General Surgery

SAN DIEGO – The implementation of an intensive preoperative screening and intervention process led to a significant decrease in 30-day mortality for general surgery and vascular procedures, results from a single-center study demonstrated.

In 2007, Carilion Roanoke (Va.) Memorial Hospital became a member of the American College of Surgeons/National Surgical Quality Improvement Program (ACS/NSQIP). "After receiving our first report, it became evident that surgical mortality at our institution was significantly higher than expected and significantly higher than the national average," Dr. Agathoklis Konstantinidis said at the ACS/NSQIP National Conference. "After further evaluation of this data, it became obvious that we were operating on people with several undiagnosed, untreated medical diseases such as diabetes, obstructive sleep apnea, hypertension, lung disease, and renal disease that all constituted significant preoperative risk factors."

In an effort to improve surgical mortality at the hospital, Dr. Konstantinidis and his associates implemented a strict preoperative screening and intervention program that began in January 2010. Since that time, every patient scheduled for surgery is required to undergo a preoperative screening appointment with a registered nurse who performs an extensive computer-based checklist of risk factors for heart disease, renal disease, abnormal EKG, sleep apnea, and pulmonary disease.

"If a problem is identified, the surgery is postponed until the issue is addressed, either by the primary care physician or by the surgeon who is directly involved in the care of the patient, and in close communication with other specialists, such as those in internal medicine, family practice, and endocrinology," explained Dr. Konstantinidis, who is a surgeon at the hospital.

Between July 2007 and December 2009 – prior to initiation of the preoperative screening and intervention program – the odds ratios for 30-day mortality in all cases were 1.40, 1.43, 1.58, and 1.56 in successive reporting periods. Beginning with the first report after implementation of the preoperative screening and intervention program, 30-day mortality in all cases progressively decreased in successive reporting periods (OR, 1.26, 1.19, 1.14, and 0.86, respectively), with similar reductions in both general surgery (OR, 0.92) and vascular surgery (OR, 0.92) for the last year.

"After the implementation of our new preoperative screening and intervention process, overall 30-day surgical mortality at our institution decreased from 3.5% to 1.9%, which is clinically and also statistically significant based on the P value (P = .007)," Dr. Konstantinidis said.

He went on to report that out of 5,866 patients who underwent screening in 2012 alone, 3,691 had undiagnosed obstructive sleep apnea, 2,361 had an abnormal preoperative EKG, 437 had undiagnosed diabetes, 192 had undiagnosed hypertension, and 167 had undiagnosed shortness of breath. "As a result of the screening intervention, surgery was canceled in 218 patients, and 147 were referred to cardiology specialists for further evaluation," he said.

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

dbrunk@frontlinemedcom.com

SAN DIEGO – The implementation of an intensive preoperative screening and intervention process led to a significant decrease in 30-day mortality for general surgery and vascular procedures, results from a single-center study demonstrated.

In 2007, Carilion Roanoke (Va.) Memorial Hospital became a member of the American College of Surgeons/National Surgical Quality Improvement Program (ACS/NSQIP). "After receiving our first report, it became evident that surgical mortality at our institution was significantly higher than expected and significantly higher than the national average," Dr. Agathoklis Konstantinidis said at the ACS/NSQIP National Conference. "After further evaluation of this data, it became obvious that we were operating on people with several undiagnosed, untreated medical diseases such as diabetes, obstructive sleep apnea, hypertension, lung disease, and renal disease that all constituted significant preoperative risk factors."

In an effort to improve surgical mortality at the hospital, Dr. Konstantinidis and his associates implemented a strict preoperative screening and intervention program that began in January 2010. Since that time, every patient scheduled for surgery is required to undergo a preoperative screening appointment with a registered nurse who performs an extensive computer-based checklist of risk factors for heart disease, renal disease, abnormal EKG, sleep apnea, and pulmonary disease.

"If a problem is identified, the surgery is postponed until the issue is addressed, either by the primary care physician or by the surgeon who is directly involved in the care of the patient, and in close communication with other specialists, such as those in internal medicine, family practice, and endocrinology," explained Dr. Konstantinidis, who is a surgeon at the hospital.

Between July 2007 and December 2009 – prior to initiation of the preoperative screening and intervention program – the odds ratios for 30-day mortality in all cases were 1.40, 1.43, 1.58, and 1.56 in successive reporting periods. Beginning with the first report after implementation of the preoperative screening and intervention program, 30-day mortality in all cases progressively decreased in successive reporting periods (OR, 1.26, 1.19, 1.14, and 0.86, respectively), with similar reductions in both general surgery (OR, 0.92) and vascular surgery (OR, 0.92) for the last year.

"After the implementation of our new preoperative screening and intervention process, overall 30-day surgical mortality at our institution decreased from 3.5% to 1.9%, which is clinically and also statistically significant based on the P value (P = .007)," Dr. Konstantinidis said.

He went on to report that out of 5,866 patients who underwent screening in 2012 alone, 3,691 had undiagnosed obstructive sleep apnea, 2,361 had an abnormal preoperative EKG, 437 had undiagnosed diabetes, 192 had undiagnosed hypertension, and 167 had undiagnosed shortness of breath. "As a result of the screening intervention, surgery was canceled in 218 patients, and 147 were referred to cardiology specialists for further evaluation," he said.

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

dbrunk@frontlinemedcom.com

SAN DIEGO – The implementation of an intensive preoperative screening and intervention process led to a significant decrease in 30-day mortality for general surgery and vascular procedures, results from a single-center study demonstrated.

In 2007, Carilion Roanoke (Va.) Memorial Hospital became a member of the American College of Surgeons/National Surgical Quality Improvement Program (ACS/NSQIP). "After receiving our first report, it became evident that surgical mortality at our institution was significantly higher than expected and significantly higher than the national average," Dr. Agathoklis Konstantinidis said at the ACS/NSQIP National Conference. "After further evaluation of this data, it became obvious that we were operating on people with several undiagnosed, untreated medical diseases such as diabetes, obstructive sleep apnea, hypertension, lung disease, and renal disease that all constituted significant preoperative risk factors."

In an effort to improve surgical mortality at the hospital, Dr. Konstantinidis and his associates implemented a strict preoperative screening and intervention program that began in January 2010. Since that time, every patient scheduled for surgery is required to undergo a preoperative screening appointment with a registered nurse who performs an extensive computer-based checklist of risk factors for heart disease, renal disease, abnormal EKG, sleep apnea, and pulmonary disease.

"If a problem is identified, the surgery is postponed until the issue is addressed, either by the primary care physician or by the surgeon who is directly involved in the care of the patient, and in close communication with other specialists, such as those in internal medicine, family practice, and endocrinology," explained Dr. Konstantinidis, who is a surgeon at the hospital.

Between July 2007 and December 2009 – prior to initiation of the preoperative screening and intervention program – the odds ratios for 30-day mortality in all cases were 1.40, 1.43, 1.58, and 1.56 in successive reporting periods. Beginning with the first report after implementation of the preoperative screening and intervention program, 30-day mortality in all cases progressively decreased in successive reporting periods (OR, 1.26, 1.19, 1.14, and 0.86, respectively), with similar reductions in both general surgery (OR, 0.92) and vascular surgery (OR, 0.92) for the last year.

"After the implementation of our new preoperative screening and intervention process, overall 30-day surgical mortality at our institution decreased from 3.5% to 1.9%, which is clinically and also statistically significant based on the P value (P = .007)," Dr. Konstantinidis said.

He went on to report that out of 5,866 patients who underwent screening in 2012 alone, 3,691 had undiagnosed obstructive sleep apnea, 2,361 had an abnormal preoperative EKG, 437 had undiagnosed diabetes, 192 had undiagnosed hypertension, and 167 had undiagnosed shortness of breath. "As a result of the screening intervention, surgery was canceled in 218 patients, and 147 were referred to cardiology specialists for further evaluation," he said.

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

dbrunk@frontlinemedcom.com

The likelihood of nodal metastases is increased in breast cancer patients whose tumors have breast cancer stem and progenitor cells with defects in PI3/Akt signaling.

The findings, drawn from an analysis of surgical specimens, "support embarking on a new way of approaching breast cancer diagnosis and treatment planning" and have potential implications for targeted treatment with PI3/Akt inhibitors currently being tested in clinical trials, Dr. Cory A. Donovan and his colleagues at the Oregon Health and Science University, Portland reported online July 24 in JAMA Surgery.

The researchers evaluated malignant and benign stem cells from 30 fresh surgical specimens of ductal breast cancers. Nine of the 10 specimens with mutations in breast cancer stem and progenitor cells (BCSCs) were associated with axillary lymph node micro- or macrometastases. Just 4 of the 20 tumors without mutations were associated with axillary lymph node metastases, the investigators said (JAMA Surg. 2013 July 17 [doi:10.1001/jamasurg.2013.3028]).

The tumor specimens were collected from patients with stage IA through IIIB cancers via cell sorting and were subjected to whole genomic amplification and subsequent screening for oncogene mutations. The 10 tumors with BCSC defects had AKT1, HRAS, or PIK3CA mutations.

"Three different mutations (E545k, N345k, and H1047R) were detected in PIK3CA, a single mutation was detected in AKT1, and a single mutation was detected in HRAS," the investigators wrote.

No difference in CD44 positivity was observed between BCSCs with and without mutations.

"When the presence of any BCSC mutation correlated with patient and breast cancer characteristics, no statistically significant correlations were found with patient age at diagnosis, tumor size, tumor histologic grade, estrogen receptor expression, progesterone receptor expression, or ERBB2 status. However, a statistically significant correlation was observed between the presence of BCSC mutations and axillary lymph node metastases. This significance was more pronounced when micrometastatic disease was included," they said.

At a mean follow-up of 29 months, disease had progressed after treatment in 3 of the 10 patients with BCSC mutations. Two patients died of disease; one had brain metastases. Conversely, there was no evidence of disease at a mean follow-up of 19 months in the patients with BCSCs without mutations.

Since 20% of patients without BCSC mutations had axillary lymph node metastases, it appears that a PI3K/Akt mutation in BCSC is not a requirement for metastases, but the link between PI3K and metastatic potential demonstrated in this study suggests that "micrometastases harboring PI3K/Akt mutations may carry a different risk for distant metastatic disease," Dr. Donovan and his associates noted.

"Longer patient follow-up periods and a larger sample size will determine if this subset of patients demonstrates an increased risk and may benefit from specifically designed use of adjuvant chemotherapy," the researchers added.

