Perioperative Medicine

NAPLES, Fla. – About one-third of elderly patients who underwent a cranial operation for traumatic brain injury die in the hospital, and one-half are dead within a year, according to a retrospective analysis of 164 patients.

Long-term follow-up for a mean of 42 months, however, demonstrated that two-thirds of survivors had a "favorable" outcome, as indicated by a GOSE (Glasgow Outcome Scale–Extended) score of at least 5, Dr. Mark Cipolle and his colleagues reported at the annual meeting of the Eastern Association for the Surgery of Trauma.

The study demonstrates that in-hospital mortality is not an adequate measure of outcome and reflects an increasing willingness to operate on the growing elderly patient population. The patients, who were at least 65 years old, had an average age of 79.

"One thing that’s very important to understand as clinicians is that these patients don’t get operated on and immediately do better," he said. "They often don’t do better and often have a decline after surgery.

"We were not thrilled with what we were seeing at 1 year, but we were fairly happy with what we saw with the patients who did survive long term."

The cohort represents 20% of the 823 patients aged at least 65 years with a head AIS (Abbreviated Injury Scale) score of 4 (severe) or 5 (critical) who were admitted in 2004-2008 to the Christiana Care Health Care System in Newark, Del. Falls were the most common mechanism of injury.

Roughly half (51%) of patients were men, 25% were taking warfarin, and 20% were on clopidogrel. Their average international normalized ratio was 2.7.

Craniotomy was the most common operation, performed in 146 patients, followed by a burr hole in 14 and craniectomy in 4, said Dr. Cipolle, chief of trauma surgery at Christiana. In all, 156 primary procedures were performed for subdural hematoma and 8 for intraparenchymal hemorrhage. Secondary procedures in 10 patients included seven craniotomies, one burr hole, and two craniectomies.

There were 46 in-hospital deaths, with 118 patients surviving until discharge to a skilled nursing facility (51%), rehabilitation (45%), or home (4%). Within 1 year, 33 of the 118 patients died.

The study, led by general surgery resident Dr. Kevin Geffe, classified 51 patients as having a favorable outcome. They included 29 patients who died more than 1 year after discharge and 22 patients with a GOSE score of at least 5 on a follow-up scripted telephone interview.

The 89 patients with an unfavorable outcome included the 46 in-hospital deaths, the 33 patients who died within a year of discharge, and 10 survivors who had a GOSE score of less than 5. Seven patients refused the GOSE interview, and 17 were lost to follow-up.

Of several factors examined by multivariate analysis, only functional independence at discharge and prehospital warfarin – but not clopidogrel (Plavix) – use were associated with outcome, Dr. Cipolle said. Not surprisingly, patients who were awake when they came in were nearly 2.5 times more likely to have a favorable outcome (odds ratio, 2.42).

The time to the operating room was 23.6 hours among patients with a favorable outcome and 27.8 hours among those with an unfavorable outcome.

"The long [operating room] times are obviously, I think, a reflection of the chronicity of many of these hemorrhages," he said. "One of the reasons we really are interested in this problem is that we can’t help but think there’s got to be a better way to deal with these patients than waiting for them to decline to decide to start operating on them."

An analysis of in-hospital mortality found that patients with a head AIS score of 4 were less likely to undergo surgery and did significantly worse with surgery than without surgery (29% vs. 7%). Dr. Cipolle pointed out, however, that patients with an AIS score of 5 were operated on at about the same rate, and there was no significant difference in mortality between the operated and nonoperated groups (28% vs. 33.5%).

Invited discussant Dr. Gary Marshall of the University of Pittsburgh Medical Center remarked that grouping the patients as favorable vs. unfavorable seemed arbitrary. Dr. Cipolle acknowledged that they struggled with the classification scheme and said they plan to more closely determine cause of death to take away additional assumptions made in the analysis.

When asked whether the hospital has reversal strategies for warfarin and clopidogrel, Dr. Cipolle responded that a statewide reversal policy for warfarin directs that patients on the anticoagulant who have a positive CT scan be given vitamin K and fresh frozen plasma, with small doses of activated factor VII therapy for those going directly to surgery. Patients on clopidogrel or aspirin with a small amount of bleeding are not treated, whereas those with substantial bleeding are given platelets. The researchers have submitted a proposal to the National Trauma Institute to conduct a pilot study evaluating reversal of antiplatelet therapy in patients with intracranial hemorrhage, Dr. Cipolle said.

The authors and Dr. Marshall reported no conflicts of interest.

NAPLES, Fla. – About one-third of elderly patients who underwent a cranial operation for traumatic brain injury die in the hospital, and one-half are dead within a year, according to a retrospective analysis of 164 patients.

Long-term follow-up for a mean of 42 months, however, demonstrated that two-thirds of survivors had a "favorable" outcome, as indicated by a GOSE (Glasgow Outcome Scale–Extended) score of at least 5, Dr. Mark Cipolle and his colleagues reported at the annual meeting of the Eastern Association for the Surgery of Trauma.

The study demonstrates that in-hospital mortality is not an adequate measure of outcome and reflects an increasing willingness to operate on the growing elderly patient population. The patients, who were at least 65 years old, had an average age of 79.

"One thing that’s very important to understand as clinicians is that these patients don’t get operated on and immediately do better," he said. "They often don’t do better and often have a decline after surgery.

"We were not thrilled with what we were seeing at 1 year, but we were fairly happy with what we saw with the patients who did survive long term."

The cohort represents 20% of the 823 patients aged at least 65 years with a head AIS (Abbreviated Injury Scale) score of 4 (severe) or 5 (critical) who were admitted in 2004-2008 to the Christiana Care Health Care System in Newark, Del. Falls were the most common mechanism of injury.

Roughly half (51%) of patients were men, 25% were taking warfarin, and 20% were on clopidogrel. Their average international normalized ratio was 2.7.

Craniotomy was the most common operation, performed in 146 patients, followed by a burr hole in 14 and craniectomy in 4, said Dr. Cipolle, chief of trauma surgery at Christiana. In all, 156 primary procedures were performed for subdural hematoma and 8 for intraparenchymal hemorrhage. Secondary procedures in 10 patients included seven craniotomies, one burr hole, and two craniectomies.

There were 46 in-hospital deaths, with 118 patients surviving until discharge to a skilled nursing facility (51%), rehabilitation (45%), or home (4%). Within 1 year, 33 of the 118 patients died.

The study, led by general surgery resident Dr. Kevin Geffe, classified 51 patients as having a favorable outcome. They included 29 patients who died more than 1 year after discharge and 22 patients with a GOSE score of at least 5 on a follow-up scripted telephone interview.

The 89 patients with an unfavorable outcome included the 46 in-hospital deaths, the 33 patients who died within a year of discharge, and 10 survivors who had a GOSE score of less than 5. Seven patients refused the GOSE interview, and 17 were lost to follow-up.

Of several factors examined by multivariate analysis, only functional independence at discharge and prehospital warfarin – but not clopidogrel (Plavix) – use were associated with outcome, Dr. Cipolle said. Not surprisingly, patients who were awake when they came in were nearly 2.5 times more likely to have a favorable outcome (odds ratio, 2.42).

The time to the operating room was 23.6 hours among patients with a favorable outcome and 27.8 hours among those with an unfavorable outcome.

"The long [operating room] times are obviously, I think, a reflection of the chronicity of many of these hemorrhages," he said. "One of the reasons we really are interested in this problem is that we can’t help but think there’s got to be a better way to deal with these patients than waiting for them to decline to decide to start operating on them."

An analysis of in-hospital mortality found that patients with a head AIS score of 4 were less likely to undergo surgery and did significantly worse with surgery than without surgery (29% vs. 7%). Dr. Cipolle pointed out, however, that patients with an AIS score of 5 were operated on at about the same rate, and there was no significant difference in mortality between the operated and nonoperated groups (28% vs. 33.5%).

Invited discussant Dr. Gary Marshall of the University of Pittsburgh Medical Center remarked that grouping the patients as favorable vs. unfavorable seemed arbitrary. Dr. Cipolle acknowledged that they struggled with the classification scheme and said they plan to more closely determine cause of death to take away additional assumptions made in the analysis.

When asked whether the hospital has reversal strategies for warfarin and clopidogrel, Dr. Cipolle responded that a statewide reversal policy for warfarin directs that patients on the anticoagulant who have a positive CT scan be given vitamin K and fresh frozen plasma, with small doses of activated factor VII therapy for those going directly to surgery. Patients on clopidogrel or aspirin with a small amount of bleeding are not treated, whereas those with substantial bleeding are given platelets. The researchers have submitted a proposal to the National Trauma Institute to conduct a pilot study evaluating reversal of antiplatelet therapy in patients with intracranial hemorrhage, Dr. Cipolle said.

The authors and Dr. Marshall reported no conflicts of interest.

NAPLES, Fla. – About one-third of elderly patients who underwent a cranial operation for traumatic brain injury die in the hospital, and one-half are dead within a year, according to a retrospective analysis of 164 patients.

Long-term follow-up for a mean of 42 months, however, demonstrated that two-thirds of survivors had a "favorable" outcome, as indicated by a GOSE (Glasgow Outcome Scale–Extended) score of at least 5, Dr. Mark Cipolle and his colleagues reported at the annual meeting of the Eastern Association for the Surgery of Trauma.

The study demonstrates that in-hospital mortality is not an adequate measure of outcome and reflects an increasing willingness to operate on the growing elderly patient population. The patients, who were at least 65 years old, had an average age of 79.

"One thing that’s very important to understand as clinicians is that these patients don’t get operated on and immediately do better," he said. "They often don’t do better and often have a decline after surgery.

"We were not thrilled with what we were seeing at 1 year, but we were fairly happy with what we saw with the patients who did survive long term."

The cohort represents 20% of the 823 patients aged at least 65 years with a head AIS (Abbreviated Injury Scale) score of 4 (severe) or 5 (critical) who were admitted in 2004-2008 to the Christiana Care Health Care System in Newark, Del. Falls were the most common mechanism of injury.

Roughly half (51%) of patients were men, 25% were taking warfarin, and 20% were on clopidogrel. Their average international normalized ratio was 2.7.

Craniotomy was the most common operation, performed in 146 patients, followed by a burr hole in 14 and craniectomy in 4, said Dr. Cipolle, chief of trauma surgery at Christiana. In all, 156 primary procedures were performed for subdural hematoma and 8 for intraparenchymal hemorrhage. Secondary procedures in 10 patients included seven craniotomies, one burr hole, and two craniectomies.

There were 46 in-hospital deaths, with 118 patients surviving until discharge to a skilled nursing facility (51%), rehabilitation (45%), or home (4%). Within 1 year, 33 of the 118 patients died.

The study, led by general surgery resident Dr. Kevin Geffe, classified 51 patients as having a favorable outcome. They included 29 patients who died more than 1 year after discharge and 22 patients with a GOSE score of at least 5 on a follow-up scripted telephone interview.

The 89 patients with an unfavorable outcome included the 46 in-hospital deaths, the 33 patients who died within a year of discharge, and 10 survivors who had a GOSE score of less than 5. Seven patients refused the GOSE interview, and 17 were lost to follow-up.

Of several factors examined by multivariate analysis, only functional independence at discharge and prehospital warfarin – but not clopidogrel (Plavix) – use were associated with outcome, Dr. Cipolle said. Not surprisingly, patients who were awake when they came in were nearly 2.5 times more likely to have a favorable outcome (odds ratio, 2.42).

The time to the operating room was 23.6 hours among patients with a favorable outcome and 27.8 hours among those with an unfavorable outcome.

"The long [operating room] times are obviously, I think, a reflection of the chronicity of many of these hemorrhages," he said. "One of the reasons we really are interested in this problem is that we can’t help but think there’s got to be a better way to deal with these patients than waiting for them to decline to decide to start operating on them."

An analysis of in-hospital mortality found that patients with a head AIS score of 4 were less likely to undergo surgery and did significantly worse with surgery than without surgery (29% vs. 7%). Dr. Cipolle pointed out, however, that patients with an AIS score of 5 were operated on at about the same rate, and there was no significant difference in mortality between the operated and nonoperated groups (28% vs. 33.5%).

Invited discussant Dr. Gary Marshall of the University of Pittsburgh Medical Center remarked that grouping the patients as favorable vs. unfavorable seemed arbitrary. Dr. Cipolle acknowledged that they struggled with the classification scheme and said they plan to more closely determine cause of death to take away additional assumptions made in the analysis.

When asked whether the hospital has reversal strategies for warfarin and clopidogrel, Dr. Cipolle responded that a statewide reversal policy for warfarin directs that patients on the anticoagulant who have a positive CT scan be given vitamin K and fresh frozen plasma, with small doses of activated factor VII therapy for those going directly to surgery. Patients on clopidogrel or aspirin with a small amount of bleeding are not treated, whereas those with substantial bleeding are given platelets. The researchers have submitted a proposal to the National Trauma Institute to conduct a pilot study evaluating reversal of antiplatelet therapy in patients with intracranial hemorrhage, Dr. Cipolle said.

The authors and Dr. Marshall reported no conflicts of interest.

The latest salvo in the battle to eliminate unnecessary deliveries before 39 weeks gestation is a Web site that lets expectant mothers compare individual hospital rates of early elective deliveries.

An annual survey by the Leapfrog Group found 57,000 early deliveries by induction or scheduled C-section for nonmedical reasons at 773 U.S. hospitals that provided data. Rates varied between hospitals by more than 100-fold. In Ohio, for example, early elective delivery rates ranged from 0.3% to 32% among the 36 hospitals reporting.

The Leapfrog Group is a project of employers that buy health insurance for employees, such as General Motors and the Boeing Company. View the survey findings.

"This is a matter of great national concern," Leapfrog chief executive officer Leah Binder said in a telephone press conference. "There are thousands of babies in neonatal intensive care units who shouldn’t be there today."

Babies need at least 39 weeks of gestation to fully develop the brain and lungs. Babies delivered before term (40 weeks or later) for nonmedical reasons are more likely to need intensive care and breathing assistance, to develop infections, and to die, previous studies have shown. Elective C-sections increase risks for mothers and affect options for future deliveries. Delivery before 39 weeks is not justified unless there is a medical indication for early delivery, Dr. Alan R. Fleischman said in the teleconference.

"Gestational dating can be grossly inaccurate, even off by as much as 2 weeks, so unindicated inductions and scheduled cesarean sections can have serious consequences, even possibly resulting in a premature birth – a baby born before 37 weeks," said Dr. Fleischman, medical director of the March of Dimes. "Every week counts," since a third of fetal development occurs in the last 5 weeks of pregnancy.

He and Barbara Rudolph, Ph.D., Leapfrog’s senior science director, will host two free national webinars in February for health care workers to promote a quality improvement toolkit for eliminating early elective deliveries; they are scheduled for Feb. 15 from noon to 1 p.m., Eastern time, and Feb. 17 from 3 p.m. to 4 p.m. For more information, contact Leapfrog’s Melissa Danforth at [email protected].

The "Less than 39 weeks toolkit," developed by the March of Dimes with the California Department of Health and the California Maternal Quality Care Collaborative, is available for free online. It includes a literature review about the risks of early elective delivery, a step-by-step guide for hospital leaders who want to eliminate early elective deliveries, a guide for measuring and tracking quality improvement, sample forms and case studies, and educational tools for clinicians, staff, and patients.

The Leapfrog data comprised a minimum of 100 births from each hospital that reported, with early elective deliveries ascertained from those. The methodology was developed by the Joint Commission and does not cover all births in 2010 at each hospital.

Rates of elective deliveries between 37 and 39 full weeks of gestation ranged from less than 5% to more than 40% at individual hospitals. There is no national benchmark for an acceptable rate of early elective delivery, so Leapfrog tapped an expert panel to say that 12% or less would be acceptable. Half of the reporting hospitals in the survey hit that benchmark and 29% reported rates below 5%, so Leapfrog will lower its acceptable rate for 2011 to 5%, Ms. Binder said.

Not all hospitals were surveyed, and many who were did not respond. In Alabama, for example, 101 hospitals declined to respond and 5 said the survey did not apply to them. The four hospitals that responded reported early elective delivery rates of 13%-24%. Rates can vary greatly on local levels too. At Los Angeles hospitals, rates ranged from 4% to 29%, and in Boston, from less than 1% to 27%.

Women need to demand that hospitals disclose their early elective delivery rate in order to make informed decisions about where to give birth, Maureen Corry of the advocacy group Childbirth Connection said in the teleconference.

Her organization commissioned a poll of 1,573 women delivering in U.S. hospitals in 2005 (the Listening to Mothers II survey) and found that 1 in 3 mothers reported labor induced by artificial means. Reasons reported for induction were caregiver concern that they were overdue (25%), maternal health problems (19%), the mother’s desire to finish the pregnancy (19%), and caregiver concern about the size of the baby (17%), Ms. Corry said.

Guidelines by the American College of Obstetricians and Gynecologists have long opposed elective early deliveries and say that a large size is not an indication for early elective delivery, Dr. Fleishman said. "It’s more than just education that’s needed. It is a commitment on the part of the hospital to set up specific guidelines and policies to empower those people who are taking the requests of doctors who are initiating inductions or scheduling cesareans to question, to have forms and a peer review process," he said.

