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Nighttime cholecystectomy may increase complication risk
ORLANDO – Older age and nighttime surgery were associated with an increased risk of complications in patients undergoing laparoscopic cholecystectomy at a high-volume safety net hospital, according to a retrospective study of cases.
Of 576 operations performed in consecutive patients for whom relevant data were available, 35% were performed at night, and although about 60% of procedures overall were nonelective, more than 90% of those performed at night were nonelective, meaning that most patients were admitted directly from the emergency department, Dr. Uma R. Phatak reported at the annual Digestive Disease Week.
A total of 35 complications occurred in 22 patients, including 18 undergoing nonelective surgery and 4 undergoing elective surgery.
Multivariate analysis demonstrated that age and nighttime surgery were significant predictors of complications, said Dr. Phatak of the University of Texas Health Science Center, Houston.
The probability of a complication increased with age for both the patients who underwent daytime surgery and those who underwent nighttime surgery, but the increase was greater in the nighttime surgery group, she said.
The predicted probability of a complication increased threefold for older patients who underwent surgery at night, according to an analysis by 10-year age intervals.
"At the upper end of the age spectrum, the predicted probability of a complication with surgery at night is about 30%, compared to about 10% in the daytime group," Dr. Phatak said.
This analysis did not adjust for disease severity, but a multivariate model that included the elective surgery patients showed that even in this group, an increased risk of a complication was associated with nighttime surgery and increasing age, she noted.
Patients included in the study underwent surgery during an 8-month period from October 2010 to May 2011 at a hospital with a large Hispanic population at high risk for gallstones where laparoscopic cholecystectomy is commonly performed at night. Most (84%) were women, and most (84%) were Hispanic.
The most common diagnoses were acute cholecystitis in the nighttime group and chronic cholecystitis in the daytime group.
Those who underwent nighttime surgery had a lower median age and a longer median length of stay, although it was unclear whether the length of stay was increased due to a delay in getting to the operating room.
The study is limited by its single-center retrospective design, which limits the generalizability. It also was underpowered to detect significant differences in complications other than surgical site infections, Dr. Phatak noted.
Nonetheless, the study demonstrates an increased risk of complications with nighttime surgery, suggesting that the benefits of early laparoscopic cholecystectomy for acute cholecystitis must be balanced against the risk of nighttime surgery, Dr. Phatak said.
"At our institution, new ambulatory operating rooms will be opening soon, decreasing the burden on the main operating room. This will allow for nonemergent cases to be booked during the daytime without imposing delays in the elective schedule," she said.
Providing increased space for elective operations, identifying high-risk patients, and prioritizing surgeries during the day for those patients may decrease the complication rate and improve outcomes, she concluded.
Dr. Phatak reported having no disclosures.
The report by Dr. Phatak and her colleagues
from the University of Texas (UT) Health
Science Center,
Houston, raises
a key issue with respect to the management of acute cholecystitis. Should these
operations be performed at night, especially in older patients? Multiple
prospective, randomized trials over the past 4 decades have concluded that
patients with acute cholecystitis who present within the first few days of the
illness should be managed urgently rather than undergo surgery 6 weeks later.
Nevertheless, a significant proportion of these operations are delayed in the United States.
The question then becomes why is evidence-based practice not being performed?
The answers probably include the surgeon’s schedule, daytime operating room
availability, and staff expertise and equipment availability at night. When an
urgent operation is delayed until the middle of the night, is the patient best
served if her surgeon is overly tired? Similarly, should the next morning’s
patient scheduled for an elective procedure undergo an operation by a surgeon
who has not had an adequate night’s sleep?
The obvious answers to these questions is no, but the
solutions are not simple. Multisurgeon groups and Acute Care Surgery services
may address these issues is schedules are constructed appropriately.
Similarly, efficient management of an operating room
during the day with flexibility for the add-on of urgent cases is ideal. In
addition, cross-training of operating room staff with knowledge and
availability of proper equipment at night is not trivial but is key for safe patient
care. Another important point is whether the findings of the report by Dr.
Phatak are generalizable. Certainly, her observations apply to safety-net
hospitals in cities with large Hispanic populations. However, a 60% incidence
of “nonelective” gallbladder surgery is unusual for the typical community
hospital, rural hospital, or academic medical center. In these settings,
appropriate management of acute cholecystitis is to have the patient take
nothing by mouth (NPO), to initiate appropriate medications, and to schedule
surgery semiurgently, ideally during the daytime. While this ideal situation
may not always be possible, insistence on daytime surgery should be a major
principle especially in older, more frail patients.
Dr. Henry
A. Pitt is an ACS Fellow and vice chairman of surgery at Indiana University, Indianapolis. Dr. Pitt has
no disclosures.
The report by Dr. Phatak and her colleagues
from the University of Texas (UT) Health
Science Center,
Houston, raises
a key issue with respect to the management of acute cholecystitis. Should these
operations be performed at night, especially in older patients? Multiple
prospective, randomized trials over the past 4 decades have concluded that
patients with acute cholecystitis who present within the first few days of the
illness should be managed urgently rather than undergo surgery 6 weeks later.
Nevertheless, a significant proportion of these operations are delayed in the United States.
The question then becomes why is evidence-based practice not being performed?
The answers probably include the surgeon’s schedule, daytime operating room
availability, and staff expertise and equipment availability at night. When an
urgent operation is delayed until the middle of the night, is the patient best
served if her surgeon is overly tired? Similarly, should the next morning’s
patient scheduled for an elective procedure undergo an operation by a surgeon
who has not had an adequate night’s sleep?
The obvious answers to these questions is no, but the
solutions are not simple. Multisurgeon groups and Acute Care Surgery services
may address these issues is schedules are constructed appropriately.
Similarly, efficient management of an operating room
during the day with flexibility for the add-on of urgent cases is ideal. In
addition, cross-training of operating room staff with knowledge and
availability of proper equipment at night is not trivial but is key for safe patient
care. Another important point is whether the findings of the report by Dr.
Phatak are generalizable. Certainly, her observations apply to safety-net
hospitals in cities with large Hispanic populations. However, a 60% incidence
of “nonelective” gallbladder surgery is unusual for the typical community
hospital, rural hospital, or academic medical center. In these settings,
appropriate management of acute cholecystitis is to have the patient take
nothing by mouth (NPO), to initiate appropriate medications, and to schedule
surgery semiurgently, ideally during the daytime. While this ideal situation
may not always be possible, insistence on daytime surgery should be a major
principle especially in older, more frail patients.
Dr. Henry
A. Pitt is an ACS Fellow and vice chairman of surgery at Indiana University, Indianapolis. Dr. Pitt has
no disclosures.
The report by Dr. Phatak and her colleagues
from the University of Texas (UT) Health
Science Center,
Houston, raises
a key issue with respect to the management of acute cholecystitis. Should these
operations be performed at night, especially in older patients? Multiple
prospective, randomized trials over the past 4 decades have concluded that
patients with acute cholecystitis who present within the first few days of the
illness should be managed urgently rather than undergo surgery 6 weeks later.
Nevertheless, a significant proportion of these operations are delayed in the United States.
The question then becomes why is evidence-based practice not being performed?
The answers probably include the surgeon’s schedule, daytime operating room
availability, and staff expertise and equipment availability at night. When an
urgent operation is delayed until the middle of the night, is the patient best
served if her surgeon is overly tired? Similarly, should the next morning’s
patient scheduled for an elective procedure undergo an operation by a surgeon
who has not had an adequate night’s sleep?
The obvious answers to these questions is no, but the
solutions are not simple. Multisurgeon groups and Acute Care Surgery services
may address these issues is schedules are constructed appropriately.
Similarly, efficient management of an operating room
during the day with flexibility for the add-on of urgent cases is ideal. In
addition, cross-training of operating room staff with knowledge and
availability of proper equipment at night is not trivial but is key for safe patient
care. Another important point is whether the findings of the report by Dr.
Phatak are generalizable. Certainly, her observations apply to safety-net
hospitals in cities with large Hispanic populations. However, a 60% incidence
of “nonelective” gallbladder surgery is unusual for the typical community
hospital, rural hospital, or academic medical center. In these settings,
appropriate management of acute cholecystitis is to have the patient take
nothing by mouth (NPO), to initiate appropriate medications, and to schedule
surgery semiurgently, ideally during the daytime. While this ideal situation
may not always be possible, insistence on daytime surgery should be a major
principle especially in older, more frail patients.
Dr. Henry
A. Pitt is an ACS Fellow and vice chairman of surgery at Indiana University, Indianapolis. Dr. Pitt has
no disclosures.
ORLANDO – Older age and nighttime surgery were associated with an increased risk of complications in patients undergoing laparoscopic cholecystectomy at a high-volume safety net hospital, according to a retrospective study of cases.
Of 576 operations performed in consecutive patients for whom relevant data were available, 35% were performed at night, and although about 60% of procedures overall were nonelective, more than 90% of those performed at night were nonelective, meaning that most patients were admitted directly from the emergency department, Dr. Uma R. Phatak reported at the annual Digestive Disease Week.
A total of 35 complications occurred in 22 patients, including 18 undergoing nonelective surgery and 4 undergoing elective surgery.
Multivariate analysis demonstrated that age and nighttime surgery were significant predictors of complications, said Dr. Phatak of the University of Texas Health Science Center, Houston.
The probability of a complication increased with age for both the patients who underwent daytime surgery and those who underwent nighttime surgery, but the increase was greater in the nighttime surgery group, she said.
The predicted probability of a complication increased threefold for older patients who underwent surgery at night, according to an analysis by 10-year age intervals.
"At the upper end of the age spectrum, the predicted probability of a complication with surgery at night is about 30%, compared to about 10% in the daytime group," Dr. Phatak said.
This analysis did not adjust for disease severity, but a multivariate model that included the elective surgery patients showed that even in this group, an increased risk of a complication was associated with nighttime surgery and increasing age, she noted.
Patients included in the study underwent surgery during an 8-month period from October 2010 to May 2011 at a hospital with a large Hispanic population at high risk for gallstones where laparoscopic cholecystectomy is commonly performed at night. Most (84%) were women, and most (84%) were Hispanic.
The most common diagnoses were acute cholecystitis in the nighttime group and chronic cholecystitis in the daytime group.
Those who underwent nighttime surgery had a lower median age and a longer median length of stay, although it was unclear whether the length of stay was increased due to a delay in getting to the operating room.
The study is limited by its single-center retrospective design, which limits the generalizability. It also was underpowered to detect significant differences in complications other than surgical site infections, Dr. Phatak noted.
Nonetheless, the study demonstrates an increased risk of complications with nighttime surgery, suggesting that the benefits of early laparoscopic cholecystectomy for acute cholecystitis must be balanced against the risk of nighttime surgery, Dr. Phatak said.
"At our institution, new ambulatory operating rooms will be opening soon, decreasing the burden on the main operating room. This will allow for nonemergent cases to be booked during the daytime without imposing delays in the elective schedule," she said.
Providing increased space for elective operations, identifying high-risk patients, and prioritizing surgeries during the day for those patients may decrease the complication rate and improve outcomes, she concluded.
Dr. Phatak reported having no disclosures.
ORLANDO – Older age and nighttime surgery were associated with an increased risk of complications in patients undergoing laparoscopic cholecystectomy at a high-volume safety net hospital, according to a retrospective study of cases.
Of 576 operations performed in consecutive patients for whom relevant data were available, 35% were performed at night, and although about 60% of procedures overall were nonelective, more than 90% of those performed at night were nonelective, meaning that most patients were admitted directly from the emergency department, Dr. Uma R. Phatak reported at the annual Digestive Disease Week.
A total of 35 complications occurred in 22 patients, including 18 undergoing nonelective surgery and 4 undergoing elective surgery.
Multivariate analysis demonstrated that age and nighttime surgery were significant predictors of complications, said Dr. Phatak of the University of Texas Health Science Center, Houston.
The probability of a complication increased with age for both the patients who underwent daytime surgery and those who underwent nighttime surgery, but the increase was greater in the nighttime surgery group, she said.
The predicted probability of a complication increased threefold for older patients who underwent surgery at night, according to an analysis by 10-year age intervals.
"At the upper end of the age spectrum, the predicted probability of a complication with surgery at night is about 30%, compared to about 10% in the daytime group," Dr. Phatak said.
This analysis did not adjust for disease severity, but a multivariate model that included the elective surgery patients showed that even in this group, an increased risk of a complication was associated with nighttime surgery and increasing age, she noted.
Patients included in the study underwent surgery during an 8-month period from October 2010 to May 2011 at a hospital with a large Hispanic population at high risk for gallstones where laparoscopic cholecystectomy is commonly performed at night. Most (84%) were women, and most (84%) were Hispanic.
The most common diagnoses were acute cholecystitis in the nighttime group and chronic cholecystitis in the daytime group.
Those who underwent nighttime surgery had a lower median age and a longer median length of stay, although it was unclear whether the length of stay was increased due to a delay in getting to the operating room.
The study is limited by its single-center retrospective design, which limits the generalizability. It also was underpowered to detect significant differences in complications other than surgical site infections, Dr. Phatak noted.
Nonetheless, the study demonstrates an increased risk of complications with nighttime surgery, suggesting that the benefits of early laparoscopic cholecystectomy for acute cholecystitis must be balanced against the risk of nighttime surgery, Dr. Phatak said.
"At our institution, new ambulatory operating rooms will be opening soon, decreasing the burden on the main operating room. This will allow for nonemergent cases to be booked during the daytime without imposing delays in the elective schedule," she said.
Providing increased space for elective operations, identifying high-risk patients, and prioritizing surgeries during the day for those patients may decrease the complication rate and improve outcomes, she concluded.
Dr. Phatak reported having no disclosures.
AT DDW 2013
Major finding: Older nighttime cholecystectomy patients had a threefold increased risk for complications.
Data source: A retrospective study of 576 cases.
Disclosures: Dr. Phatak reported having no disclosures.
Nortriptyline no better than placebo for gastroparesis symptoms
ORLANDO – The tricyclic antidepressant nortriptyline is often prescribed for treatment of nausea, vomiting, and abdominal pain from gastroparesis, but results from a randomized clinical trial suggest that it doesn’t really work, investigators said at the annual Digestive Disease Week.
In a double-masked trial, 15 weeks of treatment with nortriptyline was no better than placebo for management of overall symptoms of idiopathic gastroparesis, reported Dr. Henry P. Parkman from Temple University in Philadelphia.
Although patients started on a 10-mg dose of nortriptyline had early improvement in nausea, this benefit disappeared as the dosage increased. In addition, 19 of the 65 patients assigned to the tricyclic antidepressant (TCA) opted to discontinue treatment early, primarily because of side effects, Dr. Parkman reported.
"Further studies will be needed to determine the role for TCAs and other neuromodulators in patients with idiopathic and also other etiologies of gastroparesis, and also to look at specific symptoms’ improvement associated with TCAs in gastroparesis," he said.
The investigators observed that the practice of treating idiopathic gastroparesis with TCAs is not well supported by clinical evidence, and took it on themselves to see whether they could gather sufficient evidence for or against the efficacy of these agents for this indication.
They chose nortriptyline because of its relatively low anticholinergic side effects, and used a dose-escalating scheme similar to that used in clinical practice.
