ACS Surgery News

ACS Surgery News, the official newspaper of the American College of Surgeons, has a new look. The July issue will have a new design, new colors, and an increased focus on visual accessibility for readers. The updated format is easier to read and has more graphic elements for quicker access to data. Future issues with the new design will feature opinion columns, updates on critical practice economics issues, and news coverage of cutting-edge surgical technology.

ACS Surgery News readership has surged over the past 2 years. The growing popularity of ACS Surgery News is based on quality content: lively commentary by thought leaders of the surgical profession, timely coverage of surgery meetings, and in-depth features on those issues most important to surgeons.

In addition, the publication website has a fresh look: better layout, easier access to the digital, interactive version of the publication, and more graphic elements.

The next issue of ACS Surgery News mails on July 17. This publication has thrived on commentary, critique, and contributions from readers. Take a look at the new design and let the editorial team know what you think.

ACS Surgery News, the official newspaper of the American College of Surgeons, has a new look. The July issue will have a new design, new colors, and an increased focus on visual accessibility for readers. The updated format is easier to read and has more graphic elements for quicker access to data. Future issues with the new design will feature opinion columns, updates on critical practice economics issues, and news coverage of cutting-edge surgical technology.

ACS Surgery News readership has surged over the past 2 years. The growing popularity of ACS Surgery News is based on quality content: lively commentary by thought leaders of the surgical profession, timely coverage of surgery meetings, and in-depth features on those issues most important to surgeons.

In addition, the publication website has a fresh look: better layout, easier access to the digital, interactive version of the publication, and more graphic elements.

The next issue of ACS Surgery News mails on July 17. This publication has thrived on commentary, critique, and contributions from readers. Take a look at the new design and let the editorial team know what you think.

ACS Surgery News, the official newspaper of the American College of Surgeons, has a new look. The July issue will have a new design, new colors, and an increased focus on visual accessibility for readers. The updated format is easier to read and has more graphic elements for quicker access to data. Future issues with the new design will feature opinion columns, updates on critical practice economics issues, and news coverage of cutting-edge surgical technology.

ACS Surgery News readership has surged over the past 2 years. The growing popularity of ACS Surgery News is based on quality content: lively commentary by thought leaders of the surgical profession, timely coverage of surgery meetings, and in-depth features on those issues most important to surgeons.

In addition, the publication website has a fresh look: better layout, easier access to the digital, interactive version of the publication, and more graphic elements.

The next issue of ACS Surgery News mails on July 17. This publication has thrived on commentary, critique, and contributions from readers. Take a look at the new design and let the editorial team know what you think.

Among obese patients who underwent bariatric surgery 40% achieved at least partial remission of type 2 diabetes mellitus, compared with no patients who underwent a nonsurgical lifestyle intervention program, investigators reported online July 1 in JAMA Surgery.

The randomized clinical trial of 61 patients offers “further important evidence that at longer-term follow-up of 3 years, surgical treatments, including Roux-en-Y gastric bypass and laparoscopic adjustable gastric banding, are superior to lifestyle intervention alone for the remission of type 2 diabetes mellitus in obese individuals, including those with a body mass index (BMI) between 30 and 35 [kg/m^2],” said Dr. Anita Courcoulas at the University of Pittsburgh Medical Center and her associates. But further studies will be needed to explore exactly how bariatric surgery affects diabetes and the effect of these procedures on the microvascular and macrovascular complications of diabetes, the investigators added (JAMA Surg. 2015 July 1 [doi:10.1001/jamasurg.2015.1534]).

Several studies have reported major improvements in type 2 diabetes mellitus (T2DM) after bariatric surgery, but did not assess long-term efficacy or safety compared with lifestyle and medical management, the researchers noted. To fill that gap, they randomized obese middle-aged adults with T2DM to either an intensive lifestyle weight loss program for 1 year followed by a 2-year low-level lifestyle intervention program, or to Roux-en-Y gastric bypass (RYGB) or laparoscopic adjustable gastric banding (LAGB) followed by the low-level lifestyle intervention program during years 2 and 3.

After 3 years, 40% of RYGB patients and 29% of LAGB patients were fully or partially remitted, compared with none of the control group (P = .004), the investigators reported. The bariatric surgery groups did not significantly differ in terms of complete remission, but 65% of RYGB patients and 33% of LAGB patients were able to stop all insulin and oral diabetes medications, compared with none of the control group (P < .001). Also, RYGB patients lost an average of 25% of their baseline body weight, compared with 15% for LAGB (P = .0002) and only 5.7% for the lifestyle-only control group (P < .0001).

At baseline, patients averaged 100.5 kg (standard deviation, 13.7 kg) in body weight, mean hemoglobin A_1c level was 7.8% (standard deviation, 1.9%), average fasting plasma glucose level was 171.3 (72.5) mg per dL, the investigators said. “One important aspect of this study was that more than 40% of the sample were individuals with class I obesity (BMI ≥ 30), for whom data in the literature are largely lacking,” they added. Adverse events were uncommon after the first year, but RYGB was linked to significant drops in lean muscle and bone mass that will need further study, they noted.

The National Institutes of Health and the University of Pittsburgh Medical Center funded the study. Dr. Courcoulas reported research support from Nutrisystem, J&J Ethicon, and Covidien, and consulting relationships with Ethicon and Apollo Endosurgery. Two coauthors reported relationships with the Obesity Society/Nutrisystem, Jawbone/BodyMedia, and Weight Watchers. The other investigators declared no conflicts of interest.

Among obese patients who underwent bariatric surgery 40% achieved at least partial remission of type 2 diabetes mellitus, compared with no patients who underwent a nonsurgical lifestyle intervention program, investigators reported online July 1 in JAMA Surgery.

The randomized clinical trial of 61 patients offers “further important evidence that at longer-term follow-up of 3 years, surgical treatments, including Roux-en-Y gastric bypass and laparoscopic adjustable gastric banding, are superior to lifestyle intervention alone for the remission of type 2 diabetes mellitus in obese individuals, including those with a body mass index (BMI) between 30 and 35 [kg/m^2],” said Dr. Anita Courcoulas at the University of Pittsburgh Medical Center and her associates. But further studies will be needed to explore exactly how bariatric surgery affects diabetes and the effect of these procedures on the microvascular and macrovascular complications of diabetes, the investigators added (JAMA Surg. 2015 July 1 [doi:10.1001/jamasurg.2015.1534]).

Several studies have reported major improvements in type 2 diabetes mellitus (T2DM) after bariatric surgery, but did not assess long-term efficacy or safety compared with lifestyle and medical management, the researchers noted. To fill that gap, they randomized obese middle-aged adults with T2DM to either an intensive lifestyle weight loss program for 1 year followed by a 2-year low-level lifestyle intervention program, or to Roux-en-Y gastric bypass (RYGB) or laparoscopic adjustable gastric banding (LAGB) followed by the low-level lifestyle intervention program during years 2 and 3.

After 3 years, 40% of RYGB patients and 29% of LAGB patients were fully or partially remitted, compared with none of the control group (P = .004), the investigators reported. The bariatric surgery groups did not significantly differ in terms of complete remission, but 65% of RYGB patients and 33% of LAGB patients were able to stop all insulin and oral diabetes medications, compared with none of the control group (P < .001). Also, RYGB patients lost an average of 25% of their baseline body weight, compared with 15% for LAGB (P = .0002) and only 5.7% for the lifestyle-only control group (P < .0001).

At baseline, patients averaged 100.5 kg (standard deviation, 13.7 kg) in body weight, mean hemoglobin A_1c level was 7.8% (standard deviation, 1.9%), average fasting plasma glucose level was 171.3 (72.5) mg per dL, the investigators said. “One important aspect of this study was that more than 40% of the sample were individuals with class I obesity (BMI ≥ 30), for whom data in the literature are largely lacking,” they added. Adverse events were uncommon after the first year, but RYGB was linked to significant drops in lean muscle and bone mass that will need further study, they noted.

The National Institutes of Health and the University of Pittsburgh Medical Center funded the study. Dr. Courcoulas reported research support from Nutrisystem, J&J Ethicon, and Covidien, and consulting relationships with Ethicon and Apollo Endosurgery. Two coauthors reported relationships with the Obesity Society/Nutrisystem, Jawbone/BodyMedia, and Weight Watchers. The other investigators declared no conflicts of interest.

Among obese patients who underwent bariatric surgery 40% achieved at least partial remission of type 2 diabetes mellitus, compared with no patients who underwent a nonsurgical lifestyle intervention program, investigators reported online July 1 in JAMA Surgery.

The randomized clinical trial of 61 patients offers “further important evidence that at longer-term follow-up of 3 years, surgical treatments, including Roux-en-Y gastric bypass and laparoscopic adjustable gastric banding, are superior to lifestyle intervention alone for the remission of type 2 diabetes mellitus in obese individuals, including those with a body mass index (BMI) between 30 and 35 [kg/m^2],” said Dr. Anita Courcoulas at the University of Pittsburgh Medical Center and her associates. But further studies will be needed to explore exactly how bariatric surgery affects diabetes and the effect of these procedures on the microvascular and macrovascular complications of diabetes, the investigators added (JAMA Surg. 2015 July 1 [doi:10.1001/jamasurg.2015.1534]).

Several studies have reported major improvements in type 2 diabetes mellitus (T2DM) after bariatric surgery, but did not assess long-term efficacy or safety compared with lifestyle and medical management, the researchers noted. To fill that gap, they randomized obese middle-aged adults with T2DM to either an intensive lifestyle weight loss program for 1 year followed by a 2-year low-level lifestyle intervention program, or to Roux-en-Y gastric bypass (RYGB) or laparoscopic adjustable gastric banding (LAGB) followed by the low-level lifestyle intervention program during years 2 and 3.

After 3 years, 40% of RYGB patients and 29% of LAGB patients were fully or partially remitted, compared with none of the control group (P = .004), the investigators reported. The bariatric surgery groups did not significantly differ in terms of complete remission, but 65% of RYGB patients and 33% of LAGB patients were able to stop all insulin and oral diabetes medications, compared with none of the control group (P < .001). Also, RYGB patients lost an average of 25% of their baseline body weight, compared with 15% for LAGB (P = .0002) and only 5.7% for the lifestyle-only control group (P < .0001).

At baseline, patients averaged 100.5 kg (standard deviation, 13.7 kg) in body weight, mean hemoglobin A_1c level was 7.8% (standard deviation, 1.9%), average fasting plasma glucose level was 171.3 (72.5) mg per dL, the investigators said. “One important aspect of this study was that more than 40% of the sample were individuals with class I obesity (BMI ≥ 30), for whom data in the literature are largely lacking,” they added. Adverse events were uncommon after the first year, but RYGB was linked to significant drops in lean muscle and bone mass that will need further study, they noted.

