General Surgery

CORONADO, CALIF. – Robotic thyroid surgery performed at the highest-volume center had a lower complication rate and shorter hospital stays than did the other hospitals in the study, results from a study of national data showed.

The Food and Drug Administration suspended its approval of robotic thyroidectomy in October 2011, citing risks and lack of adequate safety and outcomes research. The researchers observed a drop in the number of robotic thyroidectomies performed in the United States after the FDA issued its restriction in 2011. “That move appears to have made a pretty large impact on the projected growth of this procedure,” Dr. Hinson said at the annual meeting of the American Thyroid Association.

Doug Brunk/Frontline Medical News

In Korea, where the procedure gained recognition in the early 2000s, “a lot of people cite cultural factors, such as aversion to neck scars, lean body habitus, and low body mass index make the procedure more feasible, so it’s a very popular approach there,” said Dr. Hinson, a research fellow at the University of Arkansas for Medical Sciences, Little Rock. In addition, until recently, there were financial incentives to do thyroid surgery with robotic assistance in the Korean health care system. “That said, in the United States, the cultural forces are distinct, our patients are larger and heavier on average, and most patients don’t have a strong aversion to a neck scar. The procedure is paid the same with or without the robot, but takes on average three times as long with the robot. Surgeons have such great results with open techniques that it’s very hard to make an argument that robotic surgery improves outcomes that much.”

In what is believed to be the largest study of its kind in the United States, Dr. Hinson and his associates evaluated data from the University HealthSystem Consortium (UHC) and an additional academic center which did not participate in the UHC discharge database. The study included 484 patients who underwent robotic thyroidectomy in the United States between 2009 and 2013. Data were compiled from discharge summaries at 110 university medical centers and another 140 of their affiliated hospitals. The researchers collected data on age, gender, race, insurance, comorbidities, complications, discharge status, length of stay, and ICU admission.

Dr. Hinson and his associates found that, compared with outpatients, inpatients had significantly greater numbers of comorbidities and complications. The most common comorbidity was hypertension (12 cases), followed by chronic pulmonary disease (8 cases) and diabetes with complications and comorbidities (6 cases). The median hospital length of stay was 1 day for inpatients, and 57% of outpatients stayed overnight. In addition, 8% of inpatients required an ICU stay, while 99% of outpatients and 97% of inpatients were discharged to home. The highest-volume institution in the data set performed most of the outpatient cases and had a lower rate of complications. “That makes sense,” Dr. Hinson said. “If you’re proficient, you’re more likely to have learned how to avoid complications.

“The approach to the neck has largely been unchanged over the last 100 years,” he said. While several other surgical fields have found highly successful and popular niches for endoscopic and/or robotic technology, the uses for these services has been largely limited in head and neck surgery. The da Vinci system was largely created with abdominal surgery in mind. As surgical techniques and robotic technology develop, systemic applications for this technology, previously unrecognized, may emerge. A lot of academic centers were/are hopeful that robotic thyroid surgery may provide the gateway for advancement of such techniques in the head and neck region.”

He reported having no financial disclosures.

[email protected]

On Twitter @dougbrunk

CORONADO, CALIF. – Robotic thyroid surgery performed at the highest-volume center had a lower complication rate and shorter hospital stays than did the other hospitals in the study, results from a study of national data showed.

The Food and Drug Administration suspended its approval of robotic thyroidectomy in October 2011, citing risks and lack of adequate safety and outcomes research. The researchers observed a drop in the number of robotic thyroidectomies performed in the United States after the FDA issued its restriction in 2011. “That move appears to have made a pretty large impact on the projected growth of this procedure,” Dr. Hinson said at the annual meeting of the American Thyroid Association.

Doug Brunk/Frontline Medical News

In Korea, where the procedure gained recognition in the early 2000s, “a lot of people cite cultural factors, such as aversion to neck scars, lean body habitus, and low body mass index make the procedure more feasible, so it’s a very popular approach there,” said Dr. Hinson, a research fellow at the University of Arkansas for Medical Sciences, Little Rock. In addition, until recently, there were financial incentives to do thyroid surgery with robotic assistance in the Korean health care system. “That said, in the United States, the cultural forces are distinct, our patients are larger and heavier on average, and most patients don’t have a strong aversion to a neck scar. The procedure is paid the same with or without the robot, but takes on average three times as long with the robot. Surgeons have such great results with open techniques that it’s very hard to make an argument that robotic surgery improves outcomes that much.”

In what is believed to be the largest study of its kind in the United States, Dr. Hinson and his associates evaluated data from the University HealthSystem Consortium (UHC) and an additional academic center which did not participate in the UHC discharge database. The study included 484 patients who underwent robotic thyroidectomy in the United States between 2009 and 2013. Data were compiled from discharge summaries at 110 university medical centers and another 140 of their affiliated hospitals. The researchers collected data on age, gender, race, insurance, comorbidities, complications, discharge status, length of stay, and ICU admission.

Dr. Hinson and his associates found that, compared with outpatients, inpatients had significantly greater numbers of comorbidities and complications. The most common comorbidity was hypertension (12 cases), followed by chronic pulmonary disease (8 cases) and diabetes with complications and comorbidities (6 cases). The median hospital length of stay was 1 day for inpatients, and 57% of outpatients stayed overnight. In addition, 8% of inpatients required an ICU stay, while 99% of outpatients and 97% of inpatients were discharged to home. The highest-volume institution in the data set performed most of the outpatient cases and had a lower rate of complications. “That makes sense,” Dr. Hinson said. “If you’re proficient, you’re more likely to have learned how to avoid complications.

“The approach to the neck has largely been unchanged over the last 100 years,” he said. While several other surgical fields have found highly successful and popular niches for endoscopic and/or robotic technology, the uses for these services has been largely limited in head and neck surgery. The da Vinci system was largely created with abdominal surgery in mind. As surgical techniques and robotic technology develop, systemic applications for this technology, previously unrecognized, may emerge. A lot of academic centers were/are hopeful that robotic thyroid surgery may provide the gateway for advancement of such techniques in the head and neck region.”

He reported having no financial disclosures.

[email protected]

On Twitter @dougbrunk

CORONADO, CALIF. – Robotic thyroid surgery performed at the highest-volume center had a lower complication rate and shorter hospital stays than did the other hospitals in the study, results from a study of national data showed.

The Food and Drug Administration suspended its approval of robotic thyroidectomy in October 2011, citing risks and lack of adequate safety and outcomes research. The researchers observed a drop in the number of robotic thyroidectomies performed in the United States after the FDA issued its restriction in 2011. “That move appears to have made a pretty large impact on the projected growth of this procedure,” Dr. Hinson said at the annual meeting of the American Thyroid Association.

Doug Brunk/Frontline Medical News

In Korea, where the procedure gained recognition in the early 2000s, “a lot of people cite cultural factors, such as aversion to neck scars, lean body habitus, and low body mass index make the procedure more feasible, so it’s a very popular approach there,” said Dr. Hinson, a research fellow at the University of Arkansas for Medical Sciences, Little Rock. In addition, until recently, there were financial incentives to do thyroid surgery with robotic assistance in the Korean health care system. “That said, in the United States, the cultural forces are distinct, our patients are larger and heavier on average, and most patients don’t have a strong aversion to a neck scar. The procedure is paid the same with or without the robot, but takes on average three times as long with the robot. Surgeons have such great results with open techniques that it’s very hard to make an argument that robotic surgery improves outcomes that much.”

In what is believed to be the largest study of its kind in the United States, Dr. Hinson and his associates evaluated data from the University HealthSystem Consortium (UHC) and an additional academic center which did not participate in the UHC discharge database. The study included 484 patients who underwent robotic thyroidectomy in the United States between 2009 and 2013. Data were compiled from discharge summaries at 110 university medical centers and another 140 of their affiliated hospitals. The researchers collected data on age, gender, race, insurance, comorbidities, complications, discharge status, length of stay, and ICU admission.

Dr. Hinson and his associates found that, compared with outpatients, inpatients had significantly greater numbers of comorbidities and complications. The most common comorbidity was hypertension (12 cases), followed by chronic pulmonary disease (8 cases) and diabetes with complications and comorbidities (6 cases). The median hospital length of stay was 1 day for inpatients, and 57% of outpatients stayed overnight. In addition, 8% of inpatients required an ICU stay, while 99% of outpatients and 97% of inpatients were discharged to home. The highest-volume institution in the data set performed most of the outpatient cases and had a lower rate of complications. “That makes sense,” Dr. Hinson said. “If you’re proficient, you’re more likely to have learned how to avoid complications.

