Perioperative Medicine

An hour of intravenous anesthetic during surgery can shave a day off the hospital stay and decrease the risk of postoperative complications for some patients, according to Dr. Marcel Durieux.

Intravenous anesthetics (for example, lidocaine) exert surprising effects on recovery from some – but not all – major abdominal surgeries. They’re associated with decreased postoperative pain, quicker return of bowel function, and a shorter length of stay. But they don’t help in all surgeries – not even in all abdominal surgeries – and the way they work is still something of a mystery, he said.

The well-documented systemic benefits of surgical epidurals got anesthesiologists thinking about intravenous agents, said Dr. Durieux, professor of anesthesiology at the University of Virginia, Charlottesville. Epidurals provide excellent postoperative pain control, but it was obvious that their effects spread much farther.

"Even if the local anesthetic goes away, its beneficial effect does not."

"They do much more than just help pain," he said in an interview. "They have significant effects on surgical outcomes that can’t be explained simply by blocking sodium channels in nerves."

Because the effects span several systems, they are probably due to systemic absorption of the anesthetic agent, he said. "If improved outcomes have little to do with blocking nerves, there is no special reason to give an anesthetic near those nerves. You should be able to give it intravenously at doses that lead to blood levels similar to what we get with an epidural."

Researchers have been looking at the issue for more than a decade, and are now honing in on inflammation as the root of these postoperative problems.

A hyperinflammatory response to surgical trauma is probably the root of many postoperative problems, including pain and thrombosis, Dr. Durieux said. "The response develops during the case and lasts into the postoperative period. If it continues, it can lead to a lot of negative effects – increased cardiac strain, impaired respiratory function that can lead to respiratory distress syndrome, nausea and ileus, and a procoagulatory state."

Intravenous local anesthetics seem to suppress that response before it explodes. The drugs likely target neutrophils and the two pathways in which they respond to a bodily injury: priming and activation.

In normal activation, a neutrophil senses bacteria and generates superoxide that kills the invader, leading to the normal inflammatory response seen with an illness. But a wound, including a surgical wound, primes the neutrophils for a superresponse. "Subsequently, when they encounter bacteria, they generate 10 times the amount of superoxide, actually damaging the body," Dr. Durieux said.

In some yet-unknown way, local anesthetics appear to inhibit neutrophilic priming. "There is no other drug around that selectively blocks priming. And if you don’t prime these neutrophils during surgery, you won’t have them there 2 days after surgery causing problems. Even if the local anesthetic goes away, its beneficial effect does not."

Recognition of this prolonged anti-inflammatory effect may eventually shape the administration of intraoperative local anesthetics. Because there is no data-driven protocol, some anesthesiologists give the drug for an hour during surgery, some continue it in the recovery room, and a few want to continue it on the surgical floor.

"This is still a matter of debate. Most of the data show that the vast majority of the benefit can be achieved by giving the drug just for the duration of the case. You can leave it on in the recovery room and turn it off when the patient is ready to go to the floor."

Unfortunately, the agents seem rather selective in their benefit. A 2010 meta-analysis found it most effective in open and laparoscopic bowel surgeries, but unhelpful in small studies on tonsillectomy, arthroscopic surgery, or coronary artery bypass. Another 2010 study found the drugs didn’t have much effect in abdominal hysterectomy, but a 1998 study found it had good effect in prostatectomy.

"I can’t explain that," Dr. Durieux said. "I’m impressed by the data we have but frustrated that the benefit has been shown in just a subset of surgeries."

Although more research is necessary – and in the offing – the drugs are cheap, safe, and easy to use.

"But I’m selective in how I use it. If someone is having an open colectomy and faces prolonged painful ileus, I would consider it, for example. And for people who can’t or won’t accept an epidural, I think this is a reasonable way to go."

He disclosed that he serves on the steering committee of a clinical trial investigating a novel system for delivering local anesthetics to surgical wounds for postoperative pain relief.

An hour of intravenous anesthetic during surgery can shave a day off the hospital stay and decrease the risk of postoperative complications for some patients, according to Dr. Marcel Durieux.

Intravenous anesthetics (for example, lidocaine) exert surprising effects on recovery from some – but not all – major abdominal surgeries. They’re associated with decreased postoperative pain, quicker return of bowel function, and a shorter length of stay. But they don’t help in all surgeries – not even in all abdominal surgeries – and the way they work is still something of a mystery, he said.

The well-documented systemic benefits of surgical epidurals got anesthesiologists thinking about intravenous agents, said Dr. Durieux, professor of anesthesiology at the University of Virginia, Charlottesville. Epidurals provide excellent postoperative pain control, but it was obvious that their effects spread much farther.

"Even if the local anesthetic goes away, its beneficial effect does not."

"They do much more than just help pain," he said in an interview. "They have significant effects on surgical outcomes that can’t be explained simply by blocking sodium channels in nerves."

Because the effects span several systems, they are probably due to systemic absorption of the anesthetic agent, he said. "If improved outcomes have little to do with blocking nerves, there is no special reason to give an anesthetic near those nerves. You should be able to give it intravenously at doses that lead to blood levels similar to what we get with an epidural."

Researchers have been looking at the issue for more than a decade, and are now honing in on inflammation as the root of these postoperative problems.

A hyperinflammatory response to surgical trauma is probably the root of many postoperative problems, including pain and thrombosis, Dr. Durieux said. "The response develops during the case and lasts into the postoperative period. If it continues, it can lead to a lot of negative effects – increased cardiac strain, impaired respiratory function that can lead to respiratory distress syndrome, nausea and ileus, and a procoagulatory state."

Intravenous local anesthetics seem to suppress that response before it explodes. The drugs likely target neutrophils and the two pathways in which they respond to a bodily injury: priming and activation.

In normal activation, a neutrophil senses bacteria and generates superoxide that kills the invader, leading to the normal inflammatory response seen with an illness. But a wound, including a surgical wound, primes the neutrophils for a superresponse. "Subsequently, when they encounter bacteria, they generate 10 times the amount of superoxide, actually damaging the body," Dr. Durieux said.

In some yet-unknown way, local anesthetics appear to inhibit neutrophilic priming. "There is no other drug around that selectively blocks priming. And if you don’t prime these neutrophils during surgery, you won’t have them there 2 days after surgery causing problems. Even if the local anesthetic goes away, its beneficial effect does not."

Recognition of this prolonged anti-inflammatory effect may eventually shape the administration of intraoperative local anesthetics. Because there is no data-driven protocol, some anesthesiologists give the drug for an hour during surgery, some continue it in the recovery room, and a few want to continue it on the surgical floor.

"This is still a matter of debate. Most of the data show that the vast majority of the benefit can be achieved by giving the drug just for the duration of the case. You can leave it on in the recovery room and turn it off when the patient is ready to go to the floor."

Unfortunately, the agents seem rather selective in their benefit. A 2010 meta-analysis found it most effective in open and laparoscopic bowel surgeries, but unhelpful in small studies on tonsillectomy, arthroscopic surgery, or coronary artery bypass. Another 2010 study found the drugs didn’t have much effect in abdominal hysterectomy, but a 1998 study found it had good effect in prostatectomy.

"I can’t explain that," Dr. Durieux said. "I’m impressed by the data we have but frustrated that the benefit has been shown in just a subset of surgeries."

Although more research is necessary – and in the offing – the drugs are cheap, safe, and easy to use.

"But I’m selective in how I use it. If someone is having an open colectomy and faces prolonged painful ileus, I would consider it, for example. And for people who can’t or won’t accept an epidural, I think this is a reasonable way to go."

He disclosed that he serves on the steering committee of a clinical trial investigating a novel system for delivering local anesthetics to surgical wounds for postoperative pain relief.

An hour of intravenous anesthetic during surgery can shave a day off the hospital stay and decrease the risk of postoperative complications for some patients, according to Dr. Marcel Durieux.

Intravenous anesthetics (for example, lidocaine) exert surprising effects on recovery from some – but not all – major abdominal surgeries. They’re associated with decreased postoperative pain, quicker return of bowel function, and a shorter length of stay. But they don’t help in all surgeries – not even in all abdominal surgeries – and the way they work is still something of a mystery, he said.

The well-documented systemic benefits of surgical epidurals got anesthesiologists thinking about intravenous agents, said Dr. Durieux, professor of anesthesiology at the University of Virginia, Charlottesville. Epidurals provide excellent postoperative pain control, but it was obvious that their effects spread much farther.

"Even if the local anesthetic goes away, its beneficial effect does not."

"They do much more than just help pain," he said in an interview. "They have significant effects on surgical outcomes that can’t be explained simply by blocking sodium channels in nerves."

Because the effects span several systems, they are probably due to systemic absorption of the anesthetic agent, he said. "If improved outcomes have little to do with blocking nerves, there is no special reason to give an anesthetic near those nerves. You should be able to give it intravenously at doses that lead to blood levels similar to what we get with an epidural."

Researchers have been looking at the issue for more than a decade, and are now honing in on inflammation as the root of these postoperative problems.

A hyperinflammatory response to surgical trauma is probably the root of many postoperative problems, including pain and thrombosis, Dr. Durieux said. "The response develops during the case and lasts into the postoperative period. If it continues, it can lead to a lot of negative effects – increased cardiac strain, impaired respiratory function that can lead to respiratory distress syndrome, nausea and ileus, and a procoagulatory state."

Intravenous local anesthetics seem to suppress that response before it explodes. The drugs likely target neutrophils and the two pathways in which they respond to a bodily injury: priming and activation.

In normal activation, a neutrophil senses bacteria and generates superoxide that kills the invader, leading to the normal inflammatory response seen with an illness. But a wound, including a surgical wound, primes the neutrophils for a superresponse. "Subsequently, when they encounter bacteria, they generate 10 times the amount of superoxide, actually damaging the body," Dr. Durieux said.

In some yet-unknown way, local anesthetics appear to inhibit neutrophilic priming. "There is no other drug around that selectively blocks priming. And if you don’t prime these neutrophils during surgery, you won’t have them there 2 days after surgery causing problems. Even if the local anesthetic goes away, its beneficial effect does not."

Recognition of this prolonged anti-inflammatory effect may eventually shape the administration of intraoperative local anesthetics. Because there is no data-driven protocol, some anesthesiologists give the drug for an hour during surgery, some continue it in the recovery room, and a few want to continue it on the surgical floor.

"This is still a matter of debate. Most of the data show that the vast majority of the benefit can be achieved by giving the drug just for the duration of the case. You can leave it on in the recovery room and turn it off when the patient is ready to go to the floor."

Unfortunately, the agents seem rather selective in their benefit. A 2010 meta-analysis found it most effective in open and laparoscopic bowel surgeries, but unhelpful in small studies on tonsillectomy, arthroscopic surgery, or coronary artery bypass. Another 2010 study found the drugs didn’t have much effect in abdominal hysterectomy, but a 1998 study found it had good effect in prostatectomy.

"I can’t explain that," Dr. Durieux said. "I’m impressed by the data we have but frustrated that the benefit has been shown in just a subset of surgeries."

Although more research is necessary – and in the offing – the drugs are cheap, safe, and easy to use.

"But I’m selective in how I use it. If someone is having an open colectomy and faces prolonged painful ileus, I would consider it, for example. And for people who can’t or won’t accept an epidural, I think this is a reasonable way to go."

He disclosed that he serves on the steering committee of a clinical trial investigating a novel system for delivering local anesthetics to surgical wounds for postoperative pain relief.

For the first time, researchers say they have established benchmarks for the rates of in-hospital venous thromboembolism that occur after total or partial hip arthroplasty and after total or partial knee arthroplasty, according to a report Jan. 18 in JAMA.

In a meta-analysis of 47 studies that documented venous thromboembolism (VTE) event rates in nearly 45,000 patients who received recommended prophylaxis during hospitalization for knee or hip arthroplasty, investigators estimated that approximately 1 in every 100 patients undergoing knee arthroplasty and 1 in every 200 undergoing hip arthroplasty will develop symptomatic VTE before they are discharged.

"These estimates are of value to individual patients and clinicians in the consideration of risks and benefits" of the two procedures. They also are important because rates of in-hospital VTE are increasingly used as indicators of patient safety at individual medical centers, even though the expected background rates haven’t been established until now, said Jean-Marie Januel, a registered nurse with the Institute of Social and Preventive Medicine, Lausanne (Switzerland) University Hospital, and his associates.

"Large numbers of patients worldwide undergo hip and knee replacement procedures annually, and VTE is a widely acknowledged complication. Yet no estimate of symptomatic VTE risk prior to hospital discharge is available from the literature that can be conveyed to patients in the informed consent process," they noted.

Mr. Januel and his colleagues performed a systemic search of the literature to identify studies performed between 1996 and 2011 in which subjects undergoing either hip or knee arthroplasty received VTE prophylaxis according to published guidelines, including either low-molecular-weight heparin or inhibitors of factor Xa or IIa. They found 41 randomized clinical trials and 6 observational studies to include in the meta-analysis.

A total of 22 of the studies were performed in Europe, 14 were in North America, and 11 were in other regions. The mean duration of follow-up after either surgery was 13 days.

This included 21 studies of partial or total hip arthroplasty, 20 of partial or total knee arthroplasty, and 6 studies of both procedures, with a total of 44,844 subjects.

There were 443 cases of symptomatic postoperative VTE that developed before hospital discharge: 288 in the 23,475 knee patients and 155 in the 23,475 hip patients. This included 182 cases of deep vein thrombosis in the knee patients and 93 in the hip patients, as well as 106 cases of pulmonary embolism in the knee patients and 43 in the hip patients.

The pooled incidence rates of VTE were approximately 1% after knee arthroplasty and approximately 0.5% after hip arthroplasty. This means that the background rate of VTE is approximately 1 in 100 knee patients and 1 in 200 hip patients, the investigators said (JAMA 2012;307:294-303).

When the data were broken down by type of VTE, the pooled incidence rates were 0.26% for deep vein thrombosis and 0.14% for pulmonary embolism after knee arthroplasty. The corresponding rates were 0.63% for deep vein thrombosis and 0.27% for pulmonary embolism after hip arthroplasty.

