ASA Annual Meeting

BOSTON – Resident participation in emergency general surgery cases was independently associated with a host of complications – pulmonary embolism, surgical site infections, and unplanned reoperation in a secondary analysis of the American College of Surgeons prospective National Surgical Quality Improvement database.

Adequate exposure of residents to emergency general surgery is crucial for surgical training, but academic operating teams should be mindful of this association, Dr. George Kasotakis said at the annual meeting of the American Surgical Association.

Patrice Wendling/Frontline Medical News

Three recent papers have shown resident participation modestly increases complications in elective surgery, but their impact is not well understood for emergency general surgery, where patient physiology is typically deranged and timely surgery is imperative.

To examine this, Dr. Kasotakis and his colleagues at Boston University identified 141,010 patients who underwent emergency general surgery procedures in the 2005-2010 American College of Surgeons prospective National Surgical Quality Improvement database. Due to the nonrandom assignment of more complex cases to resident participation, patients were matched 1:1 based on age; gender; use of alcohol, tobacco, and steroids; inpatient status; obesity; diabetes; renal failure; cardiopulmonary disease; and expected probability for morbidity and mortality. Regression models were fitted for each outcome and adjusted for the same risk factors and operative time.

The most common procedures in the matched cohort were appendectomy (40%), exploratory laparotomy (8.75%), bowel resection (9.2%), cholecystectomy (6%), and lysis of adhesions (6%).

Thirty-day mortality was similar with and without residents (3.25% vs. 2.96%; P = .082), but hospital length of stay was longer by about a half a day with residents (4.97 days vs. 4.59 days; P = .019), said Dr. Kasotakis, an acute care surgeon and intensivist.

More importantly, resident participation added about 20 minutes to operative (75 minutes vs. 59 minutes; P less than .001) and anesthesia times (122 minutes vs. 100 minutes; P less than .001).

Intraoperative transfusions were more common with residents (3.43% vs. 2.55%; P less than .001), perhaps because of longer operating room times, and, as a result, fewer postoperative transfusions were needed (1.12% vs. 1.28% P = .031), he said. Unplanned reoperations, however, were more common with residents, as well (4.22% vs. 3.80%; P = .002).

Postsurgical superficial wound infections (3.5% vs. 2.78%; P less than .001) and organ space surgical site infections (2.27% vs. 1.77%; P less than .001) were more common in the resident group, while wound dehiscence was not (0.63% vs. 0.69%; P = .266), Dr. Kasotakis noted.

Pulmonary complications were significantly more common in the resident group including postoperative pneumonia (1.85% vs. 1.67%; P = .04), reintubation (1.64% vs. 1.15%; P less than .001), and mechanical ventilation for more than 48 hours (2.87% vs. 2.06%; P less than .001).

The same was true for deep vein thrombosis (DVT) (0.80% vs. 0.62%; P = .002) and pulmonary embolism (PE) (0.43% vs. 0.28%; P less than .001).

Urinary tract infections (UTI) were higher with resident participation (1.45% vs. 1.14%; P less than .001), as was sepsis (2.42% vs. 2.13%; P = .005), likely because of the increase in surgical infections, Dr. Kasotakis said.

Thankfully, significant cardiac complications and septic shock were not more common with residents, he said.

Adjusted analyses

After adjusting for operative duration, case complexity and pre-existing comorbidities, residents did not increase length of stay (odds ratio, 0.07; P = .242) or septic events (OR, 1.07; P = .155), but their participation was still independently associated with about 20% more superficial surgical site infections (odds ratio, 1.23; P less than .001), organ space infections (OR, 1.21; P less than .001), UTIs (OR, 1.23; P = .001), and intraoperative transfusions (OR, 1.20; P = .001), he said.

Also, about 8% more patients required a return trip to the operating room when residents participated (OR, 1.08; P = .041).

"These outcomes can perhaps be attributed to their underdeveloped surgical skills," Dr. Kasotakis said.

The incidence of DVT and PE were also higher by about 25% (OR, 1.25; P = .011) and 40% (OR, 1.42; P = .005), respectively, perhaps because of delayed DVT prophylaxis initiation because of concerns of hemostasis or missed doses due to additional return trips to the emergency department, he suggested.

Interestingly, reintubation and prolonged mechanical ventilation rates were increased by about 40% (OR, 1.38; OR, 1.43; both P less than .001), perhaps due to prolonged operative times or greater resuscitation requirements, he added.

Dr. Kasotakis was quick to point out that this was a secondary analysis of a data set not originally intended to assess the effect of trainee participation, that no information was available on the degree of resident involvement during surgery or in perioperative care, and that participating institutions were skewed toward tertiary centers, which typically receive more complex cases.

"Staff surgeons should supervise as needed and minimize unnecessary [emergency department] time. And residents, for their part, should be well prepared for emergency procedures through simulation training and aim to maximize their operating room efficiency," he suggested.

The results sparked a flurry of rebuttals led off by discussant Dr. Julie Ann Sosa, chief of endocrine surgery and director of health sciences research at Duke University, Durham, N.C., who said they conflict with other analyses showing little to no impact from residents in elective cases.

"If not interpreted with care, policy makers, payers, and the public could construe that surgical care at academic health centers is compromised by trainees, which could have unfortunate ramifications for everyone in the room as well as the trainees and the patients," she said.

Dr. Sosa expressed concern about drawing causal inferences from an observational study in the setting of possible selection bias and said attempts to match for case complexity using CPT codes do not necessarily account for say, "the difference between a routine appendectomy that takes 15 to 30 minutes and a complex one that takes 3 hours for a perforation."

Some attendees questioned why the authors didn’t match the institutions in the analysis and chose to ascribe all of the outcomes to residents, with a round of applause following the suggestion that the paper should be entitled Academic centers increase emergency surgery complications. Other attendees questioned whether the poor outcomes are a reflection of resident training and supervision.

Finally, Dr. George Velmahos, chief of trauma, emergency surgery, and surgical critical care, Massachusetts General Hospital, Boston, questioned whether, based on these findings, hospitals have a responsibility from a medical/legal standpoint to inform emergency surgery patients that a resident is in the operating room and may impact outcomes.

Dr. Kasotakis responded that institutions may want to add a clause to consent paperwork stating that residents and trainees will be participating in the case.

The complete manuscript of this study and its presentation at the American Surgical Association’s 134^th Annual Meeting, April 2014, in Boston, is anticipated to be published in the Annals of Surgery, pending editorial review.

Dr. Kasotakis and his coauthors reported no conflicting interests.

pwendling@frontlinemedcom.com

BOSTON – Resident participation in emergency general surgery cases was independently associated with a host of complications – pulmonary embolism, surgical site infections, and unplanned reoperation in a secondary analysis of the American College of Surgeons prospective National Surgical Quality Improvement database.

Adequate exposure of residents to emergency general surgery is crucial for surgical training, but academic operating teams should be mindful of this association, Dr. George Kasotakis said at the annual meeting of the American Surgical Association.

Patrice Wendling/Frontline Medical News

Three recent papers have shown resident participation modestly increases complications in elective surgery, but their impact is not well understood for emergency general surgery, where patient physiology is typically deranged and timely surgery is imperative.

To examine this, Dr. Kasotakis and his colleagues at Boston University identified 141,010 patients who underwent emergency general surgery procedures in the 2005-2010 American College of Surgeons prospective National Surgical Quality Improvement database. Due to the nonrandom assignment of more complex cases to resident participation, patients were matched 1:1 based on age; gender; use of alcohol, tobacco, and steroids; inpatient status; obesity; diabetes; renal failure; cardiopulmonary disease; and expected probability for morbidity and mortality. Regression models were fitted for each outcome and adjusted for the same risk factors and operative time.

The most common procedures in the matched cohort were appendectomy (40%), exploratory laparotomy (8.75%), bowel resection (9.2%), cholecystectomy (6%), and lysis of adhesions (6%).

Thirty-day mortality was similar with and without residents (3.25% vs. 2.96%; P = .082), but hospital length of stay was longer by about a half a day with residents (4.97 days vs. 4.59 days; P = .019), said Dr. Kasotakis, an acute care surgeon and intensivist.

More importantly, resident participation added about 20 minutes to operative (75 minutes vs. 59 minutes; P less than .001) and anesthesia times (122 minutes vs. 100 minutes; P less than .001).

Intraoperative transfusions were more common with residents (3.43% vs. 2.55%; P less than .001), perhaps because of longer operating room times, and, as a result, fewer postoperative transfusions were needed (1.12% vs. 1.28% P = .031), he said. Unplanned reoperations, however, were more common with residents, as well (4.22% vs. 3.80%; P = .002).

Postsurgical superficial wound infections (3.5% vs. 2.78%; P less than .001) and organ space surgical site infections (2.27% vs. 1.77%; P less than .001) were more common in the resident group, while wound dehiscence was not (0.63% vs. 0.69%; P = .266), Dr. Kasotakis noted.

Pulmonary complications were significantly more common in the resident group including postoperative pneumonia (1.85% vs. 1.67%; P = .04), reintubation (1.64% vs. 1.15%; P less than .001), and mechanical ventilation for more than 48 hours (2.87% vs. 2.06%; P less than .001).

The same was true for deep vein thrombosis (DVT) (0.80% vs. 0.62%; P = .002) and pulmonary embolism (PE) (0.43% vs. 0.28%; P less than .001).

Urinary tract infections (UTI) were higher with resident participation (1.45% vs. 1.14%; P less than .001), as was sepsis (2.42% vs. 2.13%; P = .005), likely because of the increase in surgical infections, Dr. Kasotakis said.

Thankfully, significant cardiac complications and septic shock were not more common with residents, he said.

Adjusted analyses

After adjusting for operative duration, case complexity and pre-existing comorbidities, residents did not increase length of stay (odds ratio, 0.07; P = .242) or septic events (OR, 1.07; P = .155), but their participation was still independently associated with about 20% more superficial surgical site infections (odds ratio, 1.23; P less than .001), organ space infections (OR, 1.21; P less than .001), UTIs (OR, 1.23; P = .001), and intraoperative transfusions (OR, 1.20; P = .001), he said.

Also, about 8% more patients required a return trip to the operating room when residents participated (OR, 1.08; P = .041).

"These outcomes can perhaps be attributed to their underdeveloped surgical skills," Dr. Kasotakis said.

The incidence of DVT and PE were also higher by about 25% (OR, 1.25; P = .011) and 40% (OR, 1.42; P = .005), respectively, perhaps because of delayed DVT prophylaxis initiation because of concerns of hemostasis or missed doses due to additional return trips to the emergency department, he suggested.

Interestingly, reintubation and prolonged mechanical ventilation rates were increased by about 40% (OR, 1.38; OR, 1.43; both P less than .001), perhaps due to prolonged operative times or greater resuscitation requirements, he added.

Dr. Kasotakis was quick to point out that this was a secondary analysis of a data set not originally intended to assess the effect of trainee participation, that no information was available on the degree of resident involvement during surgery or in perioperative care, and that participating institutions were skewed toward tertiary centers, which typically receive more complex cases.

"Staff surgeons should supervise as needed and minimize unnecessary [emergency department] time. And residents, for their part, should be well prepared for emergency procedures through simulation training and aim to maximize their operating room efficiency," he suggested.

The results sparked a flurry of rebuttals led off by discussant Dr. Julie Ann Sosa, chief of endocrine surgery and director of health sciences research at Duke University, Durham, N.C., who said they conflict with other analyses showing little to no impact from residents in elective cases.

"If not interpreted with care, policy makers, payers, and the public could construe that surgical care at academic health centers is compromised by trainees, which could have unfortunate ramifications for everyone in the room as well as the trainees and the patients," she said.

Dr. Sosa expressed concern about drawing causal inferences from an observational study in the setting of possible selection bias and said attempts to match for case complexity using CPT codes do not necessarily account for say, "the difference between a routine appendectomy that takes 15 to 30 minutes and a complex one that takes 3 hours for a perforation."

Some attendees questioned why the authors didn’t match the institutions in the analysis and chose to ascribe all of the outcomes to residents, with a round of applause following the suggestion that the paper should be entitled Academic centers increase emergency surgery complications. Other attendees questioned whether the poor outcomes are a reflection of resident training and supervision.

