Doug Brunk is a San Diego-based award-winning reporter who began covering health care in 1991. Before joining the company, he wrote for the health sciences division of Columbia University and was an associate editor at Contemporary Long Term Care magazine when it won a Jesse H. Neal Award. His work has been syndicated by the Los Angeles Times and he is the author of two books related to the University of Kentucky Wildcats men's basketball program. Doug has a master’s degree in magazine journalism from the S.I. Newhouse School of Public Communications at Syracuse University. Follow him on Twitter @dougbrunk.

Oxygen debt key in multiple organ dysfunction

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SAN FRANCISCO – Multiple organ dysfunction syndrome is "underappreciated" by many of today’s clinicians, as optimal ways to treat it remain elusive, said Dr. Larry H. Hollier.

At the Vascular Annual Meeting, Dr. Hollier, professor of surgery and chancellor of the Louisiana State University Health Sciences Center, New Orleans, defined multiple organ dysfunction syndrome (MODS) as altered organ functions in an acutely ill patient requiring intervention to achieve homeostasis. "That’s a pretty broad definition, but it’s one of the most common causes of death in surgical intensive care units," he said. "Numerous precipitating factors classically described in multiple organ dysfunction syndrome include sepsis, trauma, cardiac arrest, visceral ischemia, burns, pancreatitis, shock, and major surgery with postoperative instability."

IMNG Medical Media/Martin Allred
Dr. Larry H. Hollier (right) was honored for his John Homans Lectureship on oxygen debt and MODS by Dr. Peter Gloviczki.

The pathophysiology of MODS "is fairly straightforward," he continued. "Some events result in ischemia and tissue hypoxia. Reperfusion occurs with the activation of cytokines, and an exaggerated inflammatory response generates oxygen free radicals, tissue damage, and then organ dysfunction." said Dr. Hollier, the invited speaker for the John Homans Lectureship of the SVS.

The major underlying issue in MODS stems from uncorrected oxygen debt in tissues. In fact, the level of perioperative tissue debt has a direct relationship on postoperative morbidity and mortality. According to Dr. Hollier, the predicted outcome by acutely accumulated oxygen debt in the first 4 hours post injury works like this: 8 L/m2 leads to a severe flulike syndrome (mild SIRS); 26 L/m2 leads to multiple organ dysfunction syndrome; and 33 L/m2 or more leads to death. "The uncorrected oxygen debt in tissues that is initiated is not the end of it," he said. "There’s an accumulating oxygen debt that amasses to keep biomass viable during low oxygen delivery. After resuscitation, there’s increased oxygen required above the basal rate, because explosive oxygen needs occur in order to fuel the inflammation of reperfusion injury."

Conventional therapies for MODS include volume resuscitation, ionotropic agents to improve cardiac performance and increase oxygen delivery, and ventilator support to improve oxygen input. Multiple experimental therapies have also been used, but no universal treatment has been found that reverses MODS, he said. "Early diagnosis and prompt treatment of organ hypoperfusion and hypoxia are of utmost importance. The major goal is to increase oxygen delivery as soon as possible."

Vascular surgeons are most likely to encounter MODS in cases of extensive blunt trauma, aortic transection/dissection, crush injury, severe ischemia following acute aortic occlusion, mesenteric infarction, and thoracoabdominal aortic surgery, both with extensive direct repair and with hybrid repair. The "hypoxia cascade" can occur without progression to the full multiple organ dysfunction syndrome. "The cascade can occur in refractory hypotension following repair of ruptured aortic aneurysm or other major vascular procedure, during brain ischemia, visceral ischemia, delayed onset paraplegia following repair of thoracoabdominal aortic aneurysms, and during the compartment syndrome."

Recommendations for intraoperative management of thoracoabdominal aortic aneurysms include maintaining visceral perfusion with a pump or a bypass or using visceral perfusion catheters, and perioperative CSF drainage "to allow reduction in the pressure around the spinal cord," he said.

Dr. Hollier said that management of serious injury in the commercial diver in the field has afforded two observations. First, high-dose hyperbaric oxygen, used very early in acute resuscitation of the severely injured, "effectively reduces oxygen debt." Second, the quick reduction of the oxygen debt by high-dose hyperbaric oxygen leverages chances of recovery. "What we do know is that there is only one variable that consistently predicts both mortality and multiple organ dysfunction syndrome following traumatic shock. That is oxygen debt."

Dr. Hollier had no disclosures.

dbrunk@frontlinemedcom.com

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SAN FRANCISCO – Multiple organ dysfunction syndrome is "underappreciated" by many of today’s clinicians, as optimal ways to treat it remain elusive, said Dr. Larry H. Hollier.

At the Vascular Annual Meeting, Dr. Hollier, professor of surgery and chancellor of the Louisiana State University Health Sciences Center, New Orleans, defined multiple organ dysfunction syndrome (MODS) as altered organ functions in an acutely ill patient requiring intervention to achieve homeostasis. "That’s a pretty broad definition, but it’s one of the most common causes of death in surgical intensive care units," he said. "Numerous precipitating factors classically described in multiple organ dysfunction syndrome include sepsis, trauma, cardiac arrest, visceral ischemia, burns, pancreatitis, shock, and major surgery with postoperative instability."

IMNG Medical Media/Martin Allred
Dr. Larry H. Hollier (right) was honored for his John Homans Lectureship on oxygen debt and MODS by Dr. Peter Gloviczki.

The pathophysiology of MODS "is fairly straightforward," he continued. "Some events result in ischemia and tissue hypoxia. Reperfusion occurs with the activation of cytokines, and an exaggerated inflammatory response generates oxygen free radicals, tissue damage, and then organ dysfunction." said Dr. Hollier, the invited speaker for the John Homans Lectureship of the SVS.

The major underlying issue in MODS stems from uncorrected oxygen debt in tissues. In fact, the level of perioperative tissue debt has a direct relationship on postoperative morbidity and mortality. According to Dr. Hollier, the predicted outcome by acutely accumulated oxygen debt in the first 4 hours post injury works like this: 8 L/m2 leads to a severe flulike syndrome (mild SIRS); 26 L/m2 leads to multiple organ dysfunction syndrome; and 33 L/m2 or more leads to death. "The uncorrected oxygen debt in tissues that is initiated is not the end of it," he said. "There’s an accumulating oxygen debt that amasses to keep biomass viable during low oxygen delivery. After resuscitation, there’s increased oxygen required above the basal rate, because explosive oxygen needs occur in order to fuel the inflammation of reperfusion injury."

Conventional therapies for MODS include volume resuscitation, ionotropic agents to improve cardiac performance and increase oxygen delivery, and ventilator support to improve oxygen input. Multiple experimental therapies have also been used, but no universal treatment has been found that reverses MODS, he said. "Early diagnosis and prompt treatment of organ hypoperfusion and hypoxia are of utmost importance. The major goal is to increase oxygen delivery as soon as possible."

Vascular surgeons are most likely to encounter MODS in cases of extensive blunt trauma, aortic transection/dissection, crush injury, severe ischemia following acute aortic occlusion, mesenteric infarction, and thoracoabdominal aortic surgery, both with extensive direct repair and with hybrid repair. The "hypoxia cascade" can occur without progression to the full multiple organ dysfunction syndrome. "The cascade can occur in refractory hypotension following repair of ruptured aortic aneurysm or other major vascular procedure, during brain ischemia, visceral ischemia, delayed onset paraplegia following repair of thoracoabdominal aortic aneurysms, and during the compartment syndrome."

Recommendations for intraoperative management of thoracoabdominal aortic aneurysms include maintaining visceral perfusion with a pump or a bypass or using visceral perfusion catheters, and perioperative CSF drainage "to allow reduction in the pressure around the spinal cord," he said.

Dr. Hollier said that management of serious injury in the commercial diver in the field has afforded two observations. First, high-dose hyperbaric oxygen, used very early in acute resuscitation of the severely injured, "effectively reduces oxygen debt." Second, the quick reduction of the oxygen debt by high-dose hyperbaric oxygen leverages chances of recovery. "What we do know is that there is only one variable that consistently predicts both mortality and multiple organ dysfunction syndrome following traumatic shock. That is oxygen debt."

Dr. Hollier had no disclosures.

dbrunk@frontlinemedcom.com

SAN FRANCISCO – Multiple organ dysfunction syndrome is "underappreciated" by many of today’s clinicians, as optimal ways to treat it remain elusive, said Dr. Larry H. Hollier.

At the Vascular Annual Meeting, Dr. Hollier, professor of surgery and chancellor of the Louisiana State University Health Sciences Center, New Orleans, defined multiple organ dysfunction syndrome (MODS) as altered organ functions in an acutely ill patient requiring intervention to achieve homeostasis. "That’s a pretty broad definition, but it’s one of the most common causes of death in surgical intensive care units," he said. "Numerous precipitating factors classically described in multiple organ dysfunction syndrome include sepsis, trauma, cardiac arrest, visceral ischemia, burns, pancreatitis, shock, and major surgery with postoperative instability."

IMNG Medical Media/Martin Allred
Dr. Larry H. Hollier (right) was honored for his John Homans Lectureship on oxygen debt and MODS by Dr. Peter Gloviczki.

The pathophysiology of MODS "is fairly straightforward," he continued. "Some events result in ischemia and tissue hypoxia. Reperfusion occurs with the activation of cytokines, and an exaggerated inflammatory response generates oxygen free radicals, tissue damage, and then organ dysfunction." said Dr. Hollier, the invited speaker for the John Homans Lectureship of the SVS.

The major underlying issue in MODS stems from uncorrected oxygen debt in tissues. In fact, the level of perioperative tissue debt has a direct relationship on postoperative morbidity and mortality. According to Dr. Hollier, the predicted outcome by acutely accumulated oxygen debt in the first 4 hours post injury works like this: 8 L/m2 leads to a severe flulike syndrome (mild SIRS); 26 L/m2 leads to multiple organ dysfunction syndrome; and 33 L/m2 or more leads to death. "The uncorrected oxygen debt in tissues that is initiated is not the end of it," he said. "There’s an accumulating oxygen debt that amasses to keep biomass viable during low oxygen delivery. After resuscitation, there’s increased oxygen required above the basal rate, because explosive oxygen needs occur in order to fuel the inflammation of reperfusion injury."

Conventional therapies for MODS include volume resuscitation, ionotropic agents to improve cardiac performance and increase oxygen delivery, and ventilator support to improve oxygen input. Multiple experimental therapies have also been used, but no universal treatment has been found that reverses MODS, he said. "Early diagnosis and prompt treatment of organ hypoperfusion and hypoxia are of utmost importance. The major goal is to increase oxygen delivery as soon as possible."

Vascular surgeons are most likely to encounter MODS in cases of extensive blunt trauma, aortic transection/dissection, crush injury, severe ischemia following acute aortic occlusion, mesenteric infarction, and thoracoabdominal aortic surgery, both with extensive direct repair and with hybrid repair. The "hypoxia cascade" can occur without progression to the full multiple organ dysfunction syndrome. "The cascade can occur in refractory hypotension following repair of ruptured aortic aneurysm or other major vascular procedure, during brain ischemia, visceral ischemia, delayed onset paraplegia following repair of thoracoabdominal aortic aneurysms, and during the compartment syndrome."

Recommendations for intraoperative management of thoracoabdominal aortic aneurysms include maintaining visceral perfusion with a pump or a bypass or using visceral perfusion catheters, and perioperative CSF drainage "to allow reduction in the pressure around the spinal cord," he said.

Dr. Hollier said that management of serious injury in the commercial diver in the field has afforded two observations. First, high-dose hyperbaric oxygen, used very early in acute resuscitation of the severely injured, "effectively reduces oxygen debt." Second, the quick reduction of the oxygen debt by high-dose hyperbaric oxygen leverages chances of recovery. "What we do know is that there is only one variable that consistently predicts both mortality and multiple organ dysfunction syndrome following traumatic shock. That is oxygen debt."

Dr. Hollier had no disclosures.

dbrunk@frontlinemedcom.com

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EXPERT ANALYSIS FROM THE VASCULAR ANNUAL MEETING

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Medicare-funded EVAR can mean unmet surgery costs

Cost containment through negotiation
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SAN FRANCISCO – Endovascular aneurysm repair (EVAR) is associated with negative operating margins among Medicare beneficiaries, and device costs account for more than 50% of the technical costs, results from a single-center study demonstrated.

"U.S. health care expenditures have steadily increased over several decades, with some projections now reaching 20% of gross domestic product by 2020," Dr. David H. Stone said at the Vascular Annual Meeting. "Accordingly, vigorous debate surrounding health care reform has ensued. In this setting physicians and health care system alike are placing a growing emphasis on both cost reduction and quality improvement, thus increasing the overall value of health care delivery. Endovascular aneurysm repair represents a high-value procedure, though it remains associated with significant cost. This places EVAR at odds with efforts to constrain procedure-associated health care dollars."