“The approach to the neck has largely been unchanged over the last 100 years,” he said. While several other surgical fields have found highly successful and popular niches for endoscopic and/or robotic technology, the uses for these services has been largely limited in head and neck surgery. The da Vinci system was largely created with abdominal surgery in mind. As surgical techniques and robotic technology develop, systemic applications for this technology, previously unrecognized, may emerge. A lot of academic centers were/are hopeful that robotic thyroid surgery may provide the gateway for advancement of such techniques in the head and neck region.”

He reported having no financial disclosures.

[email protected]

On Twitter @dougbrunk

SAN FRANCISCO – At least 25% of CT scans to diagnose appendicitis were unnecessary, potentially resulting in $1.8 million in costs at one institution and up to four new cancers from the radiation exposure, a retrospective study suggests.

The review of 1,054 patients who underwent appendectomy at the University of California, Davis, in 2005-2010 focused on costs for the patients who had high Alvarado scores, a clinical scoring system used to diagnose appendicitis, before they underwent appendectomy. CT scans to help diagnose appendicitis were performed on 77% of all patients.

Records showed that 26% of patients had an Alvarado score of 8-10, meaning that appendicitis was highly likely. CT was performed on 70% of patients with an Alvarado score of 8 and 77% of patients with a score of 9-10, comprising nearly 25% of all CT scans. That resulted in an estimated $1,813,399 in unnecessary costs for imaging, Dr. Adam Dougherty and his associates reported at the annual clinical congress of the American College of Surgeons.

This “overutilization” of CT scans delivered more than 4,009 mSv in unnecessary radiation exposure, averaging 19.75 mSV per scan, which is 20 times the annual limit suggested for safety, said Dr. Dougherty of the university. That excess radiation could be expected to produce up to four new cancers down the line, resulting in additional costs, he said.

The investigators also looked at the 9% of patients with low Alvarado scores, meaning that appendicitis was unlikely. CT scans were performed in 75% of patients with a score of 0-3 and 80% of patients with an Alvarado score of 4. In this subgroup, 24% showed normal/early pathology on appendectomy, which “argues against imaging and surgical treatment,” Dr. Dougherty said. The 44 CT scans in this subgroup resulted in an estimated $393,052 in unnecessary costs, he said.

That doesn’t include additional costs that could be expected from imaging, such as wait time, appendectomy and its sequelae, and potential workups of incidentalomas in the low-risk group, he added.

Previous studies have shown that a comprehensive clinical exam is as accurate as CT in diagnosing appendicitis, and that clinical assessment unaided by CT can reliably diagnose acute appendicitis, Dr. Dougherty said.

With a 72% increase in abdominal CT scans documented in other U.S. data from 2000 to 2005, he called for a “necessary, fundamental culture change” to restrain resource utilization “in order to maximize the value of the health care dollar while doing what is best for the patient.”

The investigators proposed a clinical pathway for the workup of suspected appendicitis that places greater emphasis on ultrasound imaging and conservative pathways, such as 23-hour admission for observation and next-day follow-up.

In the study, ultrasonography was underutilized across all subgroups as a viable alternative to CT scans, he said.

Dr. Dougherty reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – At least 25% of CT scans to diagnose appendicitis were unnecessary, potentially resulting in $1.8 million in costs at one institution and up to four new cancers from the radiation exposure, a retrospective study suggests.

The review of 1,054 patients who underwent appendectomy at the University of California, Davis, in 2005-2010 focused on costs for the patients who had high Alvarado scores, a clinical scoring system used to diagnose appendicitis, before they underwent appendectomy. CT scans to help diagnose appendicitis were performed on 77% of all patients.

Records showed that 26% of patients had an Alvarado score of 8-10, meaning that appendicitis was highly likely. CT was performed on 70% of patients with an Alvarado score of 8 and 77% of patients with a score of 9-10, comprising nearly 25% of all CT scans. That resulted in an estimated $1,813,399 in unnecessary costs for imaging, Dr. Adam Dougherty and his associates reported at the annual clinical congress of the American College of Surgeons.

This “overutilization” of CT scans delivered more than 4,009 mSv in unnecessary radiation exposure, averaging 19.75 mSV per scan, which is 20 times the annual limit suggested for safety, said Dr. Dougherty of the university. That excess radiation could be expected to produce up to four new cancers down the line, resulting in additional costs, he said.

The investigators also looked at the 9% of patients with low Alvarado scores, meaning that appendicitis was unlikely. CT scans were performed in 75% of patients with a score of 0-3 and 80% of patients with an Alvarado score of 4. In this subgroup, 24% showed normal/early pathology on appendectomy, which “argues against imaging and surgical treatment,” Dr. Dougherty said. The 44 CT scans in this subgroup resulted in an estimated $393,052 in unnecessary costs, he said.

That doesn’t include additional costs that could be expected from imaging, such as wait time, appendectomy and its sequelae, and potential workups of incidentalomas in the low-risk group, he added.

Previous studies have shown that a comprehensive clinical exam is as accurate as CT in diagnosing appendicitis, and that clinical assessment unaided by CT can reliably diagnose acute appendicitis, Dr. Dougherty said.

With a 72% increase in abdominal CT scans documented in other U.S. data from 2000 to 2005, he called for a “necessary, fundamental culture change” to restrain resource utilization “in order to maximize the value of the health care dollar while doing what is best for the patient.”

The investigators proposed a clinical pathway for the workup of suspected appendicitis that places greater emphasis on ultrasound imaging and conservative pathways, such as 23-hour admission for observation and next-day follow-up.

In the study, ultrasonography was underutilized across all subgroups as a viable alternative to CT scans, he said.

Dr. Dougherty reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – At least 25% of CT scans to diagnose appendicitis were unnecessary, potentially resulting in $1.8 million in costs at one institution and up to four new cancers from the radiation exposure, a retrospective study suggests.

The review of 1,054 patients who underwent appendectomy at the University of California, Davis, in 2005-2010 focused on costs for the patients who had high Alvarado scores, a clinical scoring system used to diagnose appendicitis, before they underwent appendectomy. CT scans to help diagnose appendicitis were performed on 77% of all patients.

Records showed that 26% of patients had an Alvarado score of 8-10, meaning that appendicitis was highly likely. CT was performed on 70% of patients with an Alvarado score of 8 and 77% of patients with a score of 9-10, comprising nearly 25% of all CT scans. That resulted in an estimated $1,813,399 in unnecessary costs for imaging, Dr. Adam Dougherty and his associates reported at the annual clinical congress of the American College of Surgeons.

This “overutilization” of CT scans delivered more than 4,009 mSv in unnecessary radiation exposure, averaging 19.75 mSV per scan, which is 20 times the annual limit suggested for safety, said Dr. Dougherty of the university. That excess radiation could be expected to produce up to four new cancers down the line, resulting in additional costs, he said.

The investigators also looked at the 9% of patients with low Alvarado scores, meaning that appendicitis was unlikely. CT scans were performed in 75% of patients with a score of 0-3 and 80% of patients with an Alvarado score of 4. In this subgroup, 24% showed normal/early pathology on appendectomy, which “argues against imaging and surgical treatment,” Dr. Dougherty said. The 44 CT scans in this subgroup resulted in an estimated $393,052 in unnecessary costs, he said.

That doesn’t include additional costs that could be expected from imaging, such as wait time, appendectomy and its sequelae, and potential workups of incidentalomas in the low-risk group, he added.

Previous studies have shown that a comprehensive clinical exam is as accurate as CT in diagnosing appendicitis, and that clinical assessment unaided by CT can reliably diagnose acute appendicitis, Dr. Dougherty said.

With a 72% increase in abdominal CT scans documented in other U.S. data from 2000 to 2005, he called for a “necessary, fundamental culture change” to restrain resource utilization “in order to maximize the value of the health care dollar while doing what is best for the patient.”

The investigators proposed a clinical pathway for the workup of suspected appendicitis that places greater emphasis on ultrasound imaging and conservative pathways, such as 23-hour admission for observation and next-day follow-up.

In the study, ultrasonography was underutilized across all subgroups as a viable alternative to CT scans, he said.

Dr. Dougherty reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Patients who did not undergo elective surgical resection after successful percutaneous drainage of a diverticular-associated abscess had low rates of recurrent diverticulitis in a retrospective study, a finding that suggests nonoperative management is a reasonable option in such patients, Dr. Tarek K. Jalouta said.

Percutaneous drainage of diverticular-associated abscess resolved symptoms in 118 of 165 (72%) patients who underwent the procedure at two teaching hospitals in 2001-2013. Sixty of the patients with successful drainage did not undergo elective surgical resection, and eight of these died within a year of the drainage procedure.

Among the remaining 52 patients who had nonoperative management, 72% remained free of diverticulitis after 5 years, Dr. Jalouta and his associates reported at the annual clinical congress of the American College of Surgeons.

“A significant number of patients successfully recover from complicated diverticulitis following percutaneous drainage,” Dr. Jalouta said. “Subsequent nonoperative management carries an acceptable risk for recurrent episodes and may be considered as a reasonable management option.”