Attention to early elective deliveries has been ratcheting up as rates increase despite evidence of the potential harm associated with the practice. In 2010, the Joint Commission, an accrediting body, added elective deliveries to its core measures of health care quality.

Centers for Disease Control and Prevention data show that the average time U.S. fetuses spend in the womb has decreased by 7 days since 1992, according to a Dec. 26, 2010 report by California Watch, a project of the nonprofit Center for Investigational Reporting. Between 1990 and 2006, deliveries at 36 weeks increased by approximately 30% and deliveries at 37 or 38 weeks increased by 40%. There are now more U.S. babies born at 39 weeks than at full term (40 weeks or later), the report said.

C-section deliveries are more common at for-profit hospitals, according to a separate report by California Watch on Sept. 11, 2010. The Leapfrog report did not analyze the data by type of hospital.

National statistics show that between 1990 and 2006, the rate of labor induction increased from 9% to 23% of deliveries, and the C-section rate hit a high of 32%, Leapfrog’s Dr. Rudolph said.

The Leapfrog Group, the March of Dimes, and Childbirth Connection issued a "call to action" in response to the survey findings. Four of the largest U.S. health insurers – Aetna, CIGNA, UnitedHealthcare, and Wellpoint – will conduct a campaign to educate expectant mothers about the importance of a full gestation and the wisdom of comparing elective delivery rates in their local hospitals, Ms. Binder said.

Ms. Binder, Dr. Rudolph, Dr. Fleischman, and Ms. Corry work for organizations advocating improved health and medical practices for pregnant women and infants.

The latest salvo in the battle to eliminate unnecessary deliveries before 39 weeks gestation is a Web site that lets expectant mothers compare individual hospital rates of early elective deliveries.

An annual survey by the Leapfrog Group found 57,000 early deliveries by induction or scheduled C-section for nonmedical reasons at 773 U.S. hospitals that provided data. Rates varied between hospitals by more than 100-fold. In Ohio, for example, early elective delivery rates ranged from 0.3% to 32% among the 36 hospitals reporting.

The Leapfrog Group is a project of employers that buy health insurance for employees, such as General Motors and the Boeing Company. View the survey findings.

"This is a matter of great national concern," Leapfrog chief executive officer Leah Binder said in a telephone press conference. "There are thousands of babies in neonatal intensive care units who shouldn’t be there today."

Babies need at least 39 weeks of gestation to fully develop the brain and lungs. Babies delivered before term (40 weeks or later) for nonmedical reasons are more likely to need intensive care and breathing assistance, to develop infections, and to die, previous studies have shown. Elective C-sections increase risks for mothers and affect options for future deliveries. Delivery before 39 weeks is not justified unless there is a medical indication for early delivery, Dr. Alan R. Fleischman said in the teleconference.

"Gestational dating can be grossly inaccurate, even off by as much as 2 weeks, so unindicated inductions and scheduled cesarean sections can have serious consequences, even possibly resulting in a premature birth – a baby born before 37 weeks," said Dr. Fleischman, medical director of the March of Dimes. "Every week counts," since a third of fetal development occurs in the last 5 weeks of pregnancy.

He and Barbara Rudolph, Ph.D., Leapfrog’s senior science director, will host two free national webinars in February for health care workers to promote a quality improvement toolkit for eliminating early elective deliveries; they are scheduled for Feb. 15 from noon to 1 p.m., Eastern time, and Feb. 17 from 3 p.m. to 4 p.m. For more information, contact Leapfrog’s Melissa Danforth at [email protected].

The "Less than 39 weeks toolkit," developed by the March of Dimes with the California Department of Health and the California Maternal Quality Care Collaborative, is available for free online. It includes a literature review about the risks of early elective delivery, a step-by-step guide for hospital leaders who want to eliminate early elective deliveries, a guide for measuring and tracking quality improvement, sample forms and case studies, and educational tools for clinicians, staff, and patients.

The Leapfrog data comprised a minimum of 100 births from each hospital that reported, with early elective deliveries ascertained from those. The methodology was developed by the Joint Commission and does not cover all births in 2010 at each hospital.

Rates of elective deliveries between 37 and 39 full weeks of gestation ranged from less than 5% to more than 40% at individual hospitals. There is no national benchmark for an acceptable rate of early elective delivery, so Leapfrog tapped an expert panel to say that 12% or less would be acceptable. Half of the reporting hospitals in the survey hit that benchmark and 29% reported rates below 5%, so Leapfrog will lower its acceptable rate for 2011 to 5%, Ms. Binder said.

Not all hospitals were surveyed, and many who were did not respond. In Alabama, for example, 101 hospitals declined to respond and 5 said the survey did not apply to them. The four hospitals that responded reported early elective delivery rates of 13%-24%. Rates can vary greatly on local levels too. At Los Angeles hospitals, rates ranged from 4% to 29%, and in Boston, from less than 1% to 27%.

Women need to demand that hospitals disclose their early elective delivery rate in order to make informed decisions about where to give birth, Maureen Corry of the advocacy group Childbirth Connection said in the teleconference.

Her organization commissioned a poll of 1,573 women delivering in U.S. hospitals in 2005 (the Listening to Mothers II survey) and found that 1 in 3 mothers reported labor induced by artificial means. Reasons reported for induction were caregiver concern that they were overdue (25%), maternal health problems (19%), the mother’s desire to finish the pregnancy (19%), and caregiver concern about the size of the baby (17%), Ms. Corry said.

Guidelines by the American College of Obstetricians and Gynecologists have long opposed elective early deliveries and say that a large size is not an indication for early elective delivery, Dr. Fleishman said. "It’s more than just education that’s needed. It is a commitment on the part of the hospital to set up specific guidelines and policies to empower those people who are taking the requests of doctors who are initiating inductions or scheduling cesareans to question, to have forms and a peer review process," he said.

Attention to early elective deliveries has been ratcheting up as rates increase despite evidence of the potential harm associated with the practice. In 2010, the Joint Commission, an accrediting body, added elective deliveries to its core measures of health care quality.

Centers for Disease Control and Prevention data show that the average time U.S. fetuses spend in the womb has decreased by 7 days since 1992, according to a Dec. 26, 2010 report by California Watch, a project of the nonprofit Center for Investigational Reporting. Between 1990 and 2006, deliveries at 36 weeks increased by approximately 30% and deliveries at 37 or 38 weeks increased by 40%. There are now more U.S. babies born at 39 weeks than at full term (40 weeks or later), the report said.

C-section deliveries are more common at for-profit hospitals, according to a separate report by California Watch on Sept. 11, 2010. The Leapfrog report did not analyze the data by type of hospital.

National statistics show that between 1990 and 2006, the rate of labor induction increased from 9% to 23% of deliveries, and the C-section rate hit a high of 32%, Leapfrog’s Dr. Rudolph said.

The Leapfrog Group, the March of Dimes, and Childbirth Connection issued a "call to action" in response to the survey findings. Four of the largest U.S. health insurers – Aetna, CIGNA, UnitedHealthcare, and Wellpoint – will conduct a campaign to educate expectant mothers about the importance of a full gestation and the wisdom of comparing elective delivery rates in their local hospitals, Ms. Binder said.

Ms. Binder, Dr. Rudolph, Dr. Fleischman, and Ms. Corry work for organizations advocating improved health and medical practices for pregnant women and infants.

The latest salvo in the battle to eliminate unnecessary deliveries before 39 weeks gestation is a Web site that lets expectant mothers compare individual hospital rates of early elective deliveries.

An annual survey by the Leapfrog Group found 57,000 early deliveries by induction or scheduled C-section for nonmedical reasons at 773 U.S. hospitals that provided data. Rates varied between hospitals by more than 100-fold. In Ohio, for example, early elective delivery rates ranged from 0.3% to 32% among the 36 hospitals reporting.

The Leapfrog Group is a project of employers that buy health insurance for employees, such as General Motors and the Boeing Company. View the survey findings.

"This is a matter of great national concern," Leapfrog chief executive officer Leah Binder said in a telephone press conference. "There are thousands of babies in neonatal intensive care units who shouldn’t be there today."

Babies need at least 39 weeks of gestation to fully develop the brain and lungs. Babies delivered before term (40 weeks or later) for nonmedical reasons are more likely to need intensive care and breathing assistance, to develop infections, and to die, previous studies have shown. Elective C-sections increase risks for mothers and affect options for future deliveries. Delivery before 39 weeks is not justified unless there is a medical indication for early delivery, Dr. Alan R. Fleischman said in the teleconference.

"Gestational dating can be grossly inaccurate, even off by as much as 2 weeks, so unindicated inductions and scheduled cesarean sections can have serious consequences, even possibly resulting in a premature birth – a baby born before 37 weeks," said Dr. Fleischman, medical director of the March of Dimes. "Every week counts," since a third of fetal development occurs in the last 5 weeks of pregnancy.

He and Barbara Rudolph, Ph.D., Leapfrog’s senior science director, will host two free national webinars in February for health care workers to promote a quality improvement toolkit for eliminating early elective deliveries; they are scheduled for Feb. 15 from noon to 1 p.m., Eastern time, and Feb. 17 from 3 p.m. to 4 p.m. For more information, contact Leapfrog’s Melissa Danforth at [email protected].

The "Less than 39 weeks toolkit," developed by the March of Dimes with the California Department of Health and the California Maternal Quality Care Collaborative, is available for free online. It includes a literature review about the risks of early elective delivery, a step-by-step guide for hospital leaders who want to eliminate early elective deliveries, a guide for measuring and tracking quality improvement, sample forms and case studies, and educational tools for clinicians, staff, and patients.

The Leapfrog data comprised a minimum of 100 births from each hospital that reported, with early elective deliveries ascertained from those. The methodology was developed by the Joint Commission and does not cover all births in 2010 at each hospital.

Rates of elective deliveries between 37 and 39 full weeks of gestation ranged from less than 5% to more than 40% at individual hospitals. There is no national benchmark for an acceptable rate of early elective delivery, so Leapfrog tapped an expert panel to say that 12% or less would be acceptable. Half of the reporting hospitals in the survey hit that benchmark and 29% reported rates below 5%, so Leapfrog will lower its acceptable rate for 2011 to 5%, Ms. Binder said.

Not all hospitals were surveyed, and many who were did not respond. In Alabama, for example, 101 hospitals declined to respond and 5 said the survey did not apply to them. The four hospitals that responded reported early elective delivery rates of 13%-24%. Rates can vary greatly on local levels too. At Los Angeles hospitals, rates ranged from 4% to 29%, and in Boston, from less than 1% to 27%.

Women need to demand that hospitals disclose their early elective delivery rate in order to make informed decisions about where to give birth, Maureen Corry of the advocacy group Childbirth Connection said in the teleconference.

Her organization commissioned a poll of 1,573 women delivering in U.S. hospitals in 2005 (the Listening to Mothers II survey) and found that 1 in 3 mothers reported labor induced by artificial means. Reasons reported for induction were caregiver concern that they were overdue (25%), maternal health problems (19%), the mother’s desire to finish the pregnancy (19%), and caregiver concern about the size of the baby (17%), Ms. Corry said.

Guidelines by the American College of Obstetricians and Gynecologists have long opposed elective early deliveries and say that a large size is not an indication for early elective delivery, Dr. Fleishman said. "It’s more than just education that’s needed. It is a commitment on the part of the hospital to set up specific guidelines and policies to empower those people who are taking the requests of doctors who are initiating inductions or scheduling cesareans to question, to have forms and a peer review process," he said.

Attention to early elective deliveries has been ratcheting up as rates increase despite evidence of the potential harm associated with the practice. In 2010, the Joint Commission, an accrediting body, added elective deliveries to its core measures of health care quality.

Centers for Disease Control and Prevention data show that the average time U.S. fetuses spend in the womb has decreased by 7 days since 1992, according to a Dec. 26, 2010 report by California Watch, a project of the nonprofit Center for Investigational Reporting. Between 1990 and 2006, deliveries at 36 weeks increased by approximately 30% and deliveries at 37 or 38 weeks increased by 40%. There are now more U.S. babies born at 39 weeks than at full term (40 weeks or later), the report said.

C-section deliveries are more common at for-profit hospitals, according to a separate report by California Watch on Sept. 11, 2010. The Leapfrog report did not analyze the data by type of hospital.

National statistics show that between 1990 and 2006, the rate of labor induction increased from 9% to 23% of deliveries, and the C-section rate hit a high of 32%, Leapfrog’s Dr. Rudolph said.

The Leapfrog Group, the March of Dimes, and Childbirth Connection issued a "call to action" in response to the survey findings. Four of the largest U.S. health insurers – Aetna, CIGNA, UnitedHealthcare, and Wellpoint – will conduct a campaign to educate expectant mothers about the importance of a full gestation and the wisdom of comparing elective delivery rates in their local hospitals, Ms. Binder said.

Ms. Binder, Dr. Rudolph, Dr. Fleischman, and Ms. Corry work for organizations advocating improved health and medical practices for pregnant women and infants.

CHICAGO – Transcatheter aortic valve implantation produced a dramatic improvement in quality of life scores, compared with standard medical management, in patients with inoperable, severe aortic stenosis in a pivotal trial with 358 randomized patients.

The primary end point of the trial, which was first reported in September and then published in October, showed that transcatheter aortic valve implantation (TAVI) significantly improved the rate of all-cause death, compared with medical care, in patients who were judged to be unable to undergo conventional surgical aortic valve replacement (N. Engl. J. Med. 2010;363:1597-607). Additional results in the new report showed a sharp improvement in the quality of life of these patients, with 62% having a 20-point or greater rise in their KCCQ (Kansas City Cardiomyopathy Questionnaire) summary scores, compared with baseline. That increase translates into an improvement of two classes on the New York Heart Association heart failure scale, Dr. David J. Cohen said at the annual scientific sessions of the American Heart Association.

"These findings add further support to the concept that TAVI should be considered an emerging standard of care for patients with severe aortic stenosis who are not candidates for surgical aortic valve replacement," said Dr. Cohen, professor and director of cardiovascular research at Saint Luke’s Mid America Heart Institute in Kansas City.

The substantial quality of life improvement seen in most patients who are treated with TAVI adds an important dimension to the study’s outcome because "these patients care far more about how they feel than how long they live," Dr. Cohen said in an interview. "If patients lived longer but didn’t feel any better than they felt at baseline – which was lousy – it wouldn’t be much of an accomplishment." Patients who seek care for severe aortic stenosis usually put a high value on treatment that produces an improved quality of life, he said.

"The impact of TAVI on health status [quality of life] is as important as any other outcome," including survival, commented Dr. John S. Rumsfeld, a cardiologist at the Denver VA Medical Center and the University of Colorado, Denver. It is an efficacy outcome that is very meaningful to patients, he said.

Based on the benefits for both survival and quality of life now reported from the PARTNER (Placement of Aortic Transcatheter Valves) study, staffers from Edwards Lifesciences Corp. announced in November that the company submitted an application to the Food and Drug Administration for marketing approval of the Sapien valve and delivery system used in the study. A report on the results from the second portion of the study, which randomized patients to surgical valve replacement or TAVI, is expected during the first half of 2011, a company spokeswoman said in an interview.

The PARTNER trial enrolled 358 patients with severe aortic stenosis who were judged inoperable by two independent surgeons. Their average age was 83 years, and slightly more than half the patients were women. Assessment using the KCCQ occurred in 81%-91% of the participants at baseline and at 1, 6, and 12 months following the start of the study. At baseline, the average KCCQ summary score among patients in both treatment arms was 35, and 70% of the patients in both arms had a score of 45 or less. A KCCQ score at that level indicates that the patient’s health status is comparable to someone with class IV New York Heart Association heart failure.

At 12 months after entry, patients who underwent TAVI had a KCCQ summary score that averaged 25 points higher than the score of those on medical therapy. The TAVI patients also had higher scores in four elements of the KCCQ assessment: symptoms, physical limitations, social limitations, and quality of life. The TAVI patients also showed substantial improvements at 12 months in three secondary measures of health status: the SF-12 physical scale, the SF-12 mental scale, and the Euro quality of life measure. For example, on the SF-12 physical scale, the average improvement with TAVI was 5 points better than with medical management. On this scale, an increase of at least 2 points reflects a clinically important difference, Dr. Cohen said.

Further analysis tallied the percentage of patients who had an "excellent" outcome, defined as those who survived to a particular follow-up interval and had a 20-point or better rise in their KCCQ summary score, compared with baseline. At all follow-up intervals, substantially more patients who were treated with TAVI met the excellent outcome criteria (see box), with a number-needed-to-treat of 3.5 to achieve one excellent outcome at 12 months.

A series of subgroup analyses showed no interaction of these effects by TAVI with age, sex, surgical risk score, aortic valve gradient pressure, or the severity of comorbid chronic obstructive pulmonary disease.