The existing evidence regarding the prognostic significance of specific PI3K/Akt signaling pathway mutations is conflicting, likely because of the variability of the mutations, the heterogeneity of the tumors, and the complexity of the pathway. Although the findings in BCSCs in the current study are consistent with others showing that PIK3CA and AKT mutations in breast cancers are associated with factors that may indicate poor prognosis and decreased survival, other studies have demonstrated improved survival, lower tumor grades, and increased rates of estrogen receptor positivity in patients with tumors that have PIK3CA mutations, they said.

"Our study findings indicate that the answer to this controversy may lie in identifying mutations in BCSCs, as well as mutations in the tumor as a whole," they said, adding that the findings support an evaluation of BCSCs along with overall breast cancer assessment.

"The analysis of BCSCs can generate specific information about tumor growth and metastatic potential that may not be obtained from analysis of the tumor progeny cells alone. Simultaneous molecular analyses of both the tumor and BCSCs may better identify patients who are likely to benefit from specific therapeutic regimens. Similarly, simultaneous BCSC and tumor analysis may increase the number of patients who might benefit from treatment but be missed by tumor analysis alone," Dr. Donovan and his coworkers said.

P13K/Akt signaling pathway inhibitors are currently being evaluated in clinical trials and could prove useful for the treatment of patients with BCSC mutations, they noted, adding that this may be true even in cases without PIK/Akt mutation.

"The use of BCSC-specific and tumor-targeted chemotherapeutic agents may prove to be synergistic with each other, providing a novel therapeutic approach," they said.

This study was supported by a grant from the Janet E. Bowen Foundation. The authors reported having no disclosures.

The likelihood of nodal metastases is increased in breast cancer patients whose tumors have breast cancer stem and progenitor cells with defects in PI3/Akt signaling.

The findings, drawn from an analysis of surgical specimens, "support embarking on a new way of approaching breast cancer diagnosis and treatment planning" and have potential implications for targeted treatment with PI3/Akt inhibitors currently being tested in clinical trials, Dr. Cory A. Donovan and his colleagues at the Oregon Health and Science University, Portland reported online July 24 in JAMA Surgery.

The researchers evaluated malignant and benign stem cells from 30 fresh surgical specimens of ductal breast cancers. Nine of the 10 specimens with mutations in breast cancer stem and progenitor cells (BCSCs) were associated with axillary lymph node micro- or macrometastases. Just 4 of the 20 tumors without mutations were associated with axillary lymph node metastases, the investigators said (JAMA Surg. 2013 July 17 [doi:10.1001/jamasurg.2013.3028]).

The tumor specimens were collected from patients with stage IA through IIIB cancers via cell sorting and were subjected to whole genomic amplification and subsequent screening for oncogene mutations. The 10 tumors with BCSC defects had AKT1, HRAS, or PIK3CA mutations.

"Three different mutations (E545k, N345k, and H1047R) were detected in PIK3CA, a single mutation was detected in AKT1, and a single mutation was detected in HRAS," the investigators wrote.

No difference in CD44 positivity was observed between BCSCs with and without mutations.

"When the presence of any BCSC mutation correlated with patient and breast cancer characteristics, no statistically significant correlations were found with patient age at diagnosis, tumor size, tumor histologic grade, estrogen receptor expression, progesterone receptor expression, or ERBB2 status. However, a statistically significant correlation was observed between the presence of BCSC mutations and axillary lymph node metastases. This significance was more pronounced when micrometastatic disease was included," they said.

At a mean follow-up of 29 months, disease had progressed after treatment in 3 of the 10 patients with BCSC mutations. Two patients died of disease; one had brain metastases. Conversely, there was no evidence of disease at a mean follow-up of 19 months in the patients with BCSCs without mutations.

Since 20% of patients without BCSC mutations had axillary lymph node metastases, it appears that a PI3K/Akt mutation in BCSC is not a requirement for metastases, but the link between PI3K and metastatic potential demonstrated in this study suggests that "micrometastases harboring PI3K/Akt mutations may carry a different risk for distant metastatic disease," Dr. Donovan and his associates noted.

"Longer patient follow-up periods and a larger sample size will determine if this subset of patients demonstrates an increased risk and may benefit from specifically designed use of adjuvant chemotherapy," the researchers added.

The existing evidence regarding the prognostic significance of specific PI3K/Akt signaling pathway mutations is conflicting, likely because of the variability of the mutations, the heterogeneity of the tumors, and the complexity of the pathway. Although the findings in BCSCs in the current study are consistent with others showing that PIK3CA and AKT mutations in breast cancers are associated with factors that may indicate poor prognosis and decreased survival, other studies have demonstrated improved survival, lower tumor grades, and increased rates of estrogen receptor positivity in patients with tumors that have PIK3CA mutations, they said.

"Our study findings indicate that the answer to this controversy may lie in identifying mutations in BCSCs, as well as mutations in the tumor as a whole," they said, adding that the findings support an evaluation of BCSCs along with overall breast cancer assessment.

"The analysis of BCSCs can generate specific information about tumor growth and metastatic potential that may not be obtained from analysis of the tumor progeny cells alone. Simultaneous molecular analyses of both the tumor and BCSCs may better identify patients who are likely to benefit from specific therapeutic regimens. Similarly, simultaneous BCSC and tumor analysis may increase the number of patients who might benefit from treatment but be missed by tumor analysis alone," Dr. Donovan and his coworkers said.

P13K/Akt signaling pathway inhibitors are currently being evaluated in clinical trials and could prove useful for the treatment of patients with BCSC mutations, they noted, adding that this may be true even in cases without PIK/Akt mutation.

"The use of BCSC-specific and tumor-targeted chemotherapeutic agents may prove to be synergistic with each other, providing a novel therapeutic approach," they said.

This study was supported by a grant from the Janet E. Bowen Foundation. The authors reported having no disclosures.

The likelihood of nodal metastases is increased in breast cancer patients whose tumors have breast cancer stem and progenitor cells with defects in PI3/Akt signaling.

The findings, drawn from an analysis of surgical specimens, "support embarking on a new way of approaching breast cancer diagnosis and treatment planning" and have potential implications for targeted treatment with PI3/Akt inhibitors currently being tested in clinical trials, Dr. Cory A. Donovan and his colleagues at the Oregon Health and Science University, Portland reported online July 24 in JAMA Surgery.

The researchers evaluated malignant and benign stem cells from 30 fresh surgical specimens of ductal breast cancers. Nine of the 10 specimens with mutations in breast cancer stem and progenitor cells (BCSCs) were associated with axillary lymph node micro- or macrometastases. Just 4 of the 20 tumors without mutations were associated with axillary lymph node metastases, the investigators said (JAMA Surg. 2013 July 17 [doi:10.1001/jamasurg.2013.3028]).

The tumor specimens were collected from patients with stage IA through IIIB cancers via cell sorting and were subjected to whole genomic amplification and subsequent screening for oncogene mutations. The 10 tumors with BCSC defects had AKT1, HRAS, or PIK3CA mutations.

"Three different mutations (E545k, N345k, and H1047R) were detected in PIK3CA, a single mutation was detected in AKT1, and a single mutation was detected in HRAS," the investigators wrote.

No difference in CD44 positivity was observed between BCSCs with and without mutations.

"When the presence of any BCSC mutation correlated with patient and breast cancer characteristics, no statistically significant correlations were found with patient age at diagnosis, tumor size, tumor histologic grade, estrogen receptor expression, progesterone receptor expression, or ERBB2 status. However, a statistically significant correlation was observed between the presence of BCSC mutations and axillary lymph node metastases. This significance was more pronounced when micrometastatic disease was included," they said.

At a mean follow-up of 29 months, disease had progressed after treatment in 3 of the 10 patients with BCSC mutations. Two patients died of disease; one had brain metastases. Conversely, there was no evidence of disease at a mean follow-up of 19 months in the patients with BCSCs without mutations.

Since 20% of patients without BCSC mutations had axillary lymph node metastases, it appears that a PI3K/Akt mutation in BCSC is not a requirement for metastases, but the link between PI3K and metastatic potential demonstrated in this study suggests that "micrometastases harboring PI3K/Akt mutations may carry a different risk for distant metastatic disease," Dr. Donovan and his associates noted.

"Longer patient follow-up periods and a larger sample size will determine if this subset of patients demonstrates an increased risk and may benefit from specifically designed use of adjuvant chemotherapy," the researchers added.

The existing evidence regarding the prognostic significance of specific PI3K/Akt signaling pathway mutations is conflicting, likely because of the variability of the mutations, the heterogeneity of the tumors, and the complexity of the pathway. Although the findings in BCSCs in the current study are consistent with others showing that PIK3CA and AKT mutations in breast cancers are associated with factors that may indicate poor prognosis and decreased survival, other studies have demonstrated improved survival, lower tumor grades, and increased rates of estrogen receptor positivity in patients with tumors that have PIK3CA mutations, they said.

"Our study findings indicate that the answer to this controversy may lie in identifying mutations in BCSCs, as well as mutations in the tumor as a whole," they said, adding that the findings support an evaluation of BCSCs along with overall breast cancer assessment.

"The analysis of BCSCs can generate specific information about tumor growth and metastatic potential that may not be obtained from analysis of the tumor progeny cells alone. Simultaneous molecular analyses of both the tumor and BCSCs may better identify patients who are likely to benefit from specific therapeutic regimens. Similarly, simultaneous BCSC and tumor analysis may increase the number of patients who might benefit from treatment but be missed by tumor analysis alone," Dr. Donovan and his coworkers said.

P13K/Akt signaling pathway inhibitors are currently being evaluated in clinical trials and could prove useful for the treatment of patients with BCSC mutations, they noted, adding that this may be true even in cases without PIK/Akt mutation.

"The use of BCSC-specific and tumor-targeted chemotherapeutic agents may prove to be synergistic with each other, providing a novel therapeutic approach," they said.

This study was supported by a grant from the Janet E. Bowen Foundation. The authors reported having no disclosures.

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."

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."

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."

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 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."

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."

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."

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

Should bariatric surgery be performed in certified centers only? Medicare officials think the answer might be "no."

In a proposed decision memo issued in June, the Centers for Medicare and Medicaid Services said the evidence was sufficient to end the certification requirement and that continuing the current requirements would not improve health outcomes for Medicare beneficiaries.