"Given that these rates are based on the results of rigorous studies, they may represent a lower incidence than actual rates observed in clinical practice, in which patients are selected less rigorously and prophylaxis is administered less assiduously," Mr. Januel and his associates noted.

The pooled incidence rates of deep vein thrombosis were lower for both knee patients and hip patients when factor Xa or IIa inhibitors, rather than low-molecular-weight heparin, were given for prophylaxis. "However, we cannot make assertions regarding comparative efficacy among treatments, because our meta-analysis did not directly compare [these agents] as an efficacy meta-analysis would have done," they said.

This study was supported by Alberta Innovates Health Solutions, a government research funding agency, and the International Methodology Consortium for Coded Health Information, a collaboration of health sciences researchers to promote quality of care. Dr. Heit reported ties to Daiichi Sankyo, GTC, Ortho-McNeil-Jansen, the National Heart, Lung, and Blood Institute, the National Human Genome Research Institute, the National Institutes of Health, the Centers for Disease Control and Prevention, and the Mayo Foundation.

For the first time, researchers say they have established benchmarks for the rates of in-hospital venous thromboembolism that occur after total or partial hip arthroplasty and after total or partial knee arthroplasty, according to a report Jan. 18 in JAMA.

In a meta-analysis of 47 studies that documented venous thromboembolism (VTE) event rates in nearly 45,000 patients who received recommended prophylaxis during hospitalization for knee or hip arthroplasty, investigators estimated that approximately 1 in every 100 patients undergoing knee arthroplasty and 1 in every 200 undergoing hip arthroplasty will develop symptomatic VTE before they are discharged.

"These estimates are of value to individual patients and clinicians in the consideration of risks and benefits" of the two procedures. They also are important because rates of in-hospital VTE are increasingly used as indicators of patient safety at individual medical centers, even though the expected background rates haven’t been established until now, said Jean-Marie Januel, a registered nurse with the Institute of Social and Preventive Medicine, Lausanne (Switzerland) University Hospital, and his associates.

"Large numbers of patients worldwide undergo hip and knee replacement procedures annually, and VTE is a widely acknowledged complication. Yet no estimate of symptomatic VTE risk prior to hospital discharge is available from the literature that can be conveyed to patients in the informed consent process," they noted.

Mr. Januel and his colleagues performed a systemic search of the literature to identify studies performed between 1996 and 2011 in which subjects undergoing either hip or knee arthroplasty received VTE prophylaxis according to published guidelines, including either low-molecular-weight heparin or inhibitors of factor Xa or IIa. They found 41 randomized clinical trials and 6 observational studies to include in the meta-analysis.

A total of 22 of the studies were performed in Europe, 14 were in North America, and 11 were in other regions. The mean duration of follow-up after either surgery was 13 days.

This included 21 studies of partial or total hip arthroplasty, 20 of partial or total knee arthroplasty, and 6 studies of both procedures, with a total of 44,844 subjects.

There were 443 cases of symptomatic postoperative VTE that developed before hospital discharge: 288 in the 23,475 knee patients and 155 in the 23,475 hip patients. This included 182 cases of deep vein thrombosis in the knee patients and 93 in the hip patients, as well as 106 cases of pulmonary embolism in the knee patients and 43 in the hip patients.

The pooled incidence rates of VTE were approximately 1% after knee arthroplasty and approximately 0.5% after hip arthroplasty. This means that the background rate of VTE is approximately 1 in 100 knee patients and 1 in 200 hip patients, the investigators said (JAMA 2012;307:294-303).

When the data were broken down by type of VTE, the pooled incidence rates were 0.26% for deep vein thrombosis and 0.14% for pulmonary embolism after knee arthroplasty. The corresponding rates were 0.63% for deep vein thrombosis and 0.27% for pulmonary embolism after hip arthroplasty.

"Given that these rates are based on the results of rigorous studies, they may represent a lower incidence than actual rates observed in clinical practice, in which patients are selected less rigorously and prophylaxis is administered less assiduously," Mr. Januel and his associates noted.

The pooled incidence rates of deep vein thrombosis were lower for both knee patients and hip patients when factor Xa or IIa inhibitors, rather than low-molecular-weight heparin, were given for prophylaxis. "However, we cannot make assertions regarding comparative efficacy among treatments, because our meta-analysis did not directly compare [these agents] as an efficacy meta-analysis would have done," they said.

This study was supported by Alberta Innovates Health Solutions, a government research funding agency, and the International Methodology Consortium for Coded Health Information, a collaboration of health sciences researchers to promote quality of care. Dr. Heit reported ties to Daiichi Sankyo, GTC, Ortho-McNeil-Jansen, the National Heart, Lung, and Blood Institute, the National Human Genome Research Institute, the National Institutes of Health, the Centers for Disease Control and Prevention, and the Mayo Foundation.

For the first time, researchers say they have established benchmarks for the rates of in-hospital venous thromboembolism that occur after total or partial hip arthroplasty and after total or partial knee arthroplasty, according to a report Jan. 18 in JAMA.

In a meta-analysis of 47 studies that documented venous thromboembolism (VTE) event rates in nearly 45,000 patients who received recommended prophylaxis during hospitalization for knee or hip arthroplasty, investigators estimated that approximately 1 in every 100 patients undergoing knee arthroplasty and 1 in every 200 undergoing hip arthroplasty will develop symptomatic VTE before they are discharged.

"These estimates are of value to individual patients and clinicians in the consideration of risks and benefits" of the two procedures. They also are important because rates of in-hospital VTE are increasingly used as indicators of patient safety at individual medical centers, even though the expected background rates haven’t been established until now, said Jean-Marie Januel, a registered nurse with the Institute of Social and Preventive Medicine, Lausanne (Switzerland) University Hospital, and his associates.

"Large numbers of patients worldwide undergo hip and knee replacement procedures annually, and VTE is a widely acknowledged complication. Yet no estimate of symptomatic VTE risk prior to hospital discharge is available from the literature that can be conveyed to patients in the informed consent process," they noted.

Mr. Januel and his colleagues performed a systemic search of the literature to identify studies performed between 1996 and 2011 in which subjects undergoing either hip or knee arthroplasty received VTE prophylaxis according to published guidelines, including either low-molecular-weight heparin or inhibitors of factor Xa or IIa. They found 41 randomized clinical trials and 6 observational studies to include in the meta-analysis.

A total of 22 of the studies were performed in Europe, 14 were in North America, and 11 were in other regions. The mean duration of follow-up after either surgery was 13 days.

This included 21 studies of partial or total hip arthroplasty, 20 of partial or total knee arthroplasty, and 6 studies of both procedures, with a total of 44,844 subjects.

There were 443 cases of symptomatic postoperative VTE that developed before hospital discharge: 288 in the 23,475 knee patients and 155 in the 23,475 hip patients. This included 182 cases of deep vein thrombosis in the knee patients and 93 in the hip patients, as well as 106 cases of pulmonary embolism in the knee patients and 43 in the hip patients.

The pooled incidence rates of VTE were approximately 1% after knee arthroplasty and approximately 0.5% after hip arthroplasty. This means that the background rate of VTE is approximately 1 in 100 knee patients and 1 in 200 hip patients, the investigators said (JAMA 2012;307:294-303).

When the data were broken down by type of VTE, the pooled incidence rates were 0.26% for deep vein thrombosis and 0.14% for pulmonary embolism after knee arthroplasty. The corresponding rates were 0.63% for deep vein thrombosis and 0.27% for pulmonary embolism after hip arthroplasty.

"Given that these rates are based on the results of rigorous studies, they may represent a lower incidence than actual rates observed in clinical practice, in which patients are selected less rigorously and prophylaxis is administered less assiduously," Mr. Januel and his associates noted.

The pooled incidence rates of deep vein thrombosis were lower for both knee patients and hip patients when factor Xa or IIa inhibitors, rather than low-molecular-weight heparin, were given for prophylaxis. "However, we cannot make assertions regarding comparative efficacy among treatments, because our meta-analysis did not directly compare [these agents] as an efficacy meta-analysis would have done," they said.

This study was supported by Alberta Innovates Health Solutions, a government research funding agency, and the International Methodology Consortium for Coded Health Information, a collaboration of health sciences researchers to promote quality of care. Dr. Heit reported ties to Daiichi Sankyo, GTC, Ortho-McNeil-Jansen, the National Heart, Lung, and Blood Institute, the National Human Genome Research Institute, the National Institutes of Health, the Centers for Disease Control and Prevention, and the Mayo Foundation.

MIAMI BEACH – Local or regional anesthesia is a better option than is general anesthesia for patients undergoing endovascular repair of an abdominal aortic aneurysm, based on findings from a registry with nearly 1,200 patients.

Both local anesthesia and regional anesthesia each surpassed general anesthesia in two periprocedural measures: significantly reducing procedure time, and significantly reducing postoperative hospitalization, Dr. Rutger A. Stokmans said at ISET 2012, an international symposium on endovascular therapy.

In addition, both local and regional anesthesia led to trends in reduced rates of major adverse events during the 30 days following surgery, although these differences did not reach statistical significance. All three anesthesia types linked with similar rates of both technical and clinical success of the aneurysm repairs. Regional anesthesia also led to a significantly lower rate of ICU admission, compared with both general and local anesthesia; local anesthesia showed no significant difference for this measure, compared with general anesthesia.

Based on these findings, local or regional anesthesia should be preferred when performing endovascular aneurysm repair (EVAR), whereas general anesthesia should usually be avoided, said Dr. Stokmans, a vascular surgeon at Catharina Hospital in Eindhoven, the Netherlands.

These findings support the most recent anesthesia recommendations of the European Society for Vascular Surgery, which in 2011 guidelines for managing abdominal aortic aneurysms (AAA) cited local anesthesia as preferred for EVAR, with regional or general anesthesia reserved for patients with contraindications for local anesthesia, he said (Euro. J. Vasc. Endovasc. Surg .2011;41[suppl. 1]:S1-S58). The most recent guidelines for AAA management from the Society for Vascular Surgery suggested using local or regional anesthesia over general anesthesia, he added (J. Vasc. Surg. 2009[suppl.]:50:S2-S49).

But despite these recommendations, the most commonly used anesthesia type worldwide for EVAR repair of AAA has been general anesthesia, followed by regional anesthesia, with local treatment used least often, according to the registry data reported by Dr. Stokmans. Among the 1,199 patients enrolled in ENGAGE (Endurant Stent Graft Natural Selection Global Postmarketing Registry) during March 2009 to December 2010 in 30 countries on five continents, 749 (62%) underwent their EVAR with general anesthesia, 325 (27%) with regional, and 125 (10%) with local anesthesia. (Percentages do not add up to 100% because of rounding.)

The registry data also showed striking regional variations in anesthesia use, with general anesthesia used on about 90% of patients in Canada, Australia, and New Zealand, and on about 70% of patients in Scandinavian countries and the United Kingdom. But in Central Europe, regional anesthesia – used on nearly 70% of EVAR patients – dominated. The only region favoring local anesthesia was South America (Argentina, Columbia, and Uruguay), where about 50% of patients received local, but more than 40% received general anesthesia, he said. The registry contained no U.S. patients, although the Endurant AAA stent graft system is marketed in the United States.

The average age of the EVAR patients in the registry was about 73 years. Those patients who underwent general anesthesia were significantly older, by an average of about 18 months, compared with those who received local or regional anesthesia.

The proportions of patients undergoing general, regional, or local anesthesia were similar in the subgroups of patients with American Society of Anesthesiologists (ASA) physical status scores of 1, 2, or 3. However, among the highest-risk patients included in the study – those with an ASA score of 4 – a significantly greater proportion of patients received general anesthesia. The multivariate models used in the analysis, therefore, were adjusted for age and for ASA score. About 42% of patients were in ASA class 2, and another 42% in class 3.

All patients were hemodynamically stable at the time of their enrollment. The maximum AAA diameter of registry patients was 6 cm, and about 88% of patients had an AAA diameter greater than 5 cm.

Average procedure times were 106 minutes in the general anesthesia patients, 95 minutes in the regional patients, and 81 minutes in the local anesthesia patients – statistically significant differences among the three groups.

The average postoperative hospitalization was 5.2 days in the general anesthesia patients, 4.3 days in the regional patients, and 3.6 days in the local anesthesia patients, differences that were statistically significant among each of the three groups.

The rate of technical surgical success was 98% in all three subgroups, and the rate of clinical success reached 97%-98% in all three groups.

The rates of major adverse events during the 30 days following surgery were 5.1% in the general anesthesia patients, 3.2% in the local patients, and 2.2% in the regional anesthesia patients. None of these differences reached statistical significance. Major adverse events included death, MI, stroke, renal failure, blood loss greater than 1 L, and bowel ischemia. No patients developed paraplegia or respiratory failure.

Postoperative ICU admission occurred for 27% of the regional anesthesia patients, 35% of the general patients, and 42% of the local anesthesia patients. The rate among the regional patients was significantly less than in the other two groups, but the difference in rates between the general and local anesthesia patients did not reach statistical significance.

The ENGAGE registry was organized and sponsored by Medtronic, which markets the Endurant stent. Dr. Stokmans and his associates received an unrestricted research grant from Medtronic. Dr. Stokmans said that he had no other disclosures.

MIAMI BEACH – Local or regional anesthesia is a better option than is general anesthesia for patients undergoing endovascular repair of an abdominal aortic aneurysm, based on findings from a registry with nearly 1,200 patients.

Both local anesthesia and regional anesthesia each surpassed general anesthesia in two periprocedural measures: significantly reducing procedure time, and significantly reducing postoperative hospitalization, Dr. Rutger A. Stokmans said at ISET 2012, an international symposium on endovascular therapy.

In addition, both local and regional anesthesia led to trends in reduced rates of major adverse events during the 30 days following surgery, although these differences did not reach statistical significance. All three anesthesia types linked with similar rates of both technical and clinical success of the aneurysm repairs. Regional anesthesia also led to a significantly lower rate of ICU admission, compared with both general and local anesthesia; local anesthesia showed no significant difference for this measure, compared with general anesthesia.

Based on these findings, local or regional anesthesia should be preferred when performing endovascular aneurysm repair (EVAR), whereas general anesthesia should usually be avoided, said Dr. Stokmans, a vascular surgeon at Catharina Hospital in Eindhoven, the Netherlands.