The National Institutes of Health and the University of Pittsburgh Medical Center funded the study. Dr. Courcoulas reported research support from Nutrisystem, J&J Ethicon, and Covidien, and consulting relationships with Ethicon and Apollo Endosurgery. Two coauthors reported relationships with the Obesity Society/Nutrisystem, Jawbone/BodyMedia, and Weight Watchers. The other investigators declared no conflicts of interest.

Injecting patients with a molecular contrast agent before lung cancer surgery and then using fluorescent imaging during the operation proved safe and somewhat effective at finding lung adenocarcinomas and discovering tumor metastases in a pilot clinical trial of 50 patients.

Investigators from the University of Pennsylvania, Philadelphia, and Emory (Atlanta) and Purdue (West Lafayette, Ind.) universities reported their findings online in the Journal of Thoracic and Cardiovascular Surgery (2015 [doi:10.1016/j.jtcvs.2015.05.014]).

“We believe the most important finding in this study was the ability to systemically inject our contrast agent into patients prior to surgery and have 92% of the lung adenocarcinomas fluoresce in the operating room,” Dr. Olugbenga Okusanya of the University of Pennsylvania, Philadelphia, and his colleagues said. Their approach overcomes some of the limitations of other contrast agents for imaging of lung cancer.

The approach involves intravenous administration of 0.1 mg/kg of a fluorescent folate receptor-alpha (FR-alpha)–targeted molecule contrast agent 4 hours before surgery. The specific agent they used is a synthetic conjugate between folate and fluorescein isothiocyanate that binds to serum proteins.

They set out to determine if an optical-targeted molecular contrast agent to FR-alpha could bind lung adenocarcinoma and then if real-time optical imaging, either in situ or ex vivo during surgery, would show the lesions. The 50 study subjects all had biopsy-confirmed lung adenocarcinoma. In the OR, the researchers used a gantry-mounted fluorescent imaging system to capture images of the tumors.

With the operating room lights switched off, imaging of the cancer was captured by fluorescence and white light in situ. The lung was deflated during imaging to expose as much of the lung surface to the imaging as possible. The in situ optical imaging required on average eight minutes to perform. Only seven tumors (14%) appeared fluorescent in situ before they were excised. Computed tomography (CT) before surgery showed that all seven of these tumors were below the pleural surface and within 1.2 cm of the lung surface.

Among the other 43 tumors, 39 exhibited uniform fluorescence once the surgical team exposed their surfaces while 4 – all invasive adenocarcinomas – did not. Final pathology confirmed that all 50 tumors were cancerous.

“With further refinements, this tool may prove useful in locating adenocarcinomas deeper in the lung parenchyma, lymph nodes and at pleural and resection margins,” Dr. Okusanya and his coauthors said.

The investigators noted that one advantage of this imaging strategy is that it can locate tumors of varying sizes, subtypes and metabolic activity with tumor-to-background ratios “not markedly different” among them. “This finding demonstrates that intraoperative molecular imaging may be potentially broadly applicable to all FR-alpha lung tumors,” they said.

Other advantages is that wavelength fluorophore poses no radiation exposure and that surgeons readily understand optical imaging “with no need for special training to interpret or process the data.” They did acknowledge that a significant drawback of the molecular contrast agent was its lack of penetration into the lung parenchyma.

“New molecular tools are emerging to identify lung adenocarcinomas during pulmonary resection,” Dr. Okusanya and colleagues said. “This technology will permit precise visualization of tumor margins, localization of small malignant ground-glass opacities, and accurate selection of lymph nodes with metastatic cancer cells. With miniaturization of imaging devices, this method will be particularly useful in minimally invasive surgery.”

The pilot clinical trial was partially supported by grant from the Biomedical Laboratory Research & Development Service of the Veterans Affairs Office of Research and Development and by the CHEST Foundation One Breath Clinical Research Award (SS).

Dr. Shuming Nie is a coauthor and a consultant for Spectropath, a start-up company that is developing advanced instrumentation and nanoparticle contrast agents. Dr. Philip S. Low is a coauthor and a consultant and stakeholder in OnTarget Laboratories. None of the other coauthors had any relationships to disclose.

Injecting patients with a molecular contrast agent before lung cancer surgery and then using fluorescent imaging during the operation proved safe and somewhat effective at finding lung adenocarcinomas and discovering tumor metastases in a pilot clinical trial of 50 patients.

Investigators from the University of Pennsylvania, Philadelphia, and Emory (Atlanta) and Purdue (West Lafayette, Ind.) universities reported their findings online in the Journal of Thoracic and Cardiovascular Surgery (2015 [doi:10.1016/j.jtcvs.2015.05.014]).

“We believe the most important finding in this study was the ability to systemically inject our contrast agent into patients prior to surgery and have 92% of the lung adenocarcinomas fluoresce in the operating room,” Dr. Olugbenga Okusanya of the University of Pennsylvania, Philadelphia, and his colleagues said. Their approach overcomes some of the limitations of other contrast agents for imaging of lung cancer.

The approach involves intravenous administration of 0.1 mg/kg of a fluorescent folate receptor-alpha (FR-alpha)–targeted molecule contrast agent 4 hours before surgery. The specific agent they used is a synthetic conjugate between folate and fluorescein isothiocyanate that binds to serum proteins.

They set out to determine if an optical-targeted molecular contrast agent to FR-alpha could bind lung adenocarcinoma and then if real-time optical imaging, either in situ or ex vivo during surgery, would show the lesions. The 50 study subjects all had biopsy-confirmed lung adenocarcinoma. In the OR, the researchers used a gantry-mounted fluorescent imaging system to capture images of the tumors.

With the operating room lights switched off, imaging of the cancer was captured by fluorescence and white light in situ. The lung was deflated during imaging to expose as much of the lung surface to the imaging as possible. The in situ optical imaging required on average eight minutes to perform. Only seven tumors (14%) appeared fluorescent in situ before they were excised. Computed tomography (CT) before surgery showed that all seven of these tumors were below the pleural surface and within 1.2 cm of the lung surface.

Among the other 43 tumors, 39 exhibited uniform fluorescence once the surgical team exposed their surfaces while 4 – all invasive adenocarcinomas – did not. Final pathology confirmed that all 50 tumors were cancerous.

“With further refinements, this tool may prove useful in locating adenocarcinomas deeper in the lung parenchyma, lymph nodes and at pleural and resection margins,” Dr. Okusanya and his coauthors said.

The investigators noted that one advantage of this imaging strategy is that it can locate tumors of varying sizes, subtypes and metabolic activity with tumor-to-background ratios “not markedly different” among them. “This finding demonstrates that intraoperative molecular imaging may be potentially broadly applicable to all FR-alpha lung tumors,” they said.

Other advantages is that wavelength fluorophore poses no radiation exposure and that surgeons readily understand optical imaging “with no need for special training to interpret or process the data.” They did acknowledge that a significant drawback of the molecular contrast agent was its lack of penetration into the lung parenchyma.

“New molecular tools are emerging to identify lung adenocarcinomas during pulmonary resection,” Dr. Okusanya and colleagues said. “This technology will permit precise visualization of tumor margins, localization of small malignant ground-glass opacities, and accurate selection of lymph nodes with metastatic cancer cells. With miniaturization of imaging devices, this method will be particularly useful in minimally invasive surgery.”

The pilot clinical trial was partially supported by grant from the Biomedical Laboratory Research & Development Service of the Veterans Affairs Office of Research and Development and by the CHEST Foundation One Breath Clinical Research Award (SS).

Dr. Shuming Nie is a coauthor and a consultant for Spectropath, a start-up company that is developing advanced instrumentation and nanoparticle contrast agents. Dr. Philip S. Low is a coauthor and a consultant and stakeholder in OnTarget Laboratories. None of the other coauthors had any relationships to disclose.

Injecting patients with a molecular contrast agent before lung cancer surgery and then using fluorescent imaging during the operation proved safe and somewhat effective at finding lung adenocarcinomas and discovering tumor metastases in a pilot clinical trial of 50 patients.

Investigators from the University of Pennsylvania, Philadelphia, and Emory (Atlanta) and Purdue (West Lafayette, Ind.) universities reported their findings online in the Journal of Thoracic and Cardiovascular Surgery (2015 [doi:10.1016/j.jtcvs.2015.05.014]).

“We believe the most important finding in this study was the ability to systemically inject our contrast agent into patients prior to surgery and have 92% of the lung adenocarcinomas fluoresce in the operating room,” Dr. Olugbenga Okusanya of the University of Pennsylvania, Philadelphia, and his colleagues said. Their approach overcomes some of the limitations of other contrast agents for imaging of lung cancer.

The approach involves intravenous administration of 0.1 mg/kg of a fluorescent folate receptor-alpha (FR-alpha)–targeted molecule contrast agent 4 hours before surgery. The specific agent they used is a synthetic conjugate between folate and fluorescein isothiocyanate that binds to serum proteins.

They set out to determine if an optical-targeted molecular contrast agent to FR-alpha could bind lung adenocarcinoma and then if real-time optical imaging, either in situ or ex vivo during surgery, would show the lesions. The 50 study subjects all had biopsy-confirmed lung adenocarcinoma. In the OR, the researchers used a gantry-mounted fluorescent imaging system to capture images of the tumors.

With the operating room lights switched off, imaging of the cancer was captured by fluorescence and white light in situ. The lung was deflated during imaging to expose as much of the lung surface to the imaging as possible. The in situ optical imaging required on average eight minutes to perform. Only seven tumors (14%) appeared fluorescent in situ before they were excised. Computed tomography (CT) before surgery showed that all seven of these tumors were below the pleural surface and within 1.2 cm of the lung surface.

Among the other 43 tumors, 39 exhibited uniform fluorescence once the surgical team exposed their surfaces while 4 – all invasive adenocarcinomas – did not. Final pathology confirmed that all 50 tumors were cancerous.

“With further refinements, this tool may prove useful in locating adenocarcinomas deeper in the lung parenchyma, lymph nodes and at pleural and resection margins,” Dr. Okusanya and his coauthors said.

The investigators noted that one advantage of this imaging strategy is that it can locate tumors of varying sizes, subtypes and metabolic activity with tumor-to-background ratios “not markedly different” among them. “This finding demonstrates that intraoperative molecular imaging may be potentially broadly applicable to all FR-alpha lung tumors,” they said.