While some physician experts support the proposal as improving access to bariatric surgery, others express concerns that quality and data collection efforts will suffer.

The proposal does not change which procedures are covered by Medicare. The agency will continue to cover open and laparoscopic Roux-en-Y gastric bypass; laparoscopic adjustable gastric banding; and open and laparoscopic biliopancreatic diversion with duodenal switch for Medicare beneficiaries with a body-mass index of 35 kg/m² or greater who have at least one comorbidity related to obesity and have been unsuccessful with medical treatment for obesity.

If the proposal is accepted, it would reverse the requirements the CMS put in place in February 2006. Since then, Medicare has covered only bariatric procedures performed at facilities that were certified by the American College of Surgeons as a Level 1 Bariatric Surgery Center or by the American Society for Metabolic and Bariatric Surgery as a Bariatric Surgery Center of Excellence.

CMS officials reviewed eight studies to determine if facility certification meaningfully improved health outcomes for Medicare beneficiaries. The studies had "mixed" results, the agency said, but overall, the evidence showed "no consistent statistical or clinically meaningful difference" and there was nothing in the literature to suggest a worsening of outcomes.

The factors that led to the original certification requirements – the rapid growth in bariatric procedures and concerns about higher mortality rates – have changed.

"Since that 2006 determination, bariatric surgery has experienced a trend toward less invasive procedures and lower mortality and complication rates," according to the proposed decision memo.

The policy switch was requested by a trio of health services researchers at the University of Michigan led by Dr. John D. Birkmeyer, professor of surgery and director of the university’s Center for Healthcare Outcomes and Policy. They asserted that certified hospitals were no safer than other facilities and that mortality and serious complication rates for bariatric surgery had declined across the country.

They called on the CMS to scrap the certification requirements but to encourage bariatric surgeons to participate in registry programs through their professional societies or through payer-supported collaborative improvement programs such as the one supported by Blue Cross Blue Shield of Michigan.

The Michigan researchers suggested that the agency incentivize physicians to participate in these quality improvement activities by tying them to programs such as the Physician Quality Reporting System.

Dr. Birkmeyer pointed to a study published earlier this year showing that the current certification policy has not led to better outcomes for patients (JAMA 2013;309:792-9). In the study, which Dr. Birkmeyer coauthored, the researchers found no statistically significant improvements in complications or reoperation rates after implementation of the CMS certification requirements after accounting for patient factors, changes in procedure type, and pre-existing time trends toward improved outcomes.

"There is absolutely no controversy about the fact that [the policy] didn’t steer people to safer hospitals," Dr. Birkmeyer said.

Access could improve under the proposed decision memo, Dr. Birkmeyer said. The current certification framework makes it harder for some Medicare patients to undergo bariatric surgery without traveling hours from home. The policy may also be disproportionately affecting minorities and low-income beneficiaries, Dr. Birkmeyer said.

The American College of Surgeons and the American Society for Metabolic and Bariatric Surgery continue to support certification; however, they are working to revise their processes to create a single, unified program that will include a lower volume threshold for certification, dropping from a minimum of 125 cases a year to 50 cases a year, according to Dr. Jaime Ponce, president of the American Society for Metabolic and Bariatric Surgery and a bariatric surgeon in Chattanooga, Tenn.

The volume change should help to address some of the concerns about access by opening up certification to more programs, he said.

But Dr. Ponce said his group plans to fight the "dangerous" CMS proposal to drop certification requirements completely.

"We do believe that this could be very harmful for Medicare patients because if a patient that is very sick shows up in a community hospital that doesn’t have the right structure to take care of obese patients ... accidents are going to start happening again," he said.

The majority of the literature supports facility certification for bariatric surgery, Dr. Ponce said. As for those studies showing no difference in outcomes, the results weren’t reliable because the studies were conducted at a time when most of the facilities included were pursuing certification, he noted. Even those facilities that fell short of meeting certification requirements would have been developing a culture of safety and would likely have met many of the standards.

Dr. Ponce singled out a 2011 study in Annals of Surgery, which evaluated mortality among Medicare patients before and after the certification requirements took effect (Ann. Surg. 2011;254: 860-5). The study, which used Medicare data from 2004-2008, showed that mortality, readmission, and reoperation rates all declined after the coverage decision was implemented. The 90-day mortality rate dropped from 1.5% to 0.7%, while 90-day readmission rates decreased from 19.9% to 15.4%. The researchers also noted a decrease in payments for the procedures.

But gains in safety and cost-effectiveness could be lost if the CMS removes the certification requirements, Dr. Ponce said. Without clear requirements in place, hospitals will be unlikely to make the investments they are making today in equipment, personnel, and training, he said.

Another issue is what will happen to data collection if certification requirements are eliminated. Dr. Ponce said he’s concerned that data collection efforts would dry up without those mandates from the CMS.

"We will not have that data in order to improve the quality that we need to," he said.

A final decision on the coverage memo is expected in the fall.

mschneider@frontlinemedcom.com

Should bariatric surgery be performed in certified centers only? Medicare officials think the answer might be "no."

In a proposed decision memo issued in June, the Centers for Medicare and Medicaid Services said the evidence was sufficient to end the certification requirement and that continuing the current requirements would not improve health outcomes for Medicare beneficiaries.

While some physician experts support the proposal as improving access to bariatric surgery, others express concerns that quality and data collection efforts will suffer.

The proposal does not change which procedures are covered by Medicare. The agency will continue to cover open and laparoscopic Roux-en-Y gastric bypass; laparoscopic adjustable gastric banding; and open and laparoscopic biliopancreatic diversion with duodenal switch for Medicare beneficiaries with a body-mass index of 35 kg/m² or greater who have at least one comorbidity related to obesity and have been unsuccessful with medical treatment for obesity.

If the proposal is accepted, it would reverse the requirements the CMS put in place in February 2006. Since then, Medicare has covered only bariatric procedures performed at facilities that were certified by the American College of Surgeons as a Level 1 Bariatric Surgery Center or by the American Society for Metabolic and Bariatric Surgery as a Bariatric Surgery Center of Excellence.

CMS officials reviewed eight studies to determine if facility certification meaningfully improved health outcomes for Medicare beneficiaries. The studies had "mixed" results, the agency said, but overall, the evidence showed "no consistent statistical or clinically meaningful difference" and there was nothing in the literature to suggest a worsening of outcomes.

The factors that led to the original certification requirements – the rapid growth in bariatric procedures and concerns about higher mortality rates – have changed.

"Since that 2006 determination, bariatric surgery has experienced a trend toward less invasive procedures and lower mortality and complication rates," according to the proposed decision memo.

The policy switch was requested by a trio of health services researchers at the University of Michigan led by Dr. John D. Birkmeyer, professor of surgery and director of the university’s Center for Healthcare Outcomes and Policy. They asserted that certified hospitals were no safer than other facilities and that mortality and serious complication rates for bariatric surgery had declined across the country.

They called on the CMS to scrap the certification requirements but to encourage bariatric surgeons to participate in registry programs through their professional societies or through payer-supported collaborative improvement programs such as the one supported by Blue Cross Blue Shield of Michigan.

The Michigan researchers suggested that the agency incentivize physicians to participate in these quality improvement activities by tying them to programs such as the Physician Quality Reporting System.

Dr. Birkmeyer pointed to a study published earlier this year showing that the current certification policy has not led to better outcomes for patients (JAMA 2013;309:792-9). In the study, which Dr. Birkmeyer coauthored, the researchers found no statistically significant improvements in complications or reoperation rates after implementation of the CMS certification requirements after accounting for patient factors, changes in procedure type, and pre-existing time trends toward improved outcomes.

"There is absolutely no controversy about the fact that [the policy] didn’t steer people to safer hospitals," Dr. Birkmeyer said.

Access could improve under the proposed decision memo, Dr. Birkmeyer said. The current certification framework makes it harder for some Medicare patients to undergo bariatric surgery without traveling hours from home. The policy may also be disproportionately affecting minorities and low-income beneficiaries, Dr. Birkmeyer said.

The American College of Surgeons and the American Society for Metabolic and Bariatric Surgery continue to support certification; however, they are working to revise their processes to create a single, unified program that will include a lower volume threshold for certification, dropping from a minimum of 125 cases a year to 50 cases a year, according to Dr. Jaime Ponce, president of the American Society for Metabolic and Bariatric Surgery and a bariatric surgeon in Chattanooga, Tenn.

The volume change should help to address some of the concerns about access by opening up certification to more programs, he said.

But Dr. Ponce said his group plans to fight the "dangerous" CMS proposal to drop certification requirements completely.

"We do believe that this could be very harmful for Medicare patients because if a patient that is very sick shows up in a community hospital that doesn’t have the right structure to take care of obese patients ... accidents are going to start happening again," he said.

The majority of the literature supports facility certification for bariatric surgery, Dr. Ponce said. As for those studies showing no difference in outcomes, the results weren’t reliable because the studies were conducted at a time when most of the facilities included were pursuing certification, he noted. Even those facilities that fell short of meeting certification requirements would have been developing a culture of safety and would likely have met many of the standards.

Dr. Ponce singled out a 2011 study in Annals of Surgery, which evaluated mortality among Medicare patients before and after the certification requirements took effect (Ann. Surg. 2011;254: 860-5). The study, which used Medicare data from 2004-2008, showed that mortality, readmission, and reoperation rates all declined after the coverage decision was implemented. The 90-day mortality rate dropped from 1.5% to 0.7%, while 90-day readmission rates decreased from 19.9% to 15.4%. The researchers also noted a decrease in payments for the procedures.

But gains in safety and cost-effectiveness could be lost if the CMS removes the certification requirements, Dr. Ponce said. Without clear requirements in place, hospitals will be unlikely to make the investments they are making today in equipment, personnel, and training, he said.

Another issue is what will happen to data collection if certification requirements are eliminated. Dr. Ponce said he’s concerned that data collection efforts would dry up without those mandates from the CMS.

"We will not have that data in order to improve the quality that we need to," he said.

A final decision on the coverage memo is expected in the fall.

mschneider@frontlinemedcom.com

Should bariatric surgery be performed in certified centers only? Medicare officials think the answer might be "no."

In a proposed decision memo issued in June, the Centers for Medicare and Medicaid Services said the evidence was sufficient to end the certification requirement and that continuing the current requirements would not improve health outcomes for Medicare beneficiaries.

