Patrice Wendling

SAN FRANCISCO – The widely held belief that America’s obesity epidemic has resulted in an equally staggering number of children with type 2 diabetes may well be off the mark, according to Dr. Philip Zeitler.

"This is not an epidemic; type 2 diabetes in youth remains rare," said Dr. Zeitler, head of endocrinology, Children’s Hospital Colorado, Denver.

Although the prevalence of type 2 diabetes (T2D) in youth has risen substantially over the last decade, the best evidence to date from the SEARCH for Diabetes in Youth Study (Pediatrics 2006;118:1510-8) indicates that T2D is rare in children younger than 10 years of age (0.79/1,000), regardless of race or ethnicity.

Another, more recent look at prevalence by the SEARCH investigators in 2009 found the estimated total prevalence of T2D is, if anything, a little lower than the 2006 estimate (Diabetes Care 2014;37;402-8), he said.

"So the little 5-year-old child you hear about in the paper with diabetes either is extremely rare or doesn’t have type 2 diabetes," Dr. Zeitler said at the annual advanced postgraduate course held by the American Diabetes Association.

After 10 years of age, newly diagnosed cases represent about 15% of all diabetes cases in teenagers who are white, 46% of cases in Hispanic youth, 58% in blacks, 70% in Asian/Pacific Islanders, and 86% in Native Americans.

These numbers are "striking, even horrifying perhaps," said Dr. Zeitler, but are actually quite low when one considers the total number of cases is only about 3,700 youth under age 20 diagnosed with T2D in the United States annually.

To put this in context, an estimated 1.9 million adults, aged 20 and older, were newly diagnosed with diabetes in 2010, according to the Centers for Disease Control and Prevention.

The argument could be made that juvenile T2D is simply lurking under physicians’ radar. After all, 50% of adult cases are undiagnosed or picked up on screening. This is not the case with children, "even at the peak age in the highest-risk population," Dr. Zeitler said.

In fact, just 0.4% and 0.1% of eighth graders with a body mass index exceeding the 85th percentile had diabetes by fasting criteria and, more importantly, by oral glucose tolerance testing in the STOPP-T2D (Studies to Treat or Prevent Pediatric Type 2 Diabetes) trial (Diabetes Care 2006;29:212-7).

For those children who do get diabetes during this period, however, there may be a phenomenon that could be referred to as "pubertal diabetes," Dr. Zeitler said. Insulin resistance worsens as children enter puberty, but as they come out the other side and demand on the beta-cell decreases, many are able to compensate.

Indeed, in a small study involving 117 obese children and adolescents, 32% of those with impaired glucose tolerance, not surprisingly, progressed to diabetes within about 2 years, but another 32% regressed to normal glucose tolerance with no intervention (Diabetes Care 2005;28:902-9).

"This is highly analogous to something else we see all the time – otherwise healthy people who go into a certain state and develop diabetes, but when they get out of that state are either still diabetic or normal," he said. "This really appears to be an analog of gestational diabetes."

Importantly, for adolescents who are ultimately diagnosed with T2D, loss of beta-cell function is the primary predictor of failure to maintain glycemic control, Dr. Zeitler said.

He reported research support from the National Institute of Diabetes and Digestive and Kidney Diseases and the American Diabetes Association and clinical trial design consultancy for Daiichi-Sankyo, AstraZeneca, Merck, Janssen Pharmaceuticals, and Gilead Pharmaceuticals.

pwendling@frontlinemedcom.com

SAN FRANCISCO – The widely held belief that America’s obesity epidemic has resulted in an equally staggering number of children with type 2 diabetes may well be off the mark, according to Dr. Philip Zeitler.

"This is not an epidemic; type 2 diabetes in youth remains rare," said Dr. Zeitler, head of endocrinology, Children’s Hospital Colorado, Denver.

Although the prevalence of type 2 diabetes (T2D) in youth has risen substantially over the last decade, the best evidence to date from the SEARCH for Diabetes in Youth Study (Pediatrics 2006;118:1510-8) indicates that T2D is rare in children younger than 10 years of age (0.79/1,000), regardless of race or ethnicity.

Another, more recent look at prevalence by the SEARCH investigators in 2009 found the estimated total prevalence of T2D is, if anything, a little lower than the 2006 estimate (Diabetes Care 2014;37;402-8), he said.

"So the little 5-year-old child you hear about in the paper with diabetes either is extremely rare or doesn’t have type 2 diabetes," Dr. Zeitler said at the annual advanced postgraduate course held by the American Diabetes Association.

After 10 years of age, newly diagnosed cases represent about 15% of all diabetes cases in teenagers who are white, 46% of cases in Hispanic youth, 58% in blacks, 70% in Asian/Pacific Islanders, and 86% in Native Americans.

These numbers are "striking, even horrifying perhaps," said Dr. Zeitler, but are actually quite low when one considers the total number of cases is only about 3,700 youth under age 20 diagnosed with T2D in the United States annually.

To put this in context, an estimated 1.9 million adults, aged 20 and older, were newly diagnosed with diabetes in 2010, according to the Centers for Disease Control and Prevention.

The argument could be made that juvenile T2D is simply lurking under physicians’ radar. After all, 50% of adult cases are undiagnosed or picked up on screening. This is not the case with children, "even at the peak age in the highest-risk population," Dr. Zeitler said.

In fact, just 0.4% and 0.1% of eighth graders with a body mass index exceeding the 85th percentile had diabetes by fasting criteria and, more importantly, by oral glucose tolerance testing in the STOPP-T2D (Studies to Treat or Prevent Pediatric Type 2 Diabetes) trial (Diabetes Care 2006;29:212-7).

For those children who do get diabetes during this period, however, there may be a phenomenon that could be referred to as "pubertal diabetes," Dr. Zeitler said. Insulin resistance worsens as children enter puberty, but as they come out the other side and demand on the beta-cell decreases, many are able to compensate.

Indeed, in a small study involving 117 obese children and adolescents, 32% of those with impaired glucose tolerance, not surprisingly, progressed to diabetes within about 2 years, but another 32% regressed to normal glucose tolerance with no intervention (Diabetes Care 2005;28:902-9).

"This is highly analogous to something else we see all the time – otherwise healthy people who go into a certain state and develop diabetes, but when they get out of that state are either still diabetic or normal," he said. "This really appears to be an analog of gestational diabetes."

Importantly, for adolescents who are ultimately diagnosed with T2D, loss of beta-cell function is the primary predictor of failure to maintain glycemic control, Dr. Zeitler said.

He reported research support from the National Institute of Diabetes and Digestive and Kidney Diseases and the American Diabetes Association and clinical trial design consultancy for Daiichi-Sankyo, AstraZeneca, Merck, Janssen Pharmaceuticals, and Gilead Pharmaceuticals.

pwendling@frontlinemedcom.com

SAN FRANCISCO – The widely held belief that America’s obesity epidemic has resulted in an equally staggering number of children with type 2 diabetes may well be off the mark, according to Dr. Philip Zeitler.

"This is not an epidemic; type 2 diabetes in youth remains rare," said Dr. Zeitler, head of endocrinology, Children’s Hospital Colorado, Denver.

Although the prevalence of type 2 diabetes (T2D) in youth has risen substantially over the last decade, the best evidence to date from the SEARCH for Diabetes in Youth Study (Pediatrics 2006;118:1510-8) indicates that T2D is rare in children younger than 10 years of age (0.79/1,000), regardless of race or ethnicity.

Another, more recent look at prevalence by the SEARCH investigators in 2009 found the estimated total prevalence of T2D is, if anything, a little lower than the 2006 estimate (Diabetes Care 2014;37;402-8), he said.

"So the little 5-year-old child you hear about in the paper with diabetes either is extremely rare or doesn’t have type 2 diabetes," Dr. Zeitler said at the annual advanced postgraduate course held by the American Diabetes Association.

After 10 years of age, newly diagnosed cases represent about 15% of all diabetes cases in teenagers who are white, 46% of cases in Hispanic youth, 58% in blacks, 70% in Asian/Pacific Islanders, and 86% in Native Americans.

These numbers are "striking, even horrifying perhaps," said Dr. Zeitler, but are actually quite low when one considers the total number of cases is only about 3,700 youth under age 20 diagnosed with T2D in the United States annually.

To put this in context, an estimated 1.9 million adults, aged 20 and older, were newly diagnosed with diabetes in 2010, according to the Centers for Disease Control and Prevention.

The argument could be made that juvenile T2D is simply lurking under physicians’ radar. After all, 50% of adult cases are undiagnosed or picked up on screening. This is not the case with children, "even at the peak age in the highest-risk population," Dr. Zeitler said.

In fact, just 0.4% and 0.1% of eighth graders with a body mass index exceeding the 85th percentile had diabetes by fasting criteria and, more importantly, by oral glucose tolerance testing in the STOPP-T2D (Studies to Treat or Prevent Pediatric Type 2 Diabetes) trial (Diabetes Care 2006;29:212-7).

For those children who do get diabetes during this period, however, there may be a phenomenon that could be referred to as "pubertal diabetes," Dr. Zeitler said. Insulin resistance worsens as children enter puberty, but as they come out the other side and demand on the beta-cell decreases, many are able to compensate.

Indeed, in a small study involving 117 obese children and adolescents, 32% of those with impaired glucose tolerance, not surprisingly, progressed to diabetes within about 2 years, but another 32% regressed to normal glucose tolerance with no intervention (Diabetes Care 2005;28:902-9).

"This is highly analogous to something else we see all the time – otherwise healthy people who go into a certain state and develop diabetes, but when they get out of that state are either still diabetic or normal," he said. "This really appears to be an analog of gestational diabetes."

Importantly, for adolescents who are ultimately diagnosed with T2D, loss of beta-cell function is the primary predictor of failure to maintain glycemic control, Dr. Zeitler said.

He reported research support from the National Institute of Diabetes and Digestive and Kidney Diseases and the American Diabetes Association and clinical trial design consultancy for Daiichi-Sankyo, AstraZeneca, Merck, Janssen Pharmaceuticals, and Gilead Pharmaceuticals.

pwendling@frontlinemedcom.com

NAPLES, FLA. – Only fewer prior abdominal surgeries predicted successful laparoscopic gall bladder surgery after percutaneous cholecystostomy tube placement in a review of 245 patients.

Notably, the degree of illness at the time of percutaneous cholecystostomy tube (PCT) placement did not seem to influence the rate of laparoscopy, Dr. Mohammad Khasawneh reported at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.

"Our data suggest that having three or more prior abdominal operations seemed to reliably lean toward conversion to an open cholecystectomy," he said in an interview.

Many patients with high operative morbidity and mortality risk developing cholecystitis and are treated with PCT drainage. Cholecystectomy after PCT placement is the definitive treatment for cholecystitis among patients whose risk profile improves, but it is unclear which patients will be able to have a laparoscopic cholecystectomy, explained Dr. Khasawneh, with the department of surgery at the Mayo Clinic, Rochester, Minn.

The investigators reviewed 245 patients who had a PCT placed at the clinic from 2009 to 2011. Their median age was 71 years, and two-thirds were male. Of these, 43 patients died, 131 were not surgical candidates, and 71 went on to interval cholecystectomy in a median of 55 days (range, 42-75 days).

Laparoscopy was planned for 63 patients (89%) and successfully completed in 50 (79%), with 13 converted to open surgery. Eight cases were originally planned for open surgery.

The high mortality rate after PCT placement (17.5%) was due to the presence of comorbid conditions, according to Dr. Khasawneh.

Index admission comorbidities among cholecystectomy and non-cholecystectomy patients were prior abdominal surgeries (44% vs. 55%, respectively), mechanical ventilation (8% vs. 16%), steroid use (8.5% vs. 15%), anticoagulation use (28% vs. 32%), vasopressor use (10% both), and dysrhythmia (23% vs. 27%).

Interval cholecystectomy patients had a significantly lower overall Charlson Comorbidity Index (5 vs. 6; P = .005) and spent significantly less time in the intensive care unit (3 vs. 7 days; P less than .01) and hospital (6 vs. 9 days; P less than .01), he reported.

In multivariable regression analysis, comorbidity index and number of prior abdominal operations significantly predicted interval cholecystectomy, whereas age (odds ratio, 1.1; P = .39), presence of stones (OR, 1.7; P = .11), and mechanical ventilation at the time of PCT drainage (OR, 0.55; P = .12) did not.

Only the number of prior abdominal operations significantly predicted laparoscopic cholecystectomy (OR, 0.52; P = .02), Dr. Khasawneh reported.

"Patients who are medically cleared for cholecystectomy should have an attempt at laparoscopic cholecystectomy unless they have multiple prior operations," the authors concluded.

Dr. Khasawneh and his coauthors reported having no financial disclosures.

pwendling@frontlinemedcom.com

NAPLES, FLA. – Only fewer prior abdominal surgeries predicted successful laparoscopic gall bladder surgery after percutaneous cholecystostomy tube placement in a review of 245 patients.

Notably, the degree of illness at the time of percutaneous cholecystostomy tube (PCT) placement did not seem to influence the rate of laparoscopy, Dr. Mohammad Khasawneh reported at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.

"Our data suggest that having three or more prior abdominal operations seemed to reliably lean toward conversion to an open cholecystectomy," he said in an interview.

Many patients with high operative morbidity and mortality risk developing cholecystitis and are treated with PCT drainage. Cholecystectomy after PCT placement is the definitive treatment for cholecystitis among patients whose risk profile improves, but it is unclear which patients will be able to have a laparoscopic cholecystectomy, explained Dr. Khasawneh, with the department of surgery at the Mayo Clinic, Rochester, Minn.

The investigators reviewed 245 patients who had a PCT placed at the clinic from 2009 to 2011. Their median age was 71 years, and two-thirds were male. Of these, 43 patients died, 131 were not surgical candidates, and 71 went on to interval cholecystectomy in a median of 55 days (range, 42-75 days).

