General Surgery

More than 40% of postoperative complications occurred after discharge and were more commonly associated with certain procedures – along with a significantly increased risk of reoperations and death – in a large retrospective study of adults who had undergone general surgery as inpatients.

The results indicate that postdischarge (PD) complications "account for a significant burden of postoperative complications and are an important avenue for quality improvement in inpatient general surgery," concluded Dr. Hadiza S. Kazaure of the department of general surgery, Stanford (Calif.) University, and her coauthors. "More research is needed to develop and explore the utility of a cost-effective and fastidious PD follow-up system for surgical patients," they added, noting that their findings "underscore the need for systematic collection of PD adverse event data to improve postoperative surgical care in the United States" (Arch. Surg. 2012;147:1000-07). The study was based on data from the American College of Surgeons National Surgical Quality Improvement Program (2005-2010) on 551,510 adult patients (mean age, 55 years) who had undergone inpatient surgery that fell into one of 21 types of general surgery procedure categories at U.S. hospitals. The authors analyzed the rates and types of PD complications, as well as associations between the types of surgical procedures, reoperations, and mortality, within 30 days of surgery.

Within 30 days of surgery, nearly 17% of these patients had a complication. Nearly 7% of those complications occurred after discharge, accounting for almost 42% of postoperative complications. Most – 75% – of the PD complications occurred within the first 14 days of discharge, indicating that this period is "a particularly vulnerable time" for patients undergoing general surgery, the authors said.

The highest rates of PD complications were among the patients who underwent a proctectomy (a 14.5% complication rate), followed by those who had an enteric fistula repair (13%) and a pancreatic procedure (11%). Complication rates after discharge were lowest among those undergoing fundoplasty (3%) or an endocrine procedure, which included thyroid, parathyroid, and adrenal procedures (1.5%).

Breast surgery patients accounted for the highest proportion of complications occurring during the PD period. Almost 80% of complications after breast surgery occurred after discharge, compared with 70% after bariatric procedures and 62% after ventral hernia repair. And almost 83% of the PD complications that occurred in surgical patients fell into one of the following 10 categories: colectomy, small bowel procedures, bariatric procedures, ventral hernia repair, appendectomy, cholecystectomy, pancreatic procedures, exploratory laparotomy, breast procedures, and gastrectomy.

Surgical site complications, infections, and thromboembolic events accounted for almost 91% of PD complications after discharge. Patients who had a PD complication were more likely to be older and male, and were more likely to have diabetes, to use steroids, and to have had a complication while in the hospital. Other factors associated with PD complications were an American Society of Anesthesiologist class higher than 3, a mean 35-minute longer operation time, and a mean 3-day longer hospital stay.

Reoperation rates and mortality rates were 18% and 7%, respectively, among those with a PD complication vs. 5% and 2% among those who did not have a complication after discharge – a significant difference.

Since the risk of postdischarge complications was associated with "baseline complexity of illness and potentially modifiable factors such as diabetes, obesity, and use of steroids, our findings could facilitate identification of patients at increased risk and allow for targeted preventive interventions," the authors said.

While they believe this is the largest study of complications occurring after discharge in general surgery patients in the United States, the authors noted some limitations, including possible coding errors and no markers of illness severity.

No conflict of interest disclosures were reported.

More than 40% of postoperative complications occurred after discharge and were more commonly associated with certain procedures – along with a significantly increased risk of reoperations and death – in a large retrospective study of adults who had undergone general surgery as inpatients.

The results indicate that postdischarge (PD) complications "account for a significant burden of postoperative complications and are an important avenue for quality improvement in inpatient general surgery," concluded Dr. Hadiza S. Kazaure of the department of general surgery, Stanford (Calif.) University, and her coauthors. "More research is needed to develop and explore the utility of a cost-effective and fastidious PD follow-up system for surgical patients," they added, noting that their findings "underscore the need for systematic collection of PD adverse event data to improve postoperative surgical care in the United States" (Arch. Surg. 2012;147:1000-07). The study was based on data from the American College of Surgeons National Surgical Quality Improvement Program (2005-2010) on 551,510 adult patients (mean age, 55 years) who had undergone inpatient surgery that fell into one of 21 types of general surgery procedure categories at U.S. hospitals. The authors analyzed the rates and types of PD complications, as well as associations between the types of surgical procedures, reoperations, and mortality, within 30 days of surgery.

Within 30 days of surgery, nearly 17% of these patients had a complication. Nearly 7% of those complications occurred after discharge, accounting for almost 42% of postoperative complications. Most – 75% – of the PD complications occurred within the first 14 days of discharge, indicating that this period is "a particularly vulnerable time" for patients undergoing general surgery, the authors said.

The highest rates of PD complications were among the patients who underwent a proctectomy (a 14.5% complication rate), followed by those who had an enteric fistula repair (13%) and a pancreatic procedure (11%). Complication rates after discharge were lowest among those undergoing fundoplasty (3%) or an endocrine procedure, which included thyroid, parathyroid, and adrenal procedures (1.5%).

Breast surgery patients accounted for the highest proportion of complications occurring during the PD period. Almost 80% of complications after breast surgery occurred after discharge, compared with 70% after bariatric procedures and 62% after ventral hernia repair. And almost 83% of the PD complications that occurred in surgical patients fell into one of the following 10 categories: colectomy, small bowel procedures, bariatric procedures, ventral hernia repair, appendectomy, cholecystectomy, pancreatic procedures, exploratory laparotomy, breast procedures, and gastrectomy.

Surgical site complications, infections, and thromboembolic events accounted for almost 91% of PD complications after discharge. Patients who had a PD complication were more likely to be older and male, and were more likely to have diabetes, to use steroids, and to have had a complication while in the hospital. Other factors associated with PD complications were an American Society of Anesthesiologist class higher than 3, a mean 35-minute longer operation time, and a mean 3-day longer hospital stay.

Reoperation rates and mortality rates were 18% and 7%, respectively, among those with a PD complication vs. 5% and 2% among those who did not have a complication after discharge – a significant difference.

Since the risk of postdischarge complications was associated with "baseline complexity of illness and potentially modifiable factors such as diabetes, obesity, and use of steroids, our findings could facilitate identification of patients at increased risk and allow for targeted preventive interventions," the authors said.

While they believe this is the largest study of complications occurring after discharge in general surgery patients in the United States, the authors noted some limitations, including possible coding errors and no markers of illness severity.

No conflict of interest disclosures were reported.

More than 40% of postoperative complications occurred after discharge and were more commonly associated with certain procedures – along with a significantly increased risk of reoperations and death – in a large retrospective study of adults who had undergone general surgery as inpatients.

The results indicate that postdischarge (PD) complications "account for a significant burden of postoperative complications and are an important avenue for quality improvement in inpatient general surgery," concluded Dr. Hadiza S. Kazaure of the department of general surgery, Stanford (Calif.) University, and her coauthors. "More research is needed to develop and explore the utility of a cost-effective and fastidious PD follow-up system for surgical patients," they added, noting that their findings "underscore the need for systematic collection of PD adverse event data to improve postoperative surgical care in the United States" (Arch. Surg. 2012;147:1000-07). The study was based on data from the American College of Surgeons National Surgical Quality Improvement Program (2005-2010) on 551,510 adult patients (mean age, 55 years) who had undergone inpatient surgery that fell into one of 21 types of general surgery procedure categories at U.S. hospitals. The authors analyzed the rates and types of PD complications, as well as associations between the types of surgical procedures, reoperations, and mortality, within 30 days of surgery.

Within 30 days of surgery, nearly 17% of these patients had a complication. Nearly 7% of those complications occurred after discharge, accounting for almost 42% of postoperative complications. Most – 75% – of the PD complications occurred within the first 14 days of discharge, indicating that this period is "a particularly vulnerable time" for patients undergoing general surgery, the authors said.

The highest rates of PD complications were among the patients who underwent a proctectomy (a 14.5% complication rate), followed by those who had an enteric fistula repair (13%) and a pancreatic procedure (11%). Complication rates after discharge were lowest among those undergoing fundoplasty (3%) or an endocrine procedure, which included thyroid, parathyroid, and adrenal procedures (1.5%).

Breast surgery patients accounted for the highest proportion of complications occurring during the PD period. Almost 80% of complications after breast surgery occurred after discharge, compared with 70% after bariatric procedures and 62% after ventral hernia repair. And almost 83% of the PD complications that occurred in surgical patients fell into one of the following 10 categories: colectomy, small bowel procedures, bariatric procedures, ventral hernia repair, appendectomy, cholecystectomy, pancreatic procedures, exploratory laparotomy, breast procedures, and gastrectomy.

Surgical site complications, infections, and thromboembolic events accounted for almost 91% of PD complications after discharge. Patients who had a PD complication were more likely to be older and male, and were more likely to have diabetes, to use steroids, and to have had a complication while in the hospital. Other factors associated with PD complications were an American Society of Anesthesiologist class higher than 3, a mean 35-minute longer operation time, and a mean 3-day longer hospital stay.

Reoperation rates and mortality rates were 18% and 7%, respectively, among those with a PD complication vs. 5% and 2% among those who did not have a complication after discharge – a significant difference.

Since the risk of postdischarge complications was associated with "baseline complexity of illness and potentially modifiable factors such as diabetes, obesity, and use of steroids, our findings could facilitate identification of patients at increased risk and allow for targeted preventive interventions," the authors said.

While they believe this is the largest study of complications occurring after discharge in general surgery patients in the United States, the authors noted some limitations, including possible coding errors and no markers of illness severity.

No conflict of interest disclosures were reported.

Performance of either biliary endoscopic sphincterotomy alone or dual biliary and pancreatic sphincterotomy similarly prevented approximately half of idiopathic recurrent acute pancreatitis cases in a trial in which 89 patients were randomized to treatments based on the presence or absence of sphincter of Oddi dysfunction.

The study is "the largest randomized clinical trial studying ERCP [endoscopic retrograde cholangiopancreatography] with SOM [sphincter of Oddi manometry] in this population" with long-term follow-up data, Dr. Gregory A. Coté of Indiana University in Indianapolis and his colleagues reported in the December issue of Gastroenterology (2012 [doi: 10.1053/j.gastro.2012.09.006]).

Source: American Gastroenterological Institute

Finding therapeutic equivalence between biliary endoscopic sphincterotomy (BES) and dual endoscopic sphincterotomy (DES) in preventing at least one episode of acute pancreatitis during follow-up is important, because the addition of pancreatic sphincterotomy to ERCP carries the risk of post-ERCP pancreatitis, bleeding, perforation, and sphincter restenosis, according to Dr. Coté and his associates.

