ACS Surgery News

CHICAGO – Infected ventral hernia mesh is most likely to be salvaged if it’s made from lightweight polypropylene, according to data from a series of 161 mesh infection cases at Carolinas Medical Center in Charlotte, N.C.

Investigators there were able to salvage 33% of lightweight polypropylene and 8% of polytetrafluoroethylene mesh patients, but salvage failed in patients with composite, polyester, or heavyweight polypropylene meshes. The overall salvage rate was less than 10%.

WikiMedia Commons/Zhangzhugang/Creative Commons

“We sometimes think that we’ve salvaged the mesh, but if we follow these patients long enough” – follow-up was an average of 37 months in the series – “the majority of them will need to be excised,” said investigator Dr. Vedra Augenstein of the department of surgery at the medical center.

Wound complications are common in ventral hernia repairs, and mesh infections, said Dr. Augenstein, are among “the most dreaded.” The North Carolina findings help define the small pool of patients in whom salvage might work.

The average body mass index in the series was 36 kg/m², and patients had an average of 2.6 previous ventral hernia repairs. The majority had a polypropylene mesh. Most of the cases were referred to the medical center from elsewhere, so mesh excision came an average of 10 months after the diagnosis of infection.

Almost a third of patients had their infections diagnosed a year or more after mesh implant, which goes against the common notion that mesh patients are out of the woods after a year. “It took a very long time for some of these infections to present. This was a big surprise for us,” Dr. Augenstein said.

The team tried to salvage all of their patients, using antibiotics in 90%, vacuum-assisted closure and/or debridement in 57%, and percutaneous drainage in 17%.

No patient presented with an obvious fistula, but the investigators found fistulas during surgery in about 16% of patients. Meanwhile, salvage failed in every patient who continued to smoke despite being diagnosed with a mesh infection.

The team assembled their findings into an informal algorithm for considering mesh salvage.

“Think about what you need to ask yourself. First, does the patient have a fistula or do you suspect one” from, for instance, gut bacteria in the wound or oral contrast above the mesh on CT? If so, “they are going to need an operation,” Dr. Augenstein said.

Smoking is the next stop point; salvage is likely to fail in smokers.

Mesh type is the third consideration; lightweight polypropylene is a good sign. “If they have heavyweight polypropylene, composite, or polyester mesh, they were not salvageable in our series,” she said.

For patients still in the running, Methicillin-resistant Staphylococcus aureus (MRSA) is the next concern. If it’s in the wound, mesh is going to be harder to salvage, said Dr. Augenstein. Most of the infections in the series were caused by Staphylococcus, with MRSA present in 45% of patients.

Infection recurrence is common even when salvage seems to work, so “we need to follow these patients for a very, very long time,” Dr. Augenstein said.

Along with clinical exams, the North Carolina team follows C-reactive protein and erythrocyte sedimentation rate. “If the abdomen gets red or if, for example, the C-reactive protein goes up, we’ll do a CT scan or ultrasound to make sure they are not brewing an infection,” she said.

Dr. Augenstein has received research and educational grants from Gore, Ethicon, Novadaq, Bard, and LifeCell.

aotto@frontlinemedcom.com

CHICAGO – Infected ventral hernia mesh is most likely to be salvaged if it’s made from lightweight polypropylene, according to data from a series of 161 mesh infection cases at Carolinas Medical Center in Charlotte, N.C.

Investigators there were able to salvage 33% of lightweight polypropylene and 8% of polytetrafluoroethylene mesh patients, but salvage failed in patients with composite, polyester, or heavyweight polypropylene meshes. The overall salvage rate was less than 10%.

WikiMedia Commons/Zhangzhugang/Creative Commons

“We sometimes think that we’ve salvaged the mesh, but if we follow these patients long enough” – follow-up was an average of 37 months in the series – “the majority of them will need to be excised,” said investigator Dr. Vedra Augenstein of the department of surgery at the medical center.

Wound complications are common in ventral hernia repairs, and mesh infections, said Dr. Augenstein, are among “the most dreaded.” The North Carolina findings help define the small pool of patients in whom salvage might work.

The average body mass index in the series was 36 kg/m², and patients had an average of 2.6 previous ventral hernia repairs. The majority had a polypropylene mesh. Most of the cases were referred to the medical center from elsewhere, so mesh excision came an average of 10 months after the diagnosis of infection.

Almost a third of patients had their infections diagnosed a year or more after mesh implant, which goes against the common notion that mesh patients are out of the woods after a year. “It took a very long time for some of these infections to present. This was a big surprise for us,” Dr. Augenstein said.

The team tried to salvage all of their patients, using antibiotics in 90%, vacuum-assisted closure and/or debridement in 57%, and percutaneous drainage in 17%.

No patient presented with an obvious fistula, but the investigators found fistulas during surgery in about 16% of patients. Meanwhile, salvage failed in every patient who continued to smoke despite being diagnosed with a mesh infection.

The team assembled their findings into an informal algorithm for considering mesh salvage.

“Think about what you need to ask yourself. First, does the patient have a fistula or do you suspect one” from, for instance, gut bacteria in the wound or oral contrast above the mesh on CT? If so, “they are going to need an operation,” Dr. Augenstein said.

Smoking is the next stop point; salvage is likely to fail in smokers.

Mesh type is the third consideration; lightweight polypropylene is a good sign. “If they have heavyweight polypropylene, composite, or polyester mesh, they were not salvageable in our series,” she said.

For patients still in the running, Methicillin-resistant Staphylococcus aureus (MRSA) is the next concern. If it’s in the wound, mesh is going to be harder to salvage, said Dr. Augenstein. Most of the infections in the series were caused by Staphylococcus, with MRSA present in 45% of patients.

Infection recurrence is common even when salvage seems to work, so “we need to follow these patients for a very, very long time,” Dr. Augenstein said.

Along with clinical exams, the North Carolina team follows C-reactive protein and erythrocyte sedimentation rate. “If the abdomen gets red or if, for example, the C-reactive protein goes up, we’ll do a CT scan or ultrasound to make sure they are not brewing an infection,” she said.

Dr. Augenstein has received research and educational grants from Gore, Ethicon, Novadaq, Bard, and LifeCell.

aotto@frontlinemedcom.com

CHICAGO – Infected ventral hernia mesh is most likely to be salvaged if it’s made from lightweight polypropylene, according to data from a series of 161 mesh infection cases at Carolinas Medical Center in Charlotte, N.C.

Investigators there were able to salvage 33% of lightweight polypropylene and 8% of polytetrafluoroethylene mesh patients, but salvage failed in patients with composite, polyester, or heavyweight polypropylene meshes. The overall salvage rate was less than 10%.

WikiMedia Commons/Zhangzhugang/Creative Commons

“We sometimes think that we’ve salvaged the mesh, but if we follow these patients long enough” – follow-up was an average of 37 months in the series – “the majority of them will need to be excised,” said investigator Dr. Vedra Augenstein of the department of surgery at the medical center.

Wound complications are common in ventral hernia repairs, and mesh infections, said Dr. Augenstein, are among “the most dreaded.” The North Carolina findings help define the small pool of patients in whom salvage might work.

The average body mass index in the series was 36 kg/m², and patients had an average of 2.6 previous ventral hernia repairs. The majority had a polypropylene mesh. Most of the cases were referred to the medical center from elsewhere, so mesh excision came an average of 10 months after the diagnosis of infection.

Almost a third of patients had their infections diagnosed a year or more after mesh implant, which goes against the common notion that mesh patients are out of the woods after a year. “It took a very long time for some of these infections to present. This was a big surprise for us,” Dr. Augenstein said.

The team tried to salvage all of their patients, using antibiotics in 90%, vacuum-assisted closure and/or debridement in 57%, and percutaneous drainage in 17%.

No patient presented with an obvious fistula, but the investigators found fistulas during surgery in about 16% of patients. Meanwhile, salvage failed in every patient who continued to smoke despite being diagnosed with a mesh infection.

The team assembled their findings into an informal algorithm for considering mesh salvage.

“Think about what you need to ask yourself. First, does the patient have a fistula or do you suspect one” from, for instance, gut bacteria in the wound or oral contrast above the mesh on CT? If so, “they are going to need an operation,” Dr. Augenstein said.

Smoking is the next stop point; salvage is likely to fail in smokers.

Mesh type is the third consideration; lightweight polypropylene is a good sign. “If they have heavyweight polypropylene, composite, or polyester mesh, they were not salvageable in our series,” she said.

For patients still in the running, Methicillin-resistant Staphylococcus aureus (MRSA) is the next concern. If it’s in the wound, mesh is going to be harder to salvage, said Dr. Augenstein. Most of the infections in the series were caused by Staphylococcus, with MRSA present in 45% of patients.

Infection recurrence is common even when salvage seems to work, so “we need to follow these patients for a very, very long time,” Dr. Augenstein said.

Along with clinical exams, the North Carolina team follows C-reactive protein and erythrocyte sedimentation rate. “If the abdomen gets red or if, for example, the C-reactive protein goes up, we’ll do a CT scan or ultrasound to make sure they are not brewing an infection,” she said.

