ACS Surgery News

BOSTON – An analysis of data from medullary thyroid cancer patients that partitioned the patients into groups with similar overall survival has spurred a rethink of the current American Joint Committee on Cancer (AJCC) staging system.

The results from researchers at Duke University, Durham, N.C., presented at the annual meeting of the Endocrine Society by Dr. Mohamed Abdelgadir Adam, are timely, as the AJCC has embarked on a reconsideration of the staging of cancers, including medullary thyroid cancer (MTC), as part revisions for the eighth edition of the staging system.

“The existing AJCC staging system for MTC appears to be less than optimal in discriminating the risk of mortality among disease stage groups,” said Dr. Adam, who discussed the findings in a video interview.

MTC, a neuroendocrine tumor that affects C cells of the thyroid, comprises 3%-5% of all cases of thyroid cancer and it can be a more aggressive disease than differentiated thyroid cancer. Yet the current AJCC MTC staging system has been extrapolated from differentiated thyroid cancer data.

“We sought to evaluate how well the current AJCC seventh edition stage groupings predict survival for patients with MTC, to suggest a possible staging revision to sharpen estimates of prognosis,” said Dr. Adam.

The researchers utilized the National Cancer Data Base, representing over 70% of incident cancer cases in the United States.

MTC patients who underwent thyroid surgery from 1998 to 2012 were identified. Patients with missing values for pathologic T, N, or M were excluded. The primary outcome in the 3,315 patients was survival.

The researchers used a form of decision-tree analysis called recursive partitioning. In general, recursive partitioning is able to classify a population by splitting subjects into subgroups, each of which is homogeneous based on the particular outcome. In this study, the subgroup allocations were based on T, N, and M stages, with the outcome being overall survival. Kaplan-Meier and adjusted survival analyses enabled survival differences among the four subgroups (groups I, II, III and IV) to be explored.

The four groups were distinct in terms of survival time and allowed more accurate risk stratification. In particular, groups I and II were markedly better distinguished from one another than is the case with the current staging system. Survival differences across the stages were more distinct with the newly created T, N, and M groupings, compared with the current AJCC staging system.

After adjustment, survival differences across TNM groups were more distinct with the newly created TNM groupings (compared to subgroup I, hazard ratio of 3.06 for subgroup II; HR, 6.79 for III; and HR, 17.03 for IV), compared with the current AJCC staging (compared to stage I, HR, 1.45 for stage II; HR, 2.17 for III; and HR, 5.33 for IV).

“The AJCC is reevaluating all staging schemas, including MTC. The current AJCC staging system could be improved with the newly identified TNM groupings suggested here for more accurate patient risk stratification and possibly treatment selection,” said Dr. Adam.

Dr. Adam had no disclosures.

BOSTON – An analysis of data from medullary thyroid cancer patients that partitioned the patients into groups with similar overall survival has spurred a rethink of the current American Joint Committee on Cancer (AJCC) staging system.

The results from researchers at Duke University, Durham, N.C., presented at the annual meeting of the Endocrine Society by Dr. Mohamed Abdelgadir Adam, are timely, as the AJCC has embarked on a reconsideration of the staging of cancers, including medullary thyroid cancer (MTC), as part revisions for the eighth edition of the staging system.

“The existing AJCC staging system for MTC appears to be less than optimal in discriminating the risk of mortality among disease stage groups,” said Dr. Adam, who discussed the findings in a video interview.

MTC, a neuroendocrine tumor that affects C cells of the thyroid, comprises 3%-5% of all cases of thyroid cancer and it can be a more aggressive disease than differentiated thyroid cancer. Yet the current AJCC MTC staging system has been extrapolated from differentiated thyroid cancer data.

“We sought to evaluate how well the current AJCC seventh edition stage groupings predict survival for patients with MTC, to suggest a possible staging revision to sharpen estimates of prognosis,” said Dr. Adam.

The researchers utilized the National Cancer Data Base, representing over 70% of incident cancer cases in the United States.

MTC patients who underwent thyroid surgery from 1998 to 2012 were identified. Patients with missing values for pathologic T, N, or M were excluded. The primary outcome in the 3,315 patients was survival.

The researchers used a form of decision-tree analysis called recursive partitioning. In general, recursive partitioning is able to classify a population by splitting subjects into subgroups, each of which is homogeneous based on the particular outcome. In this study, the subgroup allocations were based on T, N, and M stages, with the outcome being overall survival. Kaplan-Meier and adjusted survival analyses enabled survival differences among the four subgroups (groups I, II, III and IV) to be explored.