Inoperable patients make up a small portion – about 5%-10% – of all patients with severe aortic stenosis, Dr. Cohen said. Other patients with severe aortic stenosis don’t undergo surgical valve replacement for other, unknown reasons; thus, about one-fifth to one-quarter of U.S. aortic stenosis patients with disease that is severe enough to warrant valve replacement surgery don’t get it, he added. Although truly inoperable patients are uncommon, they stand to gain markedly when the transcatheter valve system becomes routinely available. They have "the biggest unmet need," Dr. Cohen said.

The PARTNER study was funded by Edwards Lifesciences. Dr. Cohen said that he has received research funding from Edwards Lifesciences.

CHICAGO – Transcatheter aortic valve implantation produced a dramatic improvement in quality of life scores, compared with standard medical management, in patients with inoperable, severe aortic stenosis in a pivotal trial with 358 randomized patients.

The primary end point of the trial, which was first reported in September and then published in October, showed that transcatheter aortic valve implantation (TAVI) significantly improved the rate of all-cause death, compared with medical care, in patients who were judged to be unable to undergo conventional surgical aortic valve replacement (N. Engl. J. Med. 2010;363:1597-607). Additional results in the new report showed a sharp improvement in the quality of life of these patients, with 62% having a 20-point or greater rise in their KCCQ (Kansas City Cardiomyopathy Questionnaire) summary scores, compared with baseline. That increase translates into an improvement of two classes on the New York Heart Association heart failure scale, Dr. David J. Cohen said at the annual scientific sessions of the American Heart Association.

"These findings add further support to the concept that TAVI should be considered an emerging standard of care for patients with severe aortic stenosis who are not candidates for surgical aortic valve replacement," said Dr. Cohen, professor and director of cardiovascular research at Saint Luke’s Mid America Heart Institute in Kansas City.

The substantial quality of life improvement seen in most patients who are treated with TAVI adds an important dimension to the study’s outcome because "these patients care far more about how they feel than how long they live," Dr. Cohen said in an interview. "If patients lived longer but didn’t feel any better than they felt at baseline – which was lousy – it wouldn’t be much of an accomplishment." Patients who seek care for severe aortic stenosis usually put a high value on treatment that produces an improved quality of life, he said.

"The impact of TAVI on health status [quality of life] is as important as any other outcome," including survival, commented Dr. John S. Rumsfeld, a cardiologist at the Denver VA Medical Center and the University of Colorado, Denver. It is an efficacy outcome that is very meaningful to patients, he said.

Based on the benefits for both survival and quality of life now reported from the PARTNER (Placement of Aortic Transcatheter Valves) study, staffers from Edwards Lifesciences Corp. announced in November that the company submitted an application to the Food and Drug Administration for marketing approval of the Sapien valve and delivery system used in the study. A report on the results from the second portion of the study, which randomized patients to surgical valve replacement or TAVI, is expected during the first half of 2011, a company spokeswoman said in an interview.

The PARTNER trial enrolled 358 patients with severe aortic stenosis who were judged inoperable by two independent surgeons. Their average age was 83 years, and slightly more than half the patients were women. Assessment using the KCCQ occurred in 81%-91% of the participants at baseline and at 1, 6, and 12 months following the start of the study. At baseline, the average KCCQ summary score among patients in both treatment arms was 35, and 70% of the patients in both arms had a score of 45 or less. A KCCQ score at that level indicates that the patient’s health status is comparable to someone with class IV New York Heart Association heart failure.

At 12 months after entry, patients who underwent TAVI had a KCCQ summary score that averaged 25 points higher than the score of those on medical therapy. The TAVI patients also had higher scores in four elements of the KCCQ assessment: symptoms, physical limitations, social limitations, and quality of life. The TAVI patients also showed substantial improvements at 12 months in three secondary measures of health status: the SF-12 physical scale, the SF-12 mental scale, and the Euro quality of life measure. For example, on the SF-12 physical scale, the average improvement with TAVI was 5 points better than with medical management. On this scale, an increase of at least 2 points reflects a clinically important difference, Dr. Cohen said.

Further analysis tallied the percentage of patients who had an "excellent" outcome, defined as those who survived to a particular follow-up interval and had a 20-point or better rise in their KCCQ summary score, compared with baseline. At all follow-up intervals, substantially more patients who were treated with TAVI met the excellent outcome criteria (see box), with a number-needed-to-treat of 3.5 to achieve one excellent outcome at 12 months.

A series of subgroup analyses showed no interaction of these effects by TAVI with age, sex, surgical risk score, aortic valve gradient pressure, or the severity of comorbid chronic obstructive pulmonary disease.

Inoperable patients make up a small portion – about 5%-10% – of all patients with severe aortic stenosis, Dr. Cohen said. Other patients with severe aortic stenosis don’t undergo surgical valve replacement for other, unknown reasons; thus, about one-fifth to one-quarter of U.S. aortic stenosis patients with disease that is severe enough to warrant valve replacement surgery don’t get it, he added. Although truly inoperable patients are uncommon, they stand to gain markedly when the transcatheter valve system becomes routinely available. They have "the biggest unmet need," Dr. Cohen said.

The PARTNER study was funded by Edwards Lifesciences. Dr. Cohen said that he has received research funding from Edwards Lifesciences.

CHICAGO – Transcatheter aortic valve implantation produced a dramatic improvement in quality of life scores, compared with standard medical management, in patients with inoperable, severe aortic stenosis in a pivotal trial with 358 randomized patients.

The primary end point of the trial, which was first reported in September and then published in October, showed that transcatheter aortic valve implantation (TAVI) significantly improved the rate of all-cause death, compared with medical care, in patients who were judged to be unable to undergo conventional surgical aortic valve replacement (N. Engl. J. Med. 2010;363:1597-607). Additional results in the new report showed a sharp improvement in the quality of life of these patients, with 62% having a 20-point or greater rise in their KCCQ (Kansas City Cardiomyopathy Questionnaire) summary scores, compared with baseline. That increase translates into an improvement of two classes on the New York Heart Association heart failure scale, Dr. David J. Cohen said at the annual scientific sessions of the American Heart Association.

"These findings add further support to the concept that TAVI should be considered an emerging standard of care for patients with severe aortic stenosis who are not candidates for surgical aortic valve replacement," said Dr. Cohen, professor and director of cardiovascular research at Saint Luke’s Mid America Heart Institute in Kansas City.

The substantial quality of life improvement seen in most patients who are treated with TAVI adds an important dimension to the study’s outcome because "these patients care far more about how they feel than how long they live," Dr. Cohen said in an interview. "If patients lived longer but didn’t feel any better than they felt at baseline – which was lousy – it wouldn’t be much of an accomplishment." Patients who seek care for severe aortic stenosis usually put a high value on treatment that produces an improved quality of life, he said.

"The impact of TAVI on health status [quality of life] is as important as any other outcome," including survival, commented Dr. John S. Rumsfeld, a cardiologist at the Denver VA Medical Center and the University of Colorado, Denver. It is an efficacy outcome that is very meaningful to patients, he said.

Based on the benefits for both survival and quality of life now reported from the PARTNER (Placement of Aortic Transcatheter Valves) study, staffers from Edwards Lifesciences Corp. announced in November that the company submitted an application to the Food and Drug Administration for marketing approval of the Sapien valve and delivery system used in the study. A report on the results from the second portion of the study, which randomized patients to surgical valve replacement or TAVI, is expected during the first half of 2011, a company spokeswoman said in an interview.

The PARTNER trial enrolled 358 patients with severe aortic stenosis who were judged inoperable by two independent surgeons. Their average age was 83 years, and slightly more than half the patients were women. Assessment using the KCCQ occurred in 81%-91% of the participants at baseline and at 1, 6, and 12 months following the start of the study. At baseline, the average KCCQ summary score among patients in both treatment arms was 35, and 70% of the patients in both arms had a score of 45 or less. A KCCQ score at that level indicates that the patient’s health status is comparable to someone with class IV New York Heart Association heart failure.

At 12 months after entry, patients who underwent TAVI had a KCCQ summary score that averaged 25 points higher than the score of those on medical therapy. The TAVI patients also had higher scores in four elements of the KCCQ assessment: symptoms, physical limitations, social limitations, and quality of life. The TAVI patients also showed substantial improvements at 12 months in three secondary measures of health status: the SF-12 physical scale, the SF-12 mental scale, and the Euro quality of life measure. For example, on the SF-12 physical scale, the average improvement with TAVI was 5 points better than with medical management. On this scale, an increase of at least 2 points reflects a clinically important difference, Dr. Cohen said.

Further analysis tallied the percentage of patients who had an "excellent" outcome, defined as those who survived to a particular follow-up interval and had a 20-point or better rise in their KCCQ summary score, compared with baseline. At all follow-up intervals, substantially more patients who were treated with TAVI met the excellent outcome criteria (see box), with a number-needed-to-treat of 3.5 to achieve one excellent outcome at 12 months.

A series of subgroup analyses showed no interaction of these effects by TAVI with age, sex, surgical risk score, aortic valve gradient pressure, or the severity of comorbid chronic obstructive pulmonary disease.

Inoperable patients make up a small portion – about 5%-10% – of all patients with severe aortic stenosis, Dr. Cohen said. Other patients with severe aortic stenosis don’t undergo surgical valve replacement for other, unknown reasons; thus, about one-fifth to one-quarter of U.S. aortic stenosis patients with disease that is severe enough to warrant valve replacement surgery don’t get it, he added. Although truly inoperable patients are uncommon, they stand to gain markedly when the transcatheter valve system becomes routinely available. They have "the biggest unmet need," Dr. Cohen said.

The PARTNER study was funded by Edwards Lifesciences. Dr. Cohen said that he has received research funding from Edwards Lifesciences.

PALM BEACH, FLA. – When anatomy and pathology permit, patients reap the greatest benefits from a distal pancreatectomy that spares both the spleen and the splenic vessels.

Blood loss, fistula formation, length of hospital stay, and splenic infarct were all significantly lower in the spleen-sparing, vessel-sparing procedure than in a vessel-ligation procedure, Dr. Henry Pitt said at the annual meeting of the Southern Surgical Association.

"Splenic preservation with vessel ligation really offers no advantages over distal pancreatectomy with splenectomy, so vessel preservation is the preferred procedure for splenic-sparing distal pancreatectomy," said Dr. Pitt, a professor of surgery at Indiana University, Indianapolis.

Dr. Pitt presented a retrospective analysis of 86 spleen-sparing distal pancreatectomies, 45 with ligation and 41 with a vessel-sparing procedure. These were prospectively matched with another 86 patients who had distal pancreatectomy with splenectomy.

There were no significant differences in the patients' baseline characteristics. The average age was 55 years, with an average American Society of Anesthesiologists score of 3. "Pathology was also matched," Dr. Pitt said. The most common diagnosis was intraductal papular mucinous neoplasm, followed by cystic tumors. Other tumors included neuroendocrine and adenocarcinomas. None of the patients had invasive tumors.

Coauthor Dr. Attila Nakeeb described the process by which surgeons decide which path to pursue. Although the preoperative aim may be vessel sparing, "the ability to preserve the spleen is clearly a matter of anatomy and pathology," he said. "The ideal patient is one with a benign neoplasm, and any kind of inflammation is a major problem. The assessment usually depends on several factors, including the preoperative pathology."

The branching of the splenic vessels into the hilum is also important. "If you have a long pancreas with the hilum way up into the spleen and the vessels branching early, it’s much more difficult to do either of the techniques. Most of these patients get a splenectomy. In patients with inflammation, we don’t even make an attempt to preserve the vessels," said Dr. Nakeeb, a professor of surgery at Indiana University.

Intraoperative ultrasound is used in every case to identify the vasculature and trace the branching patterns, especially in patients with excess peripancreatic fat.

"If we make the preoperative decision to preserve the spleen, we also first attempt to preserve the vessels," Dr. Nakeeb said. "If we are unsuccessful in that, we convert to a ligation; if that does not go well, we convert to a splenectomy."

For the vessel-sparing, vessel-ligating, and splenectomy groups, there was no significant difference in operative time. The average time for the spleen-preserving procedures was 3.5 hours; for splenectomy, it was 4 hours.

Blood loss was significantly different. The average loss in the vessel-preserving group was 200 mL; in the ligation group, 500 mL; and in the splenectomy group, 600 mL.

In the spleen-preserving groups, splenic infarcts occurred in 2% (1) of the vessel-preservation group and in 39% (16) of the ligation group.

Pancreatic fistulas occurred in 2% (1) of the vessel-preservation group, 12% (5) of the vessel-ligation group, and 13% (11) of the splenectomy group. One patient in the vessel-preservation group required abscess drainage, compared with 15% of the vessel-ligation group and 16% of the splenectomy group – a significant difference.

The overall postoperative morbidity was 18% in the vessel-preservation group, 39% in the vessel-ligation group, and 38% in the splenectomy group, significantly favoring vessel preservation. The hospital length of stay was also significantly in favor of the vessel-preservation group – 4.5 days – compared with 6 days in the vessel-ligation group and 7 in the splenectomy group.

"Since the vessel-ligation outcomes were so similar to the outcomes in the splenectomy group, there is no real advantage over a distal pancreatectomy with splenectomy," Dr. Pitt said. "Vessel preservation was associated with less blood loss, a lower risk of requiring drainage, lower overall morbidity, shorter length of stay, and fewer infarcts."

Dr. Pitt attributed most of the research in the study to his colleague Dr. Joal Beane, an intern. "He really did all the work," Dr. Pitt said.

Dr. Pitt and Dr. Nakeeb reported no financial conflicts.

PALM BEACH, FLA. – When anatomy and pathology permit, patients reap the greatest benefits from a distal pancreatectomy that spares both the spleen and the splenic vessels.

Blood loss, fistula formation, length of hospital stay, and splenic infarct were all significantly lower in the spleen-sparing, vessel-sparing procedure than in a vessel-ligation procedure, Dr. Henry Pitt said at the annual meeting of the Southern Surgical Association.

"Splenic preservation with vessel ligation really offers no advantages over distal pancreatectomy with splenectomy, so vessel preservation is the preferred procedure for splenic-sparing distal pancreatectomy," said Dr. Pitt, a professor of surgery at Indiana University, Indianapolis.

Dr. Pitt presented a retrospective analysis of 86 spleen-sparing distal pancreatectomies, 45 with ligation and 41 with a vessel-sparing procedure. These were prospectively matched with another 86 patients who had distal pancreatectomy with splenectomy.

There were no significant differences in the patients' baseline characteristics. The average age was 55 years, with an average American Society of Anesthesiologists score of 3. "Pathology was also matched," Dr. Pitt said. The most common diagnosis was intraductal papular mucinous neoplasm, followed by cystic tumors. Other tumors included neuroendocrine and adenocarcinomas. None of the patients had invasive tumors.

Coauthor Dr. Attila Nakeeb described the process by which surgeons decide which path to pursue. Although the preoperative aim may be vessel sparing, "the ability to preserve the spleen is clearly a matter of anatomy and pathology," he said. "The ideal patient is one with a benign neoplasm, and any kind of inflammation is a major problem. The assessment usually depends on several factors, including the preoperative pathology."

The branching of the splenic vessels into the hilum is also important. "If you have a long pancreas with the hilum way up into the spleen and the vessels branching early, it’s much more difficult to do either of the techniques. Most of these patients get a splenectomy. In patients with inflammation, we don’t even make an attempt to preserve the vessels," said Dr. Nakeeb, a professor of surgery at Indiana University.

Intraoperative ultrasound is used in every case to identify the vasculature and trace the branching patterns, especially in patients with excess peripancreatic fat.

"If we make the preoperative decision to preserve the spleen, we also first attempt to preserve the vessels," Dr. Nakeeb said. "If we are unsuccessful in that, we convert to a ligation; if that does not go well, we convert to a splenectomy."

For the vessel-sparing, vessel-ligating, and splenectomy groups, there was no significant difference in operative time. The average time for the spleen-preserving procedures was 3.5 hours; for splenectomy, it was 4 hours.

Blood loss was significantly different. The average loss in the vessel-preserving group was 200 mL; in the ligation group, 500 mL; and in the splenectomy group, 600 mL.

In the spleen-preserving groups, splenic infarcts occurred in 2% (1) of the vessel-preservation group and in 39% (16) of the ligation group.

Pancreatic fistulas occurred in 2% (1) of the vessel-preservation group, 12% (5) of the vessel-ligation group, and 13% (11) of the splenectomy group. One patient in the vessel-preservation group required abscess drainage, compared with 15% of the vessel-ligation group and 16% of the splenectomy group – a significant difference.

The overall postoperative morbidity was 18% in the vessel-preservation group, 39% in the vessel-ligation group, and 38% in the splenectomy group, significantly favoring vessel preservation. The hospital length of stay was also significantly in favor of the vessel-preservation group – 4.5 days – compared with 6 days in the vessel-ligation group and 7 in the splenectomy group.

"Since the vessel-ligation outcomes were so similar to the outcomes in the splenectomy group, there is no real advantage over a distal pancreatectomy with splenectomy," Dr. Pitt said. "Vessel preservation was associated with less blood loss, a lower risk of requiring drainage, lower overall morbidity, shorter length of stay, and fewer infarcts."