Dr. Augenstein has received research and educational grants from Gore, Ethicon, Novadaq, Bard, and LifeCell.

aotto@frontlinemedcom.com

SAN DIEGO – Among patients undergoing cardiac bypass surgery, perioperative use of corticosteroids did not alter the risk of acute kidney injury, results from a large randomized trial showed.

“Worldwide, over 20 million cardiac surgeries are done each year, but 4 million are complicated by acute kidney injury, and 200,000 are complicated by severe kidney injury treated with dialysis,” Dr. Amit X. Garg said during a press briefing at the annual meeting of the American Society of Nephrology. “So certainly people would benefit from a therapy to prevent acute kidney injury (AKI) and improve the safety of surgery.”

Dr. Garg, a nephrologist at the London Health Sciences Centre in London, Ontario, Canada, noted that cardiopulmonary bypass initiates a systemic inflammatory response syndrome, “which activates complement, inflammatory cytokines, and other inflammatory mediators, which in turn increases endothelial permeability, organ damage, and increased morbidity and mortality, including acute kidney injury.” Researchers are interested in corticosteroids, “because they suppress this inflammatory response. In other settings, such as acute glomerulonephritis, we successfully use corticosteroids to treat acute inflammation in the kidney,” he said.

In a study known as the Steroids in caRdiac Surgery Trial (SIRS), researchers at 79 centers in 18 countries set out to investigate if methylprednisolone alters the risk of acute kidney injury in patients undergoing cardiac surgery with cardiopulmonary bypass. Between June 2007 and December 2013, 7,286 patients were randomized to intravenous methylprednisolone 250 mg at anesthetic induction and 250 mg at initiation of coronary bypass, or placebo.

AKI was defined as a 0.3 mg/dL increase or greater in postoperative serum creatinine concentration from the preoperative concentration within 14 days following surgery, or a 50% increase from the preoperative value within 14 days following surgery. Secondary outcomes included different stages of AKI and receipt of acute dialysis in the 30 days following surgery. Patients, caregivers, and researchers were blinded to the treatment allocation.

Of the 7,286 patients, 3,647 received methylprednisolone and 3,639 received placebo. The mean age of patients was 60 years, 60% were men, 26% were diabetic, and 25% of patients had combined CABG and valve surgery.

The SIRS Investigators reported that the risk of AKI was similar among patients who received methylprednisolone and those who received placebo (40.9% vs. 39.5%, respectively; relative risk 1.03). Results were similar across multiple categorical definitions of AKI, including AKI or death (41.5% vs 40.2%; RR 1.03); AKI stage of 2 or greater (9.9% vs 9.9%; RR 1.01); AKI stage of 3 or greater (4% vs. 4.5%; RR .89), and being on acute dialysis (2.6% vs. 2.4%; RR 1.08).

“There was no benefit of steroids on the risk of AKI in those with or without preoperative chronic kidney disease,” Dr. Garg said. “The result was also not different in the subpopulation of patients with AKI as defined by Kidney Disease Improving Global Outcomes.” Results from SIRS “would suggest that patients undergoing cardiac surgery with cardiopulmonary bypass should not use prophylactic steroids to prevent AKI. When we consider the side effect profile, the most clinically relevant outcomes, and apply the GRADE framework [the Grading of Recommendations Assessment, Development, and Evaluation] to the available evidence, we would recommend that steroids not be used in this way, with a grade 1B recommendation.”

The study was sponsored by the Population Health Research Institute in Hamilton, Ontario and the Canadian Institutes of Health Research. Dr. Garg reported having no relevant financial disclosures for this study.

dbrunk@frontlinemedcom.com

SAN DIEGO – Among patients undergoing cardiac bypass surgery, perioperative use of corticosteroids did not alter the risk of acute kidney injury, results from a large randomized trial showed.

“Worldwide, over 20 million cardiac surgeries are done each year, but 4 million are complicated by acute kidney injury, and 200,000 are complicated by severe kidney injury treated with dialysis,” Dr. Amit X. Garg said during a press briefing at the annual meeting of the American Society of Nephrology. “So certainly people would benefit from a therapy to prevent acute kidney injury (AKI) and improve the safety of surgery.”

Dr. Garg, a nephrologist at the London Health Sciences Centre in London, Ontario, Canada, noted that cardiopulmonary bypass initiates a systemic inflammatory response syndrome, “which activates complement, inflammatory cytokines, and other inflammatory mediators, which in turn increases endothelial permeability, organ damage, and increased morbidity and mortality, including acute kidney injury.” Researchers are interested in corticosteroids, “because they suppress this inflammatory response. In other settings, such as acute glomerulonephritis, we successfully use corticosteroids to treat acute inflammation in the kidney,” he said.

In a study known as the Steroids in caRdiac Surgery Trial (SIRS), researchers at 79 centers in 18 countries set out to investigate if methylprednisolone alters the risk of acute kidney injury in patients undergoing cardiac surgery with cardiopulmonary bypass. Between June 2007 and December 2013, 7,286 patients were randomized to intravenous methylprednisolone 250 mg at anesthetic induction and 250 mg at initiation of coronary bypass, or placebo.

AKI was defined as a 0.3 mg/dL increase or greater in postoperative serum creatinine concentration from the preoperative concentration within 14 days following surgery, or a 50% increase from the preoperative value within 14 days following surgery. Secondary outcomes included different stages of AKI and receipt of acute dialysis in the 30 days following surgery. Patients, caregivers, and researchers were blinded to the treatment allocation.

Of the 7,286 patients, 3,647 received methylprednisolone and 3,639 received placebo. The mean age of patients was 60 years, 60% were men, 26% were diabetic, and 25% of patients had combined CABG and valve surgery.

The SIRS Investigators reported that the risk of AKI was similar among patients who received methylprednisolone and those who received placebo (40.9% vs. 39.5%, respectively; relative risk 1.03). Results were similar across multiple categorical definitions of AKI, including AKI or death (41.5% vs 40.2%; RR 1.03); AKI stage of 2 or greater (9.9% vs 9.9%; RR 1.01); AKI stage of 3 or greater (4% vs. 4.5%; RR .89), and being on acute dialysis (2.6% vs. 2.4%; RR 1.08).

“There was no benefit of steroids on the risk of AKI in those with or without preoperative chronic kidney disease,” Dr. Garg said. “The result was also not different in the subpopulation of patients with AKI as defined by Kidney Disease Improving Global Outcomes.” Results from SIRS “would suggest that patients undergoing cardiac surgery with cardiopulmonary bypass should not use prophylactic steroids to prevent AKI. When we consider the side effect profile, the most clinically relevant outcomes, and apply the GRADE framework [the Grading of Recommendations Assessment, Development, and Evaluation] to the available evidence, we would recommend that steroids not be used in this way, with a grade 1B recommendation.”

The study was sponsored by the Population Health Research Institute in Hamilton, Ontario and the Canadian Institutes of Health Research. Dr. Garg reported having no relevant financial disclosures for this study.

dbrunk@frontlinemedcom.com

SAN DIEGO – Among patients undergoing cardiac bypass surgery, perioperative use of corticosteroids did not alter the risk of acute kidney injury, results from a large randomized trial showed.

“Worldwide, over 20 million cardiac surgeries are done each year, but 4 million are complicated by acute kidney injury, and 200,000 are complicated by severe kidney injury treated with dialysis,” Dr. Amit X. Garg said during a press briefing at the annual meeting of the American Society of Nephrology. “So certainly people would benefit from a therapy to prevent acute kidney injury (AKI) and improve the safety of surgery.”

Dr. Garg, a nephrologist at the London Health Sciences Centre in London, Ontario, Canada, noted that cardiopulmonary bypass initiates a systemic inflammatory response syndrome, “which activates complement, inflammatory cytokines, and other inflammatory mediators, which in turn increases endothelial permeability, organ damage, and increased morbidity and mortality, including acute kidney injury.” Researchers are interested in corticosteroids, “because they suppress this inflammatory response. In other settings, such as acute glomerulonephritis, we successfully use corticosteroids to treat acute inflammation in the kidney,” he said.

In a study known as the Steroids in caRdiac Surgery Trial (SIRS), researchers at 79 centers in 18 countries set out to investigate if methylprednisolone alters the risk of acute kidney injury in patients undergoing cardiac surgery with cardiopulmonary bypass. Between June 2007 and December 2013, 7,286 patients were randomized to intravenous methylprednisolone 250 mg at anesthetic induction and 250 mg at initiation of coronary bypass, or placebo.

AKI was defined as a 0.3 mg/dL increase or greater in postoperative serum creatinine concentration from the preoperative concentration within 14 days following surgery, or a 50% increase from the preoperative value within 14 days following surgery. Secondary outcomes included different stages of AKI and receipt of acute dialysis in the 30 days following surgery. Patients, caregivers, and researchers were blinded to the treatment allocation.

Of the 7,286 patients, 3,647 received methylprednisolone and 3,639 received placebo. The mean age of patients was 60 years, 60% were men, 26% were diabetic, and 25% of patients had combined CABG and valve surgery.