All patients diagnosed with diverticular-associated abscess received IV antibiotics within 24-48 hours of diagnosis. The decision to perform percutaneous drainage was at the discretion of the consulting surgeon and the interventional radiologist.

Practice parameters issued by the American Society of Colon and Rectal Surgeons in 2014 suggest that elective colectomy “should typically be advised” following successful medical treatment of diverticular-associated abscess with or without percutaneous drainage, noted Dr. Jalouta of Spectrum Health System, Grand Rapids, Mich. Separate guidelines from the Association of Coloproctology of Great Britain and Ireland state that there is not sufficient evidence to make a formal recommendation on this topic, he added.

For the cohort of 165 patients, the abscesses averaged 6 cm in diameter and were pelvic in 73% of patients, abdominal in 22%, and in both locations in 5%. Multiple abscesses were present in 17%. Patients had a mean age of 61 years and a mean body mass index of 21 kg/m², and 52% were female.

The patients who did not undergo surgery after successful percutaneous drainage were significantly older than those who had surgery – 62 years vs. 55 years. Those subgroups did not differ in other respects.

An estimated 130,000 U.S. hospitalizations each year are due to diverticulitis, with 10%-20% of cases complicated by an associated intra-abdominal abscess, he said. Most diverticular-associated abscesses smaller than 5 cm in diameter will respond to antibiotic therapy, but patients with larger abscesses or associated sepsis often get percutaneous drainage.

The results were slightly better than those seen in two previous studies. In one study of 511 patients admitted for acute diverticulitis in 1994-2003, 5 of 12 patients (42%) who did not undergo surgery after percutaneous drainage of abscesses averaging 7 cm in size had a recurrence of diverticulitis (Am. J. Gastroenterol. 2005;100:910-7), Dr. Jalouta said. A separate study of 32 patients managed without surgery after percutaneous drainage of diverticular-associated abscesses found a recurrence-free survival rate of 58% after 7 years (Dis. Colon Rectum 2013;56:622-6).

Dr. Jalouta reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Patients who did not undergo elective surgical resection after successful percutaneous drainage of a diverticular-associated abscess had low rates of recurrent diverticulitis in a retrospective study, a finding that suggests nonoperative management is a reasonable option in such patients, Dr. Tarek K. Jalouta said.

Percutaneous drainage of diverticular-associated abscess resolved symptoms in 118 of 165 (72%) patients who underwent the procedure at two teaching hospitals in 2001-2013. Sixty of the patients with successful drainage did not undergo elective surgical resection, and eight of these died within a year of the drainage procedure.

Among the remaining 52 patients who had nonoperative management, 72% remained free of diverticulitis after 5 years, Dr. Jalouta and his associates reported at the annual clinical congress of the American College of Surgeons.

“A significant number of patients successfully recover from complicated diverticulitis following percutaneous drainage,” Dr. Jalouta said. “Subsequent nonoperative management carries an acceptable risk for recurrent episodes and may be considered as a reasonable management option.”

All patients diagnosed with diverticular-associated abscess received IV antibiotics within 24-48 hours of diagnosis. The decision to perform percutaneous drainage was at the discretion of the consulting surgeon and the interventional radiologist.

Practice parameters issued by the American Society of Colon and Rectal Surgeons in 2014 suggest that elective colectomy “should typically be advised” following successful medical treatment of diverticular-associated abscess with or without percutaneous drainage, noted Dr. Jalouta of Spectrum Health System, Grand Rapids, Mich. Separate guidelines from the Association of Coloproctology of Great Britain and Ireland state that there is not sufficient evidence to make a formal recommendation on this topic, he added.

For the cohort of 165 patients, the abscesses averaged 6 cm in diameter and were pelvic in 73% of patients, abdominal in 22%, and in both locations in 5%. Multiple abscesses were present in 17%. Patients had a mean age of 61 years and a mean body mass index of 21 kg/m², and 52% were female.

The patients who did not undergo surgery after successful percutaneous drainage were significantly older than those who had surgery – 62 years vs. 55 years. Those subgroups did not differ in other respects.

An estimated 130,000 U.S. hospitalizations each year are due to diverticulitis, with 10%-20% of cases complicated by an associated intra-abdominal abscess, he said. Most diverticular-associated abscesses smaller than 5 cm in diameter will respond to antibiotic therapy, but patients with larger abscesses or associated sepsis often get percutaneous drainage.

The results were slightly better than those seen in two previous studies. In one study of 511 patients admitted for acute diverticulitis in 1994-2003, 5 of 12 patients (42%) who did not undergo surgery after percutaneous drainage of abscesses averaging 7 cm in size had a recurrence of diverticulitis (Am. J. Gastroenterol. 2005;100:910-7), Dr. Jalouta said. A separate study of 32 patients managed without surgery after percutaneous drainage of diverticular-associated abscesses found a recurrence-free survival rate of 58% after 7 years (Dis. Colon Rectum 2013;56:622-6).

Dr. Jalouta reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Patients who did not undergo elective surgical resection after successful percutaneous drainage of a diverticular-associated abscess had low rates of recurrent diverticulitis in a retrospective study, a finding that suggests nonoperative management is a reasonable option in such patients, Dr. Tarek K. Jalouta said.

Percutaneous drainage of diverticular-associated abscess resolved symptoms in 118 of 165 (72%) patients who underwent the procedure at two teaching hospitals in 2001-2013. Sixty of the patients with successful drainage did not undergo elective surgical resection, and eight of these died within a year of the drainage procedure.

Among the remaining 52 patients who had nonoperative management, 72% remained free of diverticulitis after 5 years, Dr. Jalouta and his associates reported at the annual clinical congress of the American College of Surgeons.

“A significant number of patients successfully recover from complicated diverticulitis following percutaneous drainage,” Dr. Jalouta said. “Subsequent nonoperative management carries an acceptable risk for recurrent episodes and may be considered as a reasonable management option.”

All patients diagnosed with diverticular-associated abscess received IV antibiotics within 24-48 hours of diagnosis. The decision to perform percutaneous drainage was at the discretion of the consulting surgeon and the interventional radiologist.

Practice parameters issued by the American Society of Colon and Rectal Surgeons in 2014 suggest that elective colectomy “should typically be advised” following successful medical treatment of diverticular-associated abscess with or without percutaneous drainage, noted Dr. Jalouta of Spectrum Health System, Grand Rapids, Mich. Separate guidelines from the Association of Coloproctology of Great Britain and Ireland state that there is not sufficient evidence to make a formal recommendation on this topic, he added.

For the cohort of 165 patients, the abscesses averaged 6 cm in diameter and were pelvic in 73% of patients, abdominal in 22%, and in both locations in 5%. Multiple abscesses were present in 17%. Patients had a mean age of 61 years and a mean body mass index of 21 kg/m², and 52% were female.

The patients who did not undergo surgery after successful percutaneous drainage were significantly older than those who had surgery – 62 years vs. 55 years. Those subgroups did not differ in other respects.

An estimated 130,000 U.S. hospitalizations each year are due to diverticulitis, with 10%-20% of cases complicated by an associated intra-abdominal abscess, he said. Most diverticular-associated abscesses smaller than 5 cm in diameter will respond to antibiotic therapy, but patients with larger abscesses or associated sepsis often get percutaneous drainage.

The results were slightly better than those seen in two previous studies. In one study of 511 patients admitted for acute diverticulitis in 1994-2003, 5 of 12 patients (42%) who did not undergo surgery after percutaneous drainage of abscesses averaging 7 cm in size had a recurrence of diverticulitis (Am. J. Gastroenterol. 2005;100:910-7), Dr. Jalouta said. A separate study of 32 patients managed without surgery after percutaneous drainage of diverticular-associated abscesses found a recurrence-free survival rate of 58% after 7 years (Dis. Colon Rectum 2013;56:622-6).

Dr. Jalouta reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Too much or too little IV fluid on the day of surgery was associated with a 10%-12% increased risk for postoperative ileus in a retrospective study of 84,722 patients undergoing colon surgery.

Patients who received more than 5 liters of IV fluid on the day of surgery had a 10% increased risk of postoperative ileus and patients who received no more than 1.7 L on the surgery had a 12% increased risk of postoperative ileus, compared with patients who received 1.71-5 L of fluid, Dr. Julie K. Marosky Thacker and her associates reported at the annual clinical congress of the American College of Surgeons.

“This is one of the first studies to show that in a U.S.-based review, we have a significant number of patients getting over 5 L of fluid on the day of colon operation,” and that both high and low fluids increase the risk of postoperative ileus, Dr. Thacker said. “Observed fluid use is not compliant with the recommendations that are widespread and described in the principles of Enhance Recovery After Surgery.”