To assess the therapeutic value of two types of sphincterotomy and the prognostic value of pancreatic SOD for patients with idiopathic recurrent acute pancreatitis (RAP), the researchers randomized 69 adults with SOD to BES or DES. The other 20 patients who did not have SOD were randomized to BES or a sham therapy. SOD was defined as basal pressure of 40 mm Hg or greater, "sustained for at least 30 seconds across two transducers," the researchers noted.

The patients were aged 18 years and older, and those with chronic pancreatitis or an identified cause of RAP were excluded from the study.

Of the 69 patients with SOD, RAP occurred in 49% of patients who underwent BES and 47% who underwent DES. There was no significant difference in rates of RAP between non-SOD patients who had BES and those who had a sham procedure (27% vs. 11%, respectively).

The risk of RAP was approximately four times higher in patients with SOD than in those without SOD, they added.

"Most RAP events occurred within 30 months of randomization in all subgroups," the researchers said.

Overall, chronic pancreatitis developed in 17% of all patients over a median of 78 months, and there was no difference in the probability of developing chronic pancreatitis in patients with and without SOD.

The study was limited by several factors, including its small sample size for the non-SOD population and the impact of environmental and genetic risk factors on idiopathic RAP, the researchers noted.

The small sample of patients with normal SOM meant that the researchers could draw no conclusions about the benefit of BES in these patients, but the results "represent preliminary data for estimating the sample size of a future definitive trial of ERCP with empiric biliary sphincterotomy," they noted.

In addition, the findings suggest that SOD "may be a secondary marker of more significant inflammation related to previous acute pancreatitis," and that pancreatic sphincterotomy "cannot be recommended as a curative treatment of unexplained RAP alone," they wrote.

None of the study authors had any financial conflicts to disclose.

Performance of either biliary endoscopic sphincterotomy alone or dual biliary and pancreatic sphincterotomy similarly prevented approximately half of idiopathic recurrent acute pancreatitis cases in a trial in which 89 patients were randomized to treatments based on the presence or absence of sphincter of Oddi dysfunction.

The study is "the largest randomized clinical trial studying ERCP [endoscopic retrograde cholangiopancreatography] with SOM [sphincter of Oddi manometry] in this population" with long-term follow-up data, Dr. Gregory A. Coté of Indiana University in Indianapolis and his colleagues reported in the December issue of Gastroenterology (2012 [doi: 10.1053/j.gastro.2012.09.006]).

Source: American Gastroenterological Institute

Finding therapeutic equivalence between biliary endoscopic sphincterotomy (BES) and dual endoscopic sphincterotomy (DES) in preventing at least one episode of acute pancreatitis during follow-up is important, because the addition of pancreatic sphincterotomy to ERCP carries the risk of post-ERCP pancreatitis, bleeding, perforation, and sphincter restenosis, according to Dr. Coté and his associates.

To assess the therapeutic value of two types of sphincterotomy and the prognostic value of pancreatic SOD for patients with idiopathic recurrent acute pancreatitis (RAP), the researchers randomized 69 adults with SOD to BES or DES. The other 20 patients who did not have SOD were randomized to BES or a sham therapy. SOD was defined as basal pressure of 40 mm Hg or greater, "sustained for at least 30 seconds across two transducers," the researchers noted.

The patients were aged 18 years and older, and those with chronic pancreatitis or an identified cause of RAP were excluded from the study.

Of the 69 patients with SOD, RAP occurred in 49% of patients who underwent BES and 47% who underwent DES. There was no significant difference in rates of RAP between non-SOD patients who had BES and those who had a sham procedure (27% vs. 11%, respectively).

The risk of RAP was approximately four times higher in patients with SOD than in those without SOD, they added.

"Most RAP events occurred within 30 months of randomization in all subgroups," the researchers said.

Overall, chronic pancreatitis developed in 17% of all patients over a median of 78 months, and there was no difference in the probability of developing chronic pancreatitis in patients with and without SOD.

The study was limited by several factors, including its small sample size for the non-SOD population and the impact of environmental and genetic risk factors on idiopathic RAP, the researchers noted.

The small sample of patients with normal SOM meant that the researchers could draw no conclusions about the benefit of BES in these patients, but the results "represent preliminary data for estimating the sample size of a future definitive trial of ERCP with empiric biliary sphincterotomy," they noted.

In addition, the findings suggest that SOD "may be a secondary marker of more significant inflammation related to previous acute pancreatitis," and that pancreatic sphincterotomy "cannot be recommended as a curative treatment of unexplained RAP alone," they wrote.

None of the study authors had any financial conflicts to disclose.

Performance of either biliary endoscopic sphincterotomy alone or dual biliary and pancreatic sphincterotomy similarly prevented approximately half of idiopathic recurrent acute pancreatitis cases in a trial in which 89 patients were randomized to treatments based on the presence or absence of sphincter of Oddi dysfunction.

The study is "the largest randomized clinical trial studying ERCP [endoscopic retrograde cholangiopancreatography] with SOM [sphincter of Oddi manometry] in this population" with long-term follow-up data, Dr. Gregory A. Coté of Indiana University in Indianapolis and his colleagues reported in the December issue of Gastroenterology (2012 [doi: 10.1053/j.gastro.2012.09.006]).

Source: American Gastroenterological Institute

Finding therapeutic equivalence between biliary endoscopic sphincterotomy (BES) and dual endoscopic sphincterotomy (DES) in preventing at least one episode of acute pancreatitis during follow-up is important, because the addition of pancreatic sphincterotomy to ERCP carries the risk of post-ERCP pancreatitis, bleeding, perforation, and sphincter restenosis, according to Dr. Coté and his associates.

To assess the therapeutic value of two types of sphincterotomy and the prognostic value of pancreatic SOD for patients with idiopathic recurrent acute pancreatitis (RAP), the researchers randomized 69 adults with SOD to BES or DES. The other 20 patients who did not have SOD were randomized to BES or a sham therapy. SOD was defined as basal pressure of 40 mm Hg or greater, "sustained for at least 30 seconds across two transducers," the researchers noted.

The patients were aged 18 years and older, and those with chronic pancreatitis or an identified cause of RAP were excluded from the study.

Of the 69 patients with SOD, RAP occurred in 49% of patients who underwent BES and 47% who underwent DES. There was no significant difference in rates of RAP between non-SOD patients who had BES and those who had a sham procedure (27% vs. 11%, respectively).

The risk of RAP was approximately four times higher in patients with SOD than in those without SOD, they added.

"Most RAP events occurred within 30 months of randomization in all subgroups," the researchers said.

Overall, chronic pancreatitis developed in 17% of all patients over a median of 78 months, and there was no difference in the probability of developing chronic pancreatitis in patients with and without SOD.

The study was limited by several factors, including its small sample size for the non-SOD population and the impact of environmental and genetic risk factors on idiopathic RAP, the researchers noted.

The small sample of patients with normal SOM meant that the researchers could draw no conclusions about the benefit of BES in these patients, but the results "represent preliminary data for estimating the sample size of a future definitive trial of ERCP with empiric biliary sphincterotomy," they noted.

In addition, the findings suggest that SOD "may be a secondary marker of more significant inflammation related to previous acute pancreatitis," and that pancreatic sphincterotomy "cannot be recommended as a curative treatment of unexplained RAP alone," they wrote.

None of the study authors had any financial conflicts to disclose.

Administration of zolpidem in hospital patients is associated with a significantly higher risk of falls according to a Mayo Clinic study published Nov. 19 in the Journal of Hospital Medicine.

After accounting for a large range of confounders, the researchers found that one additional fall could be expected for every 55 inpatients who received zolpidem. Patients receiving zolpidem were more than three times more likely to fall compared with those who were prescribed it but did not receive it.

thinkstockphotos.com

Dr. Bhanu Prakash Kolla at the Mayo Clinic’s Center for Sleep Medicine in Rochester, Minn., and his associates, analyzed the fall rate among 16,320 patients admitted to Mayo Clinic hospitals in 2010. All patients over age 18 who had been prescribed zolpidem but were neither pregnant nor ICU patients were included in the analysis (J. Hosp. Med. 2012 Nov. 19 [doi: 10.1002/jhm.1985]).

Using the inpatients pharmacy electronic database and patient records, the authors compared the rate of falls among patients who were actually administered zolpidem to the rate among those who did not receive the medication despite being prescribed it on an "as-needed" basis.

Among the 4,962 patients who received zolpidem, their 151 falls resulted in a fall rate of 3.04%, compared to a fall rate of 0.71% (81 falls) in the 11,358 patients who were prescribed but not administered zolpidem during their hospital stay.

Incidentally, patients not prescribed zolpidem (n = 25,627) had a fall rate of 1.42%, just slightly lower than the overall fall rate of 1.47% among all patients prescribed zolpidem, whether they received it or not. But when all patients who did not receive zolpidem were combined independent of whether they were prescribed it, their 1.24% fall rate was a significant 1.8% higher than that of patients receiving the drug.

The authors recommended that, given the current absence of evidence for other safer hypnotic alternatives for inpatients, "nonpharmacological measures to improve the sleep of hospitalized patients should be investigated as preferred methods to provide safe relief from complaints of disturbed sleep."

The researchers controlled for confounders that may increase fall risk, including age, length of hospital stay, being on a surgical floor, zolpidem dose, visual impairment, gait abnormalities, cognitive impairment/dementia, insomnia, delirium, comorbidities (measured with the Charlson comorbidity index) and patient’s Hendrich’s fall risk score.

The analysis also controlled for medications that patients received in the 24 hours before the fall that are already associated with an increased fall risk, including antidepressants, antipsychotics, antihistamines, sedative antidepressants including trazodone and mirtazapine, benzodiazepines, and opioids.

A univariate analysis revealed that all factors significantly associated with a higher fall rate included zolpidem use (OR = 4.37), being male (OR = 1.36) and having insomnia (OR = 2.37) or delirium (OR = 4.96) as well as increasing age, zolpidem dose, comorbidity scores and fall risk scores.

When the researchers accounted for all statistically significant additional fall risk factors, the association between zolpidem use and fall risk was still significant with an OR of 6.39. There was no statistically significant association identified for the other medications accounted for in the analysis.

The study was funded through the Mayo Clinic’s fellowship training program, and the authors had no disclosures.

Administration of zolpidem in hospital patients is associated with a significantly higher risk of falls according to a Mayo Clinic study published Nov. 19 in the Journal of Hospital Medicine.