They enrolled 130 patients into a placebo-controlled, parallel-group trial. Patients randomized to nortriptyline received it at a starting dose of 10 mg daily, which was escalated every 3 weeks to 25, 50, and finally 75 mg.
At the end of the 15 weeks, there were no significant differences between the groups in the primary endpoint, overall symptomatic improvement as measured by change in the 45-point, 9-symptom Gastroparesis Cardinal Symptom Index (GCSI). In all, 15 patients who received the TCA had at least a 50% decline from baseline GCSI score over two consecutive 3-week visits, compared with 14 patients on placebo.
Patients on nortriptyline did have a significant decline in both nausea (P = .04) and abdominal pain (P = .004) at the first visit, but this difference disappeared on subsequent visits.
At the end of the study, patients on the TCA also reported a greater improvement in appetite (P = .03), and showed a nonsignificant trend toward ability to finish a meal (P = .08). Patients on nortriptyline also had a slight gain in body mass index of 0.5 kg/m2, compared with a slight loss of –0.2 kg/m2 among patients on placebo (P = .03).
More than three times as many patients on nortriptyline stopped treatment early (19 vs. 6, P = .007), primarily because of side effects.
The investigators concluded that the role of TCAs and other neuromodulators for the treatment of idiopathic gastroparesis and other forms of gastrointestinal paralysis needs further exploration.
The study was funded by the National Institutes of Health. Dr. Parkman reported serving on advisory committees and review panels for Tranzyme, and consulting for Evoke, SmartPill, and other companies.
Gastroparesis (GP) is currently defined by a combination of symptoms (e.g., epigastric pain, nausea, vomiting, anorexia, bloating, and weight loss) and delayed gastric emptying in the absence of mechanical obstruction. The etiology of GP is diverse and includes diabetes, prior surgery, ischemia, connective tissue disorders, and vaccinations, although the largest group of GP patients is labeled as idiopathic.
Treatment of GP can be vexing for clinicians, as commonly used therapies (metoclopramide, erythromycin, and domperidone) are not uniformly effective, do not improve pain (one of the most common complaints in patients with GP), and are associated with side effects, some of which may be life-altering (i.e., tardive dyskinesia with metoclopramide). This has forced clinicians to search for alternative medications to treat GP symptoms.
Anecdotal reports have suggested that tricyclic antidepressants (TCAs) can improve symptoms in some patients with idiopathic GP. Theoretically, this appears to make sense, as TCAs improve visceral pain in patients with irritable bowel syndrome and functional abdominal pain. The prospective study by Parkman and colleagues was designed to evaluate the efficacy of nortriptyline in alleviating symptoms in patients with idiopathic GP. Frustratingly, nortriptyline was no better than placebo at improving global GP symptoms as measured by the Gastroparesis Cardinal Symptom Index.
These disappointing results may have occurred for a number of reasons, including the study being underpowered, the high dropout rate, too rapid dose escalation, use of a global scale, and not subtyping patients based on extent of pain or gastric emptying rates. These results should not dissuade clinicians from treating GP patients; rather, these results should serve as a stimulus to clinicians and researchers to identify an agent that can improve these chronic and debilitating symptoms.
Brian E. Lacy, M.D., Ph.D. is professor of medicine, section chief of gastroenterology and hepatology, and director of the GI Motility Laboratory at the Dartmouth-Hitchcock Medical Center in Lebanon, N.H. He has no relevant financial disclosures.
Gastroparesis (GP) is currently defined by a combination of symptoms (e.g., epigastric pain, nausea, vomiting, anorexia, bloating, and weight loss) and delayed gastric emptying in the absence of mechanical obstruction. The etiology of GP is diverse and includes diabetes, prior surgery, ischemia, connective tissue disorders, and vaccinations, although the largest group of GP patients is labeled as idiopathic.
Treatment of GP can be vexing for clinicians, as commonly used therapies (metoclopramide, erythromycin, and domperidone) are not uniformly effective, do not improve pain (one of the most common complaints in patients with GP), and are associated with side effects, some of which may be life-altering (i.e., tardive dyskinesia with metoclopramide). This has forced clinicians to search for alternative medications to treat GP symptoms.
Anecdotal reports have suggested that tricyclic antidepressants (TCAs) can improve symptoms in some patients with idiopathic GP. Theoretically, this appears to make sense, as TCAs improve visceral pain in patients with irritable bowel syndrome and functional abdominal pain. The prospective study by Parkman and colleagues was designed to evaluate the efficacy of nortriptyline in alleviating symptoms in patients with idiopathic GP. Frustratingly, nortriptyline was no better than placebo at improving global GP symptoms as measured by the Gastroparesis Cardinal Symptom Index.
These disappointing results may have occurred for a number of reasons, including the study being underpowered, the high dropout rate, too rapid dose escalation, use of a global scale, and not subtyping patients based on extent of pain or gastric emptying rates. These results should not dissuade clinicians from treating GP patients; rather, these results should serve as a stimulus to clinicians and researchers to identify an agent that can improve these chronic and debilitating symptoms.
Brian E. Lacy, M.D., Ph.D. is professor of medicine, section chief of gastroenterology and hepatology, and director of the GI Motility Laboratory at the Dartmouth-Hitchcock Medical Center in Lebanon, N.H. He has no relevant financial disclosures.
Gastroparesis (GP) is currently defined by a combination of symptoms (e.g., epigastric pain, nausea, vomiting, anorexia, bloating, and weight loss) and delayed gastric emptying in the absence of mechanical obstruction. The etiology of GP is diverse and includes diabetes, prior surgery, ischemia, connective tissue disorders, and vaccinations, although the largest group of GP patients is labeled as idiopathic.
Treatment of GP can be vexing for clinicians, as commonly used therapies (metoclopramide, erythromycin, and domperidone) are not uniformly effective, do not improve pain (one of the most common complaints in patients with GP), and are associated with side effects, some of which may be life-altering (i.e., tardive dyskinesia with metoclopramide). This has forced clinicians to search for alternative medications to treat GP symptoms.
Anecdotal reports have suggested that tricyclic antidepressants (TCAs) can improve symptoms in some patients with idiopathic GP. Theoretically, this appears to make sense, as TCAs improve visceral pain in patients with irritable bowel syndrome and functional abdominal pain. The prospective study by Parkman and colleagues was designed to evaluate the efficacy of nortriptyline in alleviating symptoms in patients with idiopathic GP. Frustratingly, nortriptyline was no better than placebo at improving global GP symptoms as measured by the Gastroparesis Cardinal Symptom Index.
These disappointing results may have occurred for a number of reasons, including the study being underpowered, the high dropout rate, too rapid dose escalation, use of a global scale, and not subtyping patients based on extent of pain or gastric emptying rates. These results should not dissuade clinicians from treating GP patients; rather, these results should serve as a stimulus to clinicians and researchers to identify an agent that can improve these chronic and debilitating symptoms.
Brian E. Lacy, M.D., Ph.D. is professor of medicine, section chief of gastroenterology and hepatology, and director of the GI Motility Laboratory at the Dartmouth-Hitchcock Medical Center in Lebanon, N.H. He has no relevant financial disclosures.
ORLANDO – The tricyclic antidepressant nortriptyline is often prescribed for treatment of nausea, vomiting, and abdominal pain from gastroparesis, but results from a randomized clinical trial suggest that it doesn’t really work, investigators said at the annual Digestive Disease Week.
In a double-masked trial, 15 weeks of treatment with nortriptyline was no better than placebo for management of overall symptoms of idiopathic gastroparesis, reported Dr. Henry P. Parkman from Temple University in Philadelphia.
Although patients started on a 10-mg dose of nortriptyline had early improvement in nausea, this benefit disappeared as the dosage increased. In addition, 19 of the 65 patients assigned to the tricyclic antidepressant (TCA) opted to discontinue treatment early, primarily because of side effects, Dr. Parkman reported.
"Further studies will be needed to determine the role for TCAs and other neuromodulators in patients with idiopathic and also other etiologies of gastroparesis, and also to look at specific symptoms’ improvement associated with TCAs in gastroparesis," he said.
The investigators observed that the practice of treating idiopathic gastroparesis with TCAs is not well supported by clinical evidence, and took it on themselves to see whether they could gather sufficient evidence for or against the efficacy of these agents for this indication.
They chose nortriptyline because of its relatively low anticholinergic side effects, and used a dose-escalating scheme similar to that used in clinical practice.
They enrolled 130 patients into a placebo-controlled, parallel-group trial. Patients randomized to nortriptyline received it at a starting dose of 10 mg daily, which was escalated every 3 weeks to 25, 50, and finally 75 mg.
At the end of the 15 weeks, there were no significant differences between the groups in the primary endpoint, overall symptomatic improvement as measured by change in the 45-point, 9-symptom Gastroparesis Cardinal Symptom Index (GCSI). In all, 15 patients who received the TCA had at least a 50% decline from baseline GCSI score over two consecutive 3-week visits, compared with 14 patients on placebo.
Patients on nortriptyline did have a significant decline in both nausea (P = .04) and abdominal pain (P = .004) at the first visit, but this difference disappeared on subsequent visits.
At the end of the study, patients on the TCA also reported a greater improvement in appetite (P = .03), and showed a nonsignificant trend toward ability to finish a meal (P = .08). Patients on nortriptyline also had a slight gain in body mass index of 0.5 kg/m2, compared with a slight loss of –0.2 kg/m2 among patients on placebo (P = .03).
More than three times as many patients on nortriptyline stopped treatment early (19 vs. 6, P = .007), primarily because of side effects.
The investigators concluded that the role of TCAs and other neuromodulators for the treatment of idiopathic gastroparesis and other forms of gastrointestinal paralysis needs further exploration.
The study was funded by the National Institutes of Health. Dr. Parkman reported serving on advisory committees and review panels for Tranzyme, and consulting for Evoke, SmartPill, and other companies.
ORLANDO – The tricyclic antidepressant nortriptyline is often prescribed for treatment of nausea, vomiting, and abdominal pain from gastroparesis, but results from a randomized clinical trial suggest that it doesn’t really work, investigators said at the annual Digestive Disease Week.
In a double-masked trial, 15 weeks of treatment with nortriptyline was no better than placebo for management of overall symptoms of idiopathic gastroparesis, reported Dr. Henry P. Parkman from Temple University in Philadelphia.
Although patients started on a 10-mg dose of nortriptyline had early improvement in nausea, this benefit disappeared as the dosage increased. In addition, 19 of the 65 patients assigned to the tricyclic antidepressant (TCA) opted to discontinue treatment early, primarily because of side effects, Dr. Parkman reported.
"Further studies will be needed to determine the role for TCAs and other neuromodulators in patients with idiopathic and also other etiologies of gastroparesis, and also to look at specific symptoms’ improvement associated with TCAs in gastroparesis," he said.
The investigators observed that the practice of treating idiopathic gastroparesis with TCAs is not well supported by clinical evidence, and took it on themselves to see whether they could gather sufficient evidence for or against the efficacy of these agents for this indication.
They chose nortriptyline because of its relatively low anticholinergic side effects, and used a dose-escalating scheme similar to that used in clinical practice.
They enrolled 130 patients into a placebo-controlled, parallel-group trial. Patients randomized to nortriptyline received it at a starting dose of 10 mg daily, which was escalated every 3 weeks to 25, 50, and finally 75 mg.
At the end of the 15 weeks, there were no significant differences between the groups in the primary endpoint, overall symptomatic improvement as measured by change in the 45-point, 9-symptom Gastroparesis Cardinal Symptom Index (GCSI). In all, 15 patients who received the TCA had at least a 50% decline from baseline GCSI score over two consecutive 3-week visits, compared with 14 patients on placebo.
Patients on nortriptyline did have a significant decline in both nausea (P = .04) and abdominal pain (P = .004) at the first visit, but this difference disappeared on subsequent visits.
At the end of the study, patients on the TCA also reported a greater improvement in appetite (P = .03), and showed a nonsignificant trend toward ability to finish a meal (P = .08). Patients on nortriptyline also had a slight gain in body mass index of 0.5 kg/m2, compared with a slight loss of –0.2 kg/m2 among patients on placebo (P = .03).
More than three times as many patients on nortriptyline stopped treatment early (19 vs. 6, P = .007), primarily because of side effects.
The investigators concluded that the role of TCAs and other neuromodulators for the treatment of idiopathic gastroparesis and other forms of gastrointestinal paralysis needs further exploration.
The study was funded by the National Institutes of Health. Dr. Parkman reported serving on advisory committees and review panels for Tranzyme, and consulting for Evoke, SmartPill, and other companies.
AT DDW 2013
Major finding: There were no significant differences in improvement of gastroparesis symptom scores with nortriptyline vs. placebo.
Data source: Randomized, double-masked, placebo-controlled trial in 130 patients with gastroparesis.
Disclosures: The study was funded by the National Institutes of Health. Dr. Parkman reported serving on advisory committees and review panels for Tranzyme, and consulting for Evoke, SmartPill, and other companies.
Surgeons tackle readmission risk reduction
INDIANAPOLIS – Average 30-day readmission rates in a large national study varied widely by surgical specialty, ranging from 5% for general surgery patients to 12% for vascular surgery patients and 16% after hepato-pancreatic-biliary surgery.
This retrospective study was based upon American College of Surgeons National Surgical Quality Improvement Program (NSQIP) 2011 data on 240,125 patients discharged from 316 hospitals after these types of surgery. The results enabled investigators to identify the major risk factors for readmission. They used this information to generate a predictive model to identify patients at greatest risk with an eye toward introducing interventions to keep them out of the hospital, Dr. Timothy M. Pawlik said at the annual meeting of the American Surgical Association.
How effective such interventions will be in a surgical population is as yet unclear, he added.
The importance of this work lies in the growing emphasis health care payers are placing upon 30-day readmission as a quality-of-care indicator. In 2012, Medicare began cutting reimbursement by 1% to hospitals with above-average 30-day readmissions. Next year, this penalty is scheduled to increase to 3% under the Medicare Hospital Readmission Reduction Program. Prior research efforts to identify risk factors for readmission have focused chiefly on medical rather than surgical conditions, noted Dr. Pawlik, professor of surgery and chief of the division of surgical oncology at Johns Hopkins University, Baltimore.
The readmission risk predictive formula he and his coinvestigators developed is simple: American Society of Anesthesiologists physical status class + (length of stay/2). This number is rounded up to yield a risk score of 1-10. A patient with a readmission score of 1 has a 1% risk of readmission within 30 days of discharge. The risk climbs to 12% with a score of 5, 20% with a score of 8, and 40% with a score of 10.
"A score of 4 had an 8% readmission rate, with 77% sensitivity, 52% specificity, a low positive predictive value of 12%, but a high negative predictive value of 95%," the surgeon observed. "In essence, a score of 4 or higher was able to identify 80% of all readmissions, but it also included about half of all patients."
Because of a quirk in the NSQIP database – it records readmissions within 30 days of surgery instead of starting from discharge – the investigators had to limit the study population to surgery patients with a length of stay of 10 days or less and then apply statistical modeling. However, limiting the data set to patients with a maximum 10-day hospital stay only restricted the study cohort by 6%. Thus, the study results remain highly generalizable to U.S. surgery patients.
