are left permanently disabled, according to the World Health Organization.

NEW YORK (Reuters Health) - Following a quality-improvement effort at the Boston Children's Hospital emergency department, the number of head CT scans for children with blunt head trauma has dropped without missing any significant injuries, researchers say.

"A combination of an evidence-based guideline and individual provider feedback was associated with a reduction in cranial CT rates," Dr. Lise Nigrovic from Boston Children's told Reuters Health by email. "Clinicians successfully identified all children with head injuries requiring acute intervention."

The evidence-based guideline was based on the PECARN TBI clinical prediction rules, Dr. Nigrovic and her colleagues explain in a report in Pediatrics, online June 22. Immediate CT is recommended for children with either a single high-risk or at least three of the other PECARN TBI predictors.

A period of observation before deciding on CT is recommended for children with one or two predictors, and no CT is recommended for children without PECARN TBI predictors.

The goal of individual provider feedback was to improve awareness, acceptance, adoption and adherence to head trauma guideline recommendations. Each fall, ED providers receive a confidential report of annual cranial CT rates for ED patients with minor blunt head trauma for the previous year. Providers also get information on median overall division CT rate for the previous year, with the goal of reducing variability between providers while further decreasing overall CT rate.

Dr. Nigrovic's team analyzed more than 6,800 ED visits for minor head injuries, of which 62% occurred after implementation of the initiative.

From a baseline head CT rate of 21%, they observed a significant reduction of 6 percentage points in cranial CT rate after initial guideline implementation, and an additional drop of 6 percentage points after initiation of individual provider feedback, the researchers report.

"No children discharged from the ED required admission within 72 hours of initial evaluation," they note.

"Importantly," they add, the decline in the head CT rate has been sustained for two years so far after implementation, "which supports the sustainability of the QI (quality improvement) interventions."

"We believe that these changes are generalizable," Dr. Nigrovic told Reuters Health. "In fact, we have described our QI intervention in detail to help with adoption by other centers."

The study had no commercial funding and the authors have disclosed no potential conflicts of interest.

—Reuters Health

NEW YORK (Reuters Health) - Following a quality-improvement effort at the Boston Children's Hospital emergency department, the number of head CT scans for children with blunt head trauma has dropped without missing any significant injuries, researchers say.

"A combination of an evidence-based guideline and individual provider feedback was associated with a reduction in cranial CT rates," Dr. Lise Nigrovic from Boston Children's told Reuters Health by email. "Clinicians successfully identified all children with head injuries requiring acute intervention."

The evidence-based guideline was based on the PECARN TBI clinical prediction rules, Dr. Nigrovic and her colleagues explain in a report in Pediatrics, online June 22. Immediate CT is recommended for children with either a single high-risk or at least three of the other PECARN TBI predictors.

A period of observation before deciding on CT is recommended for children with one or two predictors, and no CT is recommended for children without PECARN TBI predictors.

The goal of individual provider feedback was to improve awareness, acceptance, adoption and adherence to head trauma guideline recommendations. Each fall, ED providers receive a confidential report of annual cranial CT rates for ED patients with minor blunt head trauma for the previous year. Providers also get information on median overall division CT rate for the previous year, with the goal of reducing variability between providers while further decreasing overall CT rate.

Dr. Nigrovic's team analyzed more than 6,800 ED visits for minor head injuries, of which 62% occurred after implementation of the initiative.

From a baseline head CT rate of 21%, they observed a significant reduction of 6 percentage points in cranial CT rate after initial guideline implementation, and an additional drop of 6 percentage points after initiation of individual provider feedback, the researchers report.

"No children discharged from the ED required admission within 72 hours of initial evaluation," they note.

"Importantly," they add, the decline in the head CT rate has been sustained for two years so far after implementation, "which supports the sustainability of the QI (quality improvement) interventions."

"We believe that these changes are generalizable," Dr. Nigrovic told Reuters Health. "In fact, we have described our QI intervention in detail to help with adoption by other centers."

The study had no commercial funding and the authors have disclosed no potential conflicts of interest.

—Reuters Health

NEW YORK (Reuters Health) - Following a quality-improvement effort at the Boston Children's Hospital emergency department, the number of head CT scans for children with blunt head trauma has dropped without missing any significant injuries, researchers say.

"A combination of an evidence-based guideline and individual provider feedback was associated with a reduction in cranial CT rates," Dr. Lise Nigrovic from Boston Children's told Reuters Health by email. "Clinicians successfully identified all children with head injuries requiring acute intervention."

The evidence-based guideline was based on the PECARN TBI clinical prediction rules, Dr. Nigrovic and her colleagues explain in a report in Pediatrics, online June 22. Immediate CT is recommended for children with either a single high-risk or at least three of the other PECARN TBI predictors.

A period of observation before deciding on CT is recommended for children with one or two predictors, and no CT is recommended for children without PECARN TBI predictors.

The goal of individual provider feedback was to improve awareness, acceptance, adoption and adherence to head trauma guideline recommendations. Each fall, ED providers receive a confidential report of annual cranial CT rates for ED patients with minor blunt head trauma for the previous year. Providers also get information on median overall division CT rate for the previous year, with the goal of reducing variability between providers while further decreasing overall CT rate.

Dr. Nigrovic's team analyzed more than 6,800 ED visits for minor head injuries, of which 62% occurred after implementation of the initiative.

From a baseline head CT rate of 21%, they observed a significant reduction of 6 percentage points in cranial CT rate after initial guideline implementation, and an additional drop of 6 percentage points after initiation of individual provider feedback, the researchers report.

"No children discharged from the ED required admission within 72 hours of initial evaluation," they note.