The SIRS Investigators reported that the risk of AKI was similar among patients who received methylprednisolone and those who received placebo (40.9% vs. 39.5%, respectively; relative risk 1.03). Results were similar across multiple categorical definitions of AKI, including AKI or death (41.5% vs 40.2%; RR 1.03); AKI stage of 2 or greater (9.9% vs 9.9%; RR 1.01); AKI stage of 3 or greater (4% vs. 4.5%; RR .89), and being on acute dialysis (2.6% vs. 2.4%; RR 1.08).

“There was no benefit of steroids on the risk of AKI in those with or without preoperative chronic kidney disease,” Dr. Garg said. “The result was also not different in the subpopulation of patients with AKI as defined by Kidney Disease Improving Global Outcomes.” Results from SIRS “would suggest that patients undergoing cardiac surgery with cardiopulmonary bypass should not use prophylactic steroids to prevent AKI. When we consider the side effect profile, the most clinically relevant outcomes, and apply the GRADE framework [the Grading of Recommendations Assessment, Development, and Evaluation] to the available evidence, we would recommend that steroids not be used in this way, with a grade 1B recommendation.”

The study was sponsored by the Population Health Research Institute in Hamilton, Ontario and the Canadian Institutes of Health Research. Dr. Garg reported having no relevant financial disclosures for this study.

dbrunk@frontlinemedcom.com

SAN DIEGO – A vaccine designed to lower the risk of postoperative Staphylococcus aureus infections is being tested in a phase IIb study of adults who are preparing to undergo elective spinal fusion surgery.

In phase I-II trial results, reported at an annual scientific meeting on infectious diseases, the vaccine proved to be well tolerated, and it induced durable functional antibody responses.

The phase IIb trial aims to enroll 2,600 patients undergoing elective spinal fusion surgery, and is scheduled to end in 2017, said Dr. Buddy Creech of Vanderbilt University in Nashville, Tenn.

©CDC/Janice Haney Carr

“We’re at a point where the disease frequency of Staphylococcus aureus is high enough that we could make the case for universal vaccination,” said Dr. Creech. “If we can prove it in high-risk hosts, I think that’s a win.”

Invasive staphylococcal disease causes more deaths in the United States than AIDS, viral hepatitis, and tuberculosis combined, but the complex virulence factors of S. aureus have eluded vaccine researchers for years. Other investigational vaccines failed in previous large phase III trials. The tetravalent vaccine now being tested targets type 5 and 8 capsular polysaccharides (CP5 and CP8), which are expressed by 95% of hospital-associated S. aureus strains; an adhesion molecule; and an essential recombinant manganese transport protein C.

The vaccine was well tolerated in a phase I study of healthy adults earlier this year. Single doses of vaccine or placebo were administered to 285 healthy adults aged 65-84 years in a randomized, multicenter double-blind trial. Patients averaged 71 years in age, and half were women, Dr. Creech said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

Similar rates of mild to moderate adverse events occurred in both groups, and no participants died or had serious vaccine-related side effects, Dr. Creech said.

At 1 month after vaccination, all tetravalent vaccine recipients and 5% of placebo recipients had achieved a predetermined threshold for CP5 opsonophagocytic activity. Likewise, about 92% of vaccinated recipients and 19% of placebo recipients achieved the CP8 opsonophagocytic activity threshold. Further, 84% of vaccinated recipients and none of the placebo recipients had at least a fourfold rise in antibody titers against the adhesion molecule.

In vaccine recipients, an immunoassay found substantial rises in antibodies against all four antigens by day 8; levels peaked around day 15, Dr. Creech said. “There was a decline of antibody titers over the course of the next year, as one would expect with a single-dose vaccine, but they remained over prespecified thresholds,” he added.

“Durability of response is especially important for patients who are scheduling surgeries and others who have a definitive risk period” for infection, he said.

Pfizer is funding the research, and Dr. Creech is a grant investigator for the company. One coauthor is also a grant investigator for Pfizer, nine coauthors are Pfizer employees and shareholders, and three declared no relevant conflicts of interest.

SAN DIEGO – A vaccine designed to lower the risk of postoperative Staphylococcus aureus infections is being tested in a phase IIb study of adults who are preparing to undergo elective spinal fusion surgery.

In phase I-II trial results, reported at an annual scientific meeting on infectious diseases, the vaccine proved to be well tolerated, and it induced durable functional antibody responses.

The phase IIb trial aims to enroll 2,600 patients undergoing elective spinal fusion surgery, and is scheduled to end in 2017, said Dr. Buddy Creech of Vanderbilt University in Nashville, Tenn.

©CDC/Janice Haney Carr

“We’re at a point where the disease frequency of Staphylococcus aureus is high enough that we could make the case for universal vaccination,” said Dr. Creech. “If we can prove it in high-risk hosts, I think that’s a win.”

Invasive staphylococcal disease causes more deaths in the United States than AIDS, viral hepatitis, and tuberculosis combined, but the complex virulence factors of S. aureus have eluded vaccine researchers for years. Other investigational vaccines failed in previous large phase III trials. The tetravalent vaccine now being tested targets type 5 and 8 capsular polysaccharides (CP5 and CP8), which are expressed by 95% of hospital-associated S. aureus strains; an adhesion molecule; and an essential recombinant manganese transport protein C.

The vaccine was well tolerated in a phase I study of healthy adults earlier this year. Single doses of vaccine or placebo were administered to 285 healthy adults aged 65-84 years in a randomized, multicenter double-blind trial. Patients averaged 71 years in age, and half were women, Dr. Creech said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

Similar rates of mild to moderate adverse events occurred in both groups, and no participants died or had serious vaccine-related side effects, Dr. Creech said.

At 1 month after vaccination, all tetravalent vaccine recipients and 5% of placebo recipients had achieved a predetermined threshold for CP5 opsonophagocytic activity. Likewise, about 92% of vaccinated recipients and 19% of placebo recipients achieved the CP8 opsonophagocytic activity threshold. Further, 84% of vaccinated recipients and none of the placebo recipients had at least a fourfold rise in antibody titers against the adhesion molecule.

In vaccine recipients, an immunoassay found substantial rises in antibodies against all four antigens by day 8; levels peaked around day 15, Dr. Creech said. “There was a decline of antibody titers over the course of the next year, as one would expect with a single-dose vaccine, but they remained over prespecified thresholds,” he added.

“Durability of response is especially important for patients who are scheduling surgeries and others who have a definitive risk period” for infection, he said.

Pfizer is funding the research, and Dr. Creech is a grant investigator for the company. One coauthor is also a grant investigator for Pfizer, nine coauthors are Pfizer employees and shareholders, and three declared no relevant conflicts of interest.

SAN DIEGO – A vaccine designed to lower the risk of postoperative Staphylococcus aureus infections is being tested in a phase IIb study of adults who are preparing to undergo elective spinal fusion surgery.

In phase I-II trial results, reported at an annual scientific meeting on infectious diseases, the vaccine proved to be well tolerated, and it induced durable functional antibody responses.

The phase IIb trial aims to enroll 2,600 patients undergoing elective spinal fusion surgery, and is scheduled to end in 2017, said Dr. Buddy Creech of Vanderbilt University in Nashville, Tenn.

©CDC/Janice Haney Carr

“We’re at a point where the disease frequency of Staphylococcus aureus is high enough that we could make the case for universal vaccination,” said Dr. Creech. “If we can prove it in high-risk hosts, I think that’s a win.”

Invasive staphylococcal disease causes more deaths in the United States than AIDS, viral hepatitis, and tuberculosis combined, but the complex virulence factors of S. aureus have eluded vaccine researchers for years. Other investigational vaccines failed in previous large phase III trials. The tetravalent vaccine now being tested targets type 5 and 8 capsular polysaccharides (CP5 and CP8), which are expressed by 95% of hospital-associated S. aureus strains; an adhesion molecule; and an essential recombinant manganese transport protein C.

The vaccine was well tolerated in a phase I study of healthy adults earlier this year. Single doses of vaccine or placebo were administered to 285 healthy adults aged 65-84 years in a randomized, multicenter double-blind trial. Patients averaged 71 years in age, and half were women, Dr. Creech said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.

Similar rates of mild to moderate adverse events occurred in both groups, and no participants died or had serious vaccine-related side effects, Dr. Creech said.

At 1 month after vaccination, all tetravalent vaccine recipients and 5% of placebo recipients had achieved a predetermined threshold for CP5 opsonophagocytic activity. Likewise, about 92% of vaccinated recipients and 19% of placebo recipients achieved the CP8 opsonophagocytic activity threshold. Further, 84% of vaccinated recipients and none of the placebo recipients had at least a fourfold rise in antibody titers against the adhesion molecule.

In vaccine recipients, an immunoassay found substantial rises in antibodies against all four antigens by day 8; levels peaked around day 15, Dr. Creech said. “There was a decline of antibody titers over the course of the next year, as one would expect with a single-dose vaccine, but they remained over prespecified thresholds,” he added.