Other advantages is that wavelength fluorophore poses no radiation exposure and that surgeons readily understand optical imaging “with no need for special training to interpret or process the data.” They did acknowledge that a significant drawback of the molecular contrast agent was its lack of penetration into the lung parenchyma.

“New molecular tools are emerging to identify lung adenocarcinomas during pulmonary resection,” Dr. Okusanya and colleagues said. “This technology will permit precise visualization of tumor margins, localization of small malignant ground-glass opacities, and accurate selection of lymph nodes with metastatic cancer cells. With miniaturization of imaging devices, this method will be particularly useful in minimally invasive surgery.”

The pilot clinical trial was partially supported by grant from the Biomedical Laboratory Research & Development Service of the Veterans Affairs Office of Research and Development and by the CHEST Foundation One Breath Clinical Research Award (SS).

Dr. Shuming Nie is a coauthor and a consultant for Spectropath, a start-up company that is developing advanced instrumentation and nanoparticle contrast agents. Dr. Philip S. Low is a coauthor and a consultant and stakeholder in OnTarget Laboratories. None of the other coauthors had any relationships to disclose.

When performing on-pump coronary artery bypass grafting (CABG), cardiac surgeons can control very few factors to reduce the risk of stroke – with the exception of which method of aortic manipulation they use. Debate and controversy, however, have surrounded which aortic manipulation technique is best: single- or double-clamp occlusion.

A large retrospective study of almost 8,500 patients who had CABG at the Mayo Clinic in Rochester, Minn., over a 17-year period showed that, while use of the single-aortic cross-clamp (SC) technique steadily increased, the risk of stroke is virtually the same as it is with the partial aortic cross-clamp (PC), or double cross-clamp, technique. The study authors, led by Dr. Juan C. Araque, published their results online in the Journal of Thoracic and Cardiovascular Surgery (J. Thorac. Cardiovasc. Surg. 2015 [doi:10.1016/j.jtcvs.2015.04.010]).

“It is intuitive that less aortic manipulation would result in less risk of stroke,” Dr. Araque and colleagues said, but even off-pump CABG, which requires no aortic manipulation, is not without stroke risk.

“It is conceivable that there is some inherent risk of stroke associated with any cardiac operation, and that risk may increase with manipulation of the ascending aortic with the aortic cross clamp,” they wrote. “Our data would suggest, however, that the risk does not increase further with the additional aortic manipulation of the partial occlusion clamp.”

The study comes on the heels of a 2008 meta-analysis that found no benefit of SC in comparison to PC (Interact. Cardiovasc. Thorac. Surg. 2008;7:500-3), while another study in 2011 suggested that less aortic manipulation carried a significantly lower stroke risk (Heart Lung Circ. 2011;20:318-24).

The Mayo study evaluated the SC technique in 2,051 patients and PC in 6,446 patients who had isolated on-pump CABG between 1993 and 2010. The rate of stroke was 1.2% in the SC group and 1.5% among those who had PC. In two propensity-matched cohorts of 1,333 patients each, the stroke rate was 1.2% in each group. The investigators used the Society of Thoracic Surgeons’ risk calculator variables to create the propensity-matched cohorts.

The study group excluded high-risk patients, including those who had off-pump operations or previous cardiac surgeries or required replacement of a cross clamp during an unplanned operation.

The goal of the study was not to compare outcomes with the off-pump technique. “It is only to bring attention to the associated non-zero stroke rate with both techniques,” Dr. Araque and colleagues said.

Their findings are significant because on-pump CABG is the preferred operation of cardiac surgeons, accounting for more than 80% of the CABG operations in the SYNTAX study (N. Engl. J. Med. 2009;360:961-72). “The ‘anaortic’ off-pump technique may be a more specialized technique, representing less than 15% of operations in one large series,” Dr. Araque and coauthors said.

They acknowledged a few limitations resulting from the observational nature of the study, including that surgeons may have missed some strokes because they did not use a routine, standardized procedure for evaluating stroke signs along with the lack of documented assessment of the descending aorta. But they also stated that the large number of patients in the study, along with the use of propensity matching, addresses some of the bias inherent in an observational study.

The study authors disclosed no relationships.

When performing on-pump coronary artery bypass grafting (CABG), cardiac surgeons can control very few factors to reduce the risk of stroke – with the exception of which method of aortic manipulation they use. Debate and controversy, however, have surrounded which aortic manipulation technique is best: single- or double-clamp occlusion.

A large retrospective study of almost 8,500 patients who had CABG at the Mayo Clinic in Rochester, Minn., over a 17-year period showed that, while use of the single-aortic cross-clamp (SC) technique steadily increased, the risk of stroke is virtually the same as it is with the partial aortic cross-clamp (PC), or double cross-clamp, technique. The study authors, led by Dr. Juan C. Araque, published their results online in the Journal of Thoracic and Cardiovascular Surgery (J. Thorac. Cardiovasc. Surg. 2015 [doi:10.1016/j.jtcvs.2015.04.010]).

“It is intuitive that less aortic manipulation would result in less risk of stroke,” Dr. Araque and colleagues said, but even off-pump CABG, which requires no aortic manipulation, is not without stroke risk.

“It is conceivable that there is some inherent risk of stroke associated with any cardiac operation, and that risk may increase with manipulation of the ascending aortic with the aortic cross clamp,” they wrote. “Our data would suggest, however, that the risk does not increase further with the additional aortic manipulation of the partial occlusion clamp.”

The study comes on the heels of a 2008 meta-analysis that found no benefit of SC in comparison to PC (Interact. Cardiovasc. Thorac. Surg. 2008;7:500-3), while another study in 2011 suggested that less aortic manipulation carried a significantly lower stroke risk (Heart Lung Circ. 2011;20:318-24).

The Mayo study evaluated the SC technique in 2,051 patients and PC in 6,446 patients who had isolated on-pump CABG between 1993 and 2010. The rate of stroke was 1.2% in the SC group and 1.5% among those who had PC. In two propensity-matched cohorts of 1,333 patients each, the stroke rate was 1.2% in each group. The investigators used the Society of Thoracic Surgeons’ risk calculator variables to create the propensity-matched cohorts.

The study group excluded high-risk patients, including those who had off-pump operations or previous cardiac surgeries or required replacement of a cross clamp during an unplanned operation.

The goal of the study was not to compare outcomes with the off-pump technique. “It is only to bring attention to the associated non-zero stroke rate with both techniques,” Dr. Araque and colleagues said.

Their findings are significant because on-pump CABG is the preferred operation of cardiac surgeons, accounting for more than 80% of the CABG operations in the SYNTAX study (N. Engl. J. Med. 2009;360:961-72). “The ‘anaortic’ off-pump technique may be a more specialized technique, representing less than 15% of operations in one large series,” Dr. Araque and coauthors said.

They acknowledged a few limitations resulting from the observational nature of the study, including that surgeons may have missed some strokes because they did not use a routine, standardized procedure for evaluating stroke signs along with the lack of documented assessment of the descending aorta. But they also stated that the large number of patients in the study, along with the use of propensity matching, addresses some of the bias inherent in an observational study.

The study authors disclosed no relationships.

When performing on-pump coronary artery bypass grafting (CABG), cardiac surgeons can control very few factors to reduce the risk of stroke – with the exception of which method of aortic manipulation they use. Debate and controversy, however, have surrounded which aortic manipulation technique is best: single- or double-clamp occlusion.

A large retrospective study of almost 8,500 patients who had CABG at the Mayo Clinic in Rochester, Minn., over a 17-year period showed that, while use of the single-aortic cross-clamp (SC) technique steadily increased, the risk of stroke is virtually the same as it is with the partial aortic cross-clamp (PC), or double cross-clamp, technique. The study authors, led by Dr. Juan C. Araque, published their results online in the Journal of Thoracic and Cardiovascular Surgery (J. Thorac. Cardiovasc. Surg. 2015 [doi:10.1016/j.jtcvs.2015.04.010]).

“It is intuitive that less aortic manipulation would result in less risk of stroke,” Dr. Araque and colleagues said, but even off-pump CABG, which requires no aortic manipulation, is not without stroke risk.

“It is conceivable that there is some inherent risk of stroke associated with any cardiac operation, and that risk may increase with manipulation of the ascending aortic with the aortic cross clamp,” they wrote. “Our data would suggest, however, that the risk does not increase further with the additional aortic manipulation of the partial occlusion clamp.”

The study comes on the heels of a 2008 meta-analysis that found no benefit of SC in comparison to PC (Interact. Cardiovasc. Thorac. Surg. 2008;7:500-3), while another study in 2011 suggested that less aortic manipulation carried a significantly lower stroke risk (Heart Lung Circ. 2011;20:318-24).

The Mayo study evaluated the SC technique in 2,051 patients and PC in 6,446 patients who had isolated on-pump CABG between 1993 and 2010. The rate of stroke was 1.2% in the SC group and 1.5% among those who had PC. In two propensity-matched cohorts of 1,333 patients each, the stroke rate was 1.2% in each group. The investigators used the Society of Thoracic Surgeons’ risk calculator variables to create the propensity-matched cohorts.

The study group excluded high-risk patients, including those who had off-pump operations or previous cardiac surgeries or required replacement of a cross clamp during an unplanned operation.

The goal of the study was not to compare outcomes with the off-pump technique. “It is only to bring attention to the associated non-zero stroke rate with both techniques,” Dr. Araque and colleagues said.

Their findings are significant because on-pump CABG is the preferred operation of cardiac surgeons, accounting for more than 80% of the CABG operations in the SYNTAX study (N. Engl. J. Med. 2009;360:961-72). “The ‘anaortic’ off-pump technique may be a more specialized technique, representing less than 15% of operations in one large series,” Dr. Araque and coauthors said.

They acknowledged a few limitations resulting from the observational nature of the study, including that surgeons may have missed some strokes because they did not use a routine, standardized procedure for evaluating stroke signs along with the lack of documented assessment of the descending aorta. But they also stated that the large number of patients in the study, along with the use of propensity matching, addresses some of the bias inherent in an observational study.

The study authors disclosed no relationships.

A single intravenous infusion of cefazolin can cause drug-induced liver injury, and the antibiotic ranked sixth among pharmacologic causes of hepatic injury in an analysis of 1,212 patients.

“Cephalosporins appear to be a relatively common cause of antibiotic-associated liver injury,” said Dr. Saleh Alqahtani at the University of Texas Southwestern in Dallas and his associates. “The latency period is typically 1-3 weeks after exposure, and patients may not become symptomatic until after the antibiotic is stopped – this is particularly true in the unique clinical syndrome in which a single infusion of cefazolin leads to drug-induced liver injury.”