Laparoscopy was planned for 63 patients (89%) and successfully completed in 50 (79%), with 13 converted to open surgery. Eight cases were originally planned for open surgery.

The high mortality rate after PCT placement (17.5%) was due to the presence of comorbid conditions, according to Dr. Khasawneh.

Index admission comorbidities among cholecystectomy and non-cholecystectomy patients were prior abdominal surgeries (44% vs. 55%, respectively), mechanical ventilation (8% vs. 16%), steroid use (8.5% vs. 15%), anticoagulation use (28% vs. 32%), vasopressor use (10% both), and dysrhythmia (23% vs. 27%).

Interval cholecystectomy patients had a significantly lower overall Charlson Comorbidity Index (5 vs. 6; P = .005) and spent significantly less time in the intensive care unit (3 vs. 7 days; P less than .01) and hospital (6 vs. 9 days; P less than .01), he reported.

In multivariable regression analysis, comorbidity index and number of prior abdominal operations significantly predicted interval cholecystectomy, whereas age (odds ratio, 1.1; P = .39), presence of stones (OR, 1.7; P = .11), and mechanical ventilation at the time of PCT drainage (OR, 0.55; P = .12) did not.

Only the number of prior abdominal operations significantly predicted laparoscopic cholecystectomy (OR, 0.52; P = .02), Dr. Khasawneh reported.

"Patients who are medically cleared for cholecystectomy should have an attempt at laparoscopic cholecystectomy unless they have multiple prior operations," the authors concluded.

Dr. Khasawneh and his coauthors reported having no financial disclosures.

pwendling@frontlinemedcom.com

NAPLES, FLA. – Only fewer prior abdominal surgeries predicted successful laparoscopic gall bladder surgery after percutaneous cholecystostomy tube placement in a review of 245 patients.

Notably, the degree of illness at the time of percutaneous cholecystostomy tube (PCT) placement did not seem to influence the rate of laparoscopy, Dr. Mohammad Khasawneh reported at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.

"Our data suggest that having three or more prior abdominal operations seemed to reliably lean toward conversion to an open cholecystectomy," he said in an interview.

Many patients with high operative morbidity and mortality risk developing cholecystitis and are treated with PCT drainage. Cholecystectomy after PCT placement is the definitive treatment for cholecystitis among patients whose risk profile improves, but it is unclear which patients will be able to have a laparoscopic cholecystectomy, explained Dr. Khasawneh, with the department of surgery at the Mayo Clinic, Rochester, Minn.

The investigators reviewed 245 patients who had a PCT placed at the clinic from 2009 to 2011. Their median age was 71 years, and two-thirds were male. Of these, 43 patients died, 131 were not surgical candidates, and 71 went on to interval cholecystectomy in a median of 55 days (range, 42-75 days).

Laparoscopy was planned for 63 patients (89%) and successfully completed in 50 (79%), with 13 converted to open surgery. Eight cases were originally planned for open surgery.

The high mortality rate after PCT placement (17.5%) was due to the presence of comorbid conditions, according to Dr. Khasawneh.

Index admission comorbidities among cholecystectomy and non-cholecystectomy patients were prior abdominal surgeries (44% vs. 55%, respectively), mechanical ventilation (8% vs. 16%), steroid use (8.5% vs. 15%), anticoagulation use (28% vs. 32%), vasopressor use (10% both), and dysrhythmia (23% vs. 27%).

Interval cholecystectomy patients had a significantly lower overall Charlson Comorbidity Index (5 vs. 6; P = .005) and spent significantly less time in the intensive care unit (3 vs. 7 days; P less than .01) and hospital (6 vs. 9 days; P less than .01), he reported.

In multivariable regression analysis, comorbidity index and number of prior abdominal operations significantly predicted interval cholecystectomy, whereas age (odds ratio, 1.1; P = .39), presence of stones (OR, 1.7; P = .11), and mechanical ventilation at the time of PCT drainage (OR, 0.55; P = .12) did not.

Only the number of prior abdominal operations significantly predicted laparoscopic cholecystectomy (OR, 0.52; P = .02), Dr. Khasawneh reported.

"Patients who are medically cleared for cholecystectomy should have an attempt at laparoscopic cholecystectomy unless they have multiple prior operations," the authors concluded.

Dr. Khasawneh and his coauthors reported having no financial disclosures.

pwendling@frontlinemedcom.com

CHICAGO – CHICAGO - Advanced imaging techniques may play an increasing role in targeting the delivery of bronchial thermoplasty in severe, uncontrolled asthma.

"It's off-label at this point, but I think this is where we're going with this therapy," Dr. Mario Castro, FCCP, said at the annual meeting of the American College of Chest Physicians. "Perhaps we can do a better job to target this therapy, just like phenotyping our patients [for novel biologic agents]."
Reconstruction of the airway and parenchyma using diagnostic software during an inspiratory computed tomography (CT) scan allows clinicians to measure all of the lung airways in a systematic way, said Dr. Castro, director of the asthma and airway translational research unit, Washington University School of Medicine, St. Louis.

In the case of a 50-year-old patient with severe persistent asthma, the technique revealed a clearly remodeled airway with a 63% average wall area, but also areas of great heterogeneity in all segmental airways. "What we find is that some airways are remodeled more than others," Dr. Castro said.
The university also now images its patients by combining inhaled hyperpolarized helium gas with magnetic resonance imaging from the apex all the way to the base of the lung. A color algorithm CT mask imposed on the MRI allows the team to quantify ventilation defects before and after bronchial thermoplasty.

Earlier this year, Dr. Castro's colleague, Dr. Ajay Sheshadri, reported that patients with severe asthma have asignificantly  higher baseline ventilation defect percentage (VDP) than healthy subjects (mean 24.4% vs. 3.5%; P = .003). VDP improved by about 7% overall after bronchial thermoplasty (P = .10), with some patients having a marked improvement in VDP, while others did not, Dr. Castro said.

Baseline characteristics were analyzed in an effort to identify responders, and "we were very surprised to find that sputum eosinophilia was the one that trended best in predicting a change in ventilation defect score," he added.

Dr. Castro's team is also using xenon gas instead of helium with MRI, because it is more readily available and less expensive. Other groups are using confocal CT to evaluate airways for bronchial thermoplasty, he noted.

Dr. Castro stressed that 13 years of cumulative experience have shown that bronchial thermoplasty is safe and effective, but that careful initial evaluation of candidates remains essential. The American Thoracic Society and European Respiratory Society are expected to release new guidelines early next year for the initial evaluation of all severe asthmatics that recommend six tests, including blood work, spirometry, immunoglobulin E assessment with skin prick tests or an immunoabsorbent assay, and multidetector CT, to evaluate for other conditions mimicking asthma.

"With this basic evaluation in our center, we find about one out of every three patients are really not pure asthma; they're asthma mixed with significant bronchiectasis or no asthma at all, or they have underlying emphysema from prior smoke exposure," said Dr. Castro. "So it is very important that we take a step back with these patients and look."

During a discussion following the presentation, Dr. Castro said he would use bronchial thermoplasty to treat patients with incomplete reversibility of airflow obstruction, but does not advocate repeat treatments because of the potential for additional injury.

"What we do advocate is that we extensively treat all the airways that we can access, and that you treat with continuous therapies," he said. "The average activations in the lower, lower [airway] is around 60, but in some cases I've done up to around 140-150 activations, just because they've had an extensive bronchial tree that I needed to treat." … If you have a nonresponder, even 5 years out, I wouldn't treat because I think smooth muscle is probably not their main problem."

Dr. Castro reported research support, lecturing, and consulting for numerous firms including Boston Scientific, maker of the Alair bronchial thermoplasty system.

 

Dr. Eric Gartman, FCCP, comments: Severe asthma patients are a heterogenous population, and any modality that augments our ability to discriminate the best treatment option for an individual patient is eagerly welcomed.

As this field of research matures, we may begin to tailor our therapies more effectively to those who will benefit most.

CHICAGO – CHICAGO - Advanced imaging techniques may play an increasing role in targeting the delivery of bronchial thermoplasty in severe, uncontrolled asthma.

"It's off-label at this point, but I think this is where we're going with this therapy," Dr. Mario Castro, FCCP, said at the annual meeting of the American College of Chest Physicians. "Perhaps we can do a better job to target this therapy, just like phenotyping our patients [for novel biologic agents]."
Reconstruction of the airway and parenchyma using diagnostic software during an inspiratory computed tomography (CT) scan allows clinicians to measure all of the lung airways in a systematic way, said Dr. Castro, director of the asthma and airway translational research unit, Washington University School of Medicine, St. Louis.

In the case of a 50-year-old patient with severe persistent asthma, the technique revealed a clearly remodeled airway with a 63% average wall area, but also areas of great heterogeneity in all segmental airways. "What we find is that some airways are remodeled more than others," Dr. Castro said.
The university also now images its patients by combining inhaled hyperpolarized helium gas with magnetic resonance imaging from the apex all the way to the base of the lung. A color algorithm CT mask imposed on the MRI allows the team to quantify ventilation defects before and after bronchial thermoplasty.

Earlier this year, Dr. Castro's colleague, Dr. Ajay Sheshadri, reported that patients with severe asthma have asignificantly  higher baseline ventilation defect percentage (VDP) than healthy subjects (mean 24.4% vs. 3.5%; P = .003). VDP improved by about 7% overall after bronchial thermoplasty (P = .10), with some patients having a marked improvement in VDP, while others did not, Dr. Castro said.

Baseline characteristics were analyzed in an effort to identify responders, and "we were very surprised to find that sputum eosinophilia was the one that trended best in predicting a change in ventilation defect score," he added.

Dr. Castro's team is also using xenon gas instead of helium with MRI, because it is more readily available and less expensive. Other groups are using confocal CT to evaluate airways for bronchial thermoplasty, he noted.

Dr. Castro stressed that 13 years of cumulative experience have shown that bronchial thermoplasty is safe and effective, but that careful initial evaluation of candidates remains essential. The American Thoracic Society and European Respiratory Society are expected to release new guidelines early next year for the initial evaluation of all severe asthmatics that recommend six tests, including blood work, spirometry, immunoglobulin E assessment with skin prick tests or an immunoabsorbent assay, and multidetector CT, to evaluate for other conditions mimicking asthma.

"With this basic evaluation in our center, we find about one out of every three patients are really not pure asthma; they're asthma mixed with significant bronchiectasis or no asthma at all, or they have underlying emphysema from prior smoke exposure," said Dr. Castro. "So it is very important that we take a step back with these patients and look."

During a discussion following the presentation, Dr. Castro said he would use bronchial thermoplasty to treat patients with incomplete reversibility of airflow obstruction, but does not advocate repeat treatments because of the potential for additional injury.

"What we do advocate is that we extensively treat all the airways that we can access, and that you treat with continuous therapies," he said. "The average activations in the lower, lower [airway] is around 60, but in some cases I've done up to around 140-150 activations, just because they've had an extensive bronchial tree that I needed to treat." … If you have a nonresponder, even 5 years out, I wouldn't treat because I think smooth muscle is probably not their main problem."

Dr. Castro reported research support, lecturing, and consulting for numerous firms including Boston Scientific, maker of the Alair bronchial thermoplasty system.

 

Dr. Eric Gartman, FCCP, comments: Severe asthma patients are a heterogenous population, and any modality that augments our ability to discriminate the best treatment option for an individual patient is eagerly welcomed.

As this field of research matures, we may begin to tailor our therapies more effectively to those who will benefit most.

CHICAGO – CHICAGO - Advanced imaging techniques may play an increasing role in targeting the delivery of bronchial thermoplasty in severe, uncontrolled asthma.

"It's off-label at this point, but I think this is where we're going with this therapy," Dr. Mario Castro, FCCP, said at the annual meeting of the American College of Chest Physicians. "Perhaps we can do a better job to target this therapy, just like phenotyping our patients [for novel biologic agents]."
Reconstruction of the airway and parenchyma using diagnostic software during an inspiratory computed tomography (CT) scan allows clinicians to measure all of the lung airways in a systematic way, said Dr. Castro, director of the asthma and airway translational research unit, Washington University School of Medicine, St. Louis.

In the case of a 50-year-old patient with severe persistent asthma, the technique revealed a clearly remodeled airway with a 63% average wall area, but also areas of great heterogeneity in all segmental airways. "What we find is that some airways are remodeled more than others," Dr. Castro said.
The university also now images its patients by combining inhaled hyperpolarized helium gas with magnetic resonance imaging from the apex all the way to the base of the lung. A color algorithm CT mask imposed on the MRI allows the team to quantify ventilation defects before and after bronchial thermoplasty.

Earlier this year, Dr. Castro's colleague, Dr. Ajay Sheshadri, reported that patients with severe asthma have asignificantly  higher baseline ventilation defect percentage (VDP) than healthy subjects (mean 24.4% vs. 3.5%; P = .003). VDP improved by about 7% overall after bronchial thermoplasty (P = .10), with some patients having a marked improvement in VDP, while others did not, Dr. Castro said.

Baseline characteristics were analyzed in an effort to identify responders, and "we were very surprised to find that sputum eosinophilia was the one that trended best in predicting a change in ventilation defect score," he added.

Dr. Castro's team is also using xenon gas instead of helium with MRI, because it is more readily available and less expensive. Other groups are using confocal CT to evaluate airways for bronchial thermoplasty, he noted.

Dr. Castro stressed that 13 years of cumulative experience have shown that bronchial thermoplasty is safe and effective, but that careful initial evaluation of candidates remains essential. The American Thoracic Society and European Respiratory Society are expected to release new guidelines early next year for the initial evaluation of all severe asthmatics that recommend six tests, including blood work, spirometry, immunoglobulin E assessment with skin prick tests or an immunoabsorbent assay, and multidetector CT, to evaluate for other conditions mimicking asthma.