These findings support the most recent anesthesia recommendations of the European Society for Vascular Surgery, which in 2011 guidelines for managing abdominal aortic aneurysms (AAA) cited local anesthesia as preferred for EVAR, with regional or general anesthesia reserved for patients with contraindications for local anesthesia, he said (Euro. J. Vasc. Endovasc. Surg .2011;41[suppl. 1]:S1-S58). The most recent guidelines for AAA management from the Society for Vascular Surgery suggested using local or regional anesthesia over general anesthesia, he added (J. Vasc. Surg. 2009[suppl.]:50:S2-S49).

But despite these recommendations, the most commonly used anesthesia type worldwide for EVAR repair of AAA has been general anesthesia, followed by regional anesthesia, with local treatment used least often, according to the registry data reported by Dr. Stokmans. Among the 1,199 patients enrolled in ENGAGE (Endurant Stent Graft Natural Selection Global Postmarketing Registry) during March 2009 to December 2010 in 30 countries on five continents, 749 (62%) underwent their EVAR with general anesthesia, 325 (27%) with regional, and 125 (10%) with local anesthesia. (Percentages do not add up to 100% because of rounding.)

The registry data also showed striking regional variations in anesthesia use, with general anesthesia used on about 90% of patients in Canada, Australia, and New Zealand, and on about 70% of patients in Scandinavian countries and the United Kingdom. But in Central Europe, regional anesthesia – used on nearly 70% of EVAR patients – dominated. The only region favoring local anesthesia was South America (Argentina, Columbia, and Uruguay), where about 50% of patients received local, but more than 40% received general anesthesia, he said. The registry contained no U.S. patients, although the Endurant AAA stent graft system is marketed in the United States.

The average age of the EVAR patients in the registry was about 73 years. Those patients who underwent general anesthesia were significantly older, by an average of about 18 months, compared with those who received local or regional anesthesia.

The proportions of patients undergoing general, regional, or local anesthesia were similar in the subgroups of patients with American Society of Anesthesiologists (ASA) physical status scores of 1, 2, or 3. However, among the highest-risk patients included in the study – those with an ASA score of 4 – a significantly greater proportion of patients received general anesthesia. The multivariate models used in the analysis, therefore, were adjusted for age and for ASA score. About 42% of patients were in ASA class 2, and another 42% in class 3.

All patients were hemodynamically stable at the time of their enrollment. The maximum AAA diameter of registry patients was 6 cm, and about 88% of patients had an AAA diameter greater than 5 cm.

Average procedure times were 106 minutes in the general anesthesia patients, 95 minutes in the regional patients, and 81 minutes in the local anesthesia patients – statistically significant differences among the three groups.

The average postoperative hospitalization was 5.2 days in the general anesthesia patients, 4.3 days in the regional patients, and 3.6 days in the local anesthesia patients, differences that were statistically significant among each of the three groups.

The rate of technical surgical success was 98% in all three subgroups, and the rate of clinical success reached 97%-98% in all three groups.

The rates of major adverse events during the 30 days following surgery were 5.1% in the general anesthesia patients, 3.2% in the local patients, and 2.2% in the regional anesthesia patients. None of these differences reached statistical significance. Major adverse events included death, MI, stroke, renal failure, blood loss greater than 1 L, and bowel ischemia. No patients developed paraplegia or respiratory failure.

Postoperative ICU admission occurred for 27% of the regional anesthesia patients, 35% of the general patients, and 42% of the local anesthesia patients. The rate among the regional patients was significantly less than in the other two groups, but the difference in rates between the general and local anesthesia patients did not reach statistical significance.

The ENGAGE registry was organized and sponsored by Medtronic, which markets the Endurant stent. Dr. Stokmans and his associates received an unrestricted research grant from Medtronic. Dr. Stokmans said that he had no other disclosures.

MIAMI BEACH – Local or regional anesthesia is a better option than is general anesthesia for patients undergoing endovascular repair of an abdominal aortic aneurysm, based on findings from a registry with nearly 1,200 patients.

Both local anesthesia and regional anesthesia each surpassed general anesthesia in two periprocedural measures: significantly reducing procedure time, and significantly reducing postoperative hospitalization, Dr. Rutger A. Stokmans said at ISET 2012, an international symposium on endovascular therapy.

In addition, both local and regional anesthesia led to trends in reduced rates of major adverse events during the 30 days following surgery, although these differences did not reach statistical significance. All three anesthesia types linked with similar rates of both technical and clinical success of the aneurysm repairs. Regional anesthesia also led to a significantly lower rate of ICU admission, compared with both general and local anesthesia; local anesthesia showed no significant difference for this measure, compared with general anesthesia.

Based on these findings, local or regional anesthesia should be preferred when performing endovascular aneurysm repair (EVAR), whereas general anesthesia should usually be avoided, said Dr. Stokmans, a vascular surgeon at Catharina Hospital in Eindhoven, the Netherlands.

These findings support the most recent anesthesia recommendations of the European Society for Vascular Surgery, which in 2011 guidelines for managing abdominal aortic aneurysms (AAA) cited local anesthesia as preferred for EVAR, with regional or general anesthesia reserved for patients with contraindications for local anesthesia, he said (Euro. J. Vasc. Endovasc. Surg .2011;41[suppl. 1]:S1-S58). The most recent guidelines for AAA management from the Society for Vascular Surgery suggested using local or regional anesthesia over general anesthesia, he added (J. Vasc. Surg. 2009[suppl.]:50:S2-S49).

But despite these recommendations, the most commonly used anesthesia type worldwide for EVAR repair of AAA has been general anesthesia, followed by regional anesthesia, with local treatment used least often, according to the registry data reported by Dr. Stokmans. Among the 1,199 patients enrolled in ENGAGE (Endurant Stent Graft Natural Selection Global Postmarketing Registry) during March 2009 to December 2010 in 30 countries on five continents, 749 (62%) underwent their EVAR with general anesthesia, 325 (27%) with regional, and 125 (10%) with local anesthesia. (Percentages do not add up to 100% because of rounding.)

The registry data also showed striking regional variations in anesthesia use, with general anesthesia used on about 90% of patients in Canada, Australia, and New Zealand, and on about 70% of patients in Scandinavian countries and the United Kingdom. But in Central Europe, regional anesthesia – used on nearly 70% of EVAR patients – dominated. The only region favoring local anesthesia was South America (Argentina, Columbia, and Uruguay), where about 50% of patients received local, but more than 40% received general anesthesia, he said. The registry contained no U.S. patients, although the Endurant AAA stent graft system is marketed in the United States.

The average age of the EVAR patients in the registry was about 73 years. Those patients who underwent general anesthesia were significantly older, by an average of about 18 months, compared with those who received local or regional anesthesia.

The proportions of patients undergoing general, regional, or local anesthesia were similar in the subgroups of patients with American Society of Anesthesiologists (ASA) physical status scores of 1, 2, or 3. However, among the highest-risk patients included in the study – those with an ASA score of 4 – a significantly greater proportion of patients received general anesthesia. The multivariate models used in the analysis, therefore, were adjusted for age and for ASA score. About 42% of patients were in ASA class 2, and another 42% in class 3.

All patients were hemodynamically stable at the time of their enrollment. The maximum AAA diameter of registry patients was 6 cm, and about 88% of patients had an AAA diameter greater than 5 cm.

Average procedure times were 106 minutes in the general anesthesia patients, 95 minutes in the regional patients, and 81 minutes in the local anesthesia patients – statistically significant differences among the three groups.

The average postoperative hospitalization was 5.2 days in the general anesthesia patients, 4.3 days in the regional patients, and 3.6 days in the local anesthesia patients, differences that were statistically significant among each of the three groups.

The rate of technical surgical success was 98% in all three subgroups, and the rate of clinical success reached 97%-98% in all three groups.

The rates of major adverse events during the 30 days following surgery were 5.1% in the general anesthesia patients, 3.2% in the local patients, and 2.2% in the regional anesthesia patients. None of these differences reached statistical significance. Major adverse events included death, MI, stroke, renal failure, blood loss greater than 1 L, and bowel ischemia. No patients developed paraplegia or respiratory failure.

Postoperative ICU admission occurred for 27% of the regional anesthesia patients, 35% of the general patients, and 42% of the local anesthesia patients. The rate among the regional patients was significantly less than in the other two groups, but the difference in rates between the general and local anesthesia patients did not reach statistical significance.

The ENGAGE registry was organized and sponsored by Medtronic, which markets the Endurant stent. Dr. Stokmans and his associates received an unrestricted research grant from Medtronic. Dr. Stokmans said that he had no other disclosures.

All patients admitted to the hospital in noncritical care settings should have their blood glucose tested, according to a new clinical practice guideline from the Endocrine Society.

Unlike previous guidelines based largely on data from intensive care and critical care settings, the new guideline focuses on glucose management in noncritical settings, with special emphasis on systemic issues such as patient transition between hospital units and from inpatient to outpatient settings. The guidelines also include detailed guidance for creating systems and protocols to ensure optimal patient management and safety (Diabetes Care [2009;32:1119-31]).

"Management of Hyperglycemia in Hospitalized Patients in Non-Critical Care Setting: An Endocrine Society Clinical Practice Guideline" was developed by an eight-member panel with representatives from the American Diabetes Association, American Heart Association, American Association of Diabetes Educators, European Society of Endocrinology, and the Society of Hospital Medicine. The lead author was Dr. Guillermo E. Umpierrez, professor of medicine at Emory University, and chief of diabetes and endocrinology at Grady Memorial Hospital, both in Atlanta.

The guideline has eight sections, all focused on the noncritical hospital setting: diagnosis and recognition of hyperglycemia and diabetes, monitoring glycemia, glycemic targets, management of hyperglycemia, special situations, recognition and management of hypoglycemia, implementation of a glycemic control program, and patient and professional education.

The panel’s advice was characterized as "recommended" for items with strong evidence and "suggested" for items with less evidence. In the first of the guideline’s eight sections, the panel recommended all patients be assessed on admission for a history of diabetes and suggested laboratory blood glucose testing on admission for all patients, regardless of prior diagnosis of diabetes.

"There’s abundant data to show that a very large number of people … [are admitted] with undiagnosed diabetes and people also develop stress hyperglycemia" and both conditions affect patient outcomes, Dr. Richard Hellman said in an interview. Dr. Hellman is a coauthor of the guidelines and an endocrinologist who is a clinical professor of medicine at the University of Missouri–Kansas City.

<[stk -3]>While the accuracy of point-of-care testing is not optimal, the panel recommended bedside glucose testing of capillary blood because of the need to time glucose measures to the patient’s nutritional intake and medication regimens. Personal glucose meters should not be used, and continuous glucose monitors while "promising," have not been adequately tested in acute care and therefore can’t be recommended for hospital use at this time, Dr. Umpierrez and his associates wrote.<[etk]>

As in the 2009 guideline that addressed critical care patients, the glycemic targets are less than 140 mg/dL premeal and less than 180 mg/dL random for the majority of hospitalized patients with noncritical illness. Lower targets might be considered among patients who are able to achieve them without hypoglycemia, while higher targets might be appropriate for those at high risk for hypoglycemia and those with a limited life expectancy.

Medical nutrition therapy is recommended as a component of the glycemic management program for all hospitalized patients with diabetes and hyperglycemia. Meals with consistent amounts of carbohydrate are suggested to help coordinate dosing of rapid-acting insulin.

Insulin therapy is the preferred method for achieving glycemic control in all hospitalized patients with diabetes and hyperglycemia, the panel said. At admission, they suggested, oral hypoglycemic agents should be discontinued and insulin therapy should be initiated in acutely ill patients with type 2 diabetes. Oral agents are contraindicated in hospitalized patients with decompensated heart failure, renal insufficiency, hypoperfusion, or chronic pulmonary disease, and in any patient given intravenous contrast dye, the authors noted.

<[stk -3]>For patients who are eating, the panel recommended scheduled subcutaneous basal or intermediate-acting insulin once or twice daily in combination with rapid- or short-acting insulin administered before meals. <[etk]>

Prolonged use of sliding-scale therapy should be avoided as the sole method for glycemic control, the panel wrote.

"There’s abundant data to show that a very large number of people [are admitted] with undiagnosed diabetes and people also develop stress hyperglycemia."

<[stk -3]>Two recent studies led by Dr. Umpierrez show basal-bolus insulin regimens to be superior to sliding scale insulin treatment. One of those studies was done in noncritically ill hospitalized patients with type 2 diabetes (Diabetes Care 2007;30:2181-6), and the other was done in type 2 patients undergoing general surgery (Diabetes Care 2011;34:256-61). <[etk]>

Diabetes self-management education is recommended for patients, including both short-term "survival skills" education in the hospital and referral to community sources for ongoing patient education following discharge.

At discharge, the patient’s preadmission regimen – either insulin or oral and noninsulin injectable antidiabetic drugs – can be reinstituted so long as the patient’s preadmission glycemic control was good and there are no contraindications. To assess safety and efficacy, insulin administration should be initiated at least 1 day before discharge. Patients and their caregivers should receive oral and written instructions for home glycemic management.

The guidelines also address transition from intravenous to subcutaneous insulin therapy, glycemic management of patients who are receiving enteral or parenteral nutrition, perioperative blood glucose control, and management of glucocorticoid-induced diabetes.

<[stk -3]>The panel recommended the development of protocols with specific directions for avoiding and managing hypoglycemia as well as the implementation of hospital-wide, nurse-initiated hypoglycemia treatment protocols and a system for tracking with root cause analysis the frequency of hypoglycemic events. The document lists key components of such protocols, and provides suggested nurse-initiated strategies.<[etk]>

<[stk -3]>Hospitals are advised to provide administrative support for an interdisciplinary steering committee targeting a systems approach to improve care of inpatients with hyperglycemia and diabetes. Uniform methods for collecting and evaluating point-of-care testing data and insulin use information in hospitals are recommended, as are the provision of accurate devices for glucose measurement at the bedside with ongoing staff education and competency assessments.

Dr. Hellman and Dr. Umpierrez have no financial disclosures, but three other members of the guideline panel declared relationships with manufacturers of diabetes-related products.