“Durability of response is especially important for patients who are scheduling surgeries and others who have a definitive risk period” for infection, he said.

Pfizer is funding the research, and Dr. Creech is a grant investigator for the company. One coauthor is also a grant investigator for Pfizer, nine coauthors are Pfizer employees and shareholders, and three declared no relevant conflicts of interest.

All surgical trainees eventually have to take on the challenge of finding the right fit for themselves within the workforce. Our training typically lacks a step-by-step guidance for entering the workforce. The first article of this three-part series on the Art of Negotiation (ACS Surgery News, 2015, p. 13) gave us a 30,000-foot view. Now let’s take a more granular look at the necessary components needed to get a competitive compensation package.

The process can be overwhelming, and so it is vital that you have a graduated approach to accomplishing the necessary tasks. You should begin by gathering the relevant information so that you can be prepared to negotiate and eventually make the most informed decision.

Understanding the base salary

The majority of us will focus on how much direct compensation or base salary we should ask for. While I don’t want to minimize the importance of this one number, it is far from the only thing that needs to be considered, as many variables play a role when deciding whether or not to accept a position.

There are two resources that should be used to give you a frame of reference. The first is the Association of American Medical Colleges (AAMC) report of medical school faculty salaries, which provides us with academic salary information. The second is data regarding private practice salaries that is from the MGMA physician compensation survey. These resources can be expensive to purchase on your own; however, nearly every institute will have a copy that you should be able to use.

When determining the competitiveness of base salary, one must take the following into consideration: Specialty, Practice Setting, Professional Level, and Geography.

Specialty – A wide range of salary support exists between surgeons based on specialty with neurosurgery at the top of the spectrum and other surgical specialties somewhere below. You will need to look closely at the AAMC and MGMA data to get a good idea of what salary range to expect in your specialty.

Practice Setting/Professional Level – This category is divided into two sections, academic and private practice. These can be further broken down into professional levels: assistant professor and associate/full professor in the academic setting, and starting salaries, 1-2 years in a specialty, and all physicians in the private practice setting.

The differences between salaries for these groups can vary depending upon level of experience and geography. For those that are fresh out of training it is important to notice that salaries early on in one’s career can be similar between the academic and private practice setting yet become widely disparate as surgeons become more seasoned. An example of this can be seen in neurosurgery where if you look at the physician compensation in 2011, the median starting salary for private practice is $400,000. The equivalent academic median salary is $408,000. You might look at this and think it is more beneficial from a purely monetary standpoint to be in an academic job; however, when you look at what happens after 1-2 years in private practice, that median salary jumps significantly to $634,884. Even as an associate professor, which is five or more years out, the median salary is $487,000.

Geography – Location can be important, considering the significant differences in compensation across the country. Imagine the following two opportunities: One is employment in the DMV (D.C., Maryland, Virginia), at an academically affiliated medical center just outside our nation’s capital. The other is in the rural Midwest at a comparable medical center. Taking into consideration the same professional level, which base salary is going to be higher? In the majority of circumstances it will be the rural Midwest, as they attempt to recruit candidates that might not otherwise have an attachment to the area. This can be important during the negotiation process, as it provides you with a bit of insight when it comes to how far you might be able to push the envelope. It also is important to note that in areas that are highly saturated with surgeons, or “attractive” cities that people want to live in, this will ultimately diminish your negotiating ability.

Retirement packages

One other aspect that is not typically included in these resources has to do with retirement packages. These can vary widely and should be looked at carefully. For example, there are some institutes that will put $20,000 toward your retirement while others will contribute $55,000 annually. Everything else being equal, even if the base salary is higher by $25,000 at the institute contributing $20,000 toward retirement, the other offer is still advantageous. While almost everything in a contract is negotiable, the one exception is typically the retirement package. The majority of centers have a standard that is across the board for all faculty. Therefore, focus your time and energy in other areas that can be negotiated.

Division of Time

How your contract structures your time matters a lot. Assume that you are taking a position at an academic medical center. You are interested in maintaining a “triple threat” model of clinician, teacher, and researcher. How do you ensure that you will be successful? The terminology that you should be familiar with is the clinical full-time equivalent (FTE). If your contract has you at a 100% clinical FTE, you are likely not to get any protected time for research. For those highly motivated individuals, you would end up burning the midnight oil, an using your free nights and weekends to pursue your research interests. However, most physicians would not consider this a sustainable model, not to mention the negative impact it would have on your personal life. If your focus is research heavy, the perhaps you’re looking for a position that is 50% clinical FTE. A good rule of thumb is that every 20% of an FTE equates to one day of protected time during the week. Therefore an FTE that is 80% clinical, and 20% research should average to one day a week of protected time. It is reasonable to ask the department to support you for the first 3-5 years as you build your research portfolio. Some institutions might then require you to bring in funding through grants at the end of that time period.

Get it in writing

During the negotiation process, it is highly likely that you will be negotiating with someone that has trained you – perhaps a mentor, or a prominent surgeon. You must learn to remove the emotion from the business aspect of this process. Promises are not sufficient, and your contract needs to clearly articulate the reached agreement. An example of a situation I saw where the agreement was not formalized happened to a colleague of mine, who after he was hired ended up having his division chief move to another institute. The new division chief that took over had different plans for how he would function within the team. The bottom line is that everything you believe is important to your success must be in writing.

The next article will finish highlighting other important aspects that will set you up for success when negotiating your compensation package, and provide some final tricks of the trade that will help make this somewhat intimidating yet exciting process easier!

Dr. Sakran is an assistant professor of surgery and Director of Global Health & Disaster Preparedness for the department of surgery at the Medical University of South Carolina. He is currently chair of the ACS Resident and Associate Society and recently finished a year at the Harvard Kennedy School of Government studying public policy, economics, and leadership development. He has no relevant disclosures.

All surgical trainees eventually have to take on the challenge of finding the right fit for themselves within the workforce. Our training typically lacks a step-by-step guidance for entering the workforce. The first article of this three-part series on the Art of Negotiation (ACS Surgery News, 2015, p. 13) gave us a 30,000-foot view. Now let’s take a more granular look at the necessary components needed to get a competitive compensation package.

The process can be overwhelming, and so it is vital that you have a graduated approach to accomplishing the necessary tasks. You should begin by gathering the relevant information so that you can be prepared to negotiate and eventually make the most informed decision.

Understanding the base salary

The majority of us will focus on how much direct compensation or base salary we should ask for. While I don’t want to minimize the importance of this one number, it is far from the only thing that needs to be considered, as many variables play a role when deciding whether or not to accept a position.

There are two resources that should be used to give you a frame of reference. The first is the Association of American Medical Colleges (AAMC) report of medical school faculty salaries, which provides us with academic salary information. The second is data regarding private practice salaries that is from the MGMA physician compensation survey. These resources can be expensive to purchase on your own; however, nearly every institute will have a copy that you should be able to use.

When determining the competitiveness of base salary, one must take the following into consideration: Specialty, Practice Setting, Professional Level, and Geography.

Specialty – A wide range of salary support exists between surgeons based on specialty with neurosurgery at the top of the spectrum and other surgical specialties somewhere below. You will need to look closely at the AAMC and MGMA data to get a good idea of what salary range to expect in your specialty.

Practice Setting/Professional Level – This category is divided into two sections, academic and private practice. These can be further broken down into professional levels: assistant professor and associate/full professor in the academic setting, and starting salaries, 1-2 years in a specialty, and all physicians in the private practice setting.

The differences between salaries for these groups can vary depending upon level of experience and geography. For those that are fresh out of training it is important to notice that salaries early on in one’s career can be similar between the academic and private practice setting yet become widely disparate as surgeons become more seasoned. An example of this can be seen in neurosurgery where if you look at the physician compensation in 2011, the median starting salary for private practice is $400,000. The equivalent academic median salary is $408,000. You might look at this and think it is more beneficial from a purely monetary standpoint to be in an academic job; however, when you look at what happens after 1-2 years in private practice, that median salary jumps significantly to $634,884. Even as an associate professor, which is five or more years out, the median salary is $487,000.

Geography – Location can be important, considering the significant differences in compensation across the country. Imagine the following two opportunities: One is employment in the DMV (D.C., Maryland, Virginia), at an academically affiliated medical center just outside our nation’s capital. The other is in the rural Midwest at a comparable medical center. Taking into consideration the same professional level, which base salary is going to be higher? In the majority of circumstances it will be the rural Midwest, as they attempt to recruit candidates that might not otherwise have an attachment to the area. This can be important during the negotiation process, as it provides you with a bit of insight when it comes to how far you might be able to push the envelope. It also is important to note that in areas that are highly saturated with surgeons, or “attractive” cities that people want to live in, this will ultimately diminish your negotiating ability.

Retirement packages

One other aspect that is not typically included in these resources has to do with retirement packages. These can vary widely and should be looked at carefully. For example, there are some institutes that will put $20,000 toward your retirement while others will contribute $55,000 annually. Everything else being equal, even if the base salary is higher by $25,000 at the institute contributing $20,000 toward retirement, the other offer is still advantageous. While almost everything in a contract is negotiable, the one exception is typically the retirement package. The majority of centers have a standard that is across the board for all faculty. Therefore, focus your time and energy in other areas that can be negotiated.