The area under the curve (AUC) of the receiver operating characteristic for the readmission risk formula was 0.70. Statisticians consider a test having an AUC of 0.50 to be worthless. An AUC of 1.0 would define a "perfect" test, while a test with an AUC in the 0.70-0.80 range is deemed of only "fair" accuracy.
The AUC for the readmission score varied considerably when applied to the various surgical subspecialties. For example, the AUC was 0.69 for general surgery patients but only 0.51 for thoracic surgery patients, 0.64 for vascular surgery patients, and 0.59 for colorectal surgery patients.
The fact that the predictive formula doesn’t perform any better than barely "fair" is testimony to the difficulty in identifying who will require readmission. That being said, the AUC for the readmission score after surgery compares favorably to published hospital readmission risk formulas developed for medical patients, which have similar and in many cases lower AUCs (JAMA 2011;306:1688-98), Dr. Pawlik observed.
At Johns Hopkins, the plan is to target surgery patients who have high readmission scores with interventions including more frequent follow-up phone calls and earlier scheduled postoperative clinic visits in an effort to keep them out of the hospital, he continued.
Discussant Dr. Keith D. Lillemoe was skeptical that this will result in reduced readmission rates. Indeed, he questioned whether the 30-day readmission rate is a legitimate quality measure for surgeons.
"I can look across the room and predict if a patient is going to come back in to the hospital. But what can we really do to keep such patients from being readmitted other than keeping them indeterminately long until we’ve passed that window? It seems like all the phone calls and early clinic visits in the world can’t stop the progression sometimes," reflected Dr. Lillemoe, professor and chairman of the department of surgery at Massachusetts General Hospital, Boston.
He noted with frustration that he had just stepped out of the lecture hall to arrange for readmission of a patient 1 week after discharge post pancreaticoduodenectomy.
"I made three phone calls myself to that guy trying to nurse him through his nausea and vomiting and other symptoms," the surgeon recalled.
Dr. Pawlik was sympathetic.
"It’s very hard to prevent readmissions. It’s a very complicated metric, and many would argue that it’s an inappropriate quality metric," he said. "Many things are outside our control before we even meet the patient, as are some things that occur in the hospital, and many things are beyond our control after discharge as far as where they live, their family structure, and their financial resources. In my opinion it’s a very problematic quality measure and I am not sure how we are going to tackle it."
He reported having no conflicts of interest.
INDIANAPOLIS – Average 30-day readmission rates in a large national study varied widely by surgical specialty, ranging from 5% for general surgery patients to 12% for vascular surgery patients and 16% after hepato-pancreatic-biliary surgery.
This retrospective study was based upon American College of Surgeons National Surgical Quality Improvement Program (NSQIP) 2011 data on 240,125 patients discharged from 316 hospitals after these types of surgery. The results enabled investigators to identify the major risk factors for readmission. They used this information to generate a predictive model to identify patients at greatest risk with an eye toward introducing interventions to keep them out of the hospital, Dr. Timothy M. Pawlik said at the annual meeting of the American Surgical Association.
How effective such interventions will be in a surgical population is as yet unclear, he added.
The importance of this work lies in the growing emphasis health care payers are placing upon 30-day readmission as a quality-of-care indicator. In 2012, Medicare began cutting reimbursement by 1% to hospitals with above-average 30-day readmissions. Next year, this penalty is scheduled to increase to 3% under the Medicare Hospital Readmission Reduction Program. Prior research efforts to identify risk factors for readmission have focused chiefly on medical rather than surgical conditions, noted Dr. Pawlik, professor of surgery and chief of the division of surgical oncology at Johns Hopkins University, Baltimore.
The readmission risk predictive formula he and his coinvestigators developed is simple: American Society of Anesthesiologists physical status class + (length of stay/2). This number is rounded up to yield a risk score of 1-10. A patient with a readmission score of 1 has a 1% risk of readmission within 30 days of discharge. The risk climbs to 12% with a score of 5, 20% with a score of 8, and 40% with a score of 10.
"A score of 4 had an 8% readmission rate, with 77% sensitivity, 52% specificity, a low positive predictive value of 12%, but a high negative predictive value of 95%," the surgeon observed. "In essence, a score of 4 or higher was able to identify 80% of all readmissions, but it also included about half of all patients."
Because of a quirk in the NSQIP database – it records readmissions within 30 days of surgery instead of starting from discharge – the investigators had to limit the study population to surgery patients with a length of stay of 10 days or less and then apply statistical modeling. However, limiting the data set to patients with a maximum 10-day hospital stay only restricted the study cohort by 6%. Thus, the study results remain highly generalizable to U.S. surgery patients.
The area under the curve (AUC) of the receiver operating characteristic for the readmission risk formula was 0.70. Statisticians consider a test having an AUC of 0.50 to be worthless. An AUC of 1.0 would define a "perfect" test, while a test with an AUC in the 0.70-0.80 range is deemed of only "fair" accuracy.
The AUC for the readmission score varied considerably when applied to the various surgical subspecialties. For example, the AUC was 0.69 for general surgery patients but only 0.51 for thoracic surgery patients, 0.64 for vascular surgery patients, and 0.59 for colorectal surgery patients.
The fact that the predictive formula doesn’t perform any better than barely "fair" is testimony to the difficulty in identifying who will require readmission. That being said, the AUC for the readmission score after surgery compares favorably to published hospital readmission risk formulas developed for medical patients, which have similar and in many cases lower AUCs (JAMA 2011;306:1688-98), Dr. Pawlik observed.
At Johns Hopkins, the plan is to target surgery patients who have high readmission scores with interventions including more frequent follow-up phone calls and earlier scheduled postoperative clinic visits in an effort to keep them out of the hospital, he continued.
Discussant Dr. Keith D. Lillemoe was skeptical that this will result in reduced readmission rates. Indeed, he questioned whether the 30-day readmission rate is a legitimate quality measure for surgeons.
"I can look across the room and predict if a patient is going to come back in to the hospital. But what can we really do to keep such patients from being readmitted other than keeping them indeterminately long until we’ve passed that window? It seems like all the phone calls and early clinic visits in the world can’t stop the progression sometimes," reflected Dr. Lillemoe, professor and chairman of the department of surgery at Massachusetts General Hospital, Boston.
He noted with frustration that he had just stepped out of the lecture hall to arrange for readmission of a patient 1 week after discharge post pancreaticoduodenectomy.
"I made three phone calls myself to that guy trying to nurse him through his nausea and vomiting and other symptoms," the surgeon recalled.
Dr. Pawlik was sympathetic.
"It’s very hard to prevent readmissions. It’s a very complicated metric, and many would argue that it’s an inappropriate quality metric," he said. "Many things are outside our control before we even meet the patient, as are some things that occur in the hospital, and many things are beyond our control after discharge as far as where they live, their family structure, and their financial resources. In my opinion it’s a very problematic quality measure and I am not sure how we are going to tackle it."
He reported having no conflicts of interest.
INDIANAPOLIS – Average 30-day readmission rates in a large national study varied widely by surgical specialty, ranging from 5% for general surgery patients to 12% for vascular surgery patients and 16% after hepato-pancreatic-biliary surgery.
This retrospective study was based upon American College of Surgeons National Surgical Quality Improvement Program (NSQIP) 2011 data on 240,125 patients discharged from 316 hospitals after these types of surgery. The results enabled investigators to identify the major risk factors for readmission. They used this information to generate a predictive model to identify patients at greatest risk with an eye toward introducing interventions to keep them out of the hospital, Dr. Timothy M. Pawlik said at the annual meeting of the American Surgical Association.
How effective such interventions will be in a surgical population is as yet unclear, he added.
The importance of this work lies in the growing emphasis health care payers are placing upon 30-day readmission as a quality-of-care indicator. In 2012, Medicare began cutting reimbursement by 1% to hospitals with above-average 30-day readmissions. Next year, this penalty is scheduled to increase to 3% under the Medicare Hospital Readmission Reduction Program. Prior research efforts to identify risk factors for readmission have focused chiefly on medical rather than surgical conditions, noted Dr. Pawlik, professor of surgery and chief of the division of surgical oncology at Johns Hopkins University, Baltimore.
The readmission risk predictive formula he and his coinvestigators developed is simple: American Society of Anesthesiologists physical status class + (length of stay/2). This number is rounded up to yield a risk score of 1-10. A patient with a readmission score of 1 has a 1% risk of readmission within 30 days of discharge. The risk climbs to 12% with a score of 5, 20% with a score of 8, and 40% with a score of 10.
"A score of 4 had an 8% readmission rate, with 77% sensitivity, 52% specificity, a low positive predictive value of 12%, but a high negative predictive value of 95%," the surgeon observed. "In essence, a score of 4 or higher was able to identify 80% of all readmissions, but it also included about half of all patients."
Because of a quirk in the NSQIP database – it records readmissions within 30 days of surgery instead of starting from discharge – the investigators had to limit the study population to surgery patients with a length of stay of 10 days or less and then apply statistical modeling. However, limiting the data set to patients with a maximum 10-day hospital stay only restricted the study cohort by 6%. Thus, the study results remain highly generalizable to U.S. surgery patients.
The area under the curve (AUC) of the receiver operating characteristic for the readmission risk formula was 0.70. Statisticians consider a test having an AUC of 0.50 to be worthless. An AUC of 1.0 would define a "perfect" test, while a test with an AUC in the 0.70-0.80 range is deemed of only "fair" accuracy.
The AUC for the readmission score varied considerably when applied to the various surgical subspecialties. For example, the AUC was 0.69 for general surgery patients but only 0.51 for thoracic surgery patients, 0.64 for vascular surgery patients, and 0.59 for colorectal surgery patients.
The fact that the predictive formula doesn’t perform any better than barely "fair" is testimony to the difficulty in identifying who will require readmission. That being said, the AUC for the readmission score after surgery compares favorably to published hospital readmission risk formulas developed for medical patients, which have similar and in many cases lower AUCs (JAMA 2011;306:1688-98), Dr. Pawlik observed.
At Johns Hopkins, the plan is to target surgery patients who have high readmission scores with interventions including more frequent follow-up phone calls and earlier scheduled postoperative clinic visits in an effort to keep them out of the hospital, he continued.
Discussant Dr. Keith D. Lillemoe was skeptical that this will result in reduced readmission rates. Indeed, he questioned whether the 30-day readmission rate is a legitimate quality measure for surgeons.
"I can look across the room and predict if a patient is going to come back in to the hospital. But what can we really do to keep such patients from being readmitted other than keeping them indeterminately long until we’ve passed that window? It seems like all the phone calls and early clinic visits in the world can’t stop the progression sometimes," reflected Dr. Lillemoe, professor and chairman of the department of surgery at Massachusetts General Hospital, Boston.
He noted with frustration that he had just stepped out of the lecture hall to arrange for readmission of a patient 1 week after discharge post pancreaticoduodenectomy.
"I made three phone calls myself to that guy trying to nurse him through his nausea and vomiting and other symptoms," the surgeon recalled.
Dr. Pawlik was sympathetic.
"It’s very hard to prevent readmissions. It’s a very complicated metric, and many would argue that it’s an inappropriate quality metric," he said. "Many things are outside our control before we even meet the patient, as are some things that occur in the hospital, and many things are beyond our control after discharge as far as where they live, their family structure, and their financial resources. In my opinion it’s a very problematic quality measure and I am not sure how we are going to tackle it."
He reported having no conflicts of interest.
AT THE ASA ANNUAL MEETING
Major Finding: The 30-day readmission rate following general, thoracic, and vascular surgery was 8%. It ranged from 5% to 16% depending upon the surgical subspecialty. The study led to generation of a simple readmission risk scoring system.
Data Source: A retrospective study of 240,125 patients in the American College of Surgeons National Surgical Quality Improvement Program who were discharged in 2011 following these types of surgery.
Disclosures: The presenter reported having no conflicts of interest.
Preop walking speed predicts postop morbidity
INDIANAPOLIS – Slower walking speed on the timed-up-and-go test in elderly patients scheduled for surgery is a significantly better forecaster of postoperative complications and 1-year mortality than are the considerably more complex patient risk calculators currently considered standard of care, Dr. Thomas N. Robinson reported at the annual meeting of the American Surgical Association.
"I think what walking speed reflects is global reduced physiologic reserve. It’s frailty. And by definition, an individual who’s frail will have adverse health care outcomes," explained Dr. Robinson, a general surgeon at the University of Colorado, Denver.
Use of preoperative walking speed to assess postoperative risk is a paradigm shift, he noted. Current surgical risk assessment strategies rely upon math-heavy patient risk calculators which evaluate single end-organ dysfunction, in some cases summing up the individual scores for heart, lung, liver, and other organ dysfunction in an attempt to define chronic disease burden. But in older patients, this approach is less effective than a simple frailty assessment based upon mobility: that is, walking speed, he continued.
Surgeons in the Veterans Affairs health care system use a risk calculator that involves input of 24 variables. Hitting the "compute risk" button then produces the patient’s estimated 30-day morbidity and mortality risks.
Dr. Robinson presented a prospective study in which the VA tool was compared to the timed-up-and-go (TUG) test in 272 patients aged older than 65 years who were followed for a minimum of 1 year after elective surgery. To see how the two tests performed across surgical specialties, the investigators included 174 patients with a cardiac operation and 98 who had colorectal surgery.
In the TUG test, a clinician starts a stopwatch as the patient rises from a chair, walks 10 feet, returns, and sits back down. The patient is instructed to walk at his or her normal pace and is free to use a walking aid. Dr. Robinson chose to study the TUG rather than a simple 5-meter gait speed test because he considers TUG more relevant to surgical patients.
"TUG combines lower extremity strength to stand up in addition to walking speed. And if you think about somebody who needs to make the transition from hospital to home, lower extremity strength is important," he said.
The investigators categorized a TUG time of 10 seconds or less as fast, 11-14 seconds as intermediate, and 15 seconds or longer as slow. Of note, the subjects’ TUG times were unrelated to common comorbid conditions in the elderly, including stroke, diabetes, heart failure, and hypertension.
In contrast, walking speed was strongly associated with classic indicators of frailty. For example, impaired cognition was present in 3% of subjects with a fast TUG time, 41% of those with an intermediate time, and 92% of slow performers. Another frailty indicator – a history of falling within the past 6 months – was present in 7% of the fast group, 21% of intermediate TUG walkers, and 85% of those with a TUG speed of 15 seconds or more.
In the cardiac surgery group, one or more postsurgical complications occurred in 11% of the 53 patients in the fast group, 25% of 88 patients with an intermediate TUG time, and 52% of 33 individuals in the slow group. The 1-year mortality rates were 2%, 3%, and 12%, respectively.
Similarly, in the colorectal surgery group, the complication rate was 12% among 30 fast walkers, 29% of 42 patients in the intermediate group, and 77% of 26 patients in the slow group. The 1-year mortality rates were 3%, 10%, and 31%, respectively.
The investigators judged comparative test performance in predicting postoperative morbidity and mortality on the basis of the receiver operating characteristic area under the curve, which was 77% with the TUG test compared to 55% with the VA risk calculator in the colorectal surgery patients. In the cardiac surgery group, the figures were 68% for TUG and 55% with the risk calculator.