Dr. Stone, in the section of vascular surgery at Dartmouth-Hitchcock Medical Center, Lebanon, N.H., and his associates retrospectively examined the EVAR-associated technical costs, revenues, and resulting operating margins among 127 infrarenal EVARs performed at the center between April 2011 and March 2012. They excluded cases in which anatomy was deemed outside of conventional "Instructions for Use" guidelines, included cases treated only by a single vendor’s device, and restricted the payer source to Medicare-remunerated cases billed using the DRG 238 code. This left a cohort of 49 patients. The researchers then determined mean EVAR implant costs per procedure and used 2012 University HealthSystem Consortium data to benchmark their DRG 238 costs and length of stay – another major driver for cost.

"To our surprise, we initially determined that our section’s annual net operating margin for EVAR when billed using DRG 238 was substantially negative, approaching –$500,000 per year," Dr. Stone said. Specifically, mean technical costs among the 49 patients were $31,672, while technical revenue was $27,657, resulting in a negative technical operating margin of $4,015 per case. More specifically, stent grafts accounted for 52% of the technical costs while institutional overhead costs accounted for the remaining 48%.

Among the nonimplant costs, the operating room accounted for the single greatest technical cost driver (17%). "By comparison, stent grafts account for roughly threefold more technical cost than [did] any nonimplant hospital costs," Dr. Stone said.

"Interestingly, there is an apparent inequity between the stent graft costs when considered as a percentage of cost vs. a percentage of revenue. More specifically, stent grafts currently account for 52% of the technical costs but assume 60% of the DRG payment, thus contributing in part to our institution’s negative margin."

Given the substantial impact of graft costs to the procedure, the researchers also examined Dartmouth-Hitchcock’s current vendor market share for the medical center’s entire EVAR practice. The vendors were not named but rather described as vendors A, B, C, and D. "Though historically we have not routinely integrated costs into our case planning, we were somewhat surprised to learn that vendor D – the highest-cost device – derived the largest market share, while vendors A and B – the two lowest-cost devices – derived the smallest market shares, respectively," Dr. Stone said. "Surgeons were largely unaware of this cost disparity." He said that a "lack of transparency" of the device costs among institutions has also led in part to the sustainability of this practice pattern.

Dr. Stone acknowledged certain limitations of the study, including its single-center design, "thus graft pricing and institutional overhead will likely vary among hospitals," he said. "In addition, we did not analyze DRG 237–remunerated EVAR with major complications, where costs may be higher yet. However, we nevertheless believe that the adjudicated financial costs presented here may reflect a similar trend in many institutions throughout the country for Medicare-remunerated EVAR."

He concluded his remarks by noting that the negative operating margin for Medicare-remunerated EVAR "is likely unsustainable. Surgeon awareness of price differential among grafts may allow for competitive negotiated pricing. Accordingly, we believe that EVAR as a high-value procedure must undergo care delivery redesign, reflecting cost restructuring with viable remuneration schemes in order for current practice to remain sustainable."

Dr. Stone said that he had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

Body

Dr. Stone and his colleagues at Dartmouth-Hitchcock have identified simple, uncomplicated EVAR cases as producing a negative contribution margin to the institution, primarily because of device costs. In today’s environment of cost containment, it is imperative that physicians partner with institutions to evaluate appropriate methods of cost containment, while maintaining excellence of care. These findings should not lead to the abandonment or restriction of EVAR, but rather further discussions between hospitals and physicians as to ways to decrease cost of the procedure. This will include negotiations with vendors to potentially decrease device costs and to provide, at the least, budget neutral interventions, as the current status is not sustainable.

As we move forward, these types of calculations will need to occur at all institutions for high-volume procedures to ensure viability of the institutions while maintaining excellence of medical care.

Dr. Linda Harris is the program director and division chief of vascular surgery at the State University of New York, Buffalo.

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Dr. Stone and his colleagues at Dartmouth-Hitchcock have identified simple, uncomplicated EVAR cases as producing a negative contribution margin to the institution, primarily because of device costs. In today’s environment of cost containment, it is imperative that physicians partner with institutions to evaluate appropriate methods of cost containment, while maintaining excellence of care. These findings should not lead to the abandonment or restriction of EVAR, but rather further discussions between hospitals and physicians as to ways to decrease cost of the procedure. This will include negotiations with vendors to potentially decrease device costs and to provide, at the least, budget neutral interventions, as the current status is not sustainable.

As we move forward, these types of calculations will need to occur at all institutions for high-volume procedures to ensure viability of the institutions while maintaining excellence of medical care.

Dr. Linda Harris is the program director and division chief of vascular surgery at the State University of New York, Buffalo.

Body

Dr. Stone and his colleagues at Dartmouth-Hitchcock have identified simple, uncomplicated EVAR cases as producing a negative contribution margin to the institution, primarily because of device costs. In today’s environment of cost containment, it is imperative that physicians partner with institutions to evaluate appropriate methods of cost containment, while maintaining excellence of care. These findings should not lead to the abandonment or restriction of EVAR, but rather further discussions between hospitals and physicians as to ways to decrease cost of the procedure. This will include negotiations with vendors to potentially decrease device costs and to provide, at the least, budget neutral interventions, as the current status is not sustainable.

As we move forward, these types of calculations will need to occur at all institutions for high-volume procedures to ensure viability of the institutions while maintaining excellence of medical care.

Dr. Linda Harris is the program director and division chief of vascular surgery at the State University of New York, Buffalo.

Title
Cost containment through negotiation
Cost containment through negotiation

SAN FRANCISCO – Endovascular aneurysm repair (EVAR) is associated with negative operating margins among Medicare beneficiaries, and device costs account for more than 50% of the technical costs, results from a single-center study demonstrated.

"U.S. health care expenditures have steadily increased over several decades, with some projections now reaching 20% of gross domestic product by 2020," Dr. David H. Stone said at the Vascular Annual Meeting. "Accordingly, vigorous debate surrounding health care reform has ensued. In this setting physicians and health care system alike are placing a growing emphasis on both cost reduction and quality improvement, thus increasing the overall value of health care delivery. Endovascular aneurysm repair represents a high-value procedure, though it remains associated with significant cost. This places EVAR at odds with efforts to constrain procedure-associated health care dollars."

Dr. Stone, in the section of vascular surgery at Dartmouth-Hitchcock Medical Center, Lebanon, N.H., and his associates retrospectively examined the EVAR-associated technical costs, revenues, and resulting operating margins among 127 infrarenal EVARs performed at the center between April 2011 and March 2012. They excluded cases in which anatomy was deemed outside of conventional "Instructions for Use" guidelines, included cases treated only by a single vendor’s device, and restricted the payer source to Medicare-remunerated cases billed using the DRG 238 code. This left a cohort of 49 patients. The researchers then determined mean EVAR implant costs per procedure and used 2012 University HealthSystem Consortium data to benchmark their DRG 238 costs and length of stay – another major driver for cost.

"To our surprise, we initially determined that our section’s annual net operating margin for EVAR when billed using DRG 238 was substantially negative, approaching –$500,000 per year," Dr. Stone said. Specifically, mean technical costs among the 49 patients were $31,672, while technical revenue was $27,657, resulting in a negative technical operating margin of $4,015 per case. More specifically, stent grafts accounted for 52% of the technical costs while institutional overhead costs accounted for the remaining 48%.

Among the nonimplant costs, the operating room accounted for the single greatest technical cost driver (17%). "By comparison, stent grafts account for roughly threefold more technical cost than [did] any nonimplant hospital costs," Dr. Stone said.

"Interestingly, there is an apparent inequity between the stent graft costs when considered as a percentage of cost vs. a percentage of revenue. More specifically, stent grafts currently account for 52% of the technical costs but assume 60% of the DRG payment, thus contributing in part to our institution’s negative margin."

Given the substantial impact of graft costs to the procedure, the researchers also examined Dartmouth-Hitchcock’s current vendor market share for the medical center’s entire EVAR practice. The vendors were not named but rather described as vendors A, B, C, and D. "Though historically we have not routinely integrated costs into our case planning, we were somewhat surprised to learn that vendor D – the highest-cost device – derived the largest market share, while vendors A and B – the two lowest-cost devices – derived the smallest market shares, respectively," Dr. Stone said. "Surgeons were largely unaware of this cost disparity." He said that a "lack of transparency" of the device costs among institutions has also led in part to the sustainability of this practice pattern.

Dr. Stone acknowledged certain limitations of the study, including its single-center design, "thus graft pricing and institutional overhead will likely vary among hospitals," he said. "In addition, we did not analyze DRG 237–remunerated EVAR with major complications, where costs may be higher yet. However, we nevertheless believe that the adjudicated financial costs presented here may reflect a similar trend in many institutions throughout the country for Medicare-remunerated EVAR."

He concluded his remarks by noting that the negative operating margin for Medicare-remunerated EVAR "is likely unsustainable. Surgeon awareness of price differential among grafts may allow for competitive negotiated pricing. Accordingly, we believe that EVAR as a high-value procedure must undergo care delivery redesign, reflecting cost restructuring with viable remuneration schemes in order for current practice to remain sustainable."

Dr. Stone said that he had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

SAN FRANCISCO – Endovascular aneurysm repair (EVAR) is associated with negative operating margins among Medicare beneficiaries, and device costs account for more than 50% of the technical costs, results from a single-center study demonstrated.

"U.S. health care expenditures have steadily increased over several decades, with some projections now reaching 20% of gross domestic product by 2020," Dr. David H. Stone said at the Vascular Annual Meeting. "Accordingly, vigorous debate surrounding health care reform has ensued. In this setting physicians and health care system alike are placing a growing emphasis on both cost reduction and quality improvement, thus increasing the overall value of health care delivery. Endovascular aneurysm repair represents a high-value procedure, though it remains associated with significant cost. This places EVAR at odds with efforts to constrain procedure-associated health care dollars."

Dr. Stone, in the section of vascular surgery at Dartmouth-Hitchcock Medical Center, Lebanon, N.H., and his associates retrospectively examined the EVAR-associated technical costs, revenues, and resulting operating margins among 127 infrarenal EVARs performed at the center between April 2011 and March 2012. They excluded cases in which anatomy was deemed outside of conventional "Instructions for Use" guidelines, included cases treated only by a single vendor’s device, and restricted the payer source to Medicare-remunerated cases billed using the DRG 238 code. This left a cohort of 49 patients. The researchers then determined mean EVAR implant costs per procedure and used 2012 University HealthSystem Consortium data to benchmark their DRG 238 costs and length of stay – another major driver for cost.

"To our surprise, we initially determined that our section’s annual net operating margin for EVAR when billed using DRG 238 was substantially negative, approaching –$500,000 per year," Dr. Stone said. Specifically, mean technical costs among the 49 patients were $31,672, while technical revenue was $27,657, resulting in a negative technical operating margin of $4,015 per case. More specifically, stent grafts accounted for 52% of the technical costs while institutional overhead costs accounted for the remaining 48%.

Among the nonimplant costs, the operating room accounted for the single greatest technical cost driver (17%). "By comparison, stent grafts account for roughly threefold more technical cost than [did] any nonimplant hospital costs," Dr. Stone said.

"Interestingly, there is an apparent inequity between the stent graft costs when considered as a percentage of cost vs. a percentage of revenue. More specifically, stent grafts currently account for 52% of the technical costs but assume 60% of the DRG payment, thus contributing in part to our institution’s negative margin."

Given the substantial impact of graft costs to the procedure, the researchers also examined Dartmouth-Hitchcock’s current vendor market share for the medical center’s entire EVAR practice. The vendors were not named but rather described as vendors A, B, C, and D. "Though historically we have not routinely integrated costs into our case planning, we were somewhat surprised to learn that vendor D – the highest-cost device – derived the largest market share, while vendors A and B – the two lowest-cost devices – derived the smallest market shares, respectively," Dr. Stone said. "Surgeons were largely unaware of this cost disparity." He said that a "lack of transparency" of the device costs among institutions has also led in part to the sustainability of this practice pattern.

Dr. Stone acknowledged certain limitations of the study, including its single-center design, "thus graft pricing and institutional overhead will likely vary among hospitals," he said. "In addition, we did not analyze DRG 237–remunerated EVAR with major complications, where costs may be higher yet. However, we nevertheless believe that the adjudicated financial costs presented here may reflect a similar trend in many institutions throughout the country for Medicare-remunerated EVAR."

He concluded his remarks by noting that the negative operating margin for Medicare-remunerated EVAR "is likely unsustainable. Surgeon awareness of price differential among grafts may allow for competitive negotiated pricing. Accordingly, we believe that EVAR as a high-value procedure must undergo care delivery redesign, reflecting cost restructuring with viable remuneration schemes in order for current practice to remain sustainable."

Dr. Stone said that he had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

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AT THE VASCULAR ANNUAL MEETING

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Major finding: In a study of DRG 238 remunerated EVAR, stent grafts accounted for 52% of the technical costs while institutional overhead costs accounted for the remaining 48%.

Data source: A retrospectively examination of the EVAR-associated technical costs, revenues, and resulting operating margins among 127 infrarenal EVARs performed at Dartmouth-Hitchcock Medical Center between April 2011 and March 2012.