While some physician experts support the proposal as improving access to bariatric surgery, others express concerns that quality and data collection efforts will suffer.

The proposal does not change which procedures are covered by Medicare. The agency will continue to cover open and laparoscopic Roux-en-Y gastric bypass; laparoscopic adjustable gastric banding; and open and laparoscopic biliopancreatic diversion with duodenal switch for Medicare beneficiaries with a body-mass index of 35 kg/m² or greater who have at least one comorbidity related to obesity and have been unsuccessful with medical treatment for obesity.

If the proposal is accepted, it would reverse the requirements the CMS put in place in February 2006. Since then, Medicare has covered only bariatric procedures performed at facilities that were certified by the American College of Surgeons as a Level 1 Bariatric Surgery Center or by the American Society for Metabolic and Bariatric Surgery as a Bariatric Surgery Center of Excellence.

CMS officials reviewed eight studies to determine if facility certification meaningfully improved health outcomes for Medicare beneficiaries. The studies had "mixed" results, the agency said, but overall, the evidence showed "no consistent statistical or clinically meaningful difference" and there was nothing in the literature to suggest a worsening of outcomes.

The factors that led to the original certification requirements – the rapid growth in bariatric procedures and concerns about higher mortality rates – have changed.

"Since that 2006 determination, bariatric surgery has experienced a trend toward less invasive procedures and lower mortality and complication rates," according to the proposed decision memo.

The policy switch was requested by a trio of health services researchers at the University of Michigan led by Dr. John D. Birkmeyer, professor of surgery and director of the university’s Center for Healthcare Outcomes and Policy. They asserted that certified hospitals were no safer than other facilities and that mortality and serious complication rates for bariatric surgery had declined across the country.

They called on the CMS to scrap the certification requirements but to encourage bariatric surgeons to participate in registry programs through their professional societies or through payer-supported collaborative improvement programs such as the one supported by Blue Cross Blue Shield of Michigan.

The Michigan researchers suggested that the agency incentivize physicians to participate in these quality improvement activities by tying them to programs such as the Physician Quality Reporting System.

Dr. Birkmeyer pointed to a study published earlier this year showing that the current certification policy has not led to better outcomes for patients (JAMA 2013;309:792-9). In the study, which Dr. Birkmeyer coauthored, the researchers found no statistically significant improvements in complications or reoperation rates after implementation of the CMS certification requirements after accounting for patient factors, changes in procedure type, and pre-existing time trends toward improved outcomes.

"There is absolutely no controversy about the fact that [the policy] didn’t steer people to safer hospitals," Dr. Birkmeyer said.

Access could improve under the proposed decision memo, Dr. Birkmeyer said. The current certification framework makes it harder for some Medicare patients to undergo bariatric surgery without traveling hours from home. The policy may also be disproportionately affecting minorities and low-income beneficiaries, Dr. Birkmeyer said.

The American College of Surgeons and the American Society for Metabolic and Bariatric Surgery continue to support certification; however, they are working to revise their processes to create a single, unified program that will include a lower volume threshold for certification, dropping from a minimum of 125 cases a year to 50 cases a year, according to Dr. Jaime Ponce, president of the American Society for Metabolic and Bariatric Surgery and a bariatric surgeon in Chattanooga, Tenn.

The volume change should help to address some of the concerns about access by opening up certification to more programs, he said.

But Dr. Ponce said his group plans to fight the "dangerous" CMS proposal to drop certification requirements completely.

"We do believe that this could be very harmful for Medicare patients because if a patient that is very sick shows up in a community hospital that doesn’t have the right structure to take care of obese patients ... accidents are going to start happening again," he said.

The majority of the literature supports facility certification for bariatric surgery, Dr. Ponce said. As for those studies showing no difference in outcomes, the results weren’t reliable because the studies were conducted at a time when most of the facilities included were pursuing certification, he noted. Even those facilities that fell short of meeting certification requirements would have been developing a culture of safety and would likely have met many of the standards.

Dr. Ponce singled out a 2011 study in Annals of Surgery, which evaluated mortality among Medicare patients before and after the certification requirements took effect (Ann. Surg. 2011;254: 860-5). The study, which used Medicare data from 2004-2008, showed that mortality, readmission, and reoperation rates all declined after the coverage decision was implemented. The 90-day mortality rate dropped from 1.5% to 0.7%, while 90-day readmission rates decreased from 19.9% to 15.4%. The researchers also noted a decrease in payments for the procedures.

But gains in safety and cost-effectiveness could be lost if the CMS removes the certification requirements, Dr. Ponce said. Without clear requirements in place, hospitals will be unlikely to make the investments they are making today in equipment, personnel, and training, he said.

Another issue is what will happen to data collection if certification requirements are eliminated. Dr. Ponce said he’s concerned that data collection efforts would dry up without those mandates from the CMS.

"We will not have that data in order to improve the quality that we need to," he said.

A final decision on the coverage memo is expected in the fall.

mschneider@frontlinemedcom.com

AMSTERDAM – In patients with acute venous thromboembolism, 6 months of treatment with the oral-anticoagulant apixaban was as effective as was standard therapy with subcutaneous enoxaparin for a week followed by oral warfarin, and apixaban caused significantly fewer major bleeding complications in a randomized, multicenter trial with more than 5,000 patients.

But in addition to apixaban’s sterling individual performance in this pivotal trial, which seems to clear the way for the drug to eventually receive a labeled indication for acute venous thromboembolism, the results also appeared to further anoint the new, oral anticoagulant roster of dabigatran (Pradaxa), rivaroxaban (Xarelto), and apixaban (Eliquis) as the thrombotic-disease troika to be reckoned with, the newcomers whose time has come.

Ever since rivaroxaban became the first of the trio to gain acute VTE labeling, last November, physicians who manage patients with acute VTE had to wrestle with the question of how to integrate this option into their practices. The new findings on apixaban suggest that physicians will soon have to think about deciding between rivaroxaban and apixaban for this indication. And since recent results from other major trials also established dabigatran as the equal of warfarin for efficacy when treating acute VTE patients and with superior safety, dabigatran’s entry into acute VTE management seems imminent (N. Engl. J. Med. 2013;368:709-18).

Propelling this new anticoagulant era are the indications of efficacy that’s equivalent with heparin, but safer, and with far easier drug delivery as the need for anticoagulation clinics and regular measurement of international normalized ratio (INR) is eliminated by all three new drugs.

"An oral regimen without laboratory monitoring will simplify therapy," Dr. Giancarlo Agnelli noted when he presented the new apixaban findings at the congress of the International Society on Thrombosis and Haemostasis. Concurrently with his report at the meeting, the results were published online (N. Engl. J. Med. 2013;doi:10.1056/nejmoa1302507).

"I think the argument is overwhelming" to use one of the new drugs instead of warfarin. "They are oral drugs where you do not need a blood draw every 2 or 3 weeks, they are a lot easier to use, and they are at least as good as warfarin and at least as safe," said Dr. Frits R. Rosendaal, professor of clinical epidemiology in hemostasis and thrombosis at Leiden (The Netherlands) University.

The Apixaban for the Initial Management of Pulmonary Embolism and Deep-Vein Thrombosis as First-Line Therapy (AMPLIFY) trial randomized 5,400 acute VTE patients at 358 centers in 28 countries. Patients received either apixaban starting with a 10-mg b.i.d. dosage for 7 days, followed by a dosage of 5 mg b.i.d. for 6 months, or enoxaparin at a dosage of 1 mg/kg every 12 hours for a median of 7 days followed by warfarin for 6 months with a target INR of 2.0-3.0.

The study’s primary efficacy endpoint was the combined rate of recurrent, symptomatic VTE or death related to VTE. This occurred in 59 of 2,609 patients (2.3%) who received apixaban, and in 71 of 2,635 (2.7%) patients who received enoxaparin followed by warfarin. These results met the study’s prespecified criterion for apixaban’s noninferiority to standard treatment reported Dr. Agnelli, professor of medicine at the University of Perugia, Italy.

Major bleeding events occurred in 15 of 2,676 (0.6%) patients on apixaban and in 49 of 2,689 (1.8%) patients on enoxaparin and warfarin, a statistically significant difference. A composite safety outcome of major bleeds plus clinically relevant nonmajor bleeds occurred in 4.3% of the apixaban patients and in 9.7% of the patients on standard therapy, a statistically significant difference. Aside from bleeding events, the rates of all other adverse events were similar in the two treatment arms.

The trial was sponsored by Pfizer and Bristol-Myers Squibb, which market apixaban (Eliquis). Dr. Agnelli disclosed ties to Pfizer, Boehringer Ingelheim, Sanofi, Daiichi Sankyo, and Bayer. Dr. Rosendaal said that he had no disclosures.

AMSTERDAM – In patients with acute venous thromboembolism, 6 months of treatment with the oral-anticoagulant apixaban was as effective as was standard therapy with subcutaneous enoxaparin for a week followed by oral warfarin, and apixaban caused significantly fewer major bleeding complications in a randomized, multicenter trial with more than 5,000 patients.

But in addition to apixaban’s sterling individual performance in this pivotal trial, which seems to clear the way for the drug to eventually receive a labeled indication for acute venous thromboembolism, the results also appeared to further anoint the new, oral anticoagulant roster of dabigatran (Pradaxa), rivaroxaban (Xarelto), and apixaban (Eliquis) as the thrombotic-disease troika to be reckoned with, the newcomers whose time has come.

Ever since rivaroxaban became the first of the trio to gain acute VTE labeling, last November, physicians who manage patients with acute VTE had to wrestle with the question of how to integrate this option into their practices. The new findings on apixaban suggest that physicians will soon have to think about deciding between rivaroxaban and apixaban for this indication. And since recent results from other major trials also established dabigatran as the equal of warfarin for efficacy when treating acute VTE patients and with superior safety, dabigatran’s entry into acute VTE management seems imminent (N. Engl. J. Med. 2013;368:709-18).

Propelling this new anticoagulant era are the indications of efficacy that’s equivalent with heparin, but safer, and with far easier drug delivery as the need for anticoagulation clinics and regular measurement of international normalized ratio (INR) is eliminated by all three new drugs.

"An oral regimen without laboratory monitoring will simplify therapy," Dr. Giancarlo Agnelli noted when he presented the new apixaban findings at the congress of the International Society on Thrombosis and Haemostasis. Concurrently with his report at the meeting, the results were published online (N. Engl. J. Med. 2013;doi:10.1056/nejmoa1302507).