"Importantly," they add, the decline in the head CT rate has been sustained for two years so far after implementation, "which supports the sustainability of the QI (quality improvement) interventions."

"We believe that these changes are generalizable," Dr. Nigrovic told Reuters Health. "In fact, we have described our QI intervention in detail to help with adoption by other centers."

The study had no commercial funding and the authors have disclosed no potential conflicts of interest.

—Reuters Health

State laws have played a big part in boosting the number of hospitals where specialized stroke care is available, a new study shows.

During the study, the increase in the number of hospitals certified as primary stroke centers was more than twice as high in states with stroke legislation as in states without similar laws.

At these hospitals, a dedicated stroke-focused program staffed by professionals with special training delivers emergency therapy rapidly and reliably.

All hospitals should be able to see patients with stroke, but PSC certification attests to quality of care, said lead author Dr. Ken Uchino of the Cleveland Clinic.

"It takes money and effort to organize quality care," he told Reuters Health by email. "Sometimes a hospital is so small that the facility does not expect many patients with stroke to arrive. Sometimes the resources to provide quality care are not available, such as radiology technicians on call to run a CT scanner 24 hours a day or a specialist physician in the community."

U.S. organizations first began certifying stroke centers in 2003. Some states developed their own certification programs, and many passed laws requiring ambulance personnel to take an acute stroke patient directly to a certified center, bypassing hospitals that are not certified.

These laws seem to have encouraged more hospitals to get certification, according to a paper online now in the journal Stroke.

Between 2009 and 2013, states with stroke legislation had a 16% increase in PSC certification, compared to a 6% increase in states without similar legislation.

"I think if a hospital administrator realizes that an ambulance might bypass his or her hospital because it is not stroke-certified, there is an incentive to organize stroke care in the hospital and have stroke center certification," Uchino said.

By 2013, about a third of short-term adult general hospitals with emergency departments in the U.S. were certified as primary stroke centers, he said. But growth rates have varied by state, and by 2013 there were still three states with only one certified center, he said.

Out of 4,640 general hospitals with emergency rooms in the country, 1,505 have been certified as primary stroke centers following action by state legislatures. But the proportion of stroke centers by state still varied from as low as 4% in Wyoming, which has no stroke legislation, to 100% in Delaware, which does have stroke laws.

"Massachusetts, Florida, and New Jersey, which passed stroke legislation in 2004, had 74% to 97% of the hospitals certified as stroke centers by 2013," Uchino said.

Larger, more urban hospitals in states with higher economic output are most likely to be certified as primary stroke centers, the researchers found.

Patients brought to a certified stroke center have a better chance of survival than those brought elsewhere, Uchino said.

Almost all large hospitals can and should be stroke centers, and small hospitals still need help to improve, he said.

"Small hospitals still can become stroke centers, but they had to be creative with how they pulled resources together," said Dr. Lee H. Schwamm of Massachusetts General Hospital and Harvard Medical School in Boston.

"Every community should have at least one" primary stroke center, Schwamm, who was not part of the new study, told Reuters Health by phone. "The real challenge is how do I ensure equitable access for people all over the country."

State laws have played a big part in boosting the number of hospitals where specialized stroke care is available, a new study shows.

During the study, the increase in the number of hospitals certified as primary stroke centers was more than twice as high in states with stroke legislation as in states without similar laws.

At these hospitals, a dedicated stroke-focused program staffed by professionals with special training delivers emergency therapy rapidly and reliably.

All hospitals should be able to see patients with stroke, but PSC certification attests to quality of care, said lead author Dr. Ken Uchino of the Cleveland Clinic.

"It takes money and effort to organize quality care," he told Reuters Health by email. "Sometimes a hospital is so small that the facility does not expect many patients with stroke to arrive. Sometimes the resources to provide quality care are not available, such as radiology technicians on call to run a CT scanner 24 hours a day or a specialist physician in the community."

U.S. organizations first began certifying stroke centers in 2003. Some states developed their own certification programs, and many passed laws requiring ambulance personnel to take an acute stroke patient directly to a certified center, bypassing hospitals that are not certified.

These laws seem to have encouraged more hospitals to get certification, according to a paper online now in the journal Stroke.

Between 2009 and 2013, states with stroke legislation had a 16% increase in PSC certification, compared to a 6% increase in states without similar legislation.

"I think if a hospital administrator realizes that an ambulance might bypass his or her hospital because it is not stroke-certified, there is an incentive to organize stroke care in the hospital and have stroke center certification," Uchino said.

By 2013, about a third of short-term adult general hospitals with emergency departments in the U.S. were certified as primary stroke centers, he said. But growth rates have varied by state, and by 2013 there were still three states with only one certified center, he said.

Out of 4,640 general hospitals with emergency rooms in the country, 1,505 have been certified as primary stroke centers following action by state legislatures. But the proportion of stroke centers by state still varied from as low as 4% in Wyoming, which has no stroke legislation, to 100% in Delaware, which does have stroke laws.

"Massachusetts, Florida, and New Jersey, which passed stroke legislation in 2004, had 74% to 97% of the hospitals certified as stroke centers by 2013," Uchino said.

Larger, more urban hospitals in states with higher economic output are most likely to be certified as primary stroke centers, the researchers found.

Patients brought to a certified stroke center have a better chance of survival than those brought elsewhere, Uchino said.

Almost all large hospitals can and should be stroke centers, and small hospitals still need help to improve, he said.

"Small hospitals still can become stroke centers, but they had to be creative with how they pulled resources together," said Dr. Lee H. Schwamm of Massachusetts General Hospital and Harvard Medical School in Boston.