Disclosures: Dr. Stone said that he had no relevant financial conflicts to disclose.

Early adhesiolysis for small bowel obstruction shows benefit

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SAN DIEGO – Patients who underwent adhesiolysis within 24 hours of hospital admission for acute small bowel obstruction had a significant reduction in 30-day major morbidity, mortality, and hospital length of stay, compared with those who underwent adhesiolysis after 24 hours, results from an analysis of national data showed.

"Historically, the teaching was that surgeons should never let the sun rise and set on a complete small bowel obstruction," Dr. Kristin N. Kelly said at the national conference of the American College of Surgeons/National Surgical Quality Improvement Program. "The consequences of bowel ischemia, perforation, and peritonitis were feared. Interestingly, over the past 2 decades, practice patterns have shifted."

Dr. Kristin N. Kelly

For example, she said, a recent study of data from the 2009 Nationwide Inpatient Sample researchers found that only 18% of patients with small bowel obstruction received surgical intervention and the rest were managed with conservative measures including intravenous fluid and nasogastric decompression (J. Trauma Acute Care Surg. 2013;74:181-7).

In addition, recently released guidelines (World J. Emerg. Surg. 2011;6:5) "have suggested that without peritoneal signs or evidence of bowel ischemia, nonoperative management can be extended for 3-5 days before contrast studies or surgery [is] recommended," said Dr. Kelly of the Surgical Health Outcomes and Research Enterprise (SHORE) and the department of surgery at the University of Rochester (N.Y.) Medical Center. "The concern remains that surgery may be difficult or dangerous or promote additional adhesion formation. Alternatively, delaying surgical treatment may increase morbidity and mortality. We wondered if perhaps we’ve moved too far toward conservative management. We sought to address if there is a benefit to a prompt surgical approach. Our aim was to examine whether adhesiolysis within 24 hours of admission for acute small bowel obstruction is associated with improved 30-day morbidity and mortality compared with those undergoing later adhesiolysis."

She and her associates searched the 2005-2010 American College of Surgeons/National Surgical Quality Improvement Program database for patients who had a diagnosis of adhesive small bowel obstruction. They limited their analysis to patients who were operated on within 1 week of admission. The time from admission to operation was classified as early (within 24 hours) or late (after 24 hours). The groups were compared using univariate and multivariate analysis to examine the association between numerous patient and operative factors.

Of the 8,912 patients who met inclusion criteria, 3,240 (36%) underwent early adhesiolysis while the remaining 5,692 (64%) underwent the procedure late. The mean time to surgery was 1.7 days, while about three-quarters of patients in the late group had surgery between 1 and 3 days after admission.

Compared with patients in the late adhesiolysis group, those in the early adhesiolysis group had higher rates of emergency operations (60% vs. 45%, respectively; P less than .0001), and more laparoscopic operations (19% vs. 13%; P less than .0001), but both groups had similar operative times (a mean of 93 vs. 89 minutes) and similar rates of small bowel resection (27% vs. 28%). The mean postoperative length of stay was about 2 days shorter in the early group (7.4 days vs. 9.5 days; P less than .0001).

"Patients in the early group were slightly younger, had fewer comorbodities, and better functional status," Dr. Kelly added. "But the rates of preoperative sepsis and systemic inflammatory response syndrome were similar."

On multivariate analysis patients in the early adhesiolysis group had 17% fewer major complications (odds ratio, 0.83; P = .005) and a 26% lower mortality rate (OR, 0.74; P = .041) at 30 days, compared with their counterparts in the late adhesiolysis group. The three most common complications were respiratory complications (28%), sepsis/septic shock (25%), and unexpected return to the operating room (18%).

Dr. Kelly acknowledged certain limitations of the study, including the potential for selection bias and that "perhaps surgeons postpone operating on patients with many comorbodities and poorer functional status, or perhaps it takes several days for a surgical referral," she said. "We are also limited because we do not have information regarding all of the clinical, personal, and administrative factors that may go into any individual surgeon’s decision to take a patient to the OR. Finally, we don’t have data on the case difficulty or any intraoperative occurrences. These would be useful in evaluating whether the timing really affected how challenging the case might be." Nevertheless, the findings "support early surgeon involvement and an expeditious approach to small bowel obstruction," she concluded.

Dr. Kelly said she had no relevant financial disclosures.

dbrunk@frontlinemedcom.com

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SAN DIEGO – Patients who underwent adhesiolysis within 24 hours of hospital admission for acute small bowel obstruction had a significant reduction in 30-day major morbidity, mortality, and hospital length of stay, compared with those who underwent adhesiolysis after 24 hours, results from an analysis of national data showed.

"Historically, the teaching was that surgeons should never let the sun rise and set on a complete small bowel obstruction," Dr. Kristin N. Kelly said at the national conference of the American College of Surgeons/National Surgical Quality Improvement Program. "The consequences of bowel ischemia, perforation, and peritonitis were feared. Interestingly, over the past 2 decades, practice patterns have shifted."

Dr. Kristin N. Kelly

For example, she said, a recent study of data from the 2009 Nationwide Inpatient Sample researchers found that only 18% of patients with small bowel obstruction received surgical intervention and the rest were managed with conservative measures including intravenous fluid and nasogastric decompression (J. Trauma Acute Care Surg. 2013;74:181-7).

In addition, recently released guidelines (World J. Emerg. Surg. 2011;6:5) "have suggested that without peritoneal signs or evidence of bowel ischemia, nonoperative management can be extended for 3-5 days before contrast studies or surgery [is] recommended," said Dr. Kelly of the Surgical Health Outcomes and Research Enterprise (SHORE) and the department of surgery at the University of Rochester (N.Y.) Medical Center. "The concern remains that surgery may be difficult or dangerous or promote additional adhesion formation. Alternatively, delaying surgical treatment may increase morbidity and mortality. We wondered if perhaps we’ve moved too far toward conservative management. We sought to address if there is a benefit to a prompt surgical approach. Our aim was to examine whether adhesiolysis within 24 hours of admission for acute small bowel obstruction is associated with improved 30-day morbidity and mortality compared with those undergoing later adhesiolysis."

She and her associates searched the 2005-2010 American College of Surgeons/National Surgical Quality Improvement Program database for patients who had a diagnosis of adhesive small bowel obstruction. They limited their analysis to patients who were operated on within 1 week of admission. The time from admission to operation was classified as early (within 24 hours) or late (after 24 hours). The groups were compared using univariate and multivariate analysis to examine the association between numerous patient and operative factors.

Of the 8,912 patients who met inclusion criteria, 3,240 (36%) underwent early adhesiolysis while the remaining 5,692 (64%) underwent the procedure late. The mean time to surgery was 1.7 days, while about three-quarters of patients in the late group had surgery between 1 and 3 days after admission.

Compared with patients in the late adhesiolysis group, those in the early adhesiolysis group had higher rates of emergency operations (60% vs. 45%, respectively; P less than .0001), and more laparoscopic operations (19% vs. 13%; P less than .0001), but both groups had similar operative times (a mean of 93 vs. 89 minutes) and similar rates of small bowel resection (27% vs. 28%). The mean postoperative length of stay was about 2 days shorter in the early group (7.4 days vs. 9.5 days; P less than .0001).

"Patients in the early group were slightly younger, had fewer comorbodities, and better functional status," Dr. Kelly added. "But the rates of preoperative sepsis and systemic inflammatory response syndrome were similar."

On multivariate analysis patients in the early adhesiolysis group had 17% fewer major complications (odds ratio, 0.83; P = .005) and a 26% lower mortality rate (OR, 0.74; P = .041) at 30 days, compared with their counterparts in the late adhesiolysis group. The three most common complications were respiratory complications (28%), sepsis/septic shock (25%), and unexpected return to the operating room (18%).

Dr. Kelly acknowledged certain limitations of the study, including the potential for selection bias and that "perhaps surgeons postpone operating on patients with many comorbodities and poorer functional status, or perhaps it takes several days for a surgical referral," she said. "We are also limited because we do not have information regarding all of the clinical, personal, and administrative factors that may go into any individual surgeon’s decision to take a patient to the OR. Finally, we don’t have data on the case difficulty or any intraoperative occurrences. These would be useful in evaluating whether the timing really affected how challenging the case might be." Nevertheless, the findings "support early surgeon involvement and an expeditious approach to small bowel obstruction," she concluded.

Dr. Kelly said she had no relevant financial disclosures.

dbrunk@frontlinemedcom.com

SAN DIEGO – Patients who underwent adhesiolysis within 24 hours of hospital admission for acute small bowel obstruction had a significant reduction in 30-day major morbidity, mortality, and hospital length of stay, compared with those who underwent adhesiolysis after 24 hours, results from an analysis of national data showed.

"Historically, the teaching was that surgeons should never let the sun rise and set on a complete small bowel obstruction," Dr. Kristin N. Kelly said at the national conference of the American College of Surgeons/National Surgical Quality Improvement Program. "The consequences of bowel ischemia, perforation, and peritonitis were feared. Interestingly, over the past 2 decades, practice patterns have shifted."

Dr. Kristin N. Kelly

For example, she said, a recent study of data from the 2009 Nationwide Inpatient Sample researchers found that only 18% of patients with small bowel obstruction received surgical intervention and the rest were managed with conservative measures including intravenous fluid and nasogastric decompression (J. Trauma Acute Care Surg. 2013;74:181-7).

In addition, recently released guidelines (World J. Emerg. Surg. 2011;6:5) "have suggested that without peritoneal signs or evidence of bowel ischemia, nonoperative management can be extended for 3-5 days before contrast studies or surgery [is] recommended," said Dr. Kelly of the Surgical Health Outcomes and Research Enterprise (SHORE) and the department of surgery at the University of Rochester (N.Y.) Medical Center. "The concern remains that surgery may be difficult or dangerous or promote additional adhesion formation. Alternatively, delaying surgical treatment may increase morbidity and mortality. We wondered if perhaps we’ve moved too far toward conservative management. We sought to address if there is a benefit to a prompt surgical approach. Our aim was to examine whether adhesiolysis within 24 hours of admission for acute small bowel obstruction is associated with improved 30-day morbidity and mortality compared with those undergoing later adhesiolysis."

She and her associates searched the 2005-2010 American College of Surgeons/National Surgical Quality Improvement Program database for patients who had a diagnosis of adhesive small bowel obstruction. They limited their analysis to patients who were operated on within 1 week of admission. The time from admission to operation was classified as early (within 24 hours) or late (after 24 hours). The groups were compared using univariate and multivariate analysis to examine the association between numerous patient and operative factors.

Of the 8,912 patients who met inclusion criteria, 3,240 (36%) underwent early adhesiolysis while the remaining 5,692 (64%) underwent the procedure late. The mean time to surgery was 1.7 days, while about three-quarters of patients in the late group had surgery between 1 and 3 days after admission.

Compared with patients in the late adhesiolysis group, those in the early adhesiolysis group had higher rates of emergency operations (60% vs. 45%, respectively; P less than .0001), and more laparoscopic operations (19% vs. 13%; P less than .0001), but both groups had similar operative times (a mean of 93 vs. 89 minutes) and similar rates of small bowel resection (27% vs. 28%). The mean postoperative length of stay was about 2 days shorter in the early group (7.4 days vs. 9.5 days; P less than .0001).

"Patients in the early group were slightly younger, had fewer comorbodities, and better functional status," Dr. Kelly added. "But the rates of preoperative sepsis and systemic inflammatory response syndrome were similar."

On multivariate analysis patients in the early adhesiolysis group had 17% fewer major complications (odds ratio, 0.83; P = .005) and a 26% lower mortality rate (OR, 0.74; P = .041) at 30 days, compared with their counterparts in the late adhesiolysis group. The three most common complications were respiratory complications (28%), sepsis/septic shock (25%), and unexpected return to the operating room (18%).

Dr. Kelly acknowledged certain limitations of the study, including the potential for selection bias and that "perhaps surgeons postpone operating on patients with many comorbodities and poorer functional status, or perhaps it takes several days for a surgical referral," she said. "We are also limited because we do not have information regarding all of the clinical, personal, and administrative factors that may go into any individual surgeon’s decision to take a patient to the OR. Finally, we don’t have data on the case difficulty or any intraoperative occurrences. These would be useful in evaluating whether the timing really affected how challenging the case might be." Nevertheless, the findings "support early surgeon involvement and an expeditious approach to small bowel obstruction," she concluded.

Dr. Kelly said she had no relevant financial disclosures.

dbrunk@frontlinemedcom.com

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Major finding: On multivariate analysis, patients with adhesive small bowel obstruction who underwent adhesiolysis within 24 hours of hospital admission had 17% fewer major complications (OR, 0.83; P = .005) and a 26% lower mortality rate (OR, 0.74; P = .041) at 30 days compared with their counterparts who underwent adhesiolysis after 24 hours of admission.

Data source: A study of 8,912 patients from the 2005-2010 American College of Surgeons/National Surgical Quality Improvement Program database who had a diagnosis of adhesive small bowel obstruction.