Cephalosporins have been reported as rare causes of drug-induced liver injury (DILI), but most data come from single case reports, the researchers said. To study causes of DILI, they analyzed cases from the Drug-Induced Livery Injury Network, an ongoing prospective study at eight U.S. medical centers. Enrolled patients had strong clinical suspicion for liver injury caused by a drug or an herbal agent. Liver injury was defined based on specific criteria for liver enzymes, alkaline phosphatase, or total bilirubin levels, or as an international normalized ratio greater than 1.5 that was accompanied by elevated liver enzymes or ALP. Patients were followed for at least 6 months after their baseline visit (Clin. Gastroenterol. Hepatol. 2014 Dec. 17 [doi: 10.1016/j.cgh.2015.01.010]).

Among the 1,212 cases of DILI in the analysis, one-third were linked to antimicrobial therapies, including 41 (3.3%) in which cephalosporins were implicated, the investigators reported. Nineteen of the cases were tied to a single dose of intravenous cefazolin given before surgery. These patients developed cholestatic or mixed hepatocellular-cholestatic injury 1-3 weeks after the cefazolin infusion. They almost always had jaundice and pruritus, and usually also had fever and nausea. Signs and symptoms were self-limiting, resolving within a few days to a few weeks.

“Because of confusion about the specific diagnosis, patients underwent substantial diagnostic testing (including multiple computed tomography scans, magnetic resonance imaging scans, endoscopic retrograde cholangiopancreatography exams, liver biopsies, and others), which often were unnecessary,” and in some cases led to severe complications, the investigators said.

The study also identified barriers to identifying cefazolin as a cause of DILI, they said. Patients often did not know they had received the antibiotic, and clinicians, including study investigators, often did not know that cefazolin could cause DILI. In more than half of cases, DILI was linked to cefazolin only after careful medical record reviews. “For these reasons, we speculate that cefazolin is and has been underappreciated as a cause of DILI,” the researchers noted. “The appearance of jaundice and pruritus 1-3 weeks after minor surgery should lead to a search of surgical records and medications that might have been given during surgery. These results also imply that the merits of routine use of cefazolin at the time of uncomplicated surgery should be reconsidered carefully.”

Two patients died after receiving cephalosporins other than cefazolin, and another patient developed severe liver injury, the researchers said. “However, in each of the fatal cases, patients had a complicated clinical course, with a severe hypersensitivity reaction on top of an underlying liver disease. Therefore, we urge caution in concluding that non-cefazolin cephalosporin-induced DILI may be severe or fatal,” they said. “Because cephalosporins are used commonly in clinical practice, it is likely that the overall mortality rate associated with cephalosporin use is low, but not nil, and it may be more likely in patients with underlying disorders.”

The study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institutes of Health, the National Cancer Institute, and by six Clinical and Translational Science Award grants. The investigators reported having no conflicts of interest.

A single intravenous infusion of cefazolin can cause drug-induced liver injury, and the antibiotic ranked sixth among pharmacologic causes of hepatic injury in an analysis of 1,212 patients.

“Cephalosporins appear to be a relatively common cause of antibiotic-associated liver injury,” said Dr. Saleh Alqahtani at the University of Texas Southwestern in Dallas and his associates. “The latency period is typically 1-3 weeks after exposure, and patients may not become symptomatic until after the antibiotic is stopped – this is particularly true in the unique clinical syndrome in which a single infusion of cefazolin leads to drug-induced liver injury.”

Cephalosporins have been reported as rare causes of drug-induced liver injury (DILI), but most data come from single case reports, the researchers said. To study causes of DILI, they analyzed cases from the Drug-Induced Livery Injury Network, an ongoing prospective study at eight U.S. medical centers. Enrolled patients had strong clinical suspicion for liver injury caused by a drug or an herbal agent. Liver injury was defined based on specific criteria for liver enzymes, alkaline phosphatase, or total bilirubin levels, or as an international normalized ratio greater than 1.5 that was accompanied by elevated liver enzymes or ALP. Patients were followed for at least 6 months after their baseline visit (Clin. Gastroenterol. Hepatol. 2014 Dec. 17 [doi: 10.1016/j.cgh.2015.01.010]).

Among the 1,212 cases of DILI in the analysis, one-third were linked to antimicrobial therapies, including 41 (3.3%) in which cephalosporins were implicated, the investigators reported. Nineteen of the cases were tied to a single dose of intravenous cefazolin given before surgery. These patients developed cholestatic or mixed hepatocellular-cholestatic injury 1-3 weeks after the cefazolin infusion. They almost always had jaundice and pruritus, and usually also had fever and nausea. Signs and symptoms were self-limiting, resolving within a few days to a few weeks.

“Because of confusion about the specific diagnosis, patients underwent substantial diagnostic testing (including multiple computed tomography scans, magnetic resonance imaging scans, endoscopic retrograde cholangiopancreatography exams, liver biopsies, and others), which often were unnecessary,” and in some cases led to severe complications, the investigators said.

The study also identified barriers to identifying cefazolin as a cause of DILI, they said. Patients often did not know they had received the antibiotic, and clinicians, including study investigators, often did not know that cefazolin could cause DILI. In more than half of cases, DILI was linked to cefazolin only after careful medical record reviews. “For these reasons, we speculate that cefazolin is and has been underappreciated as a cause of DILI,” the researchers noted. “The appearance of jaundice and pruritus 1-3 weeks after minor surgery should lead to a search of surgical records and medications that might have been given during surgery. These results also imply that the merits of routine use of cefazolin at the time of uncomplicated surgery should be reconsidered carefully.”

Two patients died after receiving cephalosporins other than cefazolin, and another patient developed severe liver injury, the researchers said. “However, in each of the fatal cases, patients had a complicated clinical course, with a severe hypersensitivity reaction on top of an underlying liver disease. Therefore, we urge caution in concluding that non-cefazolin cephalosporin-induced DILI may be severe or fatal,” they said. “Because cephalosporins are used commonly in clinical practice, it is likely that the overall mortality rate associated with cephalosporin use is low, but not nil, and it may be more likely in patients with underlying disorders.”

The study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institutes of Health, the National Cancer Institute, and by six Clinical and Translational Science Award grants. The investigators reported having no conflicts of interest.

A single intravenous infusion of cefazolin can cause drug-induced liver injury, and the antibiotic ranked sixth among pharmacologic causes of hepatic injury in an analysis of 1,212 patients.

“Cephalosporins appear to be a relatively common cause of antibiotic-associated liver injury,” said Dr. Saleh Alqahtani at the University of Texas Southwestern in Dallas and his associates. “The latency period is typically 1-3 weeks after exposure, and patients may not become symptomatic until after the antibiotic is stopped – this is particularly true in the unique clinical syndrome in which a single infusion of cefazolin leads to drug-induced liver injury.”

Cephalosporins have been reported as rare causes of drug-induced liver injury (DILI), but most data come from single case reports, the researchers said. To study causes of DILI, they analyzed cases from the Drug-Induced Livery Injury Network, an ongoing prospective study at eight U.S. medical centers. Enrolled patients had strong clinical suspicion for liver injury caused by a drug or an herbal agent. Liver injury was defined based on specific criteria for liver enzymes, alkaline phosphatase, or total bilirubin levels, or as an international normalized ratio greater than 1.5 that was accompanied by elevated liver enzymes or ALP. Patients were followed for at least 6 months after their baseline visit (Clin. Gastroenterol. Hepatol. 2014 Dec. 17 [doi: 10.1016/j.cgh.2015.01.010]).

Among the 1,212 cases of DILI in the analysis, one-third were linked to antimicrobial therapies, including 41 (3.3%) in which cephalosporins were implicated, the investigators reported. Nineteen of the cases were tied to a single dose of intravenous cefazolin given before surgery. These patients developed cholestatic or mixed hepatocellular-cholestatic injury 1-3 weeks after the cefazolin infusion. They almost always had jaundice and pruritus, and usually also had fever and nausea. Signs and symptoms were self-limiting, resolving within a few days to a few weeks.

“Because of confusion about the specific diagnosis, patients underwent substantial diagnostic testing (including multiple computed tomography scans, magnetic resonance imaging scans, endoscopic retrograde cholangiopancreatography exams, liver biopsies, and others), which often were unnecessary,” and in some cases led to severe complications, the investigators said.

The study also identified barriers to identifying cefazolin as a cause of DILI, they said. Patients often did not know they had received the antibiotic, and clinicians, including study investigators, often did not know that cefazolin could cause DILI. In more than half of cases, DILI was linked to cefazolin only after careful medical record reviews. “For these reasons, we speculate that cefazolin is and has been underappreciated as a cause of DILI,” the researchers noted. “The appearance of jaundice and pruritus 1-3 weeks after minor surgery should lead to a search of surgical records and medications that might have been given during surgery. These results also imply that the merits of routine use of cefazolin at the time of uncomplicated surgery should be reconsidered carefully.”

Two patients died after receiving cephalosporins other than cefazolin, and another patient developed severe liver injury, the researchers said. “However, in each of the fatal cases, patients had a complicated clinical course, with a severe hypersensitivity reaction on top of an underlying liver disease. Therefore, we urge caution in concluding that non-cefazolin cephalosporin-induced DILI may be severe or fatal,” they said. “Because cephalosporins are used commonly in clinical practice, it is likely that the overall mortality rate associated with cephalosporin use is low, but not nil, and it may be more likely in patients with underlying disorders.”

The study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institutes of Health, the National Cancer Institute, and by six Clinical and Translational Science Award grants. The investigators reported having no conflicts of interest.

An acute aortic tear can be lethal, and more cardiac surgeons are favoring extended aortic arch replacement in these cases. Cardiac surgeons have tried many different arch replacement techniques, but en bloc repair and double- or triple-branch stent grafting carry significant risks, so a team of cardiac surgeons in Beijing has reported good 2-year results with a novel technique that combines stented elephant-trunk implantation with preservation of key vessels.

The technique accomplishes total arch replacement with the stent while preserving the autologous brachiocephalic vessels.

“This technique simplified hemostasis and anastomosis, reduced the size of the residual aortic patch wall, and preserved the autologous brachiocephalic vessels, yielding satisfactory surgical results,” wrote Dr. Li-Zhong Sun and colleagues at Beijing’s Capital Medical University (J. Thorac. Cardiovasc. Surg. 2015 [doi:10.1016/j.jtcvs.2015.03.002]).

There are four keys to the procedure:

• The use of forceps to grasp the stent-free sewing edge of the stented elephant trunk and straightening of the spiral shaped Dacron graft to approximately 3 cm.

• Preservation of the native brachiocephalic vessels.

• Creating a residual aortic wall containing the innominate artery and LCCA that’s as small as possible.