"Every community should have at least one" primary stroke center, Schwamm, who was not part of the new study, told Reuters Health by phone. "The real challenge is how do I ensure equitable access for people all over the country."

State laws have played a big part in boosting the number of hospitals where specialized stroke care is available, a new study shows.

During the study, the increase in the number of hospitals certified as primary stroke centers was more than twice as high in states with stroke legislation as in states without similar laws.

At these hospitals, a dedicated stroke-focused program staffed by professionals with special training delivers emergency therapy rapidly and reliably.

All hospitals should be able to see patients with stroke, but PSC certification attests to quality of care, said lead author Dr. Ken Uchino of the Cleveland Clinic.

"It takes money and effort to organize quality care," he told Reuters Health by email. "Sometimes a hospital is so small that the facility does not expect many patients with stroke to arrive. Sometimes the resources to provide quality care are not available, such as radiology technicians on call to run a CT scanner 24 hours a day or a specialist physician in the community."

U.S. organizations first began certifying stroke centers in 2003. Some states developed their own certification programs, and many passed laws requiring ambulance personnel to take an acute stroke patient directly to a certified center, bypassing hospitals that are not certified.

These laws seem to have encouraged more hospitals to get certification, according to a paper online now in the journal Stroke.

Between 2009 and 2013, states with stroke legislation had a 16% increase in PSC certification, compared to a 6% increase in states without similar legislation.

"I think if a hospital administrator realizes that an ambulance might bypass his or her hospital because it is not stroke-certified, there is an incentive to organize stroke care in the hospital and have stroke center certification," Uchino said.

By 2013, about a third of short-term adult general hospitals with emergency departments in the U.S. were certified as primary stroke centers, he said. But growth rates have varied by state, and by 2013 there were still three states with only one certified center, he said.

Out of 4,640 general hospitals with emergency rooms in the country, 1,505 have been certified as primary stroke centers following action by state legislatures. But the proportion of stroke centers by state still varied from as low as 4% in Wyoming, which has no stroke legislation, to 100% in Delaware, which does have stroke laws.

"Massachusetts, Florida, and New Jersey, which passed stroke legislation in 2004, had 74% to 97% of the hospitals certified as stroke centers by 2013," Uchino said.

Larger, more urban hospitals in states with higher economic output are most likely to be certified as primary stroke centers, the researchers found.

Patients brought to a certified stroke center have a better chance of survival than those brought elsewhere, Uchino said.

Almost all large hospitals can and should be stroke centers, and small hospitals still need help to improve, he said.

"Small hospitals still can become stroke centers, but they had to be creative with how they pulled resources together," said Dr. Lee H. Schwamm of Massachusetts General Hospital and Harvard Medical School in Boston.

"Every community should have at least one" primary stroke center, Schwamm, who was not part of the new study, told Reuters Health by phone. "The real challenge is how do I ensure equitable access for people all over the country."

NEW YORK (Reuters Health) - Lower systolic blood pressure in patients being treated for hypertension is associated with a reduced risk of atrial fibrillation (AF), according to data from the LIFE study.

"Among hypertensive patients at high risk of atrial fibrillation who can tolerate lower systolic blood pressure (SBP) levels, treating to a SBP of 130 or less may be able to reduce or retard the incidence of new AF," Dr. Peter M. Okin from Weill Cornell Medical College, New York, told Reuters Health by email, "but caution should be used when treating to these lower SBP levels to make sure that we are not harming patients in other ways."

Although hypertension clearly increases the risk of AF, studies have not consistently shown that reductions in blood pressure can reduce that risk.

Dr. Okin's team used data from the Losartan Intervention For Endpoint (LIFE) hypertension study to examine whether lower achieved SBP (no greater than 130 mm Hg) is associated with a lower incidence of AF compared with typical SBP control (131-141 mm Hg) and less-adequate SBP control (>=142 mm Hg) in hypertensive patients with left ventricular hypertrophy on ECG.

The post hoc study included more than 8,800 men and women whose age averaged 67 years.

Compared with the group with less-adequate SBP control, patients with typical SBP control had a 24% lower risk of developing AF. And patients with lower achieved SBP had a 40% lower risk, the researchers report in Hypertension, online June8.

Only at SBP levels <=125 mm Hg was lower SBP no longer associated with a significantly reduced risk of AF.

When SBP was included as a continuous variable in multivariate analyses, every 10-mm Hg decrease in SBP was associated with a 13% lower risk of new-onset AF.

"There are a number of concerns with regards to lowering SBP to these levels in older hypertensives," Dr. Okin cautioned. "First, there are a number of studies (including data from the LIFE study that we have published) that suggests that achieving lower target SBP levels can be associated with an increased mortality risk. Indeed, the most recent US guidelines for treatment of hypertension suggest treating to higher SBP goals in patients 60 years of age and older because of some evidence that treating to lower SBP levels may increase as opposed to decrease risk. However, there is significant disagreement regarding these new recommendations."

"Additional data from the LIFE study, that have been presented but not published in manuscript form, seem to support the notion that achieving SBP levels <140 in this patient population is associated with worse outcomes than a SBP between 140 and 149," he said. "Lastly, lower SBP levels in truly elderly patients can sometimes be associated with light-headedness and an increased risk of falling which can add additional morbidity."

Dr. Okin cautioned, "These findings are based on post-hoc analysis of data from a study that was not specifically designed to address this question. As a consequence, we should use caution when interpreting these findings until there are hopefully more specific studies that address the question of whether treating to a lower SBP goal can reduce the risk of developing new AF."