Finally, Dr. George Velmahos, chief of trauma, emergency surgery, and surgical critical care, Massachusetts General Hospital, Boston, questioned whether, based on these findings, hospitals have a responsibility from a medical/legal standpoint to inform emergency surgery patients that a resident is in the operating room and may impact outcomes.

Dr. Kasotakis responded that institutions may want to add a clause to consent paperwork stating that residents and trainees will be participating in the case.

The complete manuscript of this study and its presentation at the American Surgical Association’s 134^th Annual Meeting, April 2014, in Boston, is anticipated to be published in the Annals of Surgery, pending editorial review.

Dr. Kasotakis and his coauthors reported no conflicting interests.

pwendling@frontlinemedcom.com

BOSTON – Resident participation in emergency general surgery cases was independently associated with a host of complications – pulmonary embolism, surgical site infections, and unplanned reoperation in a secondary analysis of the American College of Surgeons prospective National Surgical Quality Improvement database.

Adequate exposure of residents to emergency general surgery is crucial for surgical training, but academic operating teams should be mindful of this association, Dr. George Kasotakis said at the annual meeting of the American Surgical Association.

Patrice Wendling/Frontline Medical News

Three recent papers have shown resident participation modestly increases complications in elective surgery, but their impact is not well understood for emergency general surgery, where patient physiology is typically deranged and timely surgery is imperative.

To examine this, Dr. Kasotakis and his colleagues at Boston University identified 141,010 patients who underwent emergency general surgery procedures in the 2005-2010 American College of Surgeons prospective National Surgical Quality Improvement database. Due to the nonrandom assignment of more complex cases to resident participation, patients were matched 1:1 based on age; gender; use of alcohol, tobacco, and steroids; inpatient status; obesity; diabetes; renal failure; cardiopulmonary disease; and expected probability for morbidity and mortality. Regression models were fitted for each outcome and adjusted for the same risk factors and operative time.

The most common procedures in the matched cohort were appendectomy (40%), exploratory laparotomy (8.75%), bowel resection (9.2%), cholecystectomy (6%), and lysis of adhesions (6%).

Thirty-day mortality was similar with and without residents (3.25% vs. 2.96%; P = .082), but hospital length of stay was longer by about a half a day with residents (4.97 days vs. 4.59 days; P = .019), said Dr. Kasotakis, an acute care surgeon and intensivist.

More importantly, resident participation added about 20 minutes to operative (75 minutes vs. 59 minutes; P less than .001) and anesthesia times (122 minutes vs. 100 minutes; P less than .001).

Intraoperative transfusions were more common with residents (3.43% vs. 2.55%; P less than .001), perhaps because of longer operating room times, and, as a result, fewer postoperative transfusions were needed (1.12% vs. 1.28% P = .031), he said. Unplanned reoperations, however, were more common with residents, as well (4.22% vs. 3.80%; P = .002).

Postsurgical superficial wound infections (3.5% vs. 2.78%; P less than .001) and organ space surgical site infections (2.27% vs. 1.77%; P less than .001) were more common in the resident group, while wound dehiscence was not (0.63% vs. 0.69%; P = .266), Dr. Kasotakis noted.

Pulmonary complications were significantly more common in the resident group including postoperative pneumonia (1.85% vs. 1.67%; P = .04), reintubation (1.64% vs. 1.15%; P less than .001), and mechanical ventilation for more than 48 hours (2.87% vs. 2.06%; P less than .001).

The same was true for deep vein thrombosis (DVT) (0.80% vs. 0.62%; P = .002) and pulmonary embolism (PE) (0.43% vs. 0.28%; P less than .001).

Urinary tract infections (UTI) were higher with resident participation (1.45% vs. 1.14%; P less than .001), as was sepsis (2.42% vs. 2.13%; P = .005), likely because of the increase in surgical infections, Dr. Kasotakis said.

Thankfully, significant cardiac complications and septic shock were not more common with residents, he said.

Adjusted analyses

After adjusting for operative duration, case complexity and pre-existing comorbidities, residents did not increase length of stay (odds ratio, 0.07; P = .242) or septic events (OR, 1.07; P = .155), but their participation was still independently associated with about 20% more superficial surgical site infections (odds ratio, 1.23; P less than .001), organ space infections (OR, 1.21; P less than .001), UTIs (OR, 1.23; P = .001), and intraoperative transfusions (OR, 1.20; P = .001), he said.

Also, about 8% more patients required a return trip to the operating room when residents participated (OR, 1.08; P = .041).

"These outcomes can perhaps be attributed to their underdeveloped surgical skills," Dr. Kasotakis said.

The incidence of DVT and PE were also higher by about 25% (OR, 1.25; P = .011) and 40% (OR, 1.42; P = .005), respectively, perhaps because of delayed DVT prophylaxis initiation because of concerns of hemostasis or missed doses due to additional return trips to the emergency department, he suggested.

Interestingly, reintubation and prolonged mechanical ventilation rates were increased by about 40% (OR, 1.38; OR, 1.43; both P less than .001), perhaps due to prolonged operative times or greater resuscitation requirements, he added.

Dr. Kasotakis was quick to point out that this was a secondary analysis of a data set not originally intended to assess the effect of trainee participation, that no information was available on the degree of resident involvement during surgery or in perioperative care, and that participating institutions were skewed toward tertiary centers, which typically receive more complex cases.

"Staff surgeons should supervise as needed and minimize unnecessary [emergency department] time. And residents, for their part, should be well prepared for emergency procedures through simulation training and aim to maximize their operating room efficiency," he suggested.

The results sparked a flurry of rebuttals led off by discussant Dr. Julie Ann Sosa, chief of endocrine surgery and director of health sciences research at Duke University, Durham, N.C., who said they conflict with other analyses showing little to no impact from residents in elective cases.

"If not interpreted with care, policy makers, payers, and the public could construe that surgical care at academic health centers is compromised by trainees, which could have unfortunate ramifications for everyone in the room as well as the trainees and the patients," she said.

Dr. Sosa expressed concern about drawing causal inferences from an observational study in the setting of possible selection bias and said attempts to match for case complexity using CPT codes do not necessarily account for say, "the difference between a routine appendectomy that takes 15 to 30 minutes and a complex one that takes 3 hours for a perforation."

Some attendees questioned why the authors didn’t match the institutions in the analysis and chose to ascribe all of the outcomes to residents, with a round of applause following the suggestion that the paper should be entitled Academic centers increase emergency surgery complications. Other attendees questioned whether the poor outcomes are a reflection of resident training and supervision.

Finally, Dr. George Velmahos, chief of trauma, emergency surgery, and surgical critical care, Massachusetts General Hospital, Boston, questioned whether, based on these findings, hospitals have a responsibility from a medical/legal standpoint to inform emergency surgery patients that a resident is in the operating room and may impact outcomes.

Dr. Kasotakis responded that institutions may want to add a clause to consent paperwork stating that residents and trainees will be participating in the case.

The complete manuscript of this study and its presentation at the American Surgical Association’s 134^th Annual Meeting, April 2014, in Boston, is anticipated to be published in the Annals of Surgery, pending editorial review.

Dr. Kasotakis and his coauthors reported no conflicting interests.

pwendling@frontlinemedcom.com

BOSTON – Hospital size and operative volume were significantly associated with satisfaction among general surgery patients in an analysis of 171 U.S. hospitals.

Surprisingly, all other safety and effectiveness measures, with the exception of low hospital mortality index, did not reliably reflect patient satisfaction, "indicating that the system plays perhaps a bigger role than anything else we can do," Dr. Gregory D. Kennedy said at the annual meeting of the American Surgical Association.

Moreover, a clean room and well-controlled pain were the best predictors of high patient satisfaction.

If it’s "the quality of the hotel, not the quality of the surgeon that drives patient satisfaction," and given that this is tied to reimbursement, what should the message be to hospital CEOs? asked discussant Dr. John J. Ricotta, chief of surgery at MedStar Washington (D.C.) Hospital Center.

Patrice Wendling/Frontline Medical News

Dr. Kennedy said the message he takes to the C-suite is that patient satisfaction cannot be a surrogate marker for safety and effectiveness or the only measure of quality because, in doing the right thing, surgeons often make patients unhappy. As a colorectal surgeon, he said he has unhappy patients every day, and remarked that he sometimes feels like a used car salesman where the only thing that he worries about is whether the patient is having a good experience when they drive off the lot, not whether it’s a safe, reliable car.

Dr. Kennedy, vice chair of quality at the University of Wisconsin School of Medicine, Madison, suggested that future quality measures also may need to make the distinction between satisfied and engaged, well-informed patients because a disengaged patient can be highly satisfied, while a highly engaged patient may not.

For the current study, the investigators examined federal Hospital Consumer Assessment Healthcare Providers and Systems (HCAHPS) survey results from 171 hospitals in the University Health System Consortium database from 2011 to 2012. Patients can check one of four boxes for each question on the 27-item survey, with high satisfaction defined as median responses above the 75th percentile on the top box score. This cutoff was used because the Centers for Medicare & Medicaid Services, which developed the HCAHPS, uses only the top box score, Dr. Kennedy explained.

The median hospital size was 421 beds (range, 25-1,280 beds), the median operative volume was 6,341 cases (range, 192-24,258 cases), and the mortality index was 0.83 (range, 0-2.61).

In all, 62% of high-volume hospitals, defined as those with an operative volume above the median, achieved high patient satisfaction, compared with 38% of low-volume hospitals (P less than .001). Similar results were seen for operative volume, he said.

Other system measures such as number of ICU cases and Surgical Care Improvement Project (SCIP) compliance were not associated with high HCAHPS scores.

Among patient safety indicators, only low mortality index was associated with high satisfaction (P less than .001), while complications, early mortality, and overall mortality were not.

Interestingly, hospitals with a higher number of Patient Safety Indicator cases – those involving accidental puncture, laceration, and venous thromboembolism – had higher rates of patient satisfaction, "suggesting that unsafe care is perhaps correlated with high satisfaction," Dr. Kennedy said.

Discussant Dr. Fabrizio Michelassi, chair of surgery at Weill Cornell Medical College and surgeon-in-chief, New York–Presbyterian Hospital/Weill Cornell Medical Center, in New York City, questioned whether "unsafe care gives more options for physicians to show their compassionate side," and said the overall findings are not that surprising to practicing surgeons, who frequently hear patient complaints, despite having performed a quality operation.

Dr. Kennedy said a recent paper from the Cleveland Clinic (Dis. Colon Rectum. 2013;56:219-25) suggests that Patient Safety Indicator cases are really a reflection of surgical complexity and not unsafe care at all.

Finally, other discussants criticized the study for failing to tie satisfaction to patient outcomes; for failing to control for factors influencing patient satisfaction such as age, sex, or social status; and for not looking at geographic differences or nursing-to-staff ratios.

The complete manuscript of this study and its presentation at the American Surgical Association’s 134th Annual Meeting, April 2014, in Boston, is anticipated to be published in the Annals of Surgery, pending editorial review.

Dr. Kennedy reported no conflicting interests.

pwendling@frontlinemedcom.com

BOSTON – Hospital size and operative volume were significantly associated with satisfaction among general surgery patients in an analysis of 171 U.S. hospitals.

Surprisingly, all other safety and effectiveness measures, with the exception of low hospital mortality index, did not reliably reflect patient satisfaction, "indicating that the system plays perhaps a bigger role than anything else we can do," Dr. Gregory D. Kennedy said at the annual meeting of the American Surgical Association.

Moreover, a clean room and well-controlled pain were the best predictors of high patient satisfaction.

If it’s "the quality of the hotel, not the quality of the surgeon that drives patient satisfaction," and given that this is tied to reimbursement, what should the message be to hospital CEOs? asked discussant Dr. John J. Ricotta, chief of surgery at MedStar Washington (D.C.) Hospital Center.

Patrice Wendling/Frontline Medical News

Dr. Kennedy said the message he takes to the C-suite is that patient satisfaction cannot be a surrogate marker for safety and effectiveness or the only measure of quality because, in doing the right thing, surgeons often make patients unhappy. As a colorectal surgeon, he said he has unhappy patients every day, and remarked that he sometimes feels like a used car salesman where the only thing that he worries about is whether the patient is having a good experience when they drive off the lot, not whether it’s a safe, reliable car.

