General Surgery

SAN FRANCISCO – Hospital charges are not a reliable indicator of quality of care for patients undergoing bariatric surgery, according to results from a cohort study reported at the annual clinical congress of the American College of Surgeons.

Researchers queried the SPARCS (New York Statewide Planning and Research Cooperative System) administrative database and identified 46,180 adult patients who underwent primary bariatric surgery between 2004 and 2010.

Charges for this same surgery differed by more than $10,000 between hospitals with low, bottom-tertile charges (less than $25,027) and hospitals with high, top-tertile charges (more than $35,449), reported Dr. Aurora D. Pryor, chief of the general surgery division and director of the Bariatric and Metabolic Weight Loss Center at the State University of New York at Stony Brook Medical Center.

High-charge hospitals were more often located in New York City or on Long Island. Low-charge hospitals more commonly performed a Roux-en-Y gastric bypass surgical procedure and had proportionately more patients with diabetes and liver disease.

Overall, 24% of the patients were operated on in hospitals with low charges, 26% in those with medium charges, and 50% in those with high charges.

In univariate analysis, the rate of major perioperative complications differed significantly, at 4.1%, 4.8%, and 3.75% for patients undergoing surgery in low-, medium-, and high-charge hospitals, respectively. But in multivariate analysis that controlled for patient demographics, comorbidities, insurance provider, and operative procedure, differences were no longer significant.

Additionally, the hospitals were statistically indistinguishable with respect to rates of 30-day mortality and mortality beyond that time point.

“Hospital charge does not correlate with outcomes following bariatric surgery. The initial differences we think are really based on the higher-risk patients and higher-risk operations performed at the lower-cost centers,” Dr. Pryor proposed.

“I think we should be paying attention to the charges. They vary by geographic location, and I think it’s the higher-cost areas that have the higher charges,” she commented.

Session attendee Dr. Mark Ott, a surgeon with Intermountain Healthcare in Murray, Utah, asked, “So do you think if the patients had that information that they would travel outside New York City to go to a lower-cost center?”

“I think they might actually do that,” Dr. Pryor replied. “In particular, some of the self-pay patients are driving into New York City because they think they’ll have a better outcome, and maybe they should actually pay attention to the outcomes at their local places more.”

Dr. Benedict C. Nwomeh, one of the session’s comoderators and a pediatric surgeon at Nationwide Children’s Hospital, Columbus, Ohio, asked, “So what do you think is responsible for this disparity in charges?”

“I honestly think it’s the city effect and the cost of living in those places, that they are able to charge more for their patients,” Dr. Pryor replied.

In an interview, Dr. Maureen A. Killackey, the other comoderator and clinical director of the New York-Presbyterian/Lawrence Hospital Cancer Center in Bronxville, N.Y., commented, “This study is quite provocative, and it also adds to the body of evidence that we already have, like in colonoscopy, on the variation in charges. This information probably needs to get to the attention of both the private payers as well as the governmental payers, because it really does show a tremendous discrepancy.”

“New York is a highly regulated state, and I think this would be perhaps very interesting to the governmental payers of the state to see these differences in both charges as well as practices, as well as the case-mix index and the geographic access and utilization of these services,” she added.

Dr. Pryor disclosed that she had no relevant conflicts of interest.

SAN FRANCISCO – Hospital charges are not a reliable indicator of quality of care for patients undergoing bariatric surgery, according to results from a cohort study reported at the annual clinical congress of the American College of Surgeons.

Researchers queried the SPARCS (New York Statewide Planning and Research Cooperative System) administrative database and identified 46,180 adult patients who underwent primary bariatric surgery between 2004 and 2010.

Charges for this same surgery differed by more than $10,000 between hospitals with low, bottom-tertile charges (less than $25,027) and hospitals with high, top-tertile charges (more than $35,449), reported Dr. Aurora D. Pryor, chief of the general surgery division and director of the Bariatric and Metabolic Weight Loss Center at the State University of New York at Stony Brook Medical Center.

High-charge hospitals were more often located in New York City or on Long Island. Low-charge hospitals more commonly performed a Roux-en-Y gastric bypass surgical procedure and had proportionately more patients with diabetes and liver disease.

Overall, 24% of the patients were operated on in hospitals with low charges, 26% in those with medium charges, and 50% in those with high charges.

In univariate analysis, the rate of major perioperative complications differed significantly, at 4.1%, 4.8%, and 3.75% for patients undergoing surgery in low-, medium-, and high-charge hospitals, respectively. But in multivariate analysis that controlled for patient demographics, comorbidities, insurance provider, and operative procedure, differences were no longer significant.

Additionally, the hospitals were statistically indistinguishable with respect to rates of 30-day mortality and mortality beyond that time point.

“Hospital charge does not correlate with outcomes following bariatric surgery. The initial differences we think are really based on the higher-risk patients and higher-risk operations performed at the lower-cost centers,” Dr. Pryor proposed.

“I think we should be paying attention to the charges. They vary by geographic location, and I think it’s the higher-cost areas that have the higher charges,” she commented.

Session attendee Dr. Mark Ott, a surgeon with Intermountain Healthcare in Murray, Utah, asked, “So do you think if the patients had that information that they would travel outside New York City to go to a lower-cost center?”

“I think they might actually do that,” Dr. Pryor replied. “In particular, some of the self-pay patients are driving into New York City because they think they’ll have a better outcome, and maybe they should actually pay attention to the outcomes at their local places more.”

Dr. Benedict C. Nwomeh, one of the session’s comoderators and a pediatric surgeon at Nationwide Children’s Hospital, Columbus, Ohio, asked, “So what do you think is responsible for this disparity in charges?”

“I honestly think it’s the city effect and the cost of living in those places, that they are able to charge more for their patients,” Dr. Pryor replied.

In an interview, Dr. Maureen A. Killackey, the other comoderator and clinical director of the New York-Presbyterian/Lawrence Hospital Cancer Center in Bronxville, N.Y., commented, “This study is quite provocative, and it also adds to the body of evidence that we already have, like in colonoscopy, on the variation in charges. This information probably needs to get to the attention of both the private payers as well as the governmental payers, because it really does show a tremendous discrepancy.”