"With this basic evaluation in our center, we find about one out of every three patients are really not pure asthma; they're asthma mixed with significant bronchiectasis or no asthma at all, or they have underlying emphysema from prior smoke exposure," said Dr. Castro. "So it is very important that we take a step back with these patients and look."

During a discussion following the presentation, Dr. Castro said he would use bronchial thermoplasty to treat patients with incomplete reversibility of airflow obstruction, but does not advocate repeat treatments because of the potential for additional injury.

"What we do advocate is that we extensively treat all the airways that we can access, and that you treat with continuous therapies," he said. "The average activations in the lower, lower [airway] is around 60, but in some cases I've done up to around 140-150 activations, just because they've had an extensive bronchial tree that I needed to treat." … If you have a nonresponder, even 5 years out, I wouldn't treat because I think smooth muscle is probably not their main problem."

Dr. Castro reported research support, lecturing, and consulting for numerous firms including Boston Scientific, maker of the Alair bronchial thermoplasty system.

 

Dr. Eric Gartman, FCCP, comments: Severe asthma patients are a heterogenous population, and any modality that augments our ability to discriminate the best treatment option for an individual patient is eagerly welcomed.

As this field of research matures, we may begin to tailor our therapies more effectively to those who will benefit most.

SAN FRANCISCO – Updated guidelines from the American Diabetes Association open the door to using a two-step approach to gestational diabetes screening.

Screening is still recommended for undiagnosed type 2 diabetes at the first prenatal visit in those with risk factors, and for gestational diabetes mellitus (GDM) between weeks 24 and 28 of gestation.

What’s changed in the 2014 Standards of Medical Care in Diabetes (Diabetes Care 2014;37(suppl 1):S14-80) is how that screening is accomplished, Dr. Richard W. Grant, chair of the ADA professional practice committee, said at the annual advanced postgraduate course held by the American Diabetes Association.

In prior years, the ADA adopted the International Association of Diabetes and Pregnancy Study Groups (IADPSG) 2009 recommendation that a 2-hour, 75-gram oral glucose tolerance test (OGTT) be performed the morning after a fast of at least an 8 hours.

A two-step approach was added this year to reflect the 2013 National Institutes of Health Consensus Guidelines recommendation for a 1-hour, 50-gram glucose tolerance screening test followed by a fasting OGTT on another day, if the test is abnormal.

One-step vs. two-step approach

"The issues for these two approaches are the sensitivity with which you can diagnose GDM and the difficulty in implementing these two approaches," said Dr. Grant, a research scientist with Kaiser Permanente Northern California, Oakland.

The one-step approach tends to be more sensitive and diagnoses a broader range of GDM, but it may be a barrier to screening because it requires the patient to fast for 8 hours, he said. Though the one-step approach allows for a diagnosis of GDM within the context of a single office visit, critics also argue its tight diagnostic glucose cut points could dramatically increase the prevalence of GDM from about 5%-6% to 15%-20%, and bring added health care costs and interventions without clear evidence of improved outcomes.

On the other hand, the two-step approach may be more palatable to women because it avoids the up-front fasting requirement, but it could miss GDM in women with an abnormal screen who fail to return for a second visit.

"The bottom line is we need to make sure we do gestational diabetes screening, whichever method we use," Dr. Grant said. "What’s more important is that all women in early pregnancy get screened."

During a discussion following the presentation, a Canadian attendee said similar recommendations released last fall in Canada allowing two screening methods, albeit with different diagnostic thresholds, have resulted in confusion, particularly among referring obstetricians and endocrinologists.

Dr. Grant said there shouldn’t be confusion surrounding the new option as long as recommendations are consistent within an institution.

"I don’t think it’s actually going to make people change what they’re doing currently," he said in an interview. "There’s not a good reason to jump from one to another if you’ve already chosen an approach."

In a separate interview, Dr. R. Harsha Rao, with the Center for Diabetes and Endocrinology at the University of Pittsburgh, said he can see the rationale for the one-step method, but that the two-step approach is almost implanted in the DNA of American obstetricians and that this behavior pattern will be difficult to change for practical reasons alone.

"Patients don’t like 75 grams of Glucola; it’s an awful-tasting substance," he said. "I’ve had patients tell me they felt like [vomiting] when they got the 75-gram Glucola load, and as it is, ‘I’m pregnant and already feeling nauseated.’ "

In addition, there’s the added stress of waiting for a second appointment and a definitive diagnosis for women who screen positive.

The ADA’s bimodal approach to gestational screening reflects an overarching theme of individualized care for diabetes in the 2014 standards. The guidelines are updated annually and this year they contain 232 recommendations, of which 52% are based on high level A or B evidence.

Individualized diabetes care

"One of the themes that comes out in looking at the data very carefully is that you can’t have a one-size-fits-all approach," Dr. Grant observed.

To that end, the guidelines maintain an earlier recommendation raising the systolic blood pressure target goal for hypertension to 140 mm Hg, but also allow a target goal of less than 130 mm Hg in certain populations, such as younger patients.

Dr. Grant observed that the ADA’s position was confirmed by the U.S. Preventive Services Task Force’s recent endorsement of GDM screening using the two-step approach.

"The USPSTF said that the two-step method is an accurate approach, which is what the ADA also says," he remarked.

Based on the recently revised 2013 ADA nutrition position paper (described in the next section below), the guidelines also encourage individualized dietary approaches rather recommending one particular diet over another, Dr. Grant said.

Other revisions include:

• Clarification that the hemoglobin A_1c test is just one of three methods to diagnose diabetes in asymptomatic patients, along with the fasting plasma glucose or 75-gram, 2-hour OGTT;

• An expanded chapter on neuropathy screening and treatment, including B level evidentiary support to test for distal symmetric polyneuropathy;

• Added emphasis on the need to ask patients about symptomatic and asymptomatic hypoglycemia and perform ongoing assessments of cognitive function; and

• Added emphasis on a patient-centered communication style that assesses literacy, but also the often overlooked issue of numeracy.

"It’s really quite impressive how many patients don’t get numbers, but we as physicians speak in numbers," Dr. Grant said.

The recent controversial 2013 American College of Cardiology/American Heart Association cholesterol guideline could not be reviewed in time to for this year’s guidelines, but it will be something to keep an eye out for next year.

ADA dodges dietary dogma

Highlights of the American Diabetes Association’s nutrition recommendations, updated in late 2013, and also presented at the meeting by Patti Urbanski, M.Ed., a member of the ADA Nutrition Recommendations Writing Group Committee, include:

• Select an "eating pattern" based on an individual’s personal and cultural preferences; literacy and numeracy; readiness; and ability to change, because no one dietary plan – be it the Mediterranean, low-carb, or DASH (Dietary Approaches to Stop Hypertension) diet – is best.

• In the absence of evidence supporting an ideal percentage of calories from carbohydrates, protein, or fat for all patients with diabetes, macronutrient distribution should be based on individualized assessment of current eating patterns, preferences, and goals.

• Reduce energy intake/carbohydrate portions and number of servings per meal, as indicated by individual assessment.

• Early referral to registered dietitians and nutritionists for nutrition therapy.

• First-ever call to avoid sugar-sweetened beverages.

• Continued support to limit sodium intake to 2,300 mg/day, as recommended for the general population, with lower sodium targets an option for those with comorbid hypertension.

• Routine supplementation with oxidants, such as vitamin E and C and carotene, is not advised, nor is routine use of micronutrients such as chromium, magnesium, and vitamin D to improve glycemic control.

Dr. Grant disclosed no conflicts of interest.

pwendling@frontlinemedcom.com

SAN FRANCISCO – Updated guidelines from the American Diabetes Association open the door to using a two-step approach to gestational diabetes screening.

Screening is still recommended for undiagnosed type 2 diabetes at the first prenatal visit in those with risk factors, and for gestational diabetes mellitus (GDM) between weeks 24 and 28 of gestation.

What’s changed in the 2014 Standards of Medical Care in Diabetes (Diabetes Care 2014;37(suppl 1):S14-80) is how that screening is accomplished, Dr. Richard W. Grant, chair of the ADA professional practice committee, said at the annual advanced postgraduate course held by the American Diabetes Association.

In prior years, the ADA adopted the International Association of Diabetes and Pregnancy Study Groups (IADPSG) 2009 recommendation that a 2-hour, 75-gram oral glucose tolerance test (OGTT) be performed the morning after a fast of at least an 8 hours.

A two-step approach was added this year to reflect the 2013 National Institutes of Health Consensus Guidelines recommendation for a 1-hour, 50-gram glucose tolerance screening test followed by a fasting OGTT on another day, if the test is abnormal.

One-step vs. two-step approach

"The issues for these two approaches are the sensitivity with which you can diagnose GDM and the difficulty in implementing these two approaches," said Dr. Grant, a research scientist with Kaiser Permanente Northern California, Oakland.

The one-step approach tends to be more sensitive and diagnoses a broader range of GDM, but it may be a barrier to screening because it requires the patient to fast for 8 hours, he said. Though the one-step approach allows for a diagnosis of GDM within the context of a single office visit, critics also argue its tight diagnostic glucose cut points could dramatically increase the prevalence of GDM from about 5%-6% to 15%-20%, and bring added health care costs and interventions without clear evidence of improved outcomes.

On the other hand, the two-step approach may be more palatable to women because it avoids the up-front fasting requirement, but it could miss GDM in women with an abnormal screen who fail to return for a second visit.

"The bottom line is we need to make sure we do gestational diabetes screening, whichever method we use," Dr. Grant said. "What’s more important is that all women in early pregnancy get screened."

During a discussion following the presentation, a Canadian attendee said similar recommendations released last fall in Canada allowing two screening methods, albeit with different diagnostic thresholds, have resulted in confusion, particularly among referring obstetricians and endocrinologists.

Dr. Grant said there shouldn’t be confusion surrounding the new option as long as recommendations are consistent within an institution.

"I don’t think it’s actually going to make people change what they’re doing currently," he said in an interview. "There’s not a good reason to jump from one to another if you’ve already chosen an approach."

In a separate interview, Dr. R. Harsha Rao, with the Center for Diabetes and Endocrinology at the University of Pittsburgh, said he can see the rationale for the one-step method, but that the two-step approach is almost implanted in the DNA of American obstetricians and that this behavior pattern will be difficult to change for practical reasons alone.

"Patients don’t like 75 grams of Glucola; it’s an awful-tasting substance," he said. "I’ve had patients tell me they felt like [vomiting] when they got the 75-gram Glucola load, and as it is, ‘I’m pregnant and already feeling nauseated.’ "

In addition, there’s the added stress of waiting for a second appointment and a definitive diagnosis for women who screen positive.

The ADA’s bimodal approach to gestational screening reflects an overarching theme of individualized care for diabetes in the 2014 standards. The guidelines are updated annually and this year they contain 232 recommendations, of which 52% are based on high level A or B evidence.

Individualized diabetes care

"One of the themes that comes out in looking at the data very carefully is that you can’t have a one-size-fits-all approach," Dr. Grant observed.

To that end, the guidelines maintain an earlier recommendation raising the systolic blood pressure target goal for hypertension to 140 mm Hg, but also allow a target goal of less than 130 mm Hg in certain populations, such as younger patients.

Dr. Grant observed that the ADA’s position was confirmed by the U.S. Preventive Services Task Force’s recent endorsement of GDM screening using the two-step approach.

"The USPSTF said that the two-step method is an accurate approach, which is what the ADA also says," he remarked.

Based on the recently revised 2013 ADA nutrition position paper (described in the next section below), the guidelines also encourage individualized dietary approaches rather recommending one particular diet over another, Dr. Grant said.

Other revisions include:

• Clarification that the hemoglobin A_1c test is just one of three methods to diagnose diabetes in asymptomatic patients, along with the fasting plasma glucose or 75-gram, 2-hour OGTT;

• An expanded chapter on neuropathy screening and treatment, including B level evidentiary support to test for distal symmetric polyneuropathy;

• Added emphasis on the need to ask patients about symptomatic and asymptomatic hypoglycemia and perform ongoing assessments of cognitive function; and

• Added emphasis on a patient-centered communication style that assesses literacy, but also the often overlooked issue of numeracy.

"It’s really quite impressive how many patients don’t get numbers, but we as physicians speak in numbers," Dr. Grant said.

The recent controversial 2013 American College of Cardiology/American Heart Association cholesterol guideline could not be reviewed in time to for this year’s guidelines, but it will be something to keep an eye out for next year.

ADA dodges dietary dogma

Highlights of the American Diabetes Association’s nutrition recommendations, updated in late 2013, and also presented at the meeting by Patti Urbanski, M.Ed., a member of the ADA Nutrition Recommendations Writing Group Committee, include:

• Select an "eating pattern" based on an individual’s personal and cultural preferences; literacy and numeracy; readiness; and ability to change, because no one dietary plan – be it the Mediterranean, low-carb, or DASH (Dietary Approaches to Stop Hypertension) diet – is best.

• In the absence of evidence supporting an ideal percentage of calories from carbohydrates, protein, or fat for all patients with diabetes, macronutrient distribution should be based on individualized assessment of current eating patterns, preferences, and goals.

• Reduce energy intake/carbohydrate portions and number of servings per meal, as indicated by individual assessment.

• Early referral to registered dietitians and nutritionists for nutrition therapy.

• First-ever call to avoid sugar-sweetened beverages.

• Continued support to limit sodium intake to 2,300 mg/day, as recommended for the general population, with lower sodium targets an option for those with comorbid hypertension.

• Routine supplementation with oxidants, such as vitamin E and C and carotene, is not advised, nor is routine use of micronutrients such as chromium, magnesium, and vitamin D to improve glycemic control.