Perhaps optimizing fluids could decrease postoperative ileus and improve outcomes, she added.

The observational study of data on adults undergoing colon surgery at 524 U.S. hospitals found a wide variation in the amount of IV fluids used on the day of surgery, ranging from none to more than 8 L, with a median of 3.1 L, Dr. Thacker of Duke University, Durham, N.C., said. The researchers defined excessive fluids as the highest quartile of fluid levels and low fluids as the lowest quartile.

Overall, 18% of patients developed postoperative ileus. The higher risk for ileus with low or high IV fluids on the day of surgery was seen in open and laparoscopic procedures.

Patients with ileus had significantly longer hospitalizations, higher costs, and increased likelihood of readmission, compared with patients without ileus. The hospital length of stay averaged 10 days with ileus and 6 days without ileus. Total costs averaged $20,734 per patient with ileus and $13,865 without ileus. Among patients with ileus, readmission rates were 14% within 30 days, 17% within 60 days, and 20% within 90 days. Among patients without ileus, readmission rates were 9%, 12%, and 14% at those time points, respectively.

Data for the study came from the Premier Data research database of a nationally representative sample of adult patients having colon surgery from January 1, 2008 through June 30, 2012. Procedures included laparoscopic partial excision of the large intestine, isolation of a segment of the large intestine, open and other partial excisions of the large intestine, total intra-abdominal colectomy, anastomosis of the small intestine to the rectal stump, and other small-to-large intestinal anastomoses.

Patients had a mean age of 62 years, 46% were male, and 73% were white. Forty-six percent of patients were covered by Medicare and 36% by managed care plans. Sixty-one percent of hospitals were nonteaching hospitals, and 89% were in an urban location.

The analysis adjusted for the influence of multiple other factors that may be associated with the risk of ileus, she said.

Deltex Medical, which markets fluid monitoring systems, funded the study. Dr. Thacker has been a consultant for Deltex and for Premier Data Inc., which acquired the data.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Too much or too little IV fluid on the day of surgery was associated with a 10%-12% increased risk for postoperative ileus in a retrospective study of 84,722 patients undergoing colon surgery.

Patients who received more than 5 liters of IV fluid on the day of surgery had a 10% increased risk of postoperative ileus and patients who received no more than 1.7 L on the surgery had a 12% increased risk of postoperative ileus, compared with patients who received 1.71-5 L of fluid, Dr. Julie K. Marosky Thacker and her associates reported at the annual clinical congress of the American College of Surgeons.

“This is one of the first studies to show that in a U.S.-based review, we have a significant number of patients getting over 5 L of fluid on the day of colon operation,” and that both high and low fluids increase the risk of postoperative ileus, Dr. Thacker said. “Observed fluid use is not compliant with the recommendations that are widespread and described in the principles of Enhance Recovery After Surgery.”

Perhaps optimizing fluids could decrease postoperative ileus and improve outcomes, she added.

The observational study of data on adults undergoing colon surgery at 524 U.S. hospitals found a wide variation in the amount of IV fluids used on the day of surgery, ranging from none to more than 8 L, with a median of 3.1 L, Dr. Thacker of Duke University, Durham, N.C., said. The researchers defined excessive fluids as the highest quartile of fluid levels and low fluids as the lowest quartile.

Overall, 18% of patients developed postoperative ileus. The higher risk for ileus with low or high IV fluids on the day of surgery was seen in open and laparoscopic procedures.

Patients with ileus had significantly longer hospitalizations, higher costs, and increased likelihood of readmission, compared with patients without ileus. The hospital length of stay averaged 10 days with ileus and 6 days without ileus. Total costs averaged $20,734 per patient with ileus and $13,865 without ileus. Among patients with ileus, readmission rates were 14% within 30 days, 17% within 60 days, and 20% within 90 days. Among patients without ileus, readmission rates were 9%, 12%, and 14% at those time points, respectively.

Data for the study came from the Premier Data research database of a nationally representative sample of adult patients having colon surgery from January 1, 2008 through June 30, 2012. Procedures included laparoscopic partial excision of the large intestine, isolation of a segment of the large intestine, open and other partial excisions of the large intestine, total intra-abdominal colectomy, anastomosis of the small intestine to the rectal stump, and other small-to-large intestinal anastomoses.

Patients had a mean age of 62 years, 46% were male, and 73% were white. Forty-six percent of patients were covered by Medicare and 36% by managed care plans. Sixty-one percent of hospitals were nonteaching hospitals, and 89% were in an urban location.

The analysis adjusted for the influence of multiple other factors that may be associated with the risk of ileus, she said.

Deltex Medical, which markets fluid monitoring systems, funded the study. Dr. Thacker has been a consultant for Deltex and for Premier Data Inc., which acquired the data.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Too much or too little IV fluid on the day of surgery was associated with a 10%-12% increased risk for postoperative ileus in a retrospective study of 84,722 patients undergoing colon surgery.

Patients who received more than 5 liters of IV fluid on the day of surgery had a 10% increased risk of postoperative ileus and patients who received no more than 1.7 L on the surgery had a 12% increased risk of postoperative ileus, compared with patients who received 1.71-5 L of fluid, Dr. Julie K. Marosky Thacker and her associates reported at the annual clinical congress of the American College of Surgeons.

“This is one of the first studies to show that in a U.S.-based review, we have a significant number of patients getting over 5 L of fluid on the day of colon operation,” and that both high and low fluids increase the risk of postoperative ileus, Dr. Thacker said. “Observed fluid use is not compliant with the recommendations that are widespread and described in the principles of Enhance Recovery After Surgery.”

Perhaps optimizing fluids could decrease postoperative ileus and improve outcomes, she added.

The observational study of data on adults undergoing colon surgery at 524 U.S. hospitals found a wide variation in the amount of IV fluids used on the day of surgery, ranging from none to more than 8 L, with a median of 3.1 L, Dr. Thacker of Duke University, Durham, N.C., said. The researchers defined excessive fluids as the highest quartile of fluid levels and low fluids as the lowest quartile.

Overall, 18% of patients developed postoperative ileus. The higher risk for ileus with low or high IV fluids on the day of surgery was seen in open and laparoscopic procedures.

Patients with ileus had significantly longer hospitalizations, higher costs, and increased likelihood of readmission, compared with patients without ileus. The hospital length of stay averaged 10 days with ileus and 6 days without ileus. Total costs averaged $20,734 per patient with ileus and $13,865 without ileus. Among patients with ileus, readmission rates were 14% within 30 days, 17% within 60 days, and 20% within 90 days. Among patients without ileus, readmission rates were 9%, 12%, and 14% at those time points, respectively.

Data for the study came from the Premier Data research database of a nationally representative sample of adult patients having colon surgery from January 1, 2008 through June 30, 2012. Procedures included laparoscopic partial excision of the large intestine, isolation of a segment of the large intestine, open and other partial excisions of the large intestine, total intra-abdominal colectomy, anastomosis of the small intestine to the rectal stump, and other small-to-large intestinal anastomoses.

Patients had a mean age of 62 years, 46% were male, and 73% were white. Forty-six percent of patients were covered by Medicare and 36% by managed care plans. Sixty-one percent of hospitals were nonteaching hospitals, and 89% were in an urban location.

The analysis adjusted for the influence of multiple other factors that may be associated with the risk of ileus, she said.

Deltex Medical, which markets fluid monitoring systems, funded the study. Dr. Thacker has been a consultant for Deltex and for Premier Data Inc., which acquired the data.

[email protected]

On Twitter @sherryboschert

A patient’s body mass index before bariatric surgery is unrelated to remission of his or her diabetes afterward, according to a report published online in Annals of Surgery.

In a meta-analysis of 94 observational and interventional clinical studies, the efficacy of the surgery as a metabolic procedure had nothing to do with baseline body mass index (BMI) and instead depended on the degree of diabetic compromise at baseline. “We believe therefore that the use of baseline BMIs to gauge the metabolic effect of surgery is misleading and should be avoided,” said Simona Panunzi, Ph.D., of the Italian National Council of Research-Institute of Systems Analysis and Computer Sciences, Biomathematics Laboratory, Rome, and her associates.

At present, baseline BMI is considered the only valid selection criterion for bariatric surgery in diabetic adults, even though numerous studies have reported that neither BMI nor body weight are good predictors of diabetes remission. In contrast, many other studies have reported that body fat distribution, and visceral obesity in particular, directly affects glycemic control, insulin resistance, and the metabolic syndrome, the investigators commented (Ann. Surg. 2014 Oct. 30 [E-pub ahead of print]).

To assess which factors best predict diabetes remission after bariatric surgery, Dr. Panunzi and her associates performed a systematic review and meta-analysis of the literature. They screened 1,437 articles and focused on 94: 35 studies included patients with a baseline BMI of less than 35 kg/m², 56 studies included patients with a baseline BMI of 35 kg/m² or more, and 3 studies included patients with any baseline BMI. There were a total of 94,579 patients, of whom 4,944 had type 2 diabetes.