“New York is a highly regulated state, and I think this would be perhaps very interesting to the governmental payers of the state to see these differences in both charges as well as practices, as well as the case-mix index and the geographic access and utilization of these services,” she added.

Dr. Pryor disclosed that she had no relevant conflicts of interest.

SAN FRANCISCO – Hospital charges are not a reliable indicator of quality of care for patients undergoing bariatric surgery, according to results from a cohort study reported at the annual clinical congress of the American College of Surgeons.

Researchers queried the SPARCS (New York Statewide Planning and Research Cooperative System) administrative database and identified 46,180 adult patients who underwent primary bariatric surgery between 2004 and 2010.

Charges for this same surgery differed by more than $10,000 between hospitals with low, bottom-tertile charges (less than $25,027) and hospitals with high, top-tertile charges (more than $35,449), reported Dr. Aurora D. Pryor, chief of the general surgery division and director of the Bariatric and Metabolic Weight Loss Center at the State University of New York at Stony Brook Medical Center.

High-charge hospitals were more often located in New York City or on Long Island. Low-charge hospitals more commonly performed a Roux-en-Y gastric bypass surgical procedure and had proportionately more patients with diabetes and liver disease.

Overall, 24% of the patients were operated on in hospitals with low charges, 26% in those with medium charges, and 50% in those with high charges.

In univariate analysis, the rate of major perioperative complications differed significantly, at 4.1%, 4.8%, and 3.75% for patients undergoing surgery in low-, medium-, and high-charge hospitals, respectively. But in multivariate analysis that controlled for patient demographics, comorbidities, insurance provider, and operative procedure, differences were no longer significant.

Additionally, the hospitals were statistically indistinguishable with respect to rates of 30-day mortality and mortality beyond that time point.

“Hospital charge does not correlate with outcomes following bariatric surgery. The initial differences we think are really based on the higher-risk patients and higher-risk operations performed at the lower-cost centers,” Dr. Pryor proposed.

“I think we should be paying attention to the charges. They vary by geographic location, and I think it’s the higher-cost areas that have the higher charges,” she commented.

Session attendee Dr. Mark Ott, a surgeon with Intermountain Healthcare in Murray, Utah, asked, “So do you think if the patients had that information that they would travel outside New York City to go to a lower-cost center?”

“I think they might actually do that,” Dr. Pryor replied. “In particular, some of the self-pay patients are driving into New York City because they think they’ll have a better outcome, and maybe they should actually pay attention to the outcomes at their local places more.”

Dr. Benedict C. Nwomeh, one of the session’s comoderators and a pediatric surgeon at Nationwide Children’s Hospital, Columbus, Ohio, asked, “So what do you think is responsible for this disparity in charges?”

“I honestly think it’s the city effect and the cost of living in those places, that they are able to charge more for their patients,” Dr. Pryor replied.

In an interview, Dr. Maureen A. Killackey, the other comoderator and clinical director of the New York-Presbyterian/Lawrence Hospital Cancer Center in Bronxville, N.Y., commented, “This study is quite provocative, and it also adds to the body of evidence that we already have, like in colonoscopy, on the variation in charges. This information probably needs to get to the attention of both the private payers as well as the governmental payers, because it really does show a tremendous discrepancy.”

“New York is a highly regulated state, and I think this would be perhaps very interesting to the governmental payers of the state to see these differences in both charges as well as practices, as well as the case-mix index and the geographic access and utilization of these services,” she added.

Dr. Pryor disclosed that she had no relevant conflicts of interest.

SAN FRANCISCO– Little steps, when added together, lead to big reductions in serious reportable events in the operating room, according to investigators from the Phoenix-based Banner Health system.

After slight modifications to the count, timeout, and other OR procedures, Banner saw a 52% reduction in serious reportable events (SREs), including a 70% reduction in wrong-site surgeries, across its 22 hospitals and 8 ambulatory surgery centers (J. Am. Coll. Surg. 2014 Oct. 4 [doi:http://dx.doi.org/10.1016/j.jamcollsurg.2014.09.018]).

In an interview at the annual clinical congress of the American College of Surgeons, lead investigator Dr. Terrence Loftus, the health system’s medical director of surgery services and clinical resources, explained how they did it. He also explained why surgical SREs are seven times more common in the system’s robotic surgery program, despite overall improvements, and what Banner is planning to do about it.

[email protected]

SAN FRANCISCO– Little steps, when added together, lead to big reductions in serious reportable events in the operating room, according to investigators from the Phoenix-based Banner Health system.

After slight modifications to the count, timeout, and other OR procedures, Banner saw a 52% reduction in serious reportable events (SREs), including a 70% reduction in wrong-site surgeries, across its 22 hospitals and 8 ambulatory surgery centers (J. Am. Coll. Surg. 2014 Oct. 4 [doi:http://dx.doi.org/10.1016/j.jamcollsurg.2014.09.018]).

In an interview at the annual clinical congress of the American College of Surgeons, lead investigator Dr. Terrence Loftus, the health system’s medical director of surgery services and clinical resources, explained how they did it. He also explained why surgical SREs are seven times more common in the system’s robotic surgery program, despite overall improvements, and what Banner is planning to do about it.

[email protected]

SAN FRANCISCO– Little steps, when added together, lead to big reductions in serious reportable events in the operating room, according to investigators from the Phoenix-based Banner Health system.

After slight modifications to the count, timeout, and other OR procedures, Banner saw a 52% reduction in serious reportable events (SREs), including a 70% reduction in wrong-site surgeries, across its 22 hospitals and 8 ambulatory surgery centers (J. Am. Coll. Surg. 2014 Oct. 4 [doi:http://dx.doi.org/10.1016/j.jamcollsurg.2014.09.018]).

In an interview at the annual clinical congress of the American College of Surgeons, lead investigator Dr. Terrence Loftus, the health system’s medical director of surgery services and clinical resources, explained how they did it. He also explained why surgical SREs are seven times more common in the system’s robotic surgery program, despite overall improvements, and what Banner is planning to do about it.

[email protected]

SAN FRANCISCO – If current trends continue, vagotomy and gastrectomy for bleeding peptic ulcers will be mostly a thing of the past, according to Dr. Mikhail Kryzhanouski, a surgery resident at the University of Illinois, Chicago.