Dr. Grant disclosed no conflicts of interest.

pwendling@frontlinemedcom.com

SAN FRANCISCO – Updated guidelines from the American Diabetes Association open the door to using a two-step approach to gestational diabetes screening.

Screening is still recommended for undiagnosed type 2 diabetes at the first prenatal visit in those with risk factors, and for gestational diabetes mellitus (GDM) between weeks 24 and 28 of gestation.

What’s changed in the 2014 Standards of Medical Care in Diabetes (Diabetes Care 2014;37(suppl 1):S14-80) is how that screening is accomplished, Dr. Richard W. Grant, chair of the ADA professional practice committee, said at the annual advanced postgraduate course held by the American Diabetes Association.

In prior years, the ADA adopted the International Association of Diabetes and Pregnancy Study Groups (IADPSG) 2009 recommendation that a 2-hour, 75-gram oral glucose tolerance test (OGTT) be performed the morning after a fast of at least an 8 hours.

A two-step approach was added this year to reflect the 2013 National Institutes of Health Consensus Guidelines recommendation for a 1-hour, 50-gram glucose tolerance screening test followed by a fasting OGTT on another day, if the test is abnormal.

One-step vs. two-step approach

"The issues for these two approaches are the sensitivity with which you can diagnose GDM and the difficulty in implementing these two approaches," said Dr. Grant, a research scientist with Kaiser Permanente Northern California, Oakland.

The one-step approach tends to be more sensitive and diagnoses a broader range of GDM, but it may be a barrier to screening because it requires the patient to fast for 8 hours, he said. Though the one-step approach allows for a diagnosis of GDM within the context of a single office visit, critics also argue its tight diagnostic glucose cut points could dramatically increase the prevalence of GDM from about 5%-6% to 15%-20%, and bring added health care costs and interventions without clear evidence of improved outcomes.

On the other hand, the two-step approach may be more palatable to women because it avoids the up-front fasting requirement, but it could miss GDM in women with an abnormal screen who fail to return for a second visit.

"The bottom line is we need to make sure we do gestational diabetes screening, whichever method we use," Dr. Grant said. "What’s more important is that all women in early pregnancy get screened."

During a discussion following the presentation, a Canadian attendee said similar recommendations released last fall in Canada allowing two screening methods, albeit with different diagnostic thresholds, have resulted in confusion, particularly among referring obstetricians and endocrinologists.

Dr. Grant said there shouldn’t be confusion surrounding the new option as long as recommendations are consistent within an institution.

"I don’t think it’s actually going to make people change what they’re doing currently," he said in an interview. "There’s not a good reason to jump from one to another if you’ve already chosen an approach."

In a separate interview, Dr. R. Harsha Rao, with the Center for Diabetes and Endocrinology at the University of Pittsburgh, said he can see the rationale for the one-step method, but that the two-step approach is almost implanted in the DNA of American obstetricians and that this behavior pattern will be difficult to change for practical reasons alone.

"Patients don’t like 75 grams of Glucola; it’s an awful-tasting substance," he said. "I’ve had patients tell me they felt like [vomiting] when they got the 75-gram Glucola load, and as it is, ‘I’m pregnant and already feeling nauseated.’ "

In addition, there’s the added stress of waiting for a second appointment and a definitive diagnosis for women who screen positive.

The ADA’s bimodal approach to gestational screening reflects an overarching theme of individualized care for diabetes in the 2014 standards. The guidelines are updated annually and this year they contain 232 recommendations, of which 52% are based on high level A or B evidence.

Individualized diabetes care

"One of the themes that comes out in looking at the data very carefully is that you can’t have a one-size-fits-all approach," Dr. Grant observed.

To that end, the guidelines maintain an earlier recommendation raising the systolic blood pressure target goal for hypertension to 140 mm Hg, but also allow a target goal of less than 130 mm Hg in certain populations, such as younger patients.

Dr. Grant observed that the ADA’s position was confirmed by the U.S. Preventive Services Task Force’s recent endorsement of GDM screening using the two-step approach.

"The USPSTF said that the two-step method is an accurate approach, which is what the ADA also says," he remarked.

Based on the recently revised 2013 ADA nutrition position paper (described in the next section below), the guidelines also encourage individualized dietary approaches rather recommending one particular diet over another, Dr. Grant said.

Other revisions include:

• Clarification that the hemoglobin A_1c test is just one of three methods to diagnose diabetes in asymptomatic patients, along with the fasting plasma glucose or 75-gram, 2-hour OGTT;

• An expanded chapter on neuropathy screening and treatment, including B level evidentiary support to test for distal symmetric polyneuropathy;

• Added emphasis on the need to ask patients about symptomatic and asymptomatic hypoglycemia and perform ongoing assessments of cognitive function; and

• Added emphasis on a patient-centered communication style that assesses literacy, but also the often overlooked issue of numeracy.

"It’s really quite impressive how many patients don’t get numbers, but we as physicians speak in numbers," Dr. Grant said.

The recent controversial 2013 American College of Cardiology/American Heart Association cholesterol guideline could not be reviewed in time to for this year’s guidelines, but it will be something to keep an eye out for next year.

ADA dodges dietary dogma

Highlights of the American Diabetes Association’s nutrition recommendations, updated in late 2013, and also presented at the meeting by Patti Urbanski, M.Ed., a member of the ADA Nutrition Recommendations Writing Group Committee, include:

• Select an "eating pattern" based on an individual’s personal and cultural preferences; literacy and numeracy; readiness; and ability to change, because no one dietary plan – be it the Mediterranean, low-carb, or DASH (Dietary Approaches to Stop Hypertension) diet – is best.

• In the absence of evidence supporting an ideal percentage of calories from carbohydrates, protein, or fat for all patients with diabetes, macronutrient distribution should be based on individualized assessment of current eating patterns, preferences, and goals.

• Reduce energy intake/carbohydrate portions and number of servings per meal, as indicated by individual assessment.

• Early referral to registered dietitians and nutritionists for nutrition therapy.

• First-ever call to avoid sugar-sweetened beverages.

• Continued support to limit sodium intake to 2,300 mg/day, as recommended for the general population, with lower sodium targets an option for those with comorbid hypertension.

• Routine supplementation with oxidants, such as vitamin E and C and carotene, is not advised, nor is routine use of micronutrients such as chromium, magnesium, and vitamin D to improve glycemic control.

Dr. Grant disclosed no conflicts of interest.

pwendling@frontlinemedcom.com

NAPLES, FLA. – Complication rates are similar for advanced clinical practitioners and resident physicians performing key routine procedures in the ICU or trauma setting, a retrospective study found.

Advanced clinical practitioners (ACPs) performed 555 procedures with 11 complications (2%), while resident physicians (RPs) performed 1,020 procedures with 20 complications (2%).

Procedures consisted of arterial lines, central venous lines, bronchoalveolar lavage, thoracotomy tubes, percutaneous endoscopic gastrostomy (PEG), and tracheostomies, Massanu Sirleaf, a board-certified acute care nurse practitioner, said at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.

No differences were observed between the ACP and RP groups in mean ICU length of stay (3.7 days vs. 3.9 days) or hospital stay (13.3 days vs. 12.2 days).

Mortality rates were also similar for ACPs and RPs (9.7% vs. 11%; P = .07), despite significantly higher age (mean 54.5 years vs. 49.9 years; P less than .05) and APACHE III scores for the ACP group (mean 47.7 vs. 40.8; P less than .05).

"Our results demonstrate that ACPs have become a very important part of our health care team and substantiate the safety of ACPs in performing surgical procedures in critically ill patients," Ms. Sirleaf said.

Restrictions in resident work hours have imposed workload challenges on trauma centers, leading some to recruit nurse practitioners and physician assistants to care for critically ill patients in the ICU and to perform invasive procedures previously done exclusively by physicians, she observed. Very few studies, however, have addressed ACPs’ procedural competence and complication rates.

The retrospective study included all procedures performed from January to December 2011 in the trauma and surgical ICUs at the F.H. "Sammy" Ross Jr. Trauma Center, Carolinas Medical Center in Charlotte, N.C. Eight ACPs performed invasive procedures for surgical critical care patients under attending supervision, while three postgraduate year two (PGY2) surgical and emergency residents performed procedures for trauma patients.

Invited discussant Dr. Jeffrey Claridge, director of trauma, critical care, and burns at MetroHealth Medical Center in Cleveland, agreed with the study’s conclusion that complications were similar between ACPs and RPs, but went on to say that 2% is extremely low and that "something is missing or oversimplified."

In particular, he pressed Ms. Sirleaf on where the procedures were performed, the level of supervision provided to ACPs, and how extensive the review of complications was other than procedural notes. For example, did the authors look at whether chest tubes fell out within 24 hours because they were inappropriately secured, PEG or tracheostomy sites that got infected, or breaks occurred in sterile technique.

"Determining a more comprehensive complication panel would give more power to detect differences and, truthfully, more credibility to the paper," Dr. Claridge said.

Ms. Sirleaf replied that in addition to reviewing postprocedural notes, radiologists looked for complications 24 hours after chest tube placement and patients with a tracheostomy were followed for complications for 7 days by the attending.

Urgency of the procedure was not evaluated since the procedures were elective and most were performed at the bedside.

"For the ACPs with a level of competency, just like interns at the beginning, they assisted the attending and as they got better, the majority of the procedure was performed by the ACP at the bedside with the attending scrubbed in," she said.

At the time of the study, three ACPs had 1 year of experience, with up to 7 years’ experience in the remaining ACPs. Senior ACPs provided training along with the attendings, and both ACPs and RPs underwent quarterly simulation lab training on procedures. To maintain competency, Carolinas Medical Center also requires ACPs perform a set number of each type of procedure on a yearly basis and have these procedures witnessed and signed off on by an attending, said Ms. Sirleaf, now with Sharp Memorial Hospital, San Diego.

Ms. Sirleaf and her coauthors reported having no financial disclosures.

pwendling@frontlinemedcom.com

NAPLES, FLA. – Complication rates are similar for advanced clinical practitioners and resident physicians performing key routine procedures in the ICU or trauma setting, a retrospective study found.

Advanced clinical practitioners (ACPs) performed 555 procedures with 11 complications (2%), while resident physicians (RPs) performed 1,020 procedures with 20 complications (2%).

Procedures consisted of arterial lines, central venous lines, bronchoalveolar lavage, thoracotomy tubes, percutaneous endoscopic gastrostomy (PEG), and tracheostomies, Massanu Sirleaf, a board-certified acute care nurse practitioner, said at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.

No differences were observed between the ACP and RP groups in mean ICU length of stay (3.7 days vs. 3.9 days) or hospital stay (13.3 days vs. 12.2 days).

Mortality rates were also similar for ACPs and RPs (9.7% vs. 11%; P = .07), despite significantly higher age (mean 54.5 years vs. 49.9 years; P less than .05) and APACHE III scores for the ACP group (mean 47.7 vs. 40.8; P less than .05).

"Our results demonstrate that ACPs have become a very important part of our health care team and substantiate the safety of ACPs in performing surgical procedures in critically ill patients," Ms. Sirleaf said.

Restrictions in resident work hours have imposed workload challenges on trauma centers, leading some to recruit nurse practitioners and physician assistants to care for critically ill patients in the ICU and to perform invasive procedures previously done exclusively by physicians, she observed. Very few studies, however, have addressed ACPs’ procedural competence and complication rates.

The retrospective study included all procedures performed from January to December 2011 in the trauma and surgical ICUs at the F.H. "Sammy" Ross Jr. Trauma Center, Carolinas Medical Center in Charlotte, N.C. Eight ACPs performed invasive procedures for surgical critical care patients under attending supervision, while three postgraduate year two (PGY2) surgical and emergency residents performed procedures for trauma patients.

Invited discussant Dr. Jeffrey Claridge, director of trauma, critical care, and burns at MetroHealth Medical Center in Cleveland, agreed with the study’s conclusion that complications were similar between ACPs and RPs, but went on to say that 2% is extremely low and that "something is missing or oversimplified."

In particular, he pressed Ms. Sirleaf on where the procedures were performed, the level of supervision provided to ACPs, and how extensive the review of complications was other than procedural notes. For example, did the authors look at whether chest tubes fell out within 24 hours because they were inappropriately secured, PEG or tracheostomy sites that got infected, or breaks occurred in sterile technique.

"Determining a more comprehensive complication panel would give more power to detect differences and, truthfully, more credibility to the paper," Dr. Claridge said.

Ms. Sirleaf replied that in addition to reviewing postprocedural notes, radiologists looked for complications 24 hours after chest tube placement and patients with a tracheostomy were followed for complications for 7 days by the attending.

Urgency of the procedure was not evaluated since the procedures were elective and most were performed at the bedside.

"For the ACPs with a level of competency, just like interns at the beginning, they assisted the attending and as they got better, the majority of the procedure was performed by the ACP at the bedside with the attending scrubbed in," she said.

At the time of the study, three ACPs had 1 year of experience, with up to 7 years’ experience in the remaining ACPs. Senior ACPs provided training along with the attendings, and both ACPs and RPs underwent quarterly simulation lab training on procedures. To maintain competency, Carolinas Medical Center also requires ACPs perform a set number of each type of procedure on a yearly basis and have these procedures witnessed and signed off on by an attending, said Ms. Sirleaf, now with Sharp Memorial Hospital, San Diego.

Ms. Sirleaf and her coauthors reported having no financial disclosures.

pwendling@frontlinemedcom.com

NAPLES, FLA. – Complication rates are similar for advanced clinical practitioners and resident physicians performing key routine procedures in the ICU or trauma setting, a retrospective study found.

Advanced clinical practitioners (ACPs) performed 555 procedures with 11 complications (2%), while resident physicians (RPs) performed 1,020 procedures with 20 complications (2%).