Division of Time

How your contract structures your time matters a lot. Assume that you are taking a position at an academic medical center. You are interested in maintaining a “triple threat” model of clinician, teacher, and researcher. How do you ensure that you will be successful? The terminology that you should be familiar with is the clinical full-time equivalent (FTE). If your contract has you at a 100% clinical FTE, you are likely not to get any protected time for research. For those highly motivated individuals, you would end up burning the midnight oil, an using your free nights and weekends to pursue your research interests. However, most physicians would not consider this a sustainable model, not to mention the negative impact it would have on your personal life. If your focus is research heavy, the perhaps you’re looking for a position that is 50% clinical FTE. A good rule of thumb is that every 20% of an FTE equates to one day of protected time during the week. Therefore an FTE that is 80% clinical, and 20% research should average to one day a week of protected time. It is reasonable to ask the department to support you for the first 3-5 years as you build your research portfolio. Some institutions might then require you to bring in funding through grants at the end of that time period.

Get it in writing

During the negotiation process, it is highly likely that you will be negotiating with someone that has trained you – perhaps a mentor, or a prominent surgeon. You must learn to remove the emotion from the business aspect of this process. Promises are not sufficient, and your contract needs to clearly articulate the reached agreement. An example of a situation I saw where the agreement was not formalized happened to a colleague of mine, who after he was hired ended up having his division chief move to another institute. The new division chief that took over had different plans for how he would function within the team. The bottom line is that everything you believe is important to your success must be in writing.

The next article will finish highlighting other important aspects that will set you up for success when negotiating your compensation package, and provide some final tricks of the trade that will help make this somewhat intimidating yet exciting process easier!

Dr. Sakran is an assistant professor of surgery and Director of Global Health & Disaster Preparedness for the department of surgery at the Medical University of South Carolina. He is currently chair of the ACS Resident and Associate Society and recently finished a year at the Harvard Kennedy School of Government studying public policy, economics, and leadership development. He has no relevant disclosures.

All surgical trainees eventually have to take on the challenge of finding the right fit for themselves within the workforce. Our training typically lacks a step-by-step guidance for entering the workforce. The first article of this three-part series on the Art of Negotiation (ACS Surgery News, 2015, p. 13) gave us a 30,000-foot view. Now let’s take a more granular look at the necessary components needed to get a competitive compensation package.

The process can be overwhelming, and so it is vital that you have a graduated approach to accomplishing the necessary tasks. You should begin by gathering the relevant information so that you can be prepared to negotiate and eventually make the most informed decision.

Understanding the base salary

The majority of us will focus on how much direct compensation or base salary we should ask for. While I don’t want to minimize the importance of this one number, it is far from the only thing that needs to be considered, as many variables play a role when deciding whether or not to accept a position.

There are two resources that should be used to give you a frame of reference. The first is the Association of American Medical Colleges (AAMC) report of medical school faculty salaries, which provides us with academic salary information. The second is data regarding private practice salaries that is from the MGMA physician compensation survey. These resources can be expensive to purchase on your own; however, nearly every institute will have a copy that you should be able to use.

When determining the competitiveness of base salary, one must take the following into consideration: Specialty, Practice Setting, Professional Level, and Geography.

Specialty – A wide range of salary support exists between surgeons based on specialty with neurosurgery at the top of the spectrum and other surgical specialties somewhere below. You will need to look closely at the AAMC and MGMA data to get a good idea of what salary range to expect in your specialty.

Practice Setting/Professional Level – This category is divided into two sections, academic and private practice. These can be further broken down into professional levels: assistant professor and associate/full professor in the academic setting, and starting salaries, 1-2 years in a specialty, and all physicians in the private practice setting.

The differences between salaries for these groups can vary depending upon level of experience and geography. For those that are fresh out of training it is important to notice that salaries early on in one’s career can be similar between the academic and private practice setting yet become widely disparate as surgeons become more seasoned. An example of this can be seen in neurosurgery where if you look at the physician compensation in 2011, the median starting salary for private practice is $400,000. The equivalent academic median salary is $408,000. You might look at this and think it is more beneficial from a purely monetary standpoint to be in an academic job; however, when you look at what happens after 1-2 years in private practice, that median salary jumps significantly to $634,884. Even as an associate professor, which is five or more years out, the median salary is $487,000.

Geography – Location can be important, considering the significant differences in compensation across the country. Imagine the following two opportunities: One is employment in the DMV (D.C., Maryland, Virginia), at an academically affiliated medical center just outside our nation’s capital. The other is in the rural Midwest at a comparable medical center. Taking into consideration the same professional level, which base salary is going to be higher? In the majority of circumstances it will be the rural Midwest, as they attempt to recruit candidates that might not otherwise have an attachment to the area. This can be important during the negotiation process, as it provides you with a bit of insight when it comes to how far you might be able to push the envelope. It also is important to note that in areas that are highly saturated with surgeons, or “attractive” cities that people want to live in, this will ultimately diminish your negotiating ability.

Retirement packages

One other aspect that is not typically included in these resources has to do with retirement packages. These can vary widely and should be looked at carefully. For example, there are some institutes that will put $20,000 toward your retirement while others will contribute $55,000 annually. Everything else being equal, even if the base salary is higher by $25,000 at the institute contributing $20,000 toward retirement, the other offer is still advantageous. While almost everything in a contract is negotiable, the one exception is typically the retirement package. The majority of centers have a standard that is across the board for all faculty. Therefore, focus your time and energy in other areas that can be negotiated.

Division of Time

How your contract structures your time matters a lot. Assume that you are taking a position at an academic medical center. You are interested in maintaining a “triple threat” model of clinician, teacher, and researcher. How do you ensure that you will be successful? The terminology that you should be familiar with is the clinical full-time equivalent (FTE). If your contract has you at a 100% clinical FTE, you are likely not to get any protected time for research. For those highly motivated individuals, you would end up burning the midnight oil, an using your free nights and weekends to pursue your research interests. However, most physicians would not consider this a sustainable model, not to mention the negative impact it would have on your personal life. If your focus is research heavy, the perhaps you’re looking for a position that is 50% clinical FTE. A good rule of thumb is that every 20% of an FTE equates to one day of protected time during the week. Therefore an FTE that is 80% clinical, and 20% research should average to one day a week of protected time. It is reasonable to ask the department to support you for the first 3-5 years as you build your research portfolio. Some institutions might then require you to bring in funding through grants at the end of that time period.

Get it in writing

During the negotiation process, it is highly likely that you will be negotiating with someone that has trained you – perhaps a mentor, or a prominent surgeon. You must learn to remove the emotion from the business aspect of this process. Promises are not sufficient, and your contract needs to clearly articulate the reached agreement. An example of a situation I saw where the agreement was not formalized happened to a colleague of mine, who after he was hired ended up having his division chief move to another institute. The new division chief that took over had different plans for how he would function within the team. The bottom line is that everything you believe is important to your success must be in writing.

The next article will finish highlighting other important aspects that will set you up for success when negotiating your compensation package, and provide some final tricks of the trade that will help make this somewhat intimidating yet exciting process easier!

Dr. Sakran is an assistant professor of surgery and Director of Global Health & Disaster Preparedness for the department of surgery at the Medical University of South Carolina. He is currently chair of the ACS Resident and Associate Society and recently finished a year at the Harvard Kennedy School of Government studying public policy, economics, and leadership development. He has no relevant disclosures.

LOS ANGELES – A nationwide analysis shows modest early morbidity and low mortality following bariatric surgery in patients with type 2 diabetes who are not morbidly obese.

At 30 days’ follow-up among 1,003 patients, the composite complication rate, defined as the presence of any of 16 adverse events, was 4.2%; the reoperation rate was 1.6%; and two patients (0.2%) died.

Patrice Wendling/Frontline Medical News

“A 2-hour surgical procedure requiring a 2-day hospital stay that is associated with low morbidity and mortality can lead to remission of a chronic, progressive, and disabling disease,” lead author Dr. Ali Aminian of the Cleveland Clinic said at Obesity Week 2015.

“Based on these findings, bariatric surgery can be considered a relatively safe option for managing type 2 diabetes in patients with mild obesity.”

The analysis included adults with a body mass index of at least 25 kg/m², but less than 35 kg/m² (mean, 33 kg/m²).

These data are important because most patients with type 2 diabetes fall into this BMI category, he said.

Most of the patients were women (74.3%), 40% were using insulin, 78% had hypertension, and 9% had cardiac disease, according to the analysis, drawn from the American College of Surgery National Surgical Quality Improvement Program 2005-2013 database.

Roux-en-Y bypass was performed in 574 patients, adjustable gastric banding in 227, sleeve gastrectomy in 189, and duodenal switch in 13.

The most common adverse events overall were blood transfusion and reoperation (both 1.6%), a hospital stay longer than 7 days (0.6%), and organ space surgical-site infection (0.5%).