Their use is quickly fading, eclipsed by better techniques and a steady drop in adverse outcomes, even though patients are presenting with more comorbidities, Dr. Kryzhanouski found in a review of patients in the U.S. Nationwide Inpatient Sample who were hospitalized for peptic ulcers from 1998 to 2011 (J. Am. Coll. Surg. 2014;219:e142).

Dr. Kryzhanouski shared the results of his study – and the reasons for his prediction – at the American College of Surgeons Clinical Congress.

[email protected]

SAN FRANCISCO – If current trends continue, vagotomy and gastrectomy for bleeding peptic ulcers will be mostly a thing of the past, according to Dr. Mikhail Kryzhanouski, a surgery resident at the University of Illinois, Chicago.

Their use is quickly fading, eclipsed by better techniques and a steady drop in adverse outcomes, even though patients are presenting with more comorbidities, Dr. Kryzhanouski found in a review of patients in the U.S. Nationwide Inpatient Sample who were hospitalized for peptic ulcers from 1998 to 2011 (J. Am. Coll. Surg. 2014;219:e142).

Dr. Kryzhanouski shared the results of his study – and the reasons for his prediction – at the American College of Surgeons Clinical Congress.

[email protected]

SAN FRANCISCO – If current trends continue, vagotomy and gastrectomy for bleeding peptic ulcers will be mostly a thing of the past, according to Dr. Mikhail Kryzhanouski, a surgery resident at the University of Illinois, Chicago.

Their use is quickly fading, eclipsed by better techniques and a steady drop in adverse outcomes, even though patients are presenting with more comorbidities, Dr. Kryzhanouski found in a review of patients in the U.S. Nationwide Inpatient Sample who were hospitalized for peptic ulcers from 1998 to 2011 (J. Am. Coll. Surg. 2014;219:e142).

Dr. Kryzhanouski shared the results of his study – and the reasons for his prediction – at the American College of Surgeons Clinical Congress.

[email protected]

SAN FRANCISCO – Surgeons improve if they know they are behind the curve, according to Dr. Judy A. Tjoe, a breast cancer surgeon with Milwaukee-based Aurora Health Care.

She and her colleagues used that principle to significantly increase Aurora’s use of minimally invasive breast biopsies, the gold standard to diagnose breast cancer.

Although Dr. Tjoe and the system’s other three dedicated breast surgeons were using MIBB as appropriate, they found that 9 of 42 general surgeons (21%) were not, opting instead for open biopsies.

All it took to fix the problem was letting those surgeons know that minimally invasive breast biopsies was the preferred method, and that most of their peers were using it.

In a video interview at the American College of Surgeons Clinical Congress, Dr. Tjoe, also chair of Aurora’s quality committee for breast cancer care, explained why that message was so powerful, and how, in an era of pay for performance, the project is a model for improving health care without punitive measures.

[email protected]

SAN FRANCISCO – Surgeons improve if they know they are behind the curve, according to Dr. Judy A. Tjoe, a breast cancer surgeon with Milwaukee-based Aurora Health Care.

She and her colleagues used that principle to significantly increase Aurora’s use of minimally invasive breast biopsies, the gold standard to diagnose breast cancer.

Although Dr. Tjoe and the system’s other three dedicated breast surgeons were using MIBB as appropriate, they found that 9 of 42 general surgeons (21%) were not, opting instead for open biopsies.

All it took to fix the problem was letting those surgeons know that minimally invasive breast biopsies was the preferred method, and that most of their peers were using it.

In a video interview at the American College of Surgeons Clinical Congress, Dr. Tjoe, also chair of Aurora’s quality committee for breast cancer care, explained why that message was so powerful, and how, in an era of pay for performance, the project is a model for improving health care without punitive measures.

[email protected]

SAN FRANCISCO – Surgeons improve if they know they are behind the curve, according to Dr. Judy A. Tjoe, a breast cancer surgeon with Milwaukee-based Aurora Health Care.

She and her colleagues used that principle to significantly increase Aurora’s use of minimally invasive breast biopsies, the gold standard to diagnose breast cancer.

Although Dr. Tjoe and the system’s other three dedicated breast surgeons were using MIBB as appropriate, they found that 9 of 42 general surgeons (21%) were not, opting instead for open biopsies.

All it took to fix the problem was letting those surgeons know that minimally invasive breast biopsies was the preferred method, and that most of their peers were using it.

In a video interview at the American College of Surgeons Clinical Congress, Dr. Tjoe, also chair of Aurora’s quality committee for breast cancer care, explained why that message was so powerful, and how, in an era of pay for performance, the project is a model for improving health care without punitive measures.

[email protected]

SAN FRANCISCO– A large retrospective study identified risk factors for anastomotic leak within 30 days of colectomy.

The analysis of data on 13,684 patients looked at a multicenter cohort, compared with previous smaller studies that generally focused on single institutions, Dr. Emily F. Midura and her associates reported at the annual clinical congress of the American College of Surgeons.

In a video interview at the meeting, Dr. Midura described the risk factors identified in the study.

The 4% of patients who developed a leak averaged 13 days in the hospital, compared with 8 days for patients with no leak, said Dr. Midura of the University of Cincinnati. A total of 6% of patients who developed an anastomotic leak died, compared with a 2% mortality rate in patients without a leak.

Indications for colectomy included cancer in 42% of patients, diverticulitis in 23%, inflammatory bowel disease in 6%, and other reasons in the rest of the cohort.

Dr. Midura reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO– A large retrospective study identified risk factors for anastomotic leak within 30 days of colectomy.

The analysis of data on 13,684 patients looked at a multicenter cohort, compared with previous smaller studies that generally focused on single institutions, Dr. Emily F. Midura and her associates reported at the annual clinical congress of the American College of Surgeons.

In a video interview at the meeting, Dr. Midura described the risk factors identified in the study.

The 4% of patients who developed a leak averaged 13 days in the hospital, compared with 8 days for patients with no leak, said Dr. Midura of the University of Cincinnati. A total of 6% of patients who developed an anastomotic leak died, compared with a 2% mortality rate in patients without a leak.