Geriatricians typically measure TUG in seconds as a continuous variable. Dr. Robinson and coworkers decided the test would be more useful for surgeons if they created the three discrete categories of fast, intermediate, and slow.
Discussant Dr. Michael E. Zenilman praised the investigators for what he called "an outstanding study," and one that’s particularly welcome right now, as the wave of aging baby boomers swells.
"As we take care of more elderly patients, it’s important that we develop tools like this to quickly and objectively assess risk. The tools that we have now, such as the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) models and the VA risk calculator, are for me just too complicated," said Dr. Zenilman of Johns Hopkins University, Baltimore. Dr. Zenilman is the university’s vice chair and regional director of surgery for the Washington area. Noting that TUG, Mini-Mental Status scores, history of falling, and serum albumin levels all have been shown to serve as proxies for frailty, he asked Dr. Robinson to predict which one he thinks will win out as a postoperative risk predictor.
Dr. Robinson replied that TUG is a good frailty assessment tool for now, but he and others are trying to develop something better. The American College of Surgeons geriatric task force is collaborating with the NSQIP to identify variables present in patients’ charts that correlate with global frailty and can serve as reliable predictors of postoperative risk.
He reported having no financial conflicts.
INDIANAPOLIS – Slower walking speed on the timed-up-and-go test in elderly patients scheduled for surgery is a significantly better forecaster of postoperative complications and 1-year mortality than are the considerably more complex patient risk calculators currently considered standard of care, Dr. Thomas N. Robinson reported at the annual meeting of the American Surgical Association.
"I think what walking speed reflects is global reduced physiologic reserve. It’s frailty. And by definition, an individual who’s frail will have adverse health care outcomes," explained Dr. Robinson, a general surgeon at the University of Colorado, Denver.
Use of preoperative walking speed to assess postoperative risk is a paradigm shift, he noted. Current surgical risk assessment strategies rely upon math-heavy patient risk calculators which evaluate single end-organ dysfunction, in some cases summing up the individual scores for heart, lung, liver, and other organ dysfunction in an attempt to define chronic disease burden. But in older patients, this approach is less effective than a simple frailty assessment based upon mobility: that is, walking speed, he continued.
Surgeons in the Veterans Affairs health care system use a risk calculator that involves input of 24 variables. Hitting the "compute risk" button then produces the patient’s estimated 30-day morbidity and mortality risks.
Dr. Robinson presented a prospective study in which the VA tool was compared to the timed-up-and-go (TUG) test in 272 patients aged older than 65 years who were followed for a minimum of 1 year after elective surgery. To see how the two tests performed across surgical specialties, the investigators included 174 patients with a cardiac operation and 98 who had colorectal surgery.
In the TUG test, a clinician starts a stopwatch as the patient rises from a chair, walks 10 feet, returns, and sits back down. The patient is instructed to walk at his or her normal pace and is free to use a walking aid. Dr. Robinson chose to study the TUG rather than a simple 5-meter gait speed test because he considers TUG more relevant to surgical patients.
"TUG combines lower extremity strength to stand up in addition to walking speed. And if you think about somebody who needs to make the transition from hospital to home, lower extremity strength is important," he said.
The investigators categorized a TUG time of 10 seconds or less as fast, 11-14 seconds as intermediate, and 15 seconds or longer as slow. Of note, the subjects’ TUG times were unrelated to common comorbid conditions in the elderly, including stroke, diabetes, heart failure, and hypertension.
In contrast, walking speed was strongly associated with classic indicators of frailty. For example, impaired cognition was present in 3% of subjects with a fast TUG time, 41% of those with an intermediate time, and 92% of slow performers. Another frailty indicator – a history of falling within the past 6 months – was present in 7% of the fast group, 21% of intermediate TUG walkers, and 85% of those with a TUG speed of 15 seconds or more.
In the cardiac surgery group, one or more postsurgical complications occurred in 11% of the 53 patients in the fast group, 25% of 88 patients with an intermediate TUG time, and 52% of 33 individuals in the slow group. The 1-year mortality rates were 2%, 3%, and 12%, respectively.
Similarly, in the colorectal surgery group, the complication rate was 12% among 30 fast walkers, 29% of 42 patients in the intermediate group, and 77% of 26 patients in the slow group. The 1-year mortality rates were 3%, 10%, and 31%, respectively.
The investigators judged comparative test performance in predicting postoperative morbidity and mortality on the basis of the receiver operating characteristic area under the curve, which was 77% with the TUG test compared to 55% with the VA risk calculator in the colorectal surgery patients. In the cardiac surgery group, the figures were 68% for TUG and 55% with the risk calculator.
Geriatricians typically measure TUG in seconds as a continuous variable. Dr. Robinson and coworkers decided the test would be more useful for surgeons if they created the three discrete categories of fast, intermediate, and slow.
Discussant Dr. Michael E. Zenilman praised the investigators for what he called "an outstanding study," and one that’s particularly welcome right now, as the wave of aging baby boomers swells.
"As we take care of more elderly patients, it’s important that we develop tools like this to quickly and objectively assess risk. The tools that we have now, such as the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) models and the VA risk calculator, are for me just too complicated," said Dr. Zenilman of Johns Hopkins University, Baltimore. Dr. Zenilman is the university’s vice chair and regional director of surgery for the Washington area. Noting that TUG, Mini-Mental Status scores, history of falling, and serum albumin levels all have been shown to serve as proxies for frailty, he asked Dr. Robinson to predict which one he thinks will win out as a postoperative risk predictor.
Dr. Robinson replied that TUG is a good frailty assessment tool for now, but he and others are trying to develop something better. The American College of Surgeons geriatric task force is collaborating with the NSQIP to identify variables present in patients’ charts that correlate with global frailty and can serve as reliable predictors of postoperative risk.
He reported having no financial conflicts.
INDIANAPOLIS – Slower walking speed on the timed-up-and-go test in elderly patients scheduled for surgery is a significantly better forecaster of postoperative complications and 1-year mortality than are the considerably more complex patient risk calculators currently considered standard of care, Dr. Thomas N. Robinson reported at the annual meeting of the American Surgical Association.
"I think what walking speed reflects is global reduced physiologic reserve. It’s frailty. And by definition, an individual who’s frail will have adverse health care outcomes," explained Dr. Robinson, a general surgeon at the University of Colorado, Denver.
Use of preoperative walking speed to assess postoperative risk is a paradigm shift, he noted. Current surgical risk assessment strategies rely upon math-heavy patient risk calculators which evaluate single end-organ dysfunction, in some cases summing up the individual scores for heart, lung, liver, and other organ dysfunction in an attempt to define chronic disease burden. But in older patients, this approach is less effective than a simple frailty assessment based upon mobility: that is, walking speed, he continued.
Surgeons in the Veterans Affairs health care system use a risk calculator that involves input of 24 variables. Hitting the "compute risk" button then produces the patient’s estimated 30-day morbidity and mortality risks.
Dr. Robinson presented a prospective study in which the VA tool was compared to the timed-up-and-go (TUG) test in 272 patients aged older than 65 years who were followed for a minimum of 1 year after elective surgery. To see how the two tests performed across surgical specialties, the investigators included 174 patients with a cardiac operation and 98 who had colorectal surgery.
In the TUG test, a clinician starts a stopwatch as the patient rises from a chair, walks 10 feet, returns, and sits back down. The patient is instructed to walk at his or her normal pace and is free to use a walking aid. Dr. Robinson chose to study the TUG rather than a simple 5-meter gait speed test because he considers TUG more relevant to surgical patients.
"TUG combines lower extremity strength to stand up in addition to walking speed. And if you think about somebody who needs to make the transition from hospital to home, lower extremity strength is important," he said.
The investigators categorized a TUG time of 10 seconds or less as fast, 11-14 seconds as intermediate, and 15 seconds or longer as slow. Of note, the subjects’ TUG times were unrelated to common comorbid conditions in the elderly, including stroke, diabetes, heart failure, and hypertension.
In contrast, walking speed was strongly associated with classic indicators of frailty. For example, impaired cognition was present in 3% of subjects with a fast TUG time, 41% of those with an intermediate time, and 92% of slow performers. Another frailty indicator – a history of falling within the past 6 months – was present in 7% of the fast group, 21% of intermediate TUG walkers, and 85% of those with a TUG speed of 15 seconds or more.
In the cardiac surgery group, one or more postsurgical complications occurred in 11% of the 53 patients in the fast group, 25% of 88 patients with an intermediate TUG time, and 52% of 33 individuals in the slow group. The 1-year mortality rates were 2%, 3%, and 12%, respectively.
Similarly, in the colorectal surgery group, the complication rate was 12% among 30 fast walkers, 29% of 42 patients in the intermediate group, and 77% of 26 patients in the slow group. The 1-year mortality rates were 3%, 10%, and 31%, respectively.
The investigators judged comparative test performance in predicting postoperative morbidity and mortality on the basis of the receiver operating characteristic area under the curve, which was 77% with the TUG test compared to 55% with the VA risk calculator in the colorectal surgery patients. In the cardiac surgery group, the figures were 68% for TUG and 55% with the risk calculator.
Geriatricians typically measure TUG in seconds as a continuous variable. Dr. Robinson and coworkers decided the test would be more useful for surgeons if they created the three discrete categories of fast, intermediate, and slow.
Discussant Dr. Michael E. Zenilman praised the investigators for what he called "an outstanding study," and one that’s particularly welcome right now, as the wave of aging baby boomers swells.
"As we take care of more elderly patients, it’s important that we develop tools like this to quickly and objectively assess risk. The tools that we have now, such as the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) models and the VA risk calculator, are for me just too complicated," said Dr. Zenilman of Johns Hopkins University, Baltimore. Dr. Zenilman is the university’s vice chair and regional director of surgery for the Washington area. Noting that TUG, Mini-Mental Status scores, history of falling, and serum albumin levels all have been shown to serve as proxies for frailty, he asked Dr. Robinson to predict which one he thinks will win out as a postoperative risk predictor.
Dr. Robinson replied that TUG is a good frailty assessment tool for now, but he and others are trying to develop something better. The American College of Surgeons geriatric task force is collaborating with the NSQIP to identify variables present in patients’ charts that correlate with global frailty and can serve as reliable predictors of postoperative risk.
He reported having no financial conflicts.
AT THE ASA ANNUAL MEETING
Major Finding. One-year mortality rates for fast, intermediate, and slow cardiac patients were 2%, 3%, and 12%, respectively. In the colorectal surgery group, the 1-year mortality rates were 3%, 10%, and 31%, respectively.
Data Source: A prospective cohort study of postsurgical complications and 1-year mortality in 98 elderly patients undergoing elective colorectal surgery and 174 with elective cardiac surgery. All underwent a preoperative timed-up-and-go test as well as assessment via the Veterans Affairs surgical risk calculator.
Disclosures: The study presenter reported having no conflicts of interest.
Early surgery for adhesive bowel obstruction can save lives
INDIANAPOLIS – Patients requiring surgery for adhesive small bowel obstruction have markedly lower major morbidity and mortality rates if they’re operated on within 24 hours of hospital admission, according to an analysis of a large national database.
This finding is at odds with the conventional wisdom.
Both the World Society of Emergency Surgery and the Eastern Association for the Surgery of Trauma recommend in published guidelines an initial 3-5 days of nonoperative management to give the obstruction a chance to resolve on its own, Dr. Pedro G. Teixeira noted in presenting the study findings at the annual meeting of the American Surgical Association.
He and his coinvestigators identified 4,163 patients in the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database for 2005-2010 who underwent emergency laparotomy for adhesive bowel obstruction. Thirty-day mortality was 3% in those operated upon within 24 hours of hospital admission. It rose in stepwise fashion thereafter: 4% mortality with surgery at 24-48 hours, 7% with surgery at 48-72 hours, and 9% a threefold increase – when surgery was delayed beyond 72 hours, according to Dr. Teixeira of the University of Southern California, Los Angeles.
Similarly, the incidence of systemic infectious complications, including pneumonia, urinary tract infections, and sepsis, climbed from 12% with early operation to 17% when surgery occurred at 24-48 hours, 21% at 48-72 hours, and 24% thereafter.
In a multivariate analysis adjusted for baseline comorbidities and other potential confounding variables, surgery delayed for 24 hours or more after admission was associated with a highly significant 58% increased risk of mortality, a 33% increase in surgical site infections, a 36% greater risk of pneumonia, and a 47% increased risk of septic shock, he continued.
Discussant Gregory J. Jurkovich commented that this study challenges current dogma and harkens back to a century-old adage that has since been cast aside, namely, "Never let the sun set on a bowel obstruction."
The trouble is, however, that having a low threshold for surgery within 24 hours would subject a massive number of patients to an unnecessary operation.
An analysis of Nationwide Inpatient Sample data for 2009 by other investigators concluded that bowel obstruction resolved on its own within 3 days in 60% of patients and within 5 days in 80%. Fewer than 20% of the patients who presented with adhesive small bowel obstruction without evidence of ischemia underwent surgery, noted Dr. Jurkovich, director of surgery at Denver Health Medical Center and professor of trauma surgery and vice chairman of the department of surgery at the University of Colorado at Denver.
Dr. Teixeira concurred that bowel obstruction will resolve on its own in most patients. The challenge for surgeons in light of his study findings, he stressed, is to expedite the identification of those patients who will fail the period of nonoperative management. The best tool for that, in his view, is a CT scan of the abdomen and pelvis with water-soluble contrast.
At the University of Southern California, he explained, a patient who presents with adhesive bowel obstruction without evidence of ischemia undergoes the CT scan and is admitted to the surgical observation unit for close monitoring.
"At our institution, failure to demonstrate contrast progression through the colon within 24 hours would be a very strong indication for surgical exploration," according to Dr. Teixeira.
He reported having no financial conflicts.
The study by Dr. Teixeira is intriguing in
that it suggests a return to practice patterns from a prior era.
|
| Dr. Chad Whelan |
The study does report increased risk in
complications including mortality with delays in surgery for small bowel
obstructions, even with risk adjustment. However, this is not a controlled
trial which limits our ability to reach definitive conclusions from it. Still,
hospitalists often are the primary physicians for patients admitted for small
bowel obstructions and should be aware of these findings so that they can
ensure that they have early surgical involvement.
Chad Whelan, M.D., is associate chief medical officer for
performance improvement and innovation and an associate professor of medicine
at the University
of Chicago Medical Center.
The study by Dr. Teixeira is intriguing in
that it suggests a return to practice patterns from a prior era.
|
|
| Dr. Chad Whelan |
The study does report increased risk in
complications including mortality with delays in surgery for small bowel
obstructions, even with risk adjustment. However, this is not a controlled
trial which limits our ability to reach definitive conclusions from it. Still,
hospitalists often are the primary physicians for patients admitted for small
bowel obstructions and should be aware of these findings so that they can
ensure that they have early surgical involvement.
Chad Whelan, M.D., is associate chief medical officer for
performance improvement and innovation and an associate professor of medicine
at the University
of Chicago Medical Center.