Procedures consisted of arterial lines, central venous lines, bronchoalveolar lavage, thoracotomy tubes, percutaneous endoscopic gastrostomy (PEG), and tracheostomies, Massanu Sirleaf, a board-certified acute care nurse practitioner, said at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.

No differences were observed between the ACP and RP groups in mean ICU length of stay (3.7 days vs. 3.9 days) or hospital stay (13.3 days vs. 12.2 days).

Mortality rates were also similar for ACPs and RPs (9.7% vs. 11%; P = .07), despite significantly higher age (mean 54.5 years vs. 49.9 years; P less than .05) and APACHE III scores for the ACP group (mean 47.7 vs. 40.8; P less than .05).

"Our results demonstrate that ACPs have become a very important part of our health care team and substantiate the safety of ACPs in performing surgical procedures in critically ill patients," Ms. Sirleaf said.

Restrictions in resident work hours have imposed workload challenges on trauma centers, leading some to recruit nurse practitioners and physician assistants to care for critically ill patients in the ICU and to perform invasive procedures previously done exclusively by physicians, she observed. Very few studies, however, have addressed ACPs’ procedural competence and complication rates.

The retrospective study included all procedures performed from January to December 2011 in the trauma and surgical ICUs at the F.H. "Sammy" Ross Jr. Trauma Center, Carolinas Medical Center in Charlotte, N.C. Eight ACPs performed invasive procedures for surgical critical care patients under attending supervision, while three postgraduate year two (PGY2) surgical and emergency residents performed procedures for trauma patients.

Invited discussant Dr. Jeffrey Claridge, director of trauma, critical care, and burns at MetroHealth Medical Center in Cleveland, agreed with the study’s conclusion that complications were similar between ACPs and RPs, but went on to say that 2% is extremely low and that "something is missing or oversimplified."

In particular, he pressed Ms. Sirleaf on where the procedures were performed, the level of supervision provided to ACPs, and how extensive the review of complications was other than procedural notes. For example, did the authors look at whether chest tubes fell out within 24 hours because they were inappropriately secured, PEG or tracheostomy sites that got infected, or breaks occurred in sterile technique.

"Determining a more comprehensive complication panel would give more power to detect differences and, truthfully, more credibility to the paper," Dr. Claridge said.

Ms. Sirleaf replied that in addition to reviewing postprocedural notes, radiologists looked for complications 24 hours after chest tube placement and patients with a tracheostomy were followed for complications for 7 days by the attending.

Urgency of the procedure was not evaluated since the procedures were elective and most were performed at the bedside.

"For the ACPs with a level of competency, just like interns at the beginning, they assisted the attending and as they got better, the majority of the procedure was performed by the ACP at the bedside with the attending scrubbed in," she said.

At the time of the study, three ACPs had 1 year of experience, with up to 7 years’ experience in the remaining ACPs. Senior ACPs provided training along with the attendings, and both ACPs and RPs underwent quarterly simulation lab training on procedures. To maintain competency, Carolinas Medical Center also requires ACPs perform a set number of each type of procedure on a yearly basis and have these procedures witnessed and signed off on by an attending, said Ms. Sirleaf, now with Sharp Memorial Hospital, San Diego.

Ms. Sirleaf and her coauthors reported having no financial disclosures.

pwendling@frontlinemedcom.com

NAPLES, FLA. – Compliance with discharge instructions is mixed among children diagnosed with a concussion in the emergency department, a study showed.

In the prospective cohort study, 87% of patients, aged 8-17 years, followed the recommended stepwise return to play (RTP) protocol for concussion management.

More than one-third (39%), however, reported returning to play on the day of their injury, Dr. Vivian Hwang said at the annual scientific assembly of the Eastern Association for the Surgery of Trauma (EAST).

"Concussion education remains essential to improve early recognition of concussion symptoms and to discourage premature return to play before symptoms resolve," said Dr. Hwang, an emergency physician at the Inova Fairfax Hospital for Children, Falls Church, Va.

Invited discussant and EAST past president Dr. Michael Pasquale described the data as "troubling," observing that nearly all the states and the District of Columbia have enacted concussion laws, some featuring the RTP protocol.

He questioned whether the 39% of children returning to play on the day of their injury did so before the concussion was identified, as this would suggest a lack of awareness rather than noncompliance.

Dr. Hwang said these children were asked about return to play at their initial ED visit, so this likely does represent lack of awareness, although the high number still speaks to the need for improvement.

Student athletes in Virginia are required to have and sign off on concussion education each year, but she said she was unaware of any penalties for athletes or parents who fail to comply.

Dr. Hwang and her colleagues prospectively followed 150 patients with a diagnosis of concussion from November 2011 to November 2012 who received standardized discharge instructions stating there should be no return to play or normal activities with symptoms or without medical clearance.

The instructions also recommended the stepwise RTP protocol as described in 2009 by the international Concussion in Sport Group (J. Clin. Neurosci. 2009;16:755-63) and again in its most recent consensus statement (J. Am. Coll. Surg. 2013;216:e55-71).

The RTP protocol has six stages: no activity (complete physical and cognitive rest), light aerobic exercise, sport-specific exercise, noncontact training drills, full-contact practice following medical clearance, and return to normal play. Each step generally takes 24 hours, or about 1 week for the full protocol, with patients continuing to the next level only if they’re asymptomatic at the current level, Dr. Hwang explained.

Telephone follow-up of 125 evaluable patients at 2 weeks post ED visit found that 55 (44%) children had returned to play or normal activities. Of these, 19 (35%) returned to play with symptoms, and 32 (58%) did so without receiving medical clearance, Dr. Hwang said.

Among 116 children surveyed at week 4, 74 (64%) had returned to play, 17 (23%) with symptoms and 34 (46%) without medical clearance.

"Proper medical monitoring is necessary to guide care for pediatric patients," Dr. Hwang said.

Patients in the cohort were mostly male (63%), had private insurance (85%), and were an average age of 13 years. Most concussions were sports related (67%), with soccer the most common culprit (30%) followed by football (11%), lacrosse (8%), and basketball (8%).

The study was limited by the inability to enroll 200 additional concussion patients seen during the study period, follow-up was 83% at 2 weeks and 77% at 4 weeks, the potential for nonresponse bias, and self- and parent reporting of symptoms may have been inaccurate, she said. Standardized neurocognitive tests also were not done.

Dr. Pasquale, chair of surgery at Lehigh Valley Hospital, Allentown, Pa., suggested that the hospital’s discharge instructions are "a little soft.

"You really don’t mandate clearance by a medical professional, and I think it’s an opportunity in your community to improve upon that and drive home to parents the importance of clearing the athlete or nonathlete prior to resumption of activities," he said.

Dr. Hwang replied that the hospital recently expanded its concussion services including a multidisciplinary team to help with concussion screening, postinjury evaluation, and treatment. The hospital also has a concussion committee.

Dr. Hwang and Dr. Pasquale reported having no financial disclosures.

pwendling@frontlinemedcom.com

NAPLES, FLA. – Compliance with discharge instructions is mixed among children diagnosed with a concussion in the emergency department, a study showed.

In the prospective cohort study, 87% of patients, aged 8-17 years, followed the recommended stepwise return to play (RTP) protocol for concussion management.

More than one-third (39%), however, reported returning to play on the day of their injury, Dr. Vivian Hwang said at the annual scientific assembly of the Eastern Association for the Surgery of Trauma (EAST).

"Concussion education remains essential to improve early recognition of concussion symptoms and to discourage premature return to play before symptoms resolve," said Dr. Hwang, an emergency physician at the Inova Fairfax Hospital for Children, Falls Church, Va.

Invited discussant and EAST past president Dr. Michael Pasquale described the data as "troubling," observing that nearly all the states and the District of Columbia have enacted concussion laws, some featuring the RTP protocol.

He questioned whether the 39% of children returning to play on the day of their injury did so before the concussion was identified, as this would suggest a lack of awareness rather than noncompliance.

Dr. Hwang said these children were asked about return to play at their initial ED visit, so this likely does represent lack of awareness, although the high number still speaks to the need for improvement.

Student athletes in Virginia are required to have and sign off on concussion education each year, but she said she was unaware of any penalties for athletes or parents who fail to comply.

Dr. Hwang and her colleagues prospectively followed 150 patients with a diagnosis of concussion from November 2011 to November 2012 who received standardized discharge instructions stating there should be no return to play or normal activities with symptoms or without medical clearance.

The instructions also recommended the stepwise RTP protocol as described in 2009 by the international Concussion in Sport Group (J. Clin. Neurosci. 2009;16:755-63) and again in its most recent consensus statement (J. Am. Coll. Surg. 2013;216:e55-71).

The RTP protocol has six stages: no activity (complete physical and cognitive rest), light aerobic exercise, sport-specific exercise, noncontact training drills, full-contact practice following medical clearance, and return to normal play. Each step generally takes 24 hours, or about 1 week for the full protocol, with patients continuing to the next level only if they’re asymptomatic at the current level, Dr. Hwang explained.

Telephone follow-up of 125 evaluable patients at 2 weeks post ED visit found that 55 (44%) children had returned to play or normal activities. Of these, 19 (35%) returned to play with symptoms, and 32 (58%) did so without receiving medical clearance, Dr. Hwang said.

Among 116 children surveyed at week 4, 74 (64%) had returned to play, 17 (23%) with symptoms and 34 (46%) without medical clearance.

"Proper medical monitoring is necessary to guide care for pediatric patients," Dr. Hwang said.

Patients in the cohort were mostly male (63%), had private insurance (85%), and were an average age of 13 years. Most concussions were sports related (67%), with soccer the most common culprit (30%) followed by football (11%), lacrosse (8%), and basketball (8%).

The study was limited by the inability to enroll 200 additional concussion patients seen during the study period, follow-up was 83% at 2 weeks and 77% at 4 weeks, the potential for nonresponse bias, and self- and parent reporting of symptoms may have been inaccurate, she said. Standardized neurocognitive tests also were not done.

Dr. Pasquale, chair of surgery at Lehigh Valley Hospital, Allentown, Pa., suggested that the hospital’s discharge instructions are "a little soft.

"You really don’t mandate clearance by a medical professional, and I think it’s an opportunity in your community to improve upon that and drive home to parents the importance of clearing the athlete or nonathlete prior to resumption of activities," he said.

Dr. Hwang replied that the hospital recently expanded its concussion services including a multidisciplinary team to help with concussion screening, postinjury evaluation, and treatment. The hospital also has a concussion committee.

Dr. Hwang and Dr. Pasquale reported having no financial disclosures.

pwendling@frontlinemedcom.com

NAPLES, FLA. – Compliance with discharge instructions is mixed among children diagnosed with a concussion in the emergency department, a study showed.

In the prospective cohort study, 87% of patients, aged 8-17 years, followed the recommended stepwise return to play (RTP) protocol for concussion management.

More than one-third (39%), however, reported returning to play on the day of their injury, Dr. Vivian Hwang said at the annual scientific assembly of the Eastern Association for the Surgery of Trauma (EAST).

"Concussion education remains essential to improve early recognition of concussion symptoms and to discourage premature return to play before symptoms resolve," said Dr. Hwang, an emergency physician at the Inova Fairfax Hospital for Children, Falls Church, Va.

Invited discussant and EAST past president Dr. Michael Pasquale described the data as "troubling," observing that nearly all the states and the District of Columbia have enacted concussion laws, some featuring the RTP protocol.

He questioned whether the 39% of children returning to play on the day of their injury did so before the concussion was identified, as this would suggest a lack of awareness rather than noncompliance.

Dr. Hwang said these children were asked about return to play at their initial ED visit, so this likely does represent lack of awareness, although the high number still speaks to the need for improvement.

Student athletes in Virginia are required to have and sign off on concussion education each year, but she said she was unaware of any penalties for athletes or parents who fail to comply.

Dr. Hwang and her colleagues prospectively followed 150 patients with a diagnosis of concussion from November 2011 to November 2012 who received standardized discharge instructions stating there should be no return to play or normal activities with symptoms or without medical clearance.

The instructions also recommended the stepwise RTP protocol as described in 2009 by the international Concussion in Sport Group (J. Clin. Neurosci. 2009;16:755-63) and again in its most recent consensus statement (J. Am. Coll. Surg. 2013;216:e55-71).

The RTP protocol has six stages: no activity (complete physical and cognitive rest), light aerobic exercise, sport-specific exercise, noncontact training drills, full-contact practice following medical clearance, and return to normal play. Each step generally takes 24 hours, or about 1 week for the full protocol, with patients continuing to the next level only if they’re asymptomatic at the current level, Dr. Hwang explained.

Telephone follow-up of 125 evaluable patients at 2 weeks post ED visit found that 55 (44%) children had returned to play or normal activities. Of these, 19 (35%) returned to play with symptoms, and 32 (58%) did so without receiving medical clearance, Dr. Hwang said.

Among 116 children surveyed at week 4, 74 (64%) had returned to play, 17 (23%) with symptoms and 34 (46%) without medical clearance.

"Proper medical monitoring is necessary to guide care for pediatric patients," Dr. Hwang said.

Patients in the cohort were mostly male (63%), had private insurance (85%), and were an average age of 13 years. Most concussions were sports related (67%), with soccer the most common culprit (30%) followed by football (11%), lacrosse (8%), and basketball (8%).

The study was limited by the inability to enroll 200 additional concussion patients seen during the study period, follow-up was 83% at 2 weeks and 77% at 4 weeks, the potential for nonresponse bias, and self- and parent reporting of symptoms may have been inaccurate, she said. Standardized neurocognitive tests also were not done.

Dr. Pasquale, chair of surgery at Lehigh Valley Hospital, Allentown, Pa., suggested that the hospital’s discharge instructions are "a little soft.

"You really don’t mandate clearance by a medical professional, and I think it’s an opportunity in your community to improve upon that and drive home to parents the importance of clearing the athlete or nonathlete prior to resumption of activities," he said.