Composite morbidity and mortality was highest in the Roux-en-Y bypass group, compared with the adjustable banding and sleeve groups (5% vs. 3.1% vs. 3.2%, respectively), Dr. Aminian said at the meeting, presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

Only 3 of 46 patients with a BMI of less than 30 kg/m² had an adverse event.

Available randomized controlled trials can’t clearly resolve the safety concerns of bariatric surgery in the subgroup of patients with type 2 diabetes who are overweight and mildly obese because such small trials are unlikely to reveal uncommon but clinically serious complications, Dr. Aminian said. In addition, many of the trials have screened out low-BMI and high-risk patients.

Those in attendance at the presentation, however, weren’t entirely convinced the current analysis could allay all safety concerns.

Session comoderator Dr. Daniel Cottam, a bariatric surgeon in group practice in Salt Lake City, said, “I like the summary; however, the use of the word ‘safe’ can be taken to mean a lot of things. It’s one of those squishy words.”

Though the authors have shown that bariatric surgery can be performed in diabetics with a low BMI, in order to say it is safe, the comparison needs to be drawn to the all-cause mortality for these patients in the general population and with other surgical procedures.

“That would be useful in the manuscript because as we approach our patients, we want to be able to say, ‘Listen, if you live with diabetes and a BMI of 25-35 for 5 years, this is your all-cause mortality, and surgery is going to save your life, not hurt it,’ ” Dr. Cottam said.

Along the same lines, Dr. Harvey Sugerman emeritus professor of surgery at Virginia Commonwealth University in Richmond, commented, “Like the old days of routinely operating on any patient with diabetes and gallstones, the data were that just having one death in a young person and the quality-of-life-years lost, it would take you thousands of gallbladders to make up for that one death.”

Dr. Sugarmen also asked for details on the deaths including where they occurred, in whom, and whether the centers were inexperienced.

Dr. Aminian could not recall at the time, but in an interview with this news organization said one death was in a 61-year-old with a history of cardiac disease and chronic kidney failure secondary to insulin-dependent diabetes who developed postop bleeding after gastric bypass. The second was in a 59-year-old patient, again on insulin, who was discharged without problems after gastric bypass, but died within 30 days after surgery.

Although most serious complications occur in this period, the main limitation of the study is that the dataset does not capture adverse events beyond 30 days after surgery, which can lead to underestimation of real risk, Dr. Aminian told the crowd.

“Further large clinical studies on long-term safety and efficacy outcomes of bariatric surgery in patients with type 2 diabetes and low BMI are warranted,” he said.

pwendling@frontlinemedcom.com

LOS ANGELES – A nationwide analysis shows modest early morbidity and low mortality following bariatric surgery in patients with type 2 diabetes who are not morbidly obese.

At 30 days’ follow-up among 1,003 patients, the composite complication rate, defined as the presence of any of 16 adverse events, was 4.2%; the reoperation rate was 1.6%; and two patients (0.2%) died.

Patrice Wendling/Frontline Medical News

“A 2-hour surgical procedure requiring a 2-day hospital stay that is associated with low morbidity and mortality can lead to remission of a chronic, progressive, and disabling disease,” lead author Dr. Ali Aminian of the Cleveland Clinic said at Obesity Week 2015.

“Based on these findings, bariatric surgery can be considered a relatively safe option for managing type 2 diabetes in patients with mild obesity.”

The analysis included adults with a body mass index of at least 25 kg/m², but less than 35 kg/m² (mean, 33 kg/m²).

These data are important because most patients with type 2 diabetes fall into this BMI category, he said.

Most of the patients were women (74.3%), 40% were using insulin, 78% had hypertension, and 9% had cardiac disease, according to the analysis, drawn from the American College of Surgery National Surgical Quality Improvement Program 2005-2013 database.

Roux-en-Y bypass was performed in 574 patients, adjustable gastric banding in 227, sleeve gastrectomy in 189, and duodenal switch in 13.

The most common adverse events overall were blood transfusion and reoperation (both 1.6%), a hospital stay longer than 7 days (0.6%), and organ space surgical-site infection (0.5%).

Composite morbidity and mortality was highest in the Roux-en-Y bypass group, compared with the adjustable banding and sleeve groups (5% vs. 3.1% vs. 3.2%, respectively), Dr. Aminian said at the meeting, presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

Only 3 of 46 patients with a BMI of less than 30 kg/m² had an adverse event.

Available randomized controlled trials can’t clearly resolve the safety concerns of bariatric surgery in the subgroup of patients with type 2 diabetes who are overweight and mildly obese because such small trials are unlikely to reveal uncommon but clinically serious complications, Dr. Aminian said. In addition, many of the trials have screened out low-BMI and high-risk patients.

Those in attendance at the presentation, however, weren’t entirely convinced the current analysis could allay all safety concerns.

Session comoderator Dr. Daniel Cottam, a bariatric surgeon in group practice in Salt Lake City, said, “I like the summary; however, the use of the word ‘safe’ can be taken to mean a lot of things. It’s one of those squishy words.”

Though the authors have shown that bariatric surgery can be performed in diabetics with a low BMI, in order to say it is safe, the comparison needs to be drawn to the all-cause mortality for these patients in the general population and with other surgical procedures.

“That would be useful in the manuscript because as we approach our patients, we want to be able to say, ‘Listen, if you live with diabetes and a BMI of 25-35 for 5 years, this is your all-cause mortality, and surgery is going to save your life, not hurt it,’ ” Dr. Cottam said.

Along the same lines, Dr. Harvey Sugerman emeritus professor of surgery at Virginia Commonwealth University in Richmond, commented, “Like the old days of routinely operating on any patient with diabetes and gallstones, the data were that just having one death in a young person and the quality-of-life-years lost, it would take you thousands of gallbladders to make up for that one death.”

Dr. Sugarmen also asked for details on the deaths including where they occurred, in whom, and whether the centers were inexperienced.

Dr. Aminian could not recall at the time, but in an interview with this news organization said one death was in a 61-year-old with a history of cardiac disease and chronic kidney failure secondary to insulin-dependent diabetes who developed postop bleeding after gastric bypass. The second was in a 59-year-old patient, again on insulin, who was discharged without problems after gastric bypass, but died within 30 days after surgery.

Although most serious complications occur in this period, the main limitation of the study is that the dataset does not capture adverse events beyond 30 days after surgery, which can lead to underestimation of real risk, Dr. Aminian told the crowd.

“Further large clinical studies on long-term safety and efficacy outcomes of bariatric surgery in patients with type 2 diabetes and low BMI are warranted,” he said.

pwendling@frontlinemedcom.com

LOS ANGELES – A nationwide analysis shows modest early morbidity and low mortality following bariatric surgery in patients with type 2 diabetes who are not morbidly obese.

At 30 days’ follow-up among 1,003 patients, the composite complication rate, defined as the presence of any of 16 adverse events, was 4.2%; the reoperation rate was 1.6%; and two patients (0.2%) died.

Patrice Wendling/Frontline Medical News

“A 2-hour surgical procedure requiring a 2-day hospital stay that is associated with low morbidity and mortality can lead to remission of a chronic, progressive, and disabling disease,” lead author Dr. Ali Aminian of the Cleveland Clinic said at Obesity Week 2015.

“Based on these findings, bariatric surgery can be considered a relatively safe option for managing type 2 diabetes in patients with mild obesity.”

The analysis included adults with a body mass index of at least 25 kg/m², but less than 35 kg/m² (mean, 33 kg/m²).

These data are important because most patients with type 2 diabetes fall into this BMI category, he said.

Most of the patients were women (74.3%), 40% were using insulin, 78% had hypertension, and 9% had cardiac disease, according to the analysis, drawn from the American College of Surgery National Surgical Quality Improvement Program 2005-2013 database.

Roux-en-Y bypass was performed in 574 patients, adjustable gastric banding in 227, sleeve gastrectomy in 189, and duodenal switch in 13.

The most common adverse events overall were blood transfusion and reoperation (both 1.6%), a hospital stay longer than 7 days (0.6%), and organ space surgical-site infection (0.5%).

Composite morbidity and mortality was highest in the Roux-en-Y bypass group, compared with the adjustable banding and sleeve groups (5% vs. 3.1% vs. 3.2%, respectively), Dr. Aminian said at the meeting, presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

Only 3 of 46 patients with a BMI of less than 30 kg/m² had an adverse event.

Available randomized controlled trials can’t clearly resolve the safety concerns of bariatric surgery in the subgroup of patients with type 2 diabetes who are overweight and mildly obese because such small trials are unlikely to reveal uncommon but clinically serious complications, Dr. Aminian said. In addition, many of the trials have screened out low-BMI and high-risk patients.

Those in attendance at the presentation, however, weren’t entirely convinced the current analysis could allay all safety concerns.

Session comoderator Dr. Daniel Cottam, a bariatric surgeon in group practice in Salt Lake City, said, “I like the summary; however, the use of the word ‘safe’ can be taken to mean a lot of things. It’s one of those squishy words.”

