ACS Surgery News

PALM BEACH, FLA. – Simultaneous and staged removal of primary colorectal cancer and associated liver metastases worked equally well, a review of more than 1,000 cases at four international centers has shown.

"Long-term outcome of patients with synchronous colorectal liver metastases is dictated by biology, not by surgical strategy," Dr. Timothy M. Pawlik, FACS, said at the annual meeting of the Southern Surgical Association.

About a quarter of patients with advanced colorectal cancer present with synchronous liver metastases, and surgeons have used three different resection strategies. The classic approach has been staged removal of the primary, colorectal cancer first, followed by removal of the liver disease in a separate operation at a later time. In a much smaller number of cases, the staged approach is reversed, with initial excision of the liver disease followed later by removal of the primary tumor. The third option has been to do both excisions during a single operation. Until now, assessments that compared these approaches mostly have used data from a single center, and in several cases the reviews included relatively few patients, said Dr. Pawlik, a surgical oncologist at Johns Hopkins University in Baltimore.

The review done by Dr. Pawlik and his associates involved 1,004 patients treated between 1982 and 2011 at four major hepatobiliary centers in the United States and Europe. The series included 647 patients treated by removal of their primary colorectal tumor followed by a second surgery to remove their liver metastases, 329 patients who had both excisions done during a single operation, and 28 patients who had their liver metastases removed first and then had the primary tumor removed in a second operation.

The data showed no statistically significant difference for any outcome measure, including the incidence of complications, 90-day mortality, local recurrences, median survival, or rate of 5-year survival. For example, during a median follow-up of 34 months, the recurrence rate was 57% among patients treated with a classic, staged approach and 60% among patients who had a simultaneous excision, a difference that was not statistically significant. And in a multivariate regression analysis of factors associated with mortality during follow-up, simultaneous excision linked with an 8% higher mortality rate relative to a classic staged approach, but again the difference was not statistically significant.

"Long-term survival was associated with the location and extent of disease, but not with the surgical strategy," Dr. Pawlik said.

But he also qualified these findings with a couple of caveats. First, the findings "should only be extrapolated to academic centers, major hepatobiliary centers. The findings cannot be extrapolated to the community setting," he said.

Second, he agreed with the discussants of his report that a prospective, randomized trial should be done to definitively prove that surgical strategy has no impact on outcomes.

Dr. Pawlik said he had no relevant financial disclosures.

[email protected]

On Twitter @mitchelzoler

PALM BEACH, FLA. – Simultaneous and staged removal of primary colorectal cancer and associated liver metastases worked equally well, a review of more than 1,000 cases at four international centers has shown.

"Long-term outcome of patients with synchronous colorectal liver metastases is dictated by biology, not by surgical strategy," Dr. Timothy M. Pawlik, FACS, said at the annual meeting of the Southern Surgical Association.

About a quarter of patients with advanced colorectal cancer present with synchronous liver metastases, and surgeons have used three different resection strategies. The classic approach has been staged removal of the primary, colorectal cancer first, followed by removal of the liver disease in a separate operation at a later time. In a much smaller number of cases, the staged approach is reversed, with initial excision of the liver disease followed later by removal of the primary tumor. The third option has been to do both excisions during a single operation. Until now, assessments that compared these approaches mostly have used data from a single center, and in several cases the reviews included relatively few patients, said Dr. Pawlik, a surgical oncologist at Johns Hopkins University in Baltimore.

The review done by Dr. Pawlik and his associates involved 1,004 patients treated between 1982 and 2011 at four major hepatobiliary centers in the United States and Europe. The series included 647 patients treated by removal of their primary colorectal tumor followed by a second surgery to remove their liver metastases, 329 patients who had both excisions done during a single operation, and 28 patients who had their liver metastases removed first and then had the primary tumor removed in a second operation.

The data showed no statistically significant difference for any outcome measure, including the incidence of complications, 90-day mortality, local recurrences, median survival, or rate of 5-year survival. For example, during a median follow-up of 34 months, the recurrence rate was 57% among patients treated with a classic, staged approach and 60% among patients who had a simultaneous excision, a difference that was not statistically significant. And in a multivariate regression analysis of factors associated with mortality during follow-up, simultaneous excision linked with an 8% higher mortality rate relative to a classic staged approach, but again the difference was not statistically significant.

"Long-term survival was associated with the location and extent of disease, but not with the surgical strategy," Dr. Pawlik said.

But he also qualified these findings with a couple of caveats. First, the findings "should only be extrapolated to academic centers, major hepatobiliary centers. The findings cannot be extrapolated to the community setting," he said.

Second, he agreed with the discussants of his report that a prospective, randomized trial should be done to definitively prove that surgical strategy has no impact on outcomes.

Dr. Pawlik said he had no relevant financial disclosures.

[email protected]

On Twitter @mitchelzoler

PALM BEACH, FLA. – Simultaneous and staged removal of primary colorectal cancer and associated liver metastases worked equally well, a review of more than 1,000 cases at four international centers has shown.

"Long-term outcome of patients with synchronous colorectal liver metastases is dictated by biology, not by surgical strategy," Dr. Timothy M. Pawlik, FACS, said at the annual meeting of the Southern Surgical Association.

About a quarter of patients with advanced colorectal cancer present with synchronous liver metastases, and surgeons have used three different resection strategies. The classic approach has been staged removal of the primary, colorectal cancer first, followed by removal of the liver disease in a separate operation at a later time. In a much smaller number of cases, the staged approach is reversed, with initial excision of the liver disease followed later by removal of the primary tumor. The third option has been to do both excisions during a single operation. Until now, assessments that compared these approaches mostly have used data from a single center, and in several cases the reviews included relatively few patients, said Dr. Pawlik, a surgical oncologist at Johns Hopkins University in Baltimore.

The review done by Dr. Pawlik and his associates involved 1,004 patients treated between 1982 and 2011 at four major hepatobiliary centers in the United States and Europe. The series included 647 patients treated by removal of their primary colorectal tumor followed by a second surgery to remove their liver metastases, 329 patients who had both excisions done during a single operation, and 28 patients who had their liver metastases removed first and then had the primary tumor removed in a second operation.

The data showed no statistically significant difference for any outcome measure, including the incidence of complications, 90-day mortality, local recurrences, median survival, or rate of 5-year survival. For example, during a median follow-up of 34 months, the recurrence rate was 57% among patients treated with a classic, staged approach and 60% among patients who had a simultaneous excision, a difference that was not statistically significant. And in a multivariate regression analysis of factors associated with mortality during follow-up, simultaneous excision linked with an 8% higher mortality rate relative to a classic staged approach, but again the difference was not statistically significant.

"Long-term survival was associated with the location and extent of disease, but not with the surgical strategy," Dr. Pawlik said.

But he also qualified these findings with a couple of caveats. First, the findings "should only be extrapolated to academic centers, major hepatobiliary centers. The findings cannot be extrapolated to the community setting," he said.

Second, he agreed with the discussants of his report that a prospective, randomized trial should be done to definitively prove that surgical strategy has no impact on outcomes.

Dr. Pawlik said he had no relevant financial disclosures.

[email protected]

On Twitter @mitchelzoler

PALM BEACH, FLA. – A commercially available computer program designed to calculate optimal insulin dosages for postsurgical ICU patients halved the rate of hyperglycemic episodes that patients experienced while dropping the rate of hypoglycemic events by 95% in a single-center, U.S. experience with a total of more than 2,000 patients.

The computer program also resulted in a dramatic reduction in the number of blood glucose measures the nursing staff performed, cutting testing down from 7,495 blood glucose measures/month before the system began to 4,072 blood measures/month once it was in place, Dr. Christopher C. Baker, FACS, said at the annual meeting of the Southern Surgical Association.

An additional associated benefit was a substantial reduction in hospital-acquired infections in the postsurgery patients once computer-guided insulin dosing came online, but this was only a temporal association that may have also been driven by other improvements in patient management that happened at about the same time, said Dr. Baker, chairman of surgery at the Carilion Clinic in Roanoke, Va.

"People have shied away from glucose controls systems [like the one introduced at the Carilion Clinic] because the results from the NICE-SUGAR [Normoglycemia in Intensive Care Evaluation–Survival Using Glucose Algorithm Regulation] trial (N. Engl. J. Med. 2009;360:1283-97) showed that hypoglycemia episodes increase when you do this," commented Dr. David Herndon, FACS, professor of surgery at the University of Texas Medical branch in Galveston. "What is important in the Carilion results is that the computerized support system reduced hypoglycemia. If that can be done across the board, they might have a winner. We need to better control sugar in the ICU."

The next step is to prove the efficacy of this computer program in a prospective, randomized controlled trial, said Dr. Herndon, a suggestion that Dr. Baker also endorsed.

"The reduced incidence of hypoglycemia was incredibly impressive," commented Dr. Michael Rotondo, FACS, professor and chairman of surgery at East Carolina University in Greenville, N.C., who also called for results from a prospective, controlled study.

Surgeons at Carilion introduced the computerized support program for insulin dosing in early 2010 into five surgical intensive care departments: surgical ICU, trauma ICU, neurotrauma ICU, cardiac surgery ICU, and the cardiac surgery progressive care unit. Dr. Baker and his associates compared data collected on patients from all five units with the computerized system in place during July 2010-December 2011, a total of 1,682 patients treated using the computer program, with 449 patients treated in the five units during July 2009-December 2009, before use of the computer program started.

When using the program, nurses take an initial blood specimen from a patient newly arrived at the unit and enter the blood glucose level into the program along with the patient’s weight and blood creatinine level. The program then immediately calculates the appropriate bolus insulin dose, the insulin infusion rate, and the time to the next blood draw, said Dr. Sandy L. Fogel, FACS, a surgeon at Carilion who collaborated on the study. At first, the next blood draw is specified for about 15-30 minutes following the first, but subsequently the blood draws are directed to occur at longer and longer intervals as the patient’s blood glucose comes under control, within the target range of 70-150 mg/dL. Eventually, draws occur at 6-8 hour intervals, Dr. Fogel said.

During the 6-month historical control, nurses drew 44,972 blood specimens for glucose measurement, an average of 7,495/month, compared with 73,290 blood draws during the 18-month period with the program in place, an average of 4,072 blood specimens drawn/month.

During the 18 months with the program in use, hyperglycemic episodes, defined as a blood glucose level greater than 150 mg/dL, dropped by 45%-57% across the five units using the system compared with each unit’s historical control. Overall, hyperglycemic events fell by 50%, a statistically significant difference.

The incidence of hypoglycemic episodes, defined as a blood glucose level below 40 mg/dL, fell from a 1% rate during the historical control period, to rates that ranged from zero to 0.12% with the program in place, with an overall rate across all five units of 0.05%, a 95% relative decrease that was statistically significant.

The substantial decline in hypoglycemic episodes "was a surprise for us," Dr. Fogel said. In addition, out of all the blood measures performed using the computer program 17% had glucose levels of 60-69 mg/dL, and 3% were below 60 mg/dL. In short, the computer program "did not increase hypoglycemic episodes by any way you measure it," Dr. Fogel said.

The insulin-dosing program used at Carilion is the EndoTool, marketed by Hospira, Inc.

Dr. Baker, Dr. Herndon, Dr. Rotondo, and Dr. Fogel had no disclosures.

[email protected]

On Twitter @mitchelzoler

PALM BEACH, FLA. – A commercially available computer program designed to calculate optimal insulin dosages for postsurgical ICU patients halved the rate of hyperglycemic episodes that patients experienced while dropping the rate of hypoglycemic events by 95% in a single-center, U.S. experience with a total of more than 2,000 patients.

The computer program also resulted in a dramatic reduction in the number of blood glucose measures the nursing staff performed, cutting testing down from 7,495 blood glucose measures/month before the system began to 4,072 blood measures/month once it was in place, Dr. Christopher C. Baker, FACS, said at the annual meeting of the Southern Surgical Association.

An additional associated benefit was a substantial reduction in hospital-acquired infections in the postsurgery patients once computer-guided insulin dosing came online, but this was only a temporal association that may have also been driven by other improvements in patient management that happened at about the same time, said Dr. Baker, chairman of surgery at the Carilion Clinic in Roanoke, Va.

"People have shied away from glucose controls systems [like the one introduced at the Carilion Clinic] because the results from the NICE-SUGAR [Normoglycemia in Intensive Care Evaluation–Survival Using Glucose Algorithm Regulation] trial (N. Engl. J. Med. 2009;360:1283-97) showed that hypoglycemia episodes increase when you do this," commented Dr. David Herndon, FACS, professor of surgery at the University of Texas Medical branch in Galveston. "What is important in the Carilion results is that the computerized support system reduced hypoglycemia. If that can be done across the board, they might have a winner. We need to better control sugar in the ICU."

The next step is to prove the efficacy of this computer program in a prospective, randomized controlled trial, said Dr. Herndon, a suggestion that Dr. Baker also endorsed.

"The reduced incidence of hypoglycemia was incredibly impressive," commented Dr. Michael Rotondo, FACS, professor and chairman of surgery at East Carolina University in Greenville, N.C., who also called for results from a prospective, controlled study.

Surgeons at Carilion introduced the computerized support program for insulin dosing in early 2010 into five surgical intensive care departments: surgical ICU, trauma ICU, neurotrauma ICU, cardiac surgery ICU, and the cardiac surgery progressive care unit. Dr. Baker and his associates compared data collected on patients from all five units with the computerized system in place during July 2010-December 2011, a total of 1,682 patients treated using the computer program, with 449 patients treated in the five units during July 2009-December 2009, before use of the computer program started.