After accounting for a large range of confounders, the researchers found that one additional fall could be expected for every 55 inpatients who received zolpidem. Patients receiving zolpidem were more than three times more likely to fall compared with those who were prescribed it but did not receive it.

thinkstockphotos.com

Dr. Bhanu Prakash Kolla at the Mayo Clinic’s Center for Sleep Medicine in Rochester, Minn., and his associates, analyzed the fall rate among 16,320 patients admitted to Mayo Clinic hospitals in 2010. All patients over age 18 who had been prescribed zolpidem but were neither pregnant nor ICU patients were included in the analysis (J. Hosp. Med. 2012 Nov. 19 [doi: 10.1002/jhm.1985]).

Using the inpatients pharmacy electronic database and patient records, the authors compared the rate of falls among patients who were actually administered zolpidem to the rate among those who did not receive the medication despite being prescribed it on an "as-needed" basis.

Among the 4,962 patients who received zolpidem, their 151 falls resulted in a fall rate of 3.04%, compared to a fall rate of 0.71% (81 falls) in the 11,358 patients who were prescribed but not administered zolpidem during their hospital stay.

Incidentally, patients not prescribed zolpidem (n = 25,627) had a fall rate of 1.42%, just slightly lower than the overall fall rate of 1.47% among all patients prescribed zolpidem, whether they received it or not. But when all patients who did not receive zolpidem were combined independent of whether they were prescribed it, their 1.24% fall rate was a significant 1.8% higher than that of patients receiving the drug.

The authors recommended that, given the current absence of evidence for other safer hypnotic alternatives for inpatients, "nonpharmacological measures to improve the sleep of hospitalized patients should be investigated as preferred methods to provide safe relief from complaints of disturbed sleep."

The researchers controlled for confounders that may increase fall risk, including age, length of hospital stay, being on a surgical floor, zolpidem dose, visual impairment, gait abnormalities, cognitive impairment/dementia, insomnia, delirium, comorbidities (measured with the Charlson comorbidity index) and patient’s Hendrich’s fall risk score.

The analysis also controlled for medications that patients received in the 24 hours before the fall that are already associated with an increased fall risk, including antidepressants, antipsychotics, antihistamines, sedative antidepressants including trazodone and mirtazapine, benzodiazepines, and opioids.

A univariate analysis revealed that all factors significantly associated with a higher fall rate included zolpidem use (OR = 4.37), being male (OR = 1.36) and having insomnia (OR = 2.37) or delirium (OR = 4.96) as well as increasing age, zolpidem dose, comorbidity scores and fall risk scores.

When the researchers accounted for all statistically significant additional fall risk factors, the association between zolpidem use and fall risk was still significant with an OR of 6.39. There was no statistically significant association identified for the other medications accounted for in the analysis.

The study was funded through the Mayo Clinic’s fellowship training program, and the authors had no disclosures.

Administration of zolpidem in hospital patients is associated with a significantly higher risk of falls according to a Mayo Clinic study published Nov. 19 in the Journal of Hospital Medicine.

After accounting for a large range of confounders, the researchers found that one additional fall could be expected for every 55 inpatients who received zolpidem. Patients receiving zolpidem were more than three times more likely to fall compared with those who were prescribed it but did not receive it.

thinkstockphotos.com

Dr. Bhanu Prakash Kolla at the Mayo Clinic’s Center for Sleep Medicine in Rochester, Minn., and his associates, analyzed the fall rate among 16,320 patients admitted to Mayo Clinic hospitals in 2010. All patients over age 18 who had been prescribed zolpidem but were neither pregnant nor ICU patients were included in the analysis (J. Hosp. Med. 2012 Nov. 19 [doi: 10.1002/jhm.1985]).

Using the inpatients pharmacy electronic database and patient records, the authors compared the rate of falls among patients who were actually administered zolpidem to the rate among those who did not receive the medication despite being prescribed it on an "as-needed" basis.

Among the 4,962 patients who received zolpidem, their 151 falls resulted in a fall rate of 3.04%, compared to a fall rate of 0.71% (81 falls) in the 11,358 patients who were prescribed but not administered zolpidem during their hospital stay.

Incidentally, patients not prescribed zolpidem (n = 25,627) had a fall rate of 1.42%, just slightly lower than the overall fall rate of 1.47% among all patients prescribed zolpidem, whether they received it or not. But when all patients who did not receive zolpidem were combined independent of whether they were prescribed it, their 1.24% fall rate was a significant 1.8% higher than that of patients receiving the drug.

The authors recommended that, given the current absence of evidence for other safer hypnotic alternatives for inpatients, "nonpharmacological measures to improve the sleep of hospitalized patients should be investigated as preferred methods to provide safe relief from complaints of disturbed sleep."

The researchers controlled for confounders that may increase fall risk, including age, length of hospital stay, being on a surgical floor, zolpidem dose, visual impairment, gait abnormalities, cognitive impairment/dementia, insomnia, delirium, comorbidities (measured with the Charlson comorbidity index) and patient’s Hendrich’s fall risk score.

The analysis also controlled for medications that patients received in the 24 hours before the fall that are already associated with an increased fall risk, including antidepressants, antipsychotics, antihistamines, sedative antidepressants including trazodone and mirtazapine, benzodiazepines, and opioids.

A univariate analysis revealed that all factors significantly associated with a higher fall rate included zolpidem use (OR = 4.37), being male (OR = 1.36) and having insomnia (OR = 2.37) or delirium (OR = 4.96) as well as increasing age, zolpidem dose, comorbidity scores and fall risk scores.

When the researchers accounted for all statistically significant additional fall risk factors, the association between zolpidem use and fall risk was still significant with an OR of 6.39. There was no statistically significant association identified for the other medications accounted for in the analysis.

The study was funded through the Mayo Clinic’s fellowship training program, and the authors had no disclosures.

BOSTON – Prior bariatric surgery appears to be an independent risk factor for acetaminophen-related acute liver failure or injury, investigators reported at the annual meeting of the American Association for the Study of Liver Diseases.

A retrospective study of patients with acute liver failure (ALF) showed that 9 of 54 (17%) patients with ALF attributed to acetaminophen (APAP-ALF) had previously had bariatric surgery, compared with none of 47 patients with ALF from other causes, said Dr. Edward W. Holt, a researcher at the California Pacific Medical Center in San Francisco.

Although previous studies have shown associations between bariatric surgery and between alcohol abuse and APAP-ALF, they found that there were no significant differences in rates of suicidal ideation, depression, or alcohol abuse between patients who underwent bariatric surgery and those who had not, suggesting that bariatric surgery itself was a risk factor, Dr. Holt said.

"We feel that the implications of these findings are important," he said. "If validated in a larger cohort, our novel finding may identify a new group of patients at higher risk for APAP-ALF. If validated, additional warnings for patients with prior bariatric surgery may be warranted, similar to those currently in place for patients who consume three or more alcoholic drinks daily."

Possible explanations for the association include higher peak serum concentrations of ethanol after a challenge in patients who have undergone bariatric surgery, as well as higher rates of suicidal behaviors among these patients, compared with controls.

The investigators retrospectively reviewed data from their center on a prospectively identified cohort of 101 patients with acute liver failure from acetaminophen and other causes, including drug-induced, infections, lymphoma, ischemia, and heatstroke. Of the 54 patients with APAP-ALF, 8 had undergone roux-en-Y gastric bypass, and one had a duodenal switch procedure, at a mean of nearly 6 years before diagnosis of ALF.

Among the patients in the APAP-ALF group, the prevalence of bariatric surgery was 25.3-fold higher than the estimated prevalence in the general population (16.7% vs. 0.5%; estimate based on published literature and national hospital discharge data).

The patients with APAP-ALF and ALF from other causes were similar in age, but there were more women (P = .02) and whites (P less than .0001) in the APAP-ALF group, and patients in this group had significantly fewer deaths (P less than .0006) and transplants (P less than .0001).

When the researchers looked at possible risk factors for ALF, they found that patients in the ALF/other group had significantly lower frequencies of depression (P less than .001), alcohol abuse (P = .01), and acetaminophen-containing combination analgesics (P less than .0001). But when they compared patients with or without bariatric surgery, there were no significant differences in any of the variables mentioned above.

Dr. Holt noted that the study was limited by its single-center design, inability to test proposed mechanisms for the increased risk seen in patients who had undergone bariatric surgery (such as changes in glutathione levels), and the inability to perform a logistic regression analysis, as none of the patients with non-APAP ALF had undergone surgery.

In the question-and-response portion following his presentation, Dr. Holt was asked whether liver biopsies had been performed to see if patients had background steatohepatitis or fibrosis that might account for the results, and whether body mass index data were available.

He noted that the patients came primarily from his institution’s wide referral base, and they therefore did not have all the demographic or clinical information about each patient that they would have liked.

The study was internally funded. Dr. Holt reported no relevant financial disclosures.

BOSTON – Prior bariatric surgery appears to be an independent risk factor for acetaminophen-related acute liver failure or injury, investigators reported at the annual meeting of the American Association for the Study of Liver Diseases.

A retrospective study of patients with acute liver failure (ALF) showed that 9 of 54 (17%) patients with ALF attributed to acetaminophen (APAP-ALF) had previously had bariatric surgery, compared with none of 47 patients with ALF from other causes, said Dr. Edward W. Holt, a researcher at the California Pacific Medical Center in San Francisco.

Although previous studies have shown associations between bariatric surgery and between alcohol abuse and APAP-ALF, they found that there were no significant differences in rates of suicidal ideation, depression, or alcohol abuse between patients who underwent bariatric surgery and those who had not, suggesting that bariatric surgery itself was a risk factor, Dr. Holt said.

"We feel that the implications of these findings are important," he said. "If validated in a larger cohort, our novel finding may identify a new group of patients at higher risk for APAP-ALF. If validated, additional warnings for patients with prior bariatric surgery may be warranted, similar to those currently in place for patients who consume three or more alcoholic drinks daily."

Possible explanations for the association include higher peak serum concentrations of ethanol after a challenge in patients who have undergone bariatric surgery, as well as higher rates of suicidal behaviors among these patients, compared with controls.

The investigators retrospectively reviewed data from their center on a prospectively identified cohort of 101 patients with acute liver failure from acetaminophen and other causes, including drug-induced, infections, lymphoma, ischemia, and heatstroke. Of the 54 patients with APAP-ALF, 8 had undergone roux-en-Y gastric bypass, and one had a duodenal switch procedure, at a mean of nearly 6 years before diagnosis of ALF.

Among the patients in the APAP-ALF group, the prevalence of bariatric surgery was 25.3-fold higher than the estimated prevalence in the general population (16.7% vs. 0.5%; estimate based on published literature and national hospital discharge data).

The patients with APAP-ALF and ALF from other causes were similar in age, but there were more women (P = .02) and whites (P less than .0001) in the APAP-ALF group, and patients in this group had significantly fewer deaths (P less than .0006) and transplants (P less than .0001).