Dr. Pitt attributed most of the research in the study to his colleague Dr. Joal Beane, an intern. "He really did all the work," Dr. Pitt said.

Dr. Pitt and Dr. Nakeeb reported no financial conflicts.

PALM BEACH, FLA. – When anatomy and pathology permit, patients reap the greatest benefits from a distal pancreatectomy that spares both the spleen and the splenic vessels.

Blood loss, fistula formation, length of hospital stay, and splenic infarct were all significantly lower in the spleen-sparing, vessel-sparing procedure than in a vessel-ligation procedure, Dr. Henry Pitt said at the annual meeting of the Southern Surgical Association.

"Splenic preservation with vessel ligation really offers no advantages over distal pancreatectomy with splenectomy, so vessel preservation is the preferred procedure for splenic-sparing distal pancreatectomy," said Dr. Pitt, a professor of surgery at Indiana University, Indianapolis.

Dr. Pitt presented a retrospective analysis of 86 spleen-sparing distal pancreatectomies, 45 with ligation and 41 with a vessel-sparing procedure. These were prospectively matched with another 86 patients who had distal pancreatectomy with splenectomy.

There were no significant differences in the patients' baseline characteristics. The average age was 55 years, with an average American Society of Anesthesiologists score of 3. "Pathology was also matched," Dr. Pitt said. The most common diagnosis was intraductal papular mucinous neoplasm, followed by cystic tumors. Other tumors included neuroendocrine and adenocarcinomas. None of the patients had invasive tumors.

Coauthor Dr. Attila Nakeeb described the process by which surgeons decide which path to pursue. Although the preoperative aim may be vessel sparing, "the ability to preserve the spleen is clearly a matter of anatomy and pathology," he said. "The ideal patient is one with a benign neoplasm, and any kind of inflammation is a major problem. The assessment usually depends on several factors, including the preoperative pathology."

The branching of the splenic vessels into the hilum is also important. "If you have a long pancreas with the hilum way up into the spleen and the vessels branching early, it’s much more difficult to do either of the techniques. Most of these patients get a splenectomy. In patients with inflammation, we don’t even make an attempt to preserve the vessels," said Dr. Nakeeb, a professor of surgery at Indiana University.

Intraoperative ultrasound is used in every case to identify the vasculature and trace the branching patterns, especially in patients with excess peripancreatic fat.

"If we make the preoperative decision to preserve the spleen, we also first attempt to preserve the vessels," Dr. Nakeeb said. "If we are unsuccessful in that, we convert to a ligation; if that does not go well, we convert to a splenectomy."

For the vessel-sparing, vessel-ligating, and splenectomy groups, there was no significant difference in operative time. The average time for the spleen-preserving procedures was 3.5 hours; for splenectomy, it was 4 hours.

Blood loss was significantly different. The average loss in the vessel-preserving group was 200 mL; in the ligation group, 500 mL; and in the splenectomy group, 600 mL.

In the spleen-preserving groups, splenic infarcts occurred in 2% (1) of the vessel-preservation group and in 39% (16) of the ligation group.

Pancreatic fistulas occurred in 2% (1) of the vessel-preservation group, 12% (5) of the vessel-ligation group, and 13% (11) of the splenectomy group. One patient in the vessel-preservation group required abscess drainage, compared with 15% of the vessel-ligation group and 16% of the splenectomy group – a significant difference.

The overall postoperative morbidity was 18% in the vessel-preservation group, 39% in the vessel-ligation group, and 38% in the splenectomy group, significantly favoring vessel preservation. The hospital length of stay was also significantly in favor of the vessel-preservation group – 4.5 days – compared with 6 days in the vessel-ligation group and 7 in the splenectomy group.

"Since the vessel-ligation outcomes were so similar to the outcomes in the splenectomy group, there is no real advantage over a distal pancreatectomy with splenectomy," Dr. Pitt said. "Vessel preservation was associated with less blood loss, a lower risk of requiring drainage, lower overall morbidity, shorter length of stay, and fewer infarcts."

Dr. Pitt attributed most of the research in the study to his colleague Dr. Joal Beane, an intern. "He really did all the work," Dr. Pitt said.

Dr. Pitt and Dr. Nakeeb reported no financial conflicts.

When Dr. Daniel B. Jones was doing his surgical training at Washington University in St. Louis in the late 1990s, surgeons who performed gastric bypass procedures were considered by some of his peers to be renegades on the fringe.

He remembers many gastric bypass patients returning to the hospital with seroma, hernias, and other postoperative complications. "We never really saw the people who were doing well," recalled Dr. Jones, who now heads the section of minimally invasive surgery at Beth Israel Deaconess Medical Center, Boston. "A lot has changed since then."

Thanks in large part to the development of accreditation programs by the American College of Surgeons’ Bariatric Surgery Center Network and by the American Society for Metabolic and Bariatric Surgery (ASMBS), the current standards for performing bariatric surgery are more rigorous than ever. High-volume centers "may have two or three surgeons at a site, with dedicated floors where the nurses are keyed in and looking for complications when they arise so they can be addressed early," said Dr. Jones, a member of the ACS Bariatric Surgery Center Network Advisory Committee. "We have better equipment for doing intubations, for anesthesia, better instruments for operating – all these things have evolved to make bariatric surgery a lot safer than it was even 10 years ago. While we still have some questions about the physiology and the mechanisms involved in how these operations work, we have a very good understanding of the technical aspects of doing these operations and the complications, and how to prevent and treat them. In Massachusetts, for instance, use of accreditation programs has reduced mortality to a fraction of what it was just 5 or 7 years ago."

A study based on National Inpatient Sample data found that the national annual rate of bariatric surgery increased nearly sixfold between 1990 and 2000, from 2.4 to 14.1 per 100,000 adults (Surg. Endosc. 2005;19:616-20). The use of gastric bypass procedures increased more than ninefold during the same time period (from 1.4 to 13.1 per 100,000 adults).

According to the ASMBS, an estimated 15 million people in the United States are morbidly obese. About 220,000 Americans underwent bariatric surgery in 2009. The risk of death from the procedure is about 0.1%, down from about 0.4% between 1990 and 2000.

"I think we’re leveling off on the number of operations our surgeons and hospitals can address, yet our obesity problem continues to rise," observed Dr. Jones, who also is professor of surgery at Harvard Medical School, Boston. "It’s really important that we start thinking about how to prevent the problem as opposed to how to manage it after it occurs."

He credits the laparoscope for revolutionizing bariatric surgery in the late 1990s, though initial acceptance was slow. In fact, being overweight was once considered a contraindication to laparoscopy. "That all turned upside down," Dr. Jones said. "The bariatric surgeons at the time knew that obese persons would most benefit from laparoscopy. An incision on a larger patient is very big, because you have to get through all the fat, down into the fascia and to the target. Whereas someone might do a 10-cm incision on a thin person, that same incision might be 50 cm on an obese patient. But the poke holes of laparoscopy are the same small size."

Dr. Jones discussed the most common bariatric surgery procedures being performed today:

• Roux-en-Y. Commonly referred to as gastric bypass, this procedure involves reducing the stomach from the size of a football to the size of a golf ball. The smaller stomach is then attached to the ileum, bypassing about 60% of the small intestine. "While there can be long-term complications, such as B12, calcium, iron, and folate deficiency if there is not a nutritionist involved in follow-up, for the most part it’s reasonably safe," he said. "You’re going to achieve loss of 50%-70% of your extra body weight. So if you’re 100 pounds overweight, on average you’re going to lose 50-70 of those pounds. If you’re 200 pounds overweight, you might lose 100-plus pounds."

Dr. Jones generally performs open gastric bypass in patients who weigh more than 350 pounds because the visualization is better and he believes this procedure is safer for a person of that size. "Other surgeons modify their technique a bit to offset the fact that people are bigger," he said.

He reserves laparoscopic gastric bypass for patients who weigh less than 350 pounds because it generally produces less scarring and a shorter hospital stay – usually 1-2 days versus up to a 3-day stay in patients undergoing an open procedure. "When I came to Boston, people would say, ‘laparoscopic gastric bypass is not known, not proven,’ " Dr. Jones said. "That was only 8 years ago. Now, surgeons ask, ‘why would you ever do the open approach in this patient population?’ I’ve parked in the middle of that debate for a long time."

Women of childbearing age who undergo gastric bypass should avoid pregnancy in the first 2 years after surgery "because they’re going to compete nutritionally with the growing fetus," he said. And patients should keep postoperative alcohol consumption in check. "If you drink half a glass of wine after gastric bypass surgery, you may be legally drunk because alcohol gets absorbed so fast in the reconfiguration of the stomach," he explained. "It may also be easier to get addicted to alcohol after the surgery because the levels get so high so fast. Alcohol needs to be on the back burner if you’re thinking about gastric bypass surgery."

According to the ASMBS, the gastric bypass procedure costs between $14,000 and $26,000, but Dr. Jones puts the cost of this and other weight loss procedures in the range of $30,000.

• Laparoscopic adjustable gastric banding (LAGB). In this procedure, surgeons place a silicone band filled with saline around the upper part of the stomach, creating a small pouch which causes restriction. The band can be tightened or loosened through a port.

Ideal candidates include patients with a body mass index of 40 kg/m2 or more, or those with a BMI of 35 kg/m2 plus a serious medical conditions such as diabetes that might improve with weight loss.

"The band operation itself is not that difficult to perform, yet you’re still around some real estate," said Dr. Jones, coauthor with Dr. Mark J. Watson of the "Lap-Band Companion" handbook (Woodbury, Conn.: Cin?-Med Inc., 2007), which is intended for patients. "There’s the esophagus, the aorta, the stomach, and the diaphragm. There are plenty of opportunities for very serious, life-threatening complications. The band is deceptively simple, but there is plenty of room for problems. Many severely overweight people who come to us have other significant comorbid conditions: coronary artery disease, hypertension, sleep apnea. All of these things may put patients at very high risk for heart attacks or respiratory arrest, or [deep vein thrombosis]."

Slippage ranks as the most common reason for needing to remove bands. Dr. Jones tells patients that there is a 40% chance that their band may need to be repaired, revised, or removed at some point in their lives. "That band may be there forever, or it may come out because they have prolapse and it’s in the wrong spot, or maybe they had an appendicitis and the band was getting infected," he said. "The things I see the most are breakdowns in the tubing or hub from, say, a needle stick during the port adjustment. Early on, a port can flip over, and long term, these bands can get out of position."

On Dec. 3, 2010, the Food and Drug Administration’s Gastroenterology and Urology Devices Panel recommended the use of the Lap-Band procedure for people who don’t meet the clinical criteria for obesity. Allergan Inc., which makes the device, proposed that the Lap-Band adjustable gastric banding system be approved for weight reduction in people aged 18 years and over with no comorbidities and a BMI of at least 35 kg/m2, or a BMI of at least 30 kg/m2 and one or more comorbid conditions. Eight out of 10 FDA panel members agreed that there was "reasonable assurance" that the device was safe and effective for this population.

Such patients may find it difficult to convince their health insurers to pay for the operation in the near future. "[Insurance companies are] probably going to hang tight at BMIs of 35-40 kg/m2. It may be that a BMI of 30-35 kg/m2 is going to be a cash-pay cost."

Patients who undergo LAGB generally go home by noon the next day. Dr. Jones believes an overnight stay for these patients is advisable, whereas most gastric bypass patients leave the hospital on the second or third day. Because more cutting and connections are involved with that procedure, there are more opportunities for leaks, stenosis, or bleeding, he noted.

• Sleeve gastrectomy. During this procedure, surgeons remove about 85% of the fundus and body of the stomach, creating a vertical sleeve that restricts the amount of food that can be consumed. The operation is generally reserved for patients who cannot tolerate LAGB or gastric bypass. As an example, Dr. Jones cited a patient whose size rendered him unable to roll over. "He was getting a hernia eroding through his belly button, so he had the beginnings of infection, so I didn’t want to put in a Lap-Band. He wasn’t a candidate for the bypass because he couldn’t tolerate the fluid shifts we might expect during the procedure. We did the sleeve procedure, and he lost 200 pounds."

Most insurance companies have been slow to cover sleeve gastrectomy, and often patients must pay for the procedure. In Massachusetts, for example, insurance companies require proof that the band or bypass can’t be done, according to Dr. Jones.

An ASMBS position statement about sleeve gastrectomy noted that there are few published studies about the long-term outcomes of the procedure beyond 5 years (Surg. Obes. Relat. Dis. 2010;6:1-5). "Such long-term data might or might not ultimately confirm that the procedure should remain in the category of a staged treatment intervention," the statement reads.

Some surgeons are applying single-port surgery to sleeve procedures and to LAGB, "but I think that is pretty investigational in terms of technique," Dr. Jones said. "I suspect that the complication profile of these techniques will be more, but we don’t know how much more."

Dr. Jones disclosed that he has received research funding from Covidien, Allergan, and training grants from Covidien and Ethicon.

When Dr. Daniel B. Jones was doing his surgical training at Washington University in St. Louis in the late 1990s, surgeons who performed gastric bypass procedures were considered by some of his peers to be renegades on the fringe.

He remembers many gastric bypass patients returning to the hospital with seroma, hernias, and other postoperative complications. "We never really saw the people who were doing well," recalled Dr. Jones, who now heads the section of minimally invasive surgery at Beth Israel Deaconess Medical Center, Boston. "A lot has changed since then."

Thanks in large part to the development of accreditation programs by the American College of Surgeons’ Bariatric Surgery Center Network and by the American Society for Metabolic and Bariatric Surgery (ASMBS), the current standards for performing bariatric surgery are more rigorous than ever. High-volume centers "may have two or three surgeons at a site, with dedicated floors where the nurses are keyed in and looking for complications when they arise so they can be addressed early," said Dr. Jones, a member of the ACS Bariatric Surgery Center Network Advisory Committee. "We have better equipment for doing intubations, for anesthesia, better instruments for operating – all these things have evolved to make bariatric surgery a lot safer than it was even 10 years ago. While we still have some questions about the physiology and the mechanisms involved in how these operations work, we have a very good understanding of the technical aspects of doing these operations and the complications, and how to prevent and treat them. In Massachusetts, for instance, use of accreditation programs has reduced mortality to a fraction of what it was just 5 or 7 years ago."

A study based on National Inpatient Sample data found that the national annual rate of bariatric surgery increased nearly sixfold between 1990 and 2000, from 2.4 to 14.1 per 100,000 adults (Surg. Endosc. 2005;19:616-20). The use of gastric bypass procedures increased more than ninefold during the same time period (from 1.4 to 13.1 per 100,000 adults).

According to the ASMBS, an estimated 15 million people in the United States are morbidly obese. About 220,000 Americans underwent bariatric surgery in 2009. The risk of death from the procedure is about 0.1%, down from about 0.4% between 1990 and 2000.

"I think we’re leveling off on the number of operations our surgeons and hospitals can address, yet our obesity problem continues to rise," observed Dr. Jones, who also is professor of surgery at Harvard Medical School, Boston. "It’s really important that we start thinking about how to prevent the problem as opposed to how to manage it after it occurs."

He credits the laparoscope for revolutionizing bariatric surgery in the late 1990s, though initial acceptance was slow. In fact, being overweight was once considered a contraindication to laparoscopy. "That all turned upside down," Dr. Jones said. "The bariatric surgeons at the time knew that obese persons would most benefit from laparoscopy. An incision on a larger patient is very big, because you have to get through all the fat, down into the fascia and to the target. Whereas someone might do a 10-cm incision on a thin person, that same incision might be 50 cm on an obese patient. But the poke holes of laparoscopy are the same small size."

Dr. Jones discussed the most common bariatric surgery procedures being performed today:

• Roux-en-Y. Commonly referred to as gastric bypass, this procedure involves reducing the stomach from the size of a football to the size of a golf ball. The smaller stomach is then attached to the ileum, bypassing about 60% of the small intestine. "While there can be long-term complications, such as B12, calcium, iron, and folate deficiency if there is not a nutritionist involved in follow-up, for the most part it’s reasonably safe," he said. "You’re going to achieve loss of 50%-70% of your extra body weight. So if you’re 100 pounds overweight, on average you’re going to lose 50-70 of those pounds. If you’re 200 pounds overweight, you might lose 100-plus pounds."

Dr. Jones generally performs open gastric bypass in patients who weigh more than 350 pounds because the visualization is better and he believes this procedure is safer for a person of that size. "Other surgeons modify their technique a bit to offset the fact that people are bigger," he said.

He reserves laparoscopic gastric bypass for patients who weigh less than 350 pounds because it generally produces less scarring and a shorter hospital stay – usually 1-2 days versus up to a 3-day stay in patients undergoing an open procedure. "When I came to Boston, people would say, ‘laparoscopic gastric bypass is not known, not proven,’ " Dr. Jones said. "That was only 8 years ago. Now, surgeons ask, ‘why would you ever do the open approach in this patient population?’ I’ve parked in the middle of that debate for a long time."