When using the program, nurses take an initial blood specimen from a patient newly arrived at the unit and enter the blood glucose level into the program along with the patient’s weight and blood creatinine level. The program then immediately calculates the appropriate bolus insulin dose, the insulin infusion rate, and the time to the next blood draw, said Dr. Sandy L. Fogel, FACS, a surgeon at Carilion who collaborated on the study. At first, the next blood draw is specified for about 15-30 minutes following the first, but subsequently the blood draws are directed to occur at longer and longer intervals as the patient’s blood glucose comes under control, within the target range of 70-150 mg/dL. Eventually, draws occur at 6-8 hour intervals, Dr. Fogel said.

During the 6-month historical control, nurses drew 44,972 blood specimens for glucose measurement, an average of 7,495/month, compared with 73,290 blood draws during the 18-month period with the program in place, an average of 4,072 blood specimens drawn/month.

During the 18 months with the program in use, hyperglycemic episodes, defined as a blood glucose level greater than 150 mg/dL, dropped by 45%-57% across the five units using the system compared with each unit’s historical control. Overall, hyperglycemic events fell by 50%, a statistically significant difference.

The incidence of hypoglycemic episodes, defined as a blood glucose level below 40 mg/dL, fell from a 1% rate during the historical control period, to rates that ranged from zero to 0.12% with the program in place, with an overall rate across all five units of 0.05%, a 95% relative decrease that was statistically significant.

The substantial decline in hypoglycemic episodes "was a surprise for us," Dr. Fogel said. In addition, out of all the blood measures performed using the computer program 17% had glucose levels of 60-69 mg/dL, and 3% were below 60 mg/dL. In short, the computer program "did not increase hypoglycemic episodes by any way you measure it," Dr. Fogel said.

The insulin-dosing program used at Carilion is the EndoTool, marketed by Hospira, Inc.

Dr. Baker, Dr. Herndon, Dr. Rotondo, and Dr. Fogel had no disclosures.

[email protected]

On Twitter @mitchelzoler

PALM BEACH, FLA. – A commercially available computer program designed to calculate optimal insulin dosages for postsurgical ICU patients halved the rate of hyperglycemic episodes that patients experienced while dropping the rate of hypoglycemic events by 95% in a single-center, U.S. experience with a total of more than 2,000 patients.

The computer program also resulted in a dramatic reduction in the number of blood glucose measures the nursing staff performed, cutting testing down from 7,495 blood glucose measures/month before the system began to 4,072 blood measures/month once it was in place, Dr. Christopher C. Baker, FACS, said at the annual meeting of the Southern Surgical Association.

An additional associated benefit was a substantial reduction in hospital-acquired infections in the postsurgery patients once computer-guided insulin dosing came online, but this was only a temporal association that may have also been driven by other improvements in patient management that happened at about the same time, said Dr. Baker, chairman of surgery at the Carilion Clinic in Roanoke, Va.

"People have shied away from glucose controls systems [like the one introduced at the Carilion Clinic] because the results from the NICE-SUGAR [Normoglycemia in Intensive Care Evaluation–Survival Using Glucose Algorithm Regulation] trial (N. Engl. J. Med. 2009;360:1283-97) showed that hypoglycemia episodes increase when you do this," commented Dr. David Herndon, FACS, professor of surgery at the University of Texas Medical branch in Galveston. "What is important in the Carilion results is that the computerized support system reduced hypoglycemia. If that can be done across the board, they might have a winner. We need to better control sugar in the ICU."

The next step is to prove the efficacy of this computer program in a prospective, randomized controlled trial, said Dr. Herndon, a suggestion that Dr. Baker also endorsed.

"The reduced incidence of hypoglycemia was incredibly impressive," commented Dr. Michael Rotondo, FACS, professor and chairman of surgery at East Carolina University in Greenville, N.C., who also called for results from a prospective, controlled study.

Surgeons at Carilion introduced the computerized support program for insulin dosing in early 2010 into five surgical intensive care departments: surgical ICU, trauma ICU, neurotrauma ICU, cardiac surgery ICU, and the cardiac surgery progressive care unit. Dr. Baker and his associates compared data collected on patients from all five units with the computerized system in place during July 2010-December 2011, a total of 1,682 patients treated using the computer program, with 449 patients treated in the five units during July 2009-December 2009, before use of the computer program started.

When using the program, nurses take an initial blood specimen from a patient newly arrived at the unit and enter the blood glucose level into the program along with the patient’s weight and blood creatinine level. The program then immediately calculates the appropriate bolus insulin dose, the insulin infusion rate, and the time to the next blood draw, said Dr. Sandy L. Fogel, FACS, a surgeon at Carilion who collaborated on the study. At first, the next blood draw is specified for about 15-30 minutes following the first, but subsequently the blood draws are directed to occur at longer and longer intervals as the patient’s blood glucose comes under control, within the target range of 70-150 mg/dL. Eventually, draws occur at 6-8 hour intervals, Dr. Fogel said.

During the 6-month historical control, nurses drew 44,972 blood specimens for glucose measurement, an average of 7,495/month, compared with 73,290 blood draws during the 18-month period with the program in place, an average of 4,072 blood specimens drawn/month.

During the 18 months with the program in use, hyperglycemic episodes, defined as a blood glucose level greater than 150 mg/dL, dropped by 45%-57% across the five units using the system compared with each unit’s historical control. Overall, hyperglycemic events fell by 50%, a statistically significant difference.

The incidence of hypoglycemic episodes, defined as a blood glucose level below 40 mg/dL, fell from a 1% rate during the historical control period, to rates that ranged from zero to 0.12% with the program in place, with an overall rate across all five units of 0.05%, a 95% relative decrease that was statistically significant.

The substantial decline in hypoglycemic episodes "was a surprise for us," Dr. Fogel said. In addition, out of all the blood measures performed using the computer program 17% had glucose levels of 60-69 mg/dL, and 3% were below 60 mg/dL. In short, the computer program "did not increase hypoglycemic episodes by any way you measure it," Dr. Fogel said.

The insulin-dosing program used at Carilion is the EndoTool, marketed by Hospira, Inc.

Dr. Baker, Dr. Herndon, Dr. Rotondo, and Dr. Fogel had no disclosures.

[email protected]

On Twitter @mitchelzoler

For patients with severe acute GI bleeding, outcomes are significantly better when a restrictive transfusion strategy is used – limiting the hemoglobin threshold to 7 g/dL – rather than a liberal transfusion strategy allowing a 9 g/dL threshold, according to a report published online Jan. 2 in the New England Journal of Medicine.

In a single-center randomized controlled trial involving 889 patients, the restrictive transfusion strategy resulted in significantly lower mortality, lower rates of rebleeding, less frequent need for rescue therapy, fewer complications, and shorter hospitalizations than did the liberal transfusion strategy. "Our results suggest that in patients with acute GI bleeding, a strategy of not performing transfusion until the hemoglobin concentration falls below 7 g/dL is a safe and effective approach," said Dr. Càndid Villanueva of Hospital de Sant Pau, Barcelona, and his associates.

"Current international guidelines recommend decreasing the hemoglobin threshold level for transfusion ... from 10g/dL to 7 g/dL" in such patients, but these recommendations are based on trials involving critically ill patients with normovolemic anemia that did not include subjects with acute bleeding. "Transfusion requirements may be different for patients with acute hemorrhage due to factors such as hemodynamic instability or rapid onset of anemia" resulting from extremely low hemoglobin levels.

In particular, results of animal studies suggest that transfusion can be especially harmful in patients with bleeding from portal hypertension sources, "since restitution of blood volume after hemorrhage can lead to a rebound increase in portal pressure, which is associated with a risk of rebleeding," the investigators noted.

To examine the effects of different transfusion strategies in this setting, Dr. Villanueva and his colleagues enrolled adults who presented with hematemesis, melena, or both, randomly assigning 444 to receive restrictive transfusion (with a target range for the posttransfusion hemoglobin level of 7-9 g/dL) and 445 to receive liberal transfusion (with a target range of 9-11 g/dL).

The study protocol permitted transfusions to be administered at the discretion of the attending physician any time symptoms or signs of anemia developed, massive bleeding occurred, or surgical intervention was needed, as well as when hemoglobin levels dipped below the assigned threshold.

All the study subjects underwent emergency gastroscopy within 6 hours of presentation, with appropriate treatment when the source of the bleeding was identified. Diagnoses included peptic ulcer, esophageal varices, cirrhosis, portal hypertension, and nonvariceal lesions.

The primary outcome measure, mortality from any cause at 45 days, was significantly lower in the restrictive-strategy group (5%) than the liberal-strategy group (9%). Death resulted from uncontrolled bleeding in 0.7% vs 3.1% of the 2 groups, respectively, the researchers said (N. Engl. J. Med. 2013 Jan. 2 [doi:10.1056/NEJMoa1211801]).

The rate of rebleeding also was significantly lower with the restrictive strategy (10% vs. 16%), and length of hospital stay was significantly shorter. In addition, rescue therapy for esophageal varices with balloon tamponade or a transjugular intrahepatic portosystemic shunt was required less often in the restrictive-strategy group than in the liberal-strategy group, as was emergency surgery to control further bleeding from peptic ulcer.

The rate of overall complications was significantly lower with the restrictive strategy (40%) than with the liberal strategy (48%), as was the rate of serious adverse events. In addition, transfusion reactions and cardiac events such as pulmonary edema were more frequent with the liberal strategy.

"Our results are consistent with those from previous observational studies and randomized trials performed in other settings, which have shown that a restrictive transfusion strategy did not increase, and even decreased, the mortality observed with a liberal transfusion strategy," Dr. Villanueva and his associates said.

For patients with severe acute GI bleeding, outcomes are significantly better when a restrictive transfusion strategy is used – limiting the hemoglobin threshold to 7 g/dL – rather than a liberal transfusion strategy allowing a 9 g/dL threshold, according to a report published online Jan. 2 in the New England Journal of Medicine.

In a single-center randomized controlled trial involving 889 patients, the restrictive transfusion strategy resulted in significantly lower mortality, lower rates of rebleeding, less frequent need for rescue therapy, fewer complications, and shorter hospitalizations than did the liberal transfusion strategy. "Our results suggest that in patients with acute GI bleeding, a strategy of not performing transfusion until the hemoglobin concentration falls below 7 g/dL is a safe and effective approach," said Dr. Càndid Villanueva of Hospital de Sant Pau, Barcelona, and his associates.

"Current international guidelines recommend decreasing the hemoglobin threshold level for transfusion ... from 10g/dL to 7 g/dL" in such patients, but these recommendations are based on trials involving critically ill patients with normovolemic anemia that did not include subjects with acute bleeding. "Transfusion requirements may be different for patients with acute hemorrhage due to factors such as hemodynamic instability or rapid onset of anemia" resulting from extremely low hemoglobin levels.

In particular, results of animal studies suggest that transfusion can be especially harmful in patients with bleeding from portal hypertension sources, "since restitution of blood volume after hemorrhage can lead to a rebound increase in portal pressure, which is associated with a risk of rebleeding," the investigators noted.

To examine the effects of different transfusion strategies in this setting, Dr. Villanueva and his colleagues enrolled adults who presented with hematemesis, melena, or both, randomly assigning 444 to receive restrictive transfusion (with a target range for the posttransfusion hemoglobin level of 7-9 g/dL) and 445 to receive liberal transfusion (with a target range of 9-11 g/dL).

The study protocol permitted transfusions to be administered at the discretion of the attending physician any time symptoms or signs of anemia developed, massive bleeding occurred, or surgical intervention was needed, as well as when hemoglobin levels dipped below the assigned threshold.

All the study subjects underwent emergency gastroscopy within 6 hours of presentation, with appropriate treatment when the source of the bleeding was identified. Diagnoses included peptic ulcer, esophageal varices, cirrhosis, portal hypertension, and nonvariceal lesions.

The primary outcome measure, mortality from any cause at 45 days, was significantly lower in the restrictive-strategy group (5%) than the liberal-strategy group (9%). Death resulted from uncontrolled bleeding in 0.7% vs 3.1% of the 2 groups, respectively, the researchers said (N. Engl. J. Med. 2013 Jan. 2 [doi:10.1056/NEJMoa1211801]).

The rate of rebleeding also was significantly lower with the restrictive strategy (10% vs. 16%), and length of hospital stay was significantly shorter. In addition, rescue therapy for esophageal varices with balloon tamponade or a transjugular intrahepatic portosystemic shunt was required less often in the restrictive-strategy group than in the liberal-strategy group, as was emergency surgery to control further bleeding from peptic ulcer.

The rate of overall complications was significantly lower with the restrictive strategy (40%) than with the liberal strategy (48%), as was the rate of serious adverse events. In addition, transfusion reactions and cardiac events such as pulmonary edema were more frequent with the liberal strategy.

"Our results are consistent with those from previous observational studies and randomized trials performed in other settings, which have shown that a restrictive transfusion strategy did not increase, and even decreased, the mortality observed with a liberal transfusion strategy," Dr. Villanueva and his associates said.

For patients with severe acute GI bleeding, outcomes are significantly better when a restrictive transfusion strategy is used – limiting the hemoglobin threshold to 7 g/dL – rather than a liberal transfusion strategy allowing a 9 g/dL threshold, according to a report published online Jan. 2 in the New England Journal of Medicine.

In a single-center randomized controlled trial involving 889 patients, the restrictive transfusion strategy resulted in significantly lower mortality, lower rates of rebleeding, less frequent need for rescue therapy, fewer complications, and shorter hospitalizations than did the liberal transfusion strategy. "Our results suggest that in patients with acute GI bleeding, a strategy of not performing transfusion until the hemoglobin concentration falls below 7 g/dL is a safe and effective approach," said Dr. Càndid Villanueva of Hospital de Sant Pau, Barcelona, and his associates.

"Current international guidelines recommend decreasing the hemoglobin threshold level for transfusion ... from 10g/dL to 7 g/dL" in such patients, but these recommendations are based on trials involving critically ill patients with normovolemic anemia that did not include subjects with acute bleeding. "Transfusion requirements may be different for patients with acute hemorrhage due to factors such as hemodynamic instability or rapid onset of anemia" resulting from extremely low hemoglobin levels.