• An end-to-side anastomosis between the left subclavian artery (LSCA) and the left common carotid artery (LCCA), a key junction in their technique.

The 20 study subjects had surgery within 2 weeks of the onset of pain. All 20 were discharged after the procedure, and in a mean follow-up period of 26 months, 18 had good outcomes while 1 patient had thoracoabdominal aortic replacement 9 months after the initial surgery (1 patient was lost to follow-up).

The researchers used computed tomography to confirm patency of the anastomosis between the LSCA and LCCA.

In 2 of the 20 patients, the aorta was normal with aortic dissection limited to the descending aorta. In the remaining patients, the investigators observed thrombus obliteration of the false lumen around the surgical graft in 16, partial thrombosis in 1 and patency in 1.

The surgical technique exposes the right axillary artery through a right subclavicular incision and a median sternotomy, then dissects and exposes the brachiocephalic vessels and the transverse arch. Dissection of the LSCA and LCCA is the key step in making the end-to-end anastomosis between the two vessels. The researchers accomplished this by partially transecting the sternocleidomastoid muscle and other cervical muscles.

Dr. Sun and coauthors said that a separated graft technique offers a number of advantages over other techniques for aortic arch reconstruction. While en bloc repair preserves the native brachiocephalic vessels and, thus, results in long-term patency, the technique carries risk for postoperative rupture of the aortic patch containing the brachiocephalic vessels. Double- or triple-branched stent grafting has resulted in shifting or kinking of the graft and eventually graft occlusion or aortic disruption.

The authors acknowledged the study’s small sample size, and that the outcomes are “preliminary.” They said long-term follow-up would be required to confirm the outcomes.

They had no disclosures to report.

An acute aortic tear can be lethal, and more cardiac surgeons are favoring extended aortic arch replacement in these cases. Cardiac surgeons have tried many different arch replacement techniques, but en bloc repair and double- or triple-branch stent grafting carry significant risks, so a team of cardiac surgeons in Beijing has reported good 2-year results with a novel technique that combines stented elephant-trunk implantation with preservation of key vessels.

The technique accomplishes total arch replacement with the stent while preserving the autologous brachiocephalic vessels.

“This technique simplified hemostasis and anastomosis, reduced the size of the residual aortic patch wall, and preserved the autologous brachiocephalic vessels, yielding satisfactory surgical results,” wrote Dr. Li-Zhong Sun and colleagues at Beijing’s Capital Medical University (J. Thorac. Cardiovasc. Surg. 2015 [doi:10.1016/j.jtcvs.2015.03.002]).

There are four keys to the procedure:

• The use of forceps to grasp the stent-free sewing edge of the stented elephant trunk and straightening of the spiral shaped Dacron graft to approximately 3 cm.

• Preservation of the native brachiocephalic vessels.

• Creating a residual aortic wall containing the innominate artery and LCCA that’s as small as possible.

• An end-to-side anastomosis between the left subclavian artery (LSCA) and the left common carotid artery (LCCA), a key junction in their technique.

The 20 study subjects had surgery within 2 weeks of the onset of pain. All 20 were discharged after the procedure, and in a mean follow-up period of 26 months, 18 had good outcomes while 1 patient had thoracoabdominal aortic replacement 9 months after the initial surgery (1 patient was lost to follow-up).

The researchers used computed tomography to confirm patency of the anastomosis between the LSCA and LCCA.

In 2 of the 20 patients, the aorta was normal with aortic dissection limited to the descending aorta. In the remaining patients, the investigators observed thrombus obliteration of the false lumen around the surgical graft in 16, partial thrombosis in 1 and patency in 1.

The surgical technique exposes the right axillary artery through a right subclavicular incision and a median sternotomy, then dissects and exposes the brachiocephalic vessels and the transverse arch. Dissection of the LSCA and LCCA is the key step in making the end-to-end anastomosis between the two vessels. The researchers accomplished this by partially transecting the sternocleidomastoid muscle and other cervical muscles.

Dr. Sun and coauthors said that a separated graft technique offers a number of advantages over other techniques for aortic arch reconstruction. While en bloc repair preserves the native brachiocephalic vessels and, thus, results in long-term patency, the technique carries risk for postoperative rupture of the aortic patch containing the brachiocephalic vessels. Double- or triple-branched stent grafting has resulted in shifting or kinking of the graft and eventually graft occlusion or aortic disruption.

The authors acknowledged the study’s small sample size, and that the outcomes are “preliminary.” They said long-term follow-up would be required to confirm the outcomes.

They had no disclosures to report.

An acute aortic tear can be lethal, and more cardiac surgeons are favoring extended aortic arch replacement in these cases. Cardiac surgeons have tried many different arch replacement techniques, but en bloc repair and double- or triple-branch stent grafting carry significant risks, so a team of cardiac surgeons in Beijing has reported good 2-year results with a novel technique that combines stented elephant-trunk implantation with preservation of key vessels.

The technique accomplishes total arch replacement with the stent while preserving the autologous brachiocephalic vessels.

“This technique simplified hemostasis and anastomosis, reduced the size of the residual aortic patch wall, and preserved the autologous brachiocephalic vessels, yielding satisfactory surgical results,” wrote Dr. Li-Zhong Sun and colleagues at Beijing’s Capital Medical University (J. Thorac. Cardiovasc. Surg. 2015 [doi:10.1016/j.jtcvs.2015.03.002]).

There are four keys to the procedure:

• The use of forceps to grasp the stent-free sewing edge of the stented elephant trunk and straightening of the spiral shaped Dacron graft to approximately 3 cm.

• Preservation of the native brachiocephalic vessels.

• Creating a residual aortic wall containing the innominate artery and LCCA that’s as small as possible.

• An end-to-side anastomosis between the left subclavian artery (LSCA) and the left common carotid artery (LCCA), a key junction in their technique.

The 20 study subjects had surgery within 2 weeks of the onset of pain. All 20 were discharged after the procedure, and in a mean follow-up period of 26 months, 18 had good outcomes while 1 patient had thoracoabdominal aortic replacement 9 months after the initial surgery (1 patient was lost to follow-up).

The researchers used computed tomography to confirm patency of the anastomosis between the LSCA and LCCA.

In 2 of the 20 patients, the aorta was normal with aortic dissection limited to the descending aorta. In the remaining patients, the investigators observed thrombus obliteration of the false lumen around the surgical graft in 16, partial thrombosis in 1 and patency in 1.

The surgical technique exposes the right axillary artery through a right subclavicular incision and a median sternotomy, then dissects and exposes the brachiocephalic vessels and the transverse arch. Dissection of the LSCA and LCCA is the key step in making the end-to-end anastomosis between the two vessels. The researchers accomplished this by partially transecting the sternocleidomastoid muscle and other cervical muscles.

Dr. Sun and coauthors said that a separated graft technique offers a number of advantages over other techniques for aortic arch reconstruction. While en bloc repair preserves the native brachiocephalic vessels and, thus, results in long-term patency, the technique carries risk for postoperative rupture of the aortic patch containing the brachiocephalic vessels. Double- or triple-branched stent grafting has resulted in shifting or kinking of the graft and eventually graft occlusion or aortic disruption.

The authors acknowledged the study’s small sample size, and that the outcomes are “preliminary.” They said long-term follow-up would be required to confirm the outcomes.

They had no disclosures to report.

An emerging market of molecular markers for thyroid cancer diagnostic and prognostic evaluation challenges current medical and surgical management; however, here is a strong word of caution; Unless the markers have been tested in the context of clinical and surgical management their true efficacy has not been accurately assessed.

We must always ask two questions before ordering these tests that can cost more than $3,000: 1) Does the use of a molecular test add any additional information that would otherwise change our recommendations; in other words, is the clinical information already known enough for appropriate clinical decision making? 2) What is the basis upon which recommendations for its use have been made; in other words, how were the studies conducted and interpreted? Are they valid?

By way of background, the gene expression clarifier (GEC) Afirma is marketed as a diagnostic tool for the differential diagnosis of indeterminate thyroid cytology (atypical cells of undetermined significance or follicular neoplasm, Bethesda categories III and IV, respectively).

Most importantly, it has been tested and is marketed as a negative predictor only. It is also only useful if used in the appropriate setting and if the test result is negative; a positive Afirma test can tell us only that the nodule is indeterminate, something, by definition, already determined by fine needle aspiration (FNA). Furthermore, any study examining its efficacy must be conducted within the context of clinical scenarios. For example, for a patient with an indeterminate lesion and a symptomatic multinodular goiter, neither a negative nor positive Afirma result would have any impact on surgical decision making and yet would have cost the patient more than $3,000. The latter patient simply needs a thyroidectomy. A patient who has a nodule that is approaching 4 cm or is increasing in size or a patient who has undergone several FNAs, ultrasounds, and endocrinology consultations similarly would likely choose surgery regardless of the GEC test result.

The only scenario in which Afirma testing is useful is in a patient with otherwise no indications for surgery except an indeterminate FNA; for instance for a patient with an asymptomatic < 4cm, stable, single nodule. In this scenario only a negative result could be helpful and would obviate the need for surgical intervention. One also must ask what is the likelihood of the patient undergoing repeat FNA, having repeat indeterminate cytology and repeat Afirma testing over the ensuing years and at what point should we consider these costs prohibitive compared with the patient undergoing a thyroidectomy instead?

Similar concerns exist with regard to somatic mutation panels, the most commonly marketed and used being Asuragen. The mutation panel consists of Ras and BRAF mutation and RET/PTC and PAX8/PPAR-gamma chromosomal rearrangement analyses. Importantly, the expanding literature on molecular markers for thyroid cancer, however, has lost track of a vast body of literature that reports Ras mutations present in up to 30% of benign thyroid nodules; RET/PTC in 24% and PAX8/PPAR-gamma in 14%, dramatically challenging the validity of the panel purported to accurately identify thyroid malignancy. We know that BRAF mutation is exclusively found in papillary thyroid cancer, but generally a BRAF-positive tumor is one in which a cytological diagnosis is already clear; it is either suspicious or definitively malignant on FNA. One might suggest that these aforementioned markers might indicate a harbinger of malignancy or identify a precancerous lesion; however, there is no study that supports this theory. Furthermore, it is important to note that even among pathology experts the diagnoses of follicular adenoma, follicular cancer, and follicular variant of papillary thyroid cancer have significant and documented inter- and intra- observer variability, thus challenging the gold standard upon which these markers have been tested.