The study by Dr. Teixeira is intriguing in
that it suggests a return to practice patterns from a prior era.
|
|
| Dr. Chad Whelan |
The study does report increased risk in
complications including mortality with delays in surgery for small bowel
obstructions, even with risk adjustment. However, this is not a controlled
trial which limits our ability to reach definitive conclusions from it. Still,
hospitalists often are the primary physicians for patients admitted for small
bowel obstructions and should be aware of these findings so that they can
ensure that they have early surgical involvement.
Chad Whelan, M.D., is associate chief medical officer for
performance improvement and innovation and an associate professor of medicine
at the University
of Chicago Medical Center.
INDIANAPOLIS – Patients requiring surgery for adhesive small bowel obstruction have markedly lower major morbidity and mortality rates if they’re operated on within 24 hours of hospital admission, according to an analysis of a large national database.
This finding is at odds with the conventional wisdom.
Both the World Society of Emergency Surgery and the Eastern Association for the Surgery of Trauma recommend in published guidelines an initial 3-5 days of nonoperative management to give the obstruction a chance to resolve on its own, Dr. Pedro G. Teixeira noted in presenting the study findings at the annual meeting of the American Surgical Association.
He and his coinvestigators identified 4,163 patients in the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database for 2005-2010 who underwent emergency laparotomy for adhesive bowel obstruction. Thirty-day mortality was 3% in those operated upon within 24 hours of hospital admission. It rose in stepwise fashion thereafter: 4% mortality with surgery at 24-48 hours, 7% with surgery at 48-72 hours, and 9% a threefold increase – when surgery was delayed beyond 72 hours, according to Dr. Teixeira of the University of Southern California, Los Angeles.
Similarly, the incidence of systemic infectious complications, including pneumonia, urinary tract infections, and sepsis, climbed from 12% with early operation to 17% when surgery occurred at 24-48 hours, 21% at 48-72 hours, and 24% thereafter.
In a multivariate analysis adjusted for baseline comorbidities and other potential confounding variables, surgery delayed for 24 hours or more after admission was associated with a highly significant 58% increased risk of mortality, a 33% increase in surgical site infections, a 36% greater risk of pneumonia, and a 47% increased risk of septic shock, he continued.
Discussant Gregory J. Jurkovich commented that this study challenges current dogma and harkens back to a century-old adage that has since been cast aside, namely, "Never let the sun set on a bowel obstruction."
The trouble is, however, that having a low threshold for surgery within 24 hours would subject a massive number of patients to an unnecessary operation.
An analysis of Nationwide Inpatient Sample data for 2009 by other investigators concluded that bowel obstruction resolved on its own within 3 days in 60% of patients and within 5 days in 80%. Fewer than 20% of the patients who presented with adhesive small bowel obstruction without evidence of ischemia underwent surgery, noted Dr. Jurkovich, director of surgery at Denver Health Medical Center and professor of trauma surgery and vice chairman of the department of surgery at the University of Colorado at Denver.
Dr. Teixeira concurred that bowel obstruction will resolve on its own in most patients. The challenge for surgeons in light of his study findings, he stressed, is to expedite the identification of those patients who will fail the period of nonoperative management. The best tool for that, in his view, is a CT scan of the abdomen and pelvis with water-soluble contrast.
At the University of Southern California, he explained, a patient who presents with adhesive bowel obstruction without evidence of ischemia undergoes the CT scan and is admitted to the surgical observation unit for close monitoring.
"At our institution, failure to demonstrate contrast progression through the colon within 24 hours would be a very strong indication for surgical exploration," according to Dr. Teixeira.
He reported having no financial conflicts.
INDIANAPOLIS – Patients requiring surgery for adhesive small bowel obstruction have markedly lower major morbidity and mortality rates if they’re operated on within 24 hours of hospital admission, according to an analysis of a large national database.
This finding is at odds with the conventional wisdom.
Both the World Society of Emergency Surgery and the Eastern Association for the Surgery of Trauma recommend in published guidelines an initial 3-5 days of nonoperative management to give the obstruction a chance to resolve on its own, Dr. Pedro G. Teixeira noted in presenting the study findings at the annual meeting of the American Surgical Association.
He and his coinvestigators identified 4,163 patients in the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database for 2005-2010 who underwent emergency laparotomy for adhesive bowel obstruction. Thirty-day mortality was 3% in those operated upon within 24 hours of hospital admission. It rose in stepwise fashion thereafter: 4% mortality with surgery at 24-48 hours, 7% with surgery at 48-72 hours, and 9% a threefold increase – when surgery was delayed beyond 72 hours, according to Dr. Teixeira of the University of Southern California, Los Angeles.
Similarly, the incidence of systemic infectious complications, including pneumonia, urinary tract infections, and sepsis, climbed from 12% with early operation to 17% when surgery occurred at 24-48 hours, 21% at 48-72 hours, and 24% thereafter.
In a multivariate analysis adjusted for baseline comorbidities and other potential confounding variables, surgery delayed for 24 hours or more after admission was associated with a highly significant 58% increased risk of mortality, a 33% increase in surgical site infections, a 36% greater risk of pneumonia, and a 47% increased risk of septic shock, he continued.
Discussant Gregory J. Jurkovich commented that this study challenges current dogma and harkens back to a century-old adage that has since been cast aside, namely, "Never let the sun set on a bowel obstruction."
The trouble is, however, that having a low threshold for surgery within 24 hours would subject a massive number of patients to an unnecessary operation.
An analysis of Nationwide Inpatient Sample data for 2009 by other investigators concluded that bowel obstruction resolved on its own within 3 days in 60% of patients and within 5 days in 80%. Fewer than 20% of the patients who presented with adhesive small bowel obstruction without evidence of ischemia underwent surgery, noted Dr. Jurkovich, director of surgery at Denver Health Medical Center and professor of trauma surgery and vice chairman of the department of surgery at the University of Colorado at Denver.
Dr. Teixeira concurred that bowel obstruction will resolve on its own in most patients. The challenge for surgeons in light of his study findings, he stressed, is to expedite the identification of those patients who will fail the period of nonoperative management. The best tool for that, in his view, is a CT scan of the abdomen and pelvis with water-soluble contrast.
At the University of Southern California, he explained, a patient who presents with adhesive bowel obstruction without evidence of ischemia undergoes the CT scan and is admitted to the surgical observation unit for close monitoring.
"At our institution, failure to demonstrate contrast progression through the colon within 24 hours would be a very strong indication for surgical exploration," according to Dr. Teixeira.
He reported having no financial conflicts.
AT THE ASA ANNUAL MEETING
Major Finding: Surgery for adhesive small bowel obstruction had a 30-day mortality rate of 3% if performed within 24 hours of hospital admission, rising stepwise to 9% when the operation was delayed beyond 72 hours.
Data Source: This was a retrospective analysis of 4,163 patients in the American College of Surgeons National Quality Improvement Program database for 2005-2010 who underwent emergency laparotomy for adhesive bowel obstruction.
Disclosures: The presenter reported having no conflicts of interest.
Diabetes 'cure' holds up 6 years after bariatric surgery
INDIANAPOLIS – At 6 years of follow-up data, bariatric surgical cures of type 2 diabetes are holding steady in a single-center series of 217 patients.
"We see sustained weight loss, particularly in Roux-en-Y gastric bypass patients, 5-9 years after surgery." Diabetes remitted in 50% of patients, according to Dr. Stacy A. Brethauer of the Cleveland Clinic. "Bariatric surgery also achieved excellent long-term control of other cardiovascular risk factors; and diabetic nephropathy improved or stabilized."
Of 217 obese type 2 diabetic patients followed for a median of 6 years after bariatric surgery, 24% have been "cured." They have maintained a hemoglobin A1c level below 6% and fasting blood glucose values below 100 mg/dL for more than 5 years while off all antidiabetic medications, Dr. Brethauer reported at the annual meeting of the American Surgical Association.
Another 26% of patients have had partial remissions, meaning they maintained target HbA1c and fasting blood glucose levels off antidiabetic medications for more than 1 year but less than 5 years. In addition, 34% of patients were classified as "improved" based upon an absolute 1% or more reduction in HbA1c, a drop in fasting blood glucose in excess of 25 mg/dL, and a halving in the dose of antidiabetic medication for at least 1 year.
Diabetes recurred in 19% of subjects. Recurrence was defined as a return to an HbA1c of 6.5% or more or a fasting blood glucose level of at least 126 mg/dL.
The overall study population improved from a mean body mass index of 49 kg/m2 before surgery to 37 kg/m2 at 6 years after surgery. The mean HbA1c was 7.5% at baseline and 6.5% at 6 years. Fasting blood glucose at 6 years was a mean of 41.6 mg/dL lower than it was before surgery. LDL cholesterol levels were down by a mean of 10.1 mg/dL and HDL levels were up by 9.8 mg/dL. Systolic blood pressure was reduced by a mean of 10.9 mm Hg, with diastolic blood pressure was down by 3.2 mm Hg at 6 years after surgery.
Preoperatively, all but 5% of patients were on any antidiabetes medications; at 6 years after bariatric surgery, 54% were not on any antidiabetes drugs.
At baseline, 3% of subjects met all three key metabolic goals for diabetic patients as defined by the American Diabetes Association: an HbA1c below 7%, blood pressure below 130/80 mm Hg, and an LDL level below 100 mg/dL. At 6 years after surgery, 28% of patients met these goals. That result is particularly impressive in light of other studies that indicate 13% of the U.S. diabetic population as a whole meet all three goals.
The bariatric surgery group had a mean Framingham 10-year cardiovascular risk score of 28% preoperatively and of 22% at long-term followup.
The incidence of diabetic nephropathy among patients with type 2 diabetes is typically 2%-4% per year. Yet of 40 gastric bypass recipients known to have a normal urinary albumin-to-creatinine ratio preoperatively, only 1 developed macroalbuminuria and 1 microalbuminuria during a mean of 6 years postsurgical follow-up.
Also impressive, albuminuria regressed in 10 of the 19 gastric bypass recipients known to have the disorder at baseline. Albuminuria remained stable in the other 9 patients over the course of 6 years.
Mean excess weight loss at 1-2 years of follow-up was 61% in the 162 patients who underwent gastric bypass, 50% in the 23 with sleeve gastrectomy, and 30% in patients who had a gastric banding procedure.
In a multivariate analysis adjusted for baseline clinical characteristics, the significant predictors of diabetes remission following bariatric surgery were greater excess weight loss, preoperative diabetes duration of less than 5 years, and having a gastric bypass operation rather than sleeve gastrectomy or a gastric banding procedure.
Dr. Brethauer said this study, taken together with the findings of an earlier randomized clinical trial by the same investigators (N. Engl. J. Med. 2012;366:1567-76), conveys a clear message : "Bariatric surgery can induce a significant and sustainable remission of type 2 diabetes and other metabolic risk factors in obese patients and should be considered early in the course of the disease."
Discussant Dr. Walter J. Pories called Dr. Brethauer’s study "a really important contribution." He added that it’s high time for nonsurgeons to get on board.
"One in four adults over age 65 in this country has diabetes. One would have thought our medical colleagues would be ecstatic at the news that an operation on the gut – a safe procedure that can be done in about an hour – could produce full and durable remission of diabetes with complete prevention of amputations, blindness, and kidney failure. But that hasn’t been the case. All we’ve heard are cries for more and more evidence," said Dr. Pories, professor of surgery at East Carolina University, Greenville, N.C.
He added that in his view, Dr. Brethauer and his colleagues set the bar too high in requiring a sustained HbA1c below 6% as the definition of disease cure when the American Diabetes Association uses a figure of 7%. He noted that if the investigators had accepted the ADA metric, their combined cure/partial remission rate would have been considerably greater than the 50% figure they reported.
Dr. Brethauer replied that he and his coinvestigators chose a cutoff of 6% in order to make a point.
"When we raise this issue of ‘cure,’ which is still quite controversial and somewhat provocative, particularly with our endocrinology colleagues, I think we have to find the strictest and most conservative criteria that we can," he explained. "We continue to provide data in support of the concept that this is a surgically treated disease. It’s a major paradigm shift for our endocrinology colleagues to accept. I think it’s going to take a generation of endocrinologists before it’s embraced."
He reported that he serves as a consultant to Ethicon Endosurgery and Apollo Endosurgery.
INDIANAPOLIS – At 6 years of follow-up data, bariatric surgical cures of type 2 diabetes are holding steady in a single-center series of 217 patients.
"We see sustained weight loss, particularly in Roux-en-Y gastric bypass patients, 5-9 years after surgery." Diabetes remitted in 50% of patients, according to Dr. Stacy A. Brethauer of the Cleveland Clinic. "Bariatric surgery also achieved excellent long-term control of other cardiovascular risk factors; and diabetic nephropathy improved or stabilized."
Of 217 obese type 2 diabetic patients followed for a median of 6 years after bariatric surgery, 24% have been "cured." They have maintained a hemoglobin A1c level below 6% and fasting blood glucose values below 100 mg/dL for more than 5 years while off all antidiabetic medications, Dr. Brethauer reported at the annual meeting of the American Surgical Association.
Another 26% of patients have had partial remissions, meaning they maintained target HbA1c and fasting blood glucose levels off antidiabetic medications for more than 1 year but less than 5 years. In addition, 34% of patients were classified as "improved" based upon an absolute 1% or more reduction in HbA1c, a drop in fasting blood glucose in excess of 25 mg/dL, and a halving in the dose of antidiabetic medication for at least 1 year.
Diabetes recurred in 19% of subjects. Recurrence was defined as a return to an HbA1c of 6.5% or more or a fasting blood glucose level of at least 126 mg/dL.
The overall study population improved from a mean body mass index of 49 kg/m2 before surgery to 37 kg/m2 at 6 years after surgery. The mean HbA1c was 7.5% at baseline and 6.5% at 6 years. Fasting blood glucose at 6 years was a mean of 41.6 mg/dL lower than it was before surgery. LDL cholesterol levels were down by a mean of 10.1 mg/dL and HDL levels were up by 9.8 mg/dL. Systolic blood pressure was reduced by a mean of 10.9 mm Hg, with diastolic blood pressure was down by 3.2 mm Hg at 6 years after surgery.
Preoperatively, all but 5% of patients were on any antidiabetes medications; at 6 years after bariatric surgery, 54% were not on any antidiabetes drugs.
At baseline, 3% of subjects met all three key metabolic goals for diabetic patients as defined by the American Diabetes Association: an HbA1c below 7%, blood pressure below 130/80 mm Hg, and an LDL level below 100 mg/dL. At 6 years after surgery, 28% of patients met these goals. That result is particularly impressive in light of other studies that indicate 13% of the U.S. diabetic population as a whole meet all three goals.
The bariatric surgery group had a mean Framingham 10-year cardiovascular risk score of 28% preoperatively and of 22% at long-term followup.
The incidence of diabetic nephropathy among patients with type 2 diabetes is typically 2%-4% per year. Yet of 40 gastric bypass recipients known to have a normal urinary albumin-to-creatinine ratio preoperatively, only 1 developed macroalbuminuria and 1 microalbuminuria during a mean of 6 years postsurgical follow-up.
Also impressive, albuminuria regressed in 10 of the 19 gastric bypass recipients known to have the disorder at baseline. Albuminuria remained stable in the other 9 patients over the course of 6 years.
Mean excess weight loss at 1-2 years of follow-up was 61% in the 162 patients who underwent gastric bypass, 50% in the 23 with sleeve gastrectomy, and 30% in patients who had a gastric banding procedure.