Dr. Kennedy, vice chair of quality at the University of Wisconsin School of Medicine, Madison, suggested that future quality measures also may need to make the distinction between satisfied and engaged, well-informed patients because a disengaged patient can be highly satisfied, while a highly engaged patient may not.

For the current study, the investigators examined federal Hospital Consumer Assessment Healthcare Providers and Systems (HCAHPS) survey results from 171 hospitals in the University Health System Consortium database from 2011 to 2012. Patients can check one of four boxes for each question on the 27-item survey, with high satisfaction defined as median responses above the 75th percentile on the top box score. This cutoff was used because the Centers for Medicare & Medicaid Services, which developed the HCAHPS, uses only the top box score, Dr. Kennedy explained.

The median hospital size was 421 beds (range, 25-1,280 beds), the median operative volume was 6,341 cases (range, 192-24,258 cases), and the mortality index was 0.83 (range, 0-2.61).

In all, 62% of high-volume hospitals, defined as those with an operative volume above the median, achieved high patient satisfaction, compared with 38% of low-volume hospitals (P less than .001). Similar results were seen for operative volume, he said.

Other system measures such as number of ICU cases and Surgical Care Improvement Project (SCIP) compliance were not associated with high HCAHPS scores.

Among patient safety indicators, only low mortality index was associated with high satisfaction (P less than .001), while complications, early mortality, and overall mortality were not.

Interestingly, hospitals with a higher number of Patient Safety Indicator cases – those involving accidental puncture, laceration, and venous thromboembolism – had higher rates of patient satisfaction, "suggesting that unsafe care is perhaps correlated with high satisfaction," Dr. Kennedy said.

Discussant Dr. Fabrizio Michelassi, chair of surgery at Weill Cornell Medical College and surgeon-in-chief, New York–Presbyterian Hospital/Weill Cornell Medical Center, in New York City, questioned whether "unsafe care gives more options for physicians to show their compassionate side," and said the overall findings are not that surprising to practicing surgeons, who frequently hear patient complaints, despite having performed a quality operation.

Dr. Kennedy said a recent paper from the Cleveland Clinic (Dis. Colon Rectum. 2013;56:219-25) suggests that Patient Safety Indicator cases are really a reflection of surgical complexity and not unsafe care at all.

Finally, other discussants criticized the study for failing to tie satisfaction to patient outcomes; for failing to control for factors influencing patient satisfaction such as age, sex, or social status; and for not looking at geographic differences or nursing-to-staff ratios.

The complete manuscript of this study and its presentation at the American Surgical Association’s 134th Annual Meeting, April 2014, in Boston, is anticipated to be published in the Annals of Surgery, pending editorial review.

Dr. Kennedy reported no conflicting interests.

pwendling@frontlinemedcom.com

BOSTON – Hospital size and operative volume were significantly associated with satisfaction among general surgery patients in an analysis of 171 U.S. hospitals.

Surprisingly, all other safety and effectiveness measures, with the exception of low hospital mortality index, did not reliably reflect patient satisfaction, "indicating that the system plays perhaps a bigger role than anything else we can do," Dr. Gregory D. Kennedy said at the annual meeting of the American Surgical Association.

Moreover, a clean room and well-controlled pain were the best predictors of high patient satisfaction.

If it’s "the quality of the hotel, not the quality of the surgeon that drives patient satisfaction," and given that this is tied to reimbursement, what should the message be to hospital CEOs? asked discussant Dr. John J. Ricotta, chief of surgery at MedStar Washington (D.C.) Hospital Center.

Patrice Wendling/Frontline Medical News

Dr. Kennedy said the message he takes to the C-suite is that patient satisfaction cannot be a surrogate marker for safety and effectiveness or the only measure of quality because, in doing the right thing, surgeons often make patients unhappy. As a colorectal surgeon, he said he has unhappy patients every day, and remarked that he sometimes feels like a used car salesman where the only thing that he worries about is whether the patient is having a good experience when they drive off the lot, not whether it’s a safe, reliable car.

Dr. Kennedy, vice chair of quality at the University of Wisconsin School of Medicine, Madison, suggested that future quality measures also may need to make the distinction between satisfied and engaged, well-informed patients because a disengaged patient can be highly satisfied, while a highly engaged patient may not.

For the current study, the investigators examined federal Hospital Consumer Assessment Healthcare Providers and Systems (HCAHPS) survey results from 171 hospitals in the University Health System Consortium database from 2011 to 2012. Patients can check one of four boxes for each question on the 27-item survey, with high satisfaction defined as median responses above the 75th percentile on the top box score. This cutoff was used because the Centers for Medicare & Medicaid Services, which developed the HCAHPS, uses only the top box score, Dr. Kennedy explained.

The median hospital size was 421 beds (range, 25-1,280 beds), the median operative volume was 6,341 cases (range, 192-24,258 cases), and the mortality index was 0.83 (range, 0-2.61).

In all, 62% of high-volume hospitals, defined as those with an operative volume above the median, achieved high patient satisfaction, compared with 38% of low-volume hospitals (P less than .001). Similar results were seen for operative volume, he said.

Other system measures such as number of ICU cases and Surgical Care Improvement Project (SCIP) compliance were not associated with high HCAHPS scores.

Among patient safety indicators, only low mortality index was associated with high satisfaction (P less than .001), while complications, early mortality, and overall mortality were not.

Interestingly, hospitals with a higher number of Patient Safety Indicator cases – those involving accidental puncture, laceration, and venous thromboembolism – had higher rates of patient satisfaction, "suggesting that unsafe care is perhaps correlated with high satisfaction," Dr. Kennedy said.

Discussant Dr. Fabrizio Michelassi, chair of surgery at Weill Cornell Medical College and surgeon-in-chief, New York–Presbyterian Hospital/Weill Cornell Medical Center, in New York City, questioned whether "unsafe care gives more options for physicians to show their compassionate side," and said the overall findings are not that surprising to practicing surgeons, who frequently hear patient complaints, despite having performed a quality operation.

Dr. Kennedy said a recent paper from the Cleveland Clinic (Dis. Colon Rectum. 2013;56:219-25) suggests that Patient Safety Indicator cases are really a reflection of surgical complexity and not unsafe care at all.

Finally, other discussants criticized the study for failing to tie satisfaction to patient outcomes; for failing to control for factors influencing patient satisfaction such as age, sex, or social status; and for not looking at geographic differences or nursing-to-staff ratios.

The complete manuscript of this study and its presentation at the American Surgical Association’s 134th Annual Meeting, April 2014, in Boston, is anticipated to be published in the Annals of Surgery, pending editorial review.

Dr. Kennedy reported no conflicting interests.

pwendling@frontlinemedcom.com

BOSTON – Operative approach, as previously suggested, was not a significant predictor of postappendectomy organ space infection in children, according to a large, national database analysis.

Instead, organ space infection appears to be associated with largely nonmodifiable factors of disease severity, preoperative sepsis, and long operative duration, Dr. Fergal J. Fleming said at the annual meeting of the American Surgical Association.

Patrice Wendling/Frontline Medical News

"It would appear that the die is cast with respect to the risk of organ space infection at the time of presentation," he said. "This would suggest that our focus, in terms of quality improvement, should be on identifying patients at highest risk for complications."

The study findings are important because laparoscopic appendectomy has become widely accepted in children and adults, but has also been associated with increased odds of intra-abdominal abscess formation in adults (Ann. Surg. 2010;252:895-900), said Dr. Fleming, a colorectal surgeon at the University of Rochester (N.Y.) Medical Center.

To determine the effect of surgical approach on organ space infection (OSI) in children, Dr. Fleming and his associates analyzed 5,097 children, aged 2-18 years, undergoing open or laparoscopic appendectomy for acute appendicitis in the 2012 ACS National Surgical Quality Improvement Program (ACS NSQIP) pediatric database. The approach was laparoscopic in 4,514 patients (88.5%) and open in 583 patients.

OSI occurred in only 155 children (3%), but accounted for more than half of reoperations and nearly two-thirds of readmissions at 30 days, Dr. Fleming reported.

The unadjusted OSI rate was 0.9% (31/3,613) for uncomplicated appendicitis and 8.4% (124/1,484) for complicated appendicitis, which was a significant difference (P less than .001).

OSI rates did not differ significantly between laparoscopic and open surgery for uncomplicated appendicitis (0.8% vs. 1.7%; P = .160) and complicated appendicitis (8.7% vs. 7.3%; P = .415), defined by abscess, perforation, or sepsis.

In multivariable logistic regression analysis, complicated appendicitis was again the major factor associated with OSI (adjusted odds ratio, 4.85), he said. Other significant drivers were wound class III/IV (OR, 4.17), preoperative sepsis (OR, 2.19), and operative time of 60 minutes or more (OR, 2.15).

The model, which controlled for age, sex, pulmonary comorbidity, obesity, and emergency operations, had excellent predictive ability, with a c-statistic of 0.837, Dr. Fleming said.

He acknowledged that baseline differences between the two groups suggested that sicker children may have been selected as candidates for open surgery. Compared with the laparoscopic group, the open surgery group had significantly higher rates of preoperative sepsis/septic shock (24.7% vs. 14.7%), complicated appendicitis (58.8% vs. 25.3%), and emergency surgery (74.4% vs. 62%; all P values less than .001).

"Now that your group has identified these perioperative risk factors for children undergoing emergency appendectomy, do you have any guidelines for pediatric surgeons on how to follow their patients postop to identify organ space infections earlier?" asked discussant Dr. Paul Colombani, Children’s Surgeon-in Charge, Johns Hopkins Hospital, Baltimore.

Dr. Fleming suggested a bundle for high-risk patients that could include predischarge education for parents and patients, an early clinic visit before postoperative day 9, and a structured telephone call on day 2 or 3 post discharge to run through risk factors such as low-grade fever, malaise, and diarrhea. He noted that high-risk patients represented less than 15% of the cohort, but 80% of OSI events.

Dr. Fleming reported having no financial disclosures.

The complete manuscript of this study and its presentation at the American Surgical Association’s 134th Annual Meeting, April 2014, in Boston, is anticipated to be published in Annals of Surgery, pending editorial review.

pwendling@frontlinemedcom.com

BOSTON – Operative approach, as previously suggested, was not a significant predictor of postappendectomy organ space infection in children, according to a large, national database analysis.

Instead, organ space infection appears to be associated with largely nonmodifiable factors of disease severity, preoperative sepsis, and long operative duration, Dr. Fergal J. Fleming said at the annual meeting of the American Surgical Association.

Patrice Wendling/Frontline Medical News

"It would appear that the die is cast with respect to the risk of organ space infection at the time of presentation," he said. "This would suggest that our focus, in terms of quality improvement, should be on identifying patients at highest risk for complications."

The study findings are important because laparoscopic appendectomy has become widely accepted in children and adults, but has also been associated with increased odds of intra-abdominal abscess formation in adults (Ann. Surg. 2010;252:895-900), said Dr. Fleming, a colorectal surgeon at the University of Rochester (N.Y.) Medical Center.

To determine the effect of surgical approach on organ space infection (OSI) in children, Dr. Fleming and his associates analyzed 5,097 children, aged 2-18 years, undergoing open or laparoscopic appendectomy for acute appendicitis in the 2012 ACS National Surgical Quality Improvement Program (ACS NSQIP) pediatric database. The approach was laparoscopic in 4,514 patients (88.5%) and open in 583 patients.

OSI occurred in only 155 children (3%), but accounted for more than half of reoperations and nearly two-thirds of readmissions at 30 days, Dr. Fleming reported.

The unadjusted OSI rate was 0.9% (31/3,613) for uncomplicated appendicitis and 8.4% (124/1,484) for complicated appendicitis, which was a significant difference (P less than .001).

OSI rates did not differ significantly between laparoscopic and open surgery for uncomplicated appendicitis (0.8% vs. 1.7%; P = .160) and complicated appendicitis (8.7% vs. 7.3%; P = .415), defined by abscess, perforation, or sepsis.