All patients admitted to the hospital in noncritical care settings should have their blood glucose tested, according to a new clinical practice guideline from the Endocrine Society.

Unlike previous guidelines based largely on data from intensive care and critical care settings, the new guideline focuses on glucose management in noncritical settings, with special emphasis on systemic issues such as patient transition between hospital units and from inpatient to outpatient settings. The guidelines also include detailed guidance for creating systems and protocols to ensure optimal patient management and safety (Diabetes Care [2009;32:1119-31]).

"Management of Hyperglycemia in Hospitalized Patients in Non-Critical Care Setting: An Endocrine Society Clinical Practice Guideline" was developed by an eight-member panel with representatives from the American Diabetes Association, American Heart Association, American Association of Diabetes Educators, European Society of Endocrinology, and the Society of Hospital Medicine. The lead author was Dr. Guillermo E. Umpierrez, professor of medicine at Emory University, and chief of diabetes and endocrinology at Grady Memorial Hospital, both in Atlanta.

The guideline has eight sections, all focused on the noncritical hospital setting: diagnosis and recognition of hyperglycemia and diabetes, monitoring glycemia, glycemic targets, management of hyperglycemia, special situations, recognition and management of hypoglycemia, implementation of a glycemic control program, and patient and professional education.

The panel’s advice was characterized as "recommended" for items with strong evidence and "suggested" for items with less evidence. In the first of the guideline’s eight sections, the panel recommended all patients be assessed on admission for a history of diabetes and suggested laboratory blood glucose testing on admission for all patients, regardless of prior diagnosis of diabetes.

"There’s abundant data to show that a very large number of people … [are admitted] with undiagnosed diabetes and people also develop stress hyperglycemia" and both conditions affect patient outcomes, Dr. Richard Hellman said in an interview. Dr. Hellman is a coauthor of the guidelines and an endocrinologist who is a clinical professor of medicine at the University of Missouri–Kansas City.

<[stk -3]>While the accuracy of point-of-care testing is not optimal, the panel recommended bedside glucose testing of capillary blood because of the need to time glucose measures to the patient’s nutritional intake and medication regimens. Personal glucose meters should not be used, and continuous glucose monitors while "promising," have not been adequately tested in acute care and therefore can’t be recommended for hospital use at this time, Dr. Umpierrez and his associates wrote.<[etk]>

As in the 2009 guideline that addressed critical care patients, the glycemic targets are less than 140 mg/dL premeal and less than 180 mg/dL random for the majority of hospitalized patients with noncritical illness. Lower targets might be considered among patients who are able to achieve them without hypoglycemia, while higher targets might be appropriate for those at high risk for hypoglycemia and those with a limited life expectancy.

Medical nutrition therapy is recommended as a component of the glycemic management program for all hospitalized patients with diabetes and hyperglycemia. Meals with consistent amounts of carbohydrate are suggested to help coordinate dosing of rapid-acting insulin.

Insulin therapy is the preferred method for achieving glycemic control in all hospitalized patients with diabetes and hyperglycemia, the panel said. At admission, they suggested, oral hypoglycemic agents should be discontinued and insulin therapy should be initiated in acutely ill patients with type 2 diabetes. Oral agents are contraindicated in hospitalized patients with decompensated heart failure, renal insufficiency, hypoperfusion, or chronic pulmonary disease, and in any patient given intravenous contrast dye, the authors noted.

<[stk -3]>For patients who are eating, the panel recommended scheduled subcutaneous basal or intermediate-acting insulin once or twice daily in combination with rapid- or short-acting insulin administered before meals. <[etk]>

Prolonged use of sliding-scale therapy should be avoided as the sole method for glycemic control, the panel wrote.

"There’s abundant data to show that a very large number of people [are admitted] with undiagnosed diabetes and people also develop stress hyperglycemia."

<[stk -3]>Two recent studies led by Dr. Umpierrez show basal-bolus insulin regimens to be superior to sliding scale insulin treatment. One of those studies was done in noncritically ill hospitalized patients with type 2 diabetes (Diabetes Care 2007;30:2181-6), and the other was done in type 2 patients undergoing general surgery (Diabetes Care 2011;34:256-61). <[etk]>

Diabetes self-management education is recommended for patients, including both short-term "survival skills" education in the hospital and referral to community sources for ongoing patient education following discharge.

At discharge, the patient’s preadmission regimen – either insulin or oral and noninsulin injectable antidiabetic drugs – can be reinstituted so long as the patient’s preadmission glycemic control was good and there are no contraindications. To assess safety and efficacy, insulin administration should be initiated at least 1 day before discharge. Patients and their caregivers should receive oral and written instructions for home glycemic management.

The guidelines also address transition from intravenous to subcutaneous insulin therapy, glycemic management of patients who are receiving enteral or parenteral nutrition, perioperative blood glucose control, and management of glucocorticoid-induced diabetes.

<[stk -3]>The panel recommended the development of protocols with specific directions for avoiding and managing hypoglycemia as well as the implementation of hospital-wide, nurse-initiated hypoglycemia treatment protocols and a system for tracking with root cause analysis the frequency of hypoglycemic events. The document lists key components of such protocols, and provides suggested nurse-initiated strategies.<[etk]>

<[stk -3]>Hospitals are advised to provide administrative support for an interdisciplinary steering committee targeting a systems approach to improve care of inpatients with hyperglycemia and diabetes. Uniform methods for collecting and evaluating point-of-care testing data and insulin use information in hospitals are recommended, as are the provision of accurate devices for glucose measurement at the bedside with ongoing staff education and competency assessments.

Dr. Hellman and Dr. Umpierrez have no financial disclosures, but three other members of the guideline panel declared relationships with manufacturers of diabetes-related products.

All patients admitted to the hospital in noncritical care settings should have their blood glucose tested, according to a new clinical practice guideline from the Endocrine Society.

Unlike previous guidelines based largely on data from intensive care and critical care settings, the new guideline focuses on glucose management in noncritical settings, with special emphasis on systemic issues such as patient transition between hospital units and from inpatient to outpatient settings. The guidelines also include detailed guidance for creating systems and protocols to ensure optimal patient management and safety (Diabetes Care [2009;32:1119-31]).

"Management of Hyperglycemia in Hospitalized Patients in Non-Critical Care Setting: An Endocrine Society Clinical Practice Guideline" was developed by an eight-member panel with representatives from the American Diabetes Association, American Heart Association, American Association of Diabetes Educators, European Society of Endocrinology, and the Society of Hospital Medicine. The lead author was Dr. Guillermo E. Umpierrez, professor of medicine at Emory University, and chief of diabetes and endocrinology at Grady Memorial Hospital, both in Atlanta.

The guideline has eight sections, all focused on the noncritical hospital setting: diagnosis and recognition of hyperglycemia and diabetes, monitoring glycemia, glycemic targets, management of hyperglycemia, special situations, recognition and management of hypoglycemia, implementation of a glycemic control program, and patient and professional education.

The panel’s advice was characterized as "recommended" for items with strong evidence and "suggested" for items with less evidence. In the first of the guideline’s eight sections, the panel recommended all patients be assessed on admission for a history of diabetes and suggested laboratory blood glucose testing on admission for all patients, regardless of prior diagnosis of diabetes.

"There’s abundant data to show that a very large number of people … [are admitted] with undiagnosed diabetes and people also develop stress hyperglycemia" and both conditions affect patient outcomes, Dr. Richard Hellman said in an interview. Dr. Hellman is a coauthor of the guidelines and an endocrinologist who is a clinical professor of medicine at the University of Missouri–Kansas City.

<[stk -3]>While the accuracy of point-of-care testing is not optimal, the panel recommended bedside glucose testing of capillary blood because of the need to time glucose measures to the patient’s nutritional intake and medication regimens. Personal glucose meters should not be used, and continuous glucose monitors while "promising," have not been adequately tested in acute care and therefore can’t be recommended for hospital use at this time, Dr. Umpierrez and his associates wrote.<[etk]>

As in the 2009 guideline that addressed critical care patients, the glycemic targets are less than 140 mg/dL premeal and less than 180 mg/dL random for the majority of hospitalized patients with noncritical illness. Lower targets might be considered among patients who are able to achieve them without hypoglycemia, while higher targets might be appropriate for those at high risk for hypoglycemia and those with a limited life expectancy.

Medical nutrition therapy is recommended as a component of the glycemic management program for all hospitalized patients with diabetes and hyperglycemia. Meals with consistent amounts of carbohydrate are suggested to help coordinate dosing of rapid-acting insulin.

Insulin therapy is the preferred method for achieving glycemic control in all hospitalized patients with diabetes and hyperglycemia, the panel said. At admission, they suggested, oral hypoglycemic agents should be discontinued and insulin therapy should be initiated in acutely ill patients with type 2 diabetes. Oral agents are contraindicated in hospitalized patients with decompensated heart failure, renal insufficiency, hypoperfusion, or chronic pulmonary disease, and in any patient given intravenous contrast dye, the authors noted.

<[stk -3]>For patients who are eating, the panel recommended scheduled subcutaneous basal or intermediate-acting insulin once or twice daily in combination with rapid- or short-acting insulin administered before meals. <[etk]>

Prolonged use of sliding-scale therapy should be avoided as the sole method for glycemic control, the panel wrote.

"There’s abundant data to show that a very large number of people [are admitted] with undiagnosed diabetes and people also develop stress hyperglycemia."

<[stk -3]>Two recent studies led by Dr. Umpierrez show basal-bolus insulin regimens to be superior to sliding scale insulin treatment. One of those studies was done in noncritically ill hospitalized patients with type 2 diabetes (Diabetes Care 2007;30:2181-6), and the other was done in type 2 patients undergoing general surgery (Diabetes Care 2011;34:256-61). <[etk]>

Diabetes self-management education is recommended for patients, including both short-term "survival skills" education in the hospital and referral to community sources for ongoing patient education following discharge.

At discharge, the patient’s preadmission regimen – either insulin or oral and noninsulin injectable antidiabetic drugs – can be reinstituted so long as the patient’s preadmission glycemic control was good and there are no contraindications. To assess safety and efficacy, insulin administration should be initiated at least 1 day before discharge. Patients and their caregivers should receive oral and written instructions for home glycemic management.

The guidelines also address transition from intravenous to subcutaneous insulin therapy, glycemic management of patients who are receiving enteral or parenteral nutrition, perioperative blood glucose control, and management of glucocorticoid-induced diabetes.

<[stk -3]>The panel recommended the development of protocols with specific directions for avoiding and managing hypoglycemia as well as the implementation of hospital-wide, nurse-initiated hypoglycemia treatment protocols and a system for tracking with root cause analysis the frequency of hypoglycemic events. The document lists key components of such protocols, and provides suggested nurse-initiated strategies.<[etk]>

<[stk -3]>Hospitals are advised to provide administrative support for an interdisciplinary steering committee targeting a systems approach to improve care of inpatients with hyperglycemia and diabetes. Uniform methods for collecting and evaluating point-of-care testing data and insulin use information in hospitals are recommended, as are the provision of accurate devices for glucose measurement at the bedside with ongoing staff education and competency assessments.

Dr. Hellman and Dr. Umpierrez have no financial disclosures, but three other members of the guideline panel declared relationships with manufacturers of diabetes-related products.

HOT SPRINGS, VA – Using risk adjustment alone to compare surgical site infection rates among hospitals may not be valid, judging by a retrospective analysis of data on colorectal procedures.

An examination of data submitted on 336,190 cases by 237 hospitals participating in the National Surgical Quality Improvement Project (NSQIP) in 2009 revealed that a patient’s underlying disease state is an important contributor to the risk of surgical site infection, said Dr. Robert Cima.

Dr. Cima and his colleagues at the Mayo Clinic Rochester, Minn., identified 24,673 colorectal procedures, using CPT codes. Of those procedures, 6,324 patients had colon cancer, 2,061 had benign neoplasm, 2,859 had rectal cancer, 4,821 had diverticular disease, 764 had ulcerative colitis, 862 had regional enteritis (Crohn’s disease), and 6,982 had other conditions, which included perforation, volvulus, intestinal obstruction, rectal prolapse, fistula, vascular insufficiency and unspecified neoplasms.

"Comparisons between hospitals could be misleading if they don’t include case mix," Dr. Cima said.

They specifically analyzed colorectal procedures because they are associated with the largest rate of surgical site infections (SSI; 5%-30%) and those infections led to a longer length of stay, higher costs, and higher mortality.

To get a baseline rate of SSIs for comparison purposes, the authors queried the data set to determine which procedure had the lowest rate. Benign neoplasms had the lowest overall rate, and because they were not caused by underlying disorders or malignancies, that rate was chosen as the reference, Dr. Cima said at the annual meeting of the Southern Surgical Association.

The authors conducted a regression analysis using the same factors used in the NSQIP risk adjustment: age, body mass index, American Society of Anesthesiology classification, wound classification, and relative value units (RVU) used, which are a surrogate for CPT codes. Odds ratios for SSIs were then calculated for each procedure.

Overall, 13.5% of patients developed an SSI. Rectal cancer patients had the highest overall odds ratio at 1.9, followed by Crohn’s disease, at 1.7. Rectal cancer patients also had the highest risk of superficial incisional SSI at 1.6; diverticular disease patients had a 1.6-fold higher risk than did those with benign neoplasms.

The patients at highest risk for deep incisional infections were those with ulcerative colitis (OR, 2.4), followed by rectal cancer (2.1). Both of those conditions also put patients at higher risk for organ/space infections (OR, 2.2 and 2.1).

The difference in infection rates by underlying disease led the researchers to question whether case mix might have an effect on the infection rates at individual institutions. Looking at the Mayo Clinic’s profile, compared with all NSQIP facilities’ case mix, they found that there was a higher percentage of patients with the higher-risk conditions: rectal cancer, regional enteritis, and ulcerative colitis.

The NSQIP data include a disease diagnosis, but it does not factor that into risk-adjusted figures, which will soon be publicly reported, noted Dr. Cima. Comparisons between hospitals could be misleading if they don’t include case mix, he said. And, there are implications for quality improvement, said Dr. Cima.

"If we had just looked at the overall surgical site infection rate and tried to design studies or processes to just reduce it without consideration of case mix, we would not be able to really determine whether or not we can drive it down," he said.