In a multivariate analysis adjusted for baseline clinical characteristics, the significant predictors of diabetes remission following bariatric surgery were greater excess weight loss, preoperative diabetes duration of less than 5 years, and having a gastric bypass operation rather than sleeve gastrectomy or a gastric banding procedure.
Dr. Brethauer said this study, taken together with the findings of an earlier randomized clinical trial by the same investigators (N. Engl. J. Med. 2012;366:1567-76), conveys a clear message : "Bariatric surgery can induce a significant and sustainable remission of type 2 diabetes and other metabolic risk factors in obese patients and should be considered early in the course of the disease."
Discussant Dr. Walter J. Pories called Dr. Brethauer’s study "a really important contribution." He added that it’s high time for nonsurgeons to get on board.
"One in four adults over age 65 in this country has diabetes. One would have thought our medical colleagues would be ecstatic at the news that an operation on the gut – a safe procedure that can be done in about an hour – could produce full and durable remission of diabetes with complete prevention of amputations, blindness, and kidney failure. But that hasn’t been the case. All we’ve heard are cries for more and more evidence," said Dr. Pories, professor of surgery at East Carolina University, Greenville, N.C.
He added that in his view, Dr. Brethauer and his colleagues set the bar too high in requiring a sustained HbA1c below 6% as the definition of disease cure when the American Diabetes Association uses a figure of 7%. He noted that if the investigators had accepted the ADA metric, their combined cure/partial remission rate would have been considerably greater than the 50% figure they reported.
Dr. Brethauer replied that he and his coinvestigators chose a cutoff of 6% in order to make a point.
"When we raise this issue of ‘cure,’ which is still quite controversial and somewhat provocative, particularly with our endocrinology colleagues, I think we have to find the strictest and most conservative criteria that we can," he explained. "We continue to provide data in support of the concept that this is a surgically treated disease. It’s a major paradigm shift for our endocrinology colleagues to accept. I think it’s going to take a generation of endocrinologists before it’s embraced."
He reported that he serves as a consultant to Ethicon Endosurgery and Apollo Endosurgery.
INDIANAPOLIS – At 6 years of follow-up data, bariatric surgical cures of type 2 diabetes are holding steady in a single-center series of 217 patients.
"We see sustained weight loss, particularly in Roux-en-Y gastric bypass patients, 5-9 years after surgery." Diabetes remitted in 50% of patients, according to Dr. Stacy A. Brethauer of the Cleveland Clinic. "Bariatric surgery also achieved excellent long-term control of other cardiovascular risk factors; and diabetic nephropathy improved or stabilized."
Of 217 obese type 2 diabetic patients followed for a median of 6 years after bariatric surgery, 24% have been "cured." They have maintained a hemoglobin A1c level below 6% and fasting blood glucose values below 100 mg/dL for more than 5 years while off all antidiabetic medications, Dr. Brethauer reported at the annual meeting of the American Surgical Association.
Another 26% of patients have had partial remissions, meaning they maintained target HbA1c and fasting blood glucose levels off antidiabetic medications for more than 1 year but less than 5 years. In addition, 34% of patients were classified as "improved" based upon an absolute 1% or more reduction in HbA1c, a drop in fasting blood glucose in excess of 25 mg/dL, and a halving in the dose of antidiabetic medication for at least 1 year.
Diabetes recurred in 19% of subjects. Recurrence was defined as a return to an HbA1c of 6.5% or more or a fasting blood glucose level of at least 126 mg/dL.
The overall study population improved from a mean body mass index of 49 kg/m2 before surgery to 37 kg/m2 at 6 years after surgery. The mean HbA1c was 7.5% at baseline and 6.5% at 6 years. Fasting blood glucose at 6 years was a mean of 41.6 mg/dL lower than it was before surgery. LDL cholesterol levels were down by a mean of 10.1 mg/dL and HDL levels were up by 9.8 mg/dL. Systolic blood pressure was reduced by a mean of 10.9 mm Hg, with diastolic blood pressure was down by 3.2 mm Hg at 6 years after surgery.
Preoperatively, all but 5% of patients were on any antidiabetes medications; at 6 years after bariatric surgery, 54% were not on any antidiabetes drugs.
At baseline, 3% of subjects met all three key metabolic goals for diabetic patients as defined by the American Diabetes Association: an HbA1c below 7%, blood pressure below 130/80 mm Hg, and an LDL level below 100 mg/dL. At 6 years after surgery, 28% of patients met these goals. That result is particularly impressive in light of other studies that indicate 13% of the U.S. diabetic population as a whole meet all three goals.
The bariatric surgery group had a mean Framingham 10-year cardiovascular risk score of 28% preoperatively and of 22% at long-term followup.
The incidence of diabetic nephropathy among patients with type 2 diabetes is typically 2%-4% per year. Yet of 40 gastric bypass recipients known to have a normal urinary albumin-to-creatinine ratio preoperatively, only 1 developed macroalbuminuria and 1 microalbuminuria during a mean of 6 years postsurgical follow-up.
Also impressive, albuminuria regressed in 10 of the 19 gastric bypass recipients known to have the disorder at baseline. Albuminuria remained stable in the other 9 patients over the course of 6 years.
Mean excess weight loss at 1-2 years of follow-up was 61% in the 162 patients who underwent gastric bypass, 50% in the 23 with sleeve gastrectomy, and 30% in patients who had a gastric banding procedure.
In a multivariate analysis adjusted for baseline clinical characteristics, the significant predictors of diabetes remission following bariatric surgery were greater excess weight loss, preoperative diabetes duration of less than 5 years, and having a gastric bypass operation rather than sleeve gastrectomy or a gastric banding procedure.
Dr. Brethauer said this study, taken together with the findings of an earlier randomized clinical trial by the same investigators (N. Engl. J. Med. 2012;366:1567-76), conveys a clear message : "Bariatric surgery can induce a significant and sustainable remission of type 2 diabetes and other metabolic risk factors in obese patients and should be considered early in the course of the disease."
Discussant Dr. Walter J. Pories called Dr. Brethauer’s study "a really important contribution." He added that it’s high time for nonsurgeons to get on board.
"One in four adults over age 65 in this country has diabetes. One would have thought our medical colleagues would be ecstatic at the news that an operation on the gut – a safe procedure that can be done in about an hour – could produce full and durable remission of diabetes with complete prevention of amputations, blindness, and kidney failure. But that hasn’t been the case. All we’ve heard are cries for more and more evidence," said Dr. Pories, professor of surgery at East Carolina University, Greenville, N.C.
He added that in his view, Dr. Brethauer and his colleagues set the bar too high in requiring a sustained HbA1c below 6% as the definition of disease cure when the American Diabetes Association uses a figure of 7%. He noted that if the investigators had accepted the ADA metric, their combined cure/partial remission rate would have been considerably greater than the 50% figure they reported.
Dr. Brethauer replied that he and his coinvestigators chose a cutoff of 6% in order to make a point.
"When we raise this issue of ‘cure,’ which is still quite controversial and somewhat provocative, particularly with our endocrinology colleagues, I think we have to find the strictest and most conservative criteria that we can," he explained. "We continue to provide data in support of the concept that this is a surgically treated disease. It’s a major paradigm shift for our endocrinology colleagues to accept. I think it’s going to take a generation of endocrinologists before it’s embraced."
He reported that he serves as a consultant to Ethicon Endosurgery and Apollo Endosurgery.
AT THE ASA ANNUAL MEETING
Major finding: At a median of 6 years after bariatric surgery, 24% of patients have maintained an HbA1c below 6% and fasting blood glucose values below 100 mg/dL for more than 5 years while off all antidiabetic medications.
Data source: This is an ongoing retrospective single-center study in which 217 obese patients with type 2 diabetes have been followed for 5-9 years after bariatric surgery.
Disclosures: This study is sponsored by the Cleveland Clinic. The presenter reported serving as a consultant to Ethicon Endosurgery and Apollo Endosurgery.
Perioperative beta-blockers cut 30-day mortality, cardiac morbidity
For patients at elevated cardiac risk who are undergoing major noncardiac surgery, early perioperative use of beta-blockers is associated with significantly lower 30-day all-cause mortality and cardiac morbidity, according to a report in the April 24 issue of JAMA.
In a retrospective cohort study, this association was strongest in the patients at highest cardiac risk – those with two or more factors on the six-item Cardiac Risk Index, said Dr. Martin J. London of the department of anesthesia and perioperative care, U.S. Department of Veterans Affairs Medical Center, San Francisco, and his associates.
Beta-blocker use in this setting remains controversial, and the use of perioperative beta-blockers has been declining, because of safety concerns. To examine whether high-risk patients are helped or harmed by the treatment, Dr. London and his colleagues analyzed data from the VA Surgical Quality Improvement Program database, a VA pharmacy database, and a VA administrative database.
They assessed the records of 136,745 patients who had vascular, general, neurologic, orthopedic, thoracic, urologic, or otolaryngologic surgery at 104 VA medical centers in 2005-2010.
A total of 40.3% of these subjects had received beta-blockers on the day of or the day after surgery, and 33.2% were given outpatient prescriptions for beta-blockers within 7 days of surgery.
There was a modest but significant decline in beta-blocker use during the 5-year study period, from 43.5% in the first year to 36.2% in the last. A similar national trend has been reported in previous studies. "This may be related to the findings of the POISE trial of increased stroke and death in treated patients, leading to more conservative guideline recommendations within this period," the investigators said.
They performed 1:1 propensity matching and identified 37,805 matched pairs of exposed and nonexposed patients for the primary outcome analysis. The primary outcome measure – all-cause mortality at 30 days – was significantly lower (relative risk 0.73) among patients who used beta-blockers than among those who did not, with a number needed to treat of 241 (JAMA 2013;309:1704-13).
The study subjects were categorized according to their scores on the revised Cardiac Risk Index, which includes six variables: high-risk surgery, cerebrovascular disease, ischemic heart disease, heart failure, diabetes, and renal insufficiency. Patients who had two or more of these CRI risk factors showed the greatest mortality benefit from perioperative beta-blocker therapy, with an relative risk of 0.63.
When the data were broken down by type of surgery, mortality remained significantly lower in beta-blocker users, compared with nonusers for every category except vascular surgery. In previous studies, beta-blockers have shown equivocal benefit in this same subgroup of surgery patients, Dr. London and his associates noted.
The secondary outcome measure of the study was a composite of Q-wave myocardial infarction or nonfatal cardiac arrest at 30 days. These may be rare complications but they are highly predictive of subsequent mortality, the researchers said.
Again, patients who took beta-blockers showed significantly less cardiac morbidity than those who did not, with a relative risk of 0.67 and a number needed to treat of 339.
The study results remained robust in a sensitivity analysis that categorized patients according to whether they had been taking beta-blockers before hospitalization, as well as in a sensitivity analysis that categorized patients as either acute or chronic users of beta-blockers.
This study confirmed the previous finding that withdrawal of beta-blockers within 30 days of surgery is associated with increased mortality. In this study, the risk of death was approximately doubled if beta-blockers were withdrawn perioperatively.
In a post hoc analysis, "we were unable to demonstrate significant associations of perioperative beta-blockade with the risk of postoperative stroke." There was no significant difference in stroke rates between patients who received beta-blockers and those who did not, Dr. London and his colleagues said.
This study was supported by a grant from the Anesthesia Patient Safety Foundation. Dr. London reported no financial conflicts of interest. An associate reported ties to Roche, Resverlogie, Anthera, and Sanofi.
For patients at elevated cardiac risk who are undergoing major noncardiac surgery, early perioperative use of beta-blockers is associated with significantly lower 30-day all-cause mortality and cardiac morbidity, according to a report in the April 24 issue of JAMA.
In a retrospective cohort study, this association was strongest in the patients at highest cardiac risk – those with two or more factors on the six-item Cardiac Risk Index, said Dr. Martin J. London of the department of anesthesia and perioperative care, U.S. Department of Veterans Affairs Medical Center, San Francisco, and his associates.
Beta-blocker use in this setting remains controversial, and the use of perioperative beta-blockers has been declining, because of safety concerns. To examine whether high-risk patients are helped or harmed by the treatment, Dr. London and his colleagues analyzed data from the VA Surgical Quality Improvement Program database, a VA pharmacy database, and a VA administrative database.
They assessed the records of 136,745 patients who had vascular, general, neurologic, orthopedic, thoracic, urologic, or otolaryngologic surgery at 104 VA medical centers in 2005-2010.
A total of 40.3% of these subjects had received beta-blockers on the day of or the day after surgery, and 33.2% were given outpatient prescriptions for beta-blockers within 7 days of surgery.
There was a modest but significant decline in beta-blocker use during the 5-year study period, from 43.5% in the first year to 36.2% in the last. A similar national trend has been reported in previous studies. "This may be related to the findings of the POISE trial of increased stroke and death in treated patients, leading to more conservative guideline recommendations within this period," the investigators said.
They performed 1:1 propensity matching and identified 37,805 matched pairs of exposed and nonexposed patients for the primary outcome analysis. The primary outcome measure – all-cause mortality at 30 days – was significantly lower (relative risk 0.73) among patients who used beta-blockers than among those who did not, with a number needed to treat of 241 (JAMA 2013;309:1704-13).
The study subjects were categorized according to their scores on the revised Cardiac Risk Index, which includes six variables: high-risk surgery, cerebrovascular disease, ischemic heart disease, heart failure, diabetes, and renal insufficiency. Patients who had two or more of these CRI risk factors showed the greatest mortality benefit from perioperative beta-blocker therapy, with an relative risk of 0.63.
When the data were broken down by type of surgery, mortality remained significantly lower in beta-blocker users, compared with nonusers for every category except vascular surgery. In previous studies, beta-blockers have shown equivocal benefit in this same subgroup of surgery patients, Dr. London and his associates noted.
The secondary outcome measure of the study was a composite of Q-wave myocardial infarction or nonfatal cardiac arrest at 30 days. These may be rare complications but they are highly predictive of subsequent mortality, the researchers said.
Again, patients who took beta-blockers showed significantly less cardiac morbidity than those who did not, with a relative risk of 0.67 and a number needed to treat of 339.
The study results remained robust in a sensitivity analysis that categorized patients according to whether they had been taking beta-blockers before hospitalization, as well as in a sensitivity analysis that categorized patients as either acute or chronic users of beta-blockers.
This study confirmed the previous finding that withdrawal of beta-blockers within 30 days of surgery is associated with increased mortality. In this study, the risk of death was approximately doubled if beta-blockers were withdrawn perioperatively.
In a post hoc analysis, "we were unable to demonstrate significant associations of perioperative beta-blockade with the risk of postoperative stroke." There was no significant difference in stroke rates between patients who received beta-blockers and those who did not, Dr. London and his colleagues said.
This study was supported by a grant from the Anesthesia Patient Safety Foundation. Dr. London reported no financial conflicts of interest. An associate reported ties to Roche, Resverlogie, Anthera, and Sanofi.
For patients at elevated cardiac risk who are undergoing major noncardiac surgery, early perioperative use of beta-blockers is associated with significantly lower 30-day all-cause mortality and cardiac morbidity, according to a report in the April 24 issue of JAMA.