With regard to BRAF, Ras, RET/PTC and PAX8/PPAR-gamma as prognostic markers there are many considerations, the least of which includes the differential diagnosis of follicular lesions addressed above and the known presence of these abnormalities in benign tumors. The majority of studies to date have conducted only univariate analyses without consideration of the clinical variables already available to us to make needed clinical decisions. In order to examine the usefulness of any marker panel a multivariable study is required, incorporating the available clinical variables such as size, lymph node metastases, and extra-thyroidal extension. For instance, the majority of studies examining the presence of lymph node metastases in BRAF-negative vs. BRAF-positive tumors were almost uniformly conducted on patients in whom routine lymph node dissection was not performed, thereby skewing the results. Only patients with suspicious nodes underwent a lymph node dissection; thus for those patients who had no suspicious nodes there was no information about their nodal status. Furthermore, several studies that included patients who underwent routine lymph node dissections and, importantly, included patients who underwent prophylactic dissections for whom a marker would be most useful, did not find that BRAF mutation was associated with aggressive features, including the presence of lymph node metastases. The same can be stated for a panel that includes Ras, RET/PTC, & PAX8/PPAR-gamma. “Follicular variant of papillary thyroid cancer and follicular cancer” will more likely harbor Ras and PAX8/PPAR-gamma mutations and will, by definition, include some tumors that would be considered benign by other pathologists.

There is an emerging market for molecular markers for thyroid cancer diagnosis and prognosis, but many of the studies driving this market are lacking in scientific rigor with regard to design and interpretation of results. Furthermore, the use of the marker panel requires scrutiny of its true impact on clinical management as well as its cost-effectiveness. GEC provides a negative predictor of malignancy and should be used to obviate surgery only; if the patient requires surgery its use provides no added information. BRAF is specific for thyroid cancer diagnosis, but is often not required as FNA evaluation in BRAF-positive tumors is usually already suspicious or malignant. Finally, molecular marker panels for thyroid cancer prognosis may be promising, but scrutiny for true accuracy and true clinical impact is necessary in order to make logical and useful recommendations for our patients.

Dr. Zeiger is professor of surgery, oncology, cellular, and molecular medicine, associate vice chair for faculty development, and associate dean for postdoctoral affairs at Johns Hopkins University in Baltimore. Dr. Zeiger consults for Interpace Diagnostics.

An emerging market of molecular markers for thyroid cancer diagnostic and prognostic evaluation challenges current medical and surgical management; however, here is a strong word of caution; Unless the markers have been tested in the context of clinical and surgical management their true efficacy has not been accurately assessed.

We must always ask two questions before ordering these tests that can cost more than $3,000: 1) Does the use of a molecular test add any additional information that would otherwise change our recommendations; in other words, is the clinical information already known enough for appropriate clinical decision making? 2) What is the basis upon which recommendations for its use have been made; in other words, how were the studies conducted and interpreted? Are they valid?

By way of background, the gene expression clarifier (GEC) Afirma is marketed as a diagnostic tool for the differential diagnosis of indeterminate thyroid cytology (atypical cells of undetermined significance or follicular neoplasm, Bethesda categories III and IV, respectively).

Most importantly, it has been tested and is marketed as a negative predictor only. It is also only useful if used in the appropriate setting and if the test result is negative; a positive Afirma test can tell us only that the nodule is indeterminate, something, by definition, already determined by fine needle aspiration (FNA). Furthermore, any study examining its efficacy must be conducted within the context of clinical scenarios. For example, for a patient with an indeterminate lesion and a symptomatic multinodular goiter, neither a negative nor positive Afirma result would have any impact on surgical decision making and yet would have cost the patient more than $3,000. The latter patient simply needs a thyroidectomy. A patient who has a nodule that is approaching 4 cm or is increasing in size or a patient who has undergone several FNAs, ultrasounds, and endocrinology consultations similarly would likely choose surgery regardless of the GEC test result.

The only scenario in which Afirma testing is useful is in a patient with otherwise no indications for surgery except an indeterminate FNA; for instance for a patient with an asymptomatic < 4cm, stable, single nodule. In this scenario only a negative result could be helpful and would obviate the need for surgical intervention. One also must ask what is the likelihood of the patient undergoing repeat FNA, having repeat indeterminate cytology and repeat Afirma testing over the ensuing years and at what point should we consider these costs prohibitive compared with the patient undergoing a thyroidectomy instead?

Similar concerns exist with regard to somatic mutation panels, the most commonly marketed and used being Asuragen. The mutation panel consists of Ras and BRAF mutation and RET/PTC and PAX8/PPAR-gamma chromosomal rearrangement analyses. Importantly, the expanding literature on molecular markers for thyroid cancer, however, has lost track of a vast body of literature that reports Ras mutations present in up to 30% of benign thyroid nodules; RET/PTC in 24% and PAX8/PPAR-gamma in 14%, dramatically challenging the validity of the panel purported to accurately identify thyroid malignancy. We know that BRAF mutation is exclusively found in papillary thyroid cancer, but generally a BRAF-positive tumor is one in which a cytological diagnosis is already clear; it is either suspicious or definitively malignant on FNA. One might suggest that these aforementioned markers might indicate a harbinger of malignancy or identify a precancerous lesion; however, there is no study that supports this theory. Furthermore, it is important to note that even among pathology experts the diagnoses of follicular adenoma, follicular cancer, and follicular variant of papillary thyroid cancer have significant and documented inter- and intra- observer variability, thus challenging the gold standard upon which these markers have been tested.

With regard to BRAF, Ras, RET/PTC and PAX8/PPAR-gamma as prognostic markers there are many considerations, the least of which includes the differential diagnosis of follicular lesions addressed above and the known presence of these abnormalities in benign tumors. The majority of studies to date have conducted only univariate analyses without consideration of the clinical variables already available to us to make needed clinical decisions. In order to examine the usefulness of any marker panel a multivariable study is required, incorporating the available clinical variables such as size, lymph node metastases, and extra-thyroidal extension. For instance, the majority of studies examining the presence of lymph node metastases in BRAF-negative vs. BRAF-positive tumors were almost uniformly conducted on patients in whom routine lymph node dissection was not performed, thereby skewing the results. Only patients with suspicious nodes underwent a lymph node dissection; thus for those patients who had no suspicious nodes there was no information about their nodal status. Furthermore, several studies that included patients who underwent routine lymph node dissections and, importantly, included patients who underwent prophylactic dissections for whom a marker would be most useful, did not find that BRAF mutation was associated with aggressive features, including the presence of lymph node metastases. The same can be stated for a panel that includes Ras, RET/PTC, & PAX8/PPAR-gamma. “Follicular variant of papillary thyroid cancer and follicular cancer” will more likely harbor Ras and PAX8/PPAR-gamma mutations and will, by definition, include some tumors that would be considered benign by other pathologists.

There is an emerging market for molecular markers for thyroid cancer diagnosis and prognosis, but many of the studies driving this market are lacking in scientific rigor with regard to design and interpretation of results. Furthermore, the use of the marker panel requires scrutiny of its true impact on clinical management as well as its cost-effectiveness. GEC provides a negative predictor of malignancy and should be used to obviate surgery only; if the patient requires surgery its use provides no added information. BRAF is specific for thyroid cancer diagnosis, but is often not required as FNA evaluation in BRAF-positive tumors is usually already suspicious or malignant. Finally, molecular marker panels for thyroid cancer prognosis may be promising, but scrutiny for true accuracy and true clinical impact is necessary in order to make logical and useful recommendations for our patients.

Dr. Zeiger is professor of surgery, oncology, cellular, and molecular medicine, associate vice chair for faculty development, and associate dean for postdoctoral affairs at Johns Hopkins University in Baltimore. Dr. Zeiger consults for Interpace Diagnostics.

An emerging market of molecular markers for thyroid cancer diagnostic and prognostic evaluation challenges current medical and surgical management; however, here is a strong word of caution; Unless the markers have been tested in the context of clinical and surgical management their true efficacy has not been accurately assessed.

We must always ask two questions before ordering these tests that can cost more than $3,000: 1) Does the use of a molecular test add any additional information that would otherwise change our recommendations; in other words, is the clinical information already known enough for appropriate clinical decision making? 2) What is the basis upon which recommendations for its use have been made; in other words, how were the studies conducted and interpreted? Are they valid?

By way of background, the gene expression clarifier (GEC) Afirma is marketed as a diagnostic tool for the differential diagnosis of indeterminate thyroid cytology (atypical cells of undetermined significance or follicular neoplasm, Bethesda categories III and IV, respectively).

Most importantly, it has been tested and is marketed as a negative predictor only. It is also only useful if used in the appropriate setting and if the test result is negative; a positive Afirma test can tell us only that the nodule is indeterminate, something, by definition, already determined by fine needle aspiration (FNA). Furthermore, any study examining its efficacy must be conducted within the context of clinical scenarios. For example, for a patient with an indeterminate lesion and a symptomatic multinodular goiter, neither a negative nor positive Afirma result would have any impact on surgical decision making and yet would have cost the patient more than $3,000. The latter patient simply needs a thyroidectomy. A patient who has a nodule that is approaching 4 cm or is increasing in size or a patient who has undergone several FNAs, ultrasounds, and endocrinology consultations similarly would likely choose surgery regardless of the GEC test result.

The only scenario in which Afirma testing is useful is in a patient with otherwise no indications for surgery except an indeterminate FNA; for instance for a patient with an asymptomatic < 4cm, stable, single nodule. In this scenario only a negative result could be helpful and would obviate the need for surgical intervention. One also must ask what is the likelihood of the patient undergoing repeat FNA, having repeat indeterminate cytology and repeat Afirma testing over the ensuing years and at what point should we consider these costs prohibitive compared with the patient undergoing a thyroidectomy instead?

Similar concerns exist with regard to somatic mutation panels, the most commonly marketed and used being Asuragen. The mutation panel consists of Ras and BRAF mutation and RET/PTC and PAX8/PPAR-gamma chromosomal rearrangement analyses. Importantly, the expanding literature on molecular markers for thyroid cancer, however, has lost track of a vast body of literature that reports Ras mutations present in up to 30% of benign thyroid nodules; RET/PTC in 24% and PAX8/PPAR-gamma in 14%, dramatically challenging the validity of the panel purported to accurately identify thyroid malignancy. We know that BRAF mutation is exclusively found in papillary thyroid cancer, but generally a BRAF-positive tumor is one in which a cytological diagnosis is already clear; it is either suspicious or definitively malignant on FNA. One might suggest that these aforementioned markers might indicate a harbinger of malignancy or identify a precancerous lesion; however, there is no study that supports this theory. Furthermore, it is important to note that even among pathology experts the diagnoses of follicular adenoma, follicular cancer, and follicular variant of papillary thyroid cancer have significant and documented inter- and intra- observer variability, thus challenging the gold standard upon which these markers have been tested.