Disclosures: Dr. Kelly said she had no relevant financial disclosures.

Dialysis patients have extra morbidity risk after cholecystectomy

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SAN DIEGO – Patients who undergo dialysis before cholecystectomy face a significantly higher risk for postoperative morbidity but not mortality, results from a large analysis of national data showed.

"We hope that these data will allow surgeons to quantitate the risks that are associated with operating on these patients and help them to relay that information to their patients preoperatively," Sophia F. Tam said at the American College of Surgeons/National Surgical Quality Improvement Program National Conference. "We also would like to further study why these adverse outcomes are occurring, and any preoperative or preventive measures that we can make in order to avoid these adverse outcomes."

Sophia F. Tam

Although cholecystectomy is one of the most commonly performed surgical procedures in the United States, there is a lack of quantitative data on the postoperative risks of the procedure in patients who are undergoing dialysis, said Ms. Tam, a third-year medical student at the State University of New York Downstate Medical Center, Brooklyn.

To examine postoperative outcomes following cholecystectomy in dialysis patients, she and her associates evaluated data from the public use file of the American College of Surgeons National Surgical Quality Improvement Program. The sample included 93,703 patients aged 16 or older who underwent cholecystectomy identified by CPT codes during 2006-2010. Of these, 551 were on chronic dialysis. The researchers used ICD-9 codes to exclude cases caused by trauma and selected a matched control group of 530 nondialysis patients based on age, sex, and surgical approach. Outcomes of interest were morbidity, mortality, and hospital length of stay.

Morbidity was defined as having one or more of the following after cholecystectomy: wound infection, wound disruption, pneumonia, unplanned intubation, pulmonary embolism, being on a ventilator for more than 48 hours, cardiac arrest, myocardial infarction, bleeding requiring transfusion, deep vein thrombosis, sepsis, septic shock, and unplanned return to the operating room.

With univariate analysis, the researchers found that in comparison with nondialysis patients, dialysis patients had higher rates of at least one morbidity (14% vs. 3.6%, respectively), mortality (4.2% vs. 0.3%), and mean hospital length of stay (4.3 vs. 1.2 days). All differences were statistically significant with a P value of less than.0001. Compared with nondialysis patients, dialysis patients had higher rates of infectious, pulmonary, and cardiovascular complications, as well as returns to the OR (all significant with a P value of less than .05).

With multivariate logistic regression adjusted for confounding variables, dialysis patients were more likely than were nondialysis patients to experience at least one morbidity (13.8% vs. 4.7%; adjusted odds ratio 2.3), but there was no difference in mortality between the two groups. Hospital length of stay continued to be significantly higher among dialysis patients, compared with their nondialysis counterparts (a mean of 4.3 vs. 1.4 days; adjusted OR 2.0).

Ms. Tam had no disclosures.

dbrunk@frontlinemedcom.com

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SAN DIEGO – Patients who undergo dialysis before cholecystectomy face a significantly higher risk for postoperative morbidity but not mortality, results from a large analysis of national data showed.

"We hope that these data will allow surgeons to quantitate the risks that are associated with operating on these patients and help them to relay that information to their patients preoperatively," Sophia F. Tam said at the American College of Surgeons/National Surgical Quality Improvement Program National Conference. "We also would like to further study why these adverse outcomes are occurring, and any preoperative or preventive measures that we can make in order to avoid these adverse outcomes."

Sophia F. Tam

Although cholecystectomy is one of the most commonly performed surgical procedures in the United States, there is a lack of quantitative data on the postoperative risks of the procedure in patients who are undergoing dialysis, said Ms. Tam, a third-year medical student at the State University of New York Downstate Medical Center, Brooklyn.

To examine postoperative outcomes following cholecystectomy in dialysis patients, she and her associates evaluated data from the public use file of the American College of Surgeons National Surgical Quality Improvement Program. The sample included 93,703 patients aged 16 or older who underwent cholecystectomy identified by CPT codes during 2006-2010. Of these, 551 were on chronic dialysis. The researchers used ICD-9 codes to exclude cases caused by trauma and selected a matched control group of 530 nondialysis patients based on age, sex, and surgical approach. Outcomes of interest were morbidity, mortality, and hospital length of stay.

Morbidity was defined as having one or more of the following after cholecystectomy: wound infection, wound disruption, pneumonia, unplanned intubation, pulmonary embolism, being on a ventilator for more than 48 hours, cardiac arrest, myocardial infarction, bleeding requiring transfusion, deep vein thrombosis, sepsis, septic shock, and unplanned return to the operating room.

With univariate analysis, the researchers found that in comparison with nondialysis patients, dialysis patients had higher rates of at least one morbidity (14% vs. 3.6%, respectively), mortality (4.2% vs. 0.3%), and mean hospital length of stay (4.3 vs. 1.2 days). All differences were statistically significant with a P value of less than.0001. Compared with nondialysis patients, dialysis patients had higher rates of infectious, pulmonary, and cardiovascular complications, as well as returns to the OR (all significant with a P value of less than .05).

With multivariate logistic regression adjusted for confounding variables, dialysis patients were more likely than were nondialysis patients to experience at least one morbidity (13.8% vs. 4.7%; adjusted odds ratio 2.3), but there was no difference in mortality between the two groups. Hospital length of stay continued to be significantly higher among dialysis patients, compared with their nondialysis counterparts (a mean of 4.3 vs. 1.4 days; adjusted OR 2.0).

Ms. Tam had no disclosures.

dbrunk@frontlinemedcom.com

SAN DIEGO – Patients who undergo dialysis before cholecystectomy face a significantly higher risk for postoperative morbidity but not mortality, results from a large analysis of national data showed.

"We hope that these data will allow surgeons to quantitate the risks that are associated with operating on these patients and help them to relay that information to their patients preoperatively," Sophia F. Tam said at the American College of Surgeons/National Surgical Quality Improvement Program National Conference. "We also would like to further study why these adverse outcomes are occurring, and any preoperative or preventive measures that we can make in order to avoid these adverse outcomes."

Sophia F. Tam

Although cholecystectomy is one of the most commonly performed surgical procedures in the United States, there is a lack of quantitative data on the postoperative risks of the procedure in patients who are undergoing dialysis, said Ms. Tam, a third-year medical student at the State University of New York Downstate Medical Center, Brooklyn.

To examine postoperative outcomes following cholecystectomy in dialysis patients, she and her associates evaluated data from the public use file of the American College of Surgeons National Surgical Quality Improvement Program. The sample included 93,703 patients aged 16 or older who underwent cholecystectomy identified by CPT codes during 2006-2010. Of these, 551 were on chronic dialysis. The researchers used ICD-9 codes to exclude cases caused by trauma and selected a matched control group of 530 nondialysis patients based on age, sex, and surgical approach. Outcomes of interest were morbidity, mortality, and hospital length of stay.

Morbidity was defined as having one or more of the following after cholecystectomy: wound infection, wound disruption, pneumonia, unplanned intubation, pulmonary embolism, being on a ventilator for more than 48 hours, cardiac arrest, myocardial infarction, bleeding requiring transfusion, deep vein thrombosis, sepsis, septic shock, and unplanned return to the operating room.

With univariate analysis, the researchers found that in comparison with nondialysis patients, dialysis patients had higher rates of at least one morbidity (14% vs. 3.6%, respectively), mortality (4.2% vs. 0.3%), and mean hospital length of stay (4.3 vs. 1.2 days). All differences were statistically significant with a P value of less than.0001. Compared with nondialysis patients, dialysis patients had higher rates of infectious, pulmonary, and cardiovascular complications, as well as returns to the OR (all significant with a P value of less than .05).

With multivariate logistic regression adjusted for confounding variables, dialysis patients were more likely than were nondialysis patients to experience at least one morbidity (13.8% vs. 4.7%; adjusted odds ratio 2.3), but there was no difference in mortality between the two groups. Hospital length of stay continued to be significantly higher among dialysis patients, compared with their nondialysis counterparts (a mean of 4.3 vs. 1.4 days; adjusted OR 2.0).

Ms. Tam had no disclosures.

dbrunk@frontlinemedcom.com

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Major finding: Dialysis patients were significantly more likely than were nondialysis patients to experience at least one morbidity following cholecystectomy (13.8% vs. 4.7%, respectively; adjusted odds ratio 2.3), but there was no difference in mortality between the two groups.

Data source: A national sample of 93,703 patients aged 16 or older who underwent cholecystectomy according to CPT codes from 2006-2010.

Disclosures: Ms. Tam had no disclosures.

Excessive visceral fat linked to increased risk of CVD, cancer

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Earn 0.25 hours AMA PRA Category 1 credit: Read this article, and click the link at the end to take the post-test.

Excessive visceral fat was associated with incident cardiovascular disease and cancer after adjustment for clinical risk factors and general adiposity, results from a study of Framingham Heart Study participants showed.

The findings "support the growing appreciation of a pathogenic role of ectopic fat," researchers led by Dr. Kathryn A. Britton of the division of cardiovascular medicine at Brigham and Women’s Hospital, Boston, reported. The study was published online July 10 in the Journal of the American College of Cardiology. "Given the worldwide obesity epidemic, identification of high-risk individuals is important as it allows targeting of preventive and therapeutic measures. Furthermore, markers of risk may provide insight into the biology linking body fat distribution and outcomes."

Since few studies have examined prospective outcomes in people with ectopic fat, the researchers set out to examine the association of directly-imaged fat measurements with incident CVD, cancer, and all-cause mortality in 3,086 participants from the Framingham Heart Study. All of the patients underwent multidetector computerized tomography with an 8-slice scanner in an effort to identify and measure areas of visceral adipose tissue, pericardial adipose tissue, and periaortic adipose tissue. During a median follow-up of 5 years, the study participants were assessed for heart disease, cancer, and death risk after adjustment for standard risk factors.

The mean age of the 3,086 patients was 50 years; 51% were men. At the end of the follow-up period, there were 90 cardiovascular events, 141 cancer cases, and 71 deaths. After multivariable adjustment using Cox proportional hazards regression models, the researchers found that each standard deviation increase in visceral adipose tissue was associated with cardiovascular disease (HR 1.44; P =.01) and cancer (HR 1.43; P = .005). None of the fat depots were associated with all-cause mortality.

"Numerous experimental studies support a potential link between visceral adipose tissue and biological pathways important in the pathogenesis of multiple disease outcomes," Dr. Britton and her colleagues wrote. "Adipokines, biologically active molecules secreted from adipose tissue, are key components of these pathways and include inflammatory cytokines, angiogenic factors, lipid metabolites, and extracellular matrix components. Adipokine secretion appears to differ between specific fat depots with visceral adipose tissue demonstrating greater expression of proinflammatory and proangiogenic genes, compared with subcutaneous adipose tissue."

The researchers acknowledged certain limitations of the study including the fact that the study sample was predominately white and that weight change data were not available on the participants during the follow-up period.

The study was supported by the National Heart, Lung and Blood Institute’s Framingham Heart Study. Dr. Britton was supported by a Research Career Development Award from the NHLBI.

To earn 0.25 hours AMA PRA Category 1 credit after reading this article, take the post-test here.

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Earn 0.25 hours AMA PRA Category 1 credit: Read this article, and click the link at the end to take the post-test.

Excessive visceral fat was associated with incident cardiovascular disease and cancer after adjustment for clinical risk factors and general adiposity, results from a study of Framingham Heart Study participants showed.

The findings "support the growing appreciation of a pathogenic role of ectopic fat," researchers led by Dr. Kathryn A. Britton of the division of cardiovascular medicine at Brigham and Women’s Hospital, Boston, reported. The study was published online July 10 in the Journal of the American College of Cardiology. "Given the worldwide obesity epidemic, identification of high-risk individuals is important as it allows targeting of preventive and therapeutic measures. Furthermore, markers of risk may provide insight into the biology linking body fat distribution and outcomes."

Since few studies have examined prospective outcomes in people with ectopic fat, the researchers set out to examine the association of directly-imaged fat measurements with incident CVD, cancer, and all-cause mortality in 3,086 participants from the Framingham Heart Study. All of the patients underwent multidetector computerized tomography with an 8-slice scanner in an effort to identify and measure areas of visceral adipose tissue, pericardial adipose tissue, and periaortic adipose tissue. During a median follow-up of 5 years, the study participants were assessed for heart disease, cancer, and death risk after adjustment for standard risk factors.

The mean age of the 3,086 patients was 50 years; 51% were men. At the end of the follow-up period, there were 90 cardiovascular events, 141 cancer cases, and 71 deaths. After multivariable adjustment using Cox proportional hazards regression models, the researchers found that each standard deviation increase in visceral adipose tissue was associated with cardiovascular disease (HR 1.44; P =.01) and cancer (HR 1.43; P = .005). None of the fat depots were associated with all-cause mortality.