In a retrospective cohort study, this association was strongest in the patients at highest cardiac risk – those with two or more factors on the six-item Cardiac Risk Index, said Dr. Martin J. London of the department of anesthesia and perioperative care, U.S. Department of Veterans Affairs Medical Center, San Francisco, and his associates.
Beta-blocker use in this setting remains controversial, and the use of perioperative beta-blockers has been declining, because of safety concerns. To examine whether high-risk patients are helped or harmed by the treatment, Dr. London and his colleagues analyzed data from the VA Surgical Quality Improvement Program database, a VA pharmacy database, and a VA administrative database.
They assessed the records of 136,745 patients who had vascular, general, neurologic, orthopedic, thoracic, urologic, or otolaryngologic surgery at 104 VA medical centers in 2005-2010.
A total of 40.3% of these subjects had received beta-blockers on the day of or the day after surgery, and 33.2% were given outpatient prescriptions for beta-blockers within 7 days of surgery.
There was a modest but significant decline in beta-blocker use during the 5-year study period, from 43.5% in the first year to 36.2% in the last. A similar national trend has been reported in previous studies. "This may be related to the findings of the POISE trial of increased stroke and death in treated patients, leading to more conservative guideline recommendations within this period," the investigators said.
They performed 1:1 propensity matching and identified 37,805 matched pairs of exposed and nonexposed patients for the primary outcome analysis. The primary outcome measure – all-cause mortality at 30 days – was significantly lower (relative risk 0.73) among patients who used beta-blockers than among those who did not, with a number needed to treat of 241 (JAMA 2013;309:1704-13).
The study subjects were categorized according to their scores on the revised Cardiac Risk Index, which includes six variables: high-risk surgery, cerebrovascular disease, ischemic heart disease, heart failure, diabetes, and renal insufficiency. Patients who had two or more of these CRI risk factors showed the greatest mortality benefit from perioperative beta-blocker therapy, with an relative risk of 0.63.
When the data were broken down by type of surgery, mortality remained significantly lower in beta-blocker users, compared with nonusers for every category except vascular surgery. In previous studies, beta-blockers have shown equivocal benefit in this same subgroup of surgery patients, Dr. London and his associates noted.
The secondary outcome measure of the study was a composite of Q-wave myocardial infarction or nonfatal cardiac arrest at 30 days. These may be rare complications but they are highly predictive of subsequent mortality, the researchers said.
Again, patients who took beta-blockers showed significantly less cardiac morbidity than those who did not, with a relative risk of 0.67 and a number needed to treat of 339.
The study results remained robust in a sensitivity analysis that categorized patients according to whether they had been taking beta-blockers before hospitalization, as well as in a sensitivity analysis that categorized patients as either acute or chronic users of beta-blockers.
This study confirmed the previous finding that withdrawal of beta-blockers within 30 days of surgery is associated with increased mortality. In this study, the risk of death was approximately doubled if beta-blockers were withdrawn perioperatively.
In a post hoc analysis, "we were unable to demonstrate significant associations of perioperative beta-blockade with the risk of postoperative stroke." There was no significant difference in stroke rates between patients who received beta-blockers and those who did not, Dr. London and his colleagues said.
This study was supported by a grant from the Anesthesia Patient Safety Foundation. Dr. London reported no financial conflicts of interest. An associate reported ties to Roche, Resverlogie, Anthera, and Sanofi.
FROM JAMA
Major finding: All-cause mortality at 30 days was significantly lower in high-risk patients who received perioperative beta-blockers than in those who did not, with an RR of 0.73.
Data source: A retrospective cohort study involving 136,745 VA patients undergoing noncardiac surgery during a 5-year period.
Disclosures: This study was supported by a grant from the Anesthesia Patient Safety Foundation. Dr. London reported no financial conflicts of interest. An associate reported ties to Roche, Resverlogie, Anthera, and Sanofi.
Reflux after surgery increases risk of esophageal cancer
Patients who experience recurrent reflux despite surgical treatment are three times more likely to develop esophageal adenocarcinoma than are those who have a successful surgery.
The findings of a national database study suggest that careful observation may be key to prevention of cancer when antireflux surgery doesn’t deliver, reported Dr. Hedvig E. Lofdahl and colleagues. The study was published in the April issue of Annals of Surgery.
"From a clinical point of view, this study suggests that it might be valuable to carefully evaluate the result of the antireflux surgery, and consider the patients with recurrent GERD, particularly those with Barrett’s esophagus, for endoscopic surveillance," wrote Dr. Lofdahl of Karolinska Institutet, Stockholm, and his coauthors (Ann. Surg. 2013;257:579-82).
The case-control study drew its data from the Swedish Cancer Register. It comprised 295 patients who underwent antireflux surgery from 1996 to 2006. Fifty-five of the patients developed an adenocarcinoma of the esophagus sometime during the 7-year follow-up period.
Most of the patients in the study were male (87%). Smoking status did not differ significantly between the cases and controls (47% vs.42%, respectively). Recurrent reflux was significantly more common among the cases than among the controls (35% vs. 18%).
The multivariate analysis controlled for body mass index, smoking, and the type of antireflux surgery. In the final adjusted model, recurrent reflux conferred a threefold increase in the risk of a later esophageal adenocarcinoma. A BMI of more than 25 kg/m2 also increased the risk, but not significantly (odds ratio [OR] 1.6; confidence interval [CI]: 0.8-3.5). There were not enough patients with a BMI of greater than 30 kg/m2 to further tease out the effect of weight.
Having ever smoked tobacco also increased the risk of esophageal cancer, but again, the increase was not statistically significant (OR 1.4; CI: 0.7-2.8).
Compared with a partial fundoplication, a total 360-degree fundoplication was associated with a lower risk of cancer, but the difference was not statistically significant (OR 0.6; CI: 0.3-1.3).
"This finding might at least partly explain the lack of cancer-preventive effect of antireflux surgery," the investigators wrote.
The study was supported by the Swedish Research Council, the Swedish Cancer Society, and the Stockholm Cancer Society. None of the authors had financial disclosures.
Patients who experience recurrent reflux despite surgical treatment are three times more likely to develop esophageal adenocarcinoma than are those who have a successful surgery.
The findings of a national database study suggest that careful observation may be key to prevention of cancer when antireflux surgery doesn’t deliver, reported Dr. Hedvig E. Lofdahl and colleagues. The study was published in the April issue of Annals of Surgery.
"From a clinical point of view, this study suggests that it might be valuable to carefully evaluate the result of the antireflux surgery, and consider the patients with recurrent GERD, particularly those with Barrett’s esophagus, for endoscopic surveillance," wrote Dr. Lofdahl of Karolinska Institutet, Stockholm, and his coauthors (Ann. Surg. 2013;257:579-82).
The case-control study drew its data from the Swedish Cancer Register. It comprised 295 patients who underwent antireflux surgery from 1996 to 2006. Fifty-five of the patients developed an adenocarcinoma of the esophagus sometime during the 7-year follow-up period.
Most of the patients in the study were male (87%). Smoking status did not differ significantly between the cases and controls (47% vs.42%, respectively). Recurrent reflux was significantly more common among the cases than among the controls (35% vs. 18%).
The multivariate analysis controlled for body mass index, smoking, and the type of antireflux surgery. In the final adjusted model, recurrent reflux conferred a threefold increase in the risk of a later esophageal adenocarcinoma. A BMI of more than 25 kg/m2 also increased the risk, but not significantly (odds ratio [OR] 1.6; confidence interval [CI]: 0.8-3.5). There were not enough patients with a BMI of greater than 30 kg/m2 to further tease out the effect of weight.
Having ever smoked tobacco also increased the risk of esophageal cancer, but again, the increase was not statistically significant (OR 1.4; CI: 0.7-2.8).
Compared with a partial fundoplication, a total 360-degree fundoplication was associated with a lower risk of cancer, but the difference was not statistically significant (OR 0.6; CI: 0.3-1.3).
"This finding might at least partly explain the lack of cancer-preventive effect of antireflux surgery," the investigators wrote.
The study was supported by the Swedish Research Council, the Swedish Cancer Society, and the Stockholm Cancer Society. None of the authors had financial disclosures.
Patients who experience recurrent reflux despite surgical treatment are three times more likely to develop esophageal adenocarcinoma than are those who have a successful surgery.
The findings of a national database study suggest that careful observation may be key to prevention of cancer when antireflux surgery doesn’t deliver, reported Dr. Hedvig E. Lofdahl and colleagues. The study was published in the April issue of Annals of Surgery.
"From a clinical point of view, this study suggests that it might be valuable to carefully evaluate the result of the antireflux surgery, and consider the patients with recurrent GERD, particularly those with Barrett’s esophagus, for endoscopic surveillance," wrote Dr. Lofdahl of Karolinska Institutet, Stockholm, and his coauthors (Ann. Surg. 2013;257:579-82).
The case-control study drew its data from the Swedish Cancer Register. It comprised 295 patients who underwent antireflux surgery from 1996 to 2006. Fifty-five of the patients developed an adenocarcinoma of the esophagus sometime during the 7-year follow-up period.
Most of the patients in the study were male (87%). Smoking status did not differ significantly between the cases and controls (47% vs.42%, respectively). Recurrent reflux was significantly more common among the cases than among the controls (35% vs. 18%).
The multivariate analysis controlled for body mass index, smoking, and the type of antireflux surgery. In the final adjusted model, recurrent reflux conferred a threefold increase in the risk of a later esophageal adenocarcinoma. A BMI of more than 25 kg/m2 also increased the risk, but not significantly (odds ratio [OR] 1.6; confidence interval [CI]: 0.8-3.5). There were not enough patients with a BMI of greater than 30 kg/m2 to further tease out the effect of weight.
Having ever smoked tobacco also increased the risk of esophageal cancer, but again, the increase was not statistically significant (OR 1.4; CI: 0.7-2.8).
Compared with a partial fundoplication, a total 360-degree fundoplication was associated with a lower risk of cancer, but the difference was not statistically significant (OR 0.6; CI: 0.3-1.3).
"This finding might at least partly explain the lack of cancer-preventive effect of antireflux surgery," the investigators wrote.
The study was supported by the Swedish Research Council, the Swedish Cancer Society, and the Stockholm Cancer Society. None of the authors had financial disclosures.
FROM ANNALS OF SURGERY
Major finding: Patients with recurrent reflux after surgical treatment are three times more likely to develop an esophageal adenocarcinoma than are those whose symptoms resolve after surgery,
Data source: The case-control study comprised 295 patients included in a national cancer registry.
Disclosures: The study was supported by the Swedish Research Council, the Swedish Cancer Society, and the Stockholm Cancer Society. None of the authors had financial disclosures.
Antibiotics after damage control laparotomy up infection risk
LAS VEGAS – Trauma patients should not get antibiotics after damage control or primarily closed laparotomies because this treatment may increase the risk of postsurgical intra-abdominal infections, according to a study from Virginia Commonwealth University, Richmond, a Level 1 trauma center.
The abdomen is often left open for a while after a damage control laparotomy (DCL), especially when patients are coagulopathic, acidotic, or at risk for an abdominal compartment syndrome. In those cases, "people just automatically assume ‘Open abdomen: Throw on the antibiotics.’ What we are showing here is don’t throw on the antibiotics," said lead investigator Dr. Stephanie Goldberg of the trauma, critical care, and emergency surgery faculty at VCU. The worry is probably the same for primarily closed (PC) laparotomies, when the fascia is closed but skin is sometimes left open.
The findings are important because although – and as the team found – preoperative antibiotics are known to reduce the risk of postsurgical abdominal infections, there’s not much evidence in either direction for their use after trauma laparotomies, so "no one knows what to do." Some surgeons opt for antibiotics, others don’t, Dr. Goldberg said.
To help figure out the right approach, her team analyzed perioperative antibiotic use and infection rates in 28 DCL patients whose abdomens were left open, and 93 PC patients. The PC group had a mean injury severity score of 18; 35.5% (33) had bowel injuries. The DCL group was in worse shape, with a mean severity score of 31.4 and bowel injuries in 53.6% (15).
Everyone should have been dosed with an antibiotic before surgery; 94.6% (88) PC patients, but only 69.2% (19) DCL patients, actually were. "It’s likely," in the DCL cases especially, "that patients were so sick and there was so much chaos in the operating room that giving pre-op antibiotics got missed," Dr. Goldberg said.
Postop antibiotic use differed significantly between the groups; 50.5% (47) of PC patients got no antibiotics, 21.5% (20) got a day’s worth, and 28% (26) were treated for more than a day. In the DCL group, 21.4% (6) got no antibiotics, 25.0% (7) a 1-day course, and 53.6% (15) more than a 1-day course.
As expected, preop antibiotics protected against intra-abdominal infections (odds ratio, 0.20; 95% confidence interval 0.05-0.91; P = .037). Postoperative antibiotics, however, substantially increased the risk (OR, 6.7; 95% CI 1.33 – 33.8; P= .044).
The longer patients were on antibiotics, the greater that risk became. Among the 6 DCL patients who received no postsurgical antibiotics, 16.7% (1) developed an intra-abdominal infection. Among the 7 treated for a day, 28.6% (2) developed an intra-abdominal infection; 40% (6) did so among the 15 treated for more than a day. The trend was similar for PC patients, although the overall infection rates were lower.
Antimicrobial resistance could be to blame. As normal flora were wiped out, maybe the field was cleared for "bugs to cause problems that otherwise would not have," explained senior investigator Dr. Thèrese Duane of the department of surgery at VCU. Surgeons there tend to favor Zosyn or Cefoxitin.
The project was just the first step toward building a robust evidence base about antibiotic use after trauma laparotomies. Next on the team’s agenda is a multicenter, prospective trial.
"We need more numbers," Dr. Duane said.
Dr. Goldberg has no relevant disclosures. Dr. Duane speaks for Pfizer on behalf of its antibiotic, linezolid.
Antibiotics after damage-control laparotomy up the infection risk. This study by Dr. Goldberg and her colleagues highlights areas for process improvement with antibiotic prophylaxis to prevent organ space surgical site infection (SSI) in trauma patients undergoing damage control or primarily closed laparotomies. Preoperative antibiotic prophylaxis has been consistently demonstrated across meta-analyses of randomized trials to be effective in preventing SSIs regardless of the type of surgery; this study supports similar benefits in trauma laparotomy patients. Furthermore, given that only 69% of DCL patients received preoperative antibiotics, there was significant room for improvement.
Antibiotic stewardship has also been at the forefront of recent efforts to improve perioperative care. Level I evidence exists for not continuing postoperative antibiotics beyond 24 hours in patients undergoing trauma laparotomies for penetrating injuries. Although less well studied, there is no evidence to suggest that antibiotic prophylaxis practices after laparotomy for blunt injuries or for damage control should differ. Further studies are necessary to determine optimal methods for delivering appropriate preoperative antibiotic prophylaxis and to identify additional perioperative strategies to reduce superficial, deep, and organ space SSIs in these high-risk patients.
Dr. Lillian S. Kao is in the department of surgery at the University of Texas Health Science Center at Houston. Dr. Kao has no conflict of interest disclosures.