In particular, results of animal studies suggest that transfusion can be especially harmful in patients with bleeding from portal hypertension sources, "since restitution of blood volume after hemorrhage can lead to a rebound increase in portal pressure, which is associated with a risk of rebleeding," the investigators noted.

To examine the effects of different transfusion strategies in this setting, Dr. Villanueva and his colleagues enrolled adults who presented with hematemesis, melena, or both, randomly assigning 444 to receive restrictive transfusion (with a target range for the posttransfusion hemoglobin level of 7-9 g/dL) and 445 to receive liberal transfusion (with a target range of 9-11 g/dL).

The study protocol permitted transfusions to be administered at the discretion of the attending physician any time symptoms or signs of anemia developed, massive bleeding occurred, or surgical intervention was needed, as well as when hemoglobin levels dipped below the assigned threshold.

All the study subjects underwent emergency gastroscopy within 6 hours of presentation, with appropriate treatment when the source of the bleeding was identified. Diagnoses included peptic ulcer, esophageal varices, cirrhosis, portal hypertension, and nonvariceal lesions.

The primary outcome measure, mortality from any cause at 45 days, was significantly lower in the restrictive-strategy group (5%) than the liberal-strategy group (9%). Death resulted from uncontrolled bleeding in 0.7% vs 3.1% of the 2 groups, respectively, the researchers said (N. Engl. J. Med. 2013 Jan. 2 [doi:10.1056/NEJMoa1211801]).

The rate of rebleeding also was significantly lower with the restrictive strategy (10% vs. 16%), and length of hospital stay was significantly shorter. In addition, rescue therapy for esophageal varices with balloon tamponade or a transjugular intrahepatic portosystemic shunt was required less often in the restrictive-strategy group than in the liberal-strategy group, as was emergency surgery to control further bleeding from peptic ulcer.

The rate of overall complications was significantly lower with the restrictive strategy (40%) than with the liberal strategy (48%), as was the rate of serious adverse events. In addition, transfusion reactions and cardiac events such as pulmonary edema were more frequent with the liberal strategy.

"Our results are consistent with those from previous observational studies and randomized trials performed in other settings, which have shown that a restrictive transfusion strategy did not increase, and even decreased, the mortality observed with a liberal transfusion strategy," Dr. Villanueva and his associates said.

Higher grades of obesity were associated with greater all-cause mortality than was normal weight, but low-grade obesity and overweight were linked to lower mortality in a meta-analysis of 97 clinical studies reported in the Jan. 2 issue of JAMA.

These findings, from a systematic review that included nearly 3 million study subjects on five continents, are "broadly consistent" with those of several previous studies and two previous meta-analyses: Excess mortality occurs only at the highest levels of obesity, while mortality is lower among overweight and slightly obese individuals than among people of normal weight, said Katherine M. Flegal, Ph.D., of the National Center for Health Statistics, Hyattsville, Md., and her associates.

The investigators reviewed the literature and included in their meta-analysis all prospective, observational cohort studies that reported all-cause mortality in adults whose body mass index was measured using standard categories. A BMI of less than 18.5 was underweight, that of 18.5 to less than 25 was normal weight, a BMI of 25 to less than 30 was overweight, that of 30 to less than 35 was grade 1 obesity, a BMI of 35 to less than 40 was grade 2 obesity, and a BMI of 40 or greater was grade 3 obesity.

The researchers included 41 studies from the United States or Canada, 37 from Europe, 7 from Australia, 4 from China or Taiwan, 2 from Japan, 2 from Israel, 2 from Brazil, 1 from India, and 1 from Mexico. Overall there were 2.8 million subjects and 270,000 deaths during follow-up.

Overweight and grade 1 obesity were associated with significantly lower mortality than was normal weight, with hazard ratios of 0.94 and 0.95, respectively. In contrast, grade 1 and grade 2 obesity were associated with significantly higher mortality than was normal weight, with an HR of 1.29, Dr. Flegal and her colleagues said (JAMA 2013;309:71-82).

These findings remained robust in several sensitivity analyses.

The reasons why overweight and slight obesity might be protective are still unknown. Some have proposed that slightly heavy patients might present for medical care earlier than normal weight and severely obese patients when symptoms arise, and they also may be more likely to receive optimal medical treatment because caregivers recognize that their weight confers risk. It also is possible that slightly increased body fat may exert cardioprotective metabolic effects and provide better metabolic reserves when illness occurs, the investigators said.

Their meta-analysis also demonstrated that studies relying on patients’ self-report of weight and height are subject to important bias, because these measures are not accurately reported across all categories of age, sex, and race.

No financial conflicts of interest were reported.

Higher grades of obesity were associated with greater all-cause mortality than was normal weight, but low-grade obesity and overweight were linked to lower mortality in a meta-analysis of 97 clinical studies reported in the Jan. 2 issue of JAMA.

These findings, from a systematic review that included nearly 3 million study subjects on five continents, are "broadly consistent" with those of several previous studies and two previous meta-analyses: Excess mortality occurs only at the highest levels of obesity, while mortality is lower among overweight and slightly obese individuals than among people of normal weight, said Katherine M. Flegal, Ph.D., of the National Center for Health Statistics, Hyattsville, Md., and her associates.

The investigators reviewed the literature and included in their meta-analysis all prospective, observational cohort studies that reported all-cause mortality in adults whose body mass index was measured using standard categories. A BMI of less than 18.5 was underweight, that of 18.5 to less than 25 was normal weight, a BMI of 25 to less than 30 was overweight, that of 30 to less than 35 was grade 1 obesity, a BMI of 35 to less than 40 was grade 2 obesity, and a BMI of 40 or greater was grade 3 obesity.

The researchers included 41 studies from the United States or Canada, 37 from Europe, 7 from Australia, 4 from China or Taiwan, 2 from Japan, 2 from Israel, 2 from Brazil, 1 from India, and 1 from Mexico. Overall there were 2.8 million subjects and 270,000 deaths during follow-up.

Overweight and grade 1 obesity were associated with significantly lower mortality than was normal weight, with hazard ratios of 0.94 and 0.95, respectively. In contrast, grade 1 and grade 2 obesity were associated with significantly higher mortality than was normal weight, with an HR of 1.29, Dr. Flegal and her colleagues said (JAMA 2013;309:71-82).

These findings remained robust in several sensitivity analyses.

The reasons why overweight and slight obesity might be protective are still unknown. Some have proposed that slightly heavy patients might present for medical care earlier than normal weight and severely obese patients when symptoms arise, and they also may be more likely to receive optimal medical treatment because caregivers recognize that their weight confers risk. It also is possible that slightly increased body fat may exert cardioprotective metabolic effects and provide better metabolic reserves when illness occurs, the investigators said.

Their meta-analysis also demonstrated that studies relying on patients’ self-report of weight and height are subject to important bias, because these measures are not accurately reported across all categories of age, sex, and race.

No financial conflicts of interest were reported.

Higher grades of obesity were associated with greater all-cause mortality than was normal weight, but low-grade obesity and overweight were linked to lower mortality in a meta-analysis of 97 clinical studies reported in the Jan. 2 issue of JAMA.

These findings, from a systematic review that included nearly 3 million study subjects on five continents, are "broadly consistent" with those of several previous studies and two previous meta-analyses: Excess mortality occurs only at the highest levels of obesity, while mortality is lower among overweight and slightly obese individuals than among people of normal weight, said Katherine M. Flegal, Ph.D., of the National Center for Health Statistics, Hyattsville, Md., and her associates.

The investigators reviewed the literature and included in their meta-analysis all prospective, observational cohort studies that reported all-cause mortality in adults whose body mass index was measured using standard categories. A BMI of less than 18.5 was underweight, that of 18.5 to less than 25 was normal weight, a BMI of 25 to less than 30 was overweight, that of 30 to less than 35 was grade 1 obesity, a BMI of 35 to less than 40 was grade 2 obesity, and a BMI of 40 or greater was grade 3 obesity.

The researchers included 41 studies from the United States or Canada, 37 from Europe, 7 from Australia, 4 from China or Taiwan, 2 from Japan, 2 from Israel, 2 from Brazil, 1 from India, and 1 from Mexico. Overall there were 2.8 million subjects and 270,000 deaths during follow-up.

Overweight and grade 1 obesity were associated with significantly lower mortality than was normal weight, with hazard ratios of 0.94 and 0.95, respectively. In contrast, grade 1 and grade 2 obesity were associated with significantly higher mortality than was normal weight, with an HR of 1.29, Dr. Flegal and her colleagues said (JAMA 2013;309:71-82).

These findings remained robust in several sensitivity analyses.

The reasons why overweight and slight obesity might be protective are still unknown. Some have proposed that slightly heavy patients might present for medical care earlier than normal weight and severely obese patients when symptoms arise, and they also may be more likely to receive optimal medical treatment because caregivers recognize that their weight confers risk. It also is possible that slightly increased body fat may exert cardioprotective metabolic effects and provide better metabolic reserves when illness occurs, the investigators said.

Their meta-analysis also demonstrated that studies relying on patients’ self-report of weight and height are subject to important bias, because these measures are not accurately reported across all categories of age, sex, and race.

No financial conflicts of interest were reported.

The FDA has declared the anticoagulant dabigatran contraindicated for patients with a mechanical heart valve, following anecdotal reports of blood clots forming on mechanical prosthetic valves and the abrupt stoppage of a phase II trial that had been testing dabigatran in this patient population.

"The U.S. Food and Drug Administration is informing health care professionals and the public that the blood thinner Pradaxa [dabigatran etexilate mesylate] should not be used to prevent stroke or blood clots in patients with mechanical heart valves," the agency said in a Drug Safety Communication.

"Health care professionals should promptly transition any patient with a mechanical heart valve who is taking Pradaxa to another medication," the agency added.

The statement also noted that the European-based, randomized phase II study to evaluate the safety and pharmacokinetics of oral dabigatran versus warfarin in patients after heart valve replacement (RE-ALIGN) (Am. Heart J. 2012;163:931-7) had been halted earlier in December by Boehringer Ingelheim, the company that markets Pradaxa, because the dabigatran-treated patients had shown an excess of strokes, myocardial infarctions, and blood clots that formed on the valves. Patients on dabigatran also had more episodes of bleeding after valve surgery than did patients on warfarin.

Although Boehringer Ingelheim and the researchers who ran the RE-ALIGN trial have not yet released the details of exactly what happened in the study, a report appeared in October from a group of cardiac surgeons at the Ottawa (Ont.) Heart Institute on their experience with two patients with mechanical heart valves who developed a thrombus on their valves and significant symptoms within 2 or 3 months of being switched from warfarin to dabigatran by their primary care physicians (J. Am. Coll. Cardiol. 2012;60:1710-1). These switches, which occurred even though dabigatran treatment in patients with mechanical prosthetic valves is an off-label use, probably represent the tip of the iceberg, said Dr. Munir Boodhwani, a cardiac surgeon at the Heart Institute and lead author of the two case reports.

"I suspect [this off-label use] is more common than we know. We see the problems, but we don’t know the denominator," he said in an interview. "In Ottawa, we routinely evaluate heart valve recipients every 6-12 months, and we have seen a few patients who had been switched from warfarin to dabigatran or another new oral anticoagulant. It has not been just one or two isolated cases. When we see these patients, we switch them back, and we send a message to their physician who made the switch that maybe this was not a good idea."

One of the cases he and his associates reported was a 51-year-old woman with a mechanical aortic valve who had been on warfarin for 8 years without complications and then was switched to 150 mg dabigatran twice daily by her general practitioner. Within 2 months, she developed crackles and a systolic murmur, and an echocardiogram revealed severe prosthetic aortic valve stenosis and a probable mass on the prosthesis. She arrived at the Heart Institute in cardiogenic shock and had cardiac arrest in the operating room. Surgery revealed an extensive thrombus on the valve, which was replaced. After surgery she had a complete recovery.

The second reported case was a 59-year-old woman with a mechanical mitral valve who had been on warfarin treatment without complications for about 4 years before being switched by her family physicians to 150 mg dabigatran twice daily. She developed progressive dyspnea, and an echocardiogram revealed a large thrombus on the valve. She underwent valve replacement and had an uneventful recovery.

Although phase III trial results showed dabigatran safe and effective for preventing blood clots and strokes in patients with nonvalvular atrial fibrillation, "atrial fibrillation is very different in a patient with a mechanical heart valve," Dr. Boodhwani said. "You cannot translate efficacy for one population to another. For atrial fibrillation, dosages of 110 mg b.i.d. and 150 mg b.i.d were effective [in the RE-LY trial; N. Engl. J. Med. 2009;361:1139-51], but in RE-ALIGN, dabigatran seems to have not been effective even at a dosage of 300 mg b.i.d. I think that Boehringer Ingelheim and the other companies that make the new anticoagulants need to go back to the drawing board and do more preclinical studies to determine what is a safe and effective dosage for anticoagulating patients with mechanical heart valves. It will likely need a higher dose, and then the question will be, What is the bleeding risk?"

The safety and efficacy results from nonvalvular atrial fibrillation patients in RE-LY are impossible to extrapolate to patients with mechanical valves, agreed Dr. Michael D. Ezekowitz, who was a coprincipal investigator for RE-LY but had no involvement in RE-ALIGN.

"It may be that a direct thrombin inhibitor [such as dabigatran] is not the drug of choice for preventing clots from forming on the surface of valves," Dr. Ezekowtiz said in an interview. "We have nearly 50 years of experience using warfarin for patients with mechanical heart valves, and that is clearly the drug of choice. This [RE-ALIGN] was probably a high-risk trial" in terms of trying to show that a new drug was at least as safe and effective as warfarin for heart valve patients.