With regard to BRAF, Ras, RET/PTC and PAX8/PPAR-gamma as prognostic markers there are many considerations, the least of which includes the differential diagnosis of follicular lesions addressed above and the known presence of these abnormalities in benign tumors. The majority of studies to date have conducted only univariate analyses without consideration of the clinical variables already available to us to make needed clinical decisions. In order to examine the usefulness of any marker panel a multivariable study is required, incorporating the available clinical variables such as size, lymph node metastases, and extra-thyroidal extension. For instance, the majority of studies examining the presence of lymph node metastases in BRAF-negative vs. BRAF-positive tumors were almost uniformly conducted on patients in whom routine lymph node dissection was not performed, thereby skewing the results. Only patients with suspicious nodes underwent a lymph node dissection; thus for those patients who had no suspicious nodes there was no information about their nodal status. Furthermore, several studies that included patients who underwent routine lymph node dissections and, importantly, included patients who underwent prophylactic dissections for whom a marker would be most useful, did not find that BRAF mutation was associated with aggressive features, including the presence of lymph node metastases. The same can be stated for a panel that includes Ras, RET/PTC, & PAX8/PPAR-gamma. “Follicular variant of papillary thyroid cancer and follicular cancer” will more likely harbor Ras and PAX8/PPAR-gamma mutations and will, by definition, include some tumors that would be considered benign by other pathologists.

There is an emerging market for molecular markers for thyroid cancer diagnosis and prognosis, but many of the studies driving this market are lacking in scientific rigor with regard to design and interpretation of results. Furthermore, the use of the marker panel requires scrutiny of its true impact on clinical management as well as its cost-effectiveness. GEC provides a negative predictor of malignancy and should be used to obviate surgery only; if the patient requires surgery its use provides no added information. BRAF is specific for thyroid cancer diagnosis, but is often not required as FNA evaluation in BRAF-positive tumors is usually already suspicious or malignant. Finally, molecular marker panels for thyroid cancer prognosis may be promising, but scrutiny for true accuracy and true clinical impact is necessary in order to make logical and useful recommendations for our patients.

Dr. Zeiger is professor of surgery, oncology, cellular, and molecular medicine, associate vice chair for faculty development, and associate dean for postdoctoral affairs at Johns Hopkins University in Baltimore. Dr. Zeiger consults for Interpace Diagnostics.

CHICAGO – Autologous engineered skin substitutes (EES) reduce mortality and donor-site harvesting in children with extensive, deep burns, a randomized, paired-site comparison showed.

“Autologous ESS offer an alternative therapy for closure of extensive, excised, full-thickness burns,” Steven Boyce, Ph.D., said at the annual meeting of the American Burn Association.

Patrice Wendling/Frontline Medical News

The skin substitutes were engineered using split-thickness skin biopsies from 16 children with full-thickness burns covering an average total body surface area (TBSA) of 78% and a high of 95%.

The ESS were composed of autologous cultured keratinocytes and dermal fibroblasts attached to a collagen-based, biopolymer scaffold.

Clinicians are increasingly turning to tissue engineering as a way to address the shortfalls associated with the prevailing standard of care, autologous skin grafting, including lack of donor sites in larger burns, increased morbidity from autograft harvesting and skin grafts, and scarring.

At the 2014 ABA meeting, Canadian researchers reported on an autologous skin substitute that had both dermal and epidermal components. It took 2 months to prepare, whereas the Cincinnati model requires about 1 month to prepare and offers greater availability and stability of the closed wounds, Dr. Boyce said in an interview.

For the current study, Dr. Boyce and his associates compared mortality after treatment with ESS in 16 children with data from 1,008 patients from the National Burn Repository who were of similar ages, had 77% full-thickness TBSA burns, and were treated with meshed and expanded split-thickness skin autografts (AG). One patient died before ESS were prepared, leaving 15 patients in whom 2,056 ESS grafts were applied in 59 operations. Their average age was 6.3 years, 13 were male, and the average time to first ESS was 32 days.

Mortality was 6.25% (1/16) with the skin substitutes and 30.3% (305/1,008) with the autografts (P value < .05), said Dr. Boyce, a professor with the University of Cincinnati and director of the Skin Substitute Laboratories, Shriners Hospitals for Children, both in Cincinnati.

Rates of engraftment at postoperative day 14, however, significantly favored the AG group at 96.5 vs. 83.5% for ESS (P < .05).

One major reason for reduced rates of engraftment is lack of blood vessels in current models of engineered skin, he explained.

At day 28, the percentage of TBSA closed was approximately 30% for ESS and 47% for AG, while the ratio of closed-to-donor areas was significantly greater for ESS (108.7 vs. 4.0; P < .001).

The correlation between the percentage TBSA closed with ESS and TBSA burned generated an R-squared value of 0.65 (P < .001), Dr. Boyce said.

Regraftment rates were similar between graft types. Antibody formation to the biopolymer scaffold at postoperative day 28 was similar between patients receiving 1 or multiple ESS.

“Stable wound closure [with ESS] is interpreted to result from preservation of epidermal progenitor cells, formation in vitro of basement membrane between fibroblasts and keratinocytes, and generation of fibrovascular tissue by the biopolymer scaffold,” he said.

Tissue engineering offers patients the opportunity to survive with otherwise statistically lethal burns and “the data are very clear that happens with this product,” session comoderator and past ABA president Dr. David Ahrenholz said in an interview.

That said, “the product is very expensive, so I would not use it for patients in whom I had adequate donor sites, but it’s fairly easy to identify those patients on admission,” he added.

The study was supported by grants from the U.S. Department of Defense, National Institute of General Medical Sciences, and Shriners Hospitals for Children. The authors reported no current relevant financial disclosures.

pwendling@frontlinemedcom.com

On Twitter @pwendl

CHICAGO – Autologous engineered skin substitutes (EES) reduce mortality and donor-site harvesting in children with extensive, deep burns, a randomized, paired-site comparison showed.

“Autologous ESS offer an alternative therapy for closure of extensive, excised, full-thickness burns,” Steven Boyce, Ph.D., said at the annual meeting of the American Burn Association.

Patrice Wendling/Frontline Medical News

The skin substitutes were engineered using split-thickness skin biopsies from 16 children with full-thickness burns covering an average total body surface area (TBSA) of 78% and a high of 95%.

The ESS were composed of autologous cultured keratinocytes and dermal fibroblasts attached to a collagen-based, biopolymer scaffold.

Clinicians are increasingly turning to tissue engineering as a way to address the shortfalls associated with the prevailing standard of care, autologous skin grafting, including lack of donor sites in larger burns, increased morbidity from autograft harvesting and skin grafts, and scarring.

At the 2014 ABA meeting, Canadian researchers reported on an autologous skin substitute that had both dermal and epidermal components. It took 2 months to prepare, whereas the Cincinnati model requires about 1 month to prepare and offers greater availability and stability of the closed wounds, Dr. Boyce said in an interview.

For the current study, Dr. Boyce and his associates compared mortality after treatment with ESS in 16 children with data from 1,008 patients from the National Burn Repository who were of similar ages, had 77% full-thickness TBSA burns, and were treated with meshed and expanded split-thickness skin autografts (AG). One patient died before ESS were prepared, leaving 15 patients in whom 2,056 ESS grafts were applied in 59 operations. Their average age was 6.3 years, 13 were male, and the average time to first ESS was 32 days.

Mortality was 6.25% (1/16) with the skin substitutes and 30.3% (305/1,008) with the autografts (P value < .05), said Dr. Boyce, a professor with the University of Cincinnati and director of the Skin Substitute Laboratories, Shriners Hospitals for Children, both in Cincinnati.

Rates of engraftment at postoperative day 14, however, significantly favored the AG group at 96.5 vs. 83.5% for ESS (P < .05).

One major reason for reduced rates of engraftment is lack of blood vessels in current models of engineered skin, he explained.

At day 28, the percentage of TBSA closed was approximately 30% for ESS and 47% for AG, while the ratio of closed-to-donor areas was significantly greater for ESS (108.7 vs. 4.0; P < .001).

The correlation between the percentage TBSA closed with ESS and TBSA burned generated an R-squared value of 0.65 (P < .001), Dr. Boyce said.

Regraftment rates were similar between graft types. Antibody formation to the biopolymer scaffold at postoperative day 28 was similar between patients receiving 1 or multiple ESS.

“Stable wound closure [with ESS] is interpreted to result from preservation of epidermal progenitor cells, formation in vitro of basement membrane between fibroblasts and keratinocytes, and generation of fibrovascular tissue by the biopolymer scaffold,” he said.

Tissue engineering offers patients the opportunity to survive with otherwise statistically lethal burns and “the data are very clear that happens with this product,” session comoderator and past ABA president Dr. David Ahrenholz said in an interview.

That said, “the product is very expensive, so I would not use it for patients in whom I had adequate donor sites, but it’s fairly easy to identify those patients on admission,” he added.

The study was supported by grants from the U.S. Department of Defense, National Institute of General Medical Sciences, and Shriners Hospitals for Children. The authors reported no current relevant financial disclosures.

pwendling@frontlinemedcom.com

On Twitter @pwendl

CHICAGO – Autologous engineered skin substitutes (EES) reduce mortality and donor-site harvesting in children with extensive, deep burns, a randomized, paired-site comparison showed.

“Autologous ESS offer an alternative therapy for closure of extensive, excised, full-thickness burns,” Steven Boyce, Ph.D., said at the annual meeting of the American Burn Association.

Patrice Wendling/Frontline Medical News

The skin substitutes were engineered using split-thickness skin biopsies from 16 children with full-thickness burns covering an average total body surface area (TBSA) of 78% and a high of 95%.

The ESS were composed of autologous cultured keratinocytes and dermal fibroblasts attached to a collagen-based, biopolymer scaffold.

Clinicians are increasingly turning to tissue engineering as a way to address the shortfalls associated with the prevailing standard of care, autologous skin grafting, including lack of donor sites in larger burns, increased morbidity from autograft harvesting and skin grafts, and scarring.

At the 2014 ABA meeting, Canadian researchers reported on an autologous skin substitute that had both dermal and epidermal components. It took 2 months to prepare, whereas the Cincinnati model requires about 1 month to prepare and offers greater availability and stability of the closed wounds, Dr. Boyce said in an interview.