Though the authors have shown that bariatric surgery can be performed in diabetics with a low BMI, in order to say it is safe, the comparison needs to be drawn to the all-cause mortality for these patients in the general population and with other surgical procedures.

“That would be useful in the manuscript because as we approach our patients, we want to be able to say, ‘Listen, if you live with diabetes and a BMI of 25-35 for 5 years, this is your all-cause mortality, and surgery is going to save your life, not hurt it,’ ” Dr. Cottam said.

Along the same lines, Dr. Harvey Sugerman emeritus professor of surgery at Virginia Commonwealth University in Richmond, commented, “Like the old days of routinely operating on any patient with diabetes and gallstones, the data were that just having one death in a young person and the quality-of-life-years lost, it would take you thousands of gallbladders to make up for that one death.”

Dr. Sugarmen also asked for details on the deaths including where they occurred, in whom, and whether the centers were inexperienced.

Dr. Aminian could not recall at the time, but in an interview with this news organization said one death was in a 61-year-old with a history of cardiac disease and chronic kidney failure secondary to insulin-dependent diabetes who developed postop bleeding after gastric bypass. The second was in a 59-year-old patient, again on insulin, who was discharged without problems after gastric bypass, but died within 30 days after surgery.

Although most serious complications occur in this period, the main limitation of the study is that the dataset does not capture adverse events beyond 30 days after surgery, which can lead to underestimation of real risk, Dr. Aminian told the crowd.

“Further large clinical studies on long-term safety and efficacy outcomes of bariatric surgery in patients with type 2 diabetes and low BMI are warranted,” he said.

pwendling@frontlinemedcom.com

SAN FRANCISCO – It might be time to add psoriasis to the list of comorbidities bariatric surgery is likely to help.

New York University investigators have found a marked improvement in psoriasis and psoriatic arthritis following bariatric surgery, especially with severe disease. The more weight people lose, the better they do.

In an interview at the annual meeting of the American College of Rheumatology, investigator Dr. Soumya Reddy, codirector of NYU’s Psoriatic Arthritis Center in Manhattan, explained how the findings can be used in the clinic and their potential impact on bariatric surgery authorization.

aotto@frontlinemedcom.com

SAN FRANCISCO – It might be time to add psoriasis to the list of comorbidities bariatric surgery is likely to help.

New York University investigators have found a marked improvement in psoriasis and psoriatic arthritis following bariatric surgery, especially with severe disease. The more weight people lose, the better they do.

In an interview at the annual meeting of the American College of Rheumatology, investigator Dr. Soumya Reddy, codirector of NYU’s Psoriatic Arthritis Center in Manhattan, explained how the findings can be used in the clinic and their potential impact on bariatric surgery authorization.

aotto@frontlinemedcom.com

SAN FRANCISCO – It might be time to add psoriasis to the list of comorbidities bariatric surgery is likely to help.

New York University investigators have found a marked improvement in psoriasis and psoriatic arthritis following bariatric surgery, especially with severe disease. The more weight people lose, the better they do.

In an interview at the annual meeting of the American College of Rheumatology, investigator Dr. Soumya Reddy, codirector of NYU’s Psoriatic Arthritis Center in Manhattan, explained how the findings can be used in the clinic and their potential impact on bariatric surgery authorization.

aotto@frontlinemedcom.com

CHICAGO – Weight loss and comorbidity reduction from Roux-en-Y gastric bypass remain durable at 10 years, according to a reviewof 651 patients at the University of Virginia in Charlottesville.

Investigators checked up on their patients after a decade because “the long-term durability of this operation remains ill-defined in the American population.” Their study, likely the largest American series with 10-year follow-up, helps “to more clearly define long-term outcomes that may be achieved following performance of Roux-en-Y gastric bypass and establish a benchmark for future clinical investigation,” they said.

M. Alex Otto/Frontline Medical News

The study included 335 open and 316 laparoscopic Roux-en-Y gastric bypass (RYGB) patients. Although gastric bypass is preformed laparoscopically at the university now, the team felt comfortable including open cases in the analysis because patients and outcomes were similar in both groups. The mean preoperative body mass index, for instance, was about 53 kg/m² and the mean operative time about 230 minutes. Postoperative incisional hernia and anastomotic stenosis were more likely with open surgery.

As in other studies, weight loss peaked at 24 months, with patients shedding a mean of 74% of their excess weight. Although that had fallen to a mean of 52% at 10 years, “they still kept off half of their excess weight, which is outstanding,” investigator and general surgery resident Dr. Hunter Mehaffey said at the annual clinical congress of the American College of Surgeons.

Surgery also led to persistent reductions in obesity-related comorbidities. Before RYGB, for instance, 38% of patients had gastroesophageal reflux disease, versus 29% after 10 years. Similarly, the prevalence of degenerative joint disease fell from 61% to 32%, diabetes from 41% to 18%, obstructive sleep apnea from 36% to 16%, hypertension from 59% to 47%, pulmonary problems from 28% to 13%, and psychiatric issues from 39% to 29%. About a quarter of patients had cardiac comorbidities before RYGB, versus 16% at 10 years after surgery. The data came from chart reviews and patient interviews, and the findings were statistically significant.

Overall, patients seemed glad to have had the operation, reporting an average satisfaction score of 8.7 out of 10 points, he said, adding, “I would expect these findings to be generalizable to other institutions. This is a good, durable operation.”

Given the scope of the comorbidity reductions, “the savings in health care costs” from RYGB “are likely underestimated,” Dr. Mehaffey said.

There was another lesson from the study, as well. It took a while to track down patients for 10-year follow-up because they were no longer seeing their surgeons. “If we are not going to see these patients much after 2 years, we really have to make sure that their primary care physician knows” how to recognize and manage possible complications, such as nutritional deficiency or hypoglycemia, he said.

Dr. Mehaffey had no disclosures, and there was no outside funding for the work.

aotto@frontlinemedcom.com

CHICAGO – Weight loss and comorbidity reduction from Roux-en-Y gastric bypass remain durable at 10 years, according to a reviewof 651 patients at the University of Virginia in Charlottesville.

Investigators checked up on their patients after a decade because “the long-term durability of this operation remains ill-defined in the American population.” Their study, likely the largest American series with 10-year follow-up, helps “to more clearly define long-term outcomes that may be achieved following performance of Roux-en-Y gastric bypass and establish a benchmark for future clinical investigation,” they said.

M. Alex Otto/Frontline Medical News

The study included 335 open and 316 laparoscopic Roux-en-Y gastric bypass (RYGB) patients. Although gastric bypass is preformed laparoscopically at the university now, the team felt comfortable including open cases in the analysis because patients and outcomes were similar in both groups. The mean preoperative body mass index, for instance, was about 53 kg/m² and the mean operative time about 230 minutes. Postoperative incisional hernia and anastomotic stenosis were more likely with open surgery.

As in other studies, weight loss peaked at 24 months, with patients shedding a mean of 74% of their excess weight. Although that had fallen to a mean of 52% at 10 years, “they still kept off half of their excess weight, which is outstanding,” investigator and general surgery resident Dr. Hunter Mehaffey said at the annual clinical congress of the American College of Surgeons.

Surgery also led to persistent reductions in obesity-related comorbidities. Before RYGB, for instance, 38% of patients had gastroesophageal reflux disease, versus 29% after 10 years. Similarly, the prevalence of degenerative joint disease fell from 61% to 32%, diabetes from 41% to 18%, obstructive sleep apnea from 36% to 16%, hypertension from 59% to 47%, pulmonary problems from 28% to 13%, and psychiatric issues from 39% to 29%. About a quarter of patients had cardiac comorbidities before RYGB, versus 16% at 10 years after surgery. The data came from chart reviews and patient interviews, and the findings were statistically significant.

Overall, patients seemed glad to have had the operation, reporting an average satisfaction score of 8.7 out of 10 points, he said, adding, “I would expect these findings to be generalizable to other institutions. This is a good, durable operation.”

Given the scope of the comorbidity reductions, “the savings in health care costs” from RYGB “are likely underestimated,” Dr. Mehaffey said.

There was another lesson from the study, as well. It took a while to track down patients for 10-year follow-up because they were no longer seeing their surgeons. “If we are not going to see these patients much after 2 years, we really have to make sure that their primary care physician knows” how to recognize and manage possible complications, such as nutritional deficiency or hypoglycemia, he said.

Dr. Mehaffey had no disclosures, and there was no outside funding for the work.

aotto@frontlinemedcom.com

CHICAGO – Weight loss and comorbidity reduction from Roux-en-Y gastric bypass remain durable at 10 years, according to a reviewof 651 patients at the University of Virginia in Charlottesville.

Investigators checked up on their patients after a decade because “the long-term durability of this operation remains ill-defined in the American population.” Their study, likely the largest American series with 10-year follow-up, helps “to more clearly define long-term outcomes that may be achieved following performance of Roux-en-Y gastric bypass and establish a benchmark for future clinical investigation,” they said.