Women of childbearing age who undergo gastric bypass should avoid pregnancy in the first 2 years after surgery "because they’re going to compete nutritionally with the growing fetus," he said. And patients should keep postoperative alcohol consumption in check. "If you drink half a glass of wine after gastric bypass surgery, you may be legally drunk because alcohol gets absorbed so fast in the reconfiguration of the stomach," he explained. "It may also be easier to get addicted to alcohol after the surgery because the levels get so high so fast. Alcohol needs to be on the back burner if you’re thinking about gastric bypass surgery."

According to the ASMBS, the gastric bypass procedure costs between $14,000 and $26,000, but Dr. Jones puts the cost of this and other weight loss procedures in the range of $30,000.

• Laparoscopic adjustable gastric banding (LAGB). In this procedure, surgeons place a silicone band filled with saline around the upper part of the stomach, creating a small pouch which causes restriction. The band can be tightened or loosened through a port.

Ideal candidates include patients with a body mass index of 40 kg/m2 or more, or those with a BMI of 35 kg/m2 plus a serious medical conditions such as diabetes that might improve with weight loss.

"The band operation itself is not that difficult to perform, yet you’re still around some real estate," said Dr. Jones, coauthor with Dr. Mark J. Watson of the "Lap-Band Companion" handbook (Woodbury, Conn.: Cin?-Med Inc., 2007), which is intended for patients. "There’s the esophagus, the aorta, the stomach, and the diaphragm. There are plenty of opportunities for very serious, life-threatening complications. The band is deceptively simple, but there is plenty of room for problems. Many severely overweight people who come to us have other significant comorbid conditions: coronary artery disease, hypertension, sleep apnea. All of these things may put patients at very high risk for heart attacks or respiratory arrest, or [deep vein thrombosis]."

Slippage ranks as the most common reason for needing to remove bands. Dr. Jones tells patients that there is a 40% chance that their band may need to be repaired, revised, or removed at some point in their lives. "That band may be there forever, or it may come out because they have prolapse and it’s in the wrong spot, or maybe they had an appendicitis and the band was getting infected," he said. "The things I see the most are breakdowns in the tubing or hub from, say, a needle stick during the port adjustment. Early on, a port can flip over, and long term, these bands can get out of position."

On Dec. 3, 2010, the Food and Drug Administration’s Gastroenterology and Urology Devices Panel recommended the use of the Lap-Band procedure for people who don’t meet the clinical criteria for obesity. Allergan Inc., which makes the device, proposed that the Lap-Band adjustable gastric banding system be approved for weight reduction in people aged 18 years and over with no comorbidities and a BMI of at least 35 kg/m2, or a BMI of at least 30 kg/m2 and one or more comorbid conditions. Eight out of 10 FDA panel members agreed that there was "reasonable assurance" that the device was safe and effective for this population.

Such patients may find it difficult to convince their health insurers to pay for the operation in the near future. "[Insurance companies are] probably going to hang tight at BMIs of 35-40 kg/m2. It may be that a BMI of 30-35 kg/m2 is going to be a cash-pay cost."

Patients who undergo LAGB generally go home by noon the next day. Dr. Jones believes an overnight stay for these patients is advisable, whereas most gastric bypass patients leave the hospital on the second or third day. Because more cutting and connections are involved with that procedure, there are more opportunities for leaks, stenosis, or bleeding, he noted.

• Sleeve gastrectomy. During this procedure, surgeons remove about 85% of the fundus and body of the stomach, creating a vertical sleeve that restricts the amount of food that can be consumed. The operation is generally reserved for patients who cannot tolerate LAGB or gastric bypass. As an example, Dr. Jones cited a patient whose size rendered him unable to roll over. "He was getting a hernia eroding through his belly button, so he had the beginnings of infection, so I didn’t want to put in a Lap-Band. He wasn’t a candidate for the bypass because he couldn’t tolerate the fluid shifts we might expect during the procedure. We did the sleeve procedure, and he lost 200 pounds."

Most insurance companies have been slow to cover sleeve gastrectomy, and often patients must pay for the procedure. In Massachusetts, for example, insurance companies require proof that the band or bypass can’t be done, according to Dr. Jones.

An ASMBS position statement about sleeve gastrectomy noted that there are few published studies about the long-term outcomes of the procedure beyond 5 years (Surg. Obes. Relat. Dis. 2010;6:1-5). "Such long-term data might or might not ultimately confirm that the procedure should remain in the category of a staged treatment intervention," the statement reads.

Some surgeons are applying single-port surgery to sleeve procedures and to LAGB, "but I think that is pretty investigational in terms of technique," Dr. Jones said. "I suspect that the complication profile of these techniques will be more, but we don’t know how much more."

Dr. Jones disclosed that he has received research funding from Covidien, Allergan, and training grants from Covidien and Ethicon.

When Dr. Daniel B. Jones was doing his surgical training at Washington University in St. Louis in the late 1990s, surgeons who performed gastric bypass procedures were considered by some of his peers to be renegades on the fringe.

He remembers many gastric bypass patients returning to the hospital with seroma, hernias, and other postoperative complications. "We never really saw the people who were doing well," recalled Dr. Jones, who now heads the section of minimally invasive surgery at Beth Israel Deaconess Medical Center, Boston. "A lot has changed since then."

Thanks in large part to the development of accreditation programs by the American College of Surgeons’ Bariatric Surgery Center Network and by the American Society for Metabolic and Bariatric Surgery (ASMBS), the current standards for performing bariatric surgery are more rigorous than ever. High-volume centers "may have two or three surgeons at a site, with dedicated floors where the nurses are keyed in and looking for complications when they arise so they can be addressed early," said Dr. Jones, a member of the ACS Bariatric Surgery Center Network Advisory Committee. "We have better equipment for doing intubations, for anesthesia, better instruments for operating – all these things have evolved to make bariatric surgery a lot safer than it was even 10 years ago. While we still have some questions about the physiology and the mechanisms involved in how these operations work, we have a very good understanding of the technical aspects of doing these operations and the complications, and how to prevent and treat them. In Massachusetts, for instance, use of accreditation programs has reduced mortality to a fraction of what it was just 5 or 7 years ago."

A study based on National Inpatient Sample data found that the national annual rate of bariatric surgery increased nearly sixfold between 1990 and 2000, from 2.4 to 14.1 per 100,000 adults (Surg. Endosc. 2005;19:616-20). The use of gastric bypass procedures increased more than ninefold during the same time period (from 1.4 to 13.1 per 100,000 adults).

According to the ASMBS, an estimated 15 million people in the United States are morbidly obese. About 220,000 Americans underwent bariatric surgery in 2009. The risk of death from the procedure is about 0.1%, down from about 0.4% between 1990 and 2000.

"I think we’re leveling off on the number of operations our surgeons and hospitals can address, yet our obesity problem continues to rise," observed Dr. Jones, who also is professor of surgery at Harvard Medical School, Boston. "It’s really important that we start thinking about how to prevent the problem as opposed to how to manage it after it occurs."

He credits the laparoscope for revolutionizing bariatric surgery in the late 1990s, though initial acceptance was slow. In fact, being overweight was once considered a contraindication to laparoscopy. "That all turned upside down," Dr. Jones said. "The bariatric surgeons at the time knew that obese persons would most benefit from laparoscopy. An incision on a larger patient is very big, because you have to get through all the fat, down into the fascia and to the target. Whereas someone might do a 10-cm incision on a thin person, that same incision might be 50 cm on an obese patient. But the poke holes of laparoscopy are the same small size."

Dr. Jones discussed the most common bariatric surgery procedures being performed today:

• Roux-en-Y. Commonly referred to as gastric bypass, this procedure involves reducing the stomach from the size of a football to the size of a golf ball. The smaller stomach is then attached to the ileum, bypassing about 60% of the small intestine. "While there can be long-term complications, such as B12, calcium, iron, and folate deficiency if there is not a nutritionist involved in follow-up, for the most part it’s reasonably safe," he said. "You’re going to achieve loss of 50%-70% of your extra body weight. So if you’re 100 pounds overweight, on average you’re going to lose 50-70 of those pounds. If you’re 200 pounds overweight, you might lose 100-plus pounds."

Dr. Jones generally performs open gastric bypass in patients who weigh more than 350 pounds because the visualization is better and he believes this procedure is safer for a person of that size. "Other surgeons modify their technique a bit to offset the fact that people are bigger," he said.

He reserves laparoscopic gastric bypass for patients who weigh less than 350 pounds because it generally produces less scarring and a shorter hospital stay – usually 1-2 days versus up to a 3-day stay in patients undergoing an open procedure. "When I came to Boston, people would say, ‘laparoscopic gastric bypass is not known, not proven,’ " Dr. Jones said. "That was only 8 years ago. Now, surgeons ask, ‘why would you ever do the open approach in this patient population?’ I’ve parked in the middle of that debate for a long time."

Women of childbearing age who undergo gastric bypass should avoid pregnancy in the first 2 years after surgery "because they’re going to compete nutritionally with the growing fetus," he said. And patients should keep postoperative alcohol consumption in check. "If you drink half a glass of wine after gastric bypass surgery, you may be legally drunk because alcohol gets absorbed so fast in the reconfiguration of the stomach," he explained. "It may also be easier to get addicted to alcohol after the surgery because the levels get so high so fast. Alcohol needs to be on the back burner if you’re thinking about gastric bypass surgery."

According to the ASMBS, the gastric bypass procedure costs between $14,000 and $26,000, but Dr. Jones puts the cost of this and other weight loss procedures in the range of $30,000.

• Laparoscopic adjustable gastric banding (LAGB). In this procedure, surgeons place a silicone band filled with saline around the upper part of the stomach, creating a small pouch which causes restriction. The band can be tightened or loosened through a port.

Ideal candidates include patients with a body mass index of 40 kg/m2 or more, or those with a BMI of 35 kg/m2 plus a serious medical conditions such as diabetes that might improve with weight loss.

"The band operation itself is not that difficult to perform, yet you’re still around some real estate," said Dr. Jones, coauthor with Dr. Mark J. Watson of the "Lap-Band Companion" handbook (Woodbury, Conn.: Cin?-Med Inc., 2007), which is intended for patients. "There’s the esophagus, the aorta, the stomach, and the diaphragm. There are plenty of opportunities for very serious, life-threatening complications. The band is deceptively simple, but there is plenty of room for problems. Many severely overweight people who come to us have other significant comorbid conditions: coronary artery disease, hypertension, sleep apnea. All of these things may put patients at very high risk for heart attacks or respiratory arrest, or [deep vein thrombosis]."

Slippage ranks as the most common reason for needing to remove bands. Dr. Jones tells patients that there is a 40% chance that their band may need to be repaired, revised, or removed at some point in their lives. "That band may be there forever, or it may come out because they have prolapse and it’s in the wrong spot, or maybe they had an appendicitis and the band was getting infected," he said. "The things I see the most are breakdowns in the tubing or hub from, say, a needle stick during the port adjustment. Early on, a port can flip over, and long term, these bands can get out of position."

On Dec. 3, 2010, the Food and Drug Administration’s Gastroenterology and Urology Devices Panel recommended the use of the Lap-Band procedure for people who don’t meet the clinical criteria for obesity. Allergan Inc., which makes the device, proposed that the Lap-Band adjustable gastric banding system be approved for weight reduction in people aged 18 years and over with no comorbidities and a BMI of at least 35 kg/m2, or a BMI of at least 30 kg/m2 and one or more comorbid conditions. Eight out of 10 FDA panel members agreed that there was "reasonable assurance" that the device was safe and effective for this population.

Such patients may find it difficult to convince their health insurers to pay for the operation in the near future. "[Insurance companies are] probably going to hang tight at BMIs of 35-40 kg/m2. It may be that a BMI of 30-35 kg/m2 is going to be a cash-pay cost."

Patients who undergo LAGB generally go home by noon the next day. Dr. Jones believes an overnight stay for these patients is advisable, whereas most gastric bypass patients leave the hospital on the second or third day. Because more cutting and connections are involved with that procedure, there are more opportunities for leaks, stenosis, or bleeding, he noted.

• Sleeve gastrectomy. During this procedure, surgeons remove about 85% of the fundus and body of the stomach, creating a vertical sleeve that restricts the amount of food that can be consumed. The operation is generally reserved for patients who cannot tolerate LAGB or gastric bypass. As an example, Dr. Jones cited a patient whose size rendered him unable to roll over. "He was getting a hernia eroding through his belly button, so he had the beginnings of infection, so I didn’t want to put in a Lap-Band. He wasn’t a candidate for the bypass because he couldn’t tolerate the fluid shifts we might expect during the procedure. We did the sleeve procedure, and he lost 200 pounds."

Most insurance companies have been slow to cover sleeve gastrectomy, and often patients must pay for the procedure. In Massachusetts, for example, insurance companies require proof that the band or bypass can’t be done, according to Dr. Jones.

An ASMBS position statement about sleeve gastrectomy noted that there are few published studies about the long-term outcomes of the procedure beyond 5 years (Surg. Obes. Relat. Dis. 2010;6:1-5). "Such long-term data might or might not ultimately confirm that the procedure should remain in the category of a staged treatment intervention," the statement reads.

Some surgeons are applying single-port surgery to sleeve procedures and to LAGB, "but I think that is pretty investigational in terms of technique," Dr. Jones said. "I suspect that the complication profile of these techniques will be more, but we don’t know how much more."

Dr. Jones disclosed that he has received research funding from Covidien, Allergan, and training grants from Covidien and Ethicon.

The Food and Drug Administration’s decision not to approve a computer-assisted personalized sedation system known as the SEDASYS System has been appealed by the manufacturer, Ethicon Endo-Surgery Inc. The device is designed to administer propofol during colonoscopy and esophagogastroduodenoscopy procedures.

Because the manufacturer has appealed the decision, an independent advisory panel will review the decision, but at press time, the date of the review and other details were not available.

In October, the FDA sent a letter to the company denying the approval of the SEDASYS System, which the company had proposed be approved for the intravenous administration of 1% (10 mg/mL) propofol injectable emulsion "for the initiation and maintenance of minimal-to-moderate sedation" in adults undergoing these procedures.

The approval of the device would enable gastroenterologists and nurses to administer propofol to patients during such procedures without an anesthesiologist present; however, the system is not designed for the induction or maintenance of general anesthesia.

According to the FDA, the information submitted by the company "does not provide a reasonable assurance that the device is safe under the conditions of use prescribed, recommended, or suggested in the proposed labeling," and this is why in February 2010, the agency notified the company that the device was not approvable.

But Ethicon Endo-Surgery chose not to address the issues raised by the FDA and chose instead to consider the nonapprovable decision as denial of approval, which, under federal regulations, allows the company to appeal and request an administrative review of the decision by an independent advisory panel.

In November, Ethicon announced that the FDA had granted the company an appeal of the decision and would appoint an independent advisory panel to "reconsider" the clinical trial data and application.

Among the problems with the company’s application cited in the FDA’s October letter were insufficient evidence of the device’s safety in the pivotal study, when used by clinicians who are not trained in the administration of general anesthesia. The study did not compare propofol sedation administered with the SEDASYS system by gastroenterologists and nurses to propofol sedation administered by clinicians trained in general anesthesia, the FDA-approved labeling for the sedative. As a result, the letter says," "we cannot evaluate the distinct risks in administering propofol utilizing the SEDASYS system in comparison with propofol delivery in accordance with FDA-approved drug labeling without the device."

In May 2009, an FDA advisory panel voted 8 to 2 to recommend approval of the device for the indication proposed by the manufacturer, under several conditions, including requiring that clinicians using the device be trained in advanced airway management and that they not be involved in other aspects of the procedure.

Find more information about the FDA’s decision.

The Food and Drug Administration’s decision not to approve a computer-assisted personalized sedation system known as the SEDASYS System has been appealed by the manufacturer, Ethicon Endo-Surgery Inc. The device is designed to administer propofol during colonoscopy and esophagogastroduodenoscopy procedures.

Because the manufacturer has appealed the decision, an independent advisory panel will review the decision, but at press time, the date of the review and other details were not available.

In October, the FDA sent a letter to the company denying the approval of the SEDASYS System, which the company had proposed be approved for the intravenous administration of 1% (10 mg/mL) propofol injectable emulsion "for the initiation and maintenance of minimal-to-moderate sedation" in adults undergoing these procedures.

The approval of the device would enable gastroenterologists and nurses to administer propofol to patients during such procedures without an anesthesiologist present; however, the system is not designed for the induction or maintenance of general anesthesia.

According to the FDA, the information submitted by the company "does not provide a reasonable assurance that the device is safe under the conditions of use prescribed, recommended, or suggested in the proposed labeling," and this is why in February 2010, the agency notified the company that the device was not approvable.

But Ethicon Endo-Surgery chose not to address the issues raised by the FDA and chose instead to consider the nonapprovable decision as denial of approval, which, under federal regulations, allows the company to appeal and request an administrative review of the decision by an independent advisory panel.

In November, Ethicon announced that the FDA had granted the company an appeal of the decision and would appoint an independent advisory panel to "reconsider" the clinical trial data and application.