For the current study, Dr. Boyce and his associates compared mortality after treatment with ESS in 16 children with data from 1,008 patients from the National Burn Repository who were of similar ages, had 77% full-thickness TBSA burns, and were treated with meshed and expanded split-thickness skin autografts (AG). One patient died before ESS were prepared, leaving 15 patients in whom 2,056 ESS grafts were applied in 59 operations. Their average age was 6.3 years, 13 were male, and the average time to first ESS was 32 days.

Mortality was 6.25% (1/16) with the skin substitutes and 30.3% (305/1,008) with the autografts (P value < .05), said Dr. Boyce, a professor with the University of Cincinnati and director of the Skin Substitute Laboratories, Shriners Hospitals for Children, both in Cincinnati.

Rates of engraftment at postoperative day 14, however, significantly favored the AG group at 96.5 vs. 83.5% for ESS (P < .05).

One major reason for reduced rates of engraftment is lack of blood vessels in current models of engineered skin, he explained.

At day 28, the percentage of TBSA closed was approximately 30% for ESS and 47% for AG, while the ratio of closed-to-donor areas was significantly greater for ESS (108.7 vs. 4.0; P < .001).

The correlation between the percentage TBSA closed with ESS and TBSA burned generated an R-squared value of 0.65 (P < .001), Dr. Boyce said.

Regraftment rates were similar between graft types. Antibody formation to the biopolymer scaffold at postoperative day 28 was similar between patients receiving 1 or multiple ESS.

“Stable wound closure [with ESS] is interpreted to result from preservation of epidermal progenitor cells, formation in vitro of basement membrane between fibroblasts and keratinocytes, and generation of fibrovascular tissue by the biopolymer scaffold,” he said.

Tissue engineering offers patients the opportunity to survive with otherwise statistically lethal burns and “the data are very clear that happens with this product,” session comoderator and past ABA president Dr. David Ahrenholz said in an interview.

That said, “the product is very expensive, so I would not use it for patients in whom I had adequate donor sites, but it’s fairly easy to identify those patients on admission,” he added.

The study was supported by grants from the U.S. Department of Defense, National Institute of General Medical Sciences, and Shriners Hospitals for Children. The authors reported no current relevant financial disclosures.

pwendling@frontlinemedcom.com

On Twitter @pwendl

CHICAGO – Age greater than 76 years, plus preoperative creatinine greater than 2 mg/dL, blood pH less than 7.2, and systolic pressure at any point below 70 mm Hg collectively predicted 100% mortality with open or endovascular repair of ruptured abdominal aortic aneurysms, according to a new mortality risk score from Harborview Medical Center in Seattle.

Meeting all four criteria gives the maximum score of 4. Any one of the factors alone – a score of 1 – predicted 30% mortality with open repair and 9% with endovascular aneurysm repair (EVAR); a 2 predicted 80% mortality with open repair and 37% with EVAR; and a 3 predicted 82% mortality with open repair and 70% with EVAR.

Vascular surgeons at Harborview developed the system so they’d know whether to recommend transport or comfort care for ruptured abdominal aortic aneurysms (AAAs). The Level 1 trauma center serves more than a quarter of the U.S. landmass, and handles about 30-40 ruptured AAA’s annually. It’s not uncommon for patients to be flown in from Alaska.

Existing risk scores haven’t been validated for EVAR or rely on intraoperative variables, so they aren’t much help when counseling patients and referring physicians on what to do.

“Our ruptured AAA mortality risk score is based on four variables readily assessed preoperatively, allows accurate prediction of in-hospital mortality after repair of ruptured AAAs in the EVAR-first era, and does so better than any score thus published. It’s clinically relevant to the decision to transport and helps guide difficult discussions with patients and their families,” said investigator Dr. Ty Garland, chief vascular surgery resident at the University of Washington, Seattle.

When using the new risk score. “we don’t ever block transfer, but we have discussions with referring providers and in several cases with patients and their families over the telephone.” When the situation is hopeless, “we explain the data.” Twice in the past 6 months, patients have opted to spend their last hours at home with their families, Dr. Garland said at the Society for Vascular Surgery’s annual meeting.

To develop their system, the investigators culled through 37,000 variables from 303 ruptured AAA patients treated at Harborview from 2002-2013. Fifteen patients died in the emergency department, en route to surgery, or after choosing comfort care. Overall, 30-day mortality was 54% for open repair and 22% for EVAR.

On multivariate analysis, the team isolated the four preoperative variables most predictive of death. Preoperative creatinine greater than 2 mg/dL almost quadrupled the risk (odds ratio 3.7; P < .001); systolic blood pressure less than 70 mm Hg nearly tripled it (OR 2.7; P = .002); and pH less than 7.2 (OR 2.6; P = .009) and age greater than 76 years (OR 2.1; P = .011) more than doubled it.

The investigators then checked their results against the Vascular Study Group of New England Cardiac Index, Glasgow Aneurysm Score, and Edinburgh Ruptured Aneurysm Score. “Our preoperative risk score was most predictive of death, with an area under the curve of 0.76,” Dr. Garland said.

There was no outside funding for the work and Dr. Garland has no disclosures.

aotto@frontlinemedcom.com

CHICAGO – Age greater than 76 years, plus preoperative creatinine greater than 2 mg/dL, blood pH less than 7.2, and systolic pressure at any point below 70 mm Hg collectively predicted 100% mortality with open or endovascular repair of ruptured abdominal aortic aneurysms, according to a new mortality risk score from Harborview Medical Center in Seattle.

Meeting all four criteria gives the maximum score of 4. Any one of the factors alone – a score of 1 – predicted 30% mortality with open repair and 9% with endovascular aneurysm repair (EVAR); a 2 predicted 80% mortality with open repair and 37% with EVAR; and a 3 predicted 82% mortality with open repair and 70% with EVAR.

Vascular surgeons at Harborview developed the system so they’d know whether to recommend transport or comfort care for ruptured abdominal aortic aneurysms (AAAs). The Level 1 trauma center serves more than a quarter of the U.S. landmass, and handles about 30-40 ruptured AAA’s annually. It’s not uncommon for patients to be flown in from Alaska.

Existing risk scores haven’t been validated for EVAR or rely on intraoperative variables, so they aren’t much help when counseling patients and referring physicians on what to do.

“Our ruptured AAA mortality risk score is based on four variables readily assessed preoperatively, allows accurate prediction of in-hospital mortality after repair of ruptured AAAs in the EVAR-first era, and does so better than any score thus published. It’s clinically relevant to the decision to transport and helps guide difficult discussions with patients and their families,” said investigator Dr. Ty Garland, chief vascular surgery resident at the University of Washington, Seattle.

When using the new risk score. “we don’t ever block transfer, but we have discussions with referring providers and in several cases with patients and their families over the telephone.” When the situation is hopeless, “we explain the data.” Twice in the past 6 months, patients have opted to spend their last hours at home with their families, Dr. Garland said at the Society for Vascular Surgery’s annual meeting.

To develop their system, the investigators culled through 37,000 variables from 303 ruptured AAA patients treated at Harborview from 2002-2013. Fifteen patients died in the emergency department, en route to surgery, or after choosing comfort care. Overall, 30-day mortality was 54% for open repair and 22% for EVAR.

On multivariate analysis, the team isolated the four preoperative variables most predictive of death. Preoperative creatinine greater than 2 mg/dL almost quadrupled the risk (odds ratio 3.7; P < .001); systolic blood pressure less than 70 mm Hg nearly tripled it (OR 2.7; P = .002); and pH less than 7.2 (OR 2.6; P = .009) and age greater than 76 years (OR 2.1; P = .011) more than doubled it.

The investigators then checked their results against the Vascular Study Group of New England Cardiac Index, Glasgow Aneurysm Score, and Edinburgh Ruptured Aneurysm Score. “Our preoperative risk score was most predictive of death, with an area under the curve of 0.76,” Dr. Garland said.

There was no outside funding for the work and Dr. Garland has no disclosures.

aotto@frontlinemedcom.com

CHICAGO – Age greater than 76 years, plus preoperative creatinine greater than 2 mg/dL, blood pH less than 7.2, and systolic pressure at any point below 70 mm Hg collectively predicted 100% mortality with open or endovascular repair of ruptured abdominal aortic aneurysms, according to a new mortality risk score from Harborview Medical Center in Seattle.

Meeting all four criteria gives the maximum score of 4. Any one of the factors alone – a score of 1 – predicted 30% mortality with open repair and 9% with endovascular aneurysm repair (EVAR); a 2 predicted 80% mortality with open repair and 37% with EVAR; and a 3 predicted 82% mortality with open repair and 70% with EVAR.

Vascular surgeons at Harborview developed the system so they’d know whether to recommend transport or comfort care for ruptured abdominal aortic aneurysms (AAAs). The Level 1 trauma center serves more than a quarter of the U.S. landmass, and handles about 30-40 ruptured AAA’s annually. It’s not uncommon for patients to be flown in from Alaska.

Existing risk scores haven’t been validated for EVAR or rely on intraoperative variables, so they aren’t much help when counseling patients and referring physicians on what to do.

“Our ruptured AAA mortality risk score is based on four variables readily assessed preoperatively, allows accurate prediction of in-hospital mortality after repair of ruptured AAAs in the EVAR-first era, and does so better than any score thus published. It’s clinically relevant to the decision to transport and helps guide difficult discussions with patients and their families,” said investigator Dr. Ty Garland, chief vascular surgery resident at the University of Washington, Seattle.

When using the new risk score. “we don’t ever block transfer, but we have discussions with referring providers and in several cases with patients and their families over the telephone.” When the situation is hopeless, “we explain the data.” Twice in the past 6 months, patients have opted to spend their last hours at home with their families, Dr. Garland said at the Society for Vascular Surgery’s annual meeting.

To develop their system, the investigators culled through 37,000 variables from 303 ruptured AAA patients treated at Harborview from 2002-2013. Fifteen patients died in the emergency department, en route to surgery, or after choosing comfort care. Overall, 30-day mortality was 54% for open repair and 22% for EVAR.

On multivariate analysis, the team isolated the four preoperative variables most predictive of death. Preoperative creatinine greater than 2 mg/dL almost quadrupled the risk (odds ratio 3.7; P < .001); systolic blood pressure less than 70 mm Hg nearly tripled it (OR 2.7; P = .002); and pH less than 7.2 (OR 2.6; P = .009) and age greater than 76 years (OR 2.1; P = .011) more than doubled it.

The investigators then checked their results against the Vascular Study Group of New England Cardiac Index, Glasgow Aneurysm Score, and Edinburgh Ruptured Aneurysm Score. “Our preoperative risk score was most predictive of death, with an area under the curve of 0.76,” Dr. Garland said.

There was no outside funding for the work and Dr. Garland has no disclosures.

aotto@frontlinemedcom.com