The mean age of the study participants was approximately 46 years. Bariatric procedures included sleeve gastrectomy, Roux-en-Y gastric bypass, biliopancreatic diversion, laparoscopic gastric banding, and duodenal-jejunal bypass. Across all the studies, the percent reduction in mean BMI after surgery was 17% for patients with a baseline BMI of less than 35 kg/m² (group 1) and 35% for those with a baseline BMI of 35 kg/m² or more (group 2).

Diabetes remitted in 72% of the patients in group 1 and 71% of those in group 2, a nonsignificant difference. The only factor found to predict remission, defined as the normalization of HbA_1c, was the severity of diabetes as measured by fasting levels of glucose, insulin, and HbA_1c at baseline, the investigators said.

“The appropriateness of the BMI criterion proposed by the National Institutes of Health for determining the eligibility of patients with diabetes for bariatric surgery has already been challenged by other authors. However, until now there was no direct evidence of its lack of relevance. It seems clear from the results of [our] study that baseline BMI does not carry prognostic information for diabetes resolution after bariatric surgery,” they added.

This meta-analysis was limited in that few of the reviewed studies reported diabetes duration, a well-known predictor of remission. And the definition of diabetes remission varied widely among the studies, from simple withdrawal of diabetes medications to various specific plasma glucose or HbA_1c levels, the investigators noted.

A patient’s body mass index before bariatric surgery is unrelated to remission of his or her diabetes afterward, according to a report published online in Annals of Surgery.

In a meta-analysis of 94 observational and interventional clinical studies, the efficacy of the surgery as a metabolic procedure had nothing to do with baseline body mass index (BMI) and instead depended on the degree of diabetic compromise at baseline. “We believe therefore that the use of baseline BMIs to gauge the metabolic effect of surgery is misleading and should be avoided,” said Simona Panunzi, Ph.D., of the Italian National Council of Research-Institute of Systems Analysis and Computer Sciences, Biomathematics Laboratory, Rome, and her associates.

At present, baseline BMI is considered the only valid selection criterion for bariatric surgery in diabetic adults, even though numerous studies have reported that neither BMI nor body weight are good predictors of diabetes remission. In contrast, many other studies have reported that body fat distribution, and visceral obesity in particular, directly affects glycemic control, insulin resistance, and the metabolic syndrome, the investigators commented (Ann. Surg. 2014 Oct. 30 [E-pub ahead of print]).

To assess which factors best predict diabetes remission after bariatric surgery, Dr. Panunzi and her associates performed a systematic review and meta-analysis of the literature. They screened 1,437 articles and focused on 94: 35 studies included patients with a baseline BMI of less than 35 kg/m², 56 studies included patients with a baseline BMI of 35 kg/m² or more, and 3 studies included patients with any baseline BMI. There were a total of 94,579 patients, of whom 4,944 had type 2 diabetes.

The mean age of the study participants was approximately 46 years. Bariatric procedures included sleeve gastrectomy, Roux-en-Y gastric bypass, biliopancreatic diversion, laparoscopic gastric banding, and duodenal-jejunal bypass. Across all the studies, the percent reduction in mean BMI after surgery was 17% for patients with a baseline BMI of less than 35 kg/m² (group 1) and 35% for those with a baseline BMI of 35 kg/m² or more (group 2).

Diabetes remitted in 72% of the patients in group 1 and 71% of those in group 2, a nonsignificant difference. The only factor found to predict remission, defined as the normalization of HbA_1c, was the severity of diabetes as measured by fasting levels of glucose, insulin, and HbA_1c at baseline, the investigators said.

“The appropriateness of the BMI criterion proposed by the National Institutes of Health for determining the eligibility of patients with diabetes for bariatric surgery has already been challenged by other authors. However, until now there was no direct evidence of its lack of relevance. It seems clear from the results of [our] study that baseline BMI does not carry prognostic information for diabetes resolution after bariatric surgery,” they added.

This meta-analysis was limited in that few of the reviewed studies reported diabetes duration, a well-known predictor of remission. And the definition of diabetes remission varied widely among the studies, from simple withdrawal of diabetes medications to various specific plasma glucose or HbA_1c levels, the investigators noted.

A patient’s body mass index before bariatric surgery is unrelated to remission of his or her diabetes afterward, according to a report published online in Annals of Surgery.

In a meta-analysis of 94 observational and interventional clinical studies, the efficacy of the surgery as a metabolic procedure had nothing to do with baseline body mass index (BMI) and instead depended on the degree of diabetic compromise at baseline. “We believe therefore that the use of baseline BMIs to gauge the metabolic effect of surgery is misleading and should be avoided,” said Simona Panunzi, Ph.D., of the Italian National Council of Research-Institute of Systems Analysis and Computer Sciences, Biomathematics Laboratory, Rome, and her associates.

At present, baseline BMI is considered the only valid selection criterion for bariatric surgery in diabetic adults, even though numerous studies have reported that neither BMI nor body weight are good predictors of diabetes remission. In contrast, many other studies have reported that body fat distribution, and visceral obesity in particular, directly affects glycemic control, insulin resistance, and the metabolic syndrome, the investigators commented (Ann. Surg. 2014 Oct. 30 [E-pub ahead of print]).

To assess which factors best predict diabetes remission after bariatric surgery, Dr. Panunzi and her associates performed a systematic review and meta-analysis of the literature. They screened 1,437 articles and focused on 94: 35 studies included patients with a baseline BMI of less than 35 kg/m², 56 studies included patients with a baseline BMI of 35 kg/m² or more, and 3 studies included patients with any baseline BMI. There were a total of 94,579 patients, of whom 4,944 had type 2 diabetes.

The mean age of the study participants was approximately 46 years. Bariatric procedures included sleeve gastrectomy, Roux-en-Y gastric bypass, biliopancreatic diversion, laparoscopic gastric banding, and duodenal-jejunal bypass. Across all the studies, the percent reduction in mean BMI after surgery was 17% for patients with a baseline BMI of less than 35 kg/m² (group 1) and 35% for those with a baseline BMI of 35 kg/m² or more (group 2).

Diabetes remitted in 72% of the patients in group 1 and 71% of those in group 2, a nonsignificant difference. The only factor found to predict remission, defined as the normalization of HbA_1c, was the severity of diabetes as measured by fasting levels of glucose, insulin, and HbA_1c at baseline, the investigators said.

“The appropriateness of the BMI criterion proposed by the National Institutes of Health for determining the eligibility of patients with diabetes for bariatric surgery has already been challenged by other authors. However, until now there was no direct evidence of its lack of relevance. It seems clear from the results of [our] study that baseline BMI does not carry prognostic information for diabetes resolution after bariatric surgery,” they added.

This meta-analysis was limited in that few of the reviewed studies reported diabetes duration, a well-known predictor of remission. And the definition of diabetes remission varied widely among the studies, from simple withdrawal of diabetes medications to various specific plasma glucose or HbA_1c levels, the investigators noted.

PHILADELPHIA- Neither perioperative aspirin nor clonidine reduced the risk of an acute kidney injury in patients who underwent major noncardiac surgery, a large randomized trial has determined.

The risk of an acute kidney injury (AKI) associated with aspirin was 10% more than placebo, and the risk with clonidine, 3% more, but those differences were not statistically significant, Dr. Amit X. Garg and associates wrote online in JAMA (JAMA 2015; doi:10.1001/jama.2014.15284).

Both drugs increased the risk of postoperative conditions that are associated with AKI, Dr. Garg of the London Health Sciences Centre and Western University, London, Ontario, and his co-authors noted. The study was simultaneously presented at Kidney Week 2014, which was sponsored by the American Society of Nephrology.

In fact, there was some suggestion that the drugs increased the risk of severe AKI, he said at the meeting. “But these were secondary measures and need to be interpreted cautiosuly, because the absolute number of severe AKIs was quite small.”

The AKI investigation was a substudy of the Perioperative Ischemia Evaluation-2, (POISE-2) trial, which evaluated the risk of 30-day mortality or nonfatal myocardial infarction among 6,905 surgical patients with a moderate to high risk of a perioperative cardiac event. The aspirin regimen called for 200 mg before surgery and then 100 mg daily for up to 30 days after surgery. The clonidine regimen was 0.2 mg orally 2-4 hours before surgery, followed by a 0.3 mg/day transdermal patch worn for 72 hours after surgery. Both groups also had a placebo arm.

The patients were a mean of 69 years old. Cardiovascular disease was present in about 30%; these included coronary artery disease, stroke, and peripheral vascular disease. About a quarter smoked; 36% had diabetes; 86% had hypertension; 2% had atrial fibrillation. Medications included COX-2 inhibitors; statins; ACE, ARB or direct renin inhibitors; and antihypertensives.