Dr. Ezekowitz stressed that he has not been privy to any details of the RE-ALIGN results, but he suggested that it is hard to imagine that higher dabigatran dosages than the 300 mg b.i.d tested in RE-ALIGN could be used safely. "I was principal investigator for a phase II dabigatran study in atrial fibrillation, the PETRO [Prevention of Embolic and Thrombotic Events in Patients With Persistent AF] study (Am. J. Cardiol. 2007;100:1419-26). We tested up to 300 mg b.i.d., and in older atrial fibrillation patients this caused an excess of gastrointestinal bleeds and we decided to abandon that dosage in further testing. From a purely practical standpoint, I doubt whether a dabigatran dosage of more than 150 mg b.i.d would be tolerable," said Dr. Ezekowitz, professor of medicine at Jefferson Medical College in Philadelphia and director of atrial fibrillation research and education at the Cardiovascular Research Foundation in New York.

Some community physicians seem to have been mistakenly lured into prescribing dabigatran or other new anticoagulants to mechanical heart valve patients, perhaps because these physicians equated the newer drugs with better performance, Dr. Boodhwani said. But extrapolating the atrial fibrillation experience to heart-valve patients is premature, he warned.

"There is the potential for patients to die on these drugs. The off-label use can potentially be quite dangerous."

The FDA’s action and termination of the RE-ALIGN trial should send physicians a strong warning, he said. "This doesn’t close the door to future use of these drugs for mechanical valve patients, but physicians and industry need to be more cautious. The problems with warfarin need solutions, but only in a step-by-step way."

Dr. Boodhwani said he had no relevant financial disclosures. Dr. Ezekowitz said he has been a consultant to, has received honoraria as a lecturer on behalf of, and has received research funding from Boehringer Ingelheim, as well as from other drug companies that market antithrombotic drugs.

[email protected]

On Twitter @mitchelzoler

The FDA has declared the anticoagulant dabigatran contraindicated for patients with a mechanical heart valve, following anecdotal reports of blood clots forming on mechanical prosthetic valves and the abrupt stoppage of a phase II trial that had been testing dabigatran in this patient population.

"The U.S. Food and Drug Administration is informing health care professionals and the public that the blood thinner Pradaxa [dabigatran etexilate mesylate] should not be used to prevent stroke or blood clots in patients with mechanical heart valves," the agency said in a Drug Safety Communication.

"Health care professionals should promptly transition any patient with a mechanical heart valve who is taking Pradaxa to another medication," the agency added.

The statement also noted that the European-based, randomized phase II study to evaluate the safety and pharmacokinetics of oral dabigatran versus warfarin in patients after heart valve replacement (RE-ALIGN) (Am. Heart J. 2012;163:931-7) had been halted earlier in December by Boehringer Ingelheim, the company that markets Pradaxa, because the dabigatran-treated patients had shown an excess of strokes, myocardial infarctions, and blood clots that formed on the valves. Patients on dabigatran also had more episodes of bleeding after valve surgery than did patients on warfarin.

Although Boehringer Ingelheim and the researchers who ran the RE-ALIGN trial have not yet released the details of exactly what happened in the study, a report appeared in October from a group of cardiac surgeons at the Ottawa (Ont.) Heart Institute on their experience with two patients with mechanical heart valves who developed a thrombus on their valves and significant symptoms within 2 or 3 months of being switched from warfarin to dabigatran by their primary care physicians (J. Am. Coll. Cardiol. 2012;60:1710-1). These switches, which occurred even though dabigatran treatment in patients with mechanical prosthetic valves is an off-label use, probably represent the tip of the iceberg, said Dr. Munir Boodhwani, a cardiac surgeon at the Heart Institute and lead author of the two case reports.

"I suspect [this off-label use] is more common than we know. We see the problems, but we don’t know the denominator," he said in an interview. "In Ottawa, we routinely evaluate heart valve recipients every 6-12 months, and we have seen a few patients who had been switched from warfarin to dabigatran or another new oral anticoagulant. It has not been just one or two isolated cases. When we see these patients, we switch them back, and we send a message to their physician who made the switch that maybe this was not a good idea."

One of the cases he and his associates reported was a 51-year-old woman with a mechanical aortic valve who had been on warfarin for 8 years without complications and then was switched to 150 mg dabigatran twice daily by her general practitioner. Within 2 months, she developed crackles and a systolic murmur, and an echocardiogram revealed severe prosthetic aortic valve stenosis and a probable mass on the prosthesis. She arrived at the Heart Institute in cardiogenic shock and had cardiac arrest in the operating room. Surgery revealed an extensive thrombus on the valve, which was replaced. After surgery she had a complete recovery.

The second reported case was a 59-year-old woman with a mechanical mitral valve who had been on warfarin treatment without complications for about 4 years before being switched by her family physicians to 150 mg dabigatran twice daily. She developed progressive dyspnea, and an echocardiogram revealed a large thrombus on the valve. She underwent valve replacement and had an uneventful recovery.

Although phase III trial results showed dabigatran safe and effective for preventing blood clots and strokes in patients with nonvalvular atrial fibrillation, "atrial fibrillation is very different in a patient with a mechanical heart valve," Dr. Boodhwani said. "You cannot translate efficacy for one population to another. For atrial fibrillation, dosages of 110 mg b.i.d. and 150 mg b.i.d were effective [in the RE-LY trial; N. Engl. J. Med. 2009;361:1139-51], but in RE-ALIGN, dabigatran seems to have not been effective even at a dosage of 300 mg b.i.d. I think that Boehringer Ingelheim and the other companies that make the new anticoagulants need to go back to the drawing board and do more preclinical studies to determine what is a safe and effective dosage for anticoagulating patients with mechanical heart valves. It will likely need a higher dose, and then the question will be, What is the bleeding risk?"

The safety and efficacy results from nonvalvular atrial fibrillation patients in RE-LY are impossible to extrapolate to patients with mechanical valves, agreed Dr. Michael D. Ezekowitz, who was a coprincipal investigator for RE-LY but had no involvement in RE-ALIGN.

"It may be that a direct thrombin inhibitor [such as dabigatran] is not the drug of choice for preventing clots from forming on the surface of valves," Dr. Ezekowtiz said in an interview. "We have nearly 50 years of experience using warfarin for patients with mechanical heart valves, and that is clearly the drug of choice. This [RE-ALIGN] was probably a high-risk trial" in terms of trying to show that a new drug was at least as safe and effective as warfarin for heart valve patients.

Dr. Ezekowitz stressed that he has not been privy to any details of the RE-ALIGN results, but he suggested that it is hard to imagine that higher dabigatran dosages than the 300 mg b.i.d tested in RE-ALIGN could be used safely. "I was principal investigator for a phase II dabigatran study in atrial fibrillation, the PETRO [Prevention of Embolic and Thrombotic Events in Patients With Persistent AF] study (Am. J. Cardiol. 2007;100:1419-26). We tested up to 300 mg b.i.d., and in older atrial fibrillation patients this caused an excess of gastrointestinal bleeds and we decided to abandon that dosage in further testing. From a purely practical standpoint, I doubt whether a dabigatran dosage of more than 150 mg b.i.d would be tolerable," said Dr. Ezekowitz, professor of medicine at Jefferson Medical College in Philadelphia and director of atrial fibrillation research and education at the Cardiovascular Research Foundation in New York.

Some community physicians seem to have been mistakenly lured into prescribing dabigatran or other new anticoagulants to mechanical heart valve patients, perhaps because these physicians equated the newer drugs with better performance, Dr. Boodhwani said. But extrapolating the atrial fibrillation experience to heart-valve patients is premature, he warned.

"There is the potential for patients to die on these drugs. The off-label use can potentially be quite dangerous."

The FDA’s action and termination of the RE-ALIGN trial should send physicians a strong warning, he said. "This doesn’t close the door to future use of these drugs for mechanical valve patients, but physicians and industry need to be more cautious. The problems with warfarin need solutions, but only in a step-by-step way."

Dr. Boodhwani said he had no relevant financial disclosures. Dr. Ezekowitz said he has been a consultant to, has received honoraria as a lecturer on behalf of, and has received research funding from Boehringer Ingelheim, as well as from other drug companies that market antithrombotic drugs.

[email protected]

On Twitter @mitchelzoler

The FDA has declared the anticoagulant dabigatran contraindicated for patients with a mechanical heart valve, following anecdotal reports of blood clots forming on mechanical prosthetic valves and the abrupt stoppage of a phase II trial that had been testing dabigatran in this patient population.

"The U.S. Food and Drug Administration is informing health care professionals and the public that the blood thinner Pradaxa [dabigatran etexilate mesylate] should not be used to prevent stroke or blood clots in patients with mechanical heart valves," the agency said in a Drug Safety Communication.

"Health care professionals should promptly transition any patient with a mechanical heart valve who is taking Pradaxa to another medication," the agency added.

The statement also noted that the European-based, randomized phase II study to evaluate the safety and pharmacokinetics of oral dabigatran versus warfarin in patients after heart valve replacement (RE-ALIGN) (Am. Heart J. 2012;163:931-7) had been halted earlier in December by Boehringer Ingelheim, the company that markets Pradaxa, because the dabigatran-treated patients had shown an excess of strokes, myocardial infarctions, and blood clots that formed on the valves. Patients on dabigatran also had more episodes of bleeding after valve surgery than did patients on warfarin.

Although Boehringer Ingelheim and the researchers who ran the RE-ALIGN trial have not yet released the details of exactly what happened in the study, a report appeared in October from a group of cardiac surgeons at the Ottawa (Ont.) Heart Institute on their experience with two patients with mechanical heart valves who developed a thrombus on their valves and significant symptoms within 2 or 3 months of being switched from warfarin to dabigatran by their primary care physicians (J. Am. Coll. Cardiol. 2012;60:1710-1). These switches, which occurred even though dabigatran treatment in patients with mechanical prosthetic valves is an off-label use, probably represent the tip of the iceberg, said Dr. Munir Boodhwani, a cardiac surgeon at the Heart Institute and lead author of the two case reports.

"I suspect [this off-label use] is more common than we know. We see the problems, but we don’t know the denominator," he said in an interview. "In Ottawa, we routinely evaluate heart valve recipients every 6-12 months, and we have seen a few patients who had been switched from warfarin to dabigatran or another new oral anticoagulant. It has not been just one or two isolated cases. When we see these patients, we switch them back, and we send a message to their physician who made the switch that maybe this was not a good idea."

One of the cases he and his associates reported was a 51-year-old woman with a mechanical aortic valve who had been on warfarin for 8 years without complications and then was switched to 150 mg dabigatran twice daily by her general practitioner. Within 2 months, she developed crackles and a systolic murmur, and an echocardiogram revealed severe prosthetic aortic valve stenosis and a probable mass on the prosthesis. She arrived at the Heart Institute in cardiogenic shock and had cardiac arrest in the operating room. Surgery revealed an extensive thrombus on the valve, which was replaced. After surgery she had a complete recovery.

The second reported case was a 59-year-old woman with a mechanical mitral valve who had been on warfarin treatment without complications for about 4 years before being switched by her family physicians to 150 mg dabigatran twice daily. She developed progressive dyspnea, and an echocardiogram revealed a large thrombus on the valve. She underwent valve replacement and had an uneventful recovery.

Although phase III trial results showed dabigatran safe and effective for preventing blood clots and strokes in patients with nonvalvular atrial fibrillation, "atrial fibrillation is very different in a patient with a mechanical heart valve," Dr. Boodhwani said. "You cannot translate efficacy for one population to another. For atrial fibrillation, dosages of 110 mg b.i.d. and 150 mg b.i.d were effective [in the RE-LY trial; N. Engl. J. Med. 2009;361:1139-51], but in RE-ALIGN, dabigatran seems to have not been effective even at a dosage of 300 mg b.i.d. I think that Boehringer Ingelheim and the other companies that make the new anticoagulants need to go back to the drawing board and do more preclinical studies to determine what is a safe and effective dosage for anticoagulating patients with mechanical heart valves. It will likely need a higher dose, and then the question will be, What is the bleeding risk?"

The safety and efficacy results from nonvalvular atrial fibrillation patients in RE-LY are impossible to extrapolate to patients with mechanical valves, agreed Dr. Michael D. Ezekowitz, who was a coprincipal investigator for RE-LY but had no involvement in RE-ALIGN.

"It may be that a direct thrombin inhibitor [such as dabigatran] is not the drug of choice for preventing clots from forming on the surface of valves," Dr. Ezekowtiz said in an interview. "We have nearly 50 years of experience using warfarin for patients with mechanical heart valves, and that is clearly the drug of choice. This [RE-ALIGN] was probably a high-risk trial" in terms of trying to show that a new drug was at least as safe and effective as warfarin for heart valve patients.

Dr. Ezekowitz stressed that he has not been privy to any details of the RE-ALIGN results, but he suggested that it is hard to imagine that higher dabigatran dosages than the 300 mg b.i.d tested in RE-ALIGN could be used safely. "I was principal investigator for a phase II dabigatran study in atrial fibrillation, the PETRO [Prevention of Embolic and Thrombotic Events in Patients With Persistent AF] study (Am. J. Cardiol. 2007;100:1419-26). We tested up to 300 mg b.i.d., and in older atrial fibrillation patients this caused an excess of gastrointestinal bleeds and we decided to abandon that dosage in further testing. From a purely practical standpoint, I doubt whether a dabigatran dosage of more than 150 mg b.i.d would be tolerable," said Dr. Ezekowitz, professor of medicine at Jefferson Medical College in Philadelphia and director of atrial fibrillation research and education at the Cardiovascular Research Foundation in New York.

Some community physicians seem to have been mistakenly lured into prescribing dabigatran or other new anticoagulants to mechanical heart valve patients, perhaps because these physicians equated the newer drugs with better performance, Dr. Boodhwani said. But extrapolating the atrial fibrillation experience to heart-valve patients is premature, he warned.