"Numerous experimental studies support a potential link between visceral adipose tissue and biological pathways important in the pathogenesis of multiple disease outcomes," Dr. Britton and her colleagues wrote. "Adipokines, biologically active molecules secreted from adipose tissue, are key components of these pathways and include inflammatory cytokines, angiogenic factors, lipid metabolites, and extracellular matrix components. Adipokine secretion appears to differ between specific fat depots with visceral adipose tissue demonstrating greater expression of proinflammatory and proangiogenic genes, compared with subcutaneous adipose tissue."

The researchers acknowledged certain limitations of the study including the fact that the study sample was predominately white and that weight change data were not available on the participants during the follow-up period.

The study was supported by the National Heart, Lung and Blood Institute’s Framingham Heart Study. Dr. Britton was supported by a Research Career Development Award from the NHLBI.

To earn 0.25 hours AMA PRA Category 1 credit after reading this article, take the post-test here.

dbrunk@frontlinemedcom.com

Earn 0.25 hours AMA PRA Category 1 credit: Read this article, and click the link at the end to take the post-test.

Excessive visceral fat was associated with incident cardiovascular disease and cancer after adjustment for clinical risk factors and general adiposity, results from a study of Framingham Heart Study participants showed.

The findings "support the growing appreciation of a pathogenic role of ectopic fat," researchers led by Dr. Kathryn A. Britton of the division of cardiovascular medicine at Brigham and Women’s Hospital, Boston, reported. The study was published online July 10 in the Journal of the American College of Cardiology. "Given the worldwide obesity epidemic, identification of high-risk individuals is important as it allows targeting of preventive and therapeutic measures. Furthermore, markers of risk may provide insight into the biology linking body fat distribution and outcomes."

Since few studies have examined prospective outcomes in people with ectopic fat, the researchers set out to examine the association of directly-imaged fat measurements with incident CVD, cancer, and all-cause mortality in 3,086 participants from the Framingham Heart Study. All of the patients underwent multidetector computerized tomography with an 8-slice scanner in an effort to identify and measure areas of visceral adipose tissue, pericardial adipose tissue, and periaortic adipose tissue. During a median follow-up of 5 years, the study participants were assessed for heart disease, cancer, and death risk after adjustment for standard risk factors.

The mean age of the 3,086 patients was 50 years; 51% were men. At the end of the follow-up period, there were 90 cardiovascular events, 141 cancer cases, and 71 deaths. After multivariable adjustment using Cox proportional hazards regression models, the researchers found that each standard deviation increase in visceral adipose tissue was associated with cardiovascular disease (HR 1.44; P =.01) and cancer (HR 1.43; P = .005). None of the fat depots were associated with all-cause mortality.

"Numerous experimental studies support a potential link between visceral adipose tissue and biological pathways important in the pathogenesis of multiple disease outcomes," Dr. Britton and her colleagues wrote. "Adipokines, biologically active molecules secreted from adipose tissue, are key components of these pathways and include inflammatory cytokines, angiogenic factors, lipid metabolites, and extracellular matrix components. Adipokine secretion appears to differ between specific fat depots with visceral adipose tissue demonstrating greater expression of proinflammatory and proangiogenic genes, compared with subcutaneous adipose tissue."

The researchers acknowledged certain limitations of the study including the fact that the study sample was predominately white and that weight change data were not available on the participants during the follow-up period.

The study was supported by the National Heart, Lung and Blood Institute’s Framingham Heart Study. Dr. Britton was supported by a Research Career Development Award from the NHLBI.

To earn 0.25 hours AMA PRA Category 1 credit after reading this article, take the post-test here.

dbrunk@frontlinemedcom.com

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Excessive visceral fat linked to increased risk of CVD, cancer

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Excessive visceral fat linked to increased risk of CVD, cancer

Excessive visceral fat was associated with incident cardiovascular disease and cancer after adjustment for clinical risk factors and general adiposity, results from a study of Framingham Heart Study participants showed.

The findings "support the growing appreciation of a pathogenic role of ectopic fat," researchers led by Dr. Kathryn A. Britton of the division of cardiovascular medicine at Brigham and Women’s Hospital, Boston, reported. The study was published online July 10 in the Journal of the American College of Cardiology. "Given the worldwide obesity epidemic, identification of high-risk individuals is important as it allows targeting of preventive and therapeutic measures. Furthermore, markers of risk may provide insight into the biology linking body fat distribution and outcomes."

Dr. Kathryn Britton

Since few studies have examined prospective outcomes in people with ectopic fat, the researchers set out to examine the association of directly-imaged fat measurements with incident CVD, cancer, and all-cause mortality in 3,086 participants from the Framingham Heart Study. All of the patients underwent multidetector computerized tomography with an 8-slice scanner in an effort to identify and measure areas of visceral adipose tissue, pericardial adipose tissue, and periaortic adipose tissue. During a median follow-up of 5 years, the study participants were assessed for heart disease, cancer, and death risk after adjustment for standard risk factors.

The mean age of the 3,086 patients was 50 years; 51% were men. At the end of the follow-up period, there were 90 cardiovascular events, 141 cancer cases, and 71 deaths. After multivariable adjustment using Cox proportional hazards regression models, the researchers found that each standard deviation increase in visceral adipose tissue was associated with cardiovascular disease (HR 1.44; P =.01) and cancer (HR 1.43; P = .005). None of the fat depots were associated with all-cause mortality.

"Numerous experimental studies support a potential link between visceral adipose tissue and biological pathways important in the pathogenesis of multiple disease outcomes," Dr. Britton and her colleagues wrote. "Adipokines, biologically active molecules secreted from adipose tissue, are key components of these pathways and include inflammatory cytokines, angiogenic factors, lipid metabolites, and extracellular matrix components. Adipokine secretion appears to differ between specific fat depots with visceral adipose tissue demonstrating greater expression of proinflammatory and proangiogenic genes, compared with subcutaneous adipose tissue."

The researchers acknowledged certain limitations of the study including the fact that the study sample was predominately white and that weight change data were not available on the participants during the follow-up period.

The study was supported by the National Heart, Lung and Blood Institute’s Framingham Heart Study. Dr. Britton was supported by a Research Career Development Award from the NHLBI.

dbrunk@frontlinemedcom.com

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Excessive visceral fat was associated with incident cardiovascular disease and cancer after adjustment for clinical risk factors and general adiposity, results from a study of Framingham Heart Study participants showed.

The findings "support the growing appreciation of a pathogenic role of ectopic fat," researchers led by Dr. Kathryn A. Britton of the division of cardiovascular medicine at Brigham and Women’s Hospital, Boston, reported. The study was published online July 10 in the Journal of the American College of Cardiology. "Given the worldwide obesity epidemic, identification of high-risk individuals is important as it allows targeting of preventive and therapeutic measures. Furthermore, markers of risk may provide insight into the biology linking body fat distribution and outcomes."

Dr. Kathryn Britton

Since few studies have examined prospective outcomes in people with ectopic fat, the researchers set out to examine the association of directly-imaged fat measurements with incident CVD, cancer, and all-cause mortality in 3,086 participants from the Framingham Heart Study. All of the patients underwent multidetector computerized tomography with an 8-slice scanner in an effort to identify and measure areas of visceral adipose tissue, pericardial adipose tissue, and periaortic adipose tissue. During a median follow-up of 5 years, the study participants were assessed for heart disease, cancer, and death risk after adjustment for standard risk factors.

The mean age of the 3,086 patients was 50 years; 51% were men. At the end of the follow-up period, there were 90 cardiovascular events, 141 cancer cases, and 71 deaths. After multivariable adjustment using Cox proportional hazards regression models, the researchers found that each standard deviation increase in visceral adipose tissue was associated with cardiovascular disease (HR 1.44; P =.01) and cancer (HR 1.43; P = .005). None of the fat depots were associated with all-cause mortality.

"Numerous experimental studies support a potential link between visceral adipose tissue and biological pathways important in the pathogenesis of multiple disease outcomes," Dr. Britton and her colleagues wrote. "Adipokines, biologically active molecules secreted from adipose tissue, are key components of these pathways and include inflammatory cytokines, angiogenic factors, lipid metabolites, and extracellular matrix components. Adipokine secretion appears to differ between specific fat depots with visceral adipose tissue demonstrating greater expression of proinflammatory and proangiogenic genes, compared with subcutaneous adipose tissue."

The researchers acknowledged certain limitations of the study including the fact that the study sample was predominately white and that weight change data were not available on the participants during the follow-up period.

The study was supported by the National Heart, Lung and Blood Institute’s Framingham Heart Study. Dr. Britton was supported by a Research Career Development Award from the NHLBI.

dbrunk@frontlinemedcom.com

Excessive visceral fat was associated with incident cardiovascular disease and cancer after adjustment for clinical risk factors and general adiposity, results from a study of Framingham Heart Study participants showed.

The findings "support the growing appreciation of a pathogenic role of ectopic fat," researchers led by Dr. Kathryn A. Britton of the division of cardiovascular medicine at Brigham and Women’s Hospital, Boston, reported. The study was published online July 10 in the Journal of the American College of Cardiology. "Given the worldwide obesity epidemic, identification of high-risk individuals is important as it allows targeting of preventive and therapeutic measures. Furthermore, markers of risk may provide insight into the biology linking body fat distribution and outcomes."

Dr. Kathryn Britton

Since few studies have examined prospective outcomes in people with ectopic fat, the researchers set out to examine the association of directly-imaged fat measurements with incident CVD, cancer, and all-cause mortality in 3,086 participants from the Framingham Heart Study. All of the patients underwent multidetector computerized tomography with an 8-slice scanner in an effort to identify and measure areas of visceral adipose tissue, pericardial adipose tissue, and periaortic adipose tissue. During a median follow-up of 5 years, the study participants were assessed for heart disease, cancer, and death risk after adjustment for standard risk factors.

The mean age of the 3,086 patients was 50 years; 51% were men. At the end of the follow-up period, there were 90 cardiovascular events, 141 cancer cases, and 71 deaths. After multivariable adjustment using Cox proportional hazards regression models, the researchers found that each standard deviation increase in visceral adipose tissue was associated with cardiovascular disease (HR 1.44; P =.01) and cancer (HR 1.43; P = .005). None of the fat depots were associated with all-cause mortality.

"Numerous experimental studies support a potential link between visceral adipose tissue and biological pathways important in the pathogenesis of multiple disease outcomes," Dr. Britton and her colleagues wrote. "Adipokines, biologically active molecules secreted from adipose tissue, are key components of these pathways and include inflammatory cytokines, angiogenic factors, lipid metabolites, and extracellular matrix components. Adipokine secretion appears to differ between specific fat depots with visceral adipose tissue demonstrating greater expression of proinflammatory and proangiogenic genes, compared with subcutaneous adipose tissue."

The researchers acknowledged certain limitations of the study including the fact that the study sample was predominately white and that weight change data were not available on the participants during the follow-up period.

The study was supported by the National Heart, Lung and Blood Institute’s Framingham Heart Study. Dr. Britton was supported by a Research Career Development Award from the NHLBI.

dbrunk@frontlinemedcom.com

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Major finding: Excessive visceral adipose tissue was associated with a statistically significant increase in risk of cardiovascular disease (HR 1.44) and cancer (HR 1.43).

Data source: An analysis of 3,086 participants from the Framingham Heart Study who underwent multidetector computerized tomography with an 8-slice scanner.

Disclosures: The study was supported by the National Heart, Lung, and Blood Institute’s Framingham Heart Study. Dr. Britton was supported by a Research Career Development Award from the NHLBI.

Late cord clamping may benefit infants, review suggests

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Compared with infants who had clamping of the umbilical cord within 1 minute after birth, those who had late clamping had higher hemoglobin levels between 1 and 2 days after birth and were less likely to be iron deficient 3-6 months after birth. They also had higher birth weights.

Those are key findings from a systematic review published July 11 in the Cochrane Library. "A more liberal approach to delaying clamping of the umbilical cord in healthy term infants appears to be warranted, particularly in light of growing evidence that delayed cord clamping may be of benefit in the longer term in promoting better iron stores in infants, as long as access to treatment for jaundice requiring phototherapy is easily accessible," wrote the researchers, who were led by Susan J. McDonald, Ph.D., professor of midwifery at La Trobe University/Mercy Hospital for Women, Melbourne.

The review, which supports a World Health Organization recommendation that the optimal time for cord clamping is between 1 and 3 minutes after birth, was carried out because active management, including early cord clamping, "is still widely practised in high-income countries, although relative timing of each individual component of the strategy varies," Dr. McDonald and her associates wrote. "Most maternity units in Australia and the United Kingdom administer the uterotonic prior to placental delivery, whereas some units in the United States and Canada advocate withholding uterotonic administration until after the placenta is delivered."

The researchers reviewed data on 3,911 women and their infants who participated in 15 trials that examined the effects of different timing of umbilical cord clamping in term infants (Coch. Database Syst. Rev. 2013 July 11 [doi:10.1002/14651858.CD004074.pub3]).