"This is a provocative and important study," said Dr. Danny Jacobs, chairman of the department of surgery at Duke University, Durham, N.C., in commenting on the paper. And, he said, it raises questions about whether the risk-adjustment system being used by NSQIP is adequate.

Dr. Susan Galandiuk, a professor of surgery at the University of Louisville (Ky.), questioned whether infection rates weren’t also influenced by the duration of surgery and whether patients were given appropriate antibiotic prophylaxis.

Dr. Cima said that while many studies have shown that infections rise as the length of surgery increases, it was not clear whether that was a factor in his study.

He agreed with Dr. Jacobs that the paper raised questions. The data do "go to the very heart of using data sets to drive quality improvement," he said.

HOT SPRINGS, VA – Using risk adjustment alone to compare surgical site infection rates among hospitals may not be valid, judging by a retrospective analysis of data on colorectal procedures.

An examination of data submitted on 336,190 cases by 237 hospitals participating in the National Surgical Quality Improvement Project (NSQIP) in 2009 revealed that a patient’s underlying disease state is an important contributor to the risk of surgical site infection, said Dr. Robert Cima.

Dr. Cima and his colleagues at the Mayo Clinic Rochester, Minn., identified 24,673 colorectal procedures, using CPT codes. Of those procedures, 6,324 patients had colon cancer, 2,061 had benign neoplasm, 2,859 had rectal cancer, 4,821 had diverticular disease, 764 had ulcerative colitis, 862 had regional enteritis (Crohn’s disease), and 6,982 had other conditions, which included perforation, volvulus, intestinal obstruction, rectal prolapse, fistula, vascular insufficiency and unspecified neoplasms.

"Comparisons between hospitals could be misleading if they don’t include case mix," Dr. Cima said.

They specifically analyzed colorectal procedures because they are associated with the largest rate of surgical site infections (SSI; 5%-30%) and those infections led to a longer length of stay, higher costs, and higher mortality.

To get a baseline rate of SSIs for comparison purposes, the authors queried the data set to determine which procedure had the lowest rate. Benign neoplasms had the lowest overall rate, and because they were not caused by underlying disorders or malignancies, that rate was chosen as the reference, Dr. Cima said at the annual meeting of the Southern Surgical Association.

The authors conducted a regression analysis using the same factors used in the NSQIP risk adjustment: age, body mass index, American Society of Anesthesiology classification, wound classification, and relative value units (RVU) used, which are a surrogate for CPT codes. Odds ratios for SSIs were then calculated for each procedure.

Overall, 13.5% of patients developed an SSI. Rectal cancer patients had the highest overall odds ratio at 1.9, followed by Crohn’s disease, at 1.7. Rectal cancer patients also had the highest risk of superficial incisional SSI at 1.6; diverticular disease patients had a 1.6-fold higher risk than did those with benign neoplasms.

The patients at highest risk for deep incisional infections were those with ulcerative colitis (OR, 2.4), followed by rectal cancer (2.1). Both of those conditions also put patients at higher risk for organ/space infections (OR, 2.2 and 2.1).

The difference in infection rates by underlying disease led the researchers to question whether case mix might have an effect on the infection rates at individual institutions. Looking at the Mayo Clinic’s profile, compared with all NSQIP facilities’ case mix, they found that there was a higher percentage of patients with the higher-risk conditions: rectal cancer, regional enteritis, and ulcerative colitis.

The NSQIP data include a disease diagnosis, but it does not factor that into risk-adjusted figures, which will soon be publicly reported, noted Dr. Cima. Comparisons between hospitals could be misleading if they don’t include case mix, he said. And, there are implications for quality improvement, said Dr. Cima.

"If we had just looked at the overall surgical site infection rate and tried to design studies or processes to just reduce it without consideration of case mix, we would not be able to really determine whether or not we can drive it down," he said.

"This is a provocative and important study," said Dr. Danny Jacobs, chairman of the department of surgery at Duke University, Durham, N.C., in commenting on the paper. And, he said, it raises questions about whether the risk-adjustment system being used by NSQIP is adequate.

Dr. Susan Galandiuk, a professor of surgery at the University of Louisville (Ky.), questioned whether infection rates weren’t also influenced by the duration of surgery and whether patients were given appropriate antibiotic prophylaxis.

Dr. Cima said that while many studies have shown that infections rise as the length of surgery increases, it was not clear whether that was a factor in his study.

He agreed with Dr. Jacobs that the paper raised questions. The data do "go to the very heart of using data sets to drive quality improvement," he said.

HOT SPRINGS, VA – Using risk adjustment alone to compare surgical site infection rates among hospitals may not be valid, judging by a retrospective analysis of data on colorectal procedures.

An examination of data submitted on 336,190 cases by 237 hospitals participating in the National Surgical Quality Improvement Project (NSQIP) in 2009 revealed that a patient’s underlying disease state is an important contributor to the risk of surgical site infection, said Dr. Robert Cima.

Dr. Cima and his colleagues at the Mayo Clinic Rochester, Minn., identified 24,673 colorectal procedures, using CPT codes. Of those procedures, 6,324 patients had colon cancer, 2,061 had benign neoplasm, 2,859 had rectal cancer, 4,821 had diverticular disease, 764 had ulcerative colitis, 862 had regional enteritis (Crohn’s disease), and 6,982 had other conditions, which included perforation, volvulus, intestinal obstruction, rectal prolapse, fistula, vascular insufficiency and unspecified neoplasms.

"Comparisons between hospitals could be misleading if they don’t include case mix," Dr. Cima said.

They specifically analyzed colorectal procedures because they are associated with the largest rate of surgical site infections (SSI; 5%-30%) and those infections led to a longer length of stay, higher costs, and higher mortality.

To get a baseline rate of SSIs for comparison purposes, the authors queried the data set to determine which procedure had the lowest rate. Benign neoplasms had the lowest overall rate, and because they were not caused by underlying disorders or malignancies, that rate was chosen as the reference, Dr. Cima said at the annual meeting of the Southern Surgical Association.

The authors conducted a regression analysis using the same factors used in the NSQIP risk adjustment: age, body mass index, American Society of Anesthesiology classification, wound classification, and relative value units (RVU) used, which are a surrogate for CPT codes. Odds ratios for SSIs were then calculated for each procedure.

Overall, 13.5% of patients developed an SSI. Rectal cancer patients had the highest overall odds ratio at 1.9, followed by Crohn’s disease, at 1.7. Rectal cancer patients also had the highest risk of superficial incisional SSI at 1.6; diverticular disease patients had a 1.6-fold higher risk than did those with benign neoplasms.

The patients at highest risk for deep incisional infections were those with ulcerative colitis (OR, 2.4), followed by rectal cancer (2.1). Both of those conditions also put patients at higher risk for organ/space infections (OR, 2.2 and 2.1).

The difference in infection rates by underlying disease led the researchers to question whether case mix might have an effect on the infection rates at individual institutions. Looking at the Mayo Clinic’s profile, compared with all NSQIP facilities’ case mix, they found that there was a higher percentage of patients with the higher-risk conditions: rectal cancer, regional enteritis, and ulcerative colitis.

The NSQIP data include a disease diagnosis, but it does not factor that into risk-adjusted figures, which will soon be publicly reported, noted Dr. Cima. Comparisons between hospitals could be misleading if they don’t include case mix, he said. And, there are implications for quality improvement, said Dr. Cima.

"If we had just looked at the overall surgical site infection rate and tried to design studies or processes to just reduce it without consideration of case mix, we would not be able to really determine whether or not we can drive it down," he said.

"This is a provocative and important study," said Dr. Danny Jacobs, chairman of the department of surgery at Duke University, Durham, N.C., in commenting on the paper. And, he said, it raises questions about whether the risk-adjustment system being used by NSQIP is adequate.

Dr. Susan Galandiuk, a professor of surgery at the University of Louisville (Ky.), questioned whether infection rates weren’t also influenced by the duration of surgery and whether patients were given appropriate antibiotic prophylaxis.

Dr. Cima said that while many studies have shown that infections rise as the length of surgery increases, it was not clear whether that was a factor in his study.

He agreed with Dr. Jacobs that the paper raised questions. The data do "go to the very heart of using data sets to drive quality improvement," he said.

SAN DIEGO – Patients who receive heparin bridging during an interruption of oral anticoagulation appear to be at a 5.4-fold increased risk of overall bleeding and a 3.6-fold increased risk of major bleeding, without a reduction in risk of thromboembolic events.

Those are key findings from a systematic review and meta-analysis of recently published medical literature presented by Dr. Jovana Yudin at the annual meeting of the American Society of Hematology.

Antithrombotic and thrombolytic therapy guidelines published by the American College of Chest Physicians in 2008 recommended bridging according to an individualized approach (Chest 2008;133[suppl. 6]:299S-339S).

"They suggested bridging according to patients’ bleeding and thromboembolic risk," said Dr. Yudin, a fellow in the hematology residency program at McMaster University, Hamilton, Ont. "Within the last decade, several new studies have been published using periprocedural bridging. In these studies, low-molecular-weight heparin has been used with increased frequency. However, optimal strategies for bridging remain unclear. Our objective was to do a systematic review and meta-analysis of bridging trials published in the last decade to look at thromboembolic risk as well as bleeding risk."

Dr. Yudin and her associates searched the MEDLINE, EMBASE, and Cochrane Collaboration databases for systematic reviews and meta-analyses of studies published between Jan. 1, 2001, and July 31, 2010, that examined bleeding and thromboembolic events in patients receiving bridging therapy during temporary oral anticoagulation interruption for elective surgical or invasive procedures. Studies were excluded if the reporting of thromboembolic or bleeding outcomes was unclear, or if they focused exclusively on patients with renal failure (ASH 2011; abstract 545). All studies were reviewed by two independent investigators.

The researchers identified and screened 1,164 studies for review. Of these, 35 studies that included 7,169 bridged patients were selected for the final review. Most of the studies (33) were observational, and only two were randomized. The median follow-up was 30 days.

The most common indication for anticoagulation was atrial fibrillation (44%), followed by mechanical valve (24%), prior venous thromboembolism (22%), and other (10%).

The most common preoperative strategy was to discontinue oral anticoagulation more than 3 days in advance. Low-molecular-weight heparin was most commonly used, both preoperatively and postoperatively.

Dr. Yudin reported that thromboembolic events, which were primarily arterial in nature, occurred in 73 of the 7,169 patients (mean rate, 0.96%). The mean rate of overall bleeding was 13.01%, whereas the mean rate of major bleeding was 4.32%.

Eight of the studies included in the final analysis had control groups from which the researchers were able to pull data to determine an odds ratio for thromboembolism with bridging vs. no bridging. These studies included 1,691 bridged patients and 3,493 nonbridged patients. The odds ratio for thromboembolic events was 0.80, with a 95% confidence interval (CI) of 0.42-1.54, "suggesting no risk reduction for thromboembolic events with heparin or low-molecular-weight bridging," Dr. Yudin said. "There was also no difference between these two groups in the risk for arterial or venous thromboembolism."

To determine the risk of overall bleeding, the researchers pulled data from 13 studies that included control groups. These studies included 1,935 bridged patients and 5,160 nonbridged patients. The odds ratio for overall bleeding with bridging was 5.40 (95% CI, 3.00-9.74). "This suggested an increased risk of overall bleeding with bridging anticoagulation, but there was significant heterogeneity noted across these studies."

For major bleeding, five studies with control groups were assessed. These included 1,397 bridged patients and 2,104 nonbridged patients. The odds ratio for major bleeding was 3.60 (95% CI, 1.52-8.50), "again suggesting an increased risk in major bleeding with bridging," she said. "There was significant heterogeneity noted across studies."

Dr. Yudin acknowledged that the review had certain limitations: Most of the studies included in the analysis were observational, and only about a third had control groups. "Our control groups consisted largely of low-thromboembolic-risk patients, or patients who were not chronically on vitamin K antagonists, suggesting that they had a different risk profile for thromboembolism than many of the bridged patients," she said.

The findings "underline the need for studies of higher [methodological] quality in periprocedural bridging," she concluded. "It also tells us that there is a need for standardized definitions in terms of outcomes. We suspect that much of our heterogeneity had to do with varying definitions for outcomes such as major bleeding."

Dr. Yudin said that she had no relevant financial conflicts to disclose.

SAN DIEGO – Patients who receive heparin bridging during an interruption of oral anticoagulation appear to be at a 5.4-fold increased risk of overall bleeding and a 3.6-fold increased risk of major bleeding, without a reduction in risk of thromboembolic events.

Those are key findings from a systematic review and meta-analysis of recently published medical literature presented by Dr. Jovana Yudin at the annual meeting of the American Society of Hematology.

Antithrombotic and thrombolytic therapy guidelines published by the American College of Chest Physicians in 2008 recommended bridging according to an individualized approach (Chest 2008;133[suppl. 6]:299S-339S).

"They suggested bridging according to patients’ bleeding and thromboembolic risk," said Dr. Yudin, a fellow in the hematology residency program at McMaster University, Hamilton, Ont. "Within the last decade, several new studies have been published using periprocedural bridging. In these studies, low-molecular-weight heparin has been used with increased frequency. However, optimal strategies for bridging remain unclear. Our objective was to do a systematic review and meta-analysis of bridging trials published in the last decade to look at thromboembolic risk as well as bleeding risk."

Dr. Yudin and her associates searched the MEDLINE, EMBASE, and Cochrane Collaboration databases for systematic reviews and meta-analyses of studies published between Jan. 1, 2001, and July 31, 2010, that examined bleeding and thromboembolic events in patients receiving bridging therapy during temporary oral anticoagulation interruption for elective surgical or invasive procedures. Studies were excluded if the reporting of thromboembolic or bleeding outcomes was unclear, or if they focused exclusively on patients with renal failure (ASH 2011; abstract 545). All studies were reviewed by two independent investigators.

The researchers identified and screened 1,164 studies for review. Of these, 35 studies that included 7,169 bridged patients were selected for the final review. Most of the studies (33) were observational, and only two were randomized. The median follow-up was 30 days.