Indications for colectomy included cancer in 42% of patients, diverticulitis in 23%, inflammatory bowel disease in 6%, and other reasons in the rest of the cohort.

Dr. Midura reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO– A large retrospective study identified risk factors for anastomotic leak within 30 days of colectomy.

The analysis of data on 13,684 patients looked at a multicenter cohort, compared with previous smaller studies that generally focused on single institutions, Dr. Emily F. Midura and her associates reported at the annual clinical congress of the American College of Surgeons.

In a video interview at the meeting, Dr. Midura described the risk factors identified in the study.

The 4% of patients who developed a leak averaged 13 days in the hospital, compared with 8 days for patients with no leak, said Dr. Midura of the University of Cincinnati. A total of 6% of patients who developed an anastomotic leak died, compared with a 2% mortality rate in patients without a leak.

Indications for colectomy included cancer in 42% of patients, diverticulitis in 23%, inflammatory bowel disease in 6%, and other reasons in the rest of the cohort.

Dr. Midura reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

PHILADELPHIA – Obesity and diabetes are independent risk factors for invasive group A Streptococcus infections, with the highest risk among those with diabetes and morbid obesity.

The relative risk of invasive group A Streptococcus (iGAS) infection was 15 times higher in adults with diabetes and grade 3 morbid obesity (body mass index ≥ 40 kg/m²) than in those of normal weight, Dr. Gayle Langley reported at Infectious Diseases Week 2014.

Moreover, grades 1-2 obesity and morbid obesity increased the odds of ICU admission and death from an iGAS infection in multivariable logistic regression.

The adjusted odds ratios for ICU admission and death were 1.46 and 1.55 for patients with grades 1-2 obesity (BMI 30 < 40 kg/m²) and 2.07 and 1.62 for those with morbid obesity, she said.

Diabetes was not associated with an increased risk for either ICU admission (odds ratio, 1.06) or death (OR, 0.77) in the analysis.

Skin and soft tissue infections, which were significantly more common in obese and diabetic patients, appear to be driving the increased risk for iGAS in these groups, Dr. Langley of the Centers for Disease Control and Prevention said in an interview.

“Based on the literature, I’m not all that surprised because we definitely know that they are at increased risk for these skin and soft tissue infections, and that is a common manifestation of strep,” she said. “The mortality is slightly increased, but not to the extent of the incidence.”

The study was prompted by the limited number of prevention strategies for what Langley described as a “really serious infection” and by the rise in obesity and diabetes in the United States.

Data from select counties in 10 of the CDC’s Active Bacterial Core surveillance sites were used to identify 2,927 cases of 2010-2012 community onset iGAS. Cases were defined by isolation of GAS from a normally sterile site or from a wound in a patient with necrotizing fasciitis or streptococcal toxic shock syndrome in a resident in the surveillance area. Clinical data were obtained from medical records, with height and weight used to calculate BMI.

Diabetes was present in 859 patients (29.3%), grades 1-2 obesity in 743 (25.4%), grade 3 obesity in 399 patients (13.6%), and skin/soft tissue infections in 976 (33.3%). Most patients were aged 18-49 years (37.6%) and male (55%).

Among diabetic patients, the relative risk of an iGAS infection was 4.09 for those who were underweight (BMI < 18.5), 1.23 for the overweight (BMI 25 < 30), 3.14 for those with grade 1-2 obesity, and 15.6 for the morbidly obese. Among nondiabetics, the corresponding relative risks were 3.29, 0.87, 1.15, and 2.95, the authors reported in the poster presentation.

Dr. Langley said the next step is to look at treatment options and whether antibiotic dosing is important and “Long term, if we have a vaccine, this might be a group that needs to be targeted for vaccination.”

ID Week is a joint meeting of the Infectious Diseases Society of America, Society for Healthcare Epidemiology of America, HIV Medicine Association, and Pediatric Infectious Diseases Society.

[email protected]

PHILADELPHIA – Obesity and diabetes are independent risk factors for invasive group A Streptococcus infections, with the highest risk among those with diabetes and morbid obesity.

The relative risk of invasive group A Streptococcus (iGAS) infection was 15 times higher in adults with diabetes and grade 3 morbid obesity (body mass index ≥ 40 kg/m²) than in those of normal weight, Dr. Gayle Langley reported at Infectious Diseases Week 2014.

Moreover, grades 1-2 obesity and morbid obesity increased the odds of ICU admission and death from an iGAS infection in multivariable logistic regression.

The adjusted odds ratios for ICU admission and death were 1.46 and 1.55 for patients with grades 1-2 obesity (BMI 30 < 40 kg/m²) and 2.07 and 1.62 for those with morbid obesity, she said.

Diabetes was not associated with an increased risk for either ICU admission (odds ratio, 1.06) or death (OR, 0.77) in the analysis.

Skin and soft tissue infections, which were significantly more common in obese and diabetic patients, appear to be driving the increased risk for iGAS in these groups, Dr. Langley of the Centers for Disease Control and Prevention said in an interview.

“Based on the literature, I’m not all that surprised because we definitely know that they are at increased risk for these skin and soft tissue infections, and that is a common manifestation of strep,” she said. “The mortality is slightly increased, but not to the extent of the incidence.”

The study was prompted by the limited number of prevention strategies for what Langley described as a “really serious infection” and by the rise in obesity and diabetes in the United States.

Data from select counties in 10 of the CDC’s Active Bacterial Core surveillance sites were used to identify 2,927 cases of 2010-2012 community onset iGAS. Cases were defined by isolation of GAS from a normally sterile site or from a wound in a patient with necrotizing fasciitis or streptococcal toxic shock syndrome in a resident in the surveillance area. Clinical data were obtained from medical records, with height and weight used to calculate BMI.

Diabetes was present in 859 patients (29.3%), grades 1-2 obesity in 743 (25.4%), grade 3 obesity in 399 patients (13.6%), and skin/soft tissue infections in 976 (33.3%). Most patients were aged 18-49 years (37.6%) and male (55%).

Among diabetic patients, the relative risk of an iGAS infection was 4.09 for those who were underweight (BMI < 18.5), 1.23 for the overweight (BMI 25 < 30), 3.14 for those with grade 1-2 obesity, and 15.6 for the morbidly obese. Among nondiabetics, the corresponding relative risks were 3.29, 0.87, 1.15, and 2.95, the authors reported in the poster presentation.