Dr. Kazem Rahimi from University of Oxford's George Institute for Global Health in the UK showed in a recent meta-analysis that antihypertensive therapy modestly reduced the risk of AF.

"There may be a greater risk of adverse events with very aggressive blood pressure control," Dr. Rahimi, who was not involved in the new study, told Reuters Health by email.

"In a trial (ACCORD), which targeted a blood pressure level of <120 mm Hg, BP reduction increased the risk of serious adverse events, particularly increasing the risk of hypotension and hyperkalemia," he said. "However, at the target blood pressure levels that the authors examined (<130 mm Hg SBP), the benefits of blood pressure lowering in older patients (preventing heart attacks and strokes) are likely to outweigh any risks."

Dr. Rahimi said the new analysis is unlikely to change clinical practice due to its observational nature. "However, in the context of randomized trials showing that blood pressure lowering prevents heart attacks and strokes in elderly hypertensive patients, the suggestive evidence from this and other studies that lowering blood pressure may also lower the risk of AF provides another reason for not withholding blood pressure lowering drugs."

The LIFE trial was sponsored by Merck & Co. The authors of the new report disclosed multiple ties to the company, including employment.

—Reuters Health

NEW YORK (Reuters Health) - Lower systolic blood pressure in patients being treated for hypertension is associated with a reduced risk of atrial fibrillation (AF), according to data from the LIFE study.

"Among hypertensive patients at high risk of atrial fibrillation who can tolerate lower systolic blood pressure (SBP) levels, treating to a SBP of 130 or less may be able to reduce or retard the incidence of new AF," Dr. Peter M. Okin from Weill Cornell Medical College, New York, told Reuters Health by email, "but caution should be used when treating to these lower SBP levels to make sure that we are not harming patients in other ways."

Although hypertension clearly increases the risk of AF, studies have not consistently shown that reductions in blood pressure can reduce that risk.

Dr. Okin's team used data from the Losartan Intervention For Endpoint (LIFE) hypertension study to examine whether lower achieved SBP (no greater than 130 mm Hg) is associated with a lower incidence of AF compared with typical SBP control (131-141 mm Hg) and less-adequate SBP control (>=142 mm Hg) in hypertensive patients with left ventricular hypertrophy on ECG.

The post hoc study included more than 8,800 men and women whose age averaged 67 years.

Compared with the group with less-adequate SBP control, patients with typical SBP control had a 24% lower risk of developing AF. And patients with lower achieved SBP had a 40% lower risk, the researchers report in Hypertension, online June8.

Only at SBP levels <=125 mm Hg was lower SBP no longer associated with a significantly reduced risk of AF.

When SBP was included as a continuous variable in multivariate analyses, every 10-mm Hg decrease in SBP was associated with a 13% lower risk of new-onset AF.

"There are a number of concerns with regards to lowering SBP to these levels in older hypertensives," Dr. Okin cautioned. "First, there are a number of studies (including data from the LIFE study that we have published) that suggests that achieving lower target SBP levels can be associated with an increased mortality risk. Indeed, the most recent US guidelines for treatment of hypertension suggest treating to higher SBP goals in patients 60 years of age and older because of some evidence that treating to lower SBP levels may increase as opposed to decrease risk. However, there is significant disagreement regarding these new recommendations."

"Additional data from the LIFE study, that have been presented but not published in manuscript form, seem to support the notion that achieving SBP levels <140 in this patient population is associated with worse outcomes than a SBP between 140 and 149," he said. "Lastly, lower SBP levels in truly elderly patients can sometimes be associated with light-headedness and an increased risk of falling which can add additional morbidity."

Dr. Okin cautioned, "These findings are based on post-hoc analysis of data from a study that was not specifically designed to address this question. As a consequence, we should use caution when interpreting these findings until there are hopefully more specific studies that address the question of whether treating to a lower SBP goal can reduce the risk of developing new AF."

Dr. Kazem Rahimi from University of Oxford's George Institute for Global Health in the UK showed in a recent meta-analysis that antihypertensive therapy modestly reduced the risk of AF.

"There may be a greater risk of adverse events with very aggressive blood pressure control," Dr. Rahimi, who was not involved in the new study, told Reuters Health by email.

"In a trial (ACCORD), which targeted a blood pressure level of <120 mm Hg, BP reduction increased the risk of serious adverse events, particularly increasing the risk of hypotension and hyperkalemia," he said. "However, at the target blood pressure levels that the authors examined (<130 mm Hg SBP), the benefits of blood pressure lowering in older patients (preventing heart attacks and strokes) are likely to outweigh any risks."

Dr. Rahimi said the new analysis is unlikely to change clinical practice due to its observational nature. "However, in the context of randomized trials showing that blood pressure lowering prevents heart attacks and strokes in elderly hypertensive patients, the suggestive evidence from this and other studies that lowering blood pressure may also lower the risk of AF provides another reason for not withholding blood pressure lowering drugs."

The LIFE trial was sponsored by Merck & Co. The authors of the new report disclosed multiple ties to the company, including employment.

—Reuters Health

NEW YORK (Reuters Health) - Lower systolic blood pressure in patients being treated for hypertension is associated with a reduced risk of atrial fibrillation (AF), according to data from the LIFE study.

"Among hypertensive patients at high risk of atrial fibrillation who can tolerate lower systolic blood pressure (SBP) levels, treating to a SBP of 130 or less may be able to reduce or retard the incidence of new AF," Dr. Peter M. Okin from Weill Cornell Medical College, New York, told Reuters Health by email, "but caution should be used when treating to these lower SBP levels to make sure that we are not harming patients in other ways."