"There is the potential for patients to die on these drugs. The off-label use can potentially be quite dangerous."

The FDA’s action and termination of the RE-ALIGN trial should send physicians a strong warning, he said. "This doesn’t close the door to future use of these drugs for mechanical valve patients, but physicians and industry need to be more cautious. The problems with warfarin need solutions, but only in a step-by-step way."

Dr. Boodhwani said he had no relevant financial disclosures. Dr. Ezekowitz said he has been a consultant to, has received honoraria as a lecturer on behalf of, and has received research funding from Boehringer Ingelheim, as well as from other drug companies that market antithrombotic drugs.

[email protected]

On Twitter @mitchelzoler

PALM BEACH, FLA. – Only a small percent of all trauma and acute care surgery patients require more than 10 days in the ICU, but the ones who do rack up an enormous chunk of ICU costs, a single-center study with more than 6,000 U.S. patients has shown.

A more detailed look at what contributes to these very prolonged ICU stays and their costs may provide new opportunities for hospital cost controls, Dr. Samir M. Fakhry, FACS, said at the annual meeting of the Southern Surgical Association.

"I think we need a paradigm shift in how these patients are managed," such as a step-down protocol that allows them to exit the ICU and wean off their ventilator, said Dr. Fakhry, professor and chief of general surgery at the Medical University of South Carolina in Charleston.

But trauma and acute care surgery patients who need less than a day in the ICU can’t be ignored either. Although their per-patient cost is relatively small, their aggregate cost is high, because many patients fall into this group.

"You need two approaches" for trying to save on surgical ICU costs, one for patients who need prolonged intensive care and a second approach for patients who require only a day, he said. "For patients with short lengths of stay and lower costs, small things like one or two fewer doses of an antibiotic or fewer tests would make a difference" when multiplied by thousands of patients, Dr. Fahkry said. Further insight into ICU costs and cost-saving approaches could come from expanding his analysis to a larger number of U.S. surgical ICUs, he added.

His analysis of data collected by the surgical ICU at the Medical University of South Carolina, a level 1 trauma center, during 2007-2011 also highlighted that the number of patients admitted to the unit jumped by 26%, rising from 1,084 patients in fiscal year 2007 to 1,364 in FY 2011. The rise was especially pronounced among nontrauma patients, increasing from 319 in 2007 to 502 in 2011, a 57% rise.

Dr. Fahkry and his associates analyzed data from a total of 6,008 patients admitted to his hospital’s surgical ICU during the 5-year period studied. Costs for this care rose from $17,243 per patient in 2007 to $26,468 in 2011, a 53% increase.

A total of 423 of these patients, 7%, stayed in the ICU for more than 10 days. This group consisted primarily of trauma patients, 320 (76%) of the 423 patients. The average length of stay among the prolonged-stay patients was about 17 days, with an overall duration of hospitalization of 31 days. About three-quarters of these patients had at least three comorbidities. Mortality was also high in this subgroup, especially in the nontrauma patients, who had a 40% death rate; in-hospital mortality among the trauma patients with prolonged ICU stays was 10%.

Although accounting for just 7% of all surgical ICU patients, this subgroup racked up 41% of total ICU costs during the 5 years studied. In contrast, 4,236 surgical ICU patients who remained in the unit for less than a full day, 71% of all patients in the analysis, were responsible for 30% of total surgical ICU costs.

The analysis also identified another marker of substantially increased ICU costs: patients who ultimately died during their index hospitalization. Among nontrauma patients who died while hospitalized, the average costs were nearly $60,000 per patient, almost eightfold higher than for the nontrauma patients who survived hospitalization. Among the trauma patients, those who died ran up more than $31,000 in costs, nearly threefold higher than the trauma patients who survived.

Dr. Fahkry said he had no relevant financial disclosures.

[email protected]

On Twitter @mitchelzoler

PALM BEACH, FLA. – Only a small percent of all trauma and acute care surgery patients require more than 10 days in the ICU, but the ones who do rack up an enormous chunk of ICU costs, a single-center study with more than 6,000 U.S. patients has shown.

A more detailed look at what contributes to these very prolonged ICU stays and their costs may provide new opportunities for hospital cost controls, Dr. Samir M. Fakhry, FACS, said at the annual meeting of the Southern Surgical Association.

"I think we need a paradigm shift in how these patients are managed," such as a step-down protocol that allows them to exit the ICU and wean off their ventilator, said Dr. Fakhry, professor and chief of general surgery at the Medical University of South Carolina in Charleston.

But trauma and acute care surgery patients who need less than a day in the ICU can’t be ignored either. Although their per-patient cost is relatively small, their aggregate cost is high, because many patients fall into this group.

"You need two approaches" for trying to save on surgical ICU costs, one for patients who need prolonged intensive care and a second approach for patients who require only a day, he said. "For patients with short lengths of stay and lower costs, small things like one or two fewer doses of an antibiotic or fewer tests would make a difference" when multiplied by thousands of patients, Dr. Fahkry said. Further insight into ICU costs and cost-saving approaches could come from expanding his analysis to a larger number of U.S. surgical ICUs, he added.

His analysis of data collected by the surgical ICU at the Medical University of South Carolina, a level 1 trauma center, during 2007-2011 also highlighted that the number of patients admitted to the unit jumped by 26%, rising from 1,084 patients in fiscal year 2007 to 1,364 in FY 2011. The rise was especially pronounced among nontrauma patients, increasing from 319 in 2007 to 502 in 2011, a 57% rise.

Dr. Fahkry and his associates analyzed data from a total of 6,008 patients admitted to his hospital’s surgical ICU during the 5-year period studied. Costs for this care rose from $17,243 per patient in 2007 to $26,468 in 2011, a 53% increase.

A total of 423 of these patients, 7%, stayed in the ICU for more than 10 days. This group consisted primarily of trauma patients, 320 (76%) of the 423 patients. The average length of stay among the prolonged-stay patients was about 17 days, with an overall duration of hospitalization of 31 days. About three-quarters of these patients had at least three comorbidities. Mortality was also high in this subgroup, especially in the nontrauma patients, who had a 40% death rate; in-hospital mortality among the trauma patients with prolonged ICU stays was 10%.

Although accounting for just 7% of all surgical ICU patients, this subgroup racked up 41% of total ICU costs during the 5 years studied. In contrast, 4,236 surgical ICU patients who remained in the unit for less than a full day, 71% of all patients in the analysis, were responsible for 30% of total surgical ICU costs.

The analysis also identified another marker of substantially increased ICU costs: patients who ultimately died during their index hospitalization. Among nontrauma patients who died while hospitalized, the average costs were nearly $60,000 per patient, almost eightfold higher than for the nontrauma patients who survived hospitalization. Among the trauma patients, those who died ran up more than $31,000 in costs, nearly threefold higher than the trauma patients who survived.

Dr. Fahkry said he had no relevant financial disclosures.

[email protected]

On Twitter @mitchelzoler

PALM BEACH, FLA. – Only a small percent of all trauma and acute care surgery patients require more than 10 days in the ICU, but the ones who do rack up an enormous chunk of ICU costs, a single-center study with more than 6,000 U.S. patients has shown.

A more detailed look at what contributes to these very prolonged ICU stays and their costs may provide new opportunities for hospital cost controls, Dr. Samir M. Fakhry, FACS, said at the annual meeting of the Southern Surgical Association.

"I think we need a paradigm shift in how these patients are managed," such as a step-down protocol that allows them to exit the ICU and wean off their ventilator, said Dr. Fakhry, professor and chief of general surgery at the Medical University of South Carolina in Charleston.

But trauma and acute care surgery patients who need less than a day in the ICU can’t be ignored either. Although their per-patient cost is relatively small, their aggregate cost is high, because many patients fall into this group.

"You need two approaches" for trying to save on surgical ICU costs, one for patients who need prolonged intensive care and a second approach for patients who require only a day, he said. "For patients with short lengths of stay and lower costs, small things like one or two fewer doses of an antibiotic or fewer tests would make a difference" when multiplied by thousands of patients, Dr. Fahkry said. Further insight into ICU costs and cost-saving approaches could come from expanding his analysis to a larger number of U.S. surgical ICUs, he added.

His analysis of data collected by the surgical ICU at the Medical University of South Carolina, a level 1 trauma center, during 2007-2011 also highlighted that the number of patients admitted to the unit jumped by 26%, rising from 1,084 patients in fiscal year 2007 to 1,364 in FY 2011. The rise was especially pronounced among nontrauma patients, increasing from 319 in 2007 to 502 in 2011, a 57% rise.

Dr. Fahkry and his associates analyzed data from a total of 6,008 patients admitted to his hospital’s surgical ICU during the 5-year period studied. Costs for this care rose from $17,243 per patient in 2007 to $26,468 in 2011, a 53% increase.

A total of 423 of these patients, 7%, stayed in the ICU for more than 10 days. This group consisted primarily of trauma patients, 320 (76%) of the 423 patients. The average length of stay among the prolonged-stay patients was about 17 days, with an overall duration of hospitalization of 31 days. About three-quarters of these patients had at least three comorbidities. Mortality was also high in this subgroup, especially in the nontrauma patients, who had a 40% death rate; in-hospital mortality among the trauma patients with prolonged ICU stays was 10%.

Although accounting for just 7% of all surgical ICU patients, this subgroup racked up 41% of total ICU costs during the 5 years studied. In contrast, 4,236 surgical ICU patients who remained in the unit for less than a full day, 71% of all patients in the analysis, were responsible for 30% of total surgical ICU costs.

The analysis also identified another marker of substantially increased ICU costs: patients who ultimately died during their index hospitalization. Among nontrauma patients who died while hospitalized, the average costs were nearly $60,000 per patient, almost eightfold higher than for the nontrauma patients who survived hospitalization. Among the trauma patients, those who died ran up more than $31,000 in costs, nearly threefold higher than the trauma patients who survived.

Dr. Fahkry said he had no relevant financial disclosures.

[email protected]

On Twitter @mitchelzoler

"Thank you all for agreeing to what I think is an excellent plan." Thus concluded the meeting led by one of the division heads in our department of surgery. The key agenda item was developing consensus on a highly controversial academic incentive plan that would transfer revenue from the busy clinicians who produced it to the faculty who were more engaged in the academic and educational missions of the division.

Several faculty members later related to me that the division head had dominated the conversation, belittled suggestions from his younger and less powerful colleagues, and "convinced" them to accept his plan with minimal alterations. They were irritated and frustrated. The division head reported to me that the meeting had gone extremely well and that he was able to gain consensus on a controversial and difficult issue. He was very pleased with himself.

I think we have all experienced this scenario – a person who is highly competent and possibly even pleasant in a social setting enters a meeting and, within minutes, irritates and comes into conflict with nearly everyone present, but sadly does not realize he has done so. What is lacking here?

The ancient Greeks called it "nothi auton" or "know thyself," and the modern parlance for it is self-awareness: the essential core of emotional intelligence and one of the most valuable attributes you can possess as a human being. In essence, it represents opening a door to your mind and discovering your own reality.

If self-awareness is so valuable, what exactly is it, why do you need it, and how do you get it if you don’t have it? Self-awareness consists of a number of components. First, it is an objective recognition of your strengths and weaknesses, values and beliefs, motives, and emotions. It also consists of an ability to continuously compare your current behavior to your core values and objectively assess whether that behavior reflects those values. Self-awareness also helps you to understand other people and how they perceive you. It helps you to recognize when you are stressed, and is a prerequisite for effective communication and interpersonal relations.

Why do you need self-awareness? Having self-awareness is required for you to be able to accept who you really are, to change those aspects of your personality that need to change, and to build on your strengths and clearly define your weaknesses. It is an important ingredient for effectively communicating with the world around you. In fact, it is difficult to imagine a happy human existence without a reasonable dose of this essential elixir.

Also, knowing oneself is the component of emotional intelligence that effective leaders possess in abundance. When I have encountered a failure of leadership in my surgical world, 90% of the time it has been due to a relative lack of self-awareness. (By the way, the division head described at the beginning of this editorial is now working elsewhere and the incentive plan for which he thought he had gained consensus is on the trash heap of unrealized objectives.)

How do you get self-awareness? In my experience, it is extremely difficult to instill self-awareness in people who are starting on empty. For individuals in leadership positions, the complete lack of this attribute may be a fatal flaw. For most of us, it is a natural part of maturation and can be improved by spending time in self-reflection, a practice few surgeons utilize because of their busy lives. Self-reflection should include spending quiet time, asking yourself difficult questions, and giving honest answers. Did I live to my core values during the meeting I just led? What could I have done better to lower the temperature in the room and avoid the conflicts that ensued? This requires commitment and courage. Also helpful is to have a sounding board of friends, colleagues, and/or mentors who are willing to critique you and provide honest feedback regarding your conduct during meetings, in the operating room, and even when having informal conversations.

So if you haven’t had the opportunity or acquired the tools to introduce yourself to yourself, it is never too late. It is not an easy process, but I believe you will be pleased with the result – a happier and more productive life.

Dr. Rikkers is Editor in Chief of Surgery News.

"Thank you all for agreeing to what I think is an excellent plan." Thus concluded the meeting led by one of the division heads in our department of surgery. The key agenda item was developing consensus on a highly controversial academic incentive plan that would transfer revenue from the busy clinicians who produced it to the faculty who were more engaged in the academic and educational missions of the division.

Several faculty members later related to me that the division head had dominated the conversation, belittled suggestions from his younger and less powerful colleagues, and "convinced" them to accept his plan with minimal alterations. They were irritated and frustrated. The division head reported to me that the meeting had gone extremely well and that he was able to gain consensus on a controversial and difficult issue. He was very pleased with himself.