Dr. Langley said the next step is to look at treatment options and whether antibiotic dosing is important and “Long term, if we have a vaccine, this might be a group that needs to be targeted for vaccination.”

ID Week is a joint meeting of the Infectious Diseases Society of America, Society for Healthcare Epidemiology of America, HIV Medicine Association, and Pediatric Infectious Diseases Society.

[email protected]

PHILADELPHIA – Obesity and diabetes are independent risk factors for invasive group A Streptococcus infections, with the highest risk among those with diabetes and morbid obesity.

The relative risk of invasive group A Streptococcus (iGAS) infection was 15 times higher in adults with diabetes and grade 3 morbid obesity (body mass index ≥ 40 kg/m²) than in those of normal weight, Dr. Gayle Langley reported at Infectious Diseases Week 2014.

Moreover, grades 1-2 obesity and morbid obesity increased the odds of ICU admission and death from an iGAS infection in multivariable logistic regression.

The adjusted odds ratios for ICU admission and death were 1.46 and 1.55 for patients with grades 1-2 obesity (BMI 30 < 40 kg/m²) and 2.07 and 1.62 for those with morbid obesity, she said.

Diabetes was not associated with an increased risk for either ICU admission (odds ratio, 1.06) or death (OR, 0.77) in the analysis.

Skin and soft tissue infections, which were significantly more common in obese and diabetic patients, appear to be driving the increased risk for iGAS in these groups, Dr. Langley of the Centers for Disease Control and Prevention said in an interview.

“Based on the literature, I’m not all that surprised because we definitely know that they are at increased risk for these skin and soft tissue infections, and that is a common manifestation of strep,” she said. “The mortality is slightly increased, but not to the extent of the incidence.”

The study was prompted by the limited number of prevention strategies for what Langley described as a “really serious infection” and by the rise in obesity and diabetes in the United States.

Data from select counties in 10 of the CDC’s Active Bacterial Core surveillance sites were used to identify 2,927 cases of 2010-2012 community onset iGAS. Cases were defined by isolation of GAS from a normally sterile site or from a wound in a patient with necrotizing fasciitis or streptococcal toxic shock syndrome in a resident in the surveillance area. Clinical data were obtained from medical records, with height and weight used to calculate BMI.

Diabetes was present in 859 patients (29.3%), grades 1-2 obesity in 743 (25.4%), grade 3 obesity in 399 patients (13.6%), and skin/soft tissue infections in 976 (33.3%). Most patients were aged 18-49 years (37.6%) and male (55%).

Among diabetic patients, the relative risk of an iGAS infection was 4.09 for those who were underweight (BMI < 18.5), 1.23 for the overweight (BMI 25 < 30), 3.14 for those with grade 1-2 obesity, and 15.6 for the morbidly obese. Among nondiabetics, the corresponding relative risks were 3.29, 0.87, 1.15, and 2.95, the authors reported in the poster presentation.

Dr. Langley said the next step is to look at treatment options and whether antibiotic dosing is important and “Long term, if we have a vaccine, this might be a group that needs to be targeted for vaccination.”

ID Week is a joint meeting of the Infectious Diseases Society of America, Society for Healthcare Epidemiology of America, HIV Medicine Association, and Pediatric Infectious Diseases Society.

[email protected]

The greatest research need regarding bariatric surgery is the critical lack of information about long-term durability and complications of the procedures, according to a report published online Nov. 4 in JAMA Surgery.

Bariatric surgery “results in greater weight loss than nonsurgical treatment,” but that crucial information about long-term outcomes – “at least 10 years’ worth” – is still missing, said Dr. Bruce M. Wolfe of Oregon Health and Science University, Portland, and Steven H. Belle, Ph.D., of the epidemiology department, University of Pittsburgh. They were speaking at a symposium sponsored by the National Institute of Digestive and Kidney Diseases and the National Heart, Lung, and Blood Institute to review the best available evidence on bariatric surgery outcomes from the most recent large observational studies and randomized clinical trials.

Very large multicenter, randomized, controlled trials are the best type of study to provide this information but are prohibitively expensive, especially given the difficulty retaining participants in weight-loss studies. Any such trial would require very large numbers of treatment centers and patients to generate results that were adequately powered and generalizable, they wrote (JAMA Surg. 2014 Nov. 4 [doi: 10.1001/jamasurg.2014.2440]).

Future research must address the substantial variability in weight loss after bariatric surgery, as well as the equally substantial variability in its effect on diabetes, hypertension, dyslipidemia, obstructive sleep apnea, and psychological and psychosocial issues. And long-term gastrointestinal complications must be a specific focus because these procedures alter the GI anatomy, and adverse effects may take many years to manifest.

“In summary, bariatric surgery offers the potential to address the morbidity and mortality of the obesity epidemic, but important research questions remain unresolved,” according to Dr. Wolfe and Dr. Belle.

The symposium was convened by the National Institute of Diabetes and Digestive and Kidney Diseases and the National Heart, Lung, and Blood Institute’s division of cardiovascular sciences. Dr. Wolfe reported serving as a research consultant to EnteroMedics.

[email protected]

The greatest research need regarding bariatric surgery is the critical lack of information about long-term durability and complications of the procedures, according to a report published online Nov. 4 in JAMA Surgery.

Bariatric surgery “results in greater weight loss than nonsurgical treatment,” but that crucial information about long-term outcomes – “at least 10 years’ worth” – is still missing, said Dr. Bruce M. Wolfe of Oregon Health and Science University, Portland, and Steven H. Belle, Ph.D., of the epidemiology department, University of Pittsburgh. They were speaking at a symposium sponsored by the National Institute of Digestive and Kidney Diseases and the National Heart, Lung, and Blood Institute to review the best available evidence on bariatric surgery outcomes from the most recent large observational studies and randomized clinical trials.

Very large multicenter, randomized, controlled trials are the best type of study to provide this information but are prohibitively expensive, especially given the difficulty retaining participants in weight-loss studies. Any such trial would require very large numbers of treatment centers and patients to generate results that were adequately powered and generalizable, they wrote (JAMA Surg. 2014 Nov. 4 [doi: 10.1001/jamasurg.2014.2440]).