Although hypertension clearly increases the risk of AF, studies have not consistently shown that reductions in blood pressure can reduce that risk.

Dr. Okin's team used data from the Losartan Intervention For Endpoint (LIFE) hypertension study to examine whether lower achieved SBP (no greater than 130 mm Hg) is associated with a lower incidence of AF compared with typical SBP control (131-141 mm Hg) and less-adequate SBP control (>=142 mm Hg) in hypertensive patients with left ventricular hypertrophy on ECG.

The post hoc study included more than 8,800 men and women whose age averaged 67 years.

Compared with the group with less-adequate SBP control, patients with typical SBP control had a 24% lower risk of developing AF. And patients with lower achieved SBP had a 40% lower risk, the researchers report in Hypertension, online June8.

Only at SBP levels <=125 mm Hg was lower SBP no longer associated with a significantly reduced risk of AF.

When SBP was included as a continuous variable in multivariate analyses, every 10-mm Hg decrease in SBP was associated with a 13% lower risk of new-onset AF.

"There are a number of concerns with regards to lowering SBP to these levels in older hypertensives," Dr. Okin cautioned. "First, there are a number of studies (including data from the LIFE study that we have published) that suggests that achieving lower target SBP levels can be associated with an increased mortality risk. Indeed, the most recent US guidelines for treatment of hypertension suggest treating to higher SBP goals in patients 60 years of age and older because of some evidence that treating to lower SBP levels may increase as opposed to decrease risk. However, there is significant disagreement regarding these new recommendations."

"Additional data from the LIFE study, that have been presented but not published in manuscript form, seem to support the notion that achieving SBP levels <140 in this patient population is associated with worse outcomes than a SBP between 140 and 149," he said. "Lastly, lower SBP levels in truly elderly patients can sometimes be associated with light-headedness and an increased risk of falling which can add additional morbidity."

Dr. Okin cautioned, "These findings are based on post-hoc analysis of data from a study that was not specifically designed to address this question. As a consequence, we should use caution when interpreting these findings until there are hopefully more specific studies that address the question of whether treating to a lower SBP goal can reduce the risk of developing new AF."

Dr. Kazem Rahimi from University of Oxford's George Institute for Global Health in the UK showed in a recent meta-analysis that antihypertensive therapy modestly reduced the risk of AF.

"There may be a greater risk of adverse events with very aggressive blood pressure control," Dr. Rahimi, who was not involved in the new study, told Reuters Health by email.

"In a trial (ACCORD), which targeted a blood pressure level of <120 mm Hg, BP reduction increased the risk of serious adverse events, particularly increasing the risk of hypotension and hyperkalemia," he said. "However, at the target blood pressure levels that the authors examined (<130 mm Hg SBP), the benefits of blood pressure lowering in older patients (preventing heart attacks and strokes) are likely to outweigh any risks."

Dr. Rahimi said the new analysis is unlikely to change clinical practice due to its observational nature. "However, in the context of randomized trials showing that blood pressure lowering prevents heart attacks and strokes in elderly hypertensive patients, the suggestive evidence from this and other studies that lowering blood pressure may also lower the risk of AF provides another reason for not withholding blood pressure lowering drugs."

The LIFE trial was sponsored by Merck & Co. The authors of the new report disclosed multiple ties to the company, including employment.

—Reuters Health

NEW YORK (Reuters Health) - When patients with atrialfibrillation need surgery or other invasive therapy, doctors can safely interrupt their warfarin therapy without offering a bridging anticoagulation regimen, according to a new U.S.-Canadian study.

The test of 1,884 patients treated at 108 centers found virtually identical rates of arterial thromboembolism in people who were switched to low-molecular-weight heparin and volunteers who got matching placebo twice daily immediately before and after the procedure.

In contrast, the incidence of major bleeding nearly tripled with bridging; it was 1.3% without heparin and 3.2% with the anticoagulant (p=0.005).

The study is "the first to give us really high-quality data. It allows us to make a recommendation that, at least with atrial fibrillation, you don't need to use bridging therapy," coauthor Dr. Thomas Ortel, chief of hematology at Duke University in Durham, North Carolina, told Reuters Health by phone.

"There may be certain high-risk patients where you may still wish to use it, but the vast majority of these patients really don't need anything done in the perioperative setting," he said.

The findings were presented Monday at the International Society on Thrombosis and Haemostasis 2015 Congress in Toronto and released online by the New England Journal of Medicine.

This is an issue doctors have wrestled with for years.

"Each year, this common clinical scenario affects approximately one in six warfarin-treated patients with atrial fibrillation," the researchers wrote in the Journal.

"Recommendations and guidelines have been conflicting," said Dr. Ortel. "We feel this is something more definitive."

In all patients, warfarin was halted five days before the procedure and restarted within 24 hours after the procedure.

In the bridging group, patients subcutaneously received 100 IU of dalteparin per kilogram of body weight or matching placebo twice daily, beginning three days before the procedure. Treatment was suspended 24 hours before the procedure.

Dalteparin/placebo therapy resumed within 24 hours after the procedure if that procedure carried a low risk of bleeding, and within 48 to 72 hours if the bleeding risk was high. Treatment continued until the international normalized ratio hit 2.0, usually for five to 10 days. Patients were followed for 30 to 37 days after the procedure.

In the placebo group, 0.4% developed an arterial thromboembolism versus 0.3% of the patients who received the heparin (p=0.01 for noninferiority). The rates were based on 1,813 patients who remained in the study until the end.