"I think the argument is overwhelming" to use one of the new drugs instead of warfarin. "They are oral drugs where you do not need a blood draw every 2 or 3 weeks, they are a lot easier to use, and they are at least as good as warfarin and at least as safe," said Dr. Frits R. Rosendaal, professor of clinical epidemiology in hemostasis and thrombosis at Leiden (The Netherlands) University.

The Apixaban for the Initial Management of Pulmonary Embolism and Deep-Vein Thrombosis as First-Line Therapy (AMPLIFY) trial randomized 5,400 acute VTE patients at 358 centers in 28 countries. Patients received either apixaban starting with a 10-mg b.i.d. dosage for 7 days, followed by a dosage of 5 mg b.i.d. for 6 months, or enoxaparin at a dosage of 1 mg/kg every 12 hours for a median of 7 days followed by warfarin for 6 months with a target INR of 2.0-3.0.

The study’s primary efficacy endpoint was the combined rate of recurrent, symptomatic VTE or death related to VTE. This occurred in 59 of 2,609 patients (2.3%) who received apixaban, and in 71 of 2,635 (2.7%) patients who received enoxaparin followed by warfarin. These results met the study’s prespecified criterion for apixaban’s noninferiority to standard treatment reported Dr. Agnelli, professor of medicine at the University of Perugia, Italy.

Major bleeding events occurred in 15 of 2,676 (0.6%) patients on apixaban and in 49 of 2,689 (1.8%) patients on enoxaparin and warfarin, a statistically significant difference. A composite safety outcome of major bleeds plus clinically relevant nonmajor bleeds occurred in 4.3% of the apixaban patients and in 9.7% of the patients on standard therapy, a statistically significant difference. Aside from bleeding events, the rates of all other adverse events were similar in the two treatment arms.

The trial was sponsored by Pfizer and Bristol-Myers Squibb, which market apixaban (Eliquis). Dr. Agnelli disclosed ties to Pfizer, Boehringer Ingelheim, Sanofi, Daiichi Sankyo, and Bayer. Dr. Rosendaal said that he had no disclosures.

AMSTERDAM – In patients with acute venous thromboembolism, 6 months of treatment with the oral-anticoagulant apixaban was as effective as was standard therapy with subcutaneous enoxaparin for a week followed by oral warfarin, and apixaban caused significantly fewer major bleeding complications in a randomized, multicenter trial with more than 5,000 patients.

But in addition to apixaban’s sterling individual performance in this pivotal trial, which seems to clear the way for the drug to eventually receive a labeled indication for acute venous thromboembolism, the results also appeared to further anoint the new, oral anticoagulant roster of dabigatran (Pradaxa), rivaroxaban (Xarelto), and apixaban (Eliquis) as the thrombotic-disease troika to be reckoned with, the newcomers whose time has come.

Ever since rivaroxaban became the first of the trio to gain acute VTE labeling, last November, physicians who manage patients with acute VTE had to wrestle with the question of how to integrate this option into their practices. The new findings on apixaban suggest that physicians will soon have to think about deciding between rivaroxaban and apixaban for this indication. And since recent results from other major trials also established dabigatran as the equal of warfarin for efficacy when treating acute VTE patients and with superior safety, dabigatran’s entry into acute VTE management seems imminent (N. Engl. J. Med. 2013;368:709-18).

Propelling this new anticoagulant era are the indications of efficacy that’s equivalent with heparin, but safer, and with far easier drug delivery as the need for anticoagulation clinics and regular measurement of international normalized ratio (INR) is eliminated by all three new drugs.

"An oral regimen without laboratory monitoring will simplify therapy," Dr. Giancarlo Agnelli noted when he presented the new apixaban findings at the congress of the International Society on Thrombosis and Haemostasis. Concurrently with his report at the meeting, the results were published online (N. Engl. J. Med. 2013;doi:10.1056/nejmoa1302507).

"I think the argument is overwhelming" to use one of the new drugs instead of warfarin. "They are oral drugs where you do not need a blood draw every 2 or 3 weeks, they are a lot easier to use, and they are at least as good as warfarin and at least as safe," said Dr. Frits R. Rosendaal, professor of clinical epidemiology in hemostasis and thrombosis at Leiden (The Netherlands) University.

The Apixaban for the Initial Management of Pulmonary Embolism and Deep-Vein Thrombosis as First-Line Therapy (AMPLIFY) trial randomized 5,400 acute VTE patients at 358 centers in 28 countries. Patients received either apixaban starting with a 10-mg b.i.d. dosage for 7 days, followed by a dosage of 5 mg b.i.d. for 6 months, or enoxaparin at a dosage of 1 mg/kg every 12 hours for a median of 7 days followed by warfarin for 6 months with a target INR of 2.0-3.0.

The study’s primary efficacy endpoint was the combined rate of recurrent, symptomatic VTE or death related to VTE. This occurred in 59 of 2,609 patients (2.3%) who received apixaban, and in 71 of 2,635 (2.7%) patients who received enoxaparin followed by warfarin. These results met the study’s prespecified criterion for apixaban’s noninferiority to standard treatment reported Dr. Agnelli, professor of medicine at the University of Perugia, Italy.

Major bleeding events occurred in 15 of 2,676 (0.6%) patients on apixaban and in 49 of 2,689 (1.8%) patients on enoxaparin and warfarin, a statistically significant difference. A composite safety outcome of major bleeds plus clinically relevant nonmajor bleeds occurred in 4.3% of the apixaban patients and in 9.7% of the patients on standard therapy, a statistically significant difference. Aside from bleeding events, the rates of all other adverse events were similar in the two treatment arms.

The trial was sponsored by Pfizer and Bristol-Myers Squibb, which market apixaban (Eliquis). Dr. Agnelli disclosed ties to Pfizer, Boehringer Ingelheim, Sanofi, Daiichi Sankyo, and Bayer. Dr. Rosendaal said that he had no disclosures.

CHICAGO – Hyperglycemia is common in patients receiving enteral nutrition and is a significant risk factor for hospital mortality, according to a retrospective study involving 157 patients.

Nearly 60% of patients had capillary blood glucose (CBG) values that exceeded 140 mg/dL, and nearly one-third exceeded 180 mg/dL.

More important, almost 40% of patients had a mean CBG of more than 180 mg/dL for the entire duration of their tube feedings.

At the threshold glucose of 180 mg/dL or more, the odds of dying in the hospital during tube feeding are approximately three times higher than for patients who had better glycemic control, Dr. Michael Jakoby said at the annual scientific sessions of the American Diabetes Association.

Patrice Wendling/IMNG Medical Media

"We look at this body of work as just a stepping point to the next logical extension, which is to investigate ways that we can improve glycemic control for patients receiving any artificial nutrition, whether it’s parenteral or enteral," said Dr. Jakoby, chief of endocrinology at St. John’s Hospital in Springfield, Ill.

He previously reported that using an insulin protocol that determined insulin doses based on carbohydrate delivery and CBG was superior to ad hoc insulin dosing in the management of parenteral nutrition–induced hyperglycemia (JPEN J. Parenter. Enteral. Nutr. 2012;36:183-8).

Malnutrition among nonsurgical patients is high, and more than 40% of general surgery service patients have been reported to be malnourished (Am. J. Clin. Nutr. 1997;66:1232-9). Five studies since 2005 have established a link between parenteral nutrition and increased morbidity and in-hospital mortality, but little is available on outcomes with enteral nutrition, Dr. Jakoby explained.

The current analysis involved 157 patients receiving enteral nutrition in 2011 at St. John’s, a 350-bed hospital where each year an estimated 11,000 patients receive artificial nutrition for 2 weeks.

Of those patients, 58 were diagnosed with hyperglycemia (37%), defined as a mean CBG of 180 mg/dL or more for the duration of tube feedings.

Hyperglycemic patients were significantly older than controls (75 vs. 67), twice as likely to have a preexisting diagnosis of diabetes (81% vs. 41%), had 2 fewer days of enteral nutrition (7 vs. 9), and were less likely to be in the ICU during their tube feedings (62% vs. 83%), he said.

The two groups were well matched with regard to the amount of protein, fat, and total energy they received; however, hyperglycemic patients received significantly fewer carbohydrates than did controls (2.2 g/kg per day vs. 2.7 g/kg per day).

"With the documentation available to us, it seemed that this was an adaptive response to help combat the hyperglycemia that was happening during pure enteral nutrition," Dr. Jakoby said.

Cardiac complications – a composite of myocardial infarction, arrhythmia, and cardiac arrest – were increased in hyperglycemic patients (34% vs. 22%), but this difference was not significant in univariate analysis (odds ratio, 1.84; P = .13).

The risk of hospital mortality, however, was significantly higher in hyperglycemic patients in univariate analysis (36% vs. 16%; OR, 2.94), and remained significant in multivariate analysis after adjustment for age, sex, and preexisting diagnosis of diabetes (OR, 3.28), he noted.

During a discussion of the results, Dr. Jakoby said analyses are forthcoming looking at the impact of glycemic variability during hospitalization, observing that in a prior study he conducted, glycemic variability in the noncritical care setting strongly correlated with hospital stay and a greater likelihood of going from hospital to nursing home or the morgue.

Dr. Jakoby reported serving as a speaker for Sanofi-Aventis, Merck, and Novo Nordisk.

pwendling@frontlinemedcom.com

CHICAGO – Hyperglycemia is common in patients receiving enteral nutrition and is a significant risk factor for hospital mortality, according to a retrospective study involving 157 patients.

Nearly 60% of patients had capillary blood glucose (CBG) values that exceeded 140 mg/dL, and nearly one-third exceeded 180 mg/dL.

More important, almost 40% of patients had a mean CBG of more than 180 mg/dL for the entire duration of their tube feedings.

At the threshold glucose of 180 mg/dL or more, the odds of dying in the hospital during tube feeding are approximately three times higher than for patients who had better glycemic control, Dr. Michael Jakoby said at the annual scientific sessions of the American Diabetes Association.

Patrice Wendling/IMNG Medical Media

"We look at this body of work as just a stepping point to the next logical extension, which is to investigate ways that we can improve glycemic control for patients receiving any artificial nutrition, whether it’s parenteral or enteral," said Dr. Jakoby, chief of endocrinology at St. John’s Hospital in Springfield, Ill.