Future research must address the substantial variability in weight loss after bariatric surgery, as well as the equally substantial variability in its effect on diabetes, hypertension, dyslipidemia, obstructive sleep apnea, and psychological and psychosocial issues. And long-term gastrointestinal complications must be a specific focus because these procedures alter the GI anatomy, and adverse effects may take many years to manifest.

“In summary, bariatric surgery offers the potential to address the morbidity and mortality of the obesity epidemic, but important research questions remain unresolved,” according to Dr. Wolfe and Dr. Belle.

The symposium was convened by the National Institute of Diabetes and Digestive and Kidney Diseases and the National Heart, Lung, and Blood Institute’s division of cardiovascular sciences. Dr. Wolfe reported serving as a research consultant to EnteroMedics.

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The greatest research need regarding bariatric surgery is the critical lack of information about long-term durability and complications of the procedures, according to a report published online Nov. 4 in JAMA Surgery.

Bariatric surgery “results in greater weight loss than nonsurgical treatment,” but that crucial information about long-term outcomes – “at least 10 years’ worth” – is still missing, said Dr. Bruce M. Wolfe of Oregon Health and Science University, Portland, and Steven H. Belle, Ph.D., of the epidemiology department, University of Pittsburgh. They were speaking at a symposium sponsored by the National Institute of Digestive and Kidney Diseases and the National Heart, Lung, and Blood Institute to review the best available evidence on bariatric surgery outcomes from the most recent large observational studies and randomized clinical trials.

Very large multicenter, randomized, controlled trials are the best type of study to provide this information but are prohibitively expensive, especially given the difficulty retaining participants in weight-loss studies. Any such trial would require very large numbers of treatment centers and patients to generate results that were adequately powered and generalizable, they wrote (JAMA Surg. 2014 Nov. 4 [doi: 10.1001/jamasurg.2014.2440]).

Future research must address the substantial variability in weight loss after bariatric surgery, as well as the equally substantial variability in its effect on diabetes, hypertension, dyslipidemia, obstructive sleep apnea, and psychological and psychosocial issues. And long-term gastrointestinal complications must be a specific focus because these procedures alter the GI anatomy, and adverse effects may take many years to manifest.

“In summary, bariatric surgery offers the potential to address the morbidity and mortality of the obesity epidemic, but important research questions remain unresolved,” according to Dr. Wolfe and Dr. Belle.

The symposium was convened by the National Institute of Diabetes and Digestive and Kidney Diseases and the National Heart, Lung, and Blood Institute’s division of cardiovascular sciences. Dr. Wolfe reported serving as a research consultant to EnteroMedics.

[email protected]

LAS VEGAS – A novel device-based approach to the treatment of heart failure via vagal nerve stimulation resulted in improvements in objectively measurable cardiac function as well as in subjective heart failure symptoms in the ANTHEM-HF trial.

The improvements seen in ANTHEM-HF (Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure) were similar regardless of whether participants were randomized to stimulation of the left or right vagal nerve. That’s an important finding because left-sided vagal nerve stimulation (VNS) technology could readily be combined with implantable cardioverter-defibrillators and cardiac resynchronization therapy devices, which are routinely placed on the left side of the thorax, Dr. Inder S. Anand observed in presenting the study findings at the annual meeting of the Heart Failure Society of America.

“We believe that if this technology pans out and proves effective, it will be introduced into devices very easily. That’s the advantage of left-sided stimulation,” explained Dr. Anand, professor of medicine at the University of Minnesota, Minneapolis.

He was quick to add, however, that “There needs to be a lot more work before autonomic regulation therapy is ready for prime time.” That’s because ANTHEM-HF was a relatively small prospective study – just 60 patients – and it was uncontrolled and unblinded.

Left-sided VNS is a well-established treatment for epilepsy, with more than 100,000 patients having received devices in the last several decades. It’s also seeing increasing use in refractory depression.

The approach is still investigational for heart failure, where autonomic imbalance with increased sympathetic activity and decreased parasympathetic tone is associated with heart failure progression and worse clinical outcomes, the cardiologist explained.

In ANTHEM-HF, 60 patients on optimal medical therapy for heart failure with reduced ejection fraction were randomized to left- or right-sided implantation of the Cyberonics VNS device. Once activated, the VNS intensity was titrated over 10 weeks to the maximum tolerable current that remained below the threshold of heart rate change, side effects, and patient sensation. The chronic intermittent stimulation to the vagus nerve was delivered at 10 Hz, a 250 microsec pulse width, and an average stimulation current of 2.0 mA. The stimulation cycle was 14 seconds on, 66 seconds off.

The primary study endpoint was change in LVEF over the course of 6 months. From a baseline of 32.4% it improved significantly to 37.2%, which Dr. Anand deemed “very impressive” for just 6 months of therapy. The improvement was similar regardless of whether the VNS was left or right sided.

He said the study didn’t raise any safety concerns. The only serious treatment-related adverse event was a fatal perioperative embolic stroke in a recipient of a left-sided device.

The most common adverse events were hoarseness or other voice alterations, which occurred in 19 patients. Thirteen patients reported a new cough. These side effects mirror the experience in patients treated with the VNS device for epilepsy or depression.

Discussant Jagmeet P. Singh emphasized that “it’s important to interpret the ANTHEM-HF results with some degree of caution.” That’s because the usual variability within LVEF measurements can be in the 5% range, and the 4.8% improvement seen in this study wasn’t accompanied by a significant improvement in LV end systolic volume. Moreover, the improvements seen in secondary endpoints – 6-minute walk distance, NYHA class, and the Minnesota Living With Heart Failure qualify-of-life score – are all potentially open to bias since neither patients nor physicians were blinded.

Dr. Singh noted that the NECTAR-HF study, a blinded, sham-controlled clinical trial of VNS presented earlier at the annual congress of the European Society of Cardiology, was a negative study that showed no improvement in functional measures. While NECTAR-HF caused some skeptics to question the whole concept of VNS as a useful therapeutic strategy, the stimulation protocols used in NECTAR-HF and ANTHEM-HF were quite different, and it’s likely that the stimulation amplitude employed in NECTAR-HF wasn’t sufficient to affect the target subset of vagal nerve fibers, according to Dr. Singh, director of the cardiac resynchronization therapy program and the Holter laboratory at Massachusetts General Hospital, Boston.