Among the problems with the company’s application cited in the FDA’s October letter were insufficient evidence of the device’s safety in the pivotal study, when used by clinicians who are not trained in the administration of general anesthesia. The study did not compare propofol sedation administered with the SEDASYS system by gastroenterologists and nurses to propofol sedation administered by clinicians trained in general anesthesia, the FDA-approved labeling for the sedative. As a result, the letter says," "we cannot evaluate the distinct risks in administering propofol utilizing the SEDASYS system in comparison with propofol delivery in accordance with FDA-approved drug labeling without the device."

In May 2009, an FDA advisory panel voted 8 to 2 to recommend approval of the device for the indication proposed by the manufacturer, under several conditions, including requiring that clinicians using the device be trained in advanced airway management and that they not be involved in other aspects of the procedure.

Find more information about the FDA’s decision.

The Food and Drug Administration’s decision not to approve a computer-assisted personalized sedation system known as the SEDASYS System has been appealed by the manufacturer, Ethicon Endo-Surgery Inc. The device is designed to administer propofol during colonoscopy and esophagogastroduodenoscopy procedures.

Because the manufacturer has appealed the decision, an independent advisory panel will review the decision, but at press time, the date of the review and other details were not available.

In October, the FDA sent a letter to the company denying the approval of the SEDASYS System, which the company had proposed be approved for the intravenous administration of 1% (10 mg/mL) propofol injectable emulsion "for the initiation and maintenance of minimal-to-moderate sedation" in adults undergoing these procedures.

The approval of the device would enable gastroenterologists and nurses to administer propofol to patients during such procedures without an anesthesiologist present; however, the system is not designed for the induction or maintenance of general anesthesia.

According to the FDA, the information submitted by the company "does not provide a reasonable assurance that the device is safe under the conditions of use prescribed, recommended, or suggested in the proposed labeling," and this is why in February 2010, the agency notified the company that the device was not approvable.

But Ethicon Endo-Surgery chose not to address the issues raised by the FDA and chose instead to consider the nonapprovable decision as denial of approval, which, under federal regulations, allows the company to appeal and request an administrative review of the decision by an independent advisory panel.

In November, Ethicon announced that the FDA had granted the company an appeal of the decision and would appoint an independent advisory panel to "reconsider" the clinical trial data and application.

Among the problems with the company’s application cited in the FDA’s October letter were insufficient evidence of the device’s safety in the pivotal study, when used by clinicians who are not trained in the administration of general anesthesia. The study did not compare propofol sedation administered with the SEDASYS system by gastroenterologists and nurses to propofol sedation administered by clinicians trained in general anesthesia, the FDA-approved labeling for the sedative. As a result, the letter says," "we cannot evaluate the distinct risks in administering propofol utilizing the SEDASYS system in comparison with propofol delivery in accordance with FDA-approved drug labeling without the device."

In May 2009, an FDA advisory panel voted 8 to 2 to recommend approval of the device for the indication proposed by the manufacturer, under several conditions, including requiring that clinicians using the device be trained in advanced airway management and that they not be involved in other aspects of the procedure.

Find more information about the FDA’s decision.

PALM BEACH, Fla. – Mesh type or position during an incisional hernia repair has little impact on the technical difficulty or patient morbidity of any subsequent abdominal operation, a large retrospective study has determined.

Therefore, surgeons performing an initial hernia repair should select what they believe is the optimal method, without undue concern about the potential effects on subsequent operations, Dr. Mary Hawn said at the annual meeting of the Southern Surgical Association.

"Subsequent abdominal operations are common, with nearly 25% of our study population undergoing one over a median 80-month follow-up period," said Dr. Hawn of the Birmingham Veterans Affairs Medical Center in Alabama. Of those subsequent procedures, nearly two-thirds involved treating a recurrent incisional hernia, either as the primary procedure or in combination with another procedure. "We found a limited effect of mesh type and position, so we recommend when doing an incisional hernia repair, don’t limit your technique due to concerns of complications of future operations."

Dr. Hawn and her colleagues presented the results of a large retrospective study, which included 1,444 patients at 16 Veterans Affairs medical centers. All patients underwent an elective incisional hernia repair during 1998-2002. The investigators identified subsequent abdominal operations and associated complications. They also noted intra- and postoperative variables, including the length of the subsequent operation, the need for an enterotomy or unplanned bowel resection, postoperative infections, return to the hospital or operating room, and mortality.

A quarter of the cohort (366) required a subsequent abdominal operation. Most of these (65%) were redo hernia repairs, complications from hernia repair, or another procedure combined with a hernia repair. The remainder were other abdominal procedures – including small bowel, colorectal, biliary, gastric, or duodenal – or esophageal, urologic, or gynecologic procedures.

Most subsequent procedures (77%) were elective. The remainder were emergent repairs, which were significantly more common in patients undergoing a redo hernia repair that had been done with absorbable or biologic mesh.

About one-third of the subsequent procedures (38%) showed extensive or difficult adhesions. The rate of enterotomy or unplanned bowel resection was 10%, as was the necessity of removing the initial repair mesh. The mean operating time was 126 minutes, and the postoperative length of stay averaged 5 days.

Postoperative morbidities included surgical site infections (6%), return to the OR within 30 days (9%), and hospital readmission within 30 days (13%). There were 16 deaths within 30 days of the admission.

The investigators found no significant associations between any characteristics of the initial hernia repair (mesh position or type) when difficult or extensive adhesions were involved. However, the need for mesh removal was significantly associated with both open and laparoscopic placement of expanded polytetrafluoroethylene (ePTFE) mesh (24% and 16%, respectively).

The rates of enterotomy or unplanned bowel resection did not differ significantly, regardless of mesh positions or types (ePTFE, polypropylene, or absorbable/biologic meshes). A multivariate analysis found that the most important factors influencing risk for enterotomy or bowel resection were older age (odds ratio 1.04) and previous incisional hernia repair, which was associated with more than a fourfold increased risk of enterotomy or bowel resection. Both associations were statistically significant.

Operative time was used as a surrogate for the difficulty of the operation. "We found that after adjusting for patient variables, those with an underlay or inlay polypropylene or biologic mesh had significantly longer operative times," during the subsequent surgery, Dr. Hawn said.

A multivariate analysis found that the mean operative times were 176 minutes for underlay mesh, 207 minutes for inlay mesh, and 143 minutes for onlay mesh. Absorbable/biologic meshes required a mean operating time of 190 minutes – significantly shorter than the time needed to place polypropylene or ePTFE mesh.

The indication for the subsequent operation also significantly affected operating time. A nonincisional hernia repair (mean 212 minutes) took significantly longer than either a redo of an incisional hernia repair (139 minutes) or a redo hernia repair plus another procedure (159 minutes).

Although Dr. Hawn did not provide specific data, she said that, compared to polypropylene, ePTFE mesh that had been applied in an open repair had a significantly higher explantation rate, a lower operative time, and a similar enterotomy rate. In laparoscopic repair, ePTFE had a lower rate of explantation than did polypropylene, but this finding could have been confounded because of the low number of patients whose index hernia was laparoscopically repaired.

"Also, the patients selected for laparoscopy during that initial operation probably had less of a chance of having had prior surgery, so less of a chance of adhesions," she said.

In discussing the paper, Dr. Todd Heniford of the Carolinas Medical Center, Charlotte, N.C., emphasized the study’s take-home message: "Surgeons should do whatever is needed to perform the best hernia repair they can at the first operation to avoid reoperations and the subsequent risks of morbidity and mortality."

Dr. Hawn had no financial disclosures. The study was funded by the Department of Veterans Affairs Health Services Research and Development.

PALM BEACH, Fla. – Mesh type or position during an incisional hernia repair has little impact on the technical difficulty or patient morbidity of any subsequent abdominal operation, a large retrospective study has determined.

Therefore, surgeons performing an initial hernia repair should select what they believe is the optimal method, without undue concern about the potential effects on subsequent operations, Dr. Mary Hawn said at the annual meeting of the Southern Surgical Association.

"Subsequent abdominal operations are common, with nearly 25% of our study population undergoing one over a median 80-month follow-up period," said Dr. Hawn of the Birmingham Veterans Affairs Medical Center in Alabama. Of those subsequent procedures, nearly two-thirds involved treating a recurrent incisional hernia, either as the primary procedure or in combination with another procedure. "We found a limited effect of mesh type and position, so we recommend when doing an incisional hernia repair, don’t limit your technique due to concerns of complications of future operations."

Dr. Hawn and her colleagues presented the results of a large retrospective study, which included 1,444 patients at 16 Veterans Affairs medical centers. All patients underwent an elective incisional hernia repair during 1998-2002. The investigators identified subsequent abdominal operations and associated complications. They also noted intra- and postoperative variables, including the length of the subsequent operation, the need for an enterotomy or unplanned bowel resection, postoperative infections, return to the hospital or operating room, and mortality.

A quarter of the cohort (366) required a subsequent abdominal operation. Most of these (65%) were redo hernia repairs, complications from hernia repair, or another procedure combined with a hernia repair. The remainder were other abdominal procedures – including small bowel, colorectal, biliary, gastric, or duodenal – or esophageal, urologic, or gynecologic procedures.

Most subsequent procedures (77%) were elective. The remainder were emergent repairs, which were significantly more common in patients undergoing a redo hernia repair that had been done with absorbable or biologic mesh.

About one-third of the subsequent procedures (38%) showed extensive or difficult adhesions. The rate of enterotomy or unplanned bowel resection was 10%, as was the necessity of removing the initial repair mesh. The mean operating time was 126 minutes, and the postoperative length of stay averaged 5 days.

Postoperative morbidities included surgical site infections (6%), return to the OR within 30 days (9%), and hospital readmission within 30 days (13%). There were 16 deaths within 30 days of the admission.

The investigators found no significant associations between any characteristics of the initial hernia repair (mesh position or type) when difficult or extensive adhesions were involved. However, the need for mesh removal was significantly associated with both open and laparoscopic placement of expanded polytetrafluoroethylene (ePTFE) mesh (24% and 16%, respectively).

The rates of enterotomy or unplanned bowel resection did not differ significantly, regardless of mesh positions or types (ePTFE, polypropylene, or absorbable/biologic meshes). A multivariate analysis found that the most important factors influencing risk for enterotomy or bowel resection were older age (odds ratio 1.04) and previous incisional hernia repair, which was associated with more than a fourfold increased risk of enterotomy or bowel resection. Both associations were statistically significant.

Operative time was used as a surrogate for the difficulty of the operation. "We found that after adjusting for patient variables, those with an underlay or inlay polypropylene or biologic mesh had significantly longer operative times," during the subsequent surgery, Dr. Hawn said.

A multivariate analysis found that the mean operative times were 176 minutes for underlay mesh, 207 minutes for inlay mesh, and 143 minutes for onlay mesh. Absorbable/biologic meshes required a mean operating time of 190 minutes – significantly shorter than the time needed to place polypropylene or ePTFE mesh.

The indication for the subsequent operation also significantly affected operating time. A nonincisional hernia repair (mean 212 minutes) took significantly longer than either a redo of an incisional hernia repair (139 minutes) or a redo hernia repair plus another procedure (159 minutes).

Although Dr. Hawn did not provide specific data, she said that, compared to polypropylene, ePTFE mesh that had been applied in an open repair had a significantly higher explantation rate, a lower operative time, and a similar enterotomy rate. In laparoscopic repair, ePTFE had a lower rate of explantation than did polypropylene, but this finding could have been confounded because of the low number of patients whose index hernia was laparoscopically repaired.

"Also, the patients selected for laparoscopy during that initial operation probably had less of a chance of having had prior surgery, so less of a chance of adhesions," she said.

In discussing the paper, Dr. Todd Heniford of the Carolinas Medical Center, Charlotte, N.C., emphasized the study’s take-home message: "Surgeons should do whatever is needed to perform the best hernia repair they can at the first operation to avoid reoperations and the subsequent risks of morbidity and mortality."

Dr. Hawn had no financial disclosures. The study was funded by the Department of Veterans Affairs Health Services Research and Development.

PALM BEACH, Fla. – Mesh type or position during an incisional hernia repair has little impact on the technical difficulty or patient morbidity of any subsequent abdominal operation, a large retrospective study has determined.

Therefore, surgeons performing an initial hernia repair should select what they believe is the optimal method, without undue concern about the potential effects on subsequent operations, Dr. Mary Hawn said at the annual meeting of the Southern Surgical Association.

"Subsequent abdominal operations are common, with nearly 25% of our study population undergoing one over a median 80-month follow-up period," said Dr. Hawn of the Birmingham Veterans Affairs Medical Center in Alabama. Of those subsequent procedures, nearly two-thirds involved treating a recurrent incisional hernia, either as the primary procedure or in combination with another procedure. "We found a limited effect of mesh type and position, so we recommend when doing an incisional hernia repair, don’t limit your technique due to concerns of complications of future operations."

Dr. Hawn and her colleagues presented the results of a large retrospective study, which included 1,444 patients at 16 Veterans Affairs medical centers. All patients underwent an elective incisional hernia repair during 1998-2002. The investigators identified subsequent abdominal operations and associated complications. They also noted intra- and postoperative variables, including the length of the subsequent operation, the need for an enterotomy or unplanned bowel resection, postoperative infections, return to the hospital or operating room, and mortality.

A quarter of the cohort (366) required a subsequent abdominal operation. Most of these (65%) were redo hernia repairs, complications from hernia repair, or another procedure combined with a hernia repair. The remainder were other abdominal procedures – including small bowel, colorectal, biliary, gastric, or duodenal – or esophageal, urologic, or gynecologic procedures.

Most subsequent procedures (77%) were elective. The remainder were emergent repairs, which were significantly more common in patients undergoing a redo hernia repair that had been done with absorbable or biologic mesh.

About one-third of the subsequent procedures (38%) showed extensive or difficult adhesions. The rate of enterotomy or unplanned bowel resection was 10%, as was the necessity of removing the initial repair mesh. The mean operating time was 126 minutes, and the postoperative length of stay averaged 5 days.

Postoperative morbidities included surgical site infections (6%), return to the OR within 30 days (9%), and hospital readmission within 30 days (13%). There were 16 deaths within 30 days of the admission.

The investigators found no significant associations between any characteristics of the initial hernia repair (mesh position or type) when difficult or extensive adhesions were involved. However, the need for mesh removal was significantly associated with both open and laparoscopic placement of expanded polytetrafluoroethylene (ePTFE) mesh (24% and 16%, respectively).

The rates of enterotomy or unplanned bowel resection did not differ significantly, regardless of mesh positions or types (ePTFE, polypropylene, or absorbable/biologic meshes). A multivariate analysis found that the most important factors influencing risk for enterotomy or bowel resection were older age (odds ratio 1.04) and previous incisional hernia repair, which was associated with more than a fourfold increased risk of enterotomy or bowel resection. Both associations were statistically significant.

Operative time was used as a surrogate for the difficulty of the operation. "We found that after adjusting for patient variables, those with an underlay or inlay polypropylene or biologic mesh had significantly longer operative times," during the subsequent surgery, Dr. Hawn said.

A multivariate analysis found that the mean operative times were 176 minutes for underlay mesh, 207 minutes for inlay mesh, and 143 minutes for onlay mesh. Absorbable/biologic meshes required a mean operating time of 190 minutes – significantly shorter than the time needed to place polypropylene or ePTFE mesh.

The indication for the subsequent operation also significantly affected operating time. A nonincisional hernia repair (mean 212 minutes) took significantly longer than either a redo of an incisional hernia repair (139 minutes) or a redo hernia repair plus another procedure (159 minutes).

Although Dr. Hawn did not provide specific data, she said that, compared to polypropylene, ePTFE mesh that had been applied in an open repair had a significantly higher explantation rate, a lower operative time, and a similar enterotomy rate. In laparoscopic repair, ePTFE had a lower rate of explantation than did polypropylene, but this finding could have been confounded because of the low number of patients whose index hernia was laparoscopically repaired.

"Also, the patients selected for laparoscopy during that initial operation probably had less of a chance of having had prior surgery, so less of a chance of adhesions," she said.

In discussing the paper, Dr. Todd Heniford of the Carolinas Medical Center, Charlotte, N.C., emphasized the study’s take-home message: "Surgeons should do whatever is needed to perform the best hernia repair they can at the first operation to avoid reoperations and the subsequent risks of morbidity and mortality."

Dr. Hawn had no financial disclosures. The study was funded by the Department of Veterans Affairs Health Services Research and Development.

SAN ANTONIO – Surgical excision of breast cancer prior to sentinel lymph node dissection can displace isolated tumor cells to the sentinel lymph node, but these tumor cells appear to have little clinical significance, according to an analysis of more than 17,000 patients in a large database.

"Earlier surgical excision leads to a nearly fourfold increase in the risk of having isolated tumor cells in the sentinel node indicating iatrogenic displacement," Dr. Tove F. Tvedskov said at the annual San Antonio Breast Cancer Symposium. She advised, however, that these cells are probably without clinical significance, and that the omission of axillary lymph node dissection should be considered.