Dr. Hwang replied that the hospital recently expanded its concussion services including a multidisciplinary team to help with concussion screening, postinjury evaluation, and treatment. The hospital also has a concussion committee.

Dr. Hwang and Dr. Pasquale reported having no financial disclosures.

pwendling@frontlinemedcom.com

NAPLES, FLA. – Vitamin D deficiency is common in critically ill trauma patients and portends worse outcomes, a retrospective study suggests.

Among 200 trauma patients with available vitamin D levels, 26% were vitamin D deficient on ICU admission.

"These patients have a higher APACHE II score, have a longer ICU stay, and will likely be hospitalized greater than 2 weeks," Dr. Joseph Ibrahim reported at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.

Long known to be essential for bone development and wound healing, recent studies have demonstrated that vitamin D deficiency is a significant predictor of 30- and 90-day all-cause mortality in critically ill patients, even after adjustment for such factors as age, Charlson/Deyo index, sepsis, and season (Crit. Care. Med. 2012;40:63-72). It also has been shown to significantly predict acute kidney injury in the critically ill (Crit. Care Med. 2012;40:3170-9).

For the current analysis, vitamin D levels were drawn upon ICU admission, at 72 hours, and every 7 days until hospital discharge in 200 of 234 consecutive adult trauma patients admitted to the ICU at the Level 1 Orlando Regional Medical Center during a 4-month period. Deficiency was defined as 25-hydroxyvitamin D 20 ng/mL or less. All patients received nutritional support using a standard protocol, but not vitamin D supplementation.

Median vitamin D ICU admission levels in the 51 vitamin D–deficient patients were significantly lower than for nondeficient patients (16 ng/mL vs. 28 ng/mL; P less than .001). Levels decreased a median of 4 ng/mL at 72 hours in both groups, but only the sufficient group returned to admission baseline levels at week 2, reported Dr. Ibrahim, a critical care surgeon with the medical center.

"This demonstrates that if we wish to obtain normal vitamin D levels in these patients, we will have to supplement them with much higher doses than what we are providing with standard enteral formulas," he said in an interview.

Patients with vitamin D deficiency spent more time than did nondeficient patients in the ICU (median 3 days vs. 2.7 days) and hospital (median 8.4 days vs. 7.1 days), but these trends did not reach statistical significance.

Significantly more deficient patients, however, remained in the hospital for at least 2 weeks (37% vs. 20%; P = .01).

The investigators were unable to show a difference in mortality between the deficient and nondeficient groups (16% vs. 12%; P = .51), possibly because the study was underpowered, he said.

Deficient and sufficient patients did not differ in age (median 48 years vs. 44 years), body mass index (26.2 kg/m² vs. 25.7 kg/m²), admission ionized calcium (1.06 mmol/L for both), or Injury Severity Score (14 vs. 13). Only APACHE II scores were significantly higher in deficient patients (20 vs. 15).

"It makes sense that with the significant difference in APACHE II score, one would expect to see a similar difference in mortality, but again we were unable to show this with this study," Dr. Ibrahim said.

Prehospital factors significantly associated with low vitamin D status were African American race, diabetes, and lack of vitamin D supplementation.

Vitamin D supplementation may be helpful in critically ill trauma patients during hospitalization, but more research is needed, Dr. Ibrahim said. The group is planning a supplementation study, looking at vitamin D dosing and frequency of testing.

"Our first goal was to demonstrate a significant incidence, which we did," he said. "It should be noted that the incidence was in a location with probably one of the highest amounts of sunshine in the country and that the findings may underestimate what one would find in other areas of the United States."

Dr. Oscar Guillamondegui, of Vanderbilt University Medical Center in Nashville, Tenn., who proctored the poster session, said he would expect vitamin D levels to be lower in acutely sick patients requiring ICU management because production of vitamin D–binding protein, a subprotein in the albumin family of proteins involved in vitamin D transport and storage, is decreased in high stress situations to allow for the increase in acute phase protein production.

"Although the data are intriguing, as a retrospective study, it is too early to suggest that supplementation is essential," he said. "I do believe this is great work and will stimulate several studies to prove the need for supplementation and for that, I commend Dr. Ibrahim and his group in their efforts."

Dr. Ibrahim and Dr. Guillamondegui reported having no financial disclosures.

pwendling@frontlinemedcom.com

NAPLES, FLA. – Vitamin D deficiency is common in critically ill trauma patients and portends worse outcomes, a retrospective study suggests.

Among 200 trauma patients with available vitamin D levels, 26% were vitamin D deficient on ICU admission.

"These patients have a higher APACHE II score, have a longer ICU stay, and will likely be hospitalized greater than 2 weeks," Dr. Joseph Ibrahim reported at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.

Long known to be essential for bone development and wound healing, recent studies have demonstrated that vitamin D deficiency is a significant predictor of 30- and 90-day all-cause mortality in critically ill patients, even after adjustment for such factors as age, Charlson/Deyo index, sepsis, and season (Crit. Care. Med. 2012;40:63-72). It also has been shown to significantly predict acute kidney injury in the critically ill (Crit. Care Med. 2012;40:3170-9).

For the current analysis, vitamin D levels were drawn upon ICU admission, at 72 hours, and every 7 days until hospital discharge in 200 of 234 consecutive adult trauma patients admitted to the ICU at the Level 1 Orlando Regional Medical Center during a 4-month period. Deficiency was defined as 25-hydroxyvitamin D 20 ng/mL or less. All patients received nutritional support using a standard protocol, but not vitamin D supplementation.

Median vitamin D ICU admission levels in the 51 vitamin D–deficient patients were significantly lower than for nondeficient patients (16 ng/mL vs. 28 ng/mL; P less than .001). Levels decreased a median of 4 ng/mL at 72 hours in both groups, but only the sufficient group returned to admission baseline levels at week 2, reported Dr. Ibrahim, a critical care surgeon with the medical center.

"This demonstrates that if we wish to obtain normal vitamin D levels in these patients, we will have to supplement them with much higher doses than what we are providing with standard enteral formulas," he said in an interview.

Patients with vitamin D deficiency spent more time than did nondeficient patients in the ICU (median 3 days vs. 2.7 days) and hospital (median 8.4 days vs. 7.1 days), but these trends did not reach statistical significance.

Significantly more deficient patients, however, remained in the hospital for at least 2 weeks (37% vs. 20%; P = .01).

The investigators were unable to show a difference in mortality between the deficient and nondeficient groups (16% vs. 12%; P = .51), possibly because the study was underpowered, he said.

Deficient and sufficient patients did not differ in age (median 48 years vs. 44 years), body mass index (26.2 kg/m² vs. 25.7 kg/m²), admission ionized calcium (1.06 mmol/L for both), or Injury Severity Score (14 vs. 13). Only APACHE II scores were significantly higher in deficient patients (20 vs. 15).

"It makes sense that with the significant difference in APACHE II score, one would expect to see a similar difference in mortality, but again we were unable to show this with this study," Dr. Ibrahim said.

Prehospital factors significantly associated with low vitamin D status were African American race, diabetes, and lack of vitamin D supplementation.

Vitamin D supplementation may be helpful in critically ill trauma patients during hospitalization, but more research is needed, Dr. Ibrahim said. The group is planning a supplementation study, looking at vitamin D dosing and frequency of testing.

"Our first goal was to demonstrate a significant incidence, which we did," he said. "It should be noted that the incidence was in a location with probably one of the highest amounts of sunshine in the country and that the findings may underestimate what one would find in other areas of the United States."

Dr. Oscar Guillamondegui, of Vanderbilt University Medical Center in Nashville, Tenn., who proctored the poster session, said he would expect vitamin D levels to be lower in acutely sick patients requiring ICU management because production of vitamin D–binding protein, a subprotein in the albumin family of proteins involved in vitamin D transport and storage, is decreased in high stress situations to allow for the increase in acute phase protein production.

"Although the data are intriguing, as a retrospective study, it is too early to suggest that supplementation is essential," he said. "I do believe this is great work and will stimulate several studies to prove the need for supplementation and for that, I commend Dr. Ibrahim and his group in their efforts."

Dr. Ibrahim and Dr. Guillamondegui reported having no financial disclosures.

pwendling@frontlinemedcom.com

NAPLES, FLA. – Vitamin D deficiency is common in critically ill trauma patients and portends worse outcomes, a retrospective study suggests.

Among 200 trauma patients with available vitamin D levels, 26% were vitamin D deficient on ICU admission.

"These patients have a higher APACHE II score, have a longer ICU stay, and will likely be hospitalized greater than 2 weeks," Dr. Joseph Ibrahim reported at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.

Long known to be essential for bone development and wound healing, recent studies have demonstrated that vitamin D deficiency is a significant predictor of 30- and 90-day all-cause mortality in critically ill patients, even after adjustment for such factors as age, Charlson/Deyo index, sepsis, and season (Crit. Care. Med. 2012;40:63-72). It also has been shown to significantly predict acute kidney injury in the critically ill (Crit. Care Med. 2012;40:3170-9).

For the current analysis, vitamin D levels were drawn upon ICU admission, at 72 hours, and every 7 days until hospital discharge in 200 of 234 consecutive adult trauma patients admitted to the ICU at the Level 1 Orlando Regional Medical Center during a 4-month period. Deficiency was defined as 25-hydroxyvitamin D 20 ng/mL or less. All patients received nutritional support using a standard protocol, but not vitamin D supplementation.

Median vitamin D ICU admission levels in the 51 vitamin D–deficient patients were significantly lower than for nondeficient patients (16 ng/mL vs. 28 ng/mL; P less than .001). Levels decreased a median of 4 ng/mL at 72 hours in both groups, but only the sufficient group returned to admission baseline levels at week 2, reported Dr. Ibrahim, a critical care surgeon with the medical center.

"This demonstrates that if we wish to obtain normal vitamin D levels in these patients, we will have to supplement them with much higher doses than what we are providing with standard enteral formulas," he said in an interview.

Patients with vitamin D deficiency spent more time than did nondeficient patients in the ICU (median 3 days vs. 2.7 days) and hospital (median 8.4 days vs. 7.1 days), but these trends did not reach statistical significance.

Significantly more deficient patients, however, remained in the hospital for at least 2 weeks (37% vs. 20%; P = .01).

The investigators were unable to show a difference in mortality between the deficient and nondeficient groups (16% vs. 12%; P = .51), possibly because the study was underpowered, he said.

Deficient and sufficient patients did not differ in age (median 48 years vs. 44 years), body mass index (26.2 kg/m² vs. 25.7 kg/m²), admission ionized calcium (1.06 mmol/L for both), or Injury Severity Score (14 vs. 13). Only APACHE II scores were significantly higher in deficient patients (20 vs. 15).

"It makes sense that with the significant difference in APACHE II score, one would expect to see a similar difference in mortality, but again we were unable to show this with this study," Dr. Ibrahim said.

Prehospital factors significantly associated with low vitamin D status were African American race, diabetes, and lack of vitamin D supplementation.

Vitamin D supplementation may be helpful in critically ill trauma patients during hospitalization, but more research is needed, Dr. Ibrahim said. The group is planning a supplementation study, looking at vitamin D dosing and frequency of testing.

"Our first goal was to demonstrate a significant incidence, which we did," he said. "It should be noted that the incidence was in a location with probably one of the highest amounts of sunshine in the country and that the findings may underestimate what one would find in other areas of the United States."

Dr. Oscar Guillamondegui, of Vanderbilt University Medical Center in Nashville, Tenn., who proctored the poster session, said he would expect vitamin D levels to be lower in acutely sick patients requiring ICU management because production of vitamin D–binding protein, a subprotein in the albumin family of proteins involved in vitamin D transport and storage, is decreased in high stress situations to allow for the increase in acute phase protein production.

"Although the data are intriguing, as a retrospective study, it is too early to suggest that supplementation is essential," he said. "I do believe this is great work and will stimulate several studies to prove the need for supplementation and for that, I commend Dr. Ibrahim and his group in their efforts."

Dr. Ibrahim and Dr. Guillamondegui reported having no financial disclosures.

pwendling@frontlinemedcom.com

CHICAGO – Early recognition of mesenteric ischemia in young adults and children is essential to prevent bowel loss and other serious consequences associated with this rare condition, Dr. Michael Dalsing said at a vascular surgery symposium.

Mesenteric ischemia is generally seen in the elderly as the result of atherosclerotic and embolic occlusive diseases. Because young adults and children typically don’t have any of the telltale associated comorbidities such as cardiac arrhythmia or coronary artery disease to point physicians in this direction, the diagnosis of mesenteric ischemia is often delayed or misinterpreted as appendicitis, cholecystitis, or intra-abdominal abscess, he said.

Among 26 young adults under age 40 years who presented with acute mesenteric ischemia, only 6 were properly diagnosed preoperatively (Wien. Med. Wochenschr. 2012;162:349-53). The postoperative complication and mortality rates reached 61.5% and 27%, which is typical in this population, despite their otherwise good health, said Dr. Dalsing, director of vascular surgery at Indiana University, Indianapolis.

The hallmarks of acute mesenteric ischemia are standard in both young and old patients and include abdominal pain out of proportion to the physical exam, nausea, vomiting, and/or diarrhea. Acidosis, acute renal failure, and septic shock/sepsis can develop in roughly half of patients with more extensive liver or bowel ischemia or necrosis. The signs and symptoms of chronic ischemia are weight loss, food fear, and postprandial abdominal pain.

"For chronic mesenteric ischemia, what’s the important message? Consider the diagnosis," Dr. Dalsing said. "Do the imaging, find out what you have, and then you can worry about ancillary testing because, in general, these aren’t going to be your typical etiologies. In fact, they’re not standard fare at all."