He considers the ANTHEM-HF finding that left-sided VNS is comparable to right to be an important advance that “really moves the field forward.” Yet many critical questions about autonomic regulation therapy for heart failure remain unanswered. These include whether it truly is safe and effective, and if so, the optimal target dose and frequency of stimulation. Answers should be forthcoming from the ongoing INOVATE-HF study, a randomized, controlled, 650-patient study, sponsored by BioControl Medical. The trial features hard clinical endpoints and higher target-dose stimulation protocols than in prior studies.

“This trial will probably put an end to the debate as to whether vagal nerve stimulation has an impact on heart failure or not,” the cardiologist predicted.

“Strategies to nonpharmacologically modulate the autonomic nervous system is an area of immense interest and investigation, and it’s going to be extended,” he observed. “I think that this is the autonomic era, and so it’s really important that we get it right. I think we’ve learned from the renal denervation experience that we need to be really careful in selecting patients for any form of autonomic manipulation. I don’t think we should select patients just off their LVEF. We should have some parameter that can quantify autonomic dysregulation prior to initiation of therapy.”

It will also be important to be able to individualize VNS therapy, just as physicians now do with beta blockers and other pharmacotherapies, he added.

The ANTHEM-HF trial was sponsored by Cyberonics. Dr. Anand reported serving as a consultant to and/or recipient of research grants from Cyberonics, Amgen, Critical Diagnostics, Novartis, and Zensun. Dr. Singh has received research support and/or served on speakers bureaus for Boston Scientific, St. Jude Medical, and the Sorin Group.

[email protected]

LAS VEGAS – A novel device-based approach to the treatment of heart failure via vagal nerve stimulation resulted in improvements in objectively measurable cardiac function as well as in subjective heart failure symptoms in the ANTHEM-HF trial.

The improvements seen in ANTHEM-HF (Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure) were similar regardless of whether participants were randomized to stimulation of the left or right vagal nerve. That’s an important finding because left-sided vagal nerve stimulation (VNS) technology could readily be combined with implantable cardioverter-defibrillators and cardiac resynchronization therapy devices, which are routinely placed on the left side of the thorax, Dr. Inder S. Anand observed in presenting the study findings at the annual meeting of the Heart Failure Society of America.

“We believe that if this technology pans out and proves effective, it will be introduced into devices very easily. That’s the advantage of left-sided stimulation,” explained Dr. Anand, professor of medicine at the University of Minnesota, Minneapolis.

He was quick to add, however, that “There needs to be a lot more work before autonomic regulation therapy is ready for prime time.” That’s because ANTHEM-HF was a relatively small prospective study – just 60 patients – and it was uncontrolled and unblinded.

Left-sided VNS is a well-established treatment for epilepsy, with more than 100,000 patients having received devices in the last several decades. It’s also seeing increasing use in refractory depression.

The approach is still investigational for heart failure, where autonomic imbalance with increased sympathetic activity and decreased parasympathetic tone is associated with heart failure progression and worse clinical outcomes, the cardiologist explained.

In ANTHEM-HF, 60 patients on optimal medical therapy for heart failure with reduced ejection fraction were randomized to left- or right-sided implantation of the Cyberonics VNS device. Once activated, the VNS intensity was titrated over 10 weeks to the maximum tolerable current that remained below the threshold of heart rate change, side effects, and patient sensation. The chronic intermittent stimulation to the vagus nerve was delivered at 10 Hz, a 250 microsec pulse width, and an average stimulation current of 2.0 mA. The stimulation cycle was 14 seconds on, 66 seconds off.

The primary study endpoint was change in LVEF over the course of 6 months. From a baseline of 32.4% it improved significantly to 37.2%, which Dr. Anand deemed “very impressive” for just 6 months of therapy. The improvement was similar regardless of whether the VNS was left or right sided.

He said the study didn’t raise any safety concerns. The only serious treatment-related adverse event was a fatal perioperative embolic stroke in a recipient of a left-sided device.

The most common adverse events were hoarseness or other voice alterations, which occurred in 19 patients. Thirteen patients reported a new cough. These side effects mirror the experience in patients treated with the VNS device for epilepsy or depression.

Discussant Jagmeet P. Singh emphasized that “it’s important to interpret the ANTHEM-HF results with some degree of caution.” That’s because the usual variability within LVEF measurements can be in the 5% range, and the 4.8% improvement seen in this study wasn’t accompanied by a significant improvement in LV end systolic volume. Moreover, the improvements seen in secondary endpoints – 6-minute walk distance, NYHA class, and the Minnesota Living With Heart Failure qualify-of-life score – are all potentially open to bias since neither patients nor physicians were blinded.

Dr. Singh noted that the NECTAR-HF study, a blinded, sham-controlled clinical trial of VNS presented earlier at the annual congress of the European Society of Cardiology, was a negative study that showed no improvement in functional measures. While NECTAR-HF caused some skeptics to question the whole concept of VNS as a useful therapeutic strategy, the stimulation protocols used in NECTAR-HF and ANTHEM-HF were quite different, and it’s likely that the stimulation amplitude employed in NECTAR-HF wasn’t sufficient to affect the target subset of vagal nerve fibers, according to Dr. Singh, director of the cardiac resynchronization therapy program and the Holter laboratory at Massachusetts General Hospital, Boston.

He considers the ANTHEM-HF finding that left-sided VNS is comparable to right to be an important advance that “really moves the field forward.” Yet many critical questions about autonomic regulation therapy for heart failure remain unanswered. These include whether it truly is safe and effective, and if so, the optimal target dose and frequency of stimulation. Answers should be forthcoming from the ongoing INOVATE-HF study, a randomized, controlled, 650-patient study, sponsored by BioControl Medical. The trial features hard clinical endpoints and higher target-dose stimulation protocols than in prior studies.

“This trial will probably put an end to the debate as to whether vagal nerve stimulation has an impact on heart failure or not,” the cardiologist predicted.