When the researchers looked at possible risk factors for ALF, they found that patients in the ALF/other group had significantly lower frequencies of depression (P less than .001), alcohol abuse (P = .01), and acetaminophen-containing combination analgesics (P less than .0001). But when they compared patients with or without bariatric surgery, there were no significant differences in any of the variables mentioned above.

Dr. Holt noted that the study was limited by its single-center design, inability to test proposed mechanisms for the increased risk seen in patients who had undergone bariatric surgery (such as changes in glutathione levels), and the inability to perform a logistic regression analysis, as none of the patients with non-APAP ALF had undergone surgery.

In the question-and-response portion following his presentation, Dr. Holt was asked whether liver biopsies had been performed to see if patients had background steatohepatitis or fibrosis that might account for the results, and whether body mass index data were available.

He noted that the patients came primarily from his institution’s wide referral base, and they therefore did not have all the demographic or clinical information about each patient that they would have liked.

The study was internally funded. Dr. Holt reported no relevant financial disclosures.

BOSTON – Prior bariatric surgery appears to be an independent risk factor for acetaminophen-related acute liver failure or injury, investigators reported at the annual meeting of the American Association for the Study of Liver Diseases.

A retrospective study of patients with acute liver failure (ALF) showed that 9 of 54 (17%) patients with ALF attributed to acetaminophen (APAP-ALF) had previously had bariatric surgery, compared with none of 47 patients with ALF from other causes, said Dr. Edward W. Holt, a researcher at the California Pacific Medical Center in San Francisco.

Although previous studies have shown associations between bariatric surgery and between alcohol abuse and APAP-ALF, they found that there were no significant differences in rates of suicidal ideation, depression, or alcohol abuse between patients who underwent bariatric surgery and those who had not, suggesting that bariatric surgery itself was a risk factor, Dr. Holt said.

"We feel that the implications of these findings are important," he said. "If validated in a larger cohort, our novel finding may identify a new group of patients at higher risk for APAP-ALF. If validated, additional warnings for patients with prior bariatric surgery may be warranted, similar to those currently in place for patients who consume three or more alcoholic drinks daily."

Possible explanations for the association include higher peak serum concentrations of ethanol after a challenge in patients who have undergone bariatric surgery, as well as higher rates of suicidal behaviors among these patients, compared with controls.

The investigators retrospectively reviewed data from their center on a prospectively identified cohort of 101 patients with acute liver failure from acetaminophen and other causes, including drug-induced, infections, lymphoma, ischemia, and heatstroke. Of the 54 patients with APAP-ALF, 8 had undergone roux-en-Y gastric bypass, and one had a duodenal switch procedure, at a mean of nearly 6 years before diagnosis of ALF.

Among the patients in the APAP-ALF group, the prevalence of bariatric surgery was 25.3-fold higher than the estimated prevalence in the general population (16.7% vs. 0.5%; estimate based on published literature and national hospital discharge data).

The patients with APAP-ALF and ALF from other causes were similar in age, but there were more women (P = .02) and whites (P less than .0001) in the APAP-ALF group, and patients in this group had significantly fewer deaths (P less than .0006) and transplants (P less than .0001).

When the researchers looked at possible risk factors for ALF, they found that patients in the ALF/other group had significantly lower frequencies of depression (P less than .001), alcohol abuse (P = .01), and acetaminophen-containing combination analgesics (P less than .0001). But when they compared patients with or without bariatric surgery, there were no significant differences in any of the variables mentioned above.

Dr. Holt noted that the study was limited by its single-center design, inability to test proposed mechanisms for the increased risk seen in patients who had undergone bariatric surgery (such as changes in glutathione levels), and the inability to perform a logistic regression analysis, as none of the patients with non-APAP ALF had undergone surgery.

In the question-and-response portion following his presentation, Dr. Holt was asked whether liver biopsies had been performed to see if patients had background steatohepatitis or fibrosis that might account for the results, and whether body mass index data were available.

He noted that the patients came primarily from his institution’s wide referral base, and they therefore did not have all the demographic or clinical information about each patient that they would have liked.

The study was internally funded. Dr. Holt reported no relevant financial disclosures.

SAN DIEGO – Patients who have minor elevations in serum creatinine after noncardiac surgery may be more likely to require a longer postoperative hospital stay and face a twofold increased risk of dying during that stay, preliminary data from a German study have shown.

"This is a big problem, because minor kidney dysfunction may not be noticed postoperatively," Dr. Felix Kork said in an interview during a poster session at Kidney Week 2012 "About 2% of people in general have a small increase in serum creatinine. They are at a greater risk of dying and staying longer in the hospital. Therapeutic options are needed to prevent this minor kidney dysfunction perioperatively."

Dr. Kork of the department of anesthesiology and intensive care medicine at Charité Hospital in Berlin and his associates retrospectively studied the records of 27,616 patients who underwent noncardiac surgery at Charité between 2006 and 2012. The researchers evaluated perioperative renal function by serum creatinine level.

After doing a multivariate analysis that adjusted for age, comorbidities, renal function, high-risk surgery, and postoperative admission to the ICU, the researchers observed that minor elevations in serum creatinine (defined as a range from 0.25 to 0.50 mg/dL) were independently associated with a prolonged hospital length of stay (HR for early discharge, 0.81) and a twofold increased risk of death during the postoperative hospital stay (OR, 1.99) compared with patients without an increase in serum creatinine level. Both findings were statistically significant.

"While adjusting for covariates, we also found that having received radio contrast agent before surgery is independently associated with a greater risk of mortality and hospital length of stay, whether there was kidney dysfunction after the radio contrast agent or not," Dr. Kork added. "We’re still looking into that [association]. It could be that those patients were sicker."

He acknowledged that the study’s retrospective design is a limitation. Because of this "we can only show the association between the serum creatinine increase and the outcome," he said. "We are planning a prospective study right now." Dr. Kork explained that the current study has been submitted for publication in an undisclosed journal, which will contain more detail about these findings.

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

SAN DIEGO – Patients who have minor elevations in serum creatinine after noncardiac surgery may be more likely to require a longer postoperative hospital stay and face a twofold increased risk of dying during that stay, preliminary data from a German study have shown.

"This is a big problem, because minor kidney dysfunction may not be noticed postoperatively," Dr. Felix Kork said in an interview during a poster session at Kidney Week 2012 "About 2% of people in general have a small increase in serum creatinine. They are at a greater risk of dying and staying longer in the hospital. Therapeutic options are needed to prevent this minor kidney dysfunction perioperatively."

Dr. Kork of the department of anesthesiology and intensive care medicine at Charité Hospital in Berlin and his associates retrospectively studied the records of 27,616 patients who underwent noncardiac surgery at Charité between 2006 and 2012. The researchers evaluated perioperative renal function by serum creatinine level.

After doing a multivariate analysis that adjusted for age, comorbidities, renal function, high-risk surgery, and postoperative admission to the ICU, the researchers observed that minor elevations in serum creatinine (defined as a range from 0.25 to 0.50 mg/dL) were independently associated with a prolonged hospital length of stay (HR for early discharge, 0.81) and a twofold increased risk of death during the postoperative hospital stay (OR, 1.99) compared with patients without an increase in serum creatinine level. Both findings were statistically significant.

"While adjusting for covariates, we also found that having received radio contrast agent before surgery is independently associated with a greater risk of mortality and hospital length of stay, whether there was kidney dysfunction after the radio contrast agent or not," Dr. Kork added. "We’re still looking into that [association]. It could be that those patients were sicker."

He acknowledged that the study’s retrospective design is a limitation. Because of this "we can only show the association between the serum creatinine increase and the outcome," he said. "We are planning a prospective study right now." Dr. Kork explained that the current study has been submitted for publication in an undisclosed journal, which will contain more detail about these findings.

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

SAN DIEGO – Patients who have minor elevations in serum creatinine after noncardiac surgery may be more likely to require a longer postoperative hospital stay and face a twofold increased risk of dying during that stay, preliminary data from a German study have shown.

"This is a big problem, because minor kidney dysfunction may not be noticed postoperatively," Dr. Felix Kork said in an interview during a poster session at Kidney Week 2012 "About 2% of people in general have a small increase in serum creatinine. They are at a greater risk of dying and staying longer in the hospital. Therapeutic options are needed to prevent this minor kidney dysfunction perioperatively."

Dr. Kork of the department of anesthesiology and intensive care medicine at Charité Hospital in Berlin and his associates retrospectively studied the records of 27,616 patients who underwent noncardiac surgery at Charité between 2006 and 2012. The researchers evaluated perioperative renal function by serum creatinine level.

After doing a multivariate analysis that adjusted for age, comorbidities, renal function, high-risk surgery, and postoperative admission to the ICU, the researchers observed that minor elevations in serum creatinine (defined as a range from 0.25 to 0.50 mg/dL) were independently associated with a prolonged hospital length of stay (HR for early discharge, 0.81) and a twofold increased risk of death during the postoperative hospital stay (OR, 1.99) compared with patients without an increase in serum creatinine level. Both findings were statistically significant.

"While adjusting for covariates, we also found that having received radio contrast agent before surgery is independently associated with a greater risk of mortality and hospital length of stay, whether there was kidney dysfunction after the radio contrast agent or not," Dr. Kork added. "We’re still looking into that [association]. It could be that those patients were sicker."

He acknowledged that the study’s retrospective design is a limitation. Because of this "we can only show the association between the serum creatinine increase and the outcome," he said. "We are planning a prospective study right now." Dr. Kork explained that the current study has been submitted for publication in an undisclosed journal, which will contain more detail about these findings.

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

SAN DIEGO – Preoperative nasal application of a povidone-iodine solution may be more efficacious than nasal mupirocin for preventing deep surgical site infections caused by Staphylococcus aureus, a study has shown.

Investigators led by Dr. Michael Phillips of the New York University Langone Medical Center conducted a randomized trial, assigning 1,697 patients undergoing arthroplasty or spine fusion surgery evenly to the two treatments. All patients in the study also underwent chlorhexidine cleansing of the skin and received standard antimicrobial prophylaxis.

Trial results, reported at IDWeek, showed that the rate of S. aureus deep surgical site infections was one-sixth as high in the povidone-iodine group as in the mupirocin group. The povidone-iodine group also had a lower rate of adverse events and less often rated their treatment as unpleasant.

"We feel that individuals should consider the use of nasal povidone-iodine as a component of a multifaceted approach to prevent S. aureus infection after high-risk surgery," Dr. Phillips said.

In the trial, adult patients undergoing arthroplasty or spine fusion surgery at the NYU Hospital for Joint Diseases had nasal cultures for S. aureus before surgery and were then assigned to two groups.