In multivariable logistic regression analysis, complicated appendicitis was again the major factor associated with OSI (adjusted odds ratio, 4.85), he said. Other significant drivers were wound class III/IV (OR, 4.17), preoperative sepsis (OR, 2.19), and operative time of 60 minutes or more (OR, 2.15).

The model, which controlled for age, sex, pulmonary comorbidity, obesity, and emergency operations, had excellent predictive ability, with a c-statistic of 0.837, Dr. Fleming said.

He acknowledged that baseline differences between the two groups suggested that sicker children may have been selected as candidates for open surgery. Compared with the laparoscopic group, the open surgery group had significantly higher rates of preoperative sepsis/septic shock (24.7% vs. 14.7%), complicated appendicitis (58.8% vs. 25.3%), and emergency surgery (74.4% vs. 62%; all P values less than .001).

"Now that your group has identified these perioperative risk factors for children undergoing emergency appendectomy, do you have any guidelines for pediatric surgeons on how to follow their patients postop to identify organ space infections earlier?" asked discussant Dr. Paul Colombani, Children’s Surgeon-in Charge, Johns Hopkins Hospital, Baltimore.

Dr. Fleming suggested a bundle for high-risk patients that could include predischarge education for parents and patients, an early clinic visit before postoperative day 9, and a structured telephone call on day 2 or 3 post discharge to run through risk factors such as low-grade fever, malaise, and diarrhea. He noted that high-risk patients represented less than 15% of the cohort, but 80% of OSI events.

Dr. Fleming reported having no financial disclosures.

The complete manuscript of this study and its presentation at the American Surgical Association’s 134th Annual Meeting, April 2014, in Boston, is anticipated to be published in Annals of Surgery, pending editorial review.

pwendling@frontlinemedcom.com

BOSTON – Operative approach, as previously suggested, was not a significant predictor of postappendectomy organ space infection in children, according to a large, national database analysis.

Instead, organ space infection appears to be associated with largely nonmodifiable factors of disease severity, preoperative sepsis, and long operative duration, Dr. Fergal J. Fleming said at the annual meeting of the American Surgical Association.

Patrice Wendling/Frontline Medical News

"It would appear that the die is cast with respect to the risk of organ space infection at the time of presentation," he said. "This would suggest that our focus, in terms of quality improvement, should be on identifying patients at highest risk for complications."

The study findings are important because laparoscopic appendectomy has become widely accepted in children and adults, but has also been associated with increased odds of intra-abdominal abscess formation in adults (Ann. Surg. 2010;252:895-900), said Dr. Fleming, a colorectal surgeon at the University of Rochester (N.Y.) Medical Center.

To determine the effect of surgical approach on organ space infection (OSI) in children, Dr. Fleming and his associates analyzed 5,097 children, aged 2-18 years, undergoing open or laparoscopic appendectomy for acute appendicitis in the 2012 ACS National Surgical Quality Improvement Program (ACS NSQIP) pediatric database. The approach was laparoscopic in 4,514 patients (88.5%) and open in 583 patients.

OSI occurred in only 155 children (3%), but accounted for more than half of reoperations and nearly two-thirds of readmissions at 30 days, Dr. Fleming reported.

The unadjusted OSI rate was 0.9% (31/3,613) for uncomplicated appendicitis and 8.4% (124/1,484) for complicated appendicitis, which was a significant difference (P less than .001).

OSI rates did not differ significantly between laparoscopic and open surgery for uncomplicated appendicitis (0.8% vs. 1.7%; P = .160) and complicated appendicitis (8.7% vs. 7.3%; P = .415), defined by abscess, perforation, or sepsis.

In multivariable logistic regression analysis, complicated appendicitis was again the major factor associated with OSI (adjusted odds ratio, 4.85), he said. Other significant drivers were wound class III/IV (OR, 4.17), preoperative sepsis (OR, 2.19), and operative time of 60 minutes or more (OR, 2.15).

The model, which controlled for age, sex, pulmonary comorbidity, obesity, and emergency operations, had excellent predictive ability, with a c-statistic of 0.837, Dr. Fleming said.

He acknowledged that baseline differences between the two groups suggested that sicker children may have been selected as candidates for open surgery. Compared with the laparoscopic group, the open surgery group had significantly higher rates of preoperative sepsis/septic shock (24.7% vs. 14.7%), complicated appendicitis (58.8% vs. 25.3%), and emergency surgery (74.4% vs. 62%; all P values less than .001).

"Now that your group has identified these perioperative risk factors for children undergoing emergency appendectomy, do you have any guidelines for pediatric surgeons on how to follow their patients postop to identify organ space infections earlier?" asked discussant Dr. Paul Colombani, Children’s Surgeon-in Charge, Johns Hopkins Hospital, Baltimore.

Dr. Fleming suggested a bundle for high-risk patients that could include predischarge education for parents and patients, an early clinic visit before postoperative day 9, and a structured telephone call on day 2 or 3 post discharge to run through risk factors such as low-grade fever, malaise, and diarrhea. He noted that high-risk patients represented less than 15% of the cohort, but 80% of OSI events.

Dr. Fleming reported having no financial disclosures.

The complete manuscript of this study and its presentation at the American Surgical Association’s 134th Annual Meeting, April 2014, in Boston, is anticipated to be published in Annals of Surgery, pending editorial review.

pwendling@frontlinemedcom.com

BOSTON – The Centers for Medicare & Medicaid Services may have dropped its accreditation requirement for bariatric surgery centers, but that hasn’t stopped the flow of data calling into question that decision.

A new analysis of 72,615 patients at 145 U.S. hospitals found that, compared with unaccredited centers, accredited centers have significantly decreased mortality (0.07% vs. 0.13%; P = .019) and improved failure to rescue rates (0.55% vs. 0.97%; P = .046).

Patrice Wendling/Frontline Medical News

They also have fewer complications (11.3% vs. 12.3%; P = .001) and lower average total costs ($42,212 vs. $51,189; P less than .0001).

"We found improved outcomes for these bariatric surgery patients," study author Dr. John M. Morton of Stanford (Calif.) University Medical Center said at the annual meeting of the American Surgical Association.

The September 2013 determination by CMS that "continuing the requirement for certification for bariatric surgery facilities would not improve health outcomes for Medicare beneficiaries" has been opposed by several medical societies, which cited results from 7 of 10 studies supporting accreditation.

Among the most outspoken supporters are the American Society for Metabolic and Bariatric Surgery (ASMBS) and the American College of Surgeons (ACS), which jointly manage a certification program.

During a discussion of the results, Dr. John Kellum Jr. of the Virginia Commonwealth University, Richmond, remarked, "I do wonder though if we aren’t raising a straw dog, which is somewhat self-serving. If you look at the P values, they’re very tiny."

He also pointed to regional variances in performance identified by the analysis and said, "In my opinion, the real advantage of accreditation is the record keeping that goes with it."

Dr. Morton responded, "I think your last point is exactly right. The ability to maintain the data and collect them allows you to have quality improvement. You can’t manage what you don’t measure. . . . Mortality has become pretty rare in bariatric surgery, but I think it’s what I’d call a sentinel event."

The current analysis comprised 62% of bariatric surgery discharges from 62% of hospitals in 2010-2011 in the Nationwide Inpatient Sample database, the largest all-payer, nonfederal database in the U.S.

The 66 unaccredited hospitals and 79 accredited hospitals had similar mean volumes (279 patients vs. 265 patients). Significantly more unaccredited hospitals were teaching hospitals (66.2% vs. 58%), while significantly more accredited hospitals were high-volume centers (81% vs. 53%), defined as at least 125 gastric bypass cases yearly.

Most patients (83%) underwent surgery at accredited hospitals, with both accredited and unaccredited hospitals favoring laparoscopic Roux-en-Y gastric bypass surgery (60.3%; 69.5%) followed by lap band surgery (25.7%; 15.6%), and laparoscopic sleeve gastrectomy (14% vs. 14.8%).

In multivariable regression analysis, procedure type did not exert an influence on outcomes. Unaccredited status, however, was a positive predictor of in-hospital complication (odds ratio, 1.09; P = .005) and in-hospital mortality (OR, 2.26; P = .007), Dr. Morton reported. The analysis controlled for teaching status; hospital high-volume status; patient age, sex, race, insurance, and Charlson Comorbidity Index score.

Discussant Dr. Bruce M. Wolfe of Oregon Health and Science University, Portland, asked whether the analysis could speak to the suggestion that accreditation has limited access to care and whether it will be possible to acquire the data necessary to satisfy the doubts of CMS and others regarding the value of bariatric surgery accreditation.

Dr. Morton said that with more than 729 bariatric surgery centers in the United States, there is "ample opportunity to access care," and that no study to date has shown that any of the accreditation programs has decreased the number of surgeries being performed. If anything, two studies have shown an increase.

He observed that it would be difficult to get definitive randomized trial evidence on the value of accreditation because all hospitals will have to deal with the accreditation process independent of CMS. The "hope, belief, and desire" is for a single accreditation process where there is less administrative burden for hospitals and a single reporting scheme, as may exist currently with the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP).

"I believe CMS will rightly take a look at what’s happened since they have suspended the certification process," Dr. Morton said. "They have created a natural experiment that bears further scrutiny to see what happens to these Medicare patients after the withdrawal of the certification for them."

Dr. Morton reported having no financial disclosures.

The complete manuscript of this study and its presentation at the American Surgical Association’s 134th annual meeting, April 2014, in Boston is anticipated to be published in the Annals of Surgery, pending editorial review.

pwendling@frontlinemedcom.com

BOSTON – The Centers for Medicare & Medicaid Services may have dropped its accreditation requirement for bariatric surgery centers, but that hasn’t stopped the flow of data calling into question that decision.

A new analysis of 72,615 patients at 145 U.S. hospitals found that, compared with unaccredited centers, accredited centers have significantly decreased mortality (0.07% vs. 0.13%; P = .019) and improved failure to rescue rates (0.55% vs. 0.97%; P = .046).

Patrice Wendling/Frontline Medical News

They also have fewer complications (11.3% vs. 12.3%; P = .001) and lower average total costs ($42,212 vs. $51,189; P less than .0001).

"We found improved outcomes for these bariatric surgery patients," study author Dr. John M. Morton of Stanford (Calif.) University Medical Center said at the annual meeting of the American Surgical Association.

The September 2013 determination by CMS that "continuing the requirement for certification for bariatric surgery facilities would not improve health outcomes for Medicare beneficiaries" has been opposed by several medical societies, which cited results from 7 of 10 studies supporting accreditation.

Among the most outspoken supporters are the American Society for Metabolic and Bariatric Surgery (ASMBS) and the American College of Surgeons (ACS), which jointly manage a certification program.

During a discussion of the results, Dr. John Kellum Jr. of the Virginia Commonwealth University, Richmond, remarked, "I do wonder though if we aren’t raising a straw dog, which is somewhat self-serving. If you look at the P values, they’re very tiny."

He also pointed to regional variances in performance identified by the analysis and said, "In my opinion, the real advantage of accreditation is the record keeping that goes with it."

Dr. Morton responded, "I think your last point is exactly right. The ability to maintain the data and collect them allows you to have quality improvement. You can’t manage what you don’t measure. . . . Mortality has become pretty rare in bariatric surgery, but I think it’s what I’d call a sentinel event."

The current analysis comprised 62% of bariatric surgery discharges from 62% of hospitals in 2010-2011 in the Nationwide Inpatient Sample database, the largest all-payer, nonfederal database in the U.S.

The 66 unaccredited hospitals and 79 accredited hospitals had similar mean volumes (279 patients vs. 265 patients). Significantly more unaccredited hospitals were teaching hospitals (66.2% vs. 58%), while significantly more accredited hospitals were high-volume centers (81% vs. 53%), defined as at least 125 gastric bypass cases yearly.

Most patients (83%) underwent surgery at accredited hospitals, with both accredited and unaccredited hospitals favoring laparoscopic Roux-en-Y gastric bypass surgery (60.3%; 69.5%) followed by lap band surgery (25.7%; 15.6%), and laparoscopic sleeve gastrectomy (14% vs. 14.8%).