He previously reported that using an insulin protocol that determined insulin doses based on carbohydrate delivery and CBG was superior to ad hoc insulin dosing in the management of parenteral nutrition–induced hyperglycemia (JPEN J. Parenter. Enteral. Nutr. 2012;36:183-8).

Malnutrition among nonsurgical patients is high, and more than 40% of general surgery service patients have been reported to be malnourished (Am. J. Clin. Nutr. 1997;66:1232-9). Five studies since 2005 have established a link between parenteral nutrition and increased morbidity and in-hospital mortality, but little is available on outcomes with enteral nutrition, Dr. Jakoby explained.

The current analysis involved 157 patients receiving enteral nutrition in 2011 at St. John’s, a 350-bed hospital where each year an estimated 11,000 patients receive artificial nutrition for 2 weeks.

Of those patients, 58 were diagnosed with hyperglycemia (37%), defined as a mean CBG of 180 mg/dL or more for the duration of tube feedings.

Hyperglycemic patients were significantly older than controls (75 vs. 67), twice as likely to have a preexisting diagnosis of diabetes (81% vs. 41%), had 2 fewer days of enteral nutrition (7 vs. 9), and were less likely to be in the ICU during their tube feedings (62% vs. 83%), he said.

The two groups were well matched with regard to the amount of protein, fat, and total energy they received; however, hyperglycemic patients received significantly fewer carbohydrates than did controls (2.2 g/kg per day vs. 2.7 g/kg per day).

"With the documentation available to us, it seemed that this was an adaptive response to help combat the hyperglycemia that was happening during pure enteral nutrition," Dr. Jakoby said.

Cardiac complications – a composite of myocardial infarction, arrhythmia, and cardiac arrest – were increased in hyperglycemic patients (34% vs. 22%), but this difference was not significant in univariate analysis (odds ratio, 1.84; P = .13).

The risk of hospital mortality, however, was significantly higher in hyperglycemic patients in univariate analysis (36% vs. 16%; OR, 2.94), and remained significant in multivariate analysis after adjustment for age, sex, and preexisting diagnosis of diabetes (OR, 3.28), he noted.

During a discussion of the results, Dr. Jakoby said analyses are forthcoming looking at the impact of glycemic variability during hospitalization, observing that in a prior study he conducted, glycemic variability in the noncritical care setting strongly correlated with hospital stay and a greater likelihood of going from hospital to nursing home or the morgue.

Dr. Jakoby reported serving as a speaker for Sanofi-Aventis, Merck, and Novo Nordisk.

pwendling@frontlinemedcom.com

CHICAGO – Hyperglycemia is common in patients receiving enteral nutrition and is a significant risk factor for hospital mortality, according to a retrospective study involving 157 patients.

Nearly 60% of patients had capillary blood glucose (CBG) values that exceeded 140 mg/dL, and nearly one-third exceeded 180 mg/dL.

More important, almost 40% of patients had a mean CBG of more than 180 mg/dL for the entire duration of their tube feedings.

At the threshold glucose of 180 mg/dL or more, the odds of dying in the hospital during tube feeding are approximately three times higher than for patients who had better glycemic control, Dr. Michael Jakoby said at the annual scientific sessions of the American Diabetes Association.

Patrice Wendling/IMNG Medical Media

"We look at this body of work as just a stepping point to the next logical extension, which is to investigate ways that we can improve glycemic control for patients receiving any artificial nutrition, whether it’s parenteral or enteral," said Dr. Jakoby, chief of endocrinology at St. John’s Hospital in Springfield, Ill.

He previously reported that using an insulin protocol that determined insulin doses based on carbohydrate delivery and CBG was superior to ad hoc insulin dosing in the management of parenteral nutrition–induced hyperglycemia (JPEN J. Parenter. Enteral. Nutr. 2012;36:183-8).

Malnutrition among nonsurgical patients is high, and more than 40% of general surgery service patients have been reported to be malnourished (Am. J. Clin. Nutr. 1997;66:1232-9). Five studies since 2005 have established a link between parenteral nutrition and increased morbidity and in-hospital mortality, but little is available on outcomes with enteral nutrition, Dr. Jakoby explained.

The current analysis involved 157 patients receiving enteral nutrition in 2011 at St. John’s, a 350-bed hospital where each year an estimated 11,000 patients receive artificial nutrition for 2 weeks.

Of those patients, 58 were diagnosed with hyperglycemia (37%), defined as a mean CBG of 180 mg/dL or more for the duration of tube feedings.

Hyperglycemic patients were significantly older than controls (75 vs. 67), twice as likely to have a preexisting diagnosis of diabetes (81% vs. 41%), had 2 fewer days of enteral nutrition (7 vs. 9), and were less likely to be in the ICU during their tube feedings (62% vs. 83%), he said.

The two groups were well matched with regard to the amount of protein, fat, and total energy they received; however, hyperglycemic patients received significantly fewer carbohydrates than did controls (2.2 g/kg per day vs. 2.7 g/kg per day).

"With the documentation available to us, it seemed that this was an adaptive response to help combat the hyperglycemia that was happening during pure enteral nutrition," Dr. Jakoby said.

Cardiac complications – a composite of myocardial infarction, arrhythmia, and cardiac arrest – were increased in hyperglycemic patients (34% vs. 22%), but this difference was not significant in univariate analysis (odds ratio, 1.84; P = .13).

The risk of hospital mortality, however, was significantly higher in hyperglycemic patients in univariate analysis (36% vs. 16%; OR, 2.94), and remained significant in multivariate analysis after adjustment for age, sex, and preexisting diagnosis of diabetes (OR, 3.28), he noted.

During a discussion of the results, Dr. Jakoby said analyses are forthcoming looking at the impact of glycemic variability during hospitalization, observing that in a prior study he conducted, glycemic variability in the noncritical care setting strongly correlated with hospital stay and a greater likelihood of going from hospital to nursing home or the morgue.

Dr. Jakoby reported serving as a speaker for Sanofi-Aventis, Merck, and Novo Nordisk.

pwendling@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

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

PHOENIX – Patients with inflammatory bowel disease undergoing major abdominal surgery have a persistent elevation of the risk of blood clots postoperatively that warrants extended prophylaxis similar to that recommended for patients with colorectal cancer, new data suggest.

Investigators led by Dr. Molly Gross, a colorectal surgeon at the University of Utah in Salt Lake City, retrospectively analyzed data from the National Surgical Quality Improvement Program (NSQIP) database, assessing rates of venous thromboembolism (VTE) among nearly 46,000 patients with inflammatory bowel disease (IBD) or colorectal cancer who had major abdominal surgery.

Study results, reported at the annual meeting of the American Society of Colon and Rectal Surgeons, showed that the IBD group had a 35% higher adjusted risk of VTE at 30 days relative to the colorectal cancer group. Also, the majority of the events in the IBD group occurred a week or more after surgery, by which time most patients would have been leaving the hospital or already home.

"The National Comprehensive Cancer Network (NCCN) currently recommends that colorectal cancer patients undergoing major abdominal surgery receive up to 4 weeks of postoperative out-of-hospital prophylaxis with either subcutaneous heparin or Lovenox [enoxaparin]," Dr. Gross commented. "There are currently no such recommendations for IBD patients undergoing similar operations."

Taken together, the study’s findings "lead to our conclusion that postdischarge VTE prophylaxis recommendations for IBD patients should mirror those for colorectal cancer patients," she maintained. "This would suggest a change in clinical practice to extend out-of-hospital VTE prophylaxis in IBD patients."

"You have done excellent work, and I congratulate you on the statistical rigor that’s quite evident in your study," said Dr. Justin Lee, of St. Elizabeth’s Medical Center in Brighton, Mass., who was invited to discuss the study.

However, he questioned the low absolute 30-day rates of VTE seen in the study – 2.7% in the IBD group and 2.1% in the colorectal cancer group – as compared with those reported in other studies.

The NCCN guidelines for patients with colorectal cancer "are based on large prospective studies considered to be closer to real-time data than NSQIP. If you look at those studies, they show anywhere from a 7% to 12% 30-day rate of deep vein thrombosis in colorectal cancer patients. And if you treat them with long-term prophylaxis within 30 days after surgery, it brings the rate down to 4% or 4.5%," he explained – about twice that in the presented study.

"How do you reconcile [these rates]?" Dr. Lee asked. "And should you apply your recommended 30-day postop prophylaxis to all IBD surgical patients when in fact the 2.7% is actually lower than the literature-quoted rate of deep vein thrombosis" in patients with colorectal cancer on anticoagulation?

Dr. Gross speculated that the difference in rates between the cancer studies and the current study was multifactorial in origin, stemming from differing study designs (randomized controlled trial vs. retrospective review), differing surgical populations (patients undergoing open surgery only in an older era vs. patients undergoing open or laparoscopic surgery in the current era), and uncertainty in their study about how many patients with colorectal cancer received extended prophylaxis.

Given the generally low rates of VTE events, "it would be difficult to adequately power a large randomized controlled trial," she added. "So we are kind of making a lot of assumptions that we hope we could decrease morbidity and mortality in IBD patients without significantly causing increased cost or bleeding complications" by using extended prophylaxis.

Dr. John Migaly of the Duke University Medical Center in Durham, N.C., who comoderated the session, noted that the incidence of VTE after surgery showed a sharp drop-off at approximately day 20. "That would be about 2 weeks after discharge. Is there an optimal length, in your opinion, of VTE prophylaxis, instead of just saying 4 weeks is fine?" he asked.

The investigators based that 4-week recommendation on the conclusions of a trial among oncology patients (N. Engl. J. Med. 2002;346:975-80), according to Dr. Gross. "It is probably variable based on patient condition: how much they are ambulating, how much they are back to their regular status, and how active their IBD is. So I think it would be difficult to come up with an ideal for every patient; that [4 weeks] is an arbitrary number created from that study."

For the study, Dr. Gross’ team analyzed data from the NSQIP database for the years 2005 through 2010, restricting analyses to 8,888 patients with IBD and 37,076 patients with colorectal cancer who had major abdominal surgery.

"Previous studies looking at IBD and VTE risk included perineal and benign anorectal procedures, as well as open procedures," Dr. Gross noted. "But we only included open and laparoscopic abdominal procedures that involved resection of bowel."

The 30-day rate of VTE (deep vein thrombosis and/or pulmonary embolism) was significantly higher in the IBD group than in the colorectal cancer group (2.7% vs. 2.1%, P less than .001).