In one group, patients were given 2% mupirocin nasal ointment and told to apply it twice daily for the 5 days leading up to surgery. The mupirocin was provided directly to the patients because a survey suggested that some patients were skipping the mupirocin because of its cost, as it is not routinely covered by insurance, he explained at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

In the other group, research personnel applied a 5% solution of povidone-iodine to both nostrils in patients up to 2 hours before incision.

Both groups also were given chlorhexidine wipes and told to use them from chin to toes the evening before and again the morning of surgery. Both groups received standard perioperative antimicrobial prophylaxis (cefazolin or clindamycin, plus vancomycin for those having a positive nasal culture for methicillin-resistant S. aureus). Both also had surgical site prepping with 2% chlorhexidine and alcohol.

The patients’ median age was 62 years; 60% were women and 80% were white. Preoperative nasal culture results showed that one in five patients was colonized with S. aureus.

The rate of noncompletion of the protocol was 11% in the mupirocin group and 8% in the povidone-iodine group, Dr. Phillips reported. The leading reason for noncompletion in the mupirocin group was failure to apply mupirocin at least seven times. In the povidone-iodine group, it was failure to use the chlorhexidine wipes.

In intent-to-treat analyses, patients in the nasal povidone-iodine group had a 0.7% rate of any deep surgical site infection at 3 months; those in the mupirocin group had a 1.6% rate. The rate of S. aureus deep surgical site infections was 0.1% and. 0.6%, respectively.

In a univariate analysis, patients had a higher risk of S. aureus deep surgical site infection if they were in the mupirocin group (relative risk, 1.01; P = .04) or were colonized with S. aureus preoperatively (relative risk, 6.79; P = .02).

When patients were stratified by colonization status, there was a trend toward a lower rate of S. aureus deep surgical site infection with povidone-iodine versus mupirocin for those who were colonized (P = .08) but not for those who were not.

Patients in the povidone-iodine group had a lower rate of study drug adverse events overall (2% vs. 9%, P less than .0001). The difference was significant for rhinorrhea, headache, congestion, and pharyngeal pain individually.

In addition, patients in the povidone-iodine group were less likely to report that application of the study medication was unpleasant or very unpleasant (4% vs. 38%).

Dr. Phillips disclosed that he received a research grant from 3M Corp., manufacturer of the povidone-iodine solution. The study was supported by 3M.

SAN DIEGO – Preoperative nasal application of a povidone-iodine solution may be more efficacious than nasal mupirocin for preventing deep surgical site infections caused by Staphylococcus aureus, a study has shown.

Investigators led by Dr. Michael Phillips of the New York University Langone Medical Center conducted a randomized trial, assigning 1,697 patients undergoing arthroplasty or spine fusion surgery evenly to the two treatments. All patients in the study also underwent chlorhexidine cleansing of the skin and received standard antimicrobial prophylaxis.

Trial results, reported at IDWeek, showed that the rate of S. aureus deep surgical site infections was one-sixth as high in the povidone-iodine group as in the mupirocin group. The povidone-iodine group also had a lower rate of adverse events and less often rated their treatment as unpleasant.

"We feel that individuals should consider the use of nasal povidone-iodine as a component of a multifaceted approach to prevent S. aureus infection after high-risk surgery," Dr. Phillips said.

In the trial, adult patients undergoing arthroplasty or spine fusion surgery at the NYU Hospital for Joint Diseases had nasal cultures for S. aureus before surgery and were then assigned to two groups.

In one group, patients were given 2% mupirocin nasal ointment and told to apply it twice daily for the 5 days leading up to surgery. The mupirocin was provided directly to the patients because a survey suggested that some patients were skipping the mupirocin because of its cost, as it is not routinely covered by insurance, he explained at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

In the other group, research personnel applied a 5% solution of povidone-iodine to both nostrils in patients up to 2 hours before incision.

Both groups also were given chlorhexidine wipes and told to use them from chin to toes the evening before and again the morning of surgery. Both groups received standard perioperative antimicrobial prophylaxis (cefazolin or clindamycin, plus vancomycin for those having a positive nasal culture for methicillin-resistant S. aureus). Both also had surgical site prepping with 2% chlorhexidine and alcohol.

The patients’ median age was 62 years; 60% were women and 80% were white. Preoperative nasal culture results showed that one in five patients was colonized with S. aureus.

The rate of noncompletion of the protocol was 11% in the mupirocin group and 8% in the povidone-iodine group, Dr. Phillips reported. The leading reason for noncompletion in the mupirocin group was failure to apply mupirocin at least seven times. In the povidone-iodine group, it was failure to use the chlorhexidine wipes.

In intent-to-treat analyses, patients in the nasal povidone-iodine group had a 0.7% rate of any deep surgical site infection at 3 months; those in the mupirocin group had a 1.6% rate. The rate of S. aureus deep surgical site infections was 0.1% and. 0.6%, respectively.

In a univariate analysis, patients had a higher risk of S. aureus deep surgical site infection if they were in the mupirocin group (relative risk, 1.01; P = .04) or were colonized with S. aureus preoperatively (relative risk, 6.79; P = .02).

When patients were stratified by colonization status, there was a trend toward a lower rate of S. aureus deep surgical site infection with povidone-iodine versus mupirocin for those who were colonized (P = .08) but not for those who were not.

Patients in the povidone-iodine group had a lower rate of study drug adverse events overall (2% vs. 9%, P less than .0001). The difference was significant for rhinorrhea, headache, congestion, and pharyngeal pain individually.

In addition, patients in the povidone-iodine group were less likely to report that application of the study medication was unpleasant or very unpleasant (4% vs. 38%).

Dr. Phillips disclosed that he received a research grant from 3M Corp., manufacturer of the povidone-iodine solution. The study was supported by 3M.

SAN DIEGO – Preoperative nasal application of a povidone-iodine solution may be more efficacious than nasal mupirocin for preventing deep surgical site infections caused by Staphylococcus aureus, a study has shown.

Investigators led by Dr. Michael Phillips of the New York University Langone Medical Center conducted a randomized trial, assigning 1,697 patients undergoing arthroplasty or spine fusion surgery evenly to the two treatments. All patients in the study also underwent chlorhexidine cleansing of the skin and received standard antimicrobial prophylaxis.

Trial results, reported at IDWeek, showed that the rate of S. aureus deep surgical site infections was one-sixth as high in the povidone-iodine group as in the mupirocin group. The povidone-iodine group also had a lower rate of adverse events and less often rated their treatment as unpleasant.

"We feel that individuals should consider the use of nasal povidone-iodine as a component of a multifaceted approach to prevent S. aureus infection after high-risk surgery," Dr. Phillips said.

In the trial, adult patients undergoing arthroplasty or spine fusion surgery at the NYU Hospital for Joint Diseases had nasal cultures for S. aureus before surgery and were then assigned to two groups.

In one group, patients were given 2% mupirocin nasal ointment and told to apply it twice daily for the 5 days leading up to surgery. The mupirocin was provided directly to the patients because a survey suggested that some patients were skipping the mupirocin because of its cost, as it is not routinely covered by insurance, he explained at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

In the other group, research personnel applied a 5% solution of povidone-iodine to both nostrils in patients up to 2 hours before incision.

Both groups also were given chlorhexidine wipes and told to use them from chin to toes the evening before and again the morning of surgery. Both groups received standard perioperative antimicrobial prophylaxis (cefazolin or clindamycin, plus vancomycin for those having a positive nasal culture for methicillin-resistant S. aureus). Both also had surgical site prepping with 2% chlorhexidine and alcohol.

The patients’ median age was 62 years; 60% were women and 80% were white. Preoperative nasal culture results showed that one in five patients was colonized with S. aureus.

The rate of noncompletion of the protocol was 11% in the mupirocin group and 8% in the povidone-iodine group, Dr. Phillips reported. The leading reason for noncompletion in the mupirocin group was failure to apply mupirocin at least seven times. In the povidone-iodine group, it was failure to use the chlorhexidine wipes.

In intent-to-treat analyses, patients in the nasal povidone-iodine group had a 0.7% rate of any deep surgical site infection at 3 months; those in the mupirocin group had a 1.6% rate. The rate of S. aureus deep surgical site infections was 0.1% and. 0.6%, respectively.

In a univariate analysis, patients had a higher risk of S. aureus deep surgical site infection if they were in the mupirocin group (relative risk, 1.01; P = .04) or were colonized with S. aureus preoperatively (relative risk, 6.79; P = .02).

When patients were stratified by colonization status, there was a trend toward a lower rate of S. aureus deep surgical site infection with povidone-iodine versus mupirocin for those who were colonized (P = .08) but not for those who were not.

Patients in the povidone-iodine group had a lower rate of study drug adverse events overall (2% vs. 9%, P less than .0001). The difference was significant for rhinorrhea, headache, congestion, and pharyngeal pain individually.

In addition, patients in the povidone-iodine group were less likely to report that application of the study medication was unpleasant or very unpleasant (4% vs. 38%).

Dr. Phillips disclosed that he received a research grant from 3M Corp., manufacturer of the povidone-iodine solution. The study was supported by 3M.

CHICAGO – Laparoscopic ultrasound was as effective as transabdominal ultrasound for detecting cholelithiasis, and superior at finding gallbladder polyps, based on data from 253 adults undergoing laparoscopic gastric bypass procedures.

Morbidly obese patients are at increased risk for cholelithiasis, with approximately 22%-52% developing the condition, said Dr. Kosisochi M. Obinwanne at the annual clinical congress of the American College of Surgeons.

For surgeons who perform gallbladder surgery separate from the gastric bypass, "it becomes necessary to obtain images of the gallbladder to determine the presence of gallstones," said Dr. Obinwanne of Gundersen Lutheran Health System in La Crosse, Wisc.

"Transabdominal ultrasound is the gold standard for detecting cholelithiasis," he said. However, the increased visceral and subcutaneous fat in patients with morbid obesity can make detection of gallbladder pathology difficult using transabdominal ultrasound (TAU), but laparoscopic ultrasound (LU) has the potential to be as effective as TAU, he noted.

To evaluate the sensitivity and specificity of LU vs. TAU for detecting gallbladder pathology in morbidly obese patients, Dr. Obinwanne and his colleagues conducted a prospective study of 253 patients who underwent laparoscopic gastric bypass over a 6-year period. Their average age was 43 years, average body mass index was 48 kg/m², and 76% were women.

The patients underwent both TAU and LU during laparoscopic gastric bypass surgery. Certified ultrasonographers performed TAU, and surgeons blinded to the TAU results performed LU, Dr. Obinwanne said.