In multivariable regression analysis, procedure type did not exert an influence on outcomes. Unaccredited status, however, was a positive predictor of in-hospital complication (odds ratio, 1.09; P = .005) and in-hospital mortality (OR, 2.26; P = .007), Dr. Morton reported. The analysis controlled for teaching status; hospital high-volume status; patient age, sex, race, insurance, and Charlson Comorbidity Index score.

Discussant Dr. Bruce M. Wolfe of Oregon Health and Science University, Portland, asked whether the analysis could speak to the suggestion that accreditation has limited access to care and whether it will be possible to acquire the data necessary to satisfy the doubts of CMS and others regarding the value of bariatric surgery accreditation.

Dr. Morton said that with more than 729 bariatric surgery centers in the United States, there is "ample opportunity to access care," and that no study to date has shown that any of the accreditation programs has decreased the number of surgeries being performed. If anything, two studies have shown an increase.

He observed that it would be difficult to get definitive randomized trial evidence on the value of accreditation because all hospitals will have to deal with the accreditation process independent of CMS. The "hope, belief, and desire" is for a single accreditation process where there is less administrative burden for hospitals and a single reporting scheme, as may exist currently with the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP).

"I believe CMS will rightly take a look at what’s happened since they have suspended the certification process," Dr. Morton said. "They have created a natural experiment that bears further scrutiny to see what happens to these Medicare patients after the withdrawal of the certification for them."

Dr. Morton reported having no financial disclosures.

The complete manuscript of this study and its presentation at the American Surgical Association’s 134th annual meeting, April 2014, in Boston is anticipated to be published in the Annals of Surgery, pending editorial review.

pwendling@frontlinemedcom.com

BOSTON – The Centers for Medicare & Medicaid Services may have dropped its accreditation requirement for bariatric surgery centers, but that hasn’t stopped the flow of data calling into question that decision.

A new analysis of 72,615 patients at 145 U.S. hospitals found that, compared with unaccredited centers, accredited centers have significantly decreased mortality (0.07% vs. 0.13%; P = .019) and improved failure to rescue rates (0.55% vs. 0.97%; P = .046).

Patrice Wendling/Frontline Medical News

They also have fewer complications (11.3% vs. 12.3%; P = .001) and lower average total costs ($42,212 vs. $51,189; P less than .0001).

"We found improved outcomes for these bariatric surgery patients," study author Dr. John M. Morton of Stanford (Calif.) University Medical Center said at the annual meeting of the American Surgical Association.

The September 2013 determination by CMS that "continuing the requirement for certification for bariatric surgery facilities would not improve health outcomes for Medicare beneficiaries" has been opposed by several medical societies, which cited results from 7 of 10 studies supporting accreditation.

Among the most outspoken supporters are the American Society for Metabolic and Bariatric Surgery (ASMBS) and the American College of Surgeons (ACS), which jointly manage a certification program.

During a discussion of the results, Dr. John Kellum Jr. of the Virginia Commonwealth University, Richmond, remarked, "I do wonder though if we aren’t raising a straw dog, which is somewhat self-serving. If you look at the P values, they’re very tiny."

He also pointed to regional variances in performance identified by the analysis and said, "In my opinion, the real advantage of accreditation is the record keeping that goes with it."

Dr. Morton responded, "I think your last point is exactly right. The ability to maintain the data and collect them allows you to have quality improvement. You can’t manage what you don’t measure. . . . Mortality has become pretty rare in bariatric surgery, but I think it’s what I’d call a sentinel event."

The current analysis comprised 62% of bariatric surgery discharges from 62% of hospitals in 2010-2011 in the Nationwide Inpatient Sample database, the largest all-payer, nonfederal database in the U.S.

The 66 unaccredited hospitals and 79 accredited hospitals had similar mean volumes (279 patients vs. 265 patients). Significantly more unaccredited hospitals were teaching hospitals (66.2% vs. 58%), while significantly more accredited hospitals were high-volume centers (81% vs. 53%), defined as at least 125 gastric bypass cases yearly.

Most patients (83%) underwent surgery at accredited hospitals, with both accredited and unaccredited hospitals favoring laparoscopic Roux-en-Y gastric bypass surgery (60.3%; 69.5%) followed by lap band surgery (25.7%; 15.6%), and laparoscopic sleeve gastrectomy (14% vs. 14.8%).

In multivariable regression analysis, procedure type did not exert an influence on outcomes. Unaccredited status, however, was a positive predictor of in-hospital complication (odds ratio, 1.09; P = .005) and in-hospital mortality (OR, 2.26; P = .007), Dr. Morton reported. The analysis controlled for teaching status; hospital high-volume status; patient age, sex, race, insurance, and Charlson Comorbidity Index score.

Discussant Dr. Bruce M. Wolfe of Oregon Health and Science University, Portland, asked whether the analysis could speak to the suggestion that accreditation has limited access to care and whether it will be possible to acquire the data necessary to satisfy the doubts of CMS and others regarding the value of bariatric surgery accreditation.

Dr. Morton said that with more than 729 bariatric surgery centers in the United States, there is "ample opportunity to access care," and that no study to date has shown that any of the accreditation programs has decreased the number of surgeries being performed. If anything, two studies have shown an increase.

He observed that it would be difficult to get definitive randomized trial evidence on the value of accreditation because all hospitals will have to deal with the accreditation process independent of CMS. The "hope, belief, and desire" is for a single accreditation process where there is less administrative burden for hospitals and a single reporting scheme, as may exist currently with the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP).

"I believe CMS will rightly take a look at what’s happened since they have suspended the certification process," Dr. Morton said. "They have created a natural experiment that bears further scrutiny to see what happens to these Medicare patients after the withdrawal of the certification for them."

Dr. Morton reported having no financial disclosures.

The complete manuscript of this study and its presentation at the American Surgical Association’s 134th annual meeting, April 2014, in Boston is anticipated to be published in the Annals of Surgery, pending editorial review.

pwendling@frontlinemedcom.com

BOSTON – Though progress is being made in reducing surgery for diverticulitis, one in three elective colectomies failed to meet current indications in a prospective study.

Among 1,102 patients in Washington state with an episode-based indication for elective surgery, the proportion with three or more prior episodes of diverticulitis increased from 42% in 2010 to 58% in 2012 (P = .007), while the proportion failing to meet either complication- or episode-based indications decreased from 41.3% to 29.6% (P = .002).

"Still, there remains a significant and persistent portion of cases being done in Washington that do not meet established guidelines," Dr. Vlad V. Simianu said at the annual meeting of the American Surgical Association.

The study involved 2,031 patients having elective resection for diverticulitis in 2010-2012 in 49 hospitals in Washington state’s voluntary Surgical Care and Outcomes Assessment Program (SCOAP), which captures about 80% of the surgical volume in the state. Their mean age was 58.8 years, 24% were younger than 50 years, and most were healthy, with only 27% having a Charlson Comorbidity Index score of 1 or more.

Patrice Wendling/Frontline Medical News

Washington has seen a dramatic threefold increase in elective colectomy for diverticulitis over the last 13 years, despite evolving recommendations, observed Dr. Simianu, a general surgery resident and research fellow at the University of Washington, Seattle. The 2006 American Society of Colon and Rectal Surgeons (ASCRS) guidelines, which were used for the study end points, said elective surgery can be safely delayed until three or more acute episodes of uncomplicated diverticulitis. The ASCRS just updated its guidelines again (Dis. Colon Rectum 2014;57:284-94) and now strongly recommend that the decision to proceed to elective colectomy after recovery from uncomplicated acute diverticulitis "be individualized."

Among all 2,031 patients in the study, a clinical indication for surgery was present in 23.3% (chronic fistula 10.5%, stricture 5.4%, bleeding 2.4%, and other 5%), while 55% of the 1,102 patients with an episode-based indication had three or more episodes.

In 2010, 22% of all patients had at least three prior episodes, 17% had chronic complications, and 23% had neither. This compares with 37.7%, 18%.6%, and 16.7% in 2012.

Possible explanations for the rise in guideline-concordant cases are that surgeons are documenting their indications more carefully or are delaying more operations until three or more acute episodes, Dr. Simianu said. Indeed, there was a significant decrease in the number of cases with missing indications in the clinical record over the study period (38% vs. 27%; P = .007).

The persistence of cases not meeting indications could be because the adoption of laparoscopy has lowered the threshold for surgeons to offer colectomy, similar to what has happened with laparoscopic cholecystectomy, he said. A laparoscopic operation was performed in 60% of the patients.

Other possible explanations are that the guidelines don’t capture all relevant indications, like persistent symptoms or pain, or that evolving evidence and guidelines are forcing some surgeons to wait before they change their practice, Dr. Simianu said.

"Nonetheless, we view this as an educational opportunity in our state to give feedback to surgeons in our network," he said.

Notably, the rate of elective and emergency resections per year did not increase significantly over the study period at 28 high-volume hospitals, performing at least 10 colectomies yearly. Data, however, were incomplete or missing, in 30.4% of cases.

Discussant Dr. Conor Delaney, chief of colorectal surgery at University Hospitals Case Medical Center, Cleveland, said it was good to see that the percentage of cases performed for three or more episodes rose across all age groups in the final year of the study, suggesting that the SCOAP intervention is likely working.

"It is still shocking to see 30 or 40% of cases being performed for fewer than three attacks," he said, adding that the 30% of patients who had surgery without appropriate indications "may really be, very much a best-case scenario."

He also asked whether the investigators could identify hospitals inside and outside SCOAP that were less likely to follow guidelines and how they dealt with patients who may have had appropriate single-attack surgery because of nonresolution of symptoms or inadequate drainage.

Dr. Simianu said it wasn’t possible to determine indications for hospitals outside the SCOAP network, but that participating hospitals followed a normal distribution. High-volume hospitals were "sort of middle of the road," while four or five low-volume hospitals were outliers and never or always met indications.

In response to the second query, he said their clinical indications included an "other" category that captured appropriate first-attack patients and that about 1% of surgery was performed for an abscess.

The next phase of research will be to go into surgeons’ offices to speak with surgeons and patients to try and quantify the missing indications, Dr. Simianu said.

Dr. Simianu reported funding from the National Institute of Diabetes and Digestive and Kidney Disease, the Agency for Healthcare Research & Quality, and Life Sciences Discovery Fund. Three co-authors reported serving as an advisor, consultant, or speaker for pharmaceutical and device firms.

The complete manuscript of this study and its presentation at the American Surgical Association’s 134th Annual Meeting, April 2014, in Boston, Mass., is anticipated to be published in the Annals of Surgery, pending editorial review.

pwendling@frontlinemedcom.com

BOSTON – Though progress is being made in reducing surgery for diverticulitis, one in three elective colectomies failed to meet current indications in a prospective study.

Among 1,102 patients in Washington state with an episode-based indication for elective surgery, the proportion with three or more prior episodes of diverticulitis increased from 42% in 2010 to 58% in 2012 (P = .007), while the proportion failing to meet either complication- or episode-based indications decreased from 41.3% to 29.6% (P = .002).

"Still, there remains a significant and persistent portion of cases being done in Washington that do not meet established guidelines," Dr. Vlad V. Simianu said at the annual meeting of the American Surgical Association.

The study involved 2,031 patients having elective resection for diverticulitis in 2010-2012 in 49 hospitals in Washington state’s voluntary Surgical Care and Outcomes Assessment Program (SCOAP), which captures about 80% of the surgical volume in the state. Their mean age was 58.8 years, 24% were younger than 50 years, and most were healthy, with only 27% having a Charlson Comorbidity Index score of 1 or more.

Patrice Wendling/Frontline Medical News

Washington has seen a dramatic threefold increase in elective colectomy for diverticulitis over the last 13 years, despite evolving recommendations, observed Dr. Simianu, a general surgery resident and research fellow at the University of Washington, Seattle. The 2006 American Society of Colon and Rectal Surgeons (ASCRS) guidelines, which were used for the study end points, said elective surgery can be safely delayed until three or more acute episodes of uncomplicated diverticulitis. The ASCRS just updated its guidelines again (Dis. Colon Rectum 2014;57:284-94) and now strongly recommend that the decision to proceed to elective colectomy after recovery from uncomplicated acute diverticulitis "be individualized."