I think we have all experienced this scenario – a person who is highly competent and possibly even pleasant in a social setting enters a meeting and, within minutes, irritates and comes into conflict with nearly everyone present, but sadly does not realize he has done so. What is lacking here?

The ancient Greeks called it "nothi auton" or "know thyself," and the modern parlance for it is self-awareness: the essential core of emotional intelligence and one of the most valuable attributes you can possess as a human being. In essence, it represents opening a door to your mind and discovering your own reality.

If self-awareness is so valuable, what exactly is it, why do you need it, and how do you get it if you don’t have it? Self-awareness consists of a number of components. First, it is an objective recognition of your strengths and weaknesses, values and beliefs, motives, and emotions. It also consists of an ability to continuously compare your current behavior to your core values and objectively assess whether that behavior reflects those values. Self-awareness also helps you to understand other people and how they perceive you. It helps you to recognize when you are stressed, and is a prerequisite for effective communication and interpersonal relations.

Why do you need self-awareness? Having self-awareness is required for you to be able to accept who you really are, to change those aspects of your personality that need to change, and to build on your strengths and clearly define your weaknesses. It is an important ingredient for effectively communicating with the world around you. In fact, it is difficult to imagine a happy human existence without a reasonable dose of this essential elixir.

Also, knowing oneself is the component of emotional intelligence that effective leaders possess in abundance. When I have encountered a failure of leadership in my surgical world, 90% of the time it has been due to a relative lack of self-awareness. (By the way, the division head described at the beginning of this editorial is now working elsewhere and the incentive plan for which he thought he had gained consensus is on the trash heap of unrealized objectives.)

How do you get self-awareness? In my experience, it is extremely difficult to instill self-awareness in people who are starting on empty. For individuals in leadership positions, the complete lack of this attribute may be a fatal flaw. For most of us, it is a natural part of maturation and can be improved by spending time in self-reflection, a practice few surgeons utilize because of their busy lives. Self-reflection should include spending quiet time, asking yourself difficult questions, and giving honest answers. Did I live to my core values during the meeting I just led? What could I have done better to lower the temperature in the room and avoid the conflicts that ensued? This requires commitment and courage. Also helpful is to have a sounding board of friends, colleagues, and/or mentors who are willing to critique you and provide honest feedback regarding your conduct during meetings, in the operating room, and even when having informal conversations.

So if you haven’t had the opportunity or acquired the tools to introduce yourself to yourself, it is never too late. It is not an easy process, but I believe you will be pleased with the result – a happier and more productive life.

Dr. Rikkers is Editor in Chief of Surgery News.

"Thank you all for agreeing to what I think is an excellent plan." Thus concluded the meeting led by one of the division heads in our department of surgery. The key agenda item was developing consensus on a highly controversial academic incentive plan that would transfer revenue from the busy clinicians who produced it to the faculty who were more engaged in the academic and educational missions of the division.

Several faculty members later related to me that the division head had dominated the conversation, belittled suggestions from his younger and less powerful colleagues, and "convinced" them to accept his plan with minimal alterations. They were irritated and frustrated. The division head reported to me that the meeting had gone extremely well and that he was able to gain consensus on a controversial and difficult issue. He was very pleased with himself.

I think we have all experienced this scenario – a person who is highly competent and possibly even pleasant in a social setting enters a meeting and, within minutes, irritates and comes into conflict with nearly everyone present, but sadly does not realize he has done so. What is lacking here?

The ancient Greeks called it "nothi auton" or "know thyself," and the modern parlance for it is self-awareness: the essential core of emotional intelligence and one of the most valuable attributes you can possess as a human being. In essence, it represents opening a door to your mind and discovering your own reality.

If self-awareness is so valuable, what exactly is it, why do you need it, and how do you get it if you don’t have it? Self-awareness consists of a number of components. First, it is an objective recognition of your strengths and weaknesses, values and beliefs, motives, and emotions. It also consists of an ability to continuously compare your current behavior to your core values and objectively assess whether that behavior reflects those values. Self-awareness also helps you to understand other people and how they perceive you. It helps you to recognize when you are stressed, and is a prerequisite for effective communication and interpersonal relations.

Why do you need self-awareness? Having self-awareness is required for you to be able to accept who you really are, to change those aspects of your personality that need to change, and to build on your strengths and clearly define your weaknesses. It is an important ingredient for effectively communicating with the world around you. In fact, it is difficult to imagine a happy human existence without a reasonable dose of this essential elixir.

Also, knowing oneself is the component of emotional intelligence that effective leaders possess in abundance. When I have encountered a failure of leadership in my surgical world, 90% of the time it has been due to a relative lack of self-awareness. (By the way, the division head described at the beginning of this editorial is now working elsewhere and the incentive plan for which he thought he had gained consensus is on the trash heap of unrealized objectives.)

How do you get self-awareness? In my experience, it is extremely difficult to instill self-awareness in people who are starting on empty. For individuals in leadership positions, the complete lack of this attribute may be a fatal flaw. For most of us, it is a natural part of maturation and can be improved by spending time in self-reflection, a practice few surgeons utilize because of their busy lives. Self-reflection should include spending quiet time, asking yourself difficult questions, and giving honest answers. Did I live to my core values during the meeting I just led? What could I have done better to lower the temperature in the room and avoid the conflicts that ensued? This requires commitment and courage. Also helpful is to have a sounding board of friends, colleagues, and/or mentors who are willing to critique you and provide honest feedback regarding your conduct during meetings, in the operating room, and even when having informal conversations.

So if you haven’t had the opportunity or acquired the tools to introduce yourself to yourself, it is never too late. It is not an easy process, but I believe you will be pleased with the result – a happier and more productive life.

Dr. Rikkers is Editor in Chief of Surgery News.

POINT: Volume remains a useful outcome proxy for complex procedures.

High-volume centers have been shown to have better outcomes than low-volume centers for procedures such as pancreatic and esophageal resections and complex aortic repairs, so hospital procedure volume should be used as a proxy measure for surgical outcome quality.

We need to accept that volume affects outcome. You get better at something if you practice it regularly, whether it’s piano, tennis, or surgery. If you don’t see that effect, it probably means that everyone is far enough along on the learning curve that the effect has gone away, or you are not looking at the right outcome. After all, if a surgeon’s parent needed an esophageal resection, that surgeon would probably find the very highest-volume colleague in the area to perform the operation.

But whether or not the volume-outcome relationship should be used to steer patients to high-volume hospitals depends on how steep the relationship is. For complex operations, it’s very steep – 10 percentage points or more in mortality. For those cases, referring patients to high-volume centers and using volume as a proxy outcome measure make sense; there are just not enough cases for additional outcome measures to be statistically meaningful bases for policy decisions. Plus, once you identify the high-volume providers for those operations, you can find out what they’re doing and share those lessons with others.

For more common operations, like coronary artery bypass grafting, inguinal hernia repair, colectomy, and bariatric surgery, the magnitude of difference is much smaller and mortality is rare, so it makes sense to use adverse event rates, functional outcomes, postoperative pain, patient convenience, and similar issues as quality measures, as far as they are known. Registries that track such issues are being built; we should use them.

Some have called the distinction between low-, medium-, and high-volume hospitals arbitrary, but you have to make such distinctions in order to make policy decisions. If you advocate sending complex surgical patients to high-volume hospitals, you have to define what that means. It’s not an easy call; if you require too many procedures for the high-volume designation, you limit the number of institutions that qualify and, therefore, you limit patient access. If too few are required, the distinction is less meaningful. Where you draw the line has trade-offs.

In short, the most rare, complex procedures should be regionalized to high-volume centers of excellence. For more common procedures, we should measure outcomes and share the results so we all keep moving forward.

Dr. Dimick is an associate professor of surgery and chief of the Division of Minimally Invasive Surgery at the University of Michigan in Ann Arbor. He is a cofounder of ArborMetrix, which makes software to measure hospital and surgical outcomes.

COUNTERPOINT: Better indicators of surgical quality need to be identified.

We recently failed to find a statistically significant association between hospital volume alone and in-hospital mortality for pancreatic resection, abdominal aortic aneurysm repair, esophageal resection, and coronary artery bypass grafting (Ann. Surg. 2012;256:606-15). These results suggest that hospital procedure volume alone should not be used as a proxy measure for quality of surgical outcomes.

Hospital volume isn’t entirely irrelevant, but as a stand-alone metric upon which to base referral patterns and other policy decisions, it doesn’t appear to be the most reliable measure. In studies where volume does seem to make a difference, it may be acting as a surrogate for other factors that probably matter more, including individual surgeon experience, careful patient selection, protocol-driven approaches to perioperative care, and well-coordinated surgical and patient-care teams.

These factors may cluster in certain large-volume institutions, but it is also true that some low-volume hospitals have outstanding surgical outcomes and some high-volume hospitals do not.

We used different statistical techniques in our study than those used in previous investigations that found a link between volume and quality; we believe our methods are more robust. One of the limitations of those earlier investigations is that they used arbitrary values to define hospitals into low-, high-, and in-between volume categories, which sacrificed precision.

Instead, using discharge data from 261,412 patient records in the 2008 Nationwide Inpatient Sample, Dr. Benjamin Kozower, Dr. George Stukenborg, and I analyzed volume as a continuous function and accounted for variations in the nonlinear relationships that exist between hospital volume and mortality for the four operations – the hospital volumes of which have been used as measures of surgical quality by various policy and regulatory bodies. When we did that, not only did individual hospital volume not have a significant risk-adjusted association with mortality, but also its relative strength of association with mortality was disproportionately small compared with other factors, including patient-level factors such as nutrition status and renal health.

So there’s much more to think about when it comes to identifying indicators of surgical quality. Instead of focusing on individual hospital volumes, we need to figure out what really does contribute to good outcomes so that the information can be shared with underperforming hospitals. Identifying truly modifiable factors to improve outcomes is also important, because with an increased emphasis on the public reporting of physician and hospital outcomes, reimbursement and referral strategies will likely be tied to performance. Thus, it makes sense that we move the discussion beyond simply annual hospital volumes.

Dr. LaPar is a fourth-year surgical resident at the University of Virginia in Charlottesville. He said he has no disclosures.

POINT: Volume remains a useful outcome proxy for complex procedures.

High-volume centers have been shown to have better outcomes than low-volume centers for procedures such as pancreatic and esophageal resections and complex aortic repairs, so hospital procedure volume should be used as a proxy measure for surgical outcome quality.

We need to accept that volume affects outcome. You get better at something if you practice it regularly, whether it’s piano, tennis, or surgery. If you don’t see that effect, it probably means that everyone is far enough along on the learning curve that the effect has gone away, or you are not looking at the right outcome. After all, if a surgeon’s parent needed an esophageal resection, that surgeon would probably find the very highest-volume colleague in the area to perform the operation.

But whether or not the volume-outcome relationship should be used to steer patients to high-volume hospitals depends on how steep the relationship is. For complex operations, it’s very steep – 10 percentage points or more in mortality. For those cases, referring patients to high-volume centers and using volume as a proxy outcome measure make sense; there are just not enough cases for additional outcome measures to be statistically meaningful bases for policy decisions. Plus, once you identify the high-volume providers for those operations, you can find out what they’re doing and share those lessons with others.

For more common operations, like coronary artery bypass grafting, inguinal hernia repair, colectomy, and bariatric surgery, the magnitude of difference is much smaller and mortality is rare, so it makes sense to use adverse event rates, functional outcomes, postoperative pain, patient convenience, and similar issues as quality measures, as far as they are known. Registries that track such issues are being built; we should use them.

Some have called the distinction between low-, medium-, and high-volume hospitals arbitrary, but you have to make such distinctions in order to make policy decisions. If you advocate sending complex surgical patients to high-volume hospitals, you have to define what that means. It’s not an easy call; if you require too many procedures for the high-volume designation, you limit the number of institutions that qualify and, therefore, you limit patient access. If too few are required, the distinction is less meaningful. Where you draw the line has trade-offs.

In short, the most rare, complex procedures should be regionalized to high-volume centers of excellence. For more common procedures, we should measure outcomes and share the results so we all keep moving forward.

Dr. Dimick is an associate professor of surgery and chief of the Division of Minimally Invasive Surgery at the University of Michigan in Ann Arbor. He is a cofounder of ArborMetrix, which makes software to measure hospital and surgical outcomes.

COUNTERPOINT: Better indicators of surgical quality need to be identified.

We recently failed to find a statistically significant association between hospital volume alone and in-hospital mortality for pancreatic resection, abdominal aortic aneurysm repair, esophageal resection, and coronary artery bypass grafting (Ann. Surg. 2012;256:606-15). These results suggest that hospital procedure volume alone should not be used as a proxy measure for quality of surgical outcomes.

Hospital volume isn’t entirely irrelevant, but as a stand-alone metric upon which to base referral patterns and other policy decisions, it doesn’t appear to be the most reliable measure. In studies where volume does seem to make a difference, it may be acting as a surrogate for other factors that probably matter more, including individual surgeon experience, careful patient selection, protocol-driven approaches to perioperative care, and well-coordinated surgical and patient-care teams.

These factors may cluster in certain large-volume institutions, but it is also true that some low-volume hospitals have outstanding surgical outcomes and some high-volume hospitals do not.

We used different statistical techniques in our study than those used in previous investigations that found a link between volume and quality; we believe our methods are more robust. One of the limitations of those earlier investigations is that they used arbitrary values to define hospitals into low-, high-, and in-between volume categories, which sacrificed precision.

Instead, using discharge data from 261,412 patient records in the 2008 Nationwide Inpatient Sample, Dr. Benjamin Kozower, Dr. George Stukenborg, and I analyzed volume as a continuous function and accounted for variations in the nonlinear relationships that exist between hospital volume and mortality for the four operations – the hospital volumes of which have been used as measures of surgical quality by various policy and regulatory bodies. When we did that, not only did individual hospital volume not have a significant risk-adjusted association with mortality, but also its relative strength of association with mortality was disproportionately small compared with other factors, including patient-level factors such as nutrition status and renal health.