"For many of the patients it actually is not surprising because the risk of thromboembolism is pretty low," said Dr. Ortel. "But the issue has been that nobody has shown that you really can skip low-molecular-weight heparin as a bridge. There's quite a bit of conflicting thought out there among providers, as well as among patients, about whether something like this needs to be done."

"Major bleeding occurred in 1.3% of the patients (12 of 918) in the no-bridging group and 3.2% (29 of 895) in the bridging group, which indicated that no bridging was superior to bridging with regard to major bleeding," the researchers reported. None of the major bleeding episodes was fatal.

The two treatments produced no difference in the likelihood of death, acute myocardial infarction, pulmonary embolism ordeep vein thrombosis.

Dr. Ortel said the findings, if widely adopted, could save money by reducing the use of low-molecular-weight heparin and decreasing the expense of treating bleeding complications. "There are several different ways this could affect costs.

He cautioned that the study, known as BRIDGE, "does not apply to patients with prosthetic heart valves or patients with venous thromboembolism, like a deep vein thrombosis or pulmonary embolism. But for patients with atrial fibrillation, it's high-quality data that should indicate that people do not need to use anything to bridge these folks."

The National Heart, Lung, and Blood Institute funded this research. Ten coauthors reported relationships with pharmaceutical companies.

—Reuters Health

NEW YORK (Reuters Health) - When patients with atrialfibrillation need surgery or other invasive therapy, doctors can safely interrupt their warfarin therapy without offering a bridging anticoagulation regimen, according to a new U.S.-Canadian study.

The test of 1,884 patients treated at 108 centers found virtually identical rates of arterial thromboembolism in people who were switched to low-molecular-weight heparin and volunteers who got matching placebo twice daily immediately before and after the procedure.

In contrast, the incidence of major bleeding nearly tripled with bridging; it was 1.3% without heparin and 3.2% with the anticoagulant (p=0.005).

The study is "the first to give us really high-quality data. It allows us to make a recommendation that, at least with atrial fibrillation, you don't need to use bridging therapy," coauthor Dr. Thomas Ortel, chief of hematology at Duke University in Durham, North Carolina, told Reuters Health by phone.

"There may be certain high-risk patients where you may still wish to use it, but the vast majority of these patients really don't need anything done in the perioperative setting," he said.

The findings were presented Monday at the International Society on Thrombosis and Haemostasis 2015 Congress in Toronto and released online by the New England Journal of Medicine.

This is an issue doctors have wrestled with for years.

"Each year, this common clinical scenario affects approximately one in six warfarin-treated patients with atrial fibrillation," the researchers wrote in the Journal.

"Recommendations and guidelines have been conflicting," said Dr. Ortel. "We feel this is something more definitive."

In all patients, warfarin was halted five days before the procedure and restarted within 24 hours after the procedure.

In the bridging group, patients subcutaneously received 100 IU of dalteparin per kilogram of body weight or matching placebo twice daily, beginning three days before the procedure. Treatment was suspended 24 hours before the procedure.

Dalteparin/placebo therapy resumed within 24 hours after the procedure if that procedure carried a low risk of bleeding, and within 48 to 72 hours if the bleeding risk was high. Treatment continued until the international normalized ratio hit 2.0, usually for five to 10 days. Patients were followed for 30 to 37 days after the procedure.

In the placebo group, 0.4% developed an arterial thromboembolism versus 0.3% of the patients who received the heparin (p=0.01 for noninferiority). The rates were based on 1,813 patients who remained in the study until the end.

"For many of the patients it actually is not surprising because the risk of thromboembolism is pretty low," said Dr. Ortel. "But the issue has been that nobody has shown that you really can skip low-molecular-weight heparin as a bridge. There's quite a bit of conflicting thought out there among providers, as well as among patients, about whether something like this needs to be done."

"Major bleeding occurred in 1.3% of the patients (12 of 918) in the no-bridging group and 3.2% (29 of 895) in the bridging group, which indicated that no bridging was superior to bridging with regard to major bleeding," the researchers reported. None of the major bleeding episodes was fatal.

The two treatments produced no difference in the likelihood of death, acute myocardial infarction, pulmonary embolism ordeep vein thrombosis.

Dr. Ortel said the findings, if widely adopted, could save money by reducing the use of low-molecular-weight heparin and decreasing the expense of treating bleeding complications. "There are several different ways this could affect costs.

He cautioned that the study, known as BRIDGE, "does not apply to patients with prosthetic heart valves or patients with venous thromboembolism, like a deep vein thrombosis or pulmonary embolism. But for patients with atrial fibrillation, it's high-quality data that should indicate that people do not need to use anything to bridge these folks."

The National Heart, Lung, and Blood Institute funded this research. Ten coauthors reported relationships with pharmaceutical companies.

—Reuters Health

NEW YORK (Reuters Health) - When patients with atrialfibrillation need surgery or other invasive therapy, doctors can safely interrupt their warfarin therapy without offering a bridging anticoagulation regimen, according to a new U.S.-Canadian study.

The test of 1,884 patients treated at 108 centers found virtually identical rates of arterial thromboembolism in people who were switched to low-molecular-weight heparin and volunteers who got matching placebo twice daily immediately before and after the procedure.

In contrast, the incidence of major bleeding nearly tripled with bridging; it was 1.3% without heparin and 3.2% with the anticoagulant (p=0.005).

The study is "the first to give us really high-quality data. It allows us to make a recommendation that, at least with atrial fibrillation, you don't need to use bridging therapy," coauthor Dr. Thomas Ortel, chief of hematology at Duke University in Durham, North Carolina, told Reuters Health by phone.

"There may be certain high-risk patients where you may still wish to use it, but the vast majority of these patients really don't need anything done in the perioperative setting," he said.