Among all 2,031 patients in the study, a clinical indication for surgery was present in 23.3% (chronic fistula 10.5%, stricture 5.4%, bleeding 2.4%, and other 5%), while 55% of the 1,102 patients with an episode-based indication had three or more episodes.

In 2010, 22% of all patients had at least three prior episodes, 17% had chronic complications, and 23% had neither. This compares with 37.7%, 18%.6%, and 16.7% in 2012.

Possible explanations for the rise in guideline-concordant cases are that surgeons are documenting their indications more carefully or are delaying more operations until three or more acute episodes, Dr. Simianu said. Indeed, there was a significant decrease in the number of cases with missing indications in the clinical record over the study period (38% vs. 27%; P = .007).

The persistence of cases not meeting indications could be because the adoption of laparoscopy has lowered the threshold for surgeons to offer colectomy, similar to what has happened with laparoscopic cholecystectomy, he said. A laparoscopic operation was performed in 60% of the patients.

Other possible explanations are that the guidelines don’t capture all relevant indications, like persistent symptoms or pain, or that evolving evidence and guidelines are forcing some surgeons to wait before they change their practice, Dr. Simianu said.

"Nonetheless, we view this as an educational opportunity in our state to give feedback to surgeons in our network," he said.

Notably, the rate of elective and emergency resections per year did not increase significantly over the study period at 28 high-volume hospitals, performing at least 10 colectomies yearly. Data, however, were incomplete or missing, in 30.4% of cases.

Discussant Dr. Conor Delaney, chief of colorectal surgery at University Hospitals Case Medical Center, Cleveland, said it was good to see that the percentage of cases performed for three or more episodes rose across all age groups in the final year of the study, suggesting that the SCOAP intervention is likely working.

"It is still shocking to see 30 or 40% of cases being performed for fewer than three attacks," he said, adding that the 30% of patients who had surgery without appropriate indications "may really be, very much a best-case scenario."

He also asked whether the investigators could identify hospitals inside and outside SCOAP that were less likely to follow guidelines and how they dealt with patients who may have had appropriate single-attack surgery because of nonresolution of symptoms or inadequate drainage.

Dr. Simianu said it wasn’t possible to determine indications for hospitals outside the SCOAP network, but that participating hospitals followed a normal distribution. High-volume hospitals were "sort of middle of the road," while four or five low-volume hospitals were outliers and never or always met indications.

In response to the second query, he said their clinical indications included an "other" category that captured appropriate first-attack patients and that about 1% of surgery was performed for an abscess.

The next phase of research will be to go into surgeons’ offices to speak with surgeons and patients to try and quantify the missing indications, Dr. Simianu said.

Dr. Simianu reported funding from the National Institute of Diabetes and Digestive and Kidney Disease, the Agency for Healthcare Research & Quality, and Life Sciences Discovery Fund. Three co-authors reported serving as an advisor, consultant, or speaker for pharmaceutical and device firms.

The complete manuscript of this study and its presentation at the American Surgical Association’s 134th Annual Meeting, April 2014, in Boston, Mass., is anticipated to be published in the Annals of Surgery, pending editorial review.

pwendling@frontlinemedcom.com

BOSTON – Though progress is being made in reducing surgery for diverticulitis, one in three elective colectomies failed to meet current indications in a prospective study.

Among 1,102 patients in Washington state with an episode-based indication for elective surgery, the proportion with three or more prior episodes of diverticulitis increased from 42% in 2010 to 58% in 2012 (P = .007), while the proportion failing to meet either complication- or episode-based indications decreased from 41.3% to 29.6% (P = .002).

"Still, there remains a significant and persistent portion of cases being done in Washington that do not meet established guidelines," Dr. Vlad V. Simianu said at the annual meeting of the American Surgical Association.

The study involved 2,031 patients having elective resection for diverticulitis in 2010-2012 in 49 hospitals in Washington state’s voluntary Surgical Care and Outcomes Assessment Program (SCOAP), which captures about 80% of the surgical volume in the state. Their mean age was 58.8 years, 24% were younger than 50 years, and most were healthy, with only 27% having a Charlson Comorbidity Index score of 1 or more.

Patrice Wendling/Frontline Medical News

Washington has seen a dramatic threefold increase in elective colectomy for diverticulitis over the last 13 years, despite evolving recommendations, observed Dr. Simianu, a general surgery resident and research fellow at the University of Washington, Seattle. The 2006 American Society of Colon and Rectal Surgeons (ASCRS) guidelines, which were used for the study end points, said elective surgery can be safely delayed until three or more acute episodes of uncomplicated diverticulitis. The ASCRS just updated its guidelines again (Dis. Colon Rectum 2014;57:284-94) and now strongly recommend that the decision to proceed to elective colectomy after recovery from uncomplicated acute diverticulitis "be individualized."

Among all 2,031 patients in the study, a clinical indication for surgery was present in 23.3% (chronic fistula 10.5%, stricture 5.4%, bleeding 2.4%, and other 5%), while 55% of the 1,102 patients with an episode-based indication had three or more episodes.

In 2010, 22% of all patients had at least three prior episodes, 17% had chronic complications, and 23% had neither. This compares with 37.7%, 18%.6%, and 16.7% in 2012.

Possible explanations for the rise in guideline-concordant cases are that surgeons are documenting their indications more carefully or are delaying more operations until three or more acute episodes, Dr. Simianu said. Indeed, there was a significant decrease in the number of cases with missing indications in the clinical record over the study period (38% vs. 27%; P = .007).

The persistence of cases not meeting indications could be because the adoption of laparoscopy has lowered the threshold for surgeons to offer colectomy, similar to what has happened with laparoscopic cholecystectomy, he said. A laparoscopic operation was performed in 60% of the patients.

Other possible explanations are that the guidelines don’t capture all relevant indications, like persistent symptoms or pain, or that evolving evidence and guidelines are forcing some surgeons to wait before they change their practice, Dr. Simianu said.

"Nonetheless, we view this as an educational opportunity in our state to give feedback to surgeons in our network," he said.

Notably, the rate of elective and emergency resections per year did not increase significantly over the study period at 28 high-volume hospitals, performing at least 10 colectomies yearly. Data, however, were incomplete or missing, in 30.4% of cases.

Discussant Dr. Conor Delaney, chief of colorectal surgery at University Hospitals Case Medical Center, Cleveland, said it was good to see that the percentage of cases performed for three or more episodes rose across all age groups in the final year of the study, suggesting that the SCOAP intervention is likely working.

"It is still shocking to see 30 or 40% of cases being performed for fewer than three attacks," he said, adding that the 30% of patients who had surgery without appropriate indications "may really be, very much a best-case scenario."

He also asked whether the investigators could identify hospitals inside and outside SCOAP that were less likely to follow guidelines and how they dealt with patients who may have had appropriate single-attack surgery because of nonresolution of symptoms or inadequate drainage.

Dr. Simianu said it wasn’t possible to determine indications for hospitals outside the SCOAP network, but that participating hospitals followed a normal distribution. High-volume hospitals were "sort of middle of the road," while four or five low-volume hospitals were outliers and never or always met indications.

In response to the second query, he said their clinical indications included an "other" category that captured appropriate first-attack patients and that about 1% of surgery was performed for an abscess.

The next phase of research will be to go into surgeons’ offices to speak with surgeons and patients to try and quantify the missing indications, Dr. Simianu said.

Dr. Simianu reported funding from the National Institute of Diabetes and Digestive and Kidney Disease, the Agency for Healthcare Research & Quality, and Life Sciences Discovery Fund. Three co-authors reported serving as an advisor, consultant, or speaker for pharmaceutical and device firms.

The complete manuscript of this study and its presentation at the American Surgical Association’s 134th Annual Meeting, April 2014, in Boston, Mass., is anticipated to be published in the Annals of Surgery, pending editorial review.

pwendling@frontlinemedcom.com

BOSTON – Preoperative high-dose methylprednisolone dramatically reduced inflammation and enhanced recovery after endovascular aortic repair without increased morbidity in a prospective, double-blinded randomized study.

The primary outcome of modified systemic inflammatory response syndrome (SIRS) developed in 92% on placebo and 27% given methylprednisolone (relative risk, 0.29; P less than .001).

The effect was particularly striking in patients with three or more SIRS criteria, with an overall number needed to treat of 1.5, Dr. Henrik Kehlet said at the annual meeting of the American Surgical Association.

Tempering the postoperative inflammatory response with methylprednisolone also significantly trimmed hospital stays from 3 to 2 days (P less than .001) and morphine requirements from 10 mg to 0 mg (P less than .001).

Medical morbidity was reduced in the methylprednisolone group, but not significantly (23% vs. 36%; P = .1), as was surgical morbidity (20% vs. 21%; P = 1.0).

Importantly, there was no sign of an increase in diagnosed (23% vs. 17%) or treated (1% vs. 3%) endoleaks on computed tomography scan among 146 patients evaluable at 3 months’ follow-up, said Dr. Kehlet, professor of perioperative therapy and head of the surgical pathophysiology section at Rigshospitalet, Copenhagen University, and the oft-described "father" of rapid recovery.

Patrice Wendling/Frontline Medical News

About 40%-60% of patients undergoing endovascular aortic repair (EVAR) will develop postoperative SIRS. Although there is limited surgical injury with the minimally invasive procedure, there is still a stress response because the prosthesis releases proinflammatory mediators from the thrombus in the aortic aneurysm, he explained.

Invited discussant Dr. Basil Pruitt of the division of trauma at the University of Texas Health Science Center, San Antonio, observed that the findings take on added import in light of a 7,500-patient study presented at the recent American College of Cardiology meeting showing that methylprednisolone conferred no significant benefit and was associated with a 15% increased risk of postoperative heart attack plus death when given during cardiac surgery with cardiopulmonary bypass. He also questioned whether the glucocorticosteroid lowered the metabolic rate, as this would impair wound healing, or induced hypoglycemia or glucose intolerance.

"Do those findings and the concerns noted above simply define patient groups in whom methylprednisolone should not be infused preoperatively or, alternatively, do they define a threshold of physiologic or operative insult beyond which the effect of methylprednisolone is outweighed by the magnitude of injury and the associated systemic inflammatory response syndrome?" he asked.

Dr. Kehlet responded that he was unable to determine why that particular abstract found increased morbidity, but noted that the same authors previously published a systematic review (Eur. Heart J. 2008;29:2592-600) supporting reduced morbidity with steroid use in cardiopulmonary bypass.

He added, "The effect may depend on the type of injury, as you mention; cardiopulmonary bypass [is] a very special injury with many mediators of the stress response, compared to other surgical operations. We need more studies. And, finally, if you want to find out about the real outcomes, you must integrate the pharmacologic intervention with an optimized, fast-track setup."

Dr. Kehlet said they did not measure metabolic rate, but that no clinical problem was observed in the limited number of diabetics (n = 22) in their study. This finding is also supported by a huge, multicenter Dutch trial, in which intraoperative high-dose dexamethasone was associated with higher postoperative glucose levels in cardiopulmonary bypass patients, but had no effect on diabetes in subgroup analyses or on the primary endpoint of major morbidity at 30 days (JAMA 2012;308:1761-7).

For Dr. Kehlet's single-center, double-blinded study, 153 patients undergoing EVAR for abdominal aortic aneurysm were randomly assigned to receive a preoperative single dose of placebo or what was described as a single "old-fashioned sepsis dose of methylprednisolone" at 30 mg/kg. The two groups were similar at baseline with respect to age, comorbidities, aneurysm size, thrombus volume, EVAR procedures, and blood loss.

A modified version of SIRS was assessed during the first 4 days after surgery and defined by two or more of the following criteria: fever of more than 38° C (100.4° F) or less than 36° C (96.8° F), heart rate of more than 90 beats per minute, respiratory rate of more than 20 breaths per minute or arterial carbon dioxide tension of less than 4.3 kPa (32.25 mm Hg), and a C-reactive protein (CRP) level of more than 75 mg/L. The traditional fourth SIRS criterion of leukocytosis was replaced with CRP level because glucocorticoids always lead to leukocytosis, Dr. Kehlet noted.