The most common indication for anticoagulation was atrial fibrillation (44%), followed by mechanical valve (24%), prior venous thromboembolism (22%), and other (10%).

The most common preoperative strategy was to discontinue oral anticoagulation more than 3 days in advance. Low-molecular-weight heparin was most commonly used, both preoperatively and postoperatively.

Dr. Yudin reported that thromboembolic events, which were primarily arterial in nature, occurred in 73 of the 7,169 patients (mean rate, 0.96%). The mean rate of overall bleeding was 13.01%, whereas the mean rate of major bleeding was 4.32%.

Eight of the studies included in the final analysis had control groups from which the researchers were able to pull data to determine an odds ratio for thromboembolism with bridging vs. no bridging. These studies included 1,691 bridged patients and 3,493 nonbridged patients. The odds ratio for thromboembolic events was 0.80, with a 95% confidence interval (CI) of 0.42-1.54, "suggesting no risk reduction for thromboembolic events with heparin or low-molecular-weight bridging," Dr. Yudin said. "There was also no difference between these two groups in the risk for arterial or venous thromboembolism."

To determine the risk of overall bleeding, the researchers pulled data from 13 studies that included control groups. These studies included 1,935 bridged patients and 5,160 nonbridged patients. The odds ratio for overall bleeding with bridging was 5.40 (95% CI, 3.00-9.74). "This suggested an increased risk of overall bleeding with bridging anticoagulation, but there was significant heterogeneity noted across these studies."

For major bleeding, five studies with control groups were assessed. These included 1,397 bridged patients and 2,104 nonbridged patients. The odds ratio for major bleeding was 3.60 (95% CI, 1.52-8.50), "again suggesting an increased risk in major bleeding with bridging," she said. "There was significant heterogeneity noted across studies."

Dr. Yudin acknowledged that the review had certain limitations: Most of the studies included in the analysis were observational, and only about a third had control groups. "Our control groups consisted largely of low-thromboembolic-risk patients, or patients who were not chronically on vitamin K antagonists, suggesting that they had a different risk profile for thromboembolism than many of the bridged patients," she said.

The findings "underline the need for studies of higher [methodological] quality in periprocedural bridging," she concluded. "It also tells us that there is a need for standardized definitions in terms of outcomes. We suspect that much of our heterogeneity had to do with varying definitions for outcomes such as major bleeding."

Dr. Yudin said that she had no relevant financial conflicts to disclose.

SAN DIEGO – Patients who receive heparin bridging during an interruption of oral anticoagulation appear to be at a 5.4-fold increased risk of overall bleeding and a 3.6-fold increased risk of major bleeding, without a reduction in risk of thromboembolic events.

Those are key findings from a systematic review and meta-analysis of recently published medical literature presented by Dr. Jovana Yudin at the annual meeting of the American Society of Hematology.

Antithrombotic and thrombolytic therapy guidelines published by the American College of Chest Physicians in 2008 recommended bridging according to an individualized approach (Chest 2008;133[suppl. 6]:299S-339S).

"They suggested bridging according to patients’ bleeding and thromboembolic risk," said Dr. Yudin, a fellow in the hematology residency program at McMaster University, Hamilton, Ont. "Within the last decade, several new studies have been published using periprocedural bridging. In these studies, low-molecular-weight heparin has been used with increased frequency. However, optimal strategies for bridging remain unclear. Our objective was to do a systematic review and meta-analysis of bridging trials published in the last decade to look at thromboembolic risk as well as bleeding risk."

Dr. Yudin and her associates searched the MEDLINE, EMBASE, and Cochrane Collaboration databases for systematic reviews and meta-analyses of studies published between Jan. 1, 2001, and July 31, 2010, that examined bleeding and thromboembolic events in patients receiving bridging therapy during temporary oral anticoagulation interruption for elective surgical or invasive procedures. Studies were excluded if the reporting of thromboembolic or bleeding outcomes was unclear, or if they focused exclusively on patients with renal failure (ASH 2011; abstract 545). All studies were reviewed by two independent investigators.

The researchers identified and screened 1,164 studies for review. Of these, 35 studies that included 7,169 bridged patients were selected for the final review. Most of the studies (33) were observational, and only two were randomized. The median follow-up was 30 days.

The most common indication for anticoagulation was atrial fibrillation (44%), followed by mechanical valve (24%), prior venous thromboembolism (22%), and other (10%).

The most common preoperative strategy was to discontinue oral anticoagulation more than 3 days in advance. Low-molecular-weight heparin was most commonly used, both preoperatively and postoperatively.

Dr. Yudin reported that thromboembolic events, which were primarily arterial in nature, occurred in 73 of the 7,169 patients (mean rate, 0.96%). The mean rate of overall bleeding was 13.01%, whereas the mean rate of major bleeding was 4.32%.

Eight of the studies included in the final analysis had control groups from which the researchers were able to pull data to determine an odds ratio for thromboembolism with bridging vs. no bridging. These studies included 1,691 bridged patients and 3,493 nonbridged patients. The odds ratio for thromboembolic events was 0.80, with a 95% confidence interval (CI) of 0.42-1.54, "suggesting no risk reduction for thromboembolic events with heparin or low-molecular-weight bridging," Dr. Yudin said. "There was also no difference between these two groups in the risk for arterial or venous thromboembolism."

To determine the risk of overall bleeding, the researchers pulled data from 13 studies that included control groups. These studies included 1,935 bridged patients and 5,160 nonbridged patients. The odds ratio for overall bleeding with bridging was 5.40 (95% CI, 3.00-9.74). "This suggested an increased risk of overall bleeding with bridging anticoagulation, but there was significant heterogeneity noted across these studies."

For major bleeding, five studies with control groups were assessed. These included 1,397 bridged patients and 2,104 nonbridged patients. The odds ratio for major bleeding was 3.60 (95% CI, 1.52-8.50), "again suggesting an increased risk in major bleeding with bridging," she said. "There was significant heterogeneity noted across studies."

Dr. Yudin acknowledged that the review had certain limitations: Most of the studies included in the analysis were observational, and only about a third had control groups. "Our control groups consisted largely of low-thromboembolic-risk patients, or patients who were not chronically on vitamin K antagonists, suggesting that they had a different risk profile for thromboembolism than many of the bridged patients," she said.

The findings "underline the need for studies of higher [methodological] quality in periprocedural bridging," she concluded. "It also tells us that there is a need for standardized definitions in terms of outcomes. We suspect that much of our heterogeneity had to do with varying definitions for outcomes such as major bleeding."

Dr. Yudin said that she had no relevant financial conflicts to disclose.

SAN DIEGO – Obtaining a baseline D-dimer level can identify acutely ill patients at high risk of venous thromboembolism, results from a large analysis have shown.

In fact, the rate of venous thromboembolism (VTE) was 3.5- to 4-fold higher for patients with a baseline D-dimer level more than twice the upper limit of normal, compared with patients whose D-dimer was twice the upper limit of normal or less, Dr. Alexander T. Cohen reported at the annual meeting of the American Society of Hematology.

The findings come from a subset analysis of patients in MAGELLAN, a trial of 8,101 acutely ill, hospitalized adults who were randomized to either oral rivaroxaban (Xarelto) prophylaxis 10 mg once daily for 35 days or to standard enoxaparin (Lovenox) 40 mg once daily for 10 days, followed by placebo. The patients were assessed with ultrasonography on day 10 and day 35. In the overall study population, rivaroxaban met both of its primary outcomes: noninferiority at day 10 vs. enoxaparin and superiority at day 35 vs. enoxaparin, followed by placebo. Rates of clinically relevant bleeding were low in general but were higher for rivaroxaban than for enoxaparin with placebo. MAGELLAN’s primary findings were presented at the 2011 annual meeting of the American College of Cardiology but have not yet been published.

For the current study, outcomes in MAGELLAN were analyzed to investigate the relationship between D-dimer levels and VTE risk, and the effect of rivaroxaban on this risk. Dr. Cohen of the department of surgery at King’s College Hospital, London, and his associates divided patients into two groups: those with D-dimer levels less than or equal to two times the upper limit of normal or less (group 1) and those with D-dimer levels greater than two times the upper limit of normal (group 2).

The primary efficacy outcome was a composite of asymptomatic proximal deep vein thrombosis (DVT), symptomatic DVT, symptomatic nonfatal pulmonary embolism, and VTE-related death. The principal safety outcomes were major and nonmajor clinically relevant bleeding recorded within 2 days after the last intake of study medication. Both outcomes were assessed on day 10 and day 35, and the prespecified net clinical benefit was defined as a composite of the primary efficacy and principal safety outcomes.

The mean age of the patients was 67 years in group 1 and 71 years in group 2. The baseline median D-dimer level was 0.94 mg/L in all patients. Baseline D-dimer level was higher in patients who experienced a primary efficacy outcome event, compared with those who did not have such an event (a median of 1.98 mg/L vs. 0.92 mg/L). Patients in group 2 were about four times as likely to have a VTE by day 10, compared with those in group 1. At day 10, rivaroxaban was noninferior for the primary efficacy outcome, compared with enoxaparin, among patients in group 2.

At day 35, patients in group 2 who were assigned to the rivaroxaban arm had a reduction in their relative risk of the primary efficacy outcome by 29%, compared with those who were assigned to the enoxaparin-placebo arm, a significant difference that translated into an absolute risk reduction of 2.8% (P = .01). No such differences were observed in group 1.

Patients who had a high D-dimer level at baseline were at increased risk of an event occurring between day 11 and day 35, and rivaroxaban reduced that risk, compared with placebo, during this time period, Dr. Cohen said. "Perhaps assessment of D-dimer after 10 days of standard prophylaxis may indicate which patients benefit from rivaroxaban prophylaxis," he noted.

In both D-dimer groups, the rate of clinically relevant bleeding was significantly higher among patients treated with rivaroxaban, compared with those treated with enoxaparin, followed by placebo, across the entire study period. In the net clinical benefit outcomes analysis, the hazard ratio at day 10 was 1.63 for group 1 and 0.96 for group 2, while the hazard ratio at day 35 was 1.71 for group 1 and 1.03 for group 2.

MAGELLAN was funded by Bayer (which licenses rivaroxaban) and Johnson & Johnson (parent company of Janssen Pharmaceuticals, which manufactures rivaroxaban). Dr. Cohen disclosed that he has served as a medical consultant for, and has received honoraria and clinical trial funding from, numerous pharmaceutical companies, including Bayer, Johnson & Johnson, and Sanofi-Aventis.

SAN DIEGO – Obtaining a baseline D-dimer level can identify acutely ill patients at high risk of venous thromboembolism, results from a large analysis have shown.

In fact, the rate of venous thromboembolism (VTE) was 3.5- to 4-fold higher for patients with a baseline D-dimer level more than twice the upper limit of normal, compared with patients whose D-dimer was twice the upper limit of normal or less, Dr. Alexander T. Cohen reported at the annual meeting of the American Society of Hematology.

The findings come from a subset analysis of patients in MAGELLAN, a trial of 8,101 acutely ill, hospitalized adults who were randomized to either oral rivaroxaban (Xarelto) prophylaxis 10 mg once daily for 35 days or to standard enoxaparin (Lovenox) 40 mg once daily for 10 days, followed by placebo. The patients were assessed with ultrasonography on day 10 and day 35. In the overall study population, rivaroxaban met both of its primary outcomes: noninferiority at day 10 vs. enoxaparin and superiority at day 35 vs. enoxaparin, followed by placebo. Rates of clinically relevant bleeding were low in general but were higher for rivaroxaban than for enoxaparin with placebo. MAGELLAN’s primary findings were presented at the 2011 annual meeting of the American College of Cardiology but have not yet been published.

For the current study, outcomes in MAGELLAN were analyzed to investigate the relationship between D-dimer levels and VTE risk, and the effect of rivaroxaban on this risk. Dr. Cohen of the department of surgery at King’s College Hospital, London, and his associates divided patients into two groups: those with D-dimer levels less than or equal to two times the upper limit of normal or less (group 1) and those with D-dimer levels greater than two times the upper limit of normal (group 2).

The primary efficacy outcome was a composite of asymptomatic proximal deep vein thrombosis (DVT), symptomatic DVT, symptomatic nonfatal pulmonary embolism, and VTE-related death. The principal safety outcomes were major and nonmajor clinically relevant bleeding recorded within 2 days after the last intake of study medication. Both outcomes were assessed on day 10 and day 35, and the prespecified net clinical benefit was defined as a composite of the primary efficacy and principal safety outcomes.

The mean age of the patients was 67 years in group 1 and 71 years in group 2. The baseline median D-dimer level was 0.94 mg/L in all patients. Baseline D-dimer level was higher in patients who experienced a primary efficacy outcome event, compared with those who did not have such an event (a median of 1.98 mg/L vs. 0.92 mg/L). Patients in group 2 were about four times as likely to have a VTE by day 10, compared with those in group 1. At day 10, rivaroxaban was noninferior for the primary efficacy outcome, compared with enoxaparin, among patients in group 2.

At day 35, patients in group 2 who were assigned to the rivaroxaban arm had a reduction in their relative risk of the primary efficacy outcome by 29%, compared with those who were assigned to the enoxaparin-placebo arm, a significant difference that translated into an absolute risk reduction of 2.8% (P = .01). No such differences were observed in group 1.

Patients who had a high D-dimer level at baseline were at increased risk of an event occurring between day 11 and day 35, and rivaroxaban reduced that risk, compared with placebo, during this time period, Dr. Cohen said. "Perhaps assessment of D-dimer after 10 days of standard prophylaxis may indicate which patients benefit from rivaroxaban prophylaxis," he noted.

In both D-dimer groups, the rate of clinically relevant bleeding was significantly higher among patients treated with rivaroxaban, compared with those treated with enoxaparin, followed by placebo, across the entire study period. In the net clinical benefit outcomes analysis, the hazard ratio at day 10 was 1.63 for group 1 and 0.96 for group 2, while the hazard ratio at day 35 was 1.71 for group 1 and 1.03 for group 2.

MAGELLAN was funded by Bayer (which licenses rivaroxaban) and Johnson & Johnson (parent company of Janssen Pharmaceuticals, which manufactures rivaroxaban). Dr. Cohen disclosed that he has served as a medical consultant for, and has received honoraria and clinical trial funding from, numerous pharmaceutical companies, including Bayer, Johnson & Johnson, and Sanofi-Aventis.