Early clamping was defined as that which occurred within 1 minute of the infant’s birth while late clamping was defined as that which occurred later than 1 minute after the infant’s birth. The researchers characterized the overall methodologic quality of the trials included in the review as "moderate or high. While none of the studies was assessed as being at high risk of bias for most domains, several trials did not provide clear information on methods."

Compared with infants in the late-clamping group, those in the early-clamping group demonstrated significantly lower hemoglobin concentrations at 24-48 hours (a mean deviation of –1.49 g/dL), a difference that was not seen at subsequent assessments. Infants in the early-clamping group were 2.65 times more likely to be iron deficient at 3-6 months, compared with their counterparts in the late-clamping group, while a significant birth weight increase was observed in the late- vs. the early-clamping group (a mean of 101 g). At the same time, significantly fewer infants in the early cord-clamping group required phototherapy for jaundice, compared with those in the late cord-clamping group (risk ratio, 0.62).

"The benefits and harms seen for delayed cord clamping are compatible with the same mechanism of an increased amount of red blood cells for the infant," the authors concluded. "Additional red blood cells can improve the infant’s iron stores, but this also has the potential to overload the newborn’s metabolism, leading to increased levels of bilirubin and, in very severe cases, severe jaundice and later kernicterus. The potential for harm would need to be weighed up by clinicians in context with the settings in which they work. For instance, if treatment for moderate to severe jaundice was not easily accessible and there was a risk of causing further complications for the infant, late cord clamping may be less optimal. On the other hand, increasing iron stores in infants through delayed cord clamping may be particularly beneficial in resource-poor settings where severe anemia is common."

They acknowledged certain limitations of the review, including differences in variables such as the lengths of timing for both early- and late cord clamping, as well as the inconsistent coverage of outcomes between trials. "In addition, the use of prophylactic uterotonics was not always well described in the trials," they wrote.

The review was supported by the Department of Health and Aging, Australia; the National Institute for Health Research, United Kingdom; and the National Health and Medical Research Council, Australia.

dbrunk@frontlinemedcom.com

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Compared with infants who had clamping of the umbilical cord within 1 minute after birth, those who had late clamping had higher hemoglobin levels between 1 and 2 days after birth and were less likely to be iron deficient 3-6 months after birth. They also had higher birth weights.

Those are key findings from a systematic review published July 11 in the Cochrane Library. "A more liberal approach to delaying clamping of the umbilical cord in healthy term infants appears to be warranted, particularly in light of growing evidence that delayed cord clamping may be of benefit in the longer term in promoting better iron stores in infants, as long as access to treatment for jaundice requiring phototherapy is easily accessible," wrote the researchers, who were led by Susan J. McDonald, Ph.D., professor of midwifery at La Trobe University/Mercy Hospital for Women, Melbourne.

The review, which supports a World Health Organization recommendation that the optimal time for cord clamping is between 1 and 3 minutes after birth, was carried out because active management, including early cord clamping, "is still widely practised in high-income countries, although relative timing of each individual component of the strategy varies," Dr. McDonald and her associates wrote. "Most maternity units in Australia and the United Kingdom administer the uterotonic prior to placental delivery, whereas some units in the United States and Canada advocate withholding uterotonic administration until after the placenta is delivered."

The researchers reviewed data on 3,911 women and their infants who participated in 15 trials that examined the effects of different timing of umbilical cord clamping in term infants (Coch. Database Syst. Rev. 2013 July 11 [doi:10.1002/14651858.CD004074.pub3]).

Early clamping was defined as that which occurred within 1 minute of the infant’s birth while late clamping was defined as that which occurred later than 1 minute after the infant’s birth. The researchers characterized the overall methodologic quality of the trials included in the review as "moderate or high. While none of the studies was assessed as being at high risk of bias for most domains, several trials did not provide clear information on methods."

Compared with infants in the late-clamping group, those in the early-clamping group demonstrated significantly lower hemoglobin concentrations at 24-48 hours (a mean deviation of –1.49 g/dL), a difference that was not seen at subsequent assessments. Infants in the early-clamping group were 2.65 times more likely to be iron deficient at 3-6 months, compared with their counterparts in the late-clamping group, while a significant birth weight increase was observed in the late- vs. the early-clamping group (a mean of 101 g). At the same time, significantly fewer infants in the early cord-clamping group required phototherapy for jaundice, compared with those in the late cord-clamping group (risk ratio, 0.62).

"The benefits and harms seen for delayed cord clamping are compatible with the same mechanism of an increased amount of red blood cells for the infant," the authors concluded. "Additional red blood cells can improve the infant’s iron stores, but this also has the potential to overload the newborn’s metabolism, leading to increased levels of bilirubin and, in very severe cases, severe jaundice and later kernicterus. The potential for harm would need to be weighed up by clinicians in context with the settings in which they work. For instance, if treatment for moderate to severe jaundice was not easily accessible and there was a risk of causing further complications for the infant, late cord clamping may be less optimal. On the other hand, increasing iron stores in infants through delayed cord clamping may be particularly beneficial in resource-poor settings where severe anemia is common."

They acknowledged certain limitations of the review, including differences in variables such as the lengths of timing for both early- and late cord clamping, as well as the inconsistent coverage of outcomes between trials. "In addition, the use of prophylactic uterotonics was not always well described in the trials," they wrote.

The review was supported by the Department of Health and Aging, Australia; the National Institute for Health Research, United Kingdom; and the National Health and Medical Research Council, Australia.

dbrunk@frontlinemedcom.com

Compared with infants who had clamping of the umbilical cord within 1 minute after birth, those who had late clamping had higher hemoglobin levels between 1 and 2 days after birth and were less likely to be iron deficient 3-6 months after birth. They also had higher birth weights.

Those are key findings from a systematic review published July 11 in the Cochrane Library. "A more liberal approach to delaying clamping of the umbilical cord in healthy term infants appears to be warranted, particularly in light of growing evidence that delayed cord clamping may be of benefit in the longer term in promoting better iron stores in infants, as long as access to treatment for jaundice requiring phototherapy is easily accessible," wrote the researchers, who were led by Susan J. McDonald, Ph.D., professor of midwifery at La Trobe University/Mercy Hospital for Women, Melbourne.

The review, which supports a World Health Organization recommendation that the optimal time for cord clamping is between 1 and 3 minutes after birth, was carried out because active management, including early cord clamping, "is still widely practised in high-income countries, although relative timing of each individual component of the strategy varies," Dr. McDonald and her associates wrote. "Most maternity units in Australia and the United Kingdom administer the uterotonic prior to placental delivery, whereas some units in the United States and Canada advocate withholding uterotonic administration until after the placenta is delivered."

The researchers reviewed data on 3,911 women and their infants who participated in 15 trials that examined the effects of different timing of umbilical cord clamping in term infants (Coch. Database Syst. Rev. 2013 July 11 [doi:10.1002/14651858.CD004074.pub3]).

Early clamping was defined as that which occurred within 1 minute of the infant’s birth while late clamping was defined as that which occurred later than 1 minute after the infant’s birth. The researchers characterized the overall methodologic quality of the trials included in the review as "moderate or high. While none of the studies was assessed as being at high risk of bias for most domains, several trials did not provide clear information on methods."

Compared with infants in the late-clamping group, those in the early-clamping group demonstrated significantly lower hemoglobin concentrations at 24-48 hours (a mean deviation of –1.49 g/dL), a difference that was not seen at subsequent assessments. Infants in the early-clamping group were 2.65 times more likely to be iron deficient at 3-6 months, compared with their counterparts in the late-clamping group, while a significant birth weight increase was observed in the late- vs. the early-clamping group (a mean of 101 g). At the same time, significantly fewer infants in the early cord-clamping group required phototherapy for jaundice, compared with those in the late cord-clamping group (risk ratio, 0.62).

"The benefits and harms seen for delayed cord clamping are compatible with the same mechanism of an increased amount of red blood cells for the infant," the authors concluded. "Additional red blood cells can improve the infant’s iron stores, but this also has the potential to overload the newborn’s metabolism, leading to increased levels of bilirubin and, in very severe cases, severe jaundice and later kernicterus. The potential for harm would need to be weighed up by clinicians in context with the settings in which they work. For instance, if treatment for moderate to severe jaundice was not easily accessible and there was a risk of causing further complications for the infant, late cord clamping may be less optimal. On the other hand, increasing iron stores in infants through delayed cord clamping may be particularly beneficial in resource-poor settings where severe anemia is common."

They acknowledged certain limitations of the review, including differences in variables such as the lengths of timing for both early- and late cord clamping, as well as the inconsistent coverage of outcomes between trials. "In addition, the use of prophylactic uterotonics was not always well described in the trials," they wrote.

The review was supported by the Department of Health and Aging, Australia; the National Institute for Health Research, United Kingdom; and the National Health and Medical Research Council, Australia.

dbrunk@frontlinemedcom.com

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Major finding: Infants who had umbilical cord clamping within 1 minute after birth were 2.65 times more likely to be iron deficient at 3-6 months, compared with their counterparts in the late clamping group.

Data source: A review of data on 3,911 women and their infants who participated in 15 trials that examined the effects of different timing of umbilical cord clamping in term infants.

Disclosures: The review was supported by the Department of Health and Aging, Australia; the National Institute for Health Research, United Kingdom; and the National Health and Medical Research Council, Australia.

Carcinoembryonic antigen poor for differentiating pancreatic cysts

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The accuracy of cyst fluid carcinoembryonic antigen in differentiating between benign and malignant pancreatic cysts is poor, and the antigen should not be used as a sole marker for guiding surgical decision making, results from a meta-analysis of available literature on the topic suggests.

"The clinical value of cyst fluid CEA should be limited only to distinguishing mucinous from nonmucinous cystic lesions," Dr. Saowanee Ngamruengphong and her colleagues from the division of gastroenterology and hepatology at Mayo Clinic Florida, Jacksonville, wrote in an article in Digestive and Liver Disease (2013 June 18 [doi: 10.1016/j.dld.2013.05.002]). "Large, multicentric, well-designed trials are needed to further characterize the role of cyst fluid tumor marker and molecular analysis in the evaluation of pancreatic cysts."

Results from two previously published articles in the medical literature showed that a cyst fluid EA level of 192-200 ng/mL had 80% accuracy in differentiating between mucinous and nonmucinous cysts (Gastroenterology 2004;126:1330-6 and Pancreatology 2012;12:183-97).

In an effort to determine the diagnostic accuracy of cyst fluid CEA in discriminating benign from malignant pancreatic cystic neoplasms, the authors of the current study conducted a literature search of Medline and Embase databases for studies published before October 2012. They used the following keywords: "pancreas OR pancreatic cystic lesion," "tumor marker OR carcinoembryonic antigen OR CEA," and "diagnosis." A total of eight published articles involving 504 patients were included in the final analysis. Random-effects models were used to calculate pooled estimates of diagnostic precision.

Dr. Ngamruengphong and her colleagues reported that the CEA cutoff level for determining a malignant cyst ranged from 109.9 to 6,000 mg/mL, and that the pooled sensitivity of cyst fluid CEA in the prediction of malignant pancreatic cysts was 63% while the pooled specificity was 63%. In addition, the positive likelihood ratio was 1.89, the negative likelihood ratio was 0.62, and the diagnostic odds ratio was 3.84.

A subgroup analysis of 227 patients with mucinous cysts revealed similar results: a pooled sensitivity of 65%, a pooled specificity of 66%, and a diagnostic odds ratio of 4.74.

"Our findings support the current guidelines, which do not recommend the use of fluid cyst CEA to diagnose malignant pancreatic cysts," the researchers wrote.

They acknowledged certain limitations of the study, including the fact that there was significant heterogeneity among the studies and that the small sample sizes in the included studies "could potentially be subject to selection bias."

The researchers stated that they had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

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The accuracy of cyst fluid carcinoembryonic antigen in differentiating between benign and malignant pancreatic cysts is poor, and the antigen should not be used as a sole marker for guiding surgical decision making, results from a meta-analysis of available literature on the topic suggests.

"The clinical value of cyst fluid CEA should be limited only to distinguishing mucinous from nonmucinous cystic lesions," Dr. Saowanee Ngamruengphong and her colleagues from the division of gastroenterology and hepatology at Mayo Clinic Florida, Jacksonville, wrote in an article in Digestive and Liver Disease (2013 June 18 [doi: 10.1016/j.dld.2013.05.002]). "Large, multicentric, well-designed trials are needed to further characterize the role of cyst fluid tumor marker and molecular analysis in the evaluation of pancreatic cysts."

Results from two previously published articles in the medical literature showed that a cyst fluid EA level of 192-200 ng/mL had 80% accuracy in differentiating between mucinous and nonmucinous cysts (Gastroenterology 2004;126:1330-6 and Pancreatology 2012;12:183-97).

In an effort to determine the diagnostic accuracy of cyst fluid CEA in discriminating benign from malignant pancreatic cystic neoplasms, the authors of the current study conducted a literature search of Medline and Embase databases for studies published before October 2012. They used the following keywords: "pancreas OR pancreatic cystic lesion," "tumor marker OR carcinoembryonic antigen OR CEA," and "diagnosis." A total of eight published articles involving 504 patients were included in the final analysis. Random-effects models were used to calculate pooled estimates of diagnostic precision.