Among 150 evaluable patients, high-dose methylprednisolone almost completely eliminated the proinflammatory activities of interleukin (IL)-6 (186 pg/mL vs. 20 mg/dL; P less than .001), IL-8, and CRP.

Among other inflammatory parameters, methylprednisolone reduced soluble tumor necrosis factor receptor 1 levels, but did not modify the d-dimer response, metalloproteinase-9, or myeloperoxidase, he said.

By 3 months, mortality was similar at 3% in the methylprednisolone group and 1% in the placebo group (P less than .5).

"What we don’t know is what the optimal dose-response relationship is because we used a very high dose and, of course, this was only 150 patients, so the safety issues cannot be answered based on this study, but the results are promising for future large-scale studies in this interesting operation," Dr. Kehlet concluded.

Dr. Kehlet and his coauthors reported no financial disclosures.

The complete manuscript of this study and its presentation at the American Surgical Association’s 134th annual meeting, April 2014, in Boston, is anticipated to be published in the Annals of Surgery, pending editorial review.

pwendling@frontlinemedcom.com

BOSTON – Preoperative high-dose methylprednisolone dramatically reduced inflammation and enhanced recovery after endovascular aortic repair without increased morbidity in a prospective, double-blinded randomized study.

The primary outcome of modified systemic inflammatory response syndrome (SIRS) developed in 92% on placebo and 27% given methylprednisolone (relative risk, 0.29; P less than .001).

The effect was particularly striking in patients with three or more SIRS criteria, with an overall number needed to treat of 1.5, Dr. Henrik Kehlet said at the annual meeting of the American Surgical Association.

Tempering the postoperative inflammatory response with methylprednisolone also significantly trimmed hospital stays from 3 to 2 days (P less than .001) and morphine requirements from 10 mg to 0 mg (P less than .001).

Medical morbidity was reduced in the methylprednisolone group, but not significantly (23% vs. 36%; P = .1), as was surgical morbidity (20% vs. 21%; P = 1.0).

Importantly, there was no sign of an increase in diagnosed (23% vs. 17%) or treated (1% vs. 3%) endoleaks on computed tomography scan among 146 patients evaluable at 3 months’ follow-up, said Dr. Kehlet, professor of perioperative therapy and head of the surgical pathophysiology section at Rigshospitalet, Copenhagen University, and the oft-described "father" of rapid recovery.

Patrice Wendling/Frontline Medical News

About 40%-60% of patients undergoing endovascular aortic repair (EVAR) will develop postoperative SIRS. Although there is limited surgical injury with the minimally invasive procedure, there is still a stress response because the prosthesis releases proinflammatory mediators from the thrombus in the aortic aneurysm, he explained.

Invited discussant Dr. Basil Pruitt of the division of trauma at the University of Texas Health Science Center, San Antonio, observed that the findings take on added import in light of a 7,500-patient study presented at the recent American College of Cardiology meeting showing that methylprednisolone conferred no significant benefit and was associated with a 15% increased risk of postoperative heart attack plus death when given during cardiac surgery with cardiopulmonary bypass. He also questioned whether the glucocorticosteroid lowered the metabolic rate, as this would impair wound healing, or induced hypoglycemia or glucose intolerance.

"Do those findings and the concerns noted above simply define patient groups in whom methylprednisolone should not be infused preoperatively or, alternatively, do they define a threshold of physiologic or operative insult beyond which the effect of methylprednisolone is outweighed by the magnitude of injury and the associated systemic inflammatory response syndrome?" he asked.

Dr. Kehlet responded that he was unable to determine why that particular abstract found increased morbidity, but noted that the same authors previously published a systematic review (Eur. Heart J. 2008;29:2592-600) supporting reduced morbidity with steroid use in cardiopulmonary bypass.

He added, "The effect may depend on the type of injury, as you mention; cardiopulmonary bypass [is] a very special injury with many mediators of the stress response, compared to other surgical operations. We need more studies. And, finally, if you want to find out about the real outcomes, you must integrate the pharmacologic intervention with an optimized, fast-track setup."

Dr. Kehlet said they did not measure metabolic rate, but that no clinical problem was observed in the limited number of diabetics (n = 22) in their study. This finding is also supported by a huge, multicenter Dutch trial, in which intraoperative high-dose dexamethasone was associated with higher postoperative glucose levels in cardiopulmonary bypass patients, but had no effect on diabetes in subgroup analyses or on the primary endpoint of major morbidity at 30 days (JAMA 2012;308:1761-7).

For Dr. Kehlet's single-center, double-blinded study, 153 patients undergoing EVAR for abdominal aortic aneurysm were randomly assigned to receive a preoperative single dose of placebo or what was described as a single "old-fashioned sepsis dose of methylprednisolone" at 30 mg/kg. The two groups were similar at baseline with respect to age, comorbidities, aneurysm size, thrombus volume, EVAR procedures, and blood loss.

A modified version of SIRS was assessed during the first 4 days after surgery and defined by two or more of the following criteria: fever of more than 38° C (100.4° F) or less than 36° C (96.8° F), heart rate of more than 90 beats per minute, respiratory rate of more than 20 breaths per minute or arterial carbon dioxide tension of less than 4.3 kPa (32.25 mm Hg), and a C-reactive protein (CRP) level of more than 75 mg/L. The traditional fourth SIRS criterion of leukocytosis was replaced with CRP level because glucocorticoids always lead to leukocytosis, Dr. Kehlet noted.

Among 150 evaluable patients, high-dose methylprednisolone almost completely eliminated the proinflammatory activities of interleukin (IL)-6 (186 pg/mL vs. 20 mg/dL; P less than .001), IL-8, and CRP.

Among other inflammatory parameters, methylprednisolone reduced soluble tumor necrosis factor receptor 1 levels, but did not modify the d-dimer response, metalloproteinase-9, or myeloperoxidase, he said.

By 3 months, mortality was similar at 3% in the methylprednisolone group and 1% in the placebo group (P less than .5).

"What we don’t know is what the optimal dose-response relationship is because we used a very high dose and, of course, this was only 150 patients, so the safety issues cannot be answered based on this study, but the results are promising for future large-scale studies in this interesting operation," Dr. Kehlet concluded.

Dr. Kehlet and his coauthors reported no financial disclosures.

The complete manuscript of this study and its presentation at the American Surgical Association’s 134th annual meeting, April 2014, in Boston, is anticipated to be published in the Annals of Surgery, pending editorial review.

pwendling@frontlinemedcom.com

BOSTON – Preoperative high-dose methylprednisolone dramatically reduced inflammation and enhanced recovery after endovascular aortic repair without increased morbidity in a prospective, double-blinded randomized study.

The primary outcome of modified systemic inflammatory response syndrome (SIRS) developed in 92% on placebo and 27% given methylprednisolone (relative risk, 0.29; P less than .001).

The effect was particularly striking in patients with three or more SIRS criteria, with an overall number needed to treat of 1.5, Dr. Henrik Kehlet said at the annual meeting of the American Surgical Association.

Tempering the postoperative inflammatory response with methylprednisolone also significantly trimmed hospital stays from 3 to 2 days (P less than .001) and morphine requirements from 10 mg to 0 mg (P less than .001).

Medical morbidity was reduced in the methylprednisolone group, but not significantly (23% vs. 36%; P = .1), as was surgical morbidity (20% vs. 21%; P = 1.0).

Importantly, there was no sign of an increase in diagnosed (23% vs. 17%) or treated (1% vs. 3%) endoleaks on computed tomography scan among 146 patients evaluable at 3 months’ follow-up, said Dr. Kehlet, professor of perioperative therapy and head of the surgical pathophysiology section at Rigshospitalet, Copenhagen University, and the oft-described "father" of rapid recovery.

Patrice Wendling/Frontline Medical News

About 40%-60% of patients undergoing endovascular aortic repair (EVAR) will develop postoperative SIRS. Although there is limited surgical injury with the minimally invasive procedure, there is still a stress response because the prosthesis releases proinflammatory mediators from the thrombus in the aortic aneurysm, he explained.

Invited discussant Dr. Basil Pruitt of the division of trauma at the University of Texas Health Science Center, San Antonio, observed that the findings take on added import in light of a 7,500-patient study presented at the recent American College of Cardiology meeting showing that methylprednisolone conferred no significant benefit and was associated with a 15% increased risk of postoperative heart attack plus death when given during cardiac surgery with cardiopulmonary bypass. He also questioned whether the glucocorticosteroid lowered the metabolic rate, as this would impair wound healing, or induced hypoglycemia or glucose intolerance.

"Do those findings and the concerns noted above simply define patient groups in whom methylprednisolone should not be infused preoperatively or, alternatively, do they define a threshold of physiologic or operative insult beyond which the effect of methylprednisolone is outweighed by the magnitude of injury and the associated systemic inflammatory response syndrome?" he asked.

Dr. Kehlet responded that he was unable to determine why that particular abstract found increased morbidity, but noted that the same authors previously published a systematic review (Eur. Heart J. 2008;29:2592-600) supporting reduced morbidity with steroid use in cardiopulmonary bypass.

He added, "The effect may depend on the type of injury, as you mention; cardiopulmonary bypass [is] a very special injury with many mediators of the stress response, compared to other surgical operations. We need more studies. And, finally, if you want to find out about the real outcomes, you must integrate the pharmacologic intervention with an optimized, fast-track setup."

Dr. Kehlet said they did not measure metabolic rate, but that no clinical problem was observed in the limited number of diabetics (n = 22) in their study. This finding is also supported by a huge, multicenter Dutch trial, in which intraoperative high-dose dexamethasone was associated with higher postoperative glucose levels in cardiopulmonary bypass patients, but had no effect on diabetes in subgroup analyses or on the primary endpoint of major morbidity at 30 days (JAMA 2012;308:1761-7).

For Dr. Kehlet's single-center, double-blinded study, 153 patients undergoing EVAR for abdominal aortic aneurysm were randomly assigned to receive a preoperative single dose of placebo or what was described as a single "old-fashioned sepsis dose of methylprednisolone" at 30 mg/kg. The two groups were similar at baseline with respect to age, comorbidities, aneurysm size, thrombus volume, EVAR procedures, and blood loss.

A modified version of SIRS was assessed during the first 4 days after surgery and defined by two or more of the following criteria: fever of more than 38° C (100.4° F) or less than 36° C (96.8° F), heart rate of more than 90 beats per minute, respiratory rate of more than 20 breaths per minute or arterial carbon dioxide tension of less than 4.3 kPa (32.25 mm Hg), and a C-reactive protein (CRP) level of more than 75 mg/L. The traditional fourth SIRS criterion of leukocytosis was replaced with CRP level because glucocorticoids always lead to leukocytosis, Dr. Kehlet noted.

Among 150 evaluable patients, high-dose methylprednisolone almost completely eliminated the proinflammatory activities of interleukin (IL)-6 (186 pg/mL vs. 20 mg/dL; P less than .001), IL-8, and CRP.

Among other inflammatory parameters, methylprednisolone reduced soluble tumor necrosis factor receptor 1 levels, but did not modify the d-dimer response, metalloproteinase-9, or myeloperoxidase, he said.

By 3 months, mortality was similar at 3% in the methylprednisolone group and 1% in the placebo group (P less than .5).

"What we don’t know is what the optimal dose-response relationship is because we used a very high dose and, of course, this was only 150 patients, so the safety issues cannot be answered based on this study, but the results are promising for future large-scale studies in this interesting operation," Dr. Kehlet concluded.

Dr. Kehlet and his coauthors reported no financial disclosures.

The complete manuscript of this study and its presentation at the American Surgical Association’s 134th annual meeting, April 2014, in Boston, is anticipated to be published in the Annals of Surgery, pending editorial review.

pwendling@frontlinemedcom.com

BOSTON – The risks of readmission and emergency surgery are low for patients with acute diverticulitis initially managed nonoperatively, a population-based, competing risk analysis found.

At a median of 3.9 years (range, 1.7-6.4 years) after discharge among 14,124 patients, only 8% required urgent readmission. Of these, 22% went on to urgent surgery and 20%, to elective surgery after additional episodes.

Among the remaining 12,981 patients with no urgent readmissions, 9% went on to elective surgery, 13% died of other causes, and 78% had no events in follow-up, Dr. Debbie Li said at the annual meeting of the American Surgical Association.