SAN DIEGO – Obtaining a baseline D-dimer level can identify acutely ill patients at high risk of venous thromboembolism, results from a large analysis have shown.

In fact, the rate of venous thromboembolism (VTE) was 3.5- to 4-fold higher for patients with a baseline D-dimer level more than twice the upper limit of normal, compared with patients whose D-dimer was twice the upper limit of normal or less, Dr. Alexander T. Cohen reported at the annual meeting of the American Society of Hematology.

The findings come from a subset analysis of patients in MAGELLAN, a trial of 8,101 acutely ill, hospitalized adults who were randomized to either oral rivaroxaban (Xarelto) prophylaxis 10 mg once daily for 35 days or to standard enoxaparin (Lovenox) 40 mg once daily for 10 days, followed by placebo. The patients were assessed with ultrasonography on day 10 and day 35. In the overall study population, rivaroxaban met both of its primary outcomes: noninferiority at day 10 vs. enoxaparin and superiority at day 35 vs. enoxaparin, followed by placebo. Rates of clinically relevant bleeding were low in general but were higher for rivaroxaban than for enoxaparin with placebo. MAGELLAN’s primary findings were presented at the 2011 annual meeting of the American College of Cardiology but have not yet been published.

For the current study, outcomes in MAGELLAN were analyzed to investigate the relationship between D-dimer levels and VTE risk, and the effect of rivaroxaban on this risk. Dr. Cohen of the department of surgery at King’s College Hospital, London, and his associates divided patients into two groups: those with D-dimer levels less than or equal to two times the upper limit of normal or less (group 1) and those with D-dimer levels greater than two times the upper limit of normal (group 2).

The primary efficacy outcome was a composite of asymptomatic proximal deep vein thrombosis (DVT), symptomatic DVT, symptomatic nonfatal pulmonary embolism, and VTE-related death. The principal safety outcomes were major and nonmajor clinically relevant bleeding recorded within 2 days after the last intake of study medication. Both outcomes were assessed on day 10 and day 35, and the prespecified net clinical benefit was defined as a composite of the primary efficacy and principal safety outcomes.

The mean age of the patients was 67 years in group 1 and 71 years in group 2. The baseline median D-dimer level was 0.94 mg/L in all patients. Baseline D-dimer level was higher in patients who experienced a primary efficacy outcome event, compared with those who did not have such an event (a median of 1.98 mg/L vs. 0.92 mg/L). Patients in group 2 were about four times as likely to have a VTE by day 10, compared with those in group 1. At day 10, rivaroxaban was noninferior for the primary efficacy outcome, compared with enoxaparin, among patients in group 2.

At day 35, patients in group 2 who were assigned to the rivaroxaban arm had a reduction in their relative risk of the primary efficacy outcome by 29%, compared with those who were assigned to the enoxaparin-placebo arm, a significant difference that translated into an absolute risk reduction of 2.8% (P = .01). No such differences were observed in group 1.

Patients who had a high D-dimer level at baseline were at increased risk of an event occurring between day 11 and day 35, and rivaroxaban reduced that risk, compared with placebo, during this time period, Dr. Cohen said. "Perhaps assessment of D-dimer after 10 days of standard prophylaxis may indicate which patients benefit from rivaroxaban prophylaxis," he noted.

In both D-dimer groups, the rate of clinically relevant bleeding was significantly higher among patients treated with rivaroxaban, compared with those treated with enoxaparin, followed by placebo, across the entire study period. In the net clinical benefit outcomes analysis, the hazard ratio at day 10 was 1.63 for group 1 and 0.96 for group 2, while the hazard ratio at day 35 was 1.71 for group 1 and 1.03 for group 2.

MAGELLAN was funded by Bayer (which licenses rivaroxaban) and Johnson & Johnson (parent company of Janssen Pharmaceuticals, which manufactures rivaroxaban). Dr. Cohen disclosed that he has served as a medical consultant for, and has received honoraria and clinical trial funding from, numerous pharmaceutical companies, including Bayer, Johnson & Johnson, and Sanofi-Aventis.

SAN DIEGO – Prophylaxis with rivaroxaban achieved significant reductions in venous thromboembolism, compared with two commonly used drugs when put to the test in 5,346 consecutive, unselected patients undergoing major orthopedic surgery.

The incidence of in-hospital symptomatic venous thromboembolism (VTE) was 2.4% with rivaroxaban (Xarelto), compared with 3.9% with low molecular weight heparin (LMWH), and 5.5% with fondaparinux (Arixtra). This corresponds to a relative risk reduction of 39%, compared with LMWH, and 57% compared with fondaparinux.

Rivaroxaban, an oral Factor Xa inhibitor, also has superior safety with regard to major bleeding and surgical complications, according to Dr. Jan Beyer-Westendorf, with the University Clinic at Dresden (Germany) Technical University.

"Patients in real-world major orthopedic surgery benefit from VTE-prophylaxis with rivaroxaban even more than could be expected from the phase III results of the RECORD trial," he said at the annual meeting of the American Society of Hematology.

The four phase III RECORD (REgulation of Coagulation in ORthopedic Surgery to Prevent Deep Vein Thrombosis and Pulmonary Embolism) trials compared rivaroxaban with enoxaparin in more than 12,500 patients undergoing knee and hip replacement. The trials did not evaluate fondaparinux or LMWH, despite being the standard of care at many hospitals.

Rivaroxaban was approved in the United States in July 2011 for DVT prophylaxis in adults undergoing hip and knee replacement surgery, and gained a second indication in November 2011 for stroke prophylaxis in patients with nonvalvular atrial fibrillation.

Dr. Beyer-Westendorf and his colleagues analyzed 5,346 consecutive patients who underwent major orthopedic surgery at the university clinic during three periods: 2005-2007 when LMWH was the standard prophylaxis; 2008-2009 when fondaparinux was the standard; and finally from 2010 to June 2011 when rivaroxaban became the clinic’s standard prophylaxis.

In all, 1,055 patients were treated with rivaroxaban, 1,683 with LMWH, and 2,069 with fondaparinux. Of note, previous VTE was more common at baseline in the rivaroxaban group at 4% vs. 1.4% in the LMWH group, and 1.1% in the fondaparinux group, he said.

Rivaroxaban reduced the relative risk of the composite of proximal DVT, pulmonary embolism, and VTE-related death by 29%, compared with LMWH, and 42% compared with fondaparinux, but the difference between the three groups did not achieve statistical significance (1.0% vs. 1.4% vs. 1.7%), Dr. Beyer-Westendorf said.

In a pooled analysis of RECORD 1, 2, and 3, rivaroxaban significantly reduced the composite of symptomatic VTE and all-cause mortality during the 2-week period after surgery, compared with enoxaparin (0.4% vs. 0.8%), according to the Bayer HealthCare website.

In the current analysis, severe bleeding was significantly lower with rivaroxaban at 7.4% vs. 14.9% with LMWH, and 11.1% with fondaparinux.

Bleeding leading to surgical revisions was also significantly lower at 0.4% vs. 1.7% with LMWH, and 1.1% with fondaparinux.

Dr. Beyer-Westendorf pointed out that severe bleeding rates were less than 1% in the RECORD 1-4 trials using a more narrow definition of severe bleeding as overt bleeding outside of the surgical site. Their analysis used the International Society on Thrombosis and Hemostasis criteria for severe bleeding.

Finally, the reduction in VTE events, bleeding, and surgical revisions was correlated with a significantly shorter median hospital stay in patients given rivaroxaban prophylaxis vs. LMWH or fondaparinux (8.3 days vs. 11.6 days vs. 9.3 days).

Dr. Beyer-Westendorf said it was unlikely that changes in anesthesia or surgical practice over the study period could have attenuated the results. In addition, the researchers conducted a matched-pair analysis to evaluate whether the benefits of rivaroxaban were due to selection or detection bias. Outcomes remained superior for rivaroxaban after matching patients according to age, gender, type of surgery, and history of VTE. Complete compression ultrasound testing also remained constant at about 13% from 2005 to 2010 before falling to 8.2% in 2011 due to fewer complete compression ultrasound–positive findings, Dr. Beyer-Westendorf noted.

"These findings in a large real-world surgery cohort are robust and not significantly influenced by a selection or detection bias," he said.

Dr. Beyer-Westendorf disclosed research grants from and serving as a speaker for Bayer HealthCare, which markets Xarelto.

SAN DIEGO – Prophylaxis with rivaroxaban achieved significant reductions in venous thromboembolism, compared with two commonly used drugs when put to the test in 5,346 consecutive, unselected patients undergoing major orthopedic surgery.

The incidence of in-hospital symptomatic venous thromboembolism (VTE) was 2.4% with rivaroxaban (Xarelto), compared with 3.9% with low molecular weight heparin (LMWH), and 5.5% with fondaparinux (Arixtra). This corresponds to a relative risk reduction of 39%, compared with LMWH, and 57% compared with fondaparinux.

Rivaroxaban, an oral Factor Xa inhibitor, also has superior safety with regard to major bleeding and surgical complications, according to Dr. Jan Beyer-Westendorf, with the University Clinic at Dresden (Germany) Technical University.

"Patients in real-world major orthopedic surgery benefit from VTE-prophylaxis with rivaroxaban even more than could be expected from the phase III results of the RECORD trial," he said at the annual meeting of the American Society of Hematology.

The four phase III RECORD (REgulation of Coagulation in ORthopedic Surgery to Prevent Deep Vein Thrombosis and Pulmonary Embolism) trials compared rivaroxaban with enoxaparin in more than 12,500 patients undergoing knee and hip replacement. The trials did not evaluate fondaparinux or LMWH, despite being the standard of care at many hospitals.

Rivaroxaban was approved in the United States in July 2011 for DVT prophylaxis in adults undergoing hip and knee replacement surgery, and gained a second indication in November 2011 for stroke prophylaxis in patients with nonvalvular atrial fibrillation.

Dr. Beyer-Westendorf and his colleagues analyzed 5,346 consecutive patients who underwent major orthopedic surgery at the university clinic during three periods: 2005-2007 when LMWH was the standard prophylaxis; 2008-2009 when fondaparinux was the standard; and finally from 2010 to June 2011 when rivaroxaban became the clinic’s standard prophylaxis.

In all, 1,055 patients were treated with rivaroxaban, 1,683 with LMWH, and 2,069 with fondaparinux. Of note, previous VTE was more common at baseline in the rivaroxaban group at 4% vs. 1.4% in the LMWH group, and 1.1% in the fondaparinux group, he said.

Rivaroxaban reduced the relative risk of the composite of proximal DVT, pulmonary embolism, and VTE-related death by 29%, compared with LMWH, and 42% compared with fondaparinux, but the difference between the three groups did not achieve statistical significance (1.0% vs. 1.4% vs. 1.7%), Dr. Beyer-Westendorf said.

In a pooled analysis of RECORD 1, 2, and 3, rivaroxaban significantly reduced the composite of symptomatic VTE and all-cause mortality during the 2-week period after surgery, compared with enoxaparin (0.4% vs. 0.8%), according to the Bayer HealthCare website.

In the current analysis, severe bleeding was significantly lower with rivaroxaban at 7.4% vs. 14.9% with LMWH, and 11.1% with fondaparinux.

Bleeding leading to surgical revisions was also significantly lower at 0.4% vs. 1.7% with LMWH, and 1.1% with fondaparinux.

Dr. Beyer-Westendorf pointed out that severe bleeding rates were less than 1% in the RECORD 1-4 trials using a more narrow definition of severe bleeding as overt bleeding outside of the surgical site. Their analysis used the International Society on Thrombosis and Hemostasis criteria for severe bleeding.

Finally, the reduction in VTE events, bleeding, and surgical revisions was correlated with a significantly shorter median hospital stay in patients given rivaroxaban prophylaxis vs. LMWH or fondaparinux (8.3 days vs. 11.6 days vs. 9.3 days).

Dr. Beyer-Westendorf said it was unlikely that changes in anesthesia or surgical practice over the study period could have attenuated the results. In addition, the researchers conducted a matched-pair analysis to evaluate whether the benefits of rivaroxaban were due to selection or detection bias. Outcomes remained superior for rivaroxaban after matching patients according to age, gender, type of surgery, and history of VTE. Complete compression ultrasound testing also remained constant at about 13% from 2005 to 2010 before falling to 8.2% in 2011 due to fewer complete compression ultrasound–positive findings, Dr. Beyer-Westendorf noted.

"These findings in a large real-world surgery cohort are robust and not significantly influenced by a selection or detection bias," he said.

Dr. Beyer-Westendorf disclosed research grants from and serving as a speaker for Bayer HealthCare, which markets Xarelto.

SAN DIEGO – Prophylaxis with rivaroxaban achieved significant reductions in venous thromboembolism, compared with two commonly used drugs when put to the test in 5,346 consecutive, unselected patients undergoing major orthopedic surgery.

The incidence of in-hospital symptomatic venous thromboembolism (VTE) was 2.4% with rivaroxaban (Xarelto), compared with 3.9% with low molecular weight heparin (LMWH), and 5.5% with fondaparinux (Arixtra). This corresponds to a relative risk reduction of 39%, compared with LMWH, and 57% compared with fondaparinux.

Rivaroxaban, an oral Factor Xa inhibitor, also has superior safety with regard to major bleeding and surgical complications, according to Dr. Jan Beyer-Westendorf, with the University Clinic at Dresden (Germany) Technical University.

"Patients in real-world major orthopedic surgery benefit from VTE-prophylaxis with rivaroxaban even more than could be expected from the phase III results of the RECORD trial," he said at the annual meeting of the American Society of Hematology.

The four phase III RECORD (REgulation of Coagulation in ORthopedic Surgery to Prevent Deep Vein Thrombosis and Pulmonary Embolism) trials compared rivaroxaban with enoxaparin in more than 12,500 patients undergoing knee and hip replacement. The trials did not evaluate fondaparinux or LMWH, despite being the standard of care at many hospitals.