The broad and atypical list of etiologies to consider in those under age 40 years include congenital aortic anomalies, hypercoagulable states, inflammatory conditions, collagen vascular disorders, and environmental agents such as cocaine use, smoking, or trauma. While MI is often suspected in those using cocaine, the vasoconstrictive effects of the drug can also cause vasospasm of the smaller branches of the mesenteric vessels, leading to nonocclusive mesenteric ischemia, he explained.

Once a diagnosis of chronic mesenteric ischemia is made in a young patient, management consists of fluid resuscitation, broad spectrum antibiotics, bowel rest, and imaging, often with a CT angiogram. The need for additional work-up, including hypercoagulable and inflammatory marker panels, varies based on initial clinical symptoms.

If vascular compromise is identified, the overall management goals should be to remove frankly necrotic bowel, reperfuse ischemic bowel, limit the resection length when possible to prevent short-gut syndrome, and treat the underlying etiology, Dr. Dalsing advised. Anticoagulation is also integral to prevent thrombus propagation.

Just six cases of mesenteric ischemia have been diagnosed at Indiana University in young adults over the last 16 years, with Takayasu’s arteritis the most common etiology, he noted. This includes a 20-year-old woman with a 5-year history of Takayasu’s, who presented with worsening abdominal pain despite remission of her Takayasu’s, as indicated by a normal sedimentation rate.

Repeat CT imaging revealed more than 70% celiac artery stenosis and more than 50% stenosis of the superior mesenteric artery (SMA). A median arcuate ligament division and celiac and SMA bypass graft, both with reverse saphenous vein originating from bilateral iliac arteries, was performed. "She’s had dramatic improvement" in her symptoms and remains on clopidogrel (Plavix) and low-dose steroids, Dr. Dalsing said.

A second patient with Takayasu’s presented with a 4-month history of abdominal pain, a 50-pound weight loss, stenosis of all major mesenteric arteries, and bowel pneumatosis. Despite this, her sedimentation rate was only slightly elevated at 33 mm/hour, and all other coagulation and inflammatory tests were normal. She remains symptom free at 2 years on daily aspirin after undergoing an emergent right common iliac-to-SMA bypass graft with reversed saphenous vein and bowel resection.

In cases in which bypass grafting is necessary, the internal iliac artery is the preferred conduit in children since the saphenous vein is very thin walled and thus, more prone to aneurysmal degeneration, Dr. Dalsing observed. In grown patients, the saphenous vein may be the best conduit in terms of ease of harvest and adequate length for even bifurcated grafts or C-loop alignment.

During postoperative follow-up, special effort should be taken because of the young age of these patients to reduce the detrimental effects of radiation from recurrent CT angiograms, he said. Patients with symptomatic improvement are followed at 1 month postoperatively with a physical exam that includes their weight and a mesenteric duplex to evaluate graft or stent patency. This is repeated every 6 months for 1-2 years, and decreased to yearly visits, if no disease progression is detected. More aggressive imaging with CT angiography is reserved for patients with recurrent symptoms or if duplex ultrasound is insufficient or shows progressive disease, he said at the meeting, sponsored by Northwestern University.

Dr. Dalsing reported having no financial disclosures.

pwendling@frontlinemedcom.com

CHICAGO – Early recognition of mesenteric ischemia in young adults and children is essential to prevent bowel loss and other serious consequences associated with this rare condition, Dr. Michael Dalsing said at a vascular surgery symposium.

Mesenteric ischemia is generally seen in the elderly as the result of atherosclerotic and embolic occlusive diseases. Because young adults and children typically don’t have any of the telltale associated comorbidities such as cardiac arrhythmia or coronary artery disease to point physicians in this direction, the diagnosis of mesenteric ischemia is often delayed or misinterpreted as appendicitis, cholecystitis, or intra-abdominal abscess, he said.

Among 26 young adults under age 40 years who presented with acute mesenteric ischemia, only 6 were properly diagnosed preoperatively (Wien. Med. Wochenschr. 2012;162:349-53). The postoperative complication and mortality rates reached 61.5% and 27%, which is typical in this population, despite their otherwise good health, said Dr. Dalsing, director of vascular surgery at Indiana University, Indianapolis.

The hallmarks of acute mesenteric ischemia are standard in both young and old patients and include abdominal pain out of proportion to the physical exam, nausea, vomiting, and/or diarrhea. Acidosis, acute renal failure, and septic shock/sepsis can develop in roughly half of patients with more extensive liver or bowel ischemia or necrosis. The signs and symptoms of chronic ischemia are weight loss, food fear, and postprandial abdominal pain.

"For chronic mesenteric ischemia, what’s the important message? Consider the diagnosis," Dr. Dalsing said. "Do the imaging, find out what you have, and then you can worry about ancillary testing because, in general, these aren’t going to be your typical etiologies. In fact, they’re not standard fare at all."

The broad and atypical list of etiologies to consider in those under age 40 years include congenital aortic anomalies, hypercoagulable states, inflammatory conditions, collagen vascular disorders, and environmental agents such as cocaine use, smoking, or trauma. While MI is often suspected in those using cocaine, the vasoconstrictive effects of the drug can also cause vasospasm of the smaller branches of the mesenteric vessels, leading to nonocclusive mesenteric ischemia, he explained.

Once a diagnosis of chronic mesenteric ischemia is made in a young patient, management consists of fluid resuscitation, broad spectrum antibiotics, bowel rest, and imaging, often with a CT angiogram. The need for additional work-up, including hypercoagulable and inflammatory marker panels, varies based on initial clinical symptoms.

If vascular compromise is identified, the overall management goals should be to remove frankly necrotic bowel, reperfuse ischemic bowel, limit the resection length when possible to prevent short-gut syndrome, and treat the underlying etiology, Dr. Dalsing advised. Anticoagulation is also integral to prevent thrombus propagation.

Just six cases of mesenteric ischemia have been diagnosed at Indiana University in young adults over the last 16 years, with Takayasu’s arteritis the most common etiology, he noted. This includes a 20-year-old woman with a 5-year history of Takayasu’s, who presented with worsening abdominal pain despite remission of her Takayasu’s, as indicated by a normal sedimentation rate.

Repeat CT imaging revealed more than 70% celiac artery stenosis and more than 50% stenosis of the superior mesenteric artery (SMA). A median arcuate ligament division and celiac and SMA bypass graft, both with reverse saphenous vein originating from bilateral iliac arteries, was performed. "She’s had dramatic improvement" in her symptoms and remains on clopidogrel (Plavix) and low-dose steroids, Dr. Dalsing said.

A second patient with Takayasu’s presented with a 4-month history of abdominal pain, a 50-pound weight loss, stenosis of all major mesenteric arteries, and bowel pneumatosis. Despite this, her sedimentation rate was only slightly elevated at 33 mm/hour, and all other coagulation and inflammatory tests were normal. She remains symptom free at 2 years on daily aspirin after undergoing an emergent right common iliac-to-SMA bypass graft with reversed saphenous vein and bowel resection.

In cases in which bypass grafting is necessary, the internal iliac artery is the preferred conduit in children since the saphenous vein is very thin walled and thus, more prone to aneurysmal degeneration, Dr. Dalsing observed. In grown patients, the saphenous vein may be the best conduit in terms of ease of harvest and adequate length for even bifurcated grafts or C-loop alignment.

During postoperative follow-up, special effort should be taken because of the young age of these patients to reduce the detrimental effects of radiation from recurrent CT angiograms, he said. Patients with symptomatic improvement are followed at 1 month postoperatively with a physical exam that includes their weight and a mesenteric duplex to evaluate graft or stent patency. This is repeated every 6 months for 1-2 years, and decreased to yearly visits, if no disease progression is detected. More aggressive imaging with CT angiography is reserved for patients with recurrent symptoms or if duplex ultrasound is insufficient or shows progressive disease, he said at the meeting, sponsored by Northwestern University.

Dr. Dalsing reported having no financial disclosures.

pwendling@frontlinemedcom.com

CHICAGO – Early recognition of mesenteric ischemia in young adults and children is essential to prevent bowel loss and other serious consequences associated with this rare condition, Dr. Michael Dalsing said at a vascular surgery symposium.

Mesenteric ischemia is generally seen in the elderly as the result of atherosclerotic and embolic occlusive diseases. Because young adults and children typically don’t have any of the telltale associated comorbidities such as cardiac arrhythmia or coronary artery disease to point physicians in this direction, the diagnosis of mesenteric ischemia is often delayed or misinterpreted as appendicitis, cholecystitis, or intra-abdominal abscess, he said.

Among 26 young adults under age 40 years who presented with acute mesenteric ischemia, only 6 were properly diagnosed preoperatively (Wien. Med. Wochenschr. 2012;162:349-53). The postoperative complication and mortality rates reached 61.5% and 27%, which is typical in this population, despite their otherwise good health, said Dr. Dalsing, director of vascular surgery at Indiana University, Indianapolis.

The hallmarks of acute mesenteric ischemia are standard in both young and old patients and include abdominal pain out of proportion to the physical exam, nausea, vomiting, and/or diarrhea. Acidosis, acute renal failure, and septic shock/sepsis can develop in roughly half of patients with more extensive liver or bowel ischemia or necrosis. The signs and symptoms of chronic ischemia are weight loss, food fear, and postprandial abdominal pain.

"For chronic mesenteric ischemia, what’s the important message? Consider the diagnosis," Dr. Dalsing said. "Do the imaging, find out what you have, and then you can worry about ancillary testing because, in general, these aren’t going to be your typical etiologies. In fact, they’re not standard fare at all."

The broad and atypical list of etiologies to consider in those under age 40 years include congenital aortic anomalies, hypercoagulable states, inflammatory conditions, collagen vascular disorders, and environmental agents such as cocaine use, smoking, or trauma. While MI is often suspected in those using cocaine, the vasoconstrictive effects of the drug can also cause vasospasm of the smaller branches of the mesenteric vessels, leading to nonocclusive mesenteric ischemia, he explained.

Once a diagnosis of chronic mesenteric ischemia is made in a young patient, management consists of fluid resuscitation, broad spectrum antibiotics, bowel rest, and imaging, often with a CT angiogram. The need for additional work-up, including hypercoagulable and inflammatory marker panels, varies based on initial clinical symptoms.

If vascular compromise is identified, the overall management goals should be to remove frankly necrotic bowel, reperfuse ischemic bowel, limit the resection length when possible to prevent short-gut syndrome, and treat the underlying etiology, Dr. Dalsing advised. Anticoagulation is also integral to prevent thrombus propagation.

Just six cases of mesenteric ischemia have been diagnosed at Indiana University in young adults over the last 16 years, with Takayasu’s arteritis the most common etiology, he noted. This includes a 20-year-old woman with a 5-year history of Takayasu’s, who presented with worsening abdominal pain despite remission of her Takayasu’s, as indicated by a normal sedimentation rate.

Repeat CT imaging revealed more than 70% celiac artery stenosis and more than 50% stenosis of the superior mesenteric artery (SMA). A median arcuate ligament division and celiac and SMA bypass graft, both with reverse saphenous vein originating from bilateral iliac arteries, was performed. "She’s had dramatic improvement" in her symptoms and remains on clopidogrel (Plavix) and low-dose steroids, Dr. Dalsing said.

A second patient with Takayasu’s presented with a 4-month history of abdominal pain, a 50-pound weight loss, stenosis of all major mesenteric arteries, and bowel pneumatosis. Despite this, her sedimentation rate was only slightly elevated at 33 mm/hour, and all other coagulation and inflammatory tests were normal. She remains symptom free at 2 years on daily aspirin after undergoing an emergent right common iliac-to-SMA bypass graft with reversed saphenous vein and bowel resection.

In cases in which bypass grafting is necessary, the internal iliac artery is the preferred conduit in children since the saphenous vein is very thin walled and thus, more prone to aneurysmal degeneration, Dr. Dalsing observed. In grown patients, the saphenous vein may be the best conduit in terms of ease of harvest and adequate length for even bifurcated grafts or C-loop alignment.

During postoperative follow-up, special effort should be taken because of the young age of these patients to reduce the detrimental effects of radiation from recurrent CT angiograms, he said. Patients with symptomatic improvement are followed at 1 month postoperatively with a physical exam that includes their weight and a mesenteric duplex to evaluate graft or stent patency. This is repeated every 6 months for 1-2 years, and decreased to yearly visits, if no disease progression is detected. More aggressive imaging with CT angiography is reserved for patients with recurrent symptoms or if duplex ultrasound is insufficient or shows progressive disease, he said at the meeting, sponsored by Northwestern University.

Dr. Dalsing reported having no financial disclosures.

pwendling@frontlinemedcom.com

NAPLES, FLA. – Transfusions using cryopreserved red blood cells may be superior to those using standard blood storage techniques, updated analyses of a prospective study showed.

Cryopreservation minimizes the biochemical insult associated with transfusions and also appears to reduce the storage lesion, or the biochemical and structural changes that occur during refrigeration and adversely affect perfusion and oxygen off-loading, Dr. David A. Hampton said at the annual scientific assembly of the Eastern Association for the Surgery of Trauma (EAST).

Cryopreserved red blood cells (CPRBCs), which are Food and Drug Administration approved for a 10-year storage life, had a median shelf life of 588 days vs. just 14 days for standard liquid preserved packed red blood cells (LPRBCs) (P less than .01).

CPRBC transfusions were used by the U.S. Navy during the Vietnam War and extensively in civilian hospitals until the FDA extended the shelf life of LPRBCs from 21 to 42 days. Secondary to concerns of poor screening practices and the rise in hepatitis and HIV in the 1980s, CPRBCs fell out of favor for routine transfusion and are currently used for patients with rare blood types or if liquid stores run out.