The findings were presented Monday at the International Society on Thrombosis and Haemostasis 2015 Congress in Toronto and released online by the New England Journal of Medicine.

This is an issue doctors have wrestled with for years.

"Each year, this common clinical scenario affects approximately one in six warfarin-treated patients with atrial fibrillation," the researchers wrote in the Journal.

"Recommendations and guidelines have been conflicting," said Dr. Ortel. "We feel this is something more definitive."

In all patients, warfarin was halted five days before the procedure and restarted within 24 hours after the procedure.

In the bridging group, patients subcutaneously received 100 IU of dalteparin per kilogram of body weight or matching placebo twice daily, beginning three days before the procedure. Treatment was suspended 24 hours before the procedure.

Dalteparin/placebo therapy resumed within 24 hours after the procedure if that procedure carried a low risk of bleeding, and within 48 to 72 hours if the bleeding risk was high. Treatment continued until the international normalized ratio hit 2.0, usually for five to 10 days. Patients were followed for 30 to 37 days after the procedure.

In the placebo group, 0.4% developed an arterial thromboembolism versus 0.3% of the patients who received the heparin (p=0.01 for noninferiority). The rates were based on 1,813 patients who remained in the study until the end.

"For many of the patients it actually is not surprising because the risk of thromboembolism is pretty low," said Dr. Ortel. "But the issue has been that nobody has shown that you really can skip low-molecular-weight heparin as a bridge. There's quite a bit of conflicting thought out there among providers, as well as among patients, about whether something like this needs to be done."

"Major bleeding occurred in 1.3% of the patients (12 of 918) in the no-bridging group and 3.2% (29 of 895) in the bridging group, which indicated that no bridging was superior to bridging with regard to major bleeding," the researchers reported. None of the major bleeding episodes was fatal.

The two treatments produced no difference in the likelihood of death, acute myocardial infarction, pulmonary embolism ordeep vein thrombosis.

Dr. Ortel said the findings, if widely adopted, could save money by reducing the use of low-molecular-weight heparin and decreasing the expense of treating bleeding complications. "There are several different ways this could affect costs.

He cautioned that the study, known as BRIDGE, "does not apply to patients with prosthetic heart valves or patients with venous thromboembolism, like a deep vein thrombosis or pulmonary embolism. But for patients with atrial fibrillation, it's high-quality data that should indicate that people do not need to use anything to bridge these folks."

The National Heart, Lung, and Blood Institute funded this research. Ten coauthors reported relationships with pharmaceutical companies.

—Reuters Health

Medicare, the government-run health insurance program for elderly and disabled Americans, paid physicians $90 billion in 2013, up 17% from $77 billion in 2012, U.S. healthcare officials reported earlier this month.

Physician payments accounted for less than one-fifth of Medicare's 2013 net outlays of $492 billion, which rose from $466 billion in 2012. Payments to hospitals for the top 100 inpatient stays cost Medicare $62 billion in 2013, while the rest went for drugs, privately run Medicare Advantage plans, and other program costs.

The single-greatest hospital expense was to replace knees, hips, and other joints in 446,148 operations, with $6.6 billion paid to hospitals.

The second-greatest hospital payment, $5.6 billion, went for 398,004 cases of septicemia, or blood poisoning, often a sign of poor inpatient care. TH

—Reuters Health

Medicare, the government-run health insurance program for elderly and disabled Americans, paid physicians $90 billion in 2013, up 17% from $77 billion in 2012, U.S. healthcare officials reported earlier this month.

Physician payments accounted for less than one-fifth of Medicare's 2013 net outlays of $492 billion, which rose from $466 billion in 2012. Payments to hospitals for the top 100 inpatient stays cost Medicare $62 billion in 2013, while the rest went for drugs, privately run Medicare Advantage plans, and other program costs.

The single-greatest hospital expense was to replace knees, hips, and other joints in 446,148 operations, with $6.6 billion paid to hospitals.

The second-greatest hospital payment, $5.6 billion, went for 398,004 cases of septicemia, or blood poisoning, often a sign of poor inpatient care. TH

—Reuters Health

Medicare, the government-run health insurance program for elderly and disabled Americans, paid physicians $90 billion in 2013, up 17% from $77 billion in 2012, U.S. healthcare officials reported earlier this month.

Physician payments accounted for less than one-fifth of Medicare's 2013 net outlays of $492 billion, which rose from $466 billion in 2012. Payments to hospitals for the top 100 inpatient stays cost Medicare $62 billion in 2013, while the rest went for drugs, privately run Medicare Advantage plans, and other program costs.

The single-greatest hospital expense was to replace knees, hips, and other joints in 446,148 operations, with $6.6 billion paid to hospitals.

The second-greatest hospital payment, $5.6 billion, went for 398,004 cases of septicemia, or blood poisoning, often a sign of poor inpatient care. TH

—Reuters Health

NEW YORK—Although venous thromboembolism (VTE) rates are low in hospitalized patients following colorectal surgery, the increasing use of prophylaxis seems to have little impact, according to Washington state-based researchers.

Dr. Scott R. Steele, of Madigan Army Medical Center, Tacoma, and colleagues in JAMA Surgery note that although VTE is an important complication of such surgery its incidence in the current era of prophylaxis is unclear. To investigate further, the team examined Washington state data on more than 16,000 patients who underwent colorectal surgery between 2006 and 2011. Over the study period, the use of perioperative VTE chemoprophylaxis increased significantly from 31.6% to 86.4%. In-hospital VTE chemoprophylaxis rose from 59.6% to 91.4%. A total of 10.6% were discharged on VTE prophylaxis.