At baseline about 24% had an estimated glomerular filtration rate of 60 ml/min or lower per 1.73 m².

Surgical procedures were urgent or emergent, major vascular, major thoracic, major urological or gynecologic, and other unspecified procedures.

Aspirin did not reduce the risk of an AKI compared to placebo. AKI occurred in 462 patients taking aspirin and 426 taking placebo (13.4% vs. 12.3% respectively; adjusted risk ratio 1.10). Nor did clonidine reduce the risk of AKI compared to placebo. AKI occurred in 449 taking aspirin and 439 taking placebo (13% and 12.7% respectively; adjusted risk ratio 1.03). Neither of these findings was statistically significant.

AKI-related dialysis within 30 days occurred in 0.6% those taking aspirin and 0.3% of the matched placebo patients - a nonsignificant difference. Serum creatinine increased a mean of 11% with aspirin vs. 11% with placebo.

Dialysis was necessary in 0.5% of those taking clonidine and 0.3% of the matched placebo patients - another nonsignificant finding. A history of preoperative chronic kidney disease did not alter either of these findings.

A post hoc analysis determined that both drugs increased the incidence of conditions known to boost the risk of kidney injury. Aspirin increased the risk of major bleeding, which was associated with a greater risk of AKI (23.3% when bleeding occurred vs 12.3% when it did not; adjusted risk ratio 2.20).

Because of this doubling of risk, Dr. Garg suggested moderating pre-operative aspirin exposure in these patients.

“Among patients taking aspirin as part of a long-term regimen, these results support holding it for at least 3 days before surgery and then restarting it a week after surgery,” he recommended.

Clonidine increased the risk of clinically important hypotension, which was also related in turn to AKI (14.3% when hypotension was present vs. 11.8% when it was not; adjusted risk ratio for AKI 1.34).

Dr. Garg had no financial disclosures. A number of the POISE-2 investigators reported financial relationships with pharmaceutical companies.

[email protected]

PHILADELPHIA- Neither perioperative aspirin nor clonidine reduced the risk of an acute kidney injury in patients who underwent major noncardiac surgery, a large randomized trial has determined.

The risk of an acute kidney injury (AKI) associated with aspirin was 10% more than placebo, and the risk with clonidine, 3% more, but those differences were not statistically significant, Dr. Amit X. Garg and associates wrote online in JAMA (JAMA 2015; doi:10.1001/jama.2014.15284).

Both drugs increased the risk of postoperative conditions that are associated with AKI, Dr. Garg of the London Health Sciences Centre and Western University, London, Ontario, and his co-authors noted. The study was simultaneously presented at Kidney Week 2014, which was sponsored by the American Society of Nephrology.

In fact, there was some suggestion that the drugs increased the risk of severe AKI, he said at the meeting. “But these were secondary measures and need to be interpreted cautiosuly, because the absolute number of severe AKIs was quite small.”

The AKI investigation was a substudy of the Perioperative Ischemia Evaluation-2, (POISE-2) trial, which evaluated the risk of 30-day mortality or nonfatal myocardial infarction among 6,905 surgical patients with a moderate to high risk of a perioperative cardiac event. The aspirin regimen called for 200 mg before surgery and then 100 mg daily for up to 30 days after surgery. The clonidine regimen was 0.2 mg orally 2-4 hours before surgery, followed by a 0.3 mg/day transdermal patch worn for 72 hours after surgery. Both groups also had a placebo arm.

The patients were a mean of 69 years old. Cardiovascular disease was present in about 30%; these included coronary artery disease, stroke, and peripheral vascular disease. About a quarter smoked; 36% had diabetes; 86% had hypertension; 2% had atrial fibrillation. Medications included COX-2 inhibitors; statins; ACE, ARB or direct renin inhibitors; and antihypertensives.

At baseline about 24% had an estimated glomerular filtration rate of 60 ml/min or lower per 1.73 m².

Surgical procedures were urgent or emergent, major vascular, major thoracic, major urological or gynecologic, and other unspecified procedures.

Aspirin did not reduce the risk of an AKI compared to placebo. AKI occurred in 462 patients taking aspirin and 426 taking placebo (13.4% vs. 12.3% respectively; adjusted risk ratio 1.10). Nor did clonidine reduce the risk of AKI compared to placebo. AKI occurred in 449 taking aspirin and 439 taking placebo (13% and 12.7% respectively; adjusted risk ratio 1.03). Neither of these findings was statistically significant.

AKI-related dialysis within 30 days occurred in 0.6% those taking aspirin and 0.3% of the matched placebo patients - a nonsignificant difference. Serum creatinine increased a mean of 11% with aspirin vs. 11% with placebo.

Dialysis was necessary in 0.5% of those taking clonidine and 0.3% of the matched placebo patients - another nonsignificant finding. A history of preoperative chronic kidney disease did not alter either of these findings.

A post hoc analysis determined that both drugs increased the incidence of conditions known to boost the risk of kidney injury. Aspirin increased the risk of major bleeding, which was associated with a greater risk of AKI (23.3% when bleeding occurred vs 12.3% when it did not; adjusted risk ratio 2.20).

Because of this doubling of risk, Dr. Garg suggested moderating pre-operative aspirin exposure in these patients.

“Among patients taking aspirin as part of a long-term regimen, these results support holding it for at least 3 days before surgery and then restarting it a week after surgery,” he recommended.

Clonidine increased the risk of clinically important hypotension, which was also related in turn to AKI (14.3% when hypotension was present vs. 11.8% when it was not; adjusted risk ratio for AKI 1.34).

Dr. Garg had no financial disclosures. A number of the POISE-2 investigators reported financial relationships with pharmaceutical companies.

[email protected]

PHILADELPHIA- Neither perioperative aspirin nor clonidine reduced the risk of an acute kidney injury in patients who underwent major noncardiac surgery, a large randomized trial has determined.

The risk of an acute kidney injury (AKI) associated with aspirin was 10% more than placebo, and the risk with clonidine, 3% more, but those differences were not statistically significant, Dr. Amit X. Garg and associates wrote online in JAMA (JAMA 2015; doi:10.1001/jama.2014.15284).

Both drugs increased the risk of postoperative conditions that are associated with AKI, Dr. Garg of the London Health Sciences Centre and Western University, London, Ontario, and his co-authors noted. The study was simultaneously presented at Kidney Week 2014, which was sponsored by the American Society of Nephrology.

In fact, there was some suggestion that the drugs increased the risk of severe AKI, he said at the meeting. “But these were secondary measures and need to be interpreted cautiosuly, because the absolute number of severe AKIs was quite small.”

The AKI investigation was a substudy of the Perioperative Ischemia Evaluation-2, (POISE-2) trial, which evaluated the risk of 30-day mortality or nonfatal myocardial infarction among 6,905 surgical patients with a moderate to high risk of a perioperative cardiac event. The aspirin regimen called for 200 mg before surgery and then 100 mg daily for up to 30 days after surgery. The clonidine regimen was 0.2 mg orally 2-4 hours before surgery, followed by a 0.3 mg/day transdermal patch worn for 72 hours after surgery. Both groups also had a placebo arm.

The patients were a mean of 69 years old. Cardiovascular disease was present in about 30%; these included coronary artery disease, stroke, and peripheral vascular disease. About a quarter smoked; 36% had diabetes; 86% had hypertension; 2% had atrial fibrillation. Medications included COX-2 inhibitors; statins; ACE, ARB or direct renin inhibitors; and antihypertensives.

At baseline about 24% had an estimated glomerular filtration rate of 60 ml/min or lower per 1.73 m².

Surgical procedures were urgent or emergent, major vascular, major thoracic, major urological or gynecologic, and other unspecified procedures.

Aspirin did not reduce the risk of an AKI compared to placebo. AKI occurred in 462 patients taking aspirin and 426 taking placebo (13.4% vs. 12.3% respectively; adjusted risk ratio 1.10). Nor did clonidine reduce the risk of AKI compared to placebo. AKI occurred in 449 taking aspirin and 439 taking placebo (13% and 12.7% respectively; adjusted risk ratio 1.03). Neither of these findings was statistically significant.

AKI-related dialysis within 30 days occurred in 0.6% those taking aspirin and 0.3% of the matched placebo patients - a nonsignificant difference. Serum creatinine increased a mean of 11% with aspirin vs. 11% with placebo.

Dialysis was necessary in 0.5% of those taking clonidine and 0.3% of the matched placebo patients - another nonsignificant finding. A history of preoperative chronic kidney disease did not alter either of these findings.

A post hoc analysis determined that both drugs increased the incidence of conditions known to boost the risk of kidney injury. Aspirin increased the risk of major bleeding, which was associated with a greater risk of AKI (23.3% when bleeding occurred vs 12.3% when it did not; adjusted risk ratio 2.20).