In a multivariate analysis, relative to their peers with colorectal cancer, patients with IBD still had a significantly elevated risk of this outcome (odds ratio, 1.35; P = .005).

"The [temporal] distribution of VTE events in IBD patients mirrors that in colorectal cancer patients," commented Dr. Gross, who disclosed no conflicts of interest related to the research; in both groups, events continued to occur out to 30 days.

In the IBD group, fully 55% of events occurred on day 7 or later. "At this time, most patients will have been discharged or will be discharged soon," she pointed out.

PHOENIX – Patients with inflammatory bowel disease undergoing major abdominal surgery have a persistent elevation of the risk of blood clots postoperatively that warrants extended prophylaxis similar to that recommended for patients with colorectal cancer, new data suggest.

Investigators led by Dr. Molly Gross, a colorectal surgeon at the University of Utah in Salt Lake City, retrospectively analyzed data from the National Surgical Quality Improvement Program (NSQIP) database, assessing rates of venous thromboembolism (VTE) among nearly 46,000 patients with inflammatory bowel disease (IBD) or colorectal cancer who had major abdominal surgery.

Study results, reported at the annual meeting of the American Society of Colon and Rectal Surgeons, showed that the IBD group had a 35% higher adjusted risk of VTE at 30 days relative to the colorectal cancer group. Also, the majority of the events in the IBD group occurred a week or more after surgery, by which time most patients would have been leaving the hospital or already home.

"The National Comprehensive Cancer Network (NCCN) currently recommends that colorectal cancer patients undergoing major abdominal surgery receive up to 4 weeks of postoperative out-of-hospital prophylaxis with either subcutaneous heparin or Lovenox [enoxaparin]," Dr. Gross commented. "There are currently no such recommendations for IBD patients undergoing similar operations."

Taken together, the study’s findings "lead to our conclusion that postdischarge VTE prophylaxis recommendations for IBD patients should mirror those for colorectal cancer patients," she maintained. "This would suggest a change in clinical practice to extend out-of-hospital VTE prophylaxis in IBD patients."

"You have done excellent work, and I congratulate you on the statistical rigor that’s quite evident in your study," said Dr. Justin Lee, of St. Elizabeth’s Medical Center in Brighton, Mass., who was invited to discuss the study.

However, he questioned the low absolute 30-day rates of VTE seen in the study – 2.7% in the IBD group and 2.1% in the colorectal cancer group – as compared with those reported in other studies.

The NCCN guidelines for patients with colorectal cancer "are based on large prospective studies considered to be closer to real-time data than NSQIP. If you look at those studies, they show anywhere from a 7% to 12% 30-day rate of deep vein thrombosis in colorectal cancer patients. And if you treat them with long-term prophylaxis within 30 days after surgery, it brings the rate down to 4% or 4.5%," he explained – about twice that in the presented study.

"How do you reconcile [these rates]?" Dr. Lee asked. "And should you apply your recommended 30-day postop prophylaxis to all IBD surgical patients when in fact the 2.7% is actually lower than the literature-quoted rate of deep vein thrombosis" in patients with colorectal cancer on anticoagulation?

Dr. Gross speculated that the difference in rates between the cancer studies and the current study was multifactorial in origin, stemming from differing study designs (randomized controlled trial vs. retrospective review), differing surgical populations (patients undergoing open surgery only in an older era vs. patients undergoing open or laparoscopic surgery in the current era), and uncertainty in their study about how many patients with colorectal cancer received extended prophylaxis.

Given the generally low rates of VTE events, "it would be difficult to adequately power a large randomized controlled trial," she added. "So we are kind of making a lot of assumptions that we hope we could decrease morbidity and mortality in IBD patients without significantly causing increased cost or bleeding complications" by using extended prophylaxis.

Dr. John Migaly of the Duke University Medical Center in Durham, N.C., who comoderated the session, noted that the incidence of VTE after surgery showed a sharp drop-off at approximately day 20. "That would be about 2 weeks after discharge. Is there an optimal length, in your opinion, of VTE prophylaxis, instead of just saying 4 weeks is fine?" he asked.

The investigators based that 4-week recommendation on the conclusions of a trial among oncology patients (N. Engl. J. Med. 2002;346:975-80), according to Dr. Gross. "It is probably variable based on patient condition: how much they are ambulating, how much they are back to their regular status, and how active their IBD is. So I think it would be difficult to come up with an ideal for every patient; that [4 weeks] is an arbitrary number created from that study."

For the study, Dr. Gross’ team analyzed data from the NSQIP database for the years 2005 through 2010, restricting analyses to 8,888 patients with IBD and 37,076 patients with colorectal cancer who had major abdominal surgery.

"Previous studies looking at IBD and VTE risk included perineal and benign anorectal procedures, as well as open procedures," Dr. Gross noted. "But we only included open and laparoscopic abdominal procedures that involved resection of bowel."

The 30-day rate of VTE (deep vein thrombosis and/or pulmonary embolism) was significantly higher in the IBD group than in the colorectal cancer group (2.7% vs. 2.1%, P less than .001).

In a multivariate analysis, relative to their peers with colorectal cancer, patients with IBD still had a significantly elevated risk of this outcome (odds ratio, 1.35; P = .005).

"The [temporal] distribution of VTE events in IBD patients mirrors that in colorectal cancer patients," commented Dr. Gross, who disclosed no conflicts of interest related to the research; in both groups, events continued to occur out to 30 days.

In the IBD group, fully 55% of events occurred on day 7 or later. "At this time, most patients will have been discharged or will be discharged soon," she pointed out.

PHOENIX – Patients with inflammatory bowel disease undergoing major abdominal surgery have a persistent elevation of the risk of blood clots postoperatively that warrants extended prophylaxis similar to that recommended for patients with colorectal cancer, new data suggest.

Investigators led by Dr. Molly Gross, a colorectal surgeon at the University of Utah in Salt Lake City, retrospectively analyzed data from the National Surgical Quality Improvement Program (NSQIP) database, assessing rates of venous thromboembolism (VTE) among nearly 46,000 patients with inflammatory bowel disease (IBD) or colorectal cancer who had major abdominal surgery.

Study results, reported at the annual meeting of the American Society of Colon and Rectal Surgeons, showed that the IBD group had a 35% higher adjusted risk of VTE at 30 days relative to the colorectal cancer group. Also, the majority of the events in the IBD group occurred a week or more after surgery, by which time most patients would have been leaving the hospital or already home.

"The National Comprehensive Cancer Network (NCCN) currently recommends that colorectal cancer patients undergoing major abdominal surgery receive up to 4 weeks of postoperative out-of-hospital prophylaxis with either subcutaneous heparin or Lovenox [enoxaparin]," Dr. Gross commented. "There are currently no such recommendations for IBD patients undergoing similar operations."

Taken together, the study’s findings "lead to our conclusion that postdischarge VTE prophylaxis recommendations for IBD patients should mirror those for colorectal cancer patients," she maintained. "This would suggest a change in clinical practice to extend out-of-hospital VTE prophylaxis in IBD patients."

"You have done excellent work, and I congratulate you on the statistical rigor that’s quite evident in your study," said Dr. Justin Lee, of St. Elizabeth’s Medical Center in Brighton, Mass., who was invited to discuss the study.

However, he questioned the low absolute 30-day rates of VTE seen in the study – 2.7% in the IBD group and 2.1% in the colorectal cancer group – as compared with those reported in other studies.

The NCCN guidelines for patients with colorectal cancer "are based on large prospective studies considered to be closer to real-time data than NSQIP. If you look at those studies, they show anywhere from a 7% to 12% 30-day rate of deep vein thrombosis in colorectal cancer patients. And if you treat them with long-term prophylaxis within 30 days after surgery, it brings the rate down to 4% or 4.5%," he explained – about twice that in the presented study.

"How do you reconcile [these rates]?" Dr. Lee asked. "And should you apply your recommended 30-day postop prophylaxis to all IBD surgical patients when in fact the 2.7% is actually lower than the literature-quoted rate of deep vein thrombosis" in patients with colorectal cancer on anticoagulation?

Dr. Gross speculated that the difference in rates between the cancer studies and the current study was multifactorial in origin, stemming from differing study designs (randomized controlled trial vs. retrospective review), differing surgical populations (patients undergoing open surgery only in an older era vs. patients undergoing open or laparoscopic surgery in the current era), and uncertainty in their study about how many patients with colorectal cancer received extended prophylaxis.

Given the generally low rates of VTE events, "it would be difficult to adequately power a large randomized controlled trial," she added. "So we are kind of making a lot of assumptions that we hope we could decrease morbidity and mortality in IBD patients without significantly causing increased cost or bleeding complications" by using extended prophylaxis.

Dr. John Migaly of the Duke University Medical Center in Durham, N.C., who comoderated the session, noted that the incidence of VTE after surgery showed a sharp drop-off at approximately day 20. "That would be about 2 weeks after discharge. Is there an optimal length, in your opinion, of VTE prophylaxis, instead of just saying 4 weeks is fine?" he asked.

The investigators based that 4-week recommendation on the conclusions of a trial among oncology patients (N. Engl. J. Med. 2002;346:975-80), according to Dr. Gross. "It is probably variable based on patient condition: how much they are ambulating, how much they are back to their regular status, and how active their IBD is. So I think it would be difficult to come up with an ideal for every patient; that [4 weeks] is an arbitrary number created from that study."

For the study, Dr. Gross’ team analyzed data from the NSQIP database for the years 2005 through 2010, restricting analyses to 8,888 patients with IBD and 37,076 patients with colorectal cancer who had major abdominal surgery.

"Previous studies looking at IBD and VTE risk included perineal and benign anorectal procedures, as well as open procedures," Dr. Gross noted. "But we only included open and laparoscopic abdominal procedures that involved resection of bowel."

The 30-day rate of VTE (deep vein thrombosis and/or pulmonary embolism) was significantly higher in the IBD group than in the colorectal cancer group (2.7% vs. 2.1%, P less than .001).

In a multivariate analysis, relative to their peers with colorectal cancer, patients with IBD still had a significantly elevated risk of this outcome (odds ratio, 1.35; P = .005).

"The [temporal] distribution of VTE events in IBD patients mirrors that in colorectal cancer patients," commented Dr. Gross, who disclosed no conflicts of interest related to the research; in both groups, events continued to occur out to 30 days.

In the IBD group, fully 55% of events occurred on day 7 or later. "At this time, most patients will have been discharged or will be discharged soon," she pointed out.