VTE within 90 days was seen in 360 patients (2.2%) overall. Patients undergoing abdominal operations had higher rates than those having pelvic operations (2.5% versus 1.8%, p=0.001). Rates were similar, but nonsignificant, in patients having an operation for cancer or for nonmalignant processes (2.1% versus 2.3%).

On adjusted analysis, being older, non-elective surgery, a history of VTE, and operations for inflammatory disease were associated with increased risk of 90-day VTE. However, despite the steady increase in chemoprophylaxis use in the perioperative and in-hospital settings, the annual VTE incidence remained low and largely unchanged, the researchers say. For example, the rate was 2.6% in 2007 and 3.0% in 2011.

In fact, the investigators say, "If nonselective perioperative and in-hospital prophylaxis is not successful in reducing rates of in-hospital VTE over time, are we placing patients at undue risk without significant benefit? With almost 40% of VTE events occurring after discharge, this may represent an area for quality improvement implementation."

As Dr. Steele told Reuters Health by email, "Despite our best practices, a small percentage of patients may still develop a VTE."

Prophylaxis efforts have improved greatly in the preoperative and perioperative in-hospital settings, but "in the post-discharge setting, we likely need a much larger randomized prospective study involving patients with similar risk profiles evaluating extended prophylaxis versus none to demonstrate whether or not this is a benefit." TH

—Reuters Health

NEW YORK—Although venous thromboembolism (VTE) rates are low in hospitalized patients following colorectal surgery, the increasing use of prophylaxis seems to have little impact, according to Washington state-based researchers.

Dr. Scott R. Steele, of Madigan Army Medical Center, Tacoma, and colleagues in JAMA Surgery note that although VTE is an important complication of such surgery its incidence in the current era of prophylaxis is unclear. To investigate further, the team examined Washington state data on more than 16,000 patients who underwent colorectal surgery between 2006 and 2011. Over the study period, the use of perioperative VTE chemoprophylaxis increased significantly from 31.6% to 86.4%. In-hospital VTE chemoprophylaxis rose from 59.6% to 91.4%. A total of 10.6% were discharged on VTE prophylaxis.

VTE within 90 days was seen in 360 patients (2.2%) overall. Patients undergoing abdominal operations had higher rates than those having pelvic operations (2.5% versus 1.8%, p=0.001). Rates were similar, but nonsignificant, in patients having an operation for cancer or for nonmalignant processes (2.1% versus 2.3%).

On adjusted analysis, being older, non-elective surgery, a history of VTE, and operations for inflammatory disease were associated with increased risk of 90-day VTE. However, despite the steady increase in chemoprophylaxis use in the perioperative and in-hospital settings, the annual VTE incidence remained low and largely unchanged, the researchers say. For example, the rate was 2.6% in 2007 and 3.0% in 2011.

In fact, the investigators say, "If nonselective perioperative and in-hospital prophylaxis is not successful in reducing rates of in-hospital VTE over time, are we placing patients at undue risk without significant benefit? With almost 40% of VTE events occurring after discharge, this may represent an area for quality improvement implementation."

As Dr. Steele told Reuters Health by email, "Despite our best practices, a small percentage of patients may still develop a VTE."

Prophylaxis efforts have improved greatly in the preoperative and perioperative in-hospital settings, but "in the post-discharge setting, we likely need a much larger randomized prospective study involving patients with similar risk profiles evaluating extended prophylaxis versus none to demonstrate whether or not this is a benefit." TH

—Reuters Health

NEW YORK—Although venous thromboembolism (VTE) rates are low in hospitalized patients following colorectal surgery, the increasing use of prophylaxis seems to have little impact, according to Washington state-based researchers.

Dr. Scott R. Steele, of Madigan Army Medical Center, Tacoma, and colleagues in JAMA Surgery note that although VTE is an important complication of such surgery its incidence in the current era of prophylaxis is unclear. To investigate further, the team examined Washington state data on more than 16,000 patients who underwent colorectal surgery between 2006 and 2011. Over the study period, the use of perioperative VTE chemoprophylaxis increased significantly from 31.6% to 86.4%. In-hospital VTE chemoprophylaxis rose from 59.6% to 91.4%. A total of 10.6% were discharged on VTE prophylaxis.

VTE within 90 days was seen in 360 patients (2.2%) overall. Patients undergoing abdominal operations had higher rates than those having pelvic operations (2.5% versus 1.8%, p=0.001). Rates were similar, but nonsignificant, in patients having an operation for cancer or for nonmalignant processes (2.1% versus 2.3%).

On adjusted analysis, being older, non-elective surgery, a history of VTE, and operations for inflammatory disease were associated with increased risk of 90-day VTE. However, despite the steady increase in chemoprophylaxis use in the perioperative and in-hospital settings, the annual VTE incidence remained low and largely unchanged, the researchers say. For example, the rate was 2.6% in 2007 and 3.0% in 2011.

In fact, the investigators say, "If nonselective perioperative and in-hospital prophylaxis is not successful in reducing rates of in-hospital VTE over time, are we placing patients at undue risk without significant benefit? With almost 40% of VTE events occurring after discharge, this may represent an area for quality improvement implementation."

As Dr. Steele told Reuters Health by email, "Despite our best practices, a small percentage of patients may still develop a VTE."

Prophylaxis efforts have improved greatly in the preoperative and perioperative in-hospital settings, but "in the post-discharge setting, we likely need a much larger randomized prospective study involving patients with similar risk profiles evaluating extended prophylaxis versus none to demonstrate whether or not this is a benefit." TH

—Reuters Health