Dr. Ngamruengphong and her colleagues reported that the CEA cutoff level for determining a malignant cyst ranged from 109.9 to 6,000 mg/mL, and that the pooled sensitivity of cyst fluid CEA in the prediction of malignant pancreatic cysts was 63% while the pooled specificity was 63%. In addition, the positive likelihood ratio was 1.89, the negative likelihood ratio was 0.62, and the diagnostic odds ratio was 3.84.

A subgroup analysis of 227 patients with mucinous cysts revealed similar results: a pooled sensitivity of 65%, a pooled specificity of 66%, and a diagnostic odds ratio of 4.74.

"Our findings support the current guidelines, which do not recommend the use of fluid cyst CEA to diagnose malignant pancreatic cysts," the researchers wrote.

They acknowledged certain limitations of the study, including the fact that there was significant heterogeneity among the studies and that the small sample sizes in the included studies "could potentially be subject to selection bias."

The researchers stated that they had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

The accuracy of cyst fluid carcinoembryonic antigen in differentiating between benign and malignant pancreatic cysts is poor, and the antigen should not be used as a sole marker for guiding surgical decision making, results from a meta-analysis of available literature on the topic suggests.

"The clinical value of cyst fluid CEA should be limited only to distinguishing mucinous from nonmucinous cystic lesions," Dr. Saowanee Ngamruengphong and her colleagues from the division of gastroenterology and hepatology at Mayo Clinic Florida, Jacksonville, wrote in an article in Digestive and Liver Disease (2013 June 18 [doi: 10.1016/j.dld.2013.05.002]). "Large, multicentric, well-designed trials are needed to further characterize the role of cyst fluid tumor marker and molecular analysis in the evaluation of pancreatic cysts."

Results from two previously published articles in the medical literature showed that a cyst fluid EA level of 192-200 ng/mL had 80% accuracy in differentiating between mucinous and nonmucinous cysts (Gastroenterology 2004;126:1330-6 and Pancreatology 2012;12:183-97).

In an effort to determine the diagnostic accuracy of cyst fluid CEA in discriminating benign from malignant pancreatic cystic neoplasms, the authors of the current study conducted a literature search of Medline and Embase databases for studies published before October 2012. They used the following keywords: "pancreas OR pancreatic cystic lesion," "tumor marker OR carcinoembryonic antigen OR CEA," and "diagnosis." A total of eight published articles involving 504 patients were included in the final analysis. Random-effects models were used to calculate pooled estimates of diagnostic precision.

Dr. Ngamruengphong and her colleagues reported that the CEA cutoff level for determining a malignant cyst ranged from 109.9 to 6,000 mg/mL, and that the pooled sensitivity of cyst fluid CEA in the prediction of malignant pancreatic cysts was 63% while the pooled specificity was 63%. In addition, the positive likelihood ratio was 1.89, the negative likelihood ratio was 0.62, and the diagnostic odds ratio was 3.84.

A subgroup analysis of 227 patients with mucinous cysts revealed similar results: a pooled sensitivity of 65%, a pooled specificity of 66%, and a diagnostic odds ratio of 4.74.

"Our findings support the current guidelines, which do not recommend the use of fluid cyst CEA to diagnose malignant pancreatic cysts," the researchers wrote.

They acknowledged certain limitations of the study, including the fact that there was significant heterogeneity among the studies and that the small sample sizes in the included studies "could potentially be subject to selection bias."

The researchers stated that they had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

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Major finding: The pooled sensitivity of cyst fluid carcinoembryonic antigen in predicting malignant pancreatic cysts was 63%, while the pooled specificity was also 63%.

Data source: A meta-analysis of eight studies involving 504 patients.

Disclosures: The researchers stated that they had no relevant financial conflicts to disclose.

Boceprevir an option for patients with HIV and HCV

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Among adults infected with both HIV and hepatitis C virus, the addition of boceprevir to a combination of peginterferon and ribavirin significantly increased the rate of sustained virological response compared with those who received placebo, results from a 44-week, multicenter phase II study demonstrated.

"Rates of SVR at follow-up week 24 were increased with boceprevir in all subgroups of patients, irrespective of demographic or baseline characteristics," researchers led by Dr. Mark S. Sulkowski of Johns Hopkins University, Baltimore, reported in the July issue of the Lancet Infectious Diseases. Although SVR after treatment with peginterferon and ribavirin has been associated with improved survival, "this regimen has been relatively ineffective (SVR, 25%-30%) in patients with HIV and HCV genotype 1 infection," they wrote.

Dr. Mark S. Sulkowski

"Addition of an HCV protease inhibitor (boceprevir or telaprevir) to peginterferon-ribavirin has emerged as the standard of care for the treatment of HCV genotype 1 infection alone. Use of HCV protease inhibitors in patients infected with HIV and HCV has been restricted by the dearth of available safety and efficacy data."

For the study, which was conducted between Jan. 15 and Dec. 29, 2010, at 30 academic and nonacademic study sites, 99 adults with untreated HCV type 1 genotype infection and controlled HIV were randomized in 1:2 fashion to receive peginterferon 1.5 mcg/kg per week with weight-based ribavirin (600-1,400 mg/day) for 4 weeks, followed by peginterferon-ribavirin plus either placebo (control group) or 800 mg of boceprevir three times daily (boceprevir group) for 44 weeks (Lancet Infect. Dis. 2013;13:597-605).

The primary endpoint of interest was sustained virological response (defined as undetectable plasma HCV RNA) at follow-up week 24 after the end of treatment.

Of the 99 patients, 98 received at least one treatment dose. Of these, 64 were in the boceprevir group and 34 were in the control group. The researchers reported that at follow-up week 24, 63% of patients in the boceprevir group achieved SVR, compared with 29% of controls, a difference of 33.1% that reached significance (P = .0008). Compared with controls, a higher proportion of the boceprevir group experienced adverse events, including anemia (41% vs. 26%, respectively), pyrexia (36% vs. 21%), decreased appetite (34% vs. 18%), dysgeusia (28% vs. 15%), vomiting (28% vs. 15%), and neutropenia (19% vs. 6%). In addition, 4 patients in the control group and 3 in the boceprevir group had HIV viral breakthrough, defined as two consecutive HIV RNA values of at least 50 copies/mL.

"Boceprevir did not seem to add significant risk when used in combination with peginterferon-ribavirin therapy, and no new adverse events were reported," the researchers wrote. "HIV control was well maintained in patients taking boceprevir and HIV protease inhibitors. Drug interactions between boceprevir and HIV protease inhibitors did not have a clinically significant effect on HCV response or HIV control in this study. In view of the hepatic and extrahepatic benefits associated with SVR at follow-up week 24 in patients infected with HIV and HCV, boceprevir in combination with peginterferon-ribavirin might be an important therapeutic option for patients with such coinfection."

Merck markets boceprevir under the brand name Victrelis. Merck sponsored and funded the study. Dr. Sulkowski and numerous other coauthors disclosed having received consulting fees and research grants from the company.

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Among adults infected with both HIV and hepatitis C virus, the addition of boceprevir to a combination of peginterferon and ribavirin significantly increased the rate of sustained virological response compared with those who received placebo, results from a 44-week, multicenter phase II study demonstrated.

"Rates of SVR at follow-up week 24 were increased with boceprevir in all subgroups of patients, irrespective of demographic or baseline characteristics," researchers led by Dr. Mark S. Sulkowski of Johns Hopkins University, Baltimore, reported in the July issue of the Lancet Infectious Diseases. Although SVR after treatment with peginterferon and ribavirin has been associated with improved survival, "this regimen has been relatively ineffective (SVR, 25%-30%) in patients with HIV and HCV genotype 1 infection," they wrote.

Dr. Mark S. Sulkowski

"Addition of an HCV protease inhibitor (boceprevir or telaprevir) to peginterferon-ribavirin has emerged as the standard of care for the treatment of HCV genotype 1 infection alone. Use of HCV protease inhibitors in patients infected with HIV and HCV has been restricted by the dearth of available safety and efficacy data."

For the study, which was conducted between Jan. 15 and Dec. 29, 2010, at 30 academic and nonacademic study sites, 99 adults with untreated HCV type 1 genotype infection and controlled HIV were randomized in 1:2 fashion to receive peginterferon 1.5 mcg/kg per week with weight-based ribavirin (600-1,400 mg/day) for 4 weeks, followed by peginterferon-ribavirin plus either placebo (control group) or 800 mg of boceprevir three times daily (boceprevir group) for 44 weeks (Lancet Infect. Dis. 2013;13:597-605).

The primary endpoint of interest was sustained virological response (defined as undetectable plasma HCV RNA) at follow-up week 24 after the end of treatment.

Of the 99 patients, 98 received at least one treatment dose. Of these, 64 were in the boceprevir group and 34 were in the control group. The researchers reported that at follow-up week 24, 63% of patients in the boceprevir group achieved SVR, compared with 29% of controls, a difference of 33.1% that reached significance (P = .0008). Compared with controls, a higher proportion of the boceprevir group experienced adverse events, including anemia (41% vs. 26%, respectively), pyrexia (36% vs. 21%), decreased appetite (34% vs. 18%), dysgeusia (28% vs. 15%), vomiting (28% vs. 15%), and neutropenia (19% vs. 6%). In addition, 4 patients in the control group and 3 in the boceprevir group had HIV viral breakthrough, defined as two consecutive HIV RNA values of at least 50 copies/mL.

"Boceprevir did not seem to add significant risk when used in combination with peginterferon-ribavirin therapy, and no new adverse events were reported," the researchers wrote. "HIV control was well maintained in patients taking boceprevir and HIV protease inhibitors. Drug interactions between boceprevir and HIV protease inhibitors did not have a clinically significant effect on HCV response or HIV control in this study. In view of the hepatic and extrahepatic benefits associated with SVR at follow-up week 24 in patients infected with HIV and HCV, boceprevir in combination with peginterferon-ribavirin might be an important therapeutic option for patients with such coinfection."

Merck markets boceprevir under the brand name Victrelis. Merck sponsored and funded the study. Dr. Sulkowski and numerous other coauthors disclosed having received consulting fees and research grants from the company.

Among adults infected with both HIV and hepatitis C virus, the addition of boceprevir to a combination of peginterferon and ribavirin significantly increased the rate of sustained virological response compared with those who received placebo, results from a 44-week, multicenter phase II study demonstrated.

"Rates of SVR at follow-up week 24 were increased with boceprevir in all subgroups of patients, irrespective of demographic or baseline characteristics," researchers led by Dr. Mark S. Sulkowski of Johns Hopkins University, Baltimore, reported in the July issue of the Lancet Infectious Diseases. Although SVR after treatment with peginterferon and ribavirin has been associated with improved survival, "this regimen has been relatively ineffective (SVR, 25%-30%) in patients with HIV and HCV genotype 1 infection," they wrote.

Dr. Mark S. Sulkowski

"Addition of an HCV protease inhibitor (boceprevir or telaprevir) to peginterferon-ribavirin has emerged as the standard of care for the treatment of HCV genotype 1 infection alone. Use of HCV protease inhibitors in patients infected with HIV and HCV has been restricted by the dearth of available safety and efficacy data."

For the study, which was conducted between Jan. 15 and Dec. 29, 2010, at 30 academic and nonacademic study sites, 99 adults with untreated HCV type 1 genotype infection and controlled HIV were randomized in 1:2 fashion to receive peginterferon 1.5 mcg/kg per week with weight-based ribavirin (600-1,400 mg/day) for 4 weeks, followed by peginterferon-ribavirin plus either placebo (control group) or 800 mg of boceprevir three times daily (boceprevir group) for 44 weeks (Lancet Infect. Dis. 2013;13:597-605).

The primary endpoint of interest was sustained virological response (defined as undetectable plasma HCV RNA) at follow-up week 24 after the end of treatment.

Of the 99 patients, 98 received at least one treatment dose. Of these, 64 were in the boceprevir group and 34 were in the control group. The researchers reported that at follow-up week 24, 63% of patients in the boceprevir group achieved SVR, compared with 29% of controls, a difference of 33.1% that reached significance (P = .0008). Compared with controls, a higher proportion of the boceprevir group experienced adverse events, including anemia (41% vs. 26%, respectively), pyrexia (36% vs. 21%), decreased appetite (34% vs. 18%), dysgeusia (28% vs. 15%), vomiting (28% vs. 15%), and neutropenia (19% vs. 6%). In addition, 4 patients in the control group and 3 in the boceprevir group had HIV viral breakthrough, defined as two consecutive HIV RNA values of at least 50 copies/mL.

"Boceprevir did not seem to add significant risk when used in combination with peginterferon-ribavirin therapy, and no new adverse events were reported," the researchers wrote. "HIV control was well maintained in patients taking boceprevir and HIV protease inhibitors. Drug interactions between boceprevir and HIV protease inhibitors did not have a clinically significant effect on HCV response or HIV control in this study. In view of the hepatic and extrahepatic benefits associated with SVR at follow-up week 24 in patients infected with HIV and HCV, boceprevir in combination with peginterferon-ribavirin might be an important therapeutic option for patients with such coinfection."