So there’s much more to think about when it comes to identifying indicators of surgical quality. Instead of focusing on individual hospital volumes, we need to figure out what really does contribute to good outcomes so that the information can be shared with underperforming hospitals. Identifying truly modifiable factors to improve outcomes is also important, because with an increased emphasis on the public reporting of physician and hospital outcomes, reimbursement and referral strategies will likely be tied to performance. Thus, it makes sense that we move the discussion beyond simply annual hospital volumes.

Dr. LaPar is a fourth-year surgical resident at the University of Virginia in Charlottesville. He said he has no disclosures.

POINT: Volume remains a useful outcome proxy for complex procedures.

High-volume centers have been shown to have better outcomes than low-volume centers for procedures such as pancreatic and esophageal resections and complex aortic repairs, so hospital procedure volume should be used as a proxy measure for surgical outcome quality.

We need to accept that volume affects outcome. You get better at something if you practice it regularly, whether it’s piano, tennis, or surgery. If you don’t see that effect, it probably means that everyone is far enough along on the learning curve that the effect has gone away, or you are not looking at the right outcome. After all, if a surgeon’s parent needed an esophageal resection, that surgeon would probably find the very highest-volume colleague in the area to perform the operation.

But whether or not the volume-outcome relationship should be used to steer patients to high-volume hospitals depends on how steep the relationship is. For complex operations, it’s very steep – 10 percentage points or more in mortality. For those cases, referring patients to high-volume centers and using volume as a proxy outcome measure make sense; there are just not enough cases for additional outcome measures to be statistically meaningful bases for policy decisions. Plus, once you identify the high-volume providers for those operations, you can find out what they’re doing and share those lessons with others.

For more common operations, like coronary artery bypass grafting, inguinal hernia repair, colectomy, and bariatric surgery, the magnitude of difference is much smaller and mortality is rare, so it makes sense to use adverse event rates, functional outcomes, postoperative pain, patient convenience, and similar issues as quality measures, as far as they are known. Registries that track such issues are being built; we should use them.

Some have called the distinction between low-, medium-, and high-volume hospitals arbitrary, but you have to make such distinctions in order to make policy decisions. If you advocate sending complex surgical patients to high-volume hospitals, you have to define what that means. It’s not an easy call; if you require too many procedures for the high-volume designation, you limit the number of institutions that qualify and, therefore, you limit patient access. If too few are required, the distinction is less meaningful. Where you draw the line has trade-offs.

In short, the most rare, complex procedures should be regionalized to high-volume centers of excellence. For more common procedures, we should measure outcomes and share the results so we all keep moving forward.

Dr. Dimick is an associate professor of surgery and chief of the Division of Minimally Invasive Surgery at the University of Michigan in Ann Arbor. He is a cofounder of ArborMetrix, which makes software to measure hospital and surgical outcomes.

COUNTERPOINT: Better indicators of surgical quality need to be identified.

We recently failed to find a statistically significant association between hospital volume alone and in-hospital mortality for pancreatic resection, abdominal aortic aneurysm repair, esophageal resection, and coronary artery bypass grafting (Ann. Surg. 2012;256:606-15). These results suggest that hospital procedure volume alone should not be used as a proxy measure for quality of surgical outcomes.

Hospital volume isn’t entirely irrelevant, but as a stand-alone metric upon which to base referral patterns and other policy decisions, it doesn’t appear to be the most reliable measure. In studies where volume does seem to make a difference, it may be acting as a surrogate for other factors that probably matter more, including individual surgeon experience, careful patient selection, protocol-driven approaches to perioperative care, and well-coordinated surgical and patient-care teams.

These factors may cluster in certain large-volume institutions, but it is also true that some low-volume hospitals have outstanding surgical outcomes and some high-volume hospitals do not.

We used different statistical techniques in our study than those used in previous investigations that found a link between volume and quality; we believe our methods are more robust. One of the limitations of those earlier investigations is that they used arbitrary values to define hospitals into low-, high-, and in-between volume categories, which sacrificed precision.

Instead, using discharge data from 261,412 patient records in the 2008 Nationwide Inpatient Sample, Dr. Benjamin Kozower, Dr. George Stukenborg, and I analyzed volume as a continuous function and accounted for variations in the nonlinear relationships that exist between hospital volume and mortality for the four operations – the hospital volumes of which have been used as measures of surgical quality by various policy and regulatory bodies. When we did that, not only did individual hospital volume not have a significant risk-adjusted association with mortality, but also its relative strength of association with mortality was disproportionately small compared with other factors, including patient-level factors such as nutrition status and renal health.

So there’s much more to think about when it comes to identifying indicators of surgical quality. Instead of focusing on individual hospital volumes, we need to figure out what really does contribute to good outcomes so that the information can be shared with underperforming hospitals. Identifying truly modifiable factors to improve outcomes is also important, because with an increased emphasis on the public reporting of physician and hospital outcomes, reimbursement and referral strategies will likely be tied to performance. Thus, it makes sense that we move the discussion beyond simply annual hospital volumes.

Dr. LaPar is a fourth-year surgical resident at the University of Virginia in Charlottesville. He said he has no disclosures.

PALM BEACH, FLA.  – Florida’s statewide trauma triage system, one of America’s oldest and best organized state systems, did an increasingly better job over time from 1996 through 2010 funneling severely injured children and adults to one the state’s 22 designated trauma centers, according to data collected by the state government.

Florida’s program has had less clear-cut success triaging the elderly population with severe, acute trauma injuries to designated trauma centers, but the raw data may be misleading, Dr. David J. Ciesla, FACS, said at the annual meeting of the Southern Surgical Association.

Data collected by Florida’s Agency for Health Care Administration showed that during 2010, 41% of severely injured patients older than 65 years were discharged from a designated trauma center (DTC), compared with an 85% rate among adults 16-65 years old, and a 93% rate among children under age 16, said Dr. Ciesla, medical director of the Regional Trauma Program at Tampa General Hospital.

But the strikingly lower rate of elderly patient referral to a DTC may be an artifact of how Dr. Ciesla and his associates defined severe injury in their analysis. Their definition relied on survival. Using the ICD-9 Injury Severity Score (ICISS) to rate a patient’s need for DTC referral, they rated patients with ICISS of less than 0.85 (a less than 85% survival rate) as severely injured and candidates for DTC triage. But this criterion starts to break down for older patients, he explained.

"We defined injury severity as the risk of death, but that can be age related as well as injury related. It could be that older patients are more elderly than they are injured," he said.

Many of the elderly patients who were hospitalized for trauma "may be injured, but were they severely injured, or did they have high mortality because of their age or their comorbidities?" Dr. Ciesla said in an interview.

"I think the Florida system works well. We have shown [in these data] that the system can identify severely injured children and adults and get them to designated trauma centers. The elderly patients we’re calling ‘severely injured’ may just be elderly who can be appropriately treated in community hospitals," he said.

This interpretation received support from several surgeons who heard the talk at the meeting.

"The distribution of trauma centers on the basis of need is a critical issue in the 21st century health care paradigm. While we must assure equitable access to care delivered at the highest standard, and matched to the patient’s needs, we must assure that this is accomplished in a fiscally responsible way which avoids unnecessary duplication of resources and services. The work presented here today begins to probe this highly complex challenge," commented Dr. Michael F. Rotondo, FACS, professor and chairman of surgery at East Carolina University in Greenville, N.C.*

"Does Florida have enough trauma centers? These data basically say yes, we have enough," said Dr. Joseph J. Tepas III, FACS, professor and chief of pediatric surgery at the University of Florida in Jacksonville and a coauthor of the study. "Ninety percent of the patients were direct transfers" to a DTC, indicating that "paramedic triage discretion seems to work quite well" in routing injured patients to the appropriate hospital, he said.

The study run by Dr. Ciesla, Dr. Tepas, and their associates reviewed all patients discharged from Florida hospitals during 1996-2010 using data collected by the state agency. The researchers identified injured patients by their diagnostic codes, and analyzed them by their discharge hospital and by their home zip codes. The analysis showed that the percent of severely injured patients discharged from a DTC rose from fewer than half of the state’s patients in this category in 1996 to 63% in 2010.

Among 225 severely injured children, 210 (93%) were discharged from a DTC, with only 15 children who did not receive DTC treatment. The 2010 database also included 7,469 severely injured adults, with 85% discharged from a DTC, and 7,825 elderly patients, with 41% discharged from a DTC.

The analysis of DTC discharges of severely injured patients by their home zip codes identified an area of the Florida panhandle, near Panama City, where several adult patients failed to receive care at a DTC, suggesting that residents in this area of the state might be better served by opening another, nearby DTC, said Dr. Ciesla, who is also director of acute care surgery at the University of South Florida in Tampa.

"You need enough centers to cover everyone geographically, but not so many that you dilute" patient volume at individual centers, he said. The researchers have not yet analyzed the best DTC volume to produce optimal patient outcomes, he added.

Dr. Ciesla said that he and Dr. Tepas and their associates had no disclosures. Dr. Rotondo had no disclosures.

*CORRECTION: This story originally misquoted Dr. Michael F. Rotondo. His quote should have read: "The distribution of Trauma Centers on the basis of need is a critical issue in the 21st century health care paradigm. While we must assure equitable access to care delivered at the highest standard, and matched to the patient’s needs, we must assure that this is accomplished in a fiscally responsible way which avoids unnecessary duplication of resources and services. The work presented here today begins to probe this highly complex challenge."

PALM BEACH, FLA.  – Florida’s statewide trauma triage system, one of America’s oldest and best organized state systems, did an increasingly better job over time from 1996 through 2010 funneling severely injured children and adults to one the state’s 22 designated trauma centers, according to data collected by the state government.

Florida’s program has had less clear-cut success triaging the elderly population with severe, acute trauma injuries to designated trauma centers, but the raw data may be misleading, Dr. David J. Ciesla, FACS, said at the annual meeting of the Southern Surgical Association.

Data collected by Florida’s Agency for Health Care Administration showed that during 2010, 41% of severely injured patients older than 65 years were discharged from a designated trauma center (DTC), compared with an 85% rate among adults 16-65 years old, and a 93% rate among children under age 16, said Dr. Ciesla, medical director of the Regional Trauma Program at Tampa General Hospital.

But the strikingly lower rate of elderly patient referral to a DTC may be an artifact of how Dr. Ciesla and his associates defined severe injury in their analysis. Their definition relied on survival. Using the ICD-9 Injury Severity Score (ICISS) to rate a patient’s need for DTC referral, they rated patients with ICISS of less than 0.85 (a less than 85% survival rate) as severely injured and candidates for DTC triage. But this criterion starts to break down for older patients, he explained.

"We defined injury severity as the risk of death, but that can be age related as well as injury related. It could be that older patients are more elderly than they are injured," he said.

Many of the elderly patients who were hospitalized for trauma "may be injured, but were they severely injured, or did they have high mortality because of their age or their comorbidities?" Dr. Ciesla said in an interview.

"I think the Florida system works well. We have shown [in these data] that the system can identify severely injured children and adults and get them to designated trauma centers. The elderly patients we’re calling ‘severely injured’ may just be elderly who can be appropriately treated in community hospitals," he said.

This interpretation received support from several surgeons who heard the talk at the meeting.

"The distribution of trauma centers on the basis of need is a critical issue in the 21st century health care paradigm. While we must assure equitable access to care delivered at the highest standard, and matched to the patient’s needs, we must assure that this is accomplished in a fiscally responsible way which avoids unnecessary duplication of resources and services. The work presented here today begins to probe this highly complex challenge," commented Dr. Michael F. Rotondo, FACS, professor and chairman of surgery at East Carolina University in Greenville, N.C.*

"Does Florida have enough trauma centers? These data basically say yes, we have enough," said Dr. Joseph J. Tepas III, FACS, professor and chief of pediatric surgery at the University of Florida in Jacksonville and a coauthor of the study. "Ninety percent of the patients were direct transfers" to a DTC, indicating that "paramedic triage discretion seems to work quite well" in routing injured patients to the appropriate hospital, he said.

The study run by Dr. Ciesla, Dr. Tepas, and their associates reviewed all patients discharged from Florida hospitals during 1996-2010 using data collected by the state agency. The researchers identified injured patients by their diagnostic codes, and analyzed them by their discharge hospital and by their home zip codes. The analysis showed that the percent of severely injured patients discharged from a DTC rose from fewer than half of the state’s patients in this category in 1996 to 63% in 2010.

Among 225 severely injured children, 210 (93%) were discharged from a DTC, with only 15 children who did not receive DTC treatment. The 2010 database also included 7,469 severely injured adults, with 85% discharged from a DTC, and 7,825 elderly patients, with 41% discharged from a DTC.

The analysis of DTC discharges of severely injured patients by their home zip codes identified an area of the Florida panhandle, near Panama City, where several adult patients failed to receive care at a DTC, suggesting that residents in this area of the state might be better served by opening another, nearby DTC, said Dr. Ciesla, who is also director of acute care surgery at the University of South Florida in Tampa.

"You need enough centers to cover everyone geographically, but not so many that you dilute" patient volume at individual centers, he said. The researchers have not yet analyzed the best DTC volume to produce optimal patient outcomes, he added.

Dr. Ciesla said that he and Dr. Tepas and their associates had no disclosures. Dr. Rotondo had no disclosures.

*CORRECTION: This story originally misquoted Dr. Michael F. Rotondo. His quote should have read: "The distribution of Trauma Centers on the basis of need is a critical issue in the 21st century health care paradigm. While we must assure equitable access to care delivered at the highest standard, and matched to the patient’s needs, we must assure that this is accomplished in a fiscally responsible way which avoids unnecessary duplication of resources and services. The work presented here today begins to probe this highly complex challenge."