Antibiotics after damage-control laparotomy up the infection risk. This study by Dr. Goldberg and her colleagues highlights areas for process improvement with antibiotic prophylaxis to prevent organ space surgical site infection (SSI) in trauma patients undergoing damage control or primarily closed laparotomies. Preoperative antibiotic prophylaxis has been consistently demonstrated across meta-analyses of randomized trials to be effective in preventing SSIs regardless of the type of surgery; this study supports similar benefits in trauma laparotomy patients. Furthermore, given that only 69% of DCL patients received preoperative antibiotics, there was significant room for improvement.
Antibiotic stewardship has also been at the forefront of recent efforts to improve perioperative care. Level I evidence exists for not continuing postoperative antibiotics beyond 24 hours in patients undergoing trauma laparotomies for penetrating injuries. Although less well studied, there is no evidence to suggest that antibiotic prophylaxis practices after laparotomy for blunt injuries or for damage control should differ. Further studies are necessary to determine optimal methods for delivering appropriate preoperative antibiotic prophylaxis and to identify additional perioperative strategies to reduce superficial, deep, and organ space SSIs in these high-risk patients.
Dr. Lillian S. Kao is in the department of surgery at the University of Texas Health Science Center at Houston. Dr. Kao has no conflict of interest disclosures.
Antibiotics after damage-control laparotomy up the infection risk. This study by Dr. Goldberg and her colleagues highlights areas for process improvement with antibiotic prophylaxis to prevent organ space surgical site infection (SSI) in trauma patients undergoing damage control or primarily closed laparotomies. Preoperative antibiotic prophylaxis has been consistently demonstrated across meta-analyses of randomized trials to be effective in preventing SSIs regardless of the type of surgery; this study supports similar benefits in trauma laparotomy patients. Furthermore, given that only 69% of DCL patients received preoperative antibiotics, there was significant room for improvement.
Antibiotic stewardship has also been at the forefront of recent efforts to improve perioperative care. Level I evidence exists for not continuing postoperative antibiotics beyond 24 hours in patients undergoing trauma laparotomies for penetrating injuries. Although less well studied, there is no evidence to suggest that antibiotic prophylaxis practices after laparotomy for blunt injuries or for damage control should differ. Further studies are necessary to determine optimal methods for delivering appropriate preoperative antibiotic prophylaxis and to identify additional perioperative strategies to reduce superficial, deep, and organ space SSIs in these high-risk patients.
Dr. Lillian S. Kao is in the department of surgery at the University of Texas Health Science Center at Houston. Dr. Kao has no conflict of interest disclosures.
LAS VEGAS – Trauma patients should not get antibiotics after damage control or primarily closed laparotomies because this treatment may increase the risk of postsurgical intra-abdominal infections, according to a study from Virginia Commonwealth University, Richmond, a Level 1 trauma center.
The abdomen is often left open for a while after a damage control laparotomy (DCL), especially when patients are coagulopathic, acidotic, or at risk for an abdominal compartment syndrome. In those cases, "people just automatically assume ‘Open abdomen: Throw on the antibiotics.’ What we are showing here is don’t throw on the antibiotics," said lead investigator Dr. Stephanie Goldberg of the trauma, critical care, and emergency surgery faculty at VCU. The worry is probably the same for primarily closed (PC) laparotomies, when the fascia is closed but skin is sometimes left open.
The findings are important because although – and as the team found – preoperative antibiotics are known to reduce the risk of postsurgical abdominal infections, there’s not much evidence in either direction for their use after trauma laparotomies, so "no one knows what to do." Some surgeons opt for antibiotics, others don’t, Dr. Goldberg said.
To help figure out the right approach, her team analyzed perioperative antibiotic use and infection rates in 28 DCL patients whose abdomens were left open, and 93 PC patients. The PC group had a mean injury severity score of 18; 35.5% (33) had bowel injuries. The DCL group was in worse shape, with a mean severity score of 31.4 and bowel injuries in 53.6% (15).
Everyone should have been dosed with an antibiotic before surgery; 94.6% (88) PC patients, but only 69.2% (19) DCL patients, actually were. "It’s likely," in the DCL cases especially, "that patients were so sick and there was so much chaos in the operating room that giving pre-op antibiotics got missed," Dr. Goldberg said.
Postop antibiotic use differed significantly between the groups; 50.5% (47) of PC patients got no antibiotics, 21.5% (20) got a day’s worth, and 28% (26) were treated for more than a day. In the DCL group, 21.4% (6) got no antibiotics, 25.0% (7) a 1-day course, and 53.6% (15) more than a 1-day course.
As expected, preop antibiotics protected against intra-abdominal infections (odds ratio, 0.20; 95% confidence interval 0.05-0.91; P = .037). Postoperative antibiotics, however, substantially increased the risk (OR, 6.7; 95% CI 1.33 – 33.8; P= .044).
The longer patients were on antibiotics, the greater that risk became. Among the 6 DCL patients who received no postsurgical antibiotics, 16.7% (1) developed an intra-abdominal infection. Among the 7 treated for a day, 28.6% (2) developed an intra-abdominal infection; 40% (6) did so among the 15 treated for more than a day. The trend was similar for PC patients, although the overall infection rates were lower.
Antimicrobial resistance could be to blame. As normal flora were wiped out, maybe the field was cleared for "bugs to cause problems that otherwise would not have," explained senior investigator Dr. Thèrese Duane of the department of surgery at VCU. Surgeons there tend to favor Zosyn or Cefoxitin.
The project was just the first step toward building a robust evidence base about antibiotic use after trauma laparotomies. Next on the team’s agenda is a multicenter, prospective trial.
"We need more numbers," Dr. Duane said.
Dr. Goldberg has no relevant disclosures. Dr. Duane speaks for Pfizer on behalf of its antibiotic, linezolid.
LAS VEGAS – Trauma patients should not get antibiotics after damage control or primarily closed laparotomies because this treatment may increase the risk of postsurgical intra-abdominal infections, according to a study from Virginia Commonwealth University, Richmond, a Level 1 trauma center.
The abdomen is often left open for a while after a damage control laparotomy (DCL), especially when patients are coagulopathic, acidotic, or at risk for an abdominal compartment syndrome. In those cases, "people just automatically assume ‘Open abdomen: Throw on the antibiotics.’ What we are showing here is don’t throw on the antibiotics," said lead investigator Dr. Stephanie Goldberg of the trauma, critical care, and emergency surgery faculty at VCU. The worry is probably the same for primarily closed (PC) laparotomies, when the fascia is closed but skin is sometimes left open.
The findings are important because although – and as the team found – preoperative antibiotics are known to reduce the risk of postsurgical abdominal infections, there’s not much evidence in either direction for their use after trauma laparotomies, so "no one knows what to do." Some surgeons opt for antibiotics, others don’t, Dr. Goldberg said.
To help figure out the right approach, her team analyzed perioperative antibiotic use and infection rates in 28 DCL patients whose abdomens were left open, and 93 PC patients. The PC group had a mean injury severity score of 18; 35.5% (33) had bowel injuries. The DCL group was in worse shape, with a mean severity score of 31.4 and bowel injuries in 53.6% (15).
Everyone should have been dosed with an antibiotic before surgery; 94.6% (88) PC patients, but only 69.2% (19) DCL patients, actually were. "It’s likely," in the DCL cases especially, "that patients were so sick and there was so much chaos in the operating room that giving pre-op antibiotics got missed," Dr. Goldberg said.
Postop antibiotic use differed significantly between the groups; 50.5% (47) of PC patients got no antibiotics, 21.5% (20) got a day’s worth, and 28% (26) were treated for more than a day. In the DCL group, 21.4% (6) got no antibiotics, 25.0% (7) a 1-day course, and 53.6% (15) more than a 1-day course.
As expected, preop antibiotics protected against intra-abdominal infections (odds ratio, 0.20; 95% confidence interval 0.05-0.91; P = .037). Postoperative antibiotics, however, substantially increased the risk (OR, 6.7; 95% CI 1.33 – 33.8; P= .044).
The longer patients were on antibiotics, the greater that risk became. Among the 6 DCL patients who received no postsurgical antibiotics, 16.7% (1) developed an intra-abdominal infection. Among the 7 treated for a day, 28.6% (2) developed an intra-abdominal infection; 40% (6) did so among the 15 treated for more than a day. The trend was similar for PC patients, although the overall infection rates were lower.
Antimicrobial resistance could be to blame. As normal flora were wiped out, maybe the field was cleared for "bugs to cause problems that otherwise would not have," explained senior investigator Dr. Thèrese Duane of the department of surgery at VCU. Surgeons there tend to favor Zosyn or Cefoxitin.
The project was just the first step toward building a robust evidence base about antibiotic use after trauma laparotomies. Next on the team’s agenda is a multicenter, prospective trial.
"We need more numbers," Dr. Duane said.
Dr. Goldberg has no relevant disclosures. Dr. Duane speaks for Pfizer on behalf of its antibiotic, linezolid.
AT THE ANNUAL MEETING OF THE SURGICAL INFECTION SOCIETY
Major finding: Patients who were given antibiotics after trauma laparotomies are six times more likely to develop an intra-abdominal infection than were those who are not (OR, 6.7; 95% CI 1.33-33.8; P = .044).
Data Source: Retrospective review of 121 trauma laparotomies
Disclosures: The lead investigator has no relevant disclosures. The senior investigator speaks for Pfizer on behalf of its antibiotic, linezolid.
FDA backs abuse-deterring OxyContin, thwarts generics
In an eleventh-hour action that derailed the possibility of generic formulations of controlled-release oxycodone (OxyContin) from appearing on the U.S. market anytime soon, the Food and Drug Administration announced April 16 that it withdrew its approval of the original, conventional formulation of OxyContin.
Acting on the very day that the patent on the original formulation of OxyContin, held by Purdue Pharma, was set to expire, the FDA took an additional step to support the newer formulation of OxyContin that Purdue has marketed exclusively since August 2010. The newer version includes a polymer so that, when a pill is crushed and then mixed with water it turns into a gel rather than remaining a more easily manipulated powder. The FDA approved updated labeling for OxyContin that highlights the abuse-deterring features of the newer formulation, which means that Purdue can now cite these attributes when marketing the drug.
The FDA "approved labeling for reformulated OxyContin stating that it possesses physiochemical properties that are expected to: (1) make abuse via injection difficult, and (2) reduce abuse via the intranasal route. This is the first opioid product for which FDA has approved labeling that includes statements regarding abuse-deterrence," according to a letter from FDA Commissioner Margaret A. Hamburg sent April 16 to Rep. Fred Upton (R-Mich.) and Sen. Tom Coburn (R-Okla).
"We applaud FDA Commissioner Hamburg’s announcement that the FDA will not approve any abbreviated new drug applications that rely upon the approval of original OxyContin which did not have abuse-deterrent properties," the lawmakers said in a statement. "With more than 16,000 Americans dying from opioid drug overdoses each year, Commissioner Hamburg’s announcement is a significant step forward in the federal government’s effort to reduce opioid drug abuse and protect consumers. For too long, drug abusers have been able to crush or dissolve opioid drug products in order to defeat their time-release mechanisms for snorting or injecting the drugs."
For patients, the major downside of the FDA’s action is economic. OxyContin retails for about $7.50 per tablet and had roughly $2.7 billion in U.S. sales in 2012. The patent on the abuse-deterring formulation of the drug lasts until 2025.
On Twitter @mitchelzoler
In an eleventh-hour action that derailed the possibility of generic formulations of controlled-release oxycodone (OxyContin) from appearing on the U.S. market anytime soon, the Food and Drug Administration announced April 16 that it withdrew its approval of the original, conventional formulation of OxyContin.
Acting on the very day that the patent on the original formulation of OxyContin, held by Purdue Pharma, was set to expire, the FDA took an additional step to support the newer formulation of OxyContin that Purdue has marketed exclusively since August 2010. The newer version includes a polymer so that, when a pill is crushed and then mixed with water it turns into a gel rather than remaining a more easily manipulated powder. The FDA approved updated labeling for OxyContin that highlights the abuse-deterring features of the newer formulation, which means that Purdue can now cite these attributes when marketing the drug.
The FDA "approved labeling for reformulated OxyContin stating that it possesses physiochemical properties that are expected to: (1) make abuse via injection difficult, and (2) reduce abuse via the intranasal route. This is the first opioid product for which FDA has approved labeling that includes statements regarding abuse-deterrence," according to a letter from FDA Commissioner Margaret A. Hamburg sent April 16 to Rep. Fred Upton (R-Mich.) and Sen. Tom Coburn (R-Okla).
"We applaud FDA Commissioner Hamburg’s announcement that the FDA will not approve any abbreviated new drug applications that rely upon the approval of original OxyContin which did not have abuse-deterrent properties," the lawmakers said in a statement. "With more than 16,000 Americans dying from opioid drug overdoses each year, Commissioner Hamburg’s announcement is a significant step forward in the federal government’s effort to reduce opioid drug abuse and protect consumers. For too long, drug abusers have been able to crush or dissolve opioid drug products in order to defeat their time-release mechanisms for snorting or injecting the drugs."
For patients, the major downside of the FDA’s action is economic. OxyContin retails for about $7.50 per tablet and had roughly $2.7 billion in U.S. sales in 2012. The patent on the abuse-deterring formulation of the drug lasts until 2025.
On Twitter @mitchelzoler
In an eleventh-hour action that derailed the possibility of generic formulations of controlled-release oxycodone (OxyContin) from appearing on the U.S. market anytime soon, the Food and Drug Administration announced April 16 that it withdrew its approval of the original, conventional formulation of OxyContin.
Acting on the very day that the patent on the original formulation of OxyContin, held by Purdue Pharma, was set to expire, the FDA took an additional step to support the newer formulation of OxyContin that Purdue has marketed exclusively since August 2010. The newer version includes a polymer so that, when a pill is crushed and then mixed with water it turns into a gel rather than remaining a more easily manipulated powder. The FDA approved updated labeling for OxyContin that highlights the abuse-deterring features of the newer formulation, which means that Purdue can now cite these attributes when marketing the drug.
The FDA "approved labeling for reformulated OxyContin stating that it possesses physiochemical properties that are expected to: (1) make abuse via injection difficult, and (2) reduce abuse via the intranasal route. This is the first opioid product for which FDA has approved labeling that includes statements regarding abuse-deterrence," according to a letter from FDA Commissioner Margaret A. Hamburg sent April 16 to Rep. Fred Upton (R-Mich.) and Sen. Tom Coburn (R-Okla).
"We applaud FDA Commissioner Hamburg’s announcement that the FDA will not approve any abbreviated new drug applications that rely upon the approval of original OxyContin which did not have abuse-deterrent properties," the lawmakers said in a statement. "With more than 16,000 Americans dying from opioid drug overdoses each year, Commissioner Hamburg’s announcement is a significant step forward in the federal government’s effort to reduce opioid drug abuse and protect consumers. For too long, drug abusers have been able to crush or dissolve opioid drug products in order to defeat their time-release mechanisms for snorting or injecting the drugs."
For patients, the major downside of the FDA’s action is economic. OxyContin retails for about $7.50 per tablet and had roughly $2.7 billion in U.S. sales in 2012. The patent on the abuse-deterring formulation of the drug lasts until 2025.
On Twitter @mitchelzoler