[Women's Health Initiative: New Findings on Big-Three Cancer Rates]

The study was based on data from the Danish Breast Cancer Cooperative Group database, which includes more than 80,000 women with breast cancer. Approximately 3,000 new sentinel lymph node dissections (SLNDs) are included in the database each year, with clinical and histopathologic data prospectively collected for these cases. Data from this database were combined with data from the Danish National Health Registry, which includes all surgical procedures performed in Danish hospitals.

The researchers identified 414 breast cancer patients who underwent surgical excision up to 2 months before SLND and compared them with 16,960 breast cancer patients who underwent SLND without prior surgical tumor excision.

"The proportion of patients with isolated tumor cells was almost three times higher in the group with earlier surgical excision, compared to the group without earlier surgical excision," said Dr. Tvedskov of Copenhagen University Hospital. "One obvious explanation for these differences between groups is, of course, that the group with earlier surgical excision is a highly selected group of patients, where the cancer diagnosis was not obvious from the beginning."

Therefore, the researchers used a multivariate model to take into account these differences by adjusting for tumor size, histologic type and malignancy grade.

"We found that the risk of having isolated tumor cells in the sentinel node was nearly fourfold increased when surgical excision was performed, compared to patients without any earlier surgical excision," Dr. Tvedskov said. "Surgical excision leads to some degree of iatrogenic displacement."

[Trastuzumab/Pertuzumab Doublet Eradicates Some Early Breast Cancer]

In all, 64% of patients who underwent earlier surgical excision and 59% of those without earlier surgical excision were negative for sentinel lymph node metastases. Among the prior-excision group, 9% had isolated tumor cells in the sentinel lymph node, compared with 3% of the control group (odds ratio, 3.90; P less than .001).

Likewise, micrometastases in the sentinel lymph node were more common (15%) among the prior-excision group, compared with 12% in the control group (OR, 1.48; P = .006). However, macrometastases in the sentinel lymph node were more common in the control group (26% vs. 12%).

The researchers next looked at whether the histologic type of tumor mattered. After adjustment, "we found that the risk of having isolated tumor cells was three times higher in patients with lobular carcinomas, compared to patients with ductal carcinomas," said Dr. Tvedskov. The odds ratio was 3.02 (P less than .0001), after adjusting for tumor size, malignancy grade, and earlier surgical excision.

"Finding these results, we expected that the extra isolated tumor cells after earlier surgical excision would especially come from lobular carcinomas," she said. However, in a subanalysis, "we found that in the group of patients with ductal carcinomas, the risk of isolated tumor cells after surgical excision was nearly fivefold increased, compared to patients without surgical excision, whereas, in the group of patients with lobular carcinomas, there was no significant increased odds ratio."

Among patients with ductal carcinoma, isolated tumor cells were significantly more likely to be present in patients who underwent prior surgical excision compared with control patients (OR, 4.91; P less than .0001), after adjusting for tumor size and malignancy grade. Among lobular carcinoma patients though, isolated tumor cells were not significantly more likely to be present in those who underwent prior surgical excision (OR, 1.27; P = .69), after adjusting for tumor size and malignancy grade.

"So, despite the fact that the lobular carcinomas are, in general, more likely to present with isolated tumor cells in the sentinel node, the extra isolated tumor cells caused by the earlier surgical excision seems to come from ductal carcinomas," said Dr. Tvedskov.

The investigators also considered the question of clinical significance: Were the isolated tumor cells related to nonsentinel node metastases, or could an axillary lymph node dissection be omitted in these patients?

Looking at the distribution of nonsentinel node metastases in patients with either isolated tumor cells or micrometastases in the sentinel node, they found that isolated tumor cells were not present in nonsentinel lymph nodes among patients who underwent prior surgical excision. These cells, however, were found in nonsentinel lymph nodes in 12% of control patients.

Dr. Tvedskov pointed out that this difference did not achieve significance because of the small number of patients. There was no significant difference in the likelihood of micrometastases in nonsentinel lymph nodes between the two groups.

"This indicates that isolated tumor cells in patients with earlier surgical excision are not related to nonsentinel node metastases, and are therefore without clinical significance," she said.

The investigators reported that they have no relevant financial relationships.

[Bevacizumab Short of Mark in First Neoadjuvant Breast Cancer Trial]

SAN ANTONIO – Surgical excision of breast cancer prior to sentinel lymph node dissection can displace isolated tumor cells to the sentinel lymph node, but these tumor cells appear to have little clinical significance, according to an analysis of more than 17,000 patients in a large database.

"Earlier surgical excision leads to a nearly fourfold increase in the risk of having isolated tumor cells in the sentinel node indicating iatrogenic displacement," Dr. Tove F. Tvedskov said at the annual San Antonio Breast Cancer Symposium. She advised, however, that these cells are probably without clinical significance, and that the omission of axillary lymph node dissection should be considered.

[Women's Health Initiative: New Findings on Big-Three Cancer Rates]

The study was based on data from the Danish Breast Cancer Cooperative Group database, which includes more than 80,000 women with breast cancer. Approximately 3,000 new sentinel lymph node dissections (SLNDs) are included in the database each year, with clinical and histopathologic data prospectively collected for these cases. Data from this database were combined with data from the Danish National Health Registry, which includes all surgical procedures performed in Danish hospitals.

The researchers identified 414 breast cancer patients who underwent surgical excision up to 2 months before SLND and compared them with 16,960 breast cancer patients who underwent SLND without prior surgical tumor excision.

"The proportion of patients with isolated tumor cells was almost three times higher in the group with earlier surgical excision, compared to the group without earlier surgical excision," said Dr. Tvedskov of Copenhagen University Hospital. "One obvious explanation for these differences between groups is, of course, that the group with earlier surgical excision is a highly selected group of patients, where the cancer diagnosis was not obvious from the beginning."

Therefore, the researchers used a multivariate model to take into account these differences by adjusting for tumor size, histologic type and malignancy grade.

"We found that the risk of having isolated tumor cells in the sentinel node was nearly fourfold increased when surgical excision was performed, compared to patients without any earlier surgical excision," Dr. Tvedskov said. "Surgical excision leads to some degree of iatrogenic displacement."

[Trastuzumab/Pertuzumab Doublet Eradicates Some Early Breast Cancer]

In all, 64% of patients who underwent earlier surgical excision and 59% of those without earlier surgical excision were negative for sentinel lymph node metastases. Among the prior-excision group, 9% had isolated tumor cells in the sentinel lymph node, compared with 3% of the control group (odds ratio, 3.90; P less than .001).

Likewise, micrometastases in the sentinel lymph node were more common (15%) among the prior-excision group, compared with 12% in the control group (OR, 1.48; P = .006). However, macrometastases in the sentinel lymph node were more common in the control group (26% vs. 12%).

The researchers next looked at whether the histologic type of tumor mattered. After adjustment, "we found that the risk of having isolated tumor cells was three times higher in patients with lobular carcinomas, compared to patients with ductal carcinomas," said Dr. Tvedskov. The odds ratio was 3.02 (P less than .0001), after adjusting for tumor size, malignancy grade, and earlier surgical excision.

"Finding these results, we expected that the extra isolated tumor cells after earlier surgical excision would especially come from lobular carcinomas," she said. However, in a subanalysis, "we found that in the group of patients with ductal carcinomas, the risk of isolated tumor cells after surgical excision was nearly fivefold increased, compared to patients without surgical excision, whereas, in the group of patients with lobular carcinomas, there was no significant increased odds ratio."

Among patients with ductal carcinoma, isolated tumor cells were significantly more likely to be present in patients who underwent prior surgical excision compared with control patients (OR, 4.91; P less than .0001), after adjusting for tumor size and malignancy grade. Among lobular carcinoma patients though, isolated tumor cells were not significantly more likely to be present in those who underwent prior surgical excision (OR, 1.27; P = .69), after adjusting for tumor size and malignancy grade.

"So, despite the fact that the lobular carcinomas are, in general, more likely to present with isolated tumor cells in the sentinel node, the extra isolated tumor cells caused by the earlier surgical excision seems to come from ductal carcinomas," said Dr. Tvedskov.

The investigators also considered the question of clinical significance: Were the isolated tumor cells related to nonsentinel node metastases, or could an axillary lymph node dissection be omitted in these patients?

Looking at the distribution of nonsentinel node metastases in patients with either isolated tumor cells or micrometastases in the sentinel node, they found that isolated tumor cells were not present in nonsentinel lymph nodes among patients who underwent prior surgical excision. These cells, however, were found in nonsentinel lymph nodes in 12% of control patients.

Dr. Tvedskov pointed out that this difference did not achieve significance because of the small number of patients. There was no significant difference in the likelihood of micrometastases in nonsentinel lymph nodes between the two groups.

"This indicates that isolated tumor cells in patients with earlier surgical excision are not related to nonsentinel node metastases, and are therefore without clinical significance," she said.

The investigators reported that they have no relevant financial relationships.

[Bevacizumab Short of Mark in First Neoadjuvant Breast Cancer Trial]

SAN ANTONIO – Surgical excision of breast cancer prior to sentinel lymph node dissection can displace isolated tumor cells to the sentinel lymph node, but these tumor cells appear to have little clinical significance, according to an analysis of more than 17,000 patients in a large database.

"Earlier surgical excision leads to a nearly fourfold increase in the risk of having isolated tumor cells in the sentinel node indicating iatrogenic displacement," Dr. Tove F. Tvedskov said at the annual San Antonio Breast Cancer Symposium. She advised, however, that these cells are probably without clinical significance, and that the omission of axillary lymph node dissection should be considered.

[Women's Health Initiative: New Findings on Big-Three Cancer Rates]

The study was based on data from the Danish Breast Cancer Cooperative Group database, which includes more than 80,000 women with breast cancer. Approximately 3,000 new sentinel lymph node dissections (SLNDs) are included in the database each year, with clinical and histopathologic data prospectively collected for these cases. Data from this database were combined with data from the Danish National Health Registry, which includes all surgical procedures performed in Danish hospitals.

The researchers identified 414 breast cancer patients who underwent surgical excision up to 2 months before SLND and compared them with 16,960 breast cancer patients who underwent SLND without prior surgical tumor excision.

"The proportion of patients with isolated tumor cells was almost three times higher in the group with earlier surgical excision, compared to the group without earlier surgical excision," said Dr. Tvedskov of Copenhagen University Hospital. "One obvious explanation for these differences between groups is, of course, that the group with earlier surgical excision is a highly selected group of patients, where the cancer diagnosis was not obvious from the beginning."

Therefore, the researchers used a multivariate model to take into account these differences by adjusting for tumor size, histologic type and malignancy grade.

"We found that the risk of having isolated tumor cells in the sentinel node was nearly fourfold increased when surgical excision was performed, compared to patients without any earlier surgical excision," Dr. Tvedskov said. "Surgical excision leads to some degree of iatrogenic displacement."

[Trastuzumab/Pertuzumab Doublet Eradicates Some Early Breast Cancer]

In all, 64% of patients who underwent earlier surgical excision and 59% of those without earlier surgical excision were negative for sentinel lymph node metastases. Among the prior-excision group, 9% had isolated tumor cells in the sentinel lymph node, compared with 3% of the control group (odds ratio, 3.90; P less than .001).

Likewise, micrometastases in the sentinel lymph node were more common (15%) among the prior-excision group, compared with 12% in the control group (OR, 1.48; P = .006). However, macrometastases in the sentinel lymph node were more common in the control group (26% vs. 12%).

The researchers next looked at whether the histologic type of tumor mattered. After adjustment, "we found that the risk of having isolated tumor cells was three times higher in patients with lobular carcinomas, compared to patients with ductal carcinomas," said Dr. Tvedskov. The odds ratio was 3.02 (P less than .0001), after adjusting for tumor size, malignancy grade, and earlier surgical excision.

"Finding these results, we expected that the extra isolated tumor cells after earlier surgical excision would especially come from lobular carcinomas," she said. However, in a subanalysis, "we found that in the group of patients with ductal carcinomas, the risk of isolated tumor cells after surgical excision was nearly fivefold increased, compared to patients without surgical excision, whereas, in the group of patients with lobular carcinomas, there was no significant increased odds ratio."

Among patients with ductal carcinoma, isolated tumor cells were significantly more likely to be present in patients who underwent prior surgical excision compared with control patients (OR, 4.91; P less than .0001), after adjusting for tumor size and malignancy grade. Among lobular carcinoma patients though, isolated tumor cells were not significantly more likely to be present in those who underwent prior surgical excision (OR, 1.27; P = .69), after adjusting for tumor size and malignancy grade.

"So, despite the fact that the lobular carcinomas are, in general, more likely to present with isolated tumor cells in the sentinel node, the extra isolated tumor cells caused by the earlier surgical excision seems to come from ductal carcinomas," said Dr. Tvedskov.

The investigators also considered the question of clinical significance: Were the isolated tumor cells related to nonsentinel node metastases, or could an axillary lymph node dissection be omitted in these patients?

Looking at the distribution of nonsentinel node metastases in patients with either isolated tumor cells or micrometastases in the sentinel node, they found that isolated tumor cells were not present in nonsentinel lymph nodes among patients who underwent prior surgical excision. These cells, however, were found in nonsentinel lymph nodes in 12% of control patients.

Dr. Tvedskov pointed out that this difference did not achieve significance because of the small number of patients. There was no significant difference in the likelihood of micrometastases in nonsentinel lymph nodes between the two groups.

"This indicates that isolated tumor cells in patients with earlier surgical excision are not related to nonsentinel node metastases, and are therefore without clinical significance," she said.

The investigators reported that they have no relevant financial relationships.

[Bevacizumab Short of Mark in First Neoadjuvant Breast Cancer Trial]

CHICAGO – The involvement of surgical residents in seven common general surgery procedures was associated with higher morbidity, but lower mortality in an analysis of 37,907 operations.

Photo credit: Wikimedia Commons photo by Nagaraju Raveender

Absolute 30-day morbidity for all cases was 3% in those with surgical residents and 1% in those without surgical resident involvement (SRI).

Absolute 30-day mortality rates for all cases with and without SRI were 0.1% and 0.08%, respectively, Dr. Warren Tseng and his colleagues at the University of California, Davis, reported at the annual meeting of the Western Surgical Association.

In risk-adjusted analyses, SRI was associated with a significant 14% increase in morbidity (odds ratio, 1.14) and a 58% decrease in the risk of death (OR, 0.42).

Not surprisingly, mean incision-to-closing operative times were significantly longer for all procedures with SRI at 98 minutes, compared with 75 minutes without SRI.

Surgical residents were involved in 71% (or 27,039) of the 37,907 procedures identified from 2005 to 2007 in the American College of Surgeons’ NSQIP (National Surgical Quality Improvement Program) database.

The seven procedures and corresponding percentages of SRI were 12,829 open hernia repairs (69%), 3,404 laparoscopic hernia repairs (65%), 6,017 laparoscopic cholecystectomies (76%), 731 open right colectomies (74%), 2,614 total thyroidectomies (82%), 2,940 laparoscopic Nissen fundoplication cases (79%), and 9,372 laparoscopic Roux-en-Y bypass procedures (68%).

In risk-adjusted analysis, SRI was associated with significantly lower mortality for open right colectomy (OR, 0.32), said Dr. Tseng, a general surgery resident at the UC Davis.

"Surgical resident training is safe with respect to these seven procedures," he said, but suggested that future studies are needed to investigate the potential causes for the observed differences.

During a discussion of the study, Dr. Steven Stain of Albany (N.Y.) Medical College said that if it’s commonly believed that resident involvement increases morbidity, there will be patients, payers, and others who won’t want residents involved with cases.

"I’m sure your results are supported by the data, but my concern is that if the implications of this study are taken to the extreme, it’s going to hurt our ability to train residents," he said. "And ultimately, I believe that patients get better care with residents’ involvement, and I’m not sure that your study would support that assertion."

Dr. Stain added that although the NSQIP database is robust, it does not fully account for differences among hospitals, and thus it is not the same surgeon performing, for example, a thyroidectomy – with or without a resident.

Dr. Karen Borman of the Abington (Penn.) Memorial Hospital observed that resident involvement can be a bit of a proxy for other things at an institution, such as increased interruptions and traffic into the OR that could affect infection rates and outcomes. She also questioned whether there may be a selection bias behind cases without SRIs, as they may have been straightforward cases involving uncomplicated patients.

Dr. Richard Thirlby of Virginia Mason Medical Center, Seattle, took issue with the lack of procedure-specific mortality and relative risk calculations.

Invited discussant Dr. Amalia Cochran of the University of Utah, Salt Lake City, described the study as an important extension of previous studies, and said that it stands out for its sheer magnitude. She asked the authors to explain how they chose the seven procedures and how the working relationship between the attending surgeon and resident might influence operative times.

Dr. David Wisner, the study’s senior author, said that they selected procedures with minimal variability, whereas complicated procedures like a Whipple surgery could skew the results. He described the relationship between attending physician and resident as complicated, and said that one of the virtues of the NSQIP database is that some variables are weeded out in an analysis of more than 30,000 patients.