M. Alex Otto/Frontline Medical News

The study included 335 open and 316 laparoscopic Roux-en-Y gastric bypass (RYGB) patients. Although gastric bypass is preformed laparoscopically at the university now, the team felt comfortable including open cases in the analysis because patients and outcomes were similar in both groups. The mean preoperative body mass index, for instance, was about 53 kg/m² and the mean operative time about 230 minutes. Postoperative incisional hernia and anastomotic stenosis were more likely with open surgery.

As in other studies, weight loss peaked at 24 months, with patients shedding a mean of 74% of their excess weight. Although that had fallen to a mean of 52% at 10 years, “they still kept off half of their excess weight, which is outstanding,” investigator and general surgery resident Dr. Hunter Mehaffey said at the annual clinical congress of the American College of Surgeons.

Surgery also led to persistent reductions in obesity-related comorbidities. Before RYGB, for instance, 38% of patients had gastroesophageal reflux disease, versus 29% after 10 years. Similarly, the prevalence of degenerative joint disease fell from 61% to 32%, diabetes from 41% to 18%, obstructive sleep apnea from 36% to 16%, hypertension from 59% to 47%, pulmonary problems from 28% to 13%, and psychiatric issues from 39% to 29%. About a quarter of patients had cardiac comorbidities before RYGB, versus 16% at 10 years after surgery. The data came from chart reviews and patient interviews, and the findings were statistically significant.

Overall, patients seemed glad to have had the operation, reporting an average satisfaction score of 8.7 out of 10 points, he said, adding, “I would expect these findings to be generalizable to other institutions. This is a good, durable operation.”

Given the scope of the comorbidity reductions, “the savings in health care costs” from RYGB “are likely underestimated,” Dr. Mehaffey said.

There was another lesson from the study, as well. It took a while to track down patients for 10-year follow-up because they were no longer seeing their surgeons. “If we are not going to see these patients much after 2 years, we really have to make sure that their primary care physician knows” how to recognize and manage possible complications, such as nutritional deficiency or hypoglycemia, he said.

Dr. Mehaffey had no disclosures, and there was no outside funding for the work.

aotto@frontlinemedcom.com

Coronary stent implantation guided by intravascular ultrasound reduces the 1-year rate of major adverse cardiac events in patients who have long lesions, compared with standard angiography-guided stent implantation, Dr. Sung-Jin Hong reported at the American Heart Association annual scientific sessions, a presentation that was simultaneously published online Nov. 10 in JAMA.

Even though four meta-analyses have demonstrated the superiority of IVUS-guided implantation and recent guidelines recommend IVUS guidance for select patients to optimize results, “the effect of IVUS-guided drug-eluting stent implantation on clinical outcomes remains uncertain because of the limited number of properly powered randomized clinical trials,” said Dr. Hong of Sanggye Paik Hospital at Inje University and of Severance Cardiovascular Hospital at Yonsei University, both in Seoul, South Korea.

Dr. Hong and his associates performed a 4-year industry-sponsored randomized trial comparing the two techniques in 1,400 patients who had typical chest pain or evidence of myocardial ischemia and were eligible to receive an everolimus-eluting stent of 28 mm or more in length. The study participants were randomly assigned to undergo either IVUS-guided (700 patients) or angiography-guided (700 patients) stent implantation at 20 Korean medical centers and were followed up for 1 year. The mean patient age was 64 years, and 69% of the participants were men. The mean stent length of the targeted lesions was 39.3 mm.

The primary endpoint – a composite of major adverse cardiac events such as death, target-lesion-related MI, or ischemia-driven revascularization of the target lesion at 1 year – occurred in 2.9% of the IVUS group and 5.8% of the angiography group. This is a significant difference, with the IVUS group showing a 2.9% absolute reduction and a 48% relative reduction in the primary endpoint, the investigators said (JAMA 2015 Nov 10. doi: 10.1001/jama.2015.15454).

The superiority of IVUS-guided stent implantation was attributable primarily to a marked decrease in target-lesion revascularization in that group (2.5% of patients) compared with the angiography-guided group (5.0%). This in turn was likely due to the fact that adjunctive poststent balloon dilation was done more frequently in the IVUS group (76% vs 57%) and that the mean final balloon size was larger. Consequently, the minimum lumen diameter was greater in the IVUS-guided stent group than in the angiography-guided stent group.

“To our knowledge, [this] is the first demonstration of the clinical benefit of IVUS guidance in second-generation drug-eluting stent implantation in an adequately powered randomized clinical trial,” the investigators added.

Coronary stent implantation guided by intravascular ultrasound reduces the 1-year rate of major adverse cardiac events in patients who have long lesions, compared with standard angiography-guided stent implantation, Dr. Sung-Jin Hong reported at the American Heart Association annual scientific sessions, a presentation that was simultaneously published online Nov. 10 in JAMA.

Even though four meta-analyses have demonstrated the superiority of IVUS-guided implantation and recent guidelines recommend IVUS guidance for select patients to optimize results, “the effect of IVUS-guided drug-eluting stent implantation on clinical outcomes remains uncertain because of the limited number of properly powered randomized clinical trials,” said Dr. Hong of Sanggye Paik Hospital at Inje University and of Severance Cardiovascular Hospital at Yonsei University, both in Seoul, South Korea.

Dr. Hong and his associates performed a 4-year industry-sponsored randomized trial comparing the two techniques in 1,400 patients who had typical chest pain or evidence of myocardial ischemia and were eligible to receive an everolimus-eluting stent of 28 mm or more in length. The study participants were randomly assigned to undergo either IVUS-guided (700 patients) or angiography-guided (700 patients) stent implantation at 20 Korean medical centers and were followed up for 1 year. The mean patient age was 64 years, and 69% of the participants were men. The mean stent length of the targeted lesions was 39.3 mm.

The primary endpoint – a composite of major adverse cardiac events such as death, target-lesion-related MI, or ischemia-driven revascularization of the target lesion at 1 year – occurred in 2.9% of the IVUS group and 5.8% of the angiography group. This is a significant difference, with the IVUS group showing a 2.9% absolute reduction and a 48% relative reduction in the primary endpoint, the investigators said (JAMA 2015 Nov 10. doi: 10.1001/jama.2015.15454).

The superiority of IVUS-guided stent implantation was attributable primarily to a marked decrease in target-lesion revascularization in that group (2.5% of patients) compared with the angiography-guided group (5.0%). This in turn was likely due to the fact that adjunctive poststent balloon dilation was done more frequently in the IVUS group (76% vs 57%) and that the mean final balloon size was larger. Consequently, the minimum lumen diameter was greater in the IVUS-guided stent group than in the angiography-guided stent group.

“To our knowledge, [this] is the first demonstration of the clinical benefit of IVUS guidance in second-generation drug-eluting stent implantation in an adequately powered randomized clinical trial,” the investigators added.

Coronary stent implantation guided by intravascular ultrasound reduces the 1-year rate of major adverse cardiac events in patients who have long lesions, compared with standard angiography-guided stent implantation, Dr. Sung-Jin Hong reported at the American Heart Association annual scientific sessions, a presentation that was simultaneously published online Nov. 10 in JAMA.

Even though four meta-analyses have demonstrated the superiority of IVUS-guided implantation and recent guidelines recommend IVUS guidance for select patients to optimize results, “the effect of IVUS-guided drug-eluting stent implantation on clinical outcomes remains uncertain because of the limited number of properly powered randomized clinical trials,” said Dr. Hong of Sanggye Paik Hospital at Inje University and of Severance Cardiovascular Hospital at Yonsei University, both in Seoul, South Korea.

Dr. Hong and his associates performed a 4-year industry-sponsored randomized trial comparing the two techniques in 1,400 patients who had typical chest pain or evidence of myocardial ischemia and were eligible to receive an everolimus-eluting stent of 28 mm or more in length. The study participants were randomly assigned to undergo either IVUS-guided (700 patients) or angiography-guided (700 patients) stent implantation at 20 Korean medical centers and were followed up for 1 year. The mean patient age was 64 years, and 69% of the participants were men. The mean stent length of the targeted lesions was 39.3 mm.

The primary endpoint – a composite of major adverse cardiac events such as death, target-lesion-related MI, or ischemia-driven revascularization of the target lesion at 1 year – occurred in 2.9% of the IVUS group and 5.8% of the angiography group. This is a significant difference, with the IVUS group showing a 2.9% absolute reduction and a 48% relative reduction in the primary endpoint, the investigators said (JAMA 2015 Nov 10. doi: 10.1001/jama.2015.15454).

The superiority of IVUS-guided stent implantation was attributable primarily to a marked decrease in target-lesion revascularization in that group (2.5% of patients) compared with the angiography-guided group (5.0%). This in turn was likely due to the fact that adjunctive poststent balloon dilation was done more frequently in the IVUS group (76% vs 57%) and that the mean final balloon size was larger. Consequently, the minimum lumen diameter was greater in the IVUS-guided stent group than in the angiography-guided stent group.

“To our knowledge, [this] is the first demonstration of the clinical benefit of IVUS guidance in second-generation drug-eluting stent implantation in an adequately powered randomized clinical trial,” the investigators added.