Merck markets boceprevir under the brand name Victrelis. Merck sponsored and funded the study. Dr. Sulkowski and numerous other coauthors disclosed having received consulting fees and research grants from the company.

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Major finding: At follow-up week 24, 63% of patients in the boceprevir group achieved sustained virological response, compared with 29% of controls, a difference of 33.1% that reached significance (P = .0008).

Data source: A phase II multicenter trial of 99 patients coinfected with HIV and HCV who were randomized to receive peginterferon 1.5 mcg/kg per week with weight-based ribavirin (600-1,400 mg/day) for 4 weeks, followed by peginterferon-ribavirin plus either placebo (control group) or 800 mg of boceprevir three times daily (boceprevir group) for 44 weeks, with 24 weeks of follow-up after treatment.

Disclosures: Merck markets boceprevir under the brand name Victrelis. Merck sponsored and funded the study. Dr. Sulkowski and numerous other coauthors disclosed having received consulting fees and research grants from the company.

Opioid overdose deaths skyrocket in women

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American women are dying from prescription drug overdose at historically high rates, the Centers for Disease Control and Prevention announced July 2.

Between 1999 and 2010, the percentage increase in deaths from prescription opioid pain relievers increased more than 415% among women, compared with 265% among men, according to an analysis of national data sets.

In addition, for every woman who died of a prescription painkiller overdose, 30 went to the emergency department for painkiller misuse or abuse.

Dr. Thomas R. Frieden

"Mothers, wives, sisters, and daughters are dying from overdoses at rates that we have never seen before," Dr. Tom Frieden, CDC director, said during a media teleconference. "The increase in opiate overdoses and opiate overdose deaths is directly proportional to the increase in prescribing of painkillers."

Prescriptions for opioid pain relievers such as hydrocodone, oxycodone, and oxymorphone "are increasing to an extent that we would not have anticipated and that could not possibly be clinically indicated," he said.

The findings underscore the importance of reserving prescriptions of opioid pain relievers for situations such as severe cancer pain, "where they can provide important and essential palliation," Dr. Frieden said. "But in many other situations, the risks far outweigh the benefits. Prescribing an opiate may condemn a patient to lifelong addiction and life-threatening complications."

For the analysis, CDC researchers used data from the 1999-2010 National Vital Statistics System and the 2004-2010 Drug Abuse Warning Network to analyze rates of fatal overdoses and ED visits related to drug use or misuse among women (MMWR 2013;62:1-6).

In 2010, 15,323 deaths among women were linked to drug overdose, for a rate of 9.8 per 100,000 population. Between 1999 and 2010, 47,935 women died of opioid pain reliever overdoses. Over that time period, the percentage increase in deaths related to opioid pain relievers was 415% for women and 265% for men. Rates for all drug overdose deaths were highest among women aged 45-54 years (a rate of 21.8 per 100,000 population).

The researchers also reported that in 2010, women made 943,365 ED visits for drug misuse or abuse, a rate of 601 per 100,000 population. The highest ED visit rates were for cocaine or heroin (147.2 per 100,000), benzodiazepines (134.6 per 100,000) and opioid pain relievers (129.6 per 100,000). ED visit rates among women for all drugs tended to be highest among those aged 25-34 years.

Compared with men, Dr. Frieden said that women "are more likely to have chronic pain, to be prescribed painkillers and other medications, to be given higher doses, and to use them for longer time periods. It may be that some of the most common forms of pain are more prevalent among women than men [such as] abdominal pain, migraines, and musculoskeletal pain."

Dr. Frieden advised prescribing clinicians to talk with patients about the risks and benefits of taking opioid pain relievers and to follow guidelines for responsible prescribing "such as screening and monitoring patients for substance abuse and for mental health problems, and [using] prescription drug monitoring programs to identify patients who may be improperly using prescription painkillers."

He also called on states to "improve and implement prescription drug monitoring programs. These programs are just getting up and running in many states."

States "need to do more to ensure that the programs are real-time, complete, and actively managed so that we identify patients who need drug treatment and doctors who need [prescribing] information and education," Dr. Frieden said.

As an example, Dr. Frieden highlighted efforts made in recent years in the state of Washington. Officials there worked with clinicians, health care insurers, and worker compensation programs to develop a consensus on how and when prescription opioids should be used, what some of the alternative treatments are, and resources for patients who are addicted.

"They enforced those guidelines through regulation and saw a more than 20% reduction in opioid deaths in about 3 years," he said.

In the MMWR article, researchers acknowledged certain limitations of the study, including the fact that vital statistics "underestimate the rates of drug involvement in deaths because the type of drug is not specified on many death certificates" and that injury mortality data "might underestimate by up to 35% the actual numbers of deaths for American Indian/Alaska natives and certain other racial/ethnic populations (e.g., Hispanics) because of the misclassification of race/ethnicity of decedents on death certificates."

The researchers had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

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American women are dying from prescription drug overdose at historically high rates, the Centers for Disease Control and Prevention announced July 2.

Between 1999 and 2010, the percentage increase in deaths from prescription opioid pain relievers increased more than 415% among women, compared with 265% among men, according to an analysis of national data sets.

In addition, for every woman who died of a prescription painkiller overdose, 30 went to the emergency department for painkiller misuse or abuse.

Dr. Thomas R. Frieden

"Mothers, wives, sisters, and daughters are dying from overdoses at rates that we have never seen before," Dr. Tom Frieden, CDC director, said during a media teleconference. "The increase in opiate overdoses and opiate overdose deaths is directly proportional to the increase in prescribing of painkillers."

Prescriptions for opioid pain relievers such as hydrocodone, oxycodone, and oxymorphone "are increasing to an extent that we would not have anticipated and that could not possibly be clinically indicated," he said.

The findings underscore the importance of reserving prescriptions of opioid pain relievers for situations such as severe cancer pain, "where they can provide important and essential palliation," Dr. Frieden said. "But in many other situations, the risks far outweigh the benefits. Prescribing an opiate may condemn a patient to lifelong addiction and life-threatening complications."

For the analysis, CDC researchers used data from the 1999-2010 National Vital Statistics System and the 2004-2010 Drug Abuse Warning Network to analyze rates of fatal overdoses and ED visits related to drug use or misuse among women (MMWR 2013;62:1-6).

In 2010, 15,323 deaths among women were linked to drug overdose, for a rate of 9.8 per 100,000 population. Between 1999 and 2010, 47,935 women died of opioid pain reliever overdoses. Over that time period, the percentage increase in deaths related to opioid pain relievers was 415% for women and 265% for men. Rates for all drug overdose deaths were highest among women aged 45-54 years (a rate of 21.8 per 100,000 population).

The researchers also reported that in 2010, women made 943,365 ED visits for drug misuse or abuse, a rate of 601 per 100,000 population. The highest ED visit rates were for cocaine or heroin (147.2 per 100,000), benzodiazepines (134.6 per 100,000) and opioid pain relievers (129.6 per 100,000). ED visit rates among women for all drugs tended to be highest among those aged 25-34 years.

Compared with men, Dr. Frieden said that women "are more likely to have chronic pain, to be prescribed painkillers and other medications, to be given higher doses, and to use them for longer time periods. It may be that some of the most common forms of pain are more prevalent among women than men [such as] abdominal pain, migraines, and musculoskeletal pain."

Dr. Frieden advised prescribing clinicians to talk with patients about the risks and benefits of taking opioid pain relievers and to follow guidelines for responsible prescribing "such as screening and monitoring patients for substance abuse and for mental health problems, and [using] prescription drug monitoring programs to identify patients who may be improperly using prescription painkillers."

He also called on states to "improve and implement prescription drug monitoring programs. These programs are just getting up and running in many states."

States "need to do more to ensure that the programs are real-time, complete, and actively managed so that we identify patients who need drug treatment and doctors who need [prescribing] information and education," Dr. Frieden said.

As an example, Dr. Frieden highlighted efforts made in recent years in the state of Washington. Officials there worked with clinicians, health care insurers, and worker compensation programs to develop a consensus on how and when prescription opioids should be used, what some of the alternative treatments are, and resources for patients who are addicted.

"They enforced those guidelines through regulation and saw a more than 20% reduction in opioid deaths in about 3 years," he said.

In the MMWR article, researchers acknowledged certain limitations of the study, including the fact that vital statistics "underestimate the rates of drug involvement in deaths because the type of drug is not specified on many death certificates" and that injury mortality data "might underestimate by up to 35% the actual numbers of deaths for American Indian/Alaska natives and certain other racial/ethnic populations (e.g., Hispanics) because of the misclassification of race/ethnicity of decedents on death certificates."

The researchers had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

American women are dying from prescription drug overdose at historically high rates, the Centers for Disease Control and Prevention announced July 2.

Between 1999 and 2010, the percentage increase in deaths from prescription opioid pain relievers increased more than 415% among women, compared with 265% among men, according to an analysis of national data sets.

In addition, for every woman who died of a prescription painkiller overdose, 30 went to the emergency department for painkiller misuse or abuse.

Dr. Thomas R. Frieden

"Mothers, wives, sisters, and daughters are dying from overdoses at rates that we have never seen before," Dr. Tom Frieden, CDC director, said during a media teleconference. "The increase in opiate overdoses and opiate overdose deaths is directly proportional to the increase in prescribing of painkillers."

Prescriptions for opioid pain relievers such as hydrocodone, oxycodone, and oxymorphone "are increasing to an extent that we would not have anticipated and that could not possibly be clinically indicated," he said.

The findings underscore the importance of reserving prescriptions of opioid pain relievers for situations such as severe cancer pain, "where they can provide important and essential palliation," Dr. Frieden said. "But in many other situations, the risks far outweigh the benefits. Prescribing an opiate may condemn a patient to lifelong addiction and life-threatening complications."

For the analysis, CDC researchers used data from the 1999-2010 National Vital Statistics System and the 2004-2010 Drug Abuse Warning Network to analyze rates of fatal overdoses and ED visits related to drug use or misuse among women (MMWR 2013;62:1-6).

In 2010, 15,323 deaths among women were linked to drug overdose, for a rate of 9.8 per 100,000 population. Between 1999 and 2010, 47,935 women died of opioid pain reliever overdoses. Over that time period, the percentage increase in deaths related to opioid pain relievers was 415% for women and 265% for men. Rates for all drug overdose deaths were highest among women aged 45-54 years (a rate of 21.8 per 100,000 population).

The researchers also reported that in 2010, women made 943,365 ED visits for drug misuse or abuse, a rate of 601 per 100,000 population. The highest ED visit rates were for cocaine or heroin (147.2 per 100,000), benzodiazepines (134.6 per 100,000) and opioid pain relievers (129.6 per 100,000). ED visit rates among women for all drugs tended to be highest among those aged 25-34 years.

Compared with men, Dr. Frieden said that women "are more likely to have chronic pain, to be prescribed painkillers and other medications, to be given higher doses, and to use them for longer time periods. It may be that some of the most common forms of pain are more prevalent among women than men [such as] abdominal pain, migraines, and musculoskeletal pain."

Dr. Frieden advised prescribing clinicians to talk with patients about the risks and benefits of taking opioid pain relievers and to follow guidelines for responsible prescribing "such as screening and monitoring patients for substance abuse and for mental health problems, and [using] prescription drug monitoring programs to identify patients who may be improperly using prescription painkillers."

He also called on states to "improve and implement prescription drug monitoring programs. These programs are just getting up and running in many states."

States "need to do more to ensure that the programs are real-time, complete, and actively managed so that we identify patients who need drug treatment and doctors who need [prescribing] information and education," Dr. Frieden said.

As an example, Dr. Frieden highlighted efforts made in recent years in the state of Washington. Officials there worked with clinicians, health care insurers, and worker compensation programs to develop a consensus on how and when prescription opioids should be used, what some of the alternative treatments are, and resources for patients who are addicted.

"They enforced those guidelines through regulation and saw a more than 20% reduction in opioid deaths in about 3 years," he said.

In the MMWR article, researchers acknowledged certain limitations of the study, including the fact that vital statistics "underestimate the rates of drug involvement in deaths because the type of drug is not specified on many death certificates" and that injury mortality data "might underestimate by up to 35% the actual numbers of deaths for American Indian/Alaska natives and certain other racial/ethnic populations (e.g., Hispanics) because of the misclassification of race/ethnicity of decedents on death certificates."

The researchers had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

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FROM MORBIDITY AND MORTALITY WEEKLY REPORT

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Inside the Article

Vitals

Major finding: Between 1999 and 2010, the percentage increase in deaths from overdose of opioid pain relievers rose 415% among women, compared with 265% among men.

Data source: Analysis of data from the 1999-2010 National Vital Statistics System and the 2004-2010 Drug Abuse Warning Network.

Disclosures: The researchers disclosed no relevant financial conflicts of interest.