Dr. Wisner agreed that factors other than direct resident involvement could influence outcomes, and said that several exclusion criteria were applied to reduce the risk of selection bias. The study excluded cases with concomitant procedures, nonelective cases, moribund ASA (American Society of Anesthesiologists) category 5 patients, and cases with unknown SRI.

Residents of all levels were included as long as they were part of an Accreditation Council for Graduate Medical Education–accredited training program.

Dr. Tseng and Dr. Wisner disclosed no conflicts of interest. None of the discussants disclosed conflicts.

CHICAGO – The involvement of surgical residents in seven common general surgery procedures was associated with higher morbidity, but lower mortality in an analysis of 37,907 operations.

Photo credit: Wikimedia Commons photo by Nagaraju Raveender

Absolute 30-day morbidity for all cases was 3% in those with surgical residents and 1% in those without surgical resident involvement (SRI).

Absolute 30-day mortality rates for all cases with and without SRI were 0.1% and 0.08%, respectively, Dr. Warren Tseng and his colleagues at the University of California, Davis, reported at the annual meeting of the Western Surgical Association.

In risk-adjusted analyses, SRI was associated with a significant 14% increase in morbidity (odds ratio, 1.14) and a 58% decrease in the risk of death (OR, 0.42).

Not surprisingly, mean incision-to-closing operative times were significantly longer for all procedures with SRI at 98 minutes, compared with 75 minutes without SRI.

Surgical residents were involved in 71% (or 27,039) of the 37,907 procedures identified from 2005 to 2007 in the American College of Surgeons’ NSQIP (National Surgical Quality Improvement Program) database.

The seven procedures and corresponding percentages of SRI were 12,829 open hernia repairs (69%), 3,404 laparoscopic hernia repairs (65%), 6,017 laparoscopic cholecystectomies (76%), 731 open right colectomies (74%), 2,614 total thyroidectomies (82%), 2,940 laparoscopic Nissen fundoplication cases (79%), and 9,372 laparoscopic Roux-en-Y bypass procedures (68%).

In risk-adjusted analysis, SRI was associated with significantly lower mortality for open right colectomy (OR, 0.32), said Dr. Tseng, a general surgery resident at the UC Davis.

"Surgical resident training is safe with respect to these seven procedures," he said, but suggested that future studies are needed to investigate the potential causes for the observed differences.

During a discussion of the study, Dr. Steven Stain of Albany (N.Y.) Medical College said that if it’s commonly believed that resident involvement increases morbidity, there will be patients, payers, and others who won’t want residents involved with cases.

"I’m sure your results are supported by the data, but my concern is that if the implications of this study are taken to the extreme, it’s going to hurt our ability to train residents," he said. "And ultimately, I believe that patients get better care with residents’ involvement, and I’m not sure that your study would support that assertion."

Dr. Stain added that although the NSQIP database is robust, it does not fully account for differences among hospitals, and thus it is not the same surgeon performing, for example, a thyroidectomy – with or without a resident.

Dr. Karen Borman of the Abington (Penn.) Memorial Hospital observed that resident involvement can be a bit of a proxy for other things at an institution, such as increased interruptions and traffic into the OR that could affect infection rates and outcomes. She also questioned whether there may be a selection bias behind cases without SRIs, as they may have been straightforward cases involving uncomplicated patients.

Dr. Richard Thirlby of Virginia Mason Medical Center, Seattle, took issue with the lack of procedure-specific mortality and relative risk calculations.

Invited discussant Dr. Amalia Cochran of the University of Utah, Salt Lake City, described the study as an important extension of previous studies, and said that it stands out for its sheer magnitude. She asked the authors to explain how they chose the seven procedures and how the working relationship between the attending surgeon and resident might influence operative times.

Dr. David Wisner, the study’s senior author, said that they selected procedures with minimal variability, whereas complicated procedures like a Whipple surgery could skew the results. He described the relationship between attending physician and resident as complicated, and said that one of the virtues of the NSQIP database is that some variables are weeded out in an analysis of more than 30,000 patients.

Dr. Wisner agreed that factors other than direct resident involvement could influence outcomes, and said that several exclusion criteria were applied to reduce the risk of selection bias. The study excluded cases with concomitant procedures, nonelective cases, moribund ASA (American Society of Anesthesiologists) category 5 patients, and cases with unknown SRI.

Residents of all levels were included as long as they were part of an Accreditation Council for Graduate Medical Education–accredited training program.

Dr. Tseng and Dr. Wisner disclosed no conflicts of interest. None of the discussants disclosed conflicts.

CHICAGO – The involvement of surgical residents in seven common general surgery procedures was associated with higher morbidity, but lower mortality in an analysis of 37,907 operations.

Photo credit: Wikimedia Commons photo by Nagaraju Raveender

Absolute 30-day morbidity for all cases was 3% in those with surgical residents and 1% in those without surgical resident involvement (SRI).

Absolute 30-day mortality rates for all cases with and without SRI were 0.1% and 0.08%, respectively, Dr. Warren Tseng and his colleagues at the University of California, Davis, reported at the annual meeting of the Western Surgical Association.

In risk-adjusted analyses, SRI was associated with a significant 14% increase in morbidity (odds ratio, 1.14) and a 58% decrease in the risk of death (OR, 0.42).

Not surprisingly, mean incision-to-closing operative times were significantly longer for all procedures with SRI at 98 minutes, compared with 75 minutes without SRI.

Surgical residents were involved in 71% (or 27,039) of the 37,907 procedures identified from 2005 to 2007 in the American College of Surgeons’ NSQIP (National Surgical Quality Improvement Program) database.

The seven procedures and corresponding percentages of SRI were 12,829 open hernia repairs (69%), 3,404 laparoscopic hernia repairs (65%), 6,017 laparoscopic cholecystectomies (76%), 731 open right colectomies (74%), 2,614 total thyroidectomies (82%), 2,940 laparoscopic Nissen fundoplication cases (79%), and 9,372 laparoscopic Roux-en-Y bypass procedures (68%).

In risk-adjusted analysis, SRI was associated with significantly lower mortality for open right colectomy (OR, 0.32), said Dr. Tseng, a general surgery resident at the UC Davis.

"Surgical resident training is safe with respect to these seven procedures," he said, but suggested that future studies are needed to investigate the potential causes for the observed differences.

During a discussion of the study, Dr. Steven Stain of Albany (N.Y.) Medical College said that if it’s commonly believed that resident involvement increases morbidity, there will be patients, payers, and others who won’t want residents involved with cases.

"I’m sure your results are supported by the data, but my concern is that if the implications of this study are taken to the extreme, it’s going to hurt our ability to train residents," he said. "And ultimately, I believe that patients get better care with residents’ involvement, and I’m not sure that your study would support that assertion."

Dr. Stain added that although the NSQIP database is robust, it does not fully account for differences among hospitals, and thus it is not the same surgeon performing, for example, a thyroidectomy – with or without a resident.

Dr. Karen Borman of the Abington (Penn.) Memorial Hospital observed that resident involvement can be a bit of a proxy for other things at an institution, such as increased interruptions and traffic into the OR that could affect infection rates and outcomes. She also questioned whether there may be a selection bias behind cases without SRIs, as they may have been straightforward cases involving uncomplicated patients.

Dr. Richard Thirlby of Virginia Mason Medical Center, Seattle, took issue with the lack of procedure-specific mortality and relative risk calculations.

Invited discussant Dr. Amalia Cochran of the University of Utah, Salt Lake City, described the study as an important extension of previous studies, and said that it stands out for its sheer magnitude. She asked the authors to explain how they chose the seven procedures and how the working relationship between the attending surgeon and resident might influence operative times.

Dr. David Wisner, the study’s senior author, said that they selected procedures with minimal variability, whereas complicated procedures like a Whipple surgery could skew the results. He described the relationship between attending physician and resident as complicated, and said that one of the virtues of the NSQIP database is that some variables are weeded out in an analysis of more than 30,000 patients.

Dr. Wisner agreed that factors other than direct resident involvement could influence outcomes, and said that several exclusion criteria were applied to reduce the risk of selection bias. The study excluded cases with concomitant procedures, nonelective cases, moribund ASA (American Society of Anesthesiologists) category 5 patients, and cases with unknown SRI.

Residents of all levels were included as long as they were part of an Accreditation Council for Graduate Medical Education–accredited training program.

Dr. Tseng and Dr. Wisner disclosed no conflicts of interest. None of the discussants disclosed conflicts.

SAN DIEGO – A device recently approved in the United States could greatly speed decisions about transfusion and coagulation management in patients undergoing noncardiac surgery or liver transplantation, according to Dr. Klaus Görlinger.

Conventional coagulation tests can take 20-30 minutes to produce results, he said at the annual meeting of the American Society of Anesthesiologists. "This is too long for us to make our decisions," said Dr. Görlinger of University Hospital, Essen, Germany.

Photo credit: Tem Innovations GmbH

He and his associates retrospectively analyzed data on 866 patients who underwent liver transplantation, visceral surgery, trauma surgery, or neurosurgery that included blood analysis using the ROTEM rotational thromboelastometry device. They looked at whether maximum clot firmness could be predicted by the amplitude of clot firmness at 5, 10, or 15 minutes after clotting time or by clot formation time, to shorten time to treatment when necessary.

The amplitude of clot firmness at 10 minutes after clotting time showed excellent correlation with maximum clot firmness and was superior to using clot formation time. "So, 12-15 minutes after starting the test, we can make our decisions about what to do in our patients," he said.

A comparison of results using various assays with the ROTEM showed that the extrinsically activated test produced useful results slightly faster than did the intrinsically activated test, which takes a bit longer to start. Both showed excellent correlation with maximum clot firmness and were superior to using clot formation time.

The Food and Drug Administration cleared the ROTEM for use in early 2010, but "only the intrinsically activated tests are FDA approved. We hope all of them will be soon," commented Dr. Linda Shore-Lesserson, comoderator of the session at the meeting. "This is really useful, not having to wait 20-25 minutes for information," said Dr. Shore-Lesserson of Montefiore Medical Center, New York.

And in situations requiring even faster decisions on transfusion and coagulation management, the 5-minute amplitude of clot firmness also provides good predictive value for the maximum clot firmness, "so we can start our specific intervention 10-12 minutes after blood sampling," Dr. Görlinger added.

At his facility, eight ROTEM devices are used in operating rooms, one in the liver transplant ICU, and one in the cardiac ICU. "We can take the device on small trolleys with us to the OR. We have four channels [on the device] and different tests we can use to differentiate what kind of problem we have in our patients," he said.

Dr. Stanley Brauer, another speaker at the session, said he was impressed by Dr. Görlinger’s findings. "After seeing your presentation, I plan to go back to my hospital administrators and ask them to order the ROTEM," said Dr. Brauer, professor of anesthesiology, Loma Linda (Calif.) University.

The study excluded ROTEM analyses that had a run time shorter than 35 minutes and perhaps hadn’t reached a maximum amplitude of clot firmness, Dr. Görlinger said. The study also excluded patients with signs of hyperfibrinolysis. It included patients regardless of whether they had been treated prior to ROTEM analysis of their blood.

Dr. Görlinger said he has received consulting fees and honoraria from Tem Innovations GmbH, which makes the ROTEM device, and CSL Behring GmbH. Two of his coinvestigators have received speaking fees from CSL Behring.

SAN DIEGO – A device recently approved in the United States could greatly speed decisions about transfusion and coagulation management in patients undergoing noncardiac surgery or liver transplantation, according to Dr. Klaus Görlinger.

Conventional coagulation tests can take 20-30 minutes to produce results, he said at the annual meeting of the American Society of Anesthesiologists. "This is too long for us to make our decisions," said Dr. Görlinger of University Hospital, Essen, Germany.

Photo credit: Tem Innovations GmbH

He and his associates retrospectively analyzed data on 866 patients who underwent liver transplantation, visceral surgery, trauma surgery, or neurosurgery that included blood analysis using the ROTEM rotational thromboelastometry device. They looked at whether maximum clot firmness could be predicted by the amplitude of clot firmness at 5, 10, or 15 minutes after clotting time or by clot formation time, to shorten time to treatment when necessary.

The amplitude of clot firmness at 10 minutes after clotting time showed excellent correlation with maximum clot firmness and was superior to using clot formation time. "So, 12-15 minutes after starting the test, we can make our decisions about what to do in our patients," he said.

A comparison of results using various assays with the ROTEM showed that the extrinsically activated test produced useful results slightly faster than did the intrinsically activated test, which takes a bit longer to start. Both showed excellent correlation with maximum clot firmness and were superior to using clot formation time.

The Food and Drug Administration cleared the ROTEM for use in early 2010, but "only the intrinsically activated tests are FDA approved. We hope all of them will be soon," commented Dr. Linda Shore-Lesserson, comoderator of the session at the meeting. "This is really useful, not having to wait 20-25 minutes for information," said Dr. Shore-Lesserson of Montefiore Medical Center, New York.

And in situations requiring even faster decisions on transfusion and coagulation management, the 5-minute amplitude of clot firmness also provides good predictive value for the maximum clot firmness, "so we can start our specific intervention 10-12 minutes after blood sampling," Dr. Görlinger added.

At his facility, eight ROTEM devices are used in operating rooms, one in the liver transplant ICU, and one in the cardiac ICU. "We can take the device on small trolleys with us to the OR. We have four channels [on the device] and different tests we can use to differentiate what kind of problem we have in our patients," he said.

Dr. Stanley Brauer, another speaker at the session, said he was impressed by Dr. Görlinger’s findings. "After seeing your presentation, I plan to go back to my hospital administrators and ask them to order the ROTEM," said Dr. Brauer, professor of anesthesiology, Loma Linda (Calif.) University.

The study excluded ROTEM analyses that had a run time shorter than 35 minutes and perhaps hadn’t reached a maximum amplitude of clot firmness, Dr. Görlinger said. The study also excluded patients with signs of hyperfibrinolysis. It included patients regardless of whether they had been treated prior to ROTEM analysis of their blood.

Dr. Görlinger said he has received consulting fees and honoraria from Tem Innovations GmbH, which makes the ROTEM device, and CSL Behring GmbH. Two of his coinvestigators have received speaking fees from CSL Behring.

SAN DIEGO – A device recently approved in the United States could greatly speed decisions about transfusion and coagulation management in patients undergoing noncardiac surgery or liver transplantation, according to Dr. Klaus Görlinger.

Conventional coagulation tests can take 20-30 minutes to produce results, he said at the annual meeting of the American Society of Anesthesiologists. "This is too long for us to make our decisions," said Dr. Görlinger of University Hospital, Essen, Germany.

Photo credit: Tem Innovations GmbH

He and his associates retrospectively analyzed data on 866 patients who underwent liver transplantation, visceral surgery, trauma surgery, or neurosurgery that included blood analysis using the ROTEM rotational thromboelastometry device. They looked at whether maximum clot firmness could be predicted by the amplitude of clot firmness at 5, 10, or 15 minutes after clotting time or by clot formation time, to shorten time to treatment when necessary.

The amplitude of clot firmness at 10 minutes after clotting time showed excellent correlation with maximum clot firmness and was superior to using clot formation time. "So, 12-15 minutes after starting the test, we can make our decisions about what to do in our patients," he said.

A comparison of results using various assays with the ROTEM showed that the extrinsically activated test produced useful results slightly faster than did the intrinsically activated test, which takes a bit longer to start. Both showed excellent correlation with maximum clot firmness and were superior to using clot formation time.

The Food and Drug Administration cleared the ROTEM for use in early 2010, but "only the intrinsically activated tests are FDA approved. We hope all of them will be soon," commented Dr. Linda Shore-Lesserson, comoderator of the session at the meeting. "This is really useful, not having to wait 20-25 minutes for information," said Dr. Shore-Lesserson of Montefiore Medical Center, New York.

And in situations requiring even faster decisions on transfusion and coagulation management, the 5-minute amplitude of clot firmness also provides good predictive value for the maximum clot firmness, "so we can start our specific intervention 10-12 minutes after blood sampling," Dr. Görlinger added.

At his facility, eight ROTEM devices are used in operating rooms, one in the liver transplant ICU, and one in the cardiac ICU. "We can take the device on small trolleys with us to the OR. We have four channels [on the device] and different tests we can use to differentiate what kind of problem we have in our patients," he said.

Dr. Stanley Brauer, another speaker at the session, said he was impressed by Dr. Görlinger’s findings. "After seeing your presentation, I plan to go back to my hospital administrators and ask them to order the ROTEM," said Dr. Brauer, professor of anesthesiology, Loma Linda (Calif.) University.

The study excluded ROTEM analyses that had a run time shorter than 35 minutes and perhaps hadn’t reached a maximum amplitude of clot firmness, Dr. Görlinger said. The study also excluded patients with signs of hyperfibrinolysis. It included patients regardless of whether they had been treated prior to ROTEM analysis of their blood.

Dr. Görlinger said he has received consulting fees and honoraria from Tem Innovations GmbH, which makes the ROTEM device, and CSL Behring GmbH. Two of his coinvestigators have received speaking fees from CSL Behring.