Researchers at five U.S. centers, however, are currently investigating the efficacy and clinical outcomes of CPRBC transfusions as compared with LPRBCs, with results expected later this summer, according to Dr. Hampton, a fourth-year surgery resident at Oregon Health and Science University (OHSU), Portland.

"There haven’t been large, robust studies of this issue, but once that’s been done, we hope the paradigm will shift from LPRBCs to an increase in CPRBC usage," he said in an interview. "All of the current studies are quite favorable and support this change."

European investigators have already shown that autologous CPRBC transfusions do not elicit an inflammatory response in healthy controls (Transfusion 2013;53:28-33), while OHSU previously reported that tissue oxygenation is superior in trauma patients receiving cryopreserved rather than standard blood transfusions during the first 3 hours after transfusion (J. Trauma Acute Care Surg. 2013;74:371-6).

The results presented at EAST were based on biochemical analyses performed on the same 57 adult trauma patients with an Injury Severity Score (ISS) of more than 4 randomized to receive 1-2 U of CPRBCs or LPRBCs.

The standard and cryopreserved groups were similar with respect to age (44 years vs. 50 years), male gender (66% vs. 73%), blunt injury mechanism (97% vs. 86%), ISS (26 vs. 17), APACHE II scores (11 for both), and number of units transfused (3.1 vs. 3.6).

The correction of anemia was similar between the CPRBC and LPRBC groups 12 hours post transfusion (hemoglobin level at 24.6 g/dL vs. 24.8 g/dL) and at discharge (26.0 g/dL vs. 25.8 g/dL), Dr. Hampton said.

The CPRBC group, however, had significantly increased concentrations of 2,3-diphosphoglycerate (DPG) (P less than .04), a protein that enhances oxygen delivery and is virtually undetectable in LPRBCs after 3 weeks of storage.

The CPRBC group had significantly lower levels of serum amyloid P (1.8 mg/dL vs. 34 mg/dL; P less than .01) and C-reactive protein (0.16 mg/dL vs. 5 mg/dL; P less than .01). Elevated levels of these proteins can potentiate anticoagulation, making it difficult to dose heparin, which in turn increases bleeding risk, Dr. Hampton explained.

CPRBC patients also had significantly lower levels of interleukin-8 (P less than .04) and tumor necrosis factor–alpha (P less than .05). Elevated levels of these proinflammatory cytokines are directly associated with transfusion-related acute lung injury.

Clinical outcomes were mixed in the study, which won the Raymond H. Alexander resident paper competition at the meeting. The cryopreserved group tended to have less acute renal failure (5% vs. 9%), multiple organ failure (9% vs. 12%), and posttransfusion fever (0% vs. 3%), but were twice as likely to experience deep vein thrombosis (32% vs. 15%) and stayed longer in the hospital (16 days vs. 11 days). Respiratory failure occurred in 32% of patients in both groups. None of the differences reached statistical significance, he said.

The results clearly show that cryopreserved RBCs increase 2,3-DPG concentrations, but the oxygen metric of real interest is whether they can increase end-organ oxygen consumption, said Dr. Levi Procter of the University of Kentucky Medical Center, Lexington, who was invited to discuss the study.

He also noted that cryopreserved blood is more expensive than standard refrigerated blood and requires time to thaw, which can be problematic when patients arrive in shock and need an immediate transfusion.

Cryopreserved blood costs about $400 vs. $200 for standard blood, but the differential is negligible given the longer shelf life, Dr. Hampton said. The FDA has approved a 14-day postthaw shelf life, so cryopreserved blood can be thawed and kept on hand in the trauma bay. In a busy level I trauma center, this pre-positioned blood will be used fairly quickly by incoming patients or those within the wards.

"Any hospital that performs transfusions is a candidate for frozen blood," he told this publication. "However, the tertiary referral centers with larger patient populations are where you will most likely see the best results."

Dr. Hampton reported study sponsorship from the U.S. Air Force Research Laboratory. Dr. Procter reported no financial disclosures.

pwendling@frontlinemedcom.com

NAPLES, FLA. – Transfusions using cryopreserved red blood cells may be superior to those using standard blood storage techniques, updated analyses of a prospective study showed.

Cryopreservation minimizes the biochemical insult associated with transfusions and also appears to reduce the storage lesion, or the biochemical and structural changes that occur during refrigeration and adversely affect perfusion and oxygen off-loading, Dr. David A. Hampton said at the annual scientific assembly of the Eastern Association for the Surgery of Trauma (EAST).

Cryopreserved red blood cells (CPRBCs), which are Food and Drug Administration approved for a 10-year storage life, had a median shelf life of 588 days vs. just 14 days for standard liquid preserved packed red blood cells (LPRBCs) (P less than .01).

CPRBC transfusions were used by the U.S. Navy during the Vietnam War and extensively in civilian hospitals until the FDA extended the shelf life of LPRBCs from 21 to 42 days. Secondary to concerns of poor screening practices and the rise in hepatitis and HIV in the 1980s, CPRBCs fell out of favor for routine transfusion and are currently used for patients with rare blood types or if liquid stores run out.

Researchers at five U.S. centers, however, are currently investigating the efficacy and clinical outcomes of CPRBC transfusions as compared with LPRBCs, with results expected later this summer, according to Dr. Hampton, a fourth-year surgery resident at Oregon Health and Science University (OHSU), Portland.

"There haven’t been large, robust studies of this issue, but once that’s been done, we hope the paradigm will shift from LPRBCs to an increase in CPRBC usage," he said in an interview. "All of the current studies are quite favorable and support this change."

European investigators have already shown that autologous CPRBC transfusions do not elicit an inflammatory response in healthy controls (Transfusion 2013;53:28-33), while OHSU previously reported that tissue oxygenation is superior in trauma patients receiving cryopreserved rather than standard blood transfusions during the first 3 hours after transfusion (J. Trauma Acute Care Surg. 2013;74:371-6).

The results presented at EAST were based on biochemical analyses performed on the same 57 adult trauma patients with an Injury Severity Score (ISS) of more than 4 randomized to receive 1-2 U of CPRBCs or LPRBCs.

The standard and cryopreserved groups were similar with respect to age (44 years vs. 50 years), male gender (66% vs. 73%), blunt injury mechanism (97% vs. 86%), ISS (26 vs. 17), APACHE II scores (11 for both), and number of units transfused (3.1 vs. 3.6).

The correction of anemia was similar between the CPRBC and LPRBC groups 12 hours post transfusion (hemoglobin level at 24.6 g/dL vs. 24.8 g/dL) and at discharge (26.0 g/dL vs. 25.8 g/dL), Dr. Hampton said.

The CPRBC group, however, had significantly increased concentrations of 2,3-diphosphoglycerate (DPG) (P less than .04), a protein that enhances oxygen delivery and is virtually undetectable in LPRBCs after 3 weeks of storage.

The CPRBC group had significantly lower levels of serum amyloid P (1.8 mg/dL vs. 34 mg/dL; P less than .01) and C-reactive protein (0.16 mg/dL vs. 5 mg/dL; P less than .01). Elevated levels of these proteins can potentiate anticoagulation, making it difficult to dose heparin, which in turn increases bleeding risk, Dr. Hampton explained.

CPRBC patients also had significantly lower levels of interleukin-8 (P less than .04) and tumor necrosis factor–alpha (P less than .05). Elevated levels of these proinflammatory cytokines are directly associated with transfusion-related acute lung injury.

Clinical outcomes were mixed in the study, which won the Raymond H. Alexander resident paper competition at the meeting. The cryopreserved group tended to have less acute renal failure (5% vs. 9%), multiple organ failure (9% vs. 12%), and posttransfusion fever (0% vs. 3%), but were twice as likely to experience deep vein thrombosis (32% vs. 15%) and stayed longer in the hospital (16 days vs. 11 days). Respiratory failure occurred in 32% of patients in both groups. None of the differences reached statistical significance, he said.

The results clearly show that cryopreserved RBCs increase 2,3-DPG concentrations, but the oxygen metric of real interest is whether they can increase end-organ oxygen consumption, said Dr. Levi Procter of the University of Kentucky Medical Center, Lexington, who was invited to discuss the study.

He also noted that cryopreserved blood is more expensive than standard refrigerated blood and requires time to thaw, which can be problematic when patients arrive in shock and need an immediate transfusion.

Cryopreserved blood costs about $400 vs. $200 for standard blood, but the differential is negligible given the longer shelf life, Dr. Hampton said. The FDA has approved a 14-day postthaw shelf life, so cryopreserved blood can be thawed and kept on hand in the trauma bay. In a busy level I trauma center, this pre-positioned blood will be used fairly quickly by incoming patients or those within the wards.

"Any hospital that performs transfusions is a candidate for frozen blood," he told this publication. "However, the tertiary referral centers with larger patient populations are where you will most likely see the best results."

Dr. Hampton reported study sponsorship from the U.S. Air Force Research Laboratory. Dr. Procter reported no financial disclosures.

pwendling@frontlinemedcom.com

NAPLES, FLA. – Transfusions using cryopreserved red blood cells may be superior to those using standard blood storage techniques, updated analyses of a prospective study showed.

Cryopreservation minimizes the biochemical insult associated with transfusions and also appears to reduce the storage lesion, or the biochemical and structural changes that occur during refrigeration and adversely affect perfusion and oxygen off-loading, Dr. David A. Hampton said at the annual scientific assembly of the Eastern Association for the Surgery of Trauma (EAST).

Cryopreserved red blood cells (CPRBCs), which are Food and Drug Administration approved for a 10-year storage life, had a median shelf life of 588 days vs. just 14 days for standard liquid preserved packed red blood cells (LPRBCs) (P less than .01).

CPRBC transfusions were used by the U.S. Navy during the Vietnam War and extensively in civilian hospitals until the FDA extended the shelf life of LPRBCs from 21 to 42 days. Secondary to concerns of poor screening practices and the rise in hepatitis and HIV in the 1980s, CPRBCs fell out of favor for routine transfusion and are currently used for patients with rare blood types or if liquid stores run out.

Researchers at five U.S. centers, however, are currently investigating the efficacy and clinical outcomes of CPRBC transfusions as compared with LPRBCs, with results expected later this summer, according to Dr. Hampton, a fourth-year surgery resident at Oregon Health and Science University (OHSU), Portland.

"There haven’t been large, robust studies of this issue, but once that’s been done, we hope the paradigm will shift from LPRBCs to an increase in CPRBC usage," he said in an interview. "All of the current studies are quite favorable and support this change."

European investigators have already shown that autologous CPRBC transfusions do not elicit an inflammatory response in healthy controls (Transfusion 2013;53:28-33), while OHSU previously reported that tissue oxygenation is superior in trauma patients receiving cryopreserved rather than standard blood transfusions during the first 3 hours after transfusion (J. Trauma Acute Care Surg. 2013;74:371-6).

The results presented at EAST were based on biochemical analyses performed on the same 57 adult trauma patients with an Injury Severity Score (ISS) of more than 4 randomized to receive 1-2 U of CPRBCs or LPRBCs.

The standard and cryopreserved groups were similar with respect to age (44 years vs. 50 years), male gender (66% vs. 73%), blunt injury mechanism (97% vs. 86%), ISS (26 vs. 17), APACHE II scores (11 for both), and number of units transfused (3.1 vs. 3.6).

The correction of anemia was similar between the CPRBC and LPRBC groups 12 hours post transfusion (hemoglobin level at 24.6 g/dL vs. 24.8 g/dL) and at discharge (26.0 g/dL vs. 25.8 g/dL), Dr. Hampton said.

The CPRBC group, however, had significantly increased concentrations of 2,3-diphosphoglycerate (DPG) (P less than .04), a protein that enhances oxygen delivery and is virtually undetectable in LPRBCs after 3 weeks of storage.

The CPRBC group had significantly lower levels of serum amyloid P (1.8 mg/dL vs. 34 mg/dL; P less than .01) and C-reactive protein (0.16 mg/dL vs. 5 mg/dL; P less than .01). Elevated levels of these proteins can potentiate anticoagulation, making it difficult to dose heparin, which in turn increases bleeding risk, Dr. Hampton explained.

CPRBC patients also had significantly lower levels of interleukin-8 (P less than .04) and tumor necrosis factor–alpha (P less than .05). Elevated levels of these proinflammatory cytokines are directly associated with transfusion-related acute lung injury.

Clinical outcomes were mixed in the study, which won the Raymond H. Alexander resident paper competition at the meeting. The cryopreserved group tended to have less acute renal failure (5% vs. 9%), multiple organ failure (9% vs. 12%), and posttransfusion fever (0% vs. 3%), but were twice as likely to experience deep vein thrombosis (32% vs. 15%) and stayed longer in the hospital (16 days vs. 11 days). Respiratory failure occurred in 32% of patients in both groups. None of the differences reached statistical significance, he said.

The results clearly show that cryopreserved RBCs increase 2,3-DPG concentrations, but the oxygen metric of real interest is whether they can increase end-organ oxygen consumption, said Dr. Levi Procter of the University of Kentucky Medical Center, Lexington, who was invited to discuss the study.

He also noted that cryopreserved blood is more expensive than standard refrigerated blood and requires time to thaw, which can be problematic when patients arrive in shock and need an immediate transfusion.

Cryopreserved blood costs about $400 vs. $200 for standard blood, but the differential is negligible given the longer shelf life, Dr. Hampton said. The FDA has approved a 14-day postthaw shelf life, so cryopreserved blood can be thawed and kept on hand in the trauma bay. In a busy level I trauma center, this pre-positioned blood will be used fairly quickly by incoming patients or those within the wards.

"Any hospital that performs transfusions is a candidate for frozen blood," he told this publication. "However, the tertiary referral centers with larger patient populations are where you will most likely see the best results."

Dr. Hampton reported study sponsorship from the U.S. Air Force Research Laboratory. Dr. Procter reported no financial disclosures.

pwendling@frontlinemedcom.com