Overall, LU and TAU identified cholelithiasis in 60 and 61 patients, respectively, said Dr. Obinwanne. The average common bile duct diameter measurement was 3.7 mm with LU and 4.0 mm with TAU.

However, LU found significantly more gallbladder polyps than did TAU (41 vs. 6). The sensitivity and specificity of LU were 90% and 98%, respectively, for gallbladder pathology and 83% and 85%, respectively, for polyps.

"The mean time to complete an LU procedure was 4 minutes," Dr. Obinwanne said.

The study was limited by its small size, but the results suggest that LU is safe, quick, and easy to perform – and thus it’s an alternative to TAU for detecting gallbladder pathology in bariatric surgery patients.

Dr. Obinwanne had no financial conflicts to disclose.

CHICAGO – Laparoscopic ultrasound was as effective as transabdominal ultrasound for detecting cholelithiasis, and superior at finding gallbladder polyps, based on data from 253 adults undergoing laparoscopic gastric bypass procedures.

Morbidly obese patients are at increased risk for cholelithiasis, with approximately 22%-52% developing the condition, said Dr. Kosisochi M. Obinwanne at the annual clinical congress of the American College of Surgeons.

For surgeons who perform gallbladder surgery separate from the gastric bypass, "it becomes necessary to obtain images of the gallbladder to determine the presence of gallstones," said Dr. Obinwanne of Gundersen Lutheran Health System in La Crosse, Wisc.

"Transabdominal ultrasound is the gold standard for detecting cholelithiasis," he said. However, the increased visceral and subcutaneous fat in patients with morbid obesity can make detection of gallbladder pathology difficult using transabdominal ultrasound (TAU), but laparoscopic ultrasound (LU) has the potential to be as effective as TAU, he noted.

To evaluate the sensitivity and specificity of LU vs. TAU for detecting gallbladder pathology in morbidly obese patients, Dr. Obinwanne and his colleagues conducted a prospective study of 253 patients who underwent laparoscopic gastric bypass over a 6-year period. Their average age was 43 years, average body mass index was 48 kg/m², and 76% were women.

The patients underwent both TAU and LU during laparoscopic gastric bypass surgery. Certified ultrasonographers performed TAU, and surgeons blinded to the TAU results performed LU, Dr. Obinwanne said.

Overall, LU and TAU identified cholelithiasis in 60 and 61 patients, respectively, said Dr. Obinwanne. The average common bile duct diameter measurement was 3.7 mm with LU and 4.0 mm with TAU.

However, LU found significantly more gallbladder polyps than did TAU (41 vs. 6). The sensitivity and specificity of LU were 90% and 98%, respectively, for gallbladder pathology and 83% and 85%, respectively, for polyps.

"The mean time to complete an LU procedure was 4 minutes," Dr. Obinwanne said.

The study was limited by its small size, but the results suggest that LU is safe, quick, and easy to perform – and thus it’s an alternative to TAU for detecting gallbladder pathology in bariatric surgery patients.

Dr. Obinwanne had no financial conflicts to disclose.

CHICAGO – Laparoscopic ultrasound was as effective as transabdominal ultrasound for detecting cholelithiasis, and superior at finding gallbladder polyps, based on data from 253 adults undergoing laparoscopic gastric bypass procedures.

Morbidly obese patients are at increased risk for cholelithiasis, with approximately 22%-52% developing the condition, said Dr. Kosisochi M. Obinwanne at the annual clinical congress of the American College of Surgeons.

For surgeons who perform gallbladder surgery separate from the gastric bypass, "it becomes necessary to obtain images of the gallbladder to determine the presence of gallstones," said Dr. Obinwanne of Gundersen Lutheran Health System in La Crosse, Wisc.

"Transabdominal ultrasound is the gold standard for detecting cholelithiasis," he said. However, the increased visceral and subcutaneous fat in patients with morbid obesity can make detection of gallbladder pathology difficult using transabdominal ultrasound (TAU), but laparoscopic ultrasound (LU) has the potential to be as effective as TAU, he noted.

To evaluate the sensitivity and specificity of LU vs. TAU for detecting gallbladder pathology in morbidly obese patients, Dr. Obinwanne and his colleagues conducted a prospective study of 253 patients who underwent laparoscopic gastric bypass over a 6-year period. Their average age was 43 years, average body mass index was 48 kg/m², and 76% were women.

The patients underwent both TAU and LU during laparoscopic gastric bypass surgery. Certified ultrasonographers performed TAU, and surgeons blinded to the TAU results performed LU, Dr. Obinwanne said.

Overall, LU and TAU identified cholelithiasis in 60 and 61 patients, respectively, said Dr. Obinwanne. The average common bile duct diameter measurement was 3.7 mm with LU and 4.0 mm with TAU.

However, LU found significantly more gallbladder polyps than did TAU (41 vs. 6). The sensitivity and specificity of LU were 90% and 98%, respectively, for gallbladder pathology and 83% and 85%, respectively, for polyps.

"The mean time to complete an LU procedure was 4 minutes," Dr. Obinwanne said.

The study was limited by its small size, but the results suggest that LU is safe, quick, and easy to perform – and thus it’s an alternative to TAU for detecting gallbladder pathology in bariatric surgery patients.

Dr. Obinwanne had no financial conflicts to disclose.

Surgical residency programs have not kept up with radical changes in the practice of surgery over the past two decades, but innovations ranging from curriculum reform to increasing the length of residency could help to improve the overall performance of recent surgical residency graduates, according to an analysis in Annals of Surgery.

"The changes that have occurred have been disruptive to residency training, and to date there has been minimal compensation for these," Dr. Frank Lewis and Dr. Mary Klingensmith wrote. "Evidence is now emerging of significant issues in the overall performance of recent graduates from at least three sources – the evaluation of external agents who incorporate these graduates into their practice or group, the opinions of the residents themselves, and the performance of graduates on the oral examination of the American Board of Surgery during the last 8 years" (Ann. Surg. 2012;256:553-59).

The changes include not only the 80-hour workweek for surgical residents, but also clinical areas, according to Dr. Lewis, executive director of the American Board of Surgery, and Dr. Klingensmith, residency program director at Washington University in St. Louis.

The effect of the 80-hour workweek has been a reduction by 6 months to a year of in-hospital experience during 5 years of residency. Most of that reduced time corresponds to night and weekend experience, when residents would be more likely to see urgent and emergent conditions, and to have a greater degree of independent functioning, autonomy, and indirect supervision, they said.

The most significant clinical change has been the development of laparoscopic surgery for intra-abdominal surgical management, which is replacing open surgery and the abdominal incision. Because surgeons in academic settings have been slower to adopt laparoscopy, resident training in the use of this technology has proceeded slowly, they explained.

"While the Residency Review Committee (RRC) for Surgery has been steadily increasing the requirements for surgical resident training, it is still the rule that the most complex laparoscopic surgery is reserved for fellows in postresidency fellowships and not for residents during surgical training, although there is no reason this should be the case," they noted.

In addition, operations performed by general surgeons, and the way in which they are done, have changed significantly in the past 20 years, according to the analysis. For example, the advent of better medical management for benign peptic ulcer disease – along with flexible endoscopy and endoscopic retrograde cholangiopancreatography – means that fewer surgical interventions for peptic ulcer complications and biliary tree stone disease are necessary.

Furthermore, technological innovations have allowed vascular surgeons, rather than general surgeons, to perform most abdominal vascular surgery. Finally, the two surgeons reported, abdominal trauma injuries – which require surgical intervention in 80%-90% of cases – have declined dramatically since 1992.

These types of changes "will undoubtedly continue, and the directions in which surgery will evolve in the future are not predictable," Dr. Lewis and Dr. Klingensmith wrote.

They laid out seven potential ways in which surgical residency programs can address the changes:

• There should be a continuous process to define and continually update the surgical residency curriculum, which needs to keep pace with the fast-changing surgical practice landscape, and to "prune" information related to diseases that no longer are seen frequently in practice.

"The starting point for making changes in residency is to recognize that much of what is being taught is obsolete, and addresses diseases that are no longer a significant problem, or those for which surgical treatment is rarely needed," they said.

• Residency programs should improve the efficacy of resident learning by reducing clerical functions for residents, using physician extenders where appropriate, and utilizing mobile computing technology to deliver "a more defined and comprehensive curriculum to residents at an individual level."

• Educators could make better use of simulators in certain areas, such as laparoscopic surgery and endoscopic surgery.

• There should be an earlier specialty focus in residency training for those surgical residents who already know which specialty they would like to pursue.

• Surgical residency should include expanded laparoscopic surgery training.

• Residency programs could increase in length to make up for the time lost to the 80-hour workweek rule. Four-fifths of surgical residents already elect to take a postresidency fellowship in a specialty or subspecialty area, so "any discussion of extending residency only applies to the 20% of residents who currently complete only general surgical residency and do not seek subspecialty training," they said. "Extending residency by 1 year to obtain more extensive training in general surgery per se would not seem to be an insurmountable issue if the benefits clearly warranted it."

• Surgical training should expand to include additional skills, such as the use of ultrasound for better diagnosis of conditions in breast, endocrine, vascular, and trauma diseases and the use of interventional catheter techniques for the diagnosis or treatment of a variety of conditions.

It’s not possible to reverse the changes that have occurred over the past 2 decades, and in fact the workweek could see further shortening, as has happened in Europe, the investigators noted. "The most effective way in which to address the changes is therefore to look at the things which can be changed in resident training, the many areas in which improvements in resident teaching are possible, and the areas in which residents’ capabilities could be productively expanded."

The investigators did not report any conflicts of interest.

Surgical residency programs have not kept up with radical changes in the practice of surgery over the past two decades, but innovations ranging from curriculum reform to increasing the length of residency could help to improve the overall performance of recent surgical residency graduates, according to an analysis in Annals of Surgery.

"The changes that have occurred have been disruptive to residency training, and to date there has been minimal compensation for these," Dr. Frank Lewis and Dr. Mary Klingensmith wrote. "Evidence is now emerging of significant issues in the overall performance of recent graduates from at least three sources – the evaluation of external agents who incorporate these graduates into their practice or group, the opinions of the residents themselves, and the performance of graduates on the oral examination of the American Board of Surgery during the last 8 years" (Ann. Surg. 2012;256:553-59).

The changes include not only the 80-hour workweek for surgical residents, but also clinical areas, according to Dr. Lewis, executive director of the American Board of Surgery, and Dr. Klingensmith, residency program director at Washington University in St. Louis.

The effect of the 80-hour workweek has been a reduction by 6 months to a year of in-hospital experience during 5 years of residency. Most of that reduced time corresponds to night and weekend experience, when residents would be more likely to see urgent and emergent conditions, and to have a greater degree of independent functioning, autonomy, and indirect supervision, they said.