Because of this doubling of risk, Dr. Garg suggested moderating pre-operative aspirin exposure in these patients.

“Among patients taking aspirin as part of a long-term regimen, these results support holding it for at least 3 days before surgery and then restarting it a week after surgery,” he recommended.

Clonidine increased the risk of clinically important hypotension, which was also related in turn to AKI (14.3% when hypotension was present vs. 11.8% when it was not; adjusted risk ratio for AKI 1.34).

Dr. Garg had no financial disclosures. A number of the POISE-2 investigators reported financial relationships with pharmaceutical companies.

[email protected]

BOSTON – Moderately obese patients who either don’t want or don’t qualify for bariatric surgery may be able to benefit from a reversible procedure using an investigational intragastric balloon.

In a randomized controlled trial, patients with a body mass index (BMI) from 30 to 40 kg/m² who were assigned to receive a dual intragastric balloon (ReShape Duo) plus a diet and exercise regimen lost 25% of their excess weight, compared with only 11% of patients assigned to undergo a sham procedure plus diet and exercise, reported Dr. Jaime Ponce, medical director for the Bariatric Surgery program at Hamilton Medical Center in Dalton, Ga., and Memorial Hospital in Chattanooga, Tenn.

Neil Osterweil/Frontline Medical News

“The ReShape procedure is a reversible intervention that can be used in patients with BMI from 30 to 40 who are not ready for surgery or did not qualify for surgery. It was effective, as it showed a 2.2 times greater weight loss, compared with the diet group,” he said at the meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

At 48 weeks, patients sustained on average 65% of the weight loss they had achieved at week 24, he said.

Two-chamber device

The dual intragastric balloon consists of two silicone balloons connected by a flexible shaft to provide migration resistance. The deflated device is inserted over a guide wire into the stomach in a transoral endoscopic procedure. Once in place, the device is inflated with a saline and methylene blue solution by a powered pump, up to a total volume of 750 to 900 cc. The mean duration of the procedure is 8 minutes Dr. Ponce said.

Barring problems, the device is left in place for 6 months and is then emptied, captured with a standard endoscopic snare, and removed, a process that takes a mean of 14 minutes.

Dr. Ponce and colleagues enrolled obese adults with a BMD from 30 to 40 kg/m² and one or more obesity-related comorbidities to undergo either balloon insertion, diet and exercise (187 patients), or a sham procedure plus diet and exercise (139).

All patients had monthly counseling on diet and exercise as per obesity management guidelines from the National Heart, Lung and Blood Institute published in 2000.

The participants were blinded to treatment assignment for 24 weeks, at which time patients in the diet group could exit the study or, if they wished, receive the balloon and continue in the study for an additional 24 weeks. Patients who initially received the balloon remained in the study and continued diet and exercise during the same 24 weeks.

Balloons were successfully inserted in 99.6% of cases, and all inserted balloons were retrieved successfully. Three patients had serious adverse events related to retrieval: one case of pneumonia requiring hospitalization and antibiotics, one contained perforation of the cervical esophagus, also requiring hospitalization and antibiotics, and one proximal esophageal mucosal tear requiring hemostatic clips.

The trial met its primary endpoint of a greater than 7.5% difference between the balloon and control groups, with balloon receivers having a mean excess weight loss of 25.1%, compared with 11.3% for controls (P = .0041) in an intention to treat analysis, and 27.9% vs. 12.3%, respectively, in patients who completed the study (P = .0007).

At 48 weeks, patients initially assigned to receive the balloon had significant improvements in hemoglobin A_1c, cholesterol levels (HDL up, LDL down), systolic and diastolic blood pressures, and waist and hip circumference.

Among all implanted participants, 11.6% had mild to moderate nausea and vomiting on day 3, which gradually declined over the study. In addition, 34.1% had abdominal pain they rated as mild to moderate on a visual analog scale,

The safety analysis, including all 264 patients who received the balloon initially or at week 24, showed no deaths, balloon migration, obstructions, or required surgeries. Most adverse events were gastrointestinal in nature, mild to moderate, and resolved within the first 30 days.

Investigators saw gastric ulcers in 93 of the 264 patients who received the balloon. They determined the cause to be the distal tip of the device contacting the incisural wall, where more than 95% of the ulcers were observed. The manufacturer made minor changes to lower the profile of the tip and make it smoother and softer, resulting a “dramatically reduced ulcer rate and size,” Dr. Ponce said.

In all, 15% of the balloons were retrieved early, 6% after 2 months, associated with ulcers, and 9% within 2 months of insertions because of device intolerance. The authors found shorter patients had significantly fewer problems when the balloons were inflated with 750 cc rather than 900 cc.

The balloons spontaneously deflated in 6% of participants, signaled by the presence of blue-green urine in about two-thirds of these patients. All of the devices in these cases were successfully retrieved without problems, Dr. Ponce said.

Dr. Manoel P. Galvao Neto of the Gastro Obeso Center in São Paulo, Brazil, the invited discussant, commented that the study was well designed and carried out, with a clear methodology and frank assessment of adverse events, and it met all of its primary endpoints.

Excretable balloon

In a separate pilot study, eight patients who swallowed a limited-duration, self-emptying balloon (Elipse) that is excreted through the bowel lost an average of 12% of excess body weight, reported Dr. Evzen Machytka of the department of clinical studies at the University of Ostrava, Czech Republic.

For the trial, investigators used a custom device designed to self-deflate in 6 weeks. The device is packaged in a capsule and is attached to a thin capillary tube. The patient swallows the balloon without endoscopy or anesthesia. The capsule dissolves quickly, and when gastric positioning of the balloon is confirmed with x-rays, the balloon is then filled with 450 mL saline, in a process that takes approximately 15 minutes.

After a prespecified time (6 weeks, in the case of the trial, 3 months in the device intended for market) a self-releasing valve opens, the balloon empties and is then excreted normally, Dr. Machytka said.

In the pilot trial, all eight balloons were safely excreted. One had deflated early because of a manufacturing defect, and one asymptomatic patient withdrew from the study because she “no longer enjoyed eating.” In both cases, the balloons were punctured via endoscopy but not retrieved, and were excreted normally in the stool 4 days later.

The investigators hope to receive marketing approval for the device in 2015, Dr. Machytka said.

BOSTON – Moderately obese patients who either don’t want or don’t qualify for bariatric surgery may be able to benefit from a reversible procedure using an investigational intragastric balloon.

In a randomized controlled trial, patients with a body mass index (BMI) from 30 to 40 kg/m² who were assigned to receive a dual intragastric balloon (ReShape Duo) plus a diet and exercise regimen lost 25% of their excess weight, compared with only 11% of patients assigned to undergo a sham procedure plus diet and exercise, reported Dr. Jaime Ponce, medical director for the Bariatric Surgery program at Hamilton Medical Center in Dalton, Ga., and Memorial Hospital in Chattanooga, Tenn.

Neil Osterweil/Frontline Medical News

“The ReShape procedure is a reversible intervention that can be used in patients with BMI from 30 to 40 who are not ready for surgery or did not qualify for surgery. It was effective, as it showed a 2.2 times greater weight loss, compared with the diet group,” he said at the meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

At 48 weeks, patients sustained on average 65% of the weight loss they had achieved at week 24, he said.

Two-chamber device

The dual intragastric balloon consists of two silicone balloons connected by a flexible shaft to provide migration resistance. The deflated device is inserted over a guide wire into the stomach in a transoral endoscopic procedure. Once in place, the device is inflated with a saline and methylene blue solution by a powered pump, up to a total volume of 750 to 900 cc. The mean duration of the procedure is 8 minutes Dr. Ponce said.

Barring problems, the device is left in place for 6 months and is then emptied, captured with a standard endoscopic snare, and removed, a process that takes a mean of 14 minutes.

Dr. Ponce and colleagues enrolled obese adults with a BMD from 30 to 40 kg/m² and one or more obesity-related comorbidities to undergo either balloon insertion, diet and exercise (187 patients), or a sham procedure plus diet and exercise (139).

All patients had monthly counseling on diet and exercise as per obesity management guidelines from the National Heart, Lung and Blood Institute published in 2000.

The participants were blinded to treatment assignment for 24 weeks, at which time patients in the diet group could exit the study or, if they wished, receive the balloon and continue in the study for an additional 24 weeks. Patients who initially received the balloon remained in the study and continued diet and exercise during the same 24 weeks.

Balloons were successfully inserted in 99.6% of cases, and all inserted balloons were retrieved successfully. Three patients had serious adverse events related to retrieval: one case of pneumonia requiring hospitalization and antibiotics, one contained perforation of the cervical esophagus, also requiring hospitalization and antibiotics, and one proximal esophageal mucosal tear requiring hemostatic clips.