PALM BEACH, FLA.  – Florida’s statewide trauma triage system, one of America’s oldest and best organized state systems, did an increasingly better job over time from 1996 through 2010 funneling severely injured children and adults to one the state’s 22 designated trauma centers, according to data collected by the state government.

Florida’s program has had less clear-cut success triaging the elderly population with severe, acute trauma injuries to designated trauma centers, but the raw data may be misleading, Dr. David J. Ciesla, FACS, said at the annual meeting of the Southern Surgical Association.

Data collected by Florida’s Agency for Health Care Administration showed that during 2010, 41% of severely injured patients older than 65 years were discharged from a designated trauma center (DTC), compared with an 85% rate among adults 16-65 years old, and a 93% rate among children under age 16, said Dr. Ciesla, medical director of the Regional Trauma Program at Tampa General Hospital.

But the strikingly lower rate of elderly patient referral to a DTC may be an artifact of how Dr. Ciesla and his associates defined severe injury in their analysis. Their definition relied on survival. Using the ICD-9 Injury Severity Score (ICISS) to rate a patient’s need for DTC referral, they rated patients with ICISS of less than 0.85 (a less than 85% survival rate) as severely injured and candidates for DTC triage. But this criterion starts to break down for older patients, he explained.

"We defined injury severity as the risk of death, but that can be age related as well as injury related. It could be that older patients are more elderly than they are injured," he said.

Many of the elderly patients who were hospitalized for trauma "may be injured, but were they severely injured, or did they have high mortality because of their age or their comorbidities?" Dr. Ciesla said in an interview.

"I think the Florida system works well. We have shown [in these data] that the system can identify severely injured children and adults and get them to designated trauma centers. The elderly patients we’re calling ‘severely injured’ may just be elderly who can be appropriately treated in community hospitals," he said.

This interpretation received support from several surgeons who heard the talk at the meeting.

"The distribution of trauma centers on the basis of need is a critical issue in the 21st century health care paradigm. While we must assure equitable access to care delivered at the highest standard, and matched to the patient’s needs, we must assure that this is accomplished in a fiscally responsible way which avoids unnecessary duplication of resources and services. The work presented here today begins to probe this highly complex challenge," commented Dr. Michael F. Rotondo, FACS, professor and chairman of surgery at East Carolina University in Greenville, N.C.*

"Does Florida have enough trauma centers? These data basically say yes, we have enough," said Dr. Joseph J. Tepas III, FACS, professor and chief of pediatric surgery at the University of Florida in Jacksonville and a coauthor of the study. "Ninety percent of the patients were direct transfers" to a DTC, indicating that "paramedic triage discretion seems to work quite well" in routing injured patients to the appropriate hospital, he said.

The study run by Dr. Ciesla, Dr. Tepas, and their associates reviewed all patients discharged from Florida hospitals during 1996-2010 using data collected by the state agency. The researchers identified injured patients by their diagnostic codes, and analyzed them by their discharge hospital and by their home zip codes. The analysis showed that the percent of severely injured patients discharged from a DTC rose from fewer than half of the state’s patients in this category in 1996 to 63% in 2010.

Among 225 severely injured children, 210 (93%) were discharged from a DTC, with only 15 children who did not receive DTC treatment. The 2010 database also included 7,469 severely injured adults, with 85% discharged from a DTC, and 7,825 elderly patients, with 41% discharged from a DTC.

The analysis of DTC discharges of severely injured patients by their home zip codes identified an area of the Florida panhandle, near Panama City, where several adult patients failed to receive care at a DTC, suggesting that residents in this area of the state might be better served by opening another, nearby DTC, said Dr. Ciesla, who is also director of acute care surgery at the University of South Florida in Tampa.

"You need enough centers to cover everyone geographically, but not so many that you dilute" patient volume at individual centers, he said. The researchers have not yet analyzed the best DTC volume to produce optimal patient outcomes, he added.

Dr. Ciesla said that he and Dr. Tepas and their associates had no disclosures. Dr. Rotondo had no disclosures.

*CORRECTION: This story originally misquoted Dr. Michael F. Rotondo. His quote should have read: "The distribution of Trauma Centers on the basis of need is a critical issue in the 21st century health care paradigm. While we must assure equitable access to care delivered at the highest standard, and matched to the patient’s needs, we must assure that this is accomplished in a fiscally responsible way which avoids unnecessary duplication of resources and services. The work presented here today begins to probe this highly complex challenge."

Adhesiolysis, or the removal of adhesions immediately after abdominal surgery, is a risk factor for postoperative surgical complications, longer hospital stays, readmissions, and increased costs, according to findings from a large prospective cohort study.

And yet, to date, "adhesiolysis at repeat surgery has received less attention than bowel obstruction and infertility in reports assessing the clinical and socioeconomic burden of postoperative adhesions," wrote Dr. Richard P. G. ten Broek of Radboud University Nijmegen (the Netherlands) Medical Center and his associates.

He and his colleagues evaluated 755 consecutive elective abdominal procedures at the medical center between June 2008 and June 2010, of which adhesiolysis was deemed necessary and performed in 475. In both groups, most procedures were open rather than laparoscopic. Detailed data on adhesiolysis were gathered with direct observation of the procedures by an unaffiliated observer (Ann. Surg. 2012 Sept. 25 [doi: 10.1097/SLA.0b013e31826f4969]).

Primary outcomes were the incidence of adhesions; adhesiolysis time; and the incidence of bowel defects, seromuscular injury, injuries to other organs and structures, and major surgery-related complications.

In the adhesiolysis group, 111 (23.4%) of procedures had one or more major complications, compared with 50 (17.6%) in the nonadhesiolysis group (P = .047).

Adhesiolysis was associated with a significantly higher risk of sepsis (odds ratio, 5.12; 95% confidence interval, 1.06-24.71), intra-abdominal complications (OR, 3.46; 95% CI, 1.49-8.05), and wound infections (OR, 2.45; 95% CI, 1.01-5.94).

Operative time was a mean 20 minutes longer for the adhesiolysis group, and mean inpatient costs were $18,579 per operation, compared with $14,063 in the nonadhesiolysis group (P less than .001). Readmission within 30 days of discharge was also higher in the adhesiolysis group.

Full-thickness bowel defects, either in the form of inadvertent enterotomy or delayed diagnosed perforation, were seen in 10.5% of procedures with adhesiolysis (and in 40% of operations in which adhesiolysis lasted more than 1 hour). By contrast, no bowel defects were reported for the 280 procedures in which adhesiolysis was not performed.

Bowel defects were associated with an increase in in-hospital mortality, from 1.6% among patients without defects to 8%, along with significantly more surgical interventions and longer hospital stays. Patients with bowel defects incurred mean inpatient costs of $43,784.

The study demonstrated the substantial clinical and socioeconomic burden of adhesiolysis, "particularly when a bowel defect occurs. All physicians treating patients with disorders of the abdominal cavity that might require surgery should be aware of the adverse effects of adhesiolysis," Dr. ten Broek and his colleagues wrote.

To date, they said, few clinicians appear to be taking the risks of adhesiolysis seriously. "Underestimation of the related morbidity and the passiveness of many physicians, who consider adhesiolysis an annoying but unavoidable part of redo surgery, account for the paucity of reports on the consequences of adhesiolysis," they wrote.

The investigators noted as weaknesses of their study the need for adhesiolysis in 60% of procedures in the cohort and the low number of laparoscopies – which, they said, could limit the generalizability of the study results.

The study was sponsored by Radboud University Nijmegen Medical Center. Dr. ten Broek and his associates stated that they had no conflicts of interest.

Adhesiolysis, or the removal of adhesions immediately after abdominal surgery, is a risk factor for postoperative surgical complications, longer hospital stays, readmissions, and increased costs, according to findings from a large prospective cohort study.

And yet, to date, "adhesiolysis at repeat surgery has received less attention than bowel obstruction and infertility in reports assessing the clinical and socioeconomic burden of postoperative adhesions," wrote Dr. Richard P. G. ten Broek of Radboud University Nijmegen (the Netherlands) Medical Center and his associates.

He and his colleagues evaluated 755 consecutive elective abdominal procedures at the medical center between June 2008 and June 2010, of which adhesiolysis was deemed necessary and performed in 475. In both groups, most procedures were open rather than laparoscopic. Detailed data on adhesiolysis were gathered with direct observation of the procedures by an unaffiliated observer (Ann. Surg. 2012 Sept. 25 [doi: 10.1097/SLA.0b013e31826f4969]).

Primary outcomes were the incidence of adhesions; adhesiolysis time; and the incidence of bowel defects, seromuscular injury, injuries to other organs and structures, and major surgery-related complications.

In the adhesiolysis group, 111 (23.4%) of procedures had one or more major complications, compared with 50 (17.6%) in the nonadhesiolysis group (P = .047).

Adhesiolysis was associated with a significantly higher risk of sepsis (odds ratio, 5.12; 95% confidence interval, 1.06-24.71), intra-abdominal complications (OR, 3.46; 95% CI, 1.49-8.05), and wound infections (OR, 2.45; 95% CI, 1.01-5.94).

Operative time was a mean 20 minutes longer for the adhesiolysis group, and mean inpatient costs were $18,579 per operation, compared with $14,063 in the nonadhesiolysis group (P less than .001). Readmission within 30 days of discharge was also higher in the adhesiolysis group.

Full-thickness bowel defects, either in the form of inadvertent enterotomy or delayed diagnosed perforation, were seen in 10.5% of procedures with adhesiolysis (and in 40% of operations in which adhesiolysis lasted more than 1 hour). By contrast, no bowel defects were reported for the 280 procedures in which adhesiolysis was not performed.

Bowel defects were associated with an increase in in-hospital mortality, from 1.6% among patients without defects to 8%, along with significantly more surgical interventions and longer hospital stays. Patients with bowel defects incurred mean inpatient costs of $43,784.

The study demonstrated the substantial clinical and socioeconomic burden of adhesiolysis, "particularly when a bowel defect occurs. All physicians treating patients with disorders of the abdominal cavity that might require surgery should be aware of the adverse effects of adhesiolysis," Dr. ten Broek and his colleagues wrote.

To date, they said, few clinicians appear to be taking the risks of adhesiolysis seriously. "Underestimation of the related morbidity and the passiveness of many physicians, who consider adhesiolysis an annoying but unavoidable part of redo surgery, account for the paucity of reports on the consequences of adhesiolysis," they wrote.

The investigators noted as weaknesses of their study the need for adhesiolysis in 60% of procedures in the cohort and the low number of laparoscopies – which, they said, could limit the generalizability of the study results.

The study was sponsored by Radboud University Nijmegen Medical Center. Dr. ten Broek and his associates stated that they had no conflicts of interest.

Adhesiolysis, or the removal of adhesions immediately after abdominal surgery, is a risk factor for postoperative surgical complications, longer hospital stays, readmissions, and increased costs, according to findings from a large prospective cohort study.

And yet, to date, "adhesiolysis at repeat surgery has received less attention than bowel obstruction and infertility in reports assessing the clinical and socioeconomic burden of postoperative adhesions," wrote Dr. Richard P. G. ten Broek of Radboud University Nijmegen (the Netherlands) Medical Center and his associates.

He and his colleagues evaluated 755 consecutive elective abdominal procedures at the medical center between June 2008 and June 2010, of which adhesiolysis was deemed necessary and performed in 475. In both groups, most procedures were open rather than laparoscopic. Detailed data on adhesiolysis were gathered with direct observation of the procedures by an unaffiliated observer (Ann. Surg. 2012 Sept. 25 [doi: 10.1097/SLA.0b013e31826f4969]).

Primary outcomes were the incidence of adhesions; adhesiolysis time; and the incidence of bowel defects, seromuscular injury, injuries to other organs and structures, and major surgery-related complications.

In the adhesiolysis group, 111 (23.4%) of procedures had one or more major complications, compared with 50 (17.6%) in the nonadhesiolysis group (P = .047).

Adhesiolysis was associated with a significantly higher risk of sepsis (odds ratio, 5.12; 95% confidence interval, 1.06-24.71), intra-abdominal complications (OR, 3.46; 95% CI, 1.49-8.05), and wound infections (OR, 2.45; 95% CI, 1.01-5.94).

Operative time was a mean 20 minutes longer for the adhesiolysis group, and mean inpatient costs were $18,579 per operation, compared with $14,063 in the nonadhesiolysis group (P less than .001). Readmission within 30 days of discharge was also higher in the adhesiolysis group.

Full-thickness bowel defects, either in the form of inadvertent enterotomy or delayed diagnosed perforation, were seen in 10.5% of procedures with adhesiolysis (and in 40% of operations in which adhesiolysis lasted more than 1 hour). By contrast, no bowel defects were reported for the 280 procedures in which adhesiolysis was not performed.

Bowel defects were associated with an increase in in-hospital mortality, from 1.6% among patients without defects to 8%, along with significantly more surgical interventions and longer hospital stays. Patients with bowel defects incurred mean inpatient costs of $43,784.

The study demonstrated the substantial clinical and socioeconomic burden of adhesiolysis, "particularly when a bowel defect occurs. All physicians treating patients with disorders of the abdominal cavity that might require surgery should be aware of the adverse effects of adhesiolysis," Dr. ten Broek and his colleagues wrote.

To date, they said, few clinicians appear to be taking the risks of adhesiolysis seriously. "Underestimation of the related morbidity and the passiveness of many physicians, who consider adhesiolysis an annoying but unavoidable part of redo surgery, account for the paucity of reports on the consequences of adhesiolysis," they wrote.

The investigators noted as weaknesses of their study the need for adhesiolysis in 60% of procedures in the cohort and the low number of laparoscopies – which, they said, could limit the generalizability of the study results.

The study was sponsored by Radboud University Nijmegen Medical Center. Dr. ten Broek and his associates stated that they had no conflicts of interest.