The most significant clinical change has been the development of laparoscopic surgery for intra-abdominal surgical management, which is replacing open surgery and the abdominal incision. Because surgeons in academic settings have been slower to adopt laparoscopy, resident training in the use of this technology has proceeded slowly, they explained.

"While the Residency Review Committee (RRC) for Surgery has been steadily increasing the requirements for surgical resident training, it is still the rule that the most complex laparoscopic surgery is reserved for fellows in postresidency fellowships and not for residents during surgical training, although there is no reason this should be the case," they noted.

In addition, operations performed by general surgeons, and the way in which they are done, have changed significantly in the past 20 years, according to the analysis. For example, the advent of better medical management for benign peptic ulcer disease – along with flexible endoscopy and endoscopic retrograde cholangiopancreatography – means that fewer surgical interventions for peptic ulcer complications and biliary tree stone disease are necessary.

Furthermore, technological innovations have allowed vascular surgeons, rather than general surgeons, to perform most abdominal vascular surgery. Finally, the two surgeons reported, abdominal trauma injuries – which require surgical intervention in 80%-90% of cases – have declined dramatically since 1992.

These types of changes "will undoubtedly continue, and the directions in which surgery will evolve in the future are not predictable," Dr. Lewis and Dr. Klingensmith wrote.

They laid out seven potential ways in which surgical residency programs can address the changes:

• There should be a continuous process to define and continually update the surgical residency curriculum, which needs to keep pace with the fast-changing surgical practice landscape, and to "prune" information related to diseases that no longer are seen frequently in practice.

"The starting point for making changes in residency is to recognize that much of what is being taught is obsolete, and addresses diseases that are no longer a significant problem, or those for which surgical treatment is rarely needed," they said.

• Residency programs should improve the efficacy of resident learning by reducing clerical functions for residents, using physician extenders where appropriate, and utilizing mobile computing technology to deliver "a more defined and comprehensive curriculum to residents at an individual level."

• Educators could make better use of simulators in certain areas, such as laparoscopic surgery and endoscopic surgery.

• There should be an earlier specialty focus in residency training for those surgical residents who already know which specialty they would like to pursue.

• Surgical residency should include expanded laparoscopic surgery training.

• Residency programs could increase in length to make up for the time lost to the 80-hour workweek rule. Four-fifths of surgical residents already elect to take a postresidency fellowship in a specialty or subspecialty area, so "any discussion of extending residency only applies to the 20% of residents who currently complete only general surgical residency and do not seek subspecialty training," they said. "Extending residency by 1 year to obtain more extensive training in general surgery per se would not seem to be an insurmountable issue if the benefits clearly warranted it."

• Surgical training should expand to include additional skills, such as the use of ultrasound for better diagnosis of conditions in breast, endocrine, vascular, and trauma diseases and the use of interventional catheter techniques for the diagnosis or treatment of a variety of conditions.

It’s not possible to reverse the changes that have occurred over the past 2 decades, and in fact the workweek could see further shortening, as has happened in Europe, the investigators noted. "The most effective way in which to address the changes is therefore to look at the things which can be changed in resident training, the many areas in which improvements in resident teaching are possible, and the areas in which residents’ capabilities could be productively expanded."

The investigators did not report any conflicts of interest.

Surgical residency programs have not kept up with radical changes in the practice of surgery over the past two decades, but innovations ranging from curriculum reform to increasing the length of residency could help to improve the overall performance of recent surgical residency graduates, according to an analysis in Annals of Surgery.

"The changes that have occurred have been disruptive to residency training, and to date there has been minimal compensation for these," Dr. Frank Lewis and Dr. Mary Klingensmith wrote. "Evidence is now emerging of significant issues in the overall performance of recent graduates from at least three sources – the evaluation of external agents who incorporate these graduates into their practice or group, the opinions of the residents themselves, and the performance of graduates on the oral examination of the American Board of Surgery during the last 8 years" (Ann. Surg. 2012;256:553-59).

The changes include not only the 80-hour workweek for surgical residents, but also clinical areas, according to Dr. Lewis, executive director of the American Board of Surgery, and Dr. Klingensmith, residency program director at Washington University in St. Louis.

The effect of the 80-hour workweek has been a reduction by 6 months to a year of in-hospital experience during 5 years of residency. Most of that reduced time corresponds to night and weekend experience, when residents would be more likely to see urgent and emergent conditions, and to have a greater degree of independent functioning, autonomy, and indirect supervision, they said.

The most significant clinical change has been the development of laparoscopic surgery for intra-abdominal surgical management, which is replacing open surgery and the abdominal incision. Because surgeons in academic settings have been slower to adopt laparoscopy, resident training in the use of this technology has proceeded slowly, they explained.

"While the Residency Review Committee (RRC) for Surgery has been steadily increasing the requirements for surgical resident training, it is still the rule that the most complex laparoscopic surgery is reserved for fellows in postresidency fellowships and not for residents during surgical training, although there is no reason this should be the case," they noted.

In addition, operations performed by general surgeons, and the way in which they are done, have changed significantly in the past 20 years, according to the analysis. For example, the advent of better medical management for benign peptic ulcer disease – along with flexible endoscopy and endoscopic retrograde cholangiopancreatography – means that fewer surgical interventions for peptic ulcer complications and biliary tree stone disease are necessary.

Furthermore, technological innovations have allowed vascular surgeons, rather than general surgeons, to perform most abdominal vascular surgery. Finally, the two surgeons reported, abdominal trauma injuries – which require surgical intervention in 80%-90% of cases – have declined dramatically since 1992.

These types of changes "will undoubtedly continue, and the directions in which surgery will evolve in the future are not predictable," Dr. Lewis and Dr. Klingensmith wrote.

They laid out seven potential ways in which surgical residency programs can address the changes:

• There should be a continuous process to define and continually update the surgical residency curriculum, which needs to keep pace with the fast-changing surgical practice landscape, and to "prune" information related to diseases that no longer are seen frequently in practice.

"The starting point for making changes in residency is to recognize that much of what is being taught is obsolete, and addresses diseases that are no longer a significant problem, or those for which surgical treatment is rarely needed," they said.

• Residency programs should improve the efficacy of resident learning by reducing clerical functions for residents, using physician extenders where appropriate, and utilizing mobile computing technology to deliver "a more defined and comprehensive curriculum to residents at an individual level."

• Educators could make better use of simulators in certain areas, such as laparoscopic surgery and endoscopic surgery.

• There should be an earlier specialty focus in residency training for those surgical residents who already know which specialty they would like to pursue.

• Surgical residency should include expanded laparoscopic surgery training.

• Residency programs could increase in length to make up for the time lost to the 80-hour workweek rule. Four-fifths of surgical residents already elect to take a postresidency fellowship in a specialty or subspecialty area, so "any discussion of extending residency only applies to the 20% of residents who currently complete only general surgical residency and do not seek subspecialty training," they said. "Extending residency by 1 year to obtain more extensive training in general surgery per se would not seem to be an insurmountable issue if the benefits clearly warranted it."

• Surgical training should expand to include additional skills, such as the use of ultrasound for better diagnosis of conditions in breast, endocrine, vascular, and trauma diseases and the use of interventional catheter techniques for the diagnosis or treatment of a variety of conditions.

It’s not possible to reverse the changes that have occurred over the past 2 decades, and in fact the workweek could see further shortening, as has happened in Europe, the investigators noted. "The most effective way in which to address the changes is therefore to look at the things which can be changed in resident training, the many areas in which improvements in resident teaching are possible, and the areas in which residents’ capabilities could be productively expanded."

The investigators did not report any conflicts of interest.

CHICAGO – Complication rates for bariatric surgery patients on Medicare declined after Medicare began to cover the procedure in 2006, an analysis of state inpatient data from 12 states has found.

Data from previous studies suggest that bariatric surgery outcomes for Medicare patients improved after the implementation of Medicare’s National Coverage Determination in 2006, said Dr. Justin B. Dimick of the University of Michigan, Ann Arbor. But specific safety data on Medicare patients who have undergone bariatric surgery since the time of the decision are limited, Dr. Dimick said. The decision allowed for Medicare coverage of patients who sought care at facilities certified by the American College of Surgeons or the American Society for Metabolic and Bariatric Surgery.

To assess the impact of the National Coverage Determination on the safety of bariatric surgery, Dr. Dimick and his colleagues reviewed state inpatient data from 12 large, geographically dispersed states. Patients were identified on the basis of ICD-9 codes and diagnosis-related groups for weight loss surgery.

The outcomes were categorized according to any complication, a serious complication, or a reoperation.

The percentage of Medicare patients with any complications dropped from 12% before the determination to 8% afterward. Similarly, the percentage of non-Medicare patients with any complications dropped from 7% before to 5% after the determination.

In a multivariate analysis, the factors contributing to improved outcomes for bariatric surgery in Medicare patients were an increase in the use of laparoscopic gastric banding (lap band surgery), the transfer of patients to better hospitals, and quality improvement within individual hospitals, Dr. Dimick said.

Improvements in the safety of bariatric surgery did not, however, result from patients being redirected to safer hospitals, said Dr. Dimick. In fact, complication rates for procedures performed at Centers of Excellence versus non–Centers of Excellence were not significantly different (odds ratio for any complications, 0.97), he noted.

"CMS should consider dropping the COE [Centers of Excellence] aspect of the coverage decision [that] limits patient access without a beneficial improvement in outcomes," Dr. Dimick said. "Alternatively, CMS could revise the national coverage decision to further encourage participation in a quality improvement registry." Such a registry would need to include measures of long-term effectiveness to identify any unintended consequences of the increase in lap band surgery, he added.

Dr. Dimick is an equity owner and cofounder of ArborMetrix, a health care analytics and software firm.

CHICAGO – Complication rates for bariatric surgery patients on Medicare declined after Medicare began to cover the procedure in 2006, an analysis of state inpatient data from 12 states has found.

Data from previous studies suggest that bariatric surgery outcomes for Medicare patients improved after the implementation of Medicare’s National Coverage Determination in 2006, said Dr. Justin B. Dimick of the University of Michigan, Ann Arbor. But specific safety data on Medicare patients who have undergone bariatric surgery since the time of the decision are limited, Dr. Dimick said. The decision allowed for Medicare coverage of patients who sought care at facilities certified by the American College of Surgeons or the American Society for Metabolic and Bariatric Surgery.

To assess the impact of the National Coverage Determination on the safety of bariatric surgery, Dr. Dimick and his colleagues reviewed state inpatient data from 12 large, geographically dispersed states. Patients were identified on the basis of ICD-9 codes and diagnosis-related groups for weight loss surgery.