Rivaroxaban was approved in the United States in July 2011 for DVT prophylaxis in adults undergoing hip and knee replacement surgery, and gained a second indication in November 2011 for stroke prophylaxis in patients with nonvalvular atrial fibrillation.

Dr. Beyer-Westendorf and his colleagues analyzed 5,346 consecutive patients who underwent major orthopedic surgery at the university clinic during three periods: 2005-2007 when LMWH was the standard prophylaxis; 2008-2009 when fondaparinux was the standard; and finally from 2010 to June 2011 when rivaroxaban became the clinic’s standard prophylaxis.

In all, 1,055 patients were treated with rivaroxaban, 1,683 with LMWH, and 2,069 with fondaparinux. Of note, previous VTE was more common at baseline in the rivaroxaban group at 4% vs. 1.4% in the LMWH group, and 1.1% in the fondaparinux group, he said.

Rivaroxaban reduced the relative risk of the composite of proximal DVT, pulmonary embolism, and VTE-related death by 29%, compared with LMWH, and 42% compared with fondaparinux, but the difference between the three groups did not achieve statistical significance (1.0% vs. 1.4% vs. 1.7%), Dr. Beyer-Westendorf said.

In a pooled analysis of RECORD 1, 2, and 3, rivaroxaban significantly reduced the composite of symptomatic VTE and all-cause mortality during the 2-week period after surgery, compared with enoxaparin (0.4% vs. 0.8%), according to the Bayer HealthCare website.

In the current analysis, severe bleeding was significantly lower with rivaroxaban at 7.4% vs. 14.9% with LMWH, and 11.1% with fondaparinux.

Bleeding leading to surgical revisions was also significantly lower at 0.4% vs. 1.7% with LMWH, and 1.1% with fondaparinux.

Dr. Beyer-Westendorf pointed out that severe bleeding rates were less than 1% in the RECORD 1-4 trials using a more narrow definition of severe bleeding as overt bleeding outside of the surgical site. Their analysis used the International Society on Thrombosis and Hemostasis criteria for severe bleeding.

Finally, the reduction in VTE events, bleeding, and surgical revisions was correlated with a significantly shorter median hospital stay in patients given rivaroxaban prophylaxis vs. LMWH or fondaparinux (8.3 days vs. 11.6 days vs. 9.3 days).

Dr. Beyer-Westendorf said it was unlikely that changes in anesthesia or surgical practice over the study period could have attenuated the results. In addition, the researchers conducted a matched-pair analysis to evaluate whether the benefits of rivaroxaban were due to selection or detection bias. Outcomes remained superior for rivaroxaban after matching patients according to age, gender, type of surgery, and history of VTE. Complete compression ultrasound testing also remained constant at about 13% from 2005 to 2010 before falling to 8.2% in 2011 due to fewer complete compression ultrasound–positive findings, Dr. Beyer-Westendorf noted.

"These findings in a large real-world surgery cohort are robust and not significantly influenced by a selection or detection bias," he said.

Dr. Beyer-Westendorf disclosed research grants from and serving as a speaker for Bayer HealthCare, which markets Xarelto.

CHICAGO – A newly developed assessment tool can identify child and parent coping behaviors, and ultimately could be used to guide real-time behavioral and medical interventions to make the perioperative experience less traumatic for children.

Research on the novel assessment tool called the Perioperative Adult Child Behavioral Interaction Scale (PACBIS) earned a "Best Clinical Abstract" award at the annual meeting of the American Society of Anesthesiologists.

"Behavioral factors during pediatric surgery significantly contribute to postoperative outcomes, including delayed hospital discharge and poor parental satisfaction. While the existing real-time scales identify preoperative anxiety, they are limited because they don’t assess children’s coping efforts or parent behaviors," said Dr. Nancy Hagerman of Cincinnati Children’s Hospital Medical Center.

With PACBIS, if the child is anxious and the parent is exhibiting distress-promoting behavior during induction, an anesthesiologist can distract the child and engage the parents in the process of distraction and nonprocedural talk. If the child has excessive anxiety before anesthesia, child life specialists can explain to the child and parents what to expect during induction, offer sedation, or teach parents how to promote coping behaviors by engaging their child in nonprocedural discussions and distractions during induction of anesthesia.

PACBIS uses a scale of 1-5, with 1 being the lowest, to rate child coping and distress as well as parent and staff promotion of coping and distress (Anesth. Analg. 2009;108:822-6).

The study correlated PACBIS results with postoperative and postdischarge maladaptive behaviors by prospectively assessing 405 children, aged 3-12 years, undergoing tonsillectomies and adenoidectomies and their parents before surgery, during induction of anesthesia, upon emergence, and in the pediatric acute care unit with removal of the parenteral intravenous lines.

The researchers assessed for coping, distress, and anxiety behaviors using the PACBIS, the modified Yale Preoperative Anxiety Scale (mYPAS), and the Induction Compliance Checklist (ICC). They correlated findings on the PACBIS with postoperative pain and behavioral outcomes using the Pediatric Anesthesia Emergence Delirium (PAED) scores, the Post-discharge Parental Pain Measurements (PPPM), and Post-Hospitalization Behavior Questionnaire (PHBQ) on day 1 and day 7 (or later) after surgery (Anesthesiology 2004;100:1138-45).

"The PACBIS strongly predicted postoperative and postdischarge maladaptive behaviors and postoperative pain in children" undergoing tonsillectomy or adenoidectomy, Dr. Hagerman said. The PACBIS had strong concurrent validity with existing scales in assessing perioperative behaviors at all phases, perhaps most importantly during induction of anesthesia.

The PACBIS measures of child and parent coping and distress correlated well with those of the PAED, PPPM, and PHBQ. A 2-unit increase in PACBIS child distress measure during induction correlated with a 6-point increase in the PAED. As the PACBIS child coping measure improved 2 units (mild = 0; extreme = 2), there was a 45% reduction in the odds of the child having severe pain as measured by the PPPM on postoperative days 1-2. A preoperative child distress increase of 2 units was associated with a 4.6-fold increase in the odds of having severe pain as measured by the PPPM on postoperative days 7-8.

Higher PACBIS child distress during induction was associated with increased separation anxiety, sleep disturbances, aggression, and withdrawal (P less than .01). Higher parent distress on the PACBIS during induction was associated with increased separation anxiety and sleep disturbances (P less than .01).

Higher parent coping on the PACBIS during induction was associated with less withdrawal (P less than .01) and fewer eating disturbances (P less than .05).

The parents’ scores are very important, Dr. Hagerman emphasized, in keeping children calm during the surgical experience. "Parents who cope well and provide distracting nonprocedural talk help their child reduce distress and emergence delirium, postoperative pain, and new-onset maladaptive behaviors," she said, adding that members of the surgical team are also influential in achieving optimal perioperative behavioral outcomes.

Dr. Hagerman said she had no relevant conflicts of interest.

CHICAGO – A newly developed assessment tool can identify child and parent coping behaviors, and ultimately could be used to guide real-time behavioral and medical interventions to make the perioperative experience less traumatic for children.

Research on the novel assessment tool called the Perioperative Adult Child Behavioral Interaction Scale (PACBIS) earned a "Best Clinical Abstract" award at the annual meeting of the American Society of Anesthesiologists.

"Behavioral factors during pediatric surgery significantly contribute to postoperative outcomes, including delayed hospital discharge and poor parental satisfaction. While the existing real-time scales identify preoperative anxiety, they are limited because they don’t assess children’s coping efforts or parent behaviors," said Dr. Nancy Hagerman of Cincinnati Children’s Hospital Medical Center.

With PACBIS, if the child is anxious and the parent is exhibiting distress-promoting behavior during induction, an anesthesiologist can distract the child and engage the parents in the process of distraction and nonprocedural talk. If the child has excessive anxiety before anesthesia, child life specialists can explain to the child and parents what to expect during induction, offer sedation, or teach parents how to promote coping behaviors by engaging their child in nonprocedural discussions and distractions during induction of anesthesia.

PACBIS uses a scale of 1-5, with 1 being the lowest, to rate child coping and distress as well as parent and staff promotion of coping and distress (Anesth. Analg. 2009;108:822-6).

The study correlated PACBIS results with postoperative and postdischarge maladaptive behaviors by prospectively assessing 405 children, aged 3-12 years, undergoing tonsillectomies and adenoidectomies and their parents before surgery, during induction of anesthesia, upon emergence, and in the pediatric acute care unit with removal of the parenteral intravenous lines.

The researchers assessed for coping, distress, and anxiety behaviors using the PACBIS, the modified Yale Preoperative Anxiety Scale (mYPAS), and the Induction Compliance Checklist (ICC). They correlated findings on the PACBIS with postoperative pain and behavioral outcomes using the Pediatric Anesthesia Emergence Delirium (PAED) scores, the Post-discharge Parental Pain Measurements (PPPM), and Post-Hospitalization Behavior Questionnaire (PHBQ) on day 1 and day 7 (or later) after surgery (Anesthesiology 2004;100:1138-45).

"The PACBIS strongly predicted postoperative and postdischarge maladaptive behaviors and postoperative pain in children" undergoing tonsillectomy or adenoidectomy, Dr. Hagerman said. The PACBIS had strong concurrent validity with existing scales in assessing perioperative behaviors at all phases, perhaps most importantly during induction of anesthesia.

The PACBIS measures of child and parent coping and distress correlated well with those of the PAED, PPPM, and PHBQ. A 2-unit increase in PACBIS child distress measure during induction correlated with a 6-point increase in the PAED. As the PACBIS child coping measure improved 2 units (mild = 0; extreme = 2), there was a 45% reduction in the odds of the child having severe pain as measured by the PPPM on postoperative days 1-2. A preoperative child distress increase of 2 units was associated with a 4.6-fold increase in the odds of having severe pain as measured by the PPPM on postoperative days 7-8.

Higher PACBIS child distress during induction was associated with increased separation anxiety, sleep disturbances, aggression, and withdrawal (P less than .01). Higher parent distress on the PACBIS during induction was associated with increased separation anxiety and sleep disturbances (P less than .01).

Higher parent coping on the PACBIS during induction was associated with less withdrawal (P less than .01) and fewer eating disturbances (P less than .05).

The parents’ scores are very important, Dr. Hagerman emphasized, in keeping children calm during the surgical experience. "Parents who cope well and provide distracting nonprocedural talk help their child reduce distress and emergence delirium, postoperative pain, and new-onset maladaptive behaviors," she said, adding that members of the surgical team are also influential in achieving optimal perioperative behavioral outcomes.

Dr. Hagerman said she had no relevant conflicts of interest.

CHICAGO – A newly developed assessment tool can identify child and parent coping behaviors, and ultimately could be used to guide real-time behavioral and medical interventions to make the perioperative experience less traumatic for children.

Research on the novel assessment tool called the Perioperative Adult Child Behavioral Interaction Scale (PACBIS) earned a "Best Clinical Abstract" award at the annual meeting of the American Society of Anesthesiologists.

"Behavioral factors during pediatric surgery significantly contribute to postoperative outcomes, including delayed hospital discharge and poor parental satisfaction. While the existing real-time scales identify preoperative anxiety, they are limited because they don’t assess children’s coping efforts or parent behaviors," said Dr. Nancy Hagerman of Cincinnati Children’s Hospital Medical Center.

With PACBIS, if the child is anxious and the parent is exhibiting distress-promoting behavior during induction, an anesthesiologist can distract the child and engage the parents in the process of distraction and nonprocedural talk. If the child has excessive anxiety before anesthesia, child life specialists can explain to the child and parents what to expect during induction, offer sedation, or teach parents how to promote coping behaviors by engaging their child in nonprocedural discussions and distractions during induction of anesthesia.

PACBIS uses a scale of 1-5, with 1 being the lowest, to rate child coping and distress as well as parent and staff promotion of coping and distress (Anesth. Analg. 2009;108:822-6).

The study correlated PACBIS results with postoperative and postdischarge maladaptive behaviors by prospectively assessing 405 children, aged 3-12 years, undergoing tonsillectomies and adenoidectomies and their parents before surgery, during induction of anesthesia, upon emergence, and in the pediatric acute care unit with removal of the parenteral intravenous lines.

The researchers assessed for coping, distress, and anxiety behaviors using the PACBIS, the modified Yale Preoperative Anxiety Scale (mYPAS), and the Induction Compliance Checklist (ICC). They correlated findings on the PACBIS with postoperative pain and behavioral outcomes using the Pediatric Anesthesia Emergence Delirium (PAED) scores, the Post-discharge Parental Pain Measurements (PPPM), and Post-Hospitalization Behavior Questionnaire (PHBQ) on day 1 and day 7 (or later) after surgery (Anesthesiology 2004;100:1138-45).

"The PACBIS strongly predicted postoperative and postdischarge maladaptive behaviors and postoperative pain in children" undergoing tonsillectomy or adenoidectomy, Dr. Hagerman said. The PACBIS had strong concurrent validity with existing scales in assessing perioperative behaviors at all phases, perhaps most importantly during induction of anesthesia.

The PACBIS measures of child and parent coping and distress correlated well with those of the PAED, PPPM, and PHBQ. A 2-unit increase in PACBIS child distress measure during induction correlated with a 6-point increase in the PAED. As the PACBIS child coping measure improved 2 units (mild = 0; extreme = 2), there was a 45% reduction in the odds of the child having severe pain as measured by the PPPM on postoperative days 1-2. A preoperative child distress increase of 2 units was associated with a 4.6-fold increase in the odds of having severe pain as measured by the PPPM on postoperative days 7-8.

Higher PACBIS child distress during induction was associated with increased separation anxiety, sleep disturbances, aggression, and withdrawal (P less than .01). Higher parent distress on the PACBIS during induction was associated with increased separation anxiety and sleep disturbances (P less than .01).

Higher parent coping on the PACBIS during induction was associated with less withdrawal (P less than .01) and fewer eating disturbances (P less than .05).

The parents’ scores are very important, Dr. Hagerman emphasized, in keeping children calm during the surgical experience. "Parents who cope well and provide distracting nonprocedural talk help their child reduce distress and emergence delirium, postoperative pain, and new-onset maladaptive behaviors," she said, adding that members of the surgical team are also influential in achieving optimal perioperative behavioral outcomes.

Dr. Hagerman said she had no relevant conflicts of interest.