Patrice Wendling/Frontline Medical News

The 5-year cumulative incidence was 9% for readmission, 1.9% for emergency surgery, and 14.1% for all-cause mortality.

"Elective colectomy may not be warranted for the majority of patients in the absence of chronic symptoms or multiple frequent recurrences," she said.

Elective colectomy has traditionally been recommended for patients at high risk for future recurrence and emergency surgery based on the indications of age less than 50 years, complicated disease including perforation and abscess, and two or more episodes of uncomplicated disease. Evidence is building, however, to challenge these indications, and guidelines are evolving, said Dr. Li, a general surgery resident at the University of Toronto.

The current study used administrative data to identify all patients in Ontario, Canada, treated nonoperatively at first hospitalization for diverticulitis from 2002 to 2012. Time-to-event and competing-risk regression analyses were performed, with data adjusted for such potential confounders as sex, medical comorbidity, neighborhood income quintile, rural residency, and calendar year of index admission.

Data are limited on the natural history of diverticulitis, and the few population-based studies that have been conducted have not accounted for competing risks such as elective colectomy or death, Dr. Li said.

The patients’ median age was 59 years, 79% had uncomplicated index disease, 18% had complicated disease (abscess, fistula, and perforation) with no abscess drain, and 3% had complicated disease with an abscess drain.

Young patients had more readmissions than those 50 years and older (10.5% vs. 8.4%; P less than .001), but not more emergency surgery (1.8% vs. 2.0%; P = .52), she said.

For patients older than 50 years, the risk of death by other causes was 10 times the risk of an emergency surgery for diverticulitis (19.5% vs. 2%).

Patients with complicated rather than uncomplicated index disease had more readmissions (12% vs. 8.2%; P less than .001) and urgent surgery (4.3% vs. 1.4%; P less than .001).

In adjusted analyses, young age was associated with more readmissions (hazard ratio, 1.24), but not subsequent emergency surgery (HR, 0.83). Complicated disease (HR, 3.15) and multiple recurrences (HR, 2.41) predicted an increased risk for emergency surgery.

"Young age, complicated disease, and multiple recurrences do infer increased relative risk, but the vast majority (85%) of such patients remain recurrence free," Dr. Li said.

Invited discussant Dr. David Schoetz, professor of surgery, Tufts University, Boston, said, "While it’s reassuring that even complicated diverticulitis can be safely managed without subsequent operation, there still must be a subgroup who should be offered early surgery."

With disease severity more common in younger patients and overall mortality less than 1%, perhaps aggressive surgery would be justified in those younger than 50 years, he suggested.

Dr. Li responded that an administrative database is unable to capture clinical nuances such as which patients had ongoing symptoms, chronic persistent disease, or reduced quality of life, and that a prospective trial would be needed to identify which subgroup of patients will need aggressive surgery.

Older patients, those with more complicated disease, and those with greater medical comorbidities are more likely to undergo urgent surgery, according to ongoing analyses of roughly 4,000 patients, treated during the same time period, but excluded from the current analysis because they underwent surgery at index admission. Previously published work also suggests that patients with a higher body mass index have poorer outcomes.

A recent systematic review of diverticulitis surgery (JAMA Surg. 2014;149:292-303) reported that complicated recurrence after an episode of uncomplicated diverticulitis is rare, occurring in less than 5% of cases. The authors called for existing guidelines to be updated and said that decisions to proceed with elective surgery should be based instead on patient-reported frequency and severity of symptoms.

The complete manuscript of this study and its presentation at the American Surgical Association’s 134th annual meeting, April 2014, in Boston, is anticipated to be published in the Annals of Surgery, pending editorial review.

Dr. Li and her coauthors reported no relevant financial disclosures.

pwendling@frontlinemedcom.com

BOSTON – The risks of readmission and emergency surgery are low for patients with acute diverticulitis initially managed nonoperatively, a population-based, competing risk analysis found.

At a median of 3.9 years (range, 1.7-6.4 years) after discharge among 14,124 patients, only 8% required urgent readmission. Of these, 22% went on to urgent surgery and 20%, to elective surgery after additional episodes.

Among the remaining 12,981 patients with no urgent readmissions, 9% went on to elective surgery, 13% died of other causes, and 78% had no events in follow-up, Dr. Debbie Li said at the annual meeting of the American Surgical Association.

Patrice Wendling/Frontline Medical News

The 5-year cumulative incidence was 9% for readmission, 1.9% for emergency surgery, and 14.1% for all-cause mortality.

"Elective colectomy may not be warranted for the majority of patients in the absence of chronic symptoms or multiple frequent recurrences," she said.

Elective colectomy has traditionally been recommended for patients at high risk for future recurrence and emergency surgery based on the indications of age less than 50 years, complicated disease including perforation and abscess, and two or more episodes of uncomplicated disease. Evidence is building, however, to challenge these indications, and guidelines are evolving, said Dr. Li, a general surgery resident at the University of Toronto.

The current study used administrative data to identify all patients in Ontario, Canada, treated nonoperatively at first hospitalization for diverticulitis from 2002 to 2012. Time-to-event and competing-risk regression analyses were performed, with data adjusted for such potential confounders as sex, medical comorbidity, neighborhood income quintile, rural residency, and calendar year of index admission.

Data are limited on the natural history of diverticulitis, and the few population-based studies that have been conducted have not accounted for competing risks such as elective colectomy or death, Dr. Li said.

The patients’ median age was 59 years, 79% had uncomplicated index disease, 18% had complicated disease (abscess, fistula, and perforation) with no abscess drain, and 3% had complicated disease with an abscess drain.

Young patients had more readmissions than those 50 years and older (10.5% vs. 8.4%; P less than .001), but not more emergency surgery (1.8% vs. 2.0%; P = .52), she said.

For patients older than 50 years, the risk of death by other causes was 10 times the risk of an emergency surgery for diverticulitis (19.5% vs. 2%).

Patients with complicated rather than uncomplicated index disease had more readmissions (12% vs. 8.2%; P less than .001) and urgent surgery (4.3% vs. 1.4%; P less than .001).

In adjusted analyses, young age was associated with more readmissions (hazard ratio, 1.24), but not subsequent emergency surgery (HR, 0.83). Complicated disease (HR, 3.15) and multiple recurrences (HR, 2.41) predicted an increased risk for emergency surgery.

"Young age, complicated disease, and multiple recurrences do infer increased relative risk, but the vast majority (85%) of such patients remain recurrence free," Dr. Li said.

Invited discussant Dr. David Schoetz, professor of surgery, Tufts University, Boston, said, "While it’s reassuring that even complicated diverticulitis can be safely managed without subsequent operation, there still must be a subgroup who should be offered early surgery."

With disease severity more common in younger patients and overall mortality less than 1%, perhaps aggressive surgery would be justified in those younger than 50 years, he suggested.

Dr. Li responded that an administrative database is unable to capture clinical nuances such as which patients had ongoing symptoms, chronic persistent disease, or reduced quality of life, and that a prospective trial would be needed to identify which subgroup of patients will need aggressive surgery.

Older patients, those with more complicated disease, and those with greater medical comorbidities are more likely to undergo urgent surgery, according to ongoing analyses of roughly 4,000 patients, treated during the same time period, but excluded from the current analysis because they underwent surgery at index admission. Previously published work also suggests that patients with a higher body mass index have poorer outcomes.

A recent systematic review of diverticulitis surgery (JAMA Surg. 2014;149:292-303) reported that complicated recurrence after an episode of uncomplicated diverticulitis is rare, occurring in less than 5% of cases. The authors called for existing guidelines to be updated and said that decisions to proceed with elective surgery should be based instead on patient-reported frequency and severity of symptoms.

The complete manuscript of this study and its presentation at the American Surgical Association’s 134th annual meeting, April 2014, in Boston, is anticipated to be published in the Annals of Surgery, pending editorial review.

Dr. Li and her coauthors reported no relevant financial disclosures.

pwendling@frontlinemedcom.com

BOSTON – The risks of readmission and emergency surgery are low for patients with acute diverticulitis initially managed nonoperatively, a population-based, competing risk analysis found.

At a median of 3.9 years (range, 1.7-6.4 years) after discharge among 14,124 patients, only 8% required urgent readmission. Of these, 22% went on to urgent surgery and 20%, to elective surgery after additional episodes.

Among the remaining 12,981 patients with no urgent readmissions, 9% went on to elective surgery, 13% died of other causes, and 78% had no events in follow-up, Dr. Debbie Li said at the annual meeting of the American Surgical Association.

Patrice Wendling/Frontline Medical News

The 5-year cumulative incidence was 9% for readmission, 1.9% for emergency surgery, and 14.1% for all-cause mortality.

"Elective colectomy may not be warranted for the majority of patients in the absence of chronic symptoms or multiple frequent recurrences," she said.

Elective colectomy has traditionally been recommended for patients at high risk for future recurrence and emergency surgery based on the indications of age less than 50 years, complicated disease including perforation and abscess, and two or more episodes of uncomplicated disease. Evidence is building, however, to challenge these indications, and guidelines are evolving, said Dr. Li, a general surgery resident at the University of Toronto.

The current study used administrative data to identify all patients in Ontario, Canada, treated nonoperatively at first hospitalization for diverticulitis from 2002 to 2012. Time-to-event and competing-risk regression analyses were performed, with data adjusted for such potential confounders as sex, medical comorbidity, neighborhood income quintile, rural residency, and calendar year of index admission.

Data are limited on the natural history of diverticulitis, and the few population-based studies that have been conducted have not accounted for competing risks such as elective colectomy or death, Dr. Li said.

The patients’ median age was 59 years, 79% had uncomplicated index disease, 18% had complicated disease (abscess, fistula, and perforation) with no abscess drain, and 3% had complicated disease with an abscess drain.

Young patients had more readmissions than those 50 years and older (10.5% vs. 8.4%; P less than .001), but not more emergency surgery (1.8% vs. 2.0%; P = .52), she said.

For patients older than 50 years, the risk of death by other causes was 10 times the risk of an emergency surgery for diverticulitis (19.5% vs. 2%).

Patients with complicated rather than uncomplicated index disease had more readmissions (12% vs. 8.2%; P less than .001) and urgent surgery (4.3% vs. 1.4%; P less than .001).

In adjusted analyses, young age was associated with more readmissions (hazard ratio, 1.24), but not subsequent emergency surgery (HR, 0.83). Complicated disease (HR, 3.15) and multiple recurrences (HR, 2.41) predicted an increased risk for emergency surgery.

"Young age, complicated disease, and multiple recurrences do infer increased relative risk, but the vast majority (85%) of such patients remain recurrence free," Dr. Li said.

Invited discussant Dr. David Schoetz, professor of surgery, Tufts University, Boston, said, "While it’s reassuring that even complicated diverticulitis can be safely managed without subsequent operation, there still must be a subgroup who should be offered early surgery."

With disease severity more common in younger patients and overall mortality less than 1%, perhaps aggressive surgery would be justified in those younger than 50 years, he suggested.

Dr. Li responded that an administrative database is unable to capture clinical nuances such as which patients had ongoing symptoms, chronic persistent disease, or reduced quality of life, and that a prospective trial would be needed to identify which subgroup of patients will need aggressive surgery.

Older patients, those with more complicated disease, and those with greater medical comorbidities are more likely to undergo urgent surgery, according to ongoing analyses of roughly 4,000 patients, treated during the same time period, but excluded from the current analysis because they underwent surgery at index admission. Previously published work also suggests that patients with a higher body mass index have poorer outcomes.

A recent systematic review of diverticulitis surgery (JAMA Surg. 2014;149:292-303) reported that complicated recurrence after an episode of uncomplicated diverticulitis is rare, occurring in less than 5% of cases. The authors called for existing guidelines to be updated and said that decisions to proceed with elective surgery should be based instead on patient-reported frequency and severity of symptoms.

The complete manuscript of this study and its presentation at the American Surgical Association’s 134th annual meeting, April 2014, in Boston, is anticipated to be published in the Annals of Surgery, pending editorial review.

Dr. Li and her coauthors reported no relevant financial disclosures.

pwendling@frontlinemedcom.com