The Food and Drug Administration is warning that hydroxyethyl starch solutions should no longer be used in the treatment of critically ill adult patients –including patients with sepsis and those admitted to an intensive care unit – after completing an analysis of data indicating that treatment with these solutions increases the risk of death and renal injury in these groups.

In a statement, the agency also recommended that the use of hydroxyethyl starch (HES) solutions, used as plasma volume expanders, be avoided in patients who are having open heart surgery with cardiopulmonary bypass, because of an increased risk of excessive bleeding.

The FDA is making these recommendations after completing an analysis of data from randomized controlled trials, meta-analyses, and observational studies in thousands of critically ill patients, and from a meta-analysis of 18 randomized controlled trials of almost 1,000 patients undergoing open heart surgery with cardiopulmonary bypass. The risks and benefits of HES products were the focus of a meeting in September 2012 convened by the FDA.

"Based on the totality of the evidence, [the] FDA considers increased mortality and renal injury requiring RRT [renal replacement therapy] in critically ill adult patients, including patients with sepsis and those admitted to the ICU, and excess bleeding in patients undergoing open heart surgery in association with cardiopulmonary bypass, to be HES class effects," according to the statement. The agency also recommended that health care professionals avoid the use of these products in patients with preexisting renal dysfunction, discontinue their use at the first sign of renal injury, and monitor renal function for at least 90 days in all patients. In addition, HES products should be discontinued "at the first sign of coagulopathy."

The data on critically ill adults included three double-blind, multicenter, randomized controlled studies published in 2012, which compared HES with saline solution or Ringer’s acetate, in patients with severe sepsis (two studies), or patients in the ICU who had sepsis, had undergone elective surgery, and had an APACHE II score of at least 25. In these studies, which monitored patients for 90 days, HES was associated with increased mortality and/or renal injury requiring RRT, the FDA statements said. The results of meta-analyses and observational studies in similar populations lend additional support to these findings, the statement added.

But there was no evidence of an increased risk of renal injury associated with these products in a review of 59 randomized controlled studies of adult and pediatric surgical patients who received HES in the operating room and were followed for less than a week. This could have been due to less exposure to the product, a relatively short follow-up, being relatively healthy, or some unknown factor, the statement said.

In the meta-analysis of studies of patients undergoing open heart surgery with cardiopulmonary bypass, the "use of different HES products, irrespective of molecular weight or degree of molar substitution, was associated with increased bleeding," according to the statement. The meta-analysis was published in 2012 (J. Thoracic Cardiovasc. Surg. 2012:144;223-30).

A boxed warning about the risk in ICU and septic patients is being added to the labels of HES products, and the information about the excessive bleeding risk in open heart surgery patients is being added to the warnings and precautions section.

There are four FDA-approved HES products for treating and preventing hypovolemia; they are used when plasma volume expansion is needed: HESPAN (6% HES 450/0.7^a in sodium chloride injection) manufactured by B. Braun Medical); Hetastarch (6%) in 0.9% sodium chloride injection, a generic equivalent of Hespan, manufactured by Teva Pharmaceuticals USA; Hextend (6% HES 450/0.7 in physiologic solution), manufactured by BioTime; and Voluven (6% HES 130/0.4 in normal saline), manufactured by Fresenius Kabi USA.

The advisory is available at www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm358271.htm. Adverse events associated with HES solutions should be reported to the FDA’s MedWatch program at 80-332-1088 or www.fda.gov/Safety/MedWatch/HowToReport/default.htm.

emechcatie@frontlinemedcom.com

The Food and Drug Administration is warning that hydroxyethyl starch solutions should no longer be used in the treatment of critically ill adult patients –including patients with sepsis and those admitted to an intensive care unit – after completing an analysis of data indicating that treatment with these solutions increases the risk of death and renal injury in these groups.

In a statement, the agency also recommended that the use of hydroxyethyl starch (HES) solutions, used as plasma volume expanders, be avoided in patients who are having open heart surgery with cardiopulmonary bypass, because of an increased risk of excessive bleeding.

The FDA is making these recommendations after completing an analysis of data from randomized controlled trials, meta-analyses, and observational studies in thousands of critically ill patients, and from a meta-analysis of 18 randomized controlled trials of almost 1,000 patients undergoing open heart surgery with cardiopulmonary bypass. The risks and benefits of HES products were the focus of a meeting in September 2012 convened by the FDA.

"Based on the totality of the evidence, [the] FDA considers increased mortality and renal injury requiring RRT [renal replacement therapy] in critically ill adult patients, including patients with sepsis and those admitted to the ICU, and excess bleeding in patients undergoing open heart surgery in association with cardiopulmonary bypass, to be HES class effects," according to the statement. The agency also recommended that health care professionals avoid the use of these products in patients with preexisting renal dysfunction, discontinue their use at the first sign of renal injury, and monitor renal function for at least 90 days in all patients. In addition, HES products should be discontinued "at the first sign of coagulopathy."

The data on critically ill adults included three double-blind, multicenter, randomized controlled studies published in 2012, which compared HES with saline solution or Ringer’s acetate, in patients with severe sepsis (two studies), or patients in the ICU who had sepsis, had undergone elective surgery, and had an APACHE II score of at least 25. In these studies, which monitored patients for 90 days, HES was associated with increased mortality and/or renal injury requiring RRT, the FDA statements said. The results of meta-analyses and observational studies in similar populations lend additional support to these findings, the statement added.

But there was no evidence of an increased risk of renal injury associated with these products in a review of 59 randomized controlled studies of adult and pediatric surgical patients who received HES in the operating room and were followed for less than a week. This could have been due to less exposure to the product, a relatively short follow-up, being relatively healthy, or some unknown factor, the statement said.

In the meta-analysis of studies of patients undergoing open heart surgery with cardiopulmonary bypass, the "use of different HES products, irrespective of molecular weight or degree of molar substitution, was associated with increased bleeding," according to the statement. The meta-analysis was published in 2012 (J. Thoracic Cardiovasc. Surg. 2012:144;223-30).

A boxed warning about the risk in ICU and septic patients is being added to the labels of HES products, and the information about the excessive bleeding risk in open heart surgery patients is being added to the warnings and precautions section.

There are four FDA-approved HES products for treating and preventing hypovolemia; they are used when plasma volume expansion is needed: HESPAN (6% HES 450/0.7^a in sodium chloride injection) manufactured by B. Braun Medical); Hetastarch (6%) in 0.9% sodium chloride injection, a generic equivalent of Hespan, manufactured by Teva Pharmaceuticals USA; Hextend (6% HES 450/0.7 in physiologic solution), manufactured by BioTime; and Voluven (6% HES 130/0.4 in normal saline), manufactured by Fresenius Kabi USA.

The advisory is available at www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm358271.htm. Adverse events associated with HES solutions should be reported to the FDA’s MedWatch program at 80-332-1088 or www.fda.gov/Safety/MedWatch/HowToReport/default.htm.

emechcatie@frontlinemedcom.com

The Food and Drug Administration is warning that hydroxyethyl starch solutions should no longer be used in the treatment of critically ill adult patients –including patients with sepsis and those admitted to an intensive care unit – after completing an analysis of data indicating that treatment with these solutions increases the risk of death and renal injury in these groups.

In a statement, the agency also recommended that the use of hydroxyethyl starch (HES) solutions, used as plasma volume expanders, be avoided in patients who are having open heart surgery with cardiopulmonary bypass, because of an increased risk of excessive bleeding.

The FDA is making these recommendations after completing an analysis of data from randomized controlled trials, meta-analyses, and observational studies in thousands of critically ill patients, and from a meta-analysis of 18 randomized controlled trials of almost 1,000 patients undergoing open heart surgery with cardiopulmonary bypass. The risks and benefits of HES products were the focus of a meeting in September 2012 convened by the FDA.

"Based on the totality of the evidence, [the] FDA considers increased mortality and renal injury requiring RRT [renal replacement therapy] in critically ill adult patients, including patients with sepsis and those admitted to the ICU, and excess bleeding in patients undergoing open heart surgery in association with cardiopulmonary bypass, to be HES class effects," according to the statement. The agency also recommended that health care professionals avoid the use of these products in patients with preexisting renal dysfunction, discontinue their use at the first sign of renal injury, and monitor renal function for at least 90 days in all patients. In addition, HES products should be discontinued "at the first sign of coagulopathy."

The data on critically ill adults included three double-blind, multicenter, randomized controlled studies published in 2012, which compared HES with saline solution or Ringer’s acetate, in patients with severe sepsis (two studies), or patients in the ICU who had sepsis, had undergone elective surgery, and had an APACHE II score of at least 25. In these studies, which monitored patients for 90 days, HES was associated with increased mortality and/or renal injury requiring RRT, the FDA statements said. The results of meta-analyses and observational studies in similar populations lend additional support to these findings, the statement added.

But there was no evidence of an increased risk of renal injury associated with these products in a review of 59 randomized controlled studies of adult and pediatric surgical patients who received HES in the operating room and were followed for less than a week. This could have been due to less exposure to the product, a relatively short follow-up, being relatively healthy, or some unknown factor, the statement said.

In the meta-analysis of studies of patients undergoing open heart surgery with cardiopulmonary bypass, the "use of different HES products, irrespective of molecular weight or degree of molar substitution, was associated with increased bleeding," according to the statement. The meta-analysis was published in 2012 (J. Thoracic Cardiovasc. Surg. 2012:144;223-30).

A boxed warning about the risk in ICU and septic patients is being added to the labels of HES products, and the information about the excessive bleeding risk in open heart surgery patients is being added to the warnings and precautions section.

There are four FDA-approved HES products for treating and preventing hypovolemia; they are used when plasma volume expansion is needed: HESPAN (6% HES 450/0.7^a in sodium chloride injection) manufactured by B. Braun Medical); Hetastarch (6%) in 0.9% sodium chloride injection, a generic equivalent of Hespan, manufactured by Teva Pharmaceuticals USA; Hextend (6% HES 450/0.7 in physiologic solution), manufactured by BioTime; and Voluven (6% HES 130/0.4 in normal saline), manufactured by Fresenius Kabi USA.

The advisory is available at www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm358271.htm. Adverse events associated with HES solutions should be reported to the FDA’s MedWatch program at 80-332-1088 or www.fda.gov/Safety/MedWatch/HowToReport/default.htm.

emechcatie@frontlinemedcom.com