“Strategies to nonpharmacologically modulate the autonomic nervous system is an area of immense interest and investigation, and it’s going to be extended,” he observed. “I think that this is the autonomic era, and so it’s really important that we get it right. I think we’ve learned from the renal denervation experience that we need to be really careful in selecting patients for any form of autonomic manipulation. I don’t think we should select patients just off their LVEF. We should have some parameter that can quantify autonomic dysregulation prior to initiation of therapy.”

It will also be important to be able to individualize VNS therapy, just as physicians now do with beta blockers and other pharmacotherapies, he added.

The ANTHEM-HF trial was sponsored by Cyberonics. Dr. Anand reported serving as a consultant to and/or recipient of research grants from Cyberonics, Amgen, Critical Diagnostics, Novartis, and Zensun. Dr. Singh has received research support and/or served on speakers bureaus for Boston Scientific, St. Jude Medical, and the Sorin Group.

[email protected]

LAS VEGAS – A novel device-based approach to the treatment of heart failure via vagal nerve stimulation resulted in improvements in objectively measurable cardiac function as well as in subjective heart failure symptoms in the ANTHEM-HF trial.

The improvements seen in ANTHEM-HF (Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure) were similar regardless of whether participants were randomized to stimulation of the left or right vagal nerve. That’s an important finding because left-sided vagal nerve stimulation (VNS) technology could readily be combined with implantable cardioverter-defibrillators and cardiac resynchronization therapy devices, which are routinely placed on the left side of the thorax, Dr. Inder S. Anand observed in presenting the study findings at the annual meeting of the Heart Failure Society of America.

“We believe that if this technology pans out and proves effective, it will be introduced into devices very easily. That’s the advantage of left-sided stimulation,” explained Dr. Anand, professor of medicine at the University of Minnesota, Minneapolis.

He was quick to add, however, that “There needs to be a lot more work before autonomic regulation therapy is ready for prime time.” That’s because ANTHEM-HF was a relatively small prospective study – just 60 patients – and it was uncontrolled and unblinded.

Left-sided VNS is a well-established treatment for epilepsy, with more than 100,000 patients having received devices in the last several decades. It’s also seeing increasing use in refractory depression.

The approach is still investigational for heart failure, where autonomic imbalance with increased sympathetic activity and decreased parasympathetic tone is associated with heart failure progression and worse clinical outcomes, the cardiologist explained.

In ANTHEM-HF, 60 patients on optimal medical therapy for heart failure with reduced ejection fraction were randomized to left- or right-sided implantation of the Cyberonics VNS device. Once activated, the VNS intensity was titrated over 10 weeks to the maximum tolerable current that remained below the threshold of heart rate change, side effects, and patient sensation. The chronic intermittent stimulation to the vagus nerve was delivered at 10 Hz, a 250 microsec pulse width, and an average stimulation current of 2.0 mA. The stimulation cycle was 14 seconds on, 66 seconds off.

The primary study endpoint was change in LVEF over the course of 6 months. From a baseline of 32.4% it improved significantly to 37.2%, which Dr. Anand deemed “very impressive” for just 6 months of therapy. The improvement was similar regardless of whether the VNS was left or right sided.

He said the study didn’t raise any safety concerns. The only serious treatment-related adverse event was a fatal perioperative embolic stroke in a recipient of a left-sided device.

The most common adverse events were hoarseness or other voice alterations, which occurred in 19 patients. Thirteen patients reported a new cough. These side effects mirror the experience in patients treated with the VNS device for epilepsy or depression.

Discussant Jagmeet P. Singh emphasized that “it’s important to interpret the ANTHEM-HF results with some degree of caution.” That’s because the usual variability within LVEF measurements can be in the 5% range, and the 4.8% improvement seen in this study wasn’t accompanied by a significant improvement in LV end systolic volume. Moreover, the improvements seen in secondary endpoints – 6-minute walk distance, NYHA class, and the Minnesota Living With Heart Failure qualify-of-life score – are all potentially open to bias since neither patients nor physicians were blinded.

Dr. Singh noted that the NECTAR-HF study, a blinded, sham-controlled clinical trial of VNS presented earlier at the annual congress of the European Society of Cardiology, was a negative study that showed no improvement in functional measures. While NECTAR-HF caused some skeptics to question the whole concept of VNS as a useful therapeutic strategy, the stimulation protocols used in NECTAR-HF and ANTHEM-HF were quite different, and it’s likely that the stimulation amplitude employed in NECTAR-HF wasn’t sufficient to affect the target subset of vagal nerve fibers, according to Dr. Singh, director of the cardiac resynchronization therapy program and the Holter laboratory at Massachusetts General Hospital, Boston.

He considers the ANTHEM-HF finding that left-sided VNS is comparable to right to be an important advance that “really moves the field forward.” Yet many critical questions about autonomic regulation therapy for heart failure remain unanswered. These include whether it truly is safe and effective, and if so, the optimal target dose and frequency of stimulation. Answers should be forthcoming from the ongoing INOVATE-HF study, a randomized, controlled, 650-patient study, sponsored by BioControl Medical. The trial features hard clinical endpoints and higher target-dose stimulation protocols than in prior studies.

“This trial will probably put an end to the debate as to whether vagal nerve stimulation has an impact on heart failure or not,” the cardiologist predicted.

“Strategies to nonpharmacologically modulate the autonomic nervous system is an area of immense interest and investigation, and it’s going to be extended,” he observed. “I think that this is the autonomic era, and so it’s really important that we get it right. I think we’ve learned from the renal denervation experience that we need to be really careful in selecting patients for any form of autonomic manipulation. I don’t think we should select patients just off their LVEF. We should have some parameter that can quantify autonomic dysregulation prior to initiation of therapy.”

It will also be important to be able to individualize VNS therapy, just as physicians now do with beta blockers and other pharmacotherapies, he added.

The ANTHEM-HF trial was sponsored by Cyberonics. Dr. Anand reported serving as a consultant to and/or recipient of research grants from Cyberonics, Amgen, Critical Diagnostics, Novartis, and Zensun. Dr. Singh has received research support and/or served on speakers bureaus for Boston Scientific, St. Jude Medical, and the Sorin Group.

[email protected]