The trial met its primary endpoint of a greater than 7.5% difference between the balloon and control groups, with balloon receivers having a mean excess weight loss of 25.1%, compared with 11.3% for controls (P = .0041) in an intention to treat analysis, and 27.9% vs. 12.3%, respectively, in patients who completed the study (P = .0007).

At 48 weeks, patients initially assigned to receive the balloon had significant improvements in hemoglobin A_1c, cholesterol levels (HDL up, LDL down), systolic and diastolic blood pressures, and waist and hip circumference.

Among all implanted participants, 11.6% had mild to moderate nausea and vomiting on day 3, which gradually declined over the study. In addition, 34.1% had abdominal pain they rated as mild to moderate on a visual analog scale,

The safety analysis, including all 264 patients who received the balloon initially or at week 24, showed no deaths, balloon migration, obstructions, or required surgeries. Most adverse events were gastrointestinal in nature, mild to moderate, and resolved within the first 30 days.

Investigators saw gastric ulcers in 93 of the 264 patients who received the balloon. They determined the cause to be the distal tip of the device contacting the incisural wall, where more than 95% of the ulcers were observed. The manufacturer made minor changes to lower the profile of the tip and make it smoother and softer, resulting a “dramatically reduced ulcer rate and size,” Dr. Ponce said.

In all, 15% of the balloons were retrieved early, 6% after 2 months, associated with ulcers, and 9% within 2 months of insertions because of device intolerance. The authors found shorter patients had significantly fewer problems when the balloons were inflated with 750 cc rather than 900 cc.

The balloons spontaneously deflated in 6% of participants, signaled by the presence of blue-green urine in about two-thirds of these patients. All of the devices in these cases were successfully retrieved without problems, Dr. Ponce said.

Dr. Manoel P. Galvao Neto of the Gastro Obeso Center in São Paulo, Brazil, the invited discussant, commented that the study was well designed and carried out, with a clear methodology and frank assessment of adverse events, and it met all of its primary endpoints.

Excretable balloon

In a separate pilot study, eight patients who swallowed a limited-duration, self-emptying balloon (Elipse) that is excreted through the bowel lost an average of 12% of excess body weight, reported Dr. Evzen Machytka of the department of clinical studies at the University of Ostrava, Czech Republic.

For the trial, investigators used a custom device designed to self-deflate in 6 weeks. The device is packaged in a capsule and is attached to a thin capillary tube. The patient swallows the balloon without endoscopy or anesthesia. The capsule dissolves quickly, and when gastric positioning of the balloon is confirmed with x-rays, the balloon is then filled with 450 mL saline, in a process that takes approximately 15 minutes.

After a prespecified time (6 weeks, in the case of the trial, 3 months in the device intended for market) a self-releasing valve opens, the balloon empties and is then excreted normally, Dr. Machytka said.

In the pilot trial, all eight balloons were safely excreted. One had deflated early because of a manufacturing defect, and one asymptomatic patient withdrew from the study because she “no longer enjoyed eating.” In both cases, the balloons were punctured via endoscopy but not retrieved, and were excreted normally in the stool 4 days later.

The investigators hope to receive marketing approval for the device in 2015, Dr. Machytka said.

BOSTON – Moderately obese patients who either don’t want or don’t qualify for bariatric surgery may be able to benefit from a reversible procedure using an investigational intragastric balloon.

In a randomized controlled trial, patients with a body mass index (BMI) from 30 to 40 kg/m² who were assigned to receive a dual intragastric balloon (ReShape Duo) plus a diet and exercise regimen lost 25% of their excess weight, compared with only 11% of patients assigned to undergo a sham procedure plus diet and exercise, reported Dr. Jaime Ponce, medical director for the Bariatric Surgery program at Hamilton Medical Center in Dalton, Ga., and Memorial Hospital in Chattanooga, Tenn.

Neil Osterweil/Frontline Medical News

“The ReShape procedure is a reversible intervention that can be used in patients with BMI from 30 to 40 who are not ready for surgery or did not qualify for surgery. It was effective, as it showed a 2.2 times greater weight loss, compared with the diet group,” he said at the meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

At 48 weeks, patients sustained on average 65% of the weight loss they had achieved at week 24, he said.

Two-chamber device

The dual intragastric balloon consists of two silicone balloons connected by a flexible shaft to provide migration resistance. The deflated device is inserted over a guide wire into the stomach in a transoral endoscopic procedure. Once in place, the device is inflated with a saline and methylene blue solution by a powered pump, up to a total volume of 750 to 900 cc. The mean duration of the procedure is 8 minutes Dr. Ponce said.

Barring problems, the device is left in place for 6 months and is then emptied, captured with a standard endoscopic snare, and removed, a process that takes a mean of 14 minutes.

Dr. Ponce and colleagues enrolled obese adults with a BMD from 30 to 40 kg/m² and one or more obesity-related comorbidities to undergo either balloon insertion, diet and exercise (187 patients), or a sham procedure plus diet and exercise (139).

All patients had monthly counseling on diet and exercise as per obesity management guidelines from the National Heart, Lung and Blood Institute published in 2000.

The participants were blinded to treatment assignment for 24 weeks, at which time patients in the diet group could exit the study or, if they wished, receive the balloon and continue in the study for an additional 24 weeks. Patients who initially received the balloon remained in the study and continued diet and exercise during the same 24 weeks.

Balloons were successfully inserted in 99.6% of cases, and all inserted balloons were retrieved successfully. Three patients had serious adverse events related to retrieval: one case of pneumonia requiring hospitalization and antibiotics, one contained perforation of the cervical esophagus, also requiring hospitalization and antibiotics, and one proximal esophageal mucosal tear requiring hemostatic clips.

The trial met its primary endpoint of a greater than 7.5% difference between the balloon and control groups, with balloon receivers having a mean excess weight loss of 25.1%, compared with 11.3% for controls (P = .0041) in an intention to treat analysis, and 27.9% vs. 12.3%, respectively, in patients who completed the study (P = .0007).

At 48 weeks, patients initially assigned to receive the balloon had significant improvements in hemoglobin A_1c, cholesterol levels (HDL up, LDL down), systolic and diastolic blood pressures, and waist and hip circumference.

Among all implanted participants, 11.6% had mild to moderate nausea and vomiting on day 3, which gradually declined over the study. In addition, 34.1% had abdominal pain they rated as mild to moderate on a visual analog scale,

The safety analysis, including all 264 patients who received the balloon initially or at week 24, showed no deaths, balloon migration, obstructions, or required surgeries. Most adverse events were gastrointestinal in nature, mild to moderate, and resolved within the first 30 days.

Investigators saw gastric ulcers in 93 of the 264 patients who received the balloon. They determined the cause to be the distal tip of the device contacting the incisural wall, where more than 95% of the ulcers were observed. The manufacturer made minor changes to lower the profile of the tip and make it smoother and softer, resulting a “dramatically reduced ulcer rate and size,” Dr. Ponce said.

In all, 15% of the balloons were retrieved early, 6% after 2 months, associated with ulcers, and 9% within 2 months of insertions because of device intolerance. The authors found shorter patients had significantly fewer problems when the balloons were inflated with 750 cc rather than 900 cc.

The balloons spontaneously deflated in 6% of participants, signaled by the presence of blue-green urine in about two-thirds of these patients. All of the devices in these cases were successfully retrieved without problems, Dr. Ponce said.

Dr. Manoel P. Galvao Neto of the Gastro Obeso Center in São Paulo, Brazil, the invited discussant, commented that the study was well designed and carried out, with a clear methodology and frank assessment of adverse events, and it met all of its primary endpoints.

Excretable balloon

In a separate pilot study, eight patients who swallowed a limited-duration, self-emptying balloon (Elipse) that is excreted through the bowel lost an average of 12% of excess body weight, reported Dr. Evzen Machytka of the department of clinical studies at the University of Ostrava, Czech Republic.

For the trial, investigators used a custom device designed to self-deflate in 6 weeks. The device is packaged in a capsule and is attached to a thin capillary tube. The patient swallows the balloon without endoscopy or anesthesia. The capsule dissolves quickly, and when gastric positioning of the balloon is confirmed with x-rays, the balloon is then filled with 450 mL saline, in a process that takes approximately 15 minutes.

After a prespecified time (6 weeks, in the case of the trial, 3 months in the device intended for market) a self-releasing valve opens, the balloon empties and is then excreted normally, Dr. Machytka said.

In the pilot trial, all eight balloons were safely excreted. One had deflated early because of a manufacturing defect, and one asymptomatic patient withdrew from the study because she “no longer enjoyed eating.” In both cases, the balloons were punctured via endoscopy but not retrieved, and were excreted normally in the stool 4 days later.

The investigators hope to receive marketing approval for the device in 2015, Dr. Machytka said.