The outcomes were categorized according to any complication, a serious complication, or a reoperation.

The percentage of Medicare patients with any complications dropped from 12% before the determination to 8% afterward. Similarly, the percentage of non-Medicare patients with any complications dropped from 7% before to 5% after the determination.

In a multivariate analysis, the factors contributing to improved outcomes for bariatric surgery in Medicare patients were an increase in the use of laparoscopic gastric banding (lap band surgery), the transfer of patients to better hospitals, and quality improvement within individual hospitals, Dr. Dimick said.

Improvements in the safety of bariatric surgery did not, however, result from patients being redirected to safer hospitals, said Dr. Dimick. In fact, complication rates for procedures performed at Centers of Excellence versus non–Centers of Excellence were not significantly different (odds ratio for any complications, 0.97), he noted.

"CMS should consider dropping the COE [Centers of Excellence] aspect of the coverage decision [that] limits patient access without a beneficial improvement in outcomes," Dr. Dimick said. "Alternatively, CMS could revise the national coverage decision to further encourage participation in a quality improvement registry." Such a registry would need to include measures of long-term effectiveness to identify any unintended consequences of the increase in lap band surgery, he added.

Dr. Dimick is an equity owner and cofounder of ArborMetrix, a health care analytics and software firm.

CHICAGO – Complication rates for bariatric surgery patients on Medicare declined after Medicare began to cover the procedure in 2006, an analysis of state inpatient data from 12 states has found.

Data from previous studies suggest that bariatric surgery outcomes for Medicare patients improved after the implementation of Medicare’s National Coverage Determination in 2006, said Dr. Justin B. Dimick of the University of Michigan, Ann Arbor. But specific safety data on Medicare patients who have undergone bariatric surgery since the time of the decision are limited, Dr. Dimick said. The decision allowed for Medicare coverage of patients who sought care at facilities certified by the American College of Surgeons or the American Society for Metabolic and Bariatric Surgery.

To assess the impact of the National Coverage Determination on the safety of bariatric surgery, Dr. Dimick and his colleagues reviewed state inpatient data from 12 large, geographically dispersed states. Patients were identified on the basis of ICD-9 codes and diagnosis-related groups for weight loss surgery.

The outcomes were categorized according to any complication, a serious complication, or a reoperation.

The percentage of Medicare patients with any complications dropped from 12% before the determination to 8% afterward. Similarly, the percentage of non-Medicare patients with any complications dropped from 7% before to 5% after the determination.

In a multivariate analysis, the factors contributing to improved outcomes for bariatric surgery in Medicare patients were an increase in the use of laparoscopic gastric banding (lap band surgery), the transfer of patients to better hospitals, and quality improvement within individual hospitals, Dr. Dimick said.

Improvements in the safety of bariatric surgery did not, however, result from patients being redirected to safer hospitals, said Dr. Dimick. In fact, complication rates for procedures performed at Centers of Excellence versus non–Centers of Excellence were not significantly different (odds ratio for any complications, 0.97), he noted.

"CMS should consider dropping the COE [Centers of Excellence] aspect of the coverage decision [that] limits patient access without a beneficial improvement in outcomes," Dr. Dimick said. "Alternatively, CMS could revise the national coverage decision to further encourage participation in a quality improvement registry." Such a registry would need to include measures of long-term effectiveness to identify any unintended consequences of the increase in lap band surgery, he added.

Dr. Dimick is an equity owner and cofounder of ArborMetrix, a health care analytics and software firm.

SILVER SPRING, MD. – A Food and Drug Administration advisory panel unanimously supported the approval of teduglutide, a recombinant analogue of human glucagon-like peptide-2 (GLP-2) administered subcutaneously, as a treatment to improve the intestinal absorption of fluid and nutrients in adults with short bowel syndrome, at a meeting on Oct. 16.

The FDA’s Gastrointestinal Drugs Advisory Committee voted 12 to 0 that the benefits of teduglutide outweighed the potential risks in patients with short bowel syndrome (SBS). Clinical studies of adults with SBS, who are highly dependent on parenteral nutrition, showed that teduglutide significantly reduced the volume of parenteral nutrition and IV fluids they needed after 6 months of treatment, compared with placebo. While the panelists felt comfortable with the drug’s safety profile, they recommended that more safety data are needed. They also advised following the long-term safety and potential risks of the treatment after approval, including determining whether the risk of colorectal cancer is increased with treatment.

Produced in the small intestine and the proximal large intestine, GLP-2 is "an intestinotrophic peptide that stimulates mucosal epithelium," increasing absorption of fluids and nutrients, according to the manufacturer, NPS Pharmaceuticals. In studies, patients treated with teduglutide had evidence of increased villus height after 21 days of treatment, according to the company.

In a phase III study of 86 adults with SBS, 63% of those treated with 0.05 mg/kg daily had at least a 20% reduction in the volume of parenteral nutrition and IV fluids (the primary end point) required after 24 weeks of treatment, compared with 30% of those on placebo; this was a statistically significant difference. An extension study indicated that this effect is maintained through 1 year of treatment.

If teduglutide is approved, the company will market it as Gattex. About 10,000-15,000 adults in the United States with SBS are dependent on parenteral nutrition and IV fluids for fluid and nutrient replacement, according to NPS. Teduglutide was recently approved in Europe for the same indication. The FDA is expected to make a decision on approval by Dec. 30; if the drug is approved, the company plans to pursue studies in pediatric patients with SBS.

The two drugs currently approved by the FDA for SBS are somatropin rhGH (Zorbtive), a growth hormone approved in 2003, and L-glutamine powder for oral solution (Nutrestore), an adjunctive treatment approved in 2004.

The FDA usually follows the recommendations of its advisory panels, which are not binding. Panelists have been cleared of potential conflicts of interest related to the topic of the meeting. Occasionally, a panelist may be given a waiver, but not at this meeting.

SILVER SPRING, MD. – A Food and Drug Administration advisory panel unanimously supported the approval of teduglutide, a recombinant analogue of human glucagon-like peptide-2 (GLP-2) administered subcutaneously, as a treatment to improve the intestinal absorption of fluid and nutrients in adults with short bowel syndrome, at a meeting on Oct. 16.

The FDA’s Gastrointestinal Drugs Advisory Committee voted 12 to 0 that the benefits of teduglutide outweighed the potential risks in patients with short bowel syndrome (SBS). Clinical studies of adults with SBS, who are highly dependent on parenteral nutrition, showed that teduglutide significantly reduced the volume of parenteral nutrition and IV fluids they needed after 6 months of treatment, compared with placebo. While the panelists felt comfortable with the drug’s safety profile, they recommended that more safety data are needed. They also advised following the long-term safety and potential risks of the treatment after approval, including determining whether the risk of colorectal cancer is increased with treatment.

Produced in the small intestine and the proximal large intestine, GLP-2 is "an intestinotrophic peptide that stimulates mucosal epithelium," increasing absorption of fluids and nutrients, according to the manufacturer, NPS Pharmaceuticals. In studies, patients treated with teduglutide had evidence of increased villus height after 21 days of treatment, according to the company.

In a phase III study of 86 adults with SBS, 63% of those treated with 0.05 mg/kg daily had at least a 20% reduction in the volume of parenteral nutrition and IV fluids (the primary end point) required after 24 weeks of treatment, compared with 30% of those on placebo; this was a statistically significant difference. An extension study indicated that this effect is maintained through 1 year of treatment.

If teduglutide is approved, the company will market it as Gattex. About 10,000-15,000 adults in the United States with SBS are dependent on parenteral nutrition and IV fluids for fluid and nutrient replacement, according to NPS. Teduglutide was recently approved in Europe for the same indication. The FDA is expected to make a decision on approval by Dec. 30; if the drug is approved, the company plans to pursue studies in pediatric patients with SBS.

The two drugs currently approved by the FDA for SBS are somatropin rhGH (Zorbtive), a growth hormone approved in 2003, and L-glutamine powder for oral solution (Nutrestore), an adjunctive treatment approved in 2004.

The FDA usually follows the recommendations of its advisory panels, which are not binding. Panelists have been cleared of potential conflicts of interest related to the topic of the meeting. Occasionally, a panelist may be given a waiver, but not at this meeting.

SILVER SPRING, MD. – A Food and Drug Administration advisory panel unanimously supported the approval of teduglutide, a recombinant analogue of human glucagon-like peptide-2 (GLP-2) administered subcutaneously, as a treatment to improve the intestinal absorption of fluid and nutrients in adults with short bowel syndrome, at a meeting on Oct. 16.

The FDA’s Gastrointestinal Drugs Advisory Committee voted 12 to 0 that the benefits of teduglutide outweighed the potential risks in patients with short bowel syndrome (SBS). Clinical studies of adults with SBS, who are highly dependent on parenteral nutrition, showed that teduglutide significantly reduced the volume of parenteral nutrition and IV fluids they needed after 6 months of treatment, compared with placebo. While the panelists felt comfortable with the drug’s safety profile, they recommended that more safety data are needed. They also advised following the long-term safety and potential risks of the treatment after approval, including determining whether the risk of colorectal cancer is increased with treatment.

Produced in the small intestine and the proximal large intestine, GLP-2 is "an intestinotrophic peptide that stimulates mucosal epithelium," increasing absorption of fluids and nutrients, according to the manufacturer, NPS Pharmaceuticals. In studies, patients treated with teduglutide had evidence of increased villus height after 21 days of treatment, according to the company.

In a phase III study of 86 adults with SBS, 63% of those treated with 0.05 mg/kg daily had at least a 20% reduction in the volume of parenteral nutrition and IV fluids (the primary end point) required after 24 weeks of treatment, compared with 30% of those on placebo; this was a statistically significant difference. An extension study indicated that this effect is maintained through 1 year of treatment.

If teduglutide is approved, the company will market it as Gattex. About 10,000-15,000 adults in the United States with SBS are dependent on parenteral nutrition and IV fluids for fluid and nutrient replacement, according to NPS. Teduglutide was recently approved in Europe for the same indication. The FDA is expected to make a decision on approval by Dec. 30; if the drug is approved, the company plans to pursue studies in pediatric patients with SBS.

The two drugs currently approved by the FDA for SBS are somatropin rhGH (Zorbtive), a growth hormone approved in 2003, and L-glutamine powder for oral solution (Nutrestore), an adjunctive treatment approved in 2004.

The FDA usually follows the recommendations of its advisory panels, which are not binding. Panelists have been cleared of potential conflicts of interest related to the topic of the meeting. Occasionally, a panelist may be given a waiver, but not at this meeting.