The four groups were distinct in terms of survival time and allowed more accurate risk stratification. In particular, groups I and II were markedly better distinguished from one another than is the case with the current staging system. Survival differences across the stages were more distinct with the newly created T, N, and M groupings, compared with the current AJCC staging system.

After adjustment, survival differences across TNM groups were more distinct with the newly created TNM groupings (compared to subgroup I, hazard ratio of 3.06 for subgroup II; HR, 6.79 for III; and HR, 17.03 for IV), compared with the current AJCC staging (compared to stage I, HR, 1.45 for stage II; HR, 2.17 for III; and HR, 5.33 for IV).

“The AJCC is reevaluating all staging schemas, including MTC. The current AJCC staging system could be improved with the newly identified TNM groupings suggested here for more accurate patient risk stratification and possibly treatment selection,” said Dr. Adam.

Dr. Adam had no disclosures.

BOSTON – An analysis of data from medullary thyroid cancer patients that partitioned the patients into groups with similar overall survival has spurred a rethink of the current American Joint Committee on Cancer (AJCC) staging system.

The results from researchers at Duke University, Durham, N.C., presented at the annual meeting of the Endocrine Society by Dr. Mohamed Abdelgadir Adam, are timely, as the AJCC has embarked on a reconsideration of the staging of cancers, including medullary thyroid cancer (MTC), as part revisions for the eighth edition of the staging system.

“The existing AJCC staging system for MTC appears to be less than optimal in discriminating the risk of mortality among disease stage groups,” said Dr. Adam, who discussed the findings in a video interview.

MTC, a neuroendocrine tumor that affects C cells of the thyroid, comprises 3%-5% of all cases of thyroid cancer and it can be a more aggressive disease than differentiated thyroid cancer. Yet the current AJCC MTC staging system has been extrapolated from differentiated thyroid cancer data.

“We sought to evaluate how well the current AJCC seventh edition stage groupings predict survival for patients with MTC, to suggest a possible staging revision to sharpen estimates of prognosis,” said Dr. Adam.

The researchers utilized the National Cancer Data Base, representing over 70% of incident cancer cases in the United States.

MTC patients who underwent thyroid surgery from 1998 to 2012 were identified. Patients with missing values for pathologic T, N, or M were excluded. The primary outcome in the 3,315 patients was survival.

The researchers used a form of decision-tree analysis called recursive partitioning. In general, recursive partitioning is able to classify a population by splitting subjects into subgroups, each of which is homogeneous based on the particular outcome. In this study, the subgroup allocations were based on T, N, and M stages, with the outcome being overall survival. Kaplan-Meier and adjusted survival analyses enabled survival differences among the four subgroups (groups I, II, III and IV) to be explored.

The four groups were distinct in terms of survival time and allowed more accurate risk stratification. In particular, groups I and II were markedly better distinguished from one another than is the case with the current staging system. Survival differences across the stages were more distinct with the newly created T, N, and M groupings, compared with the current AJCC staging system.

After adjustment, survival differences across TNM groups were more distinct with the newly created TNM groupings (compared to subgroup I, hazard ratio of 3.06 for subgroup II; HR, 6.79 for III; and HR, 17.03 for IV), compared with the current AJCC staging (compared to stage I, HR, 1.45 for stage II; HR, 2.17 for III; and HR, 5.33 for IV).

“The AJCC is reevaluating all staging schemas, including MTC. The current AJCC staging system could be improved with the newly identified TNM groupings suggested here for more accurate patient risk stratification and possibly treatment selection,” said Dr. Adam.

Dr. Adam had no disclosures.

AMSTERDAM – Accounting for less than 1% of cases, Propionibacterium acnes has been considered an uncommon cause of infective endocarditis.

But data presented at the annual congress of the European Society of Clinical Microbiology and Infectious Diseases suggest that the common anaerobe may be responsible for many more cases than is now believed. The bacteria are difficult to culture and grow very slowly, Dr. Jona Banzon said at the meeting. Incubating it for the standard 5 days may simply not be long enough.

“Due to this slow-growing nature, the standard incubation period may not be enough to detect it,” said Dr. Banzon, an infectious disease fellow at the Cleveland Clinic. “And since P. acnes is part of our commensal flora, it’s frequently a contaminate in culture, and we might be inappropriately dismissing it as such. In fact, we now wonder if this lack of extended incubation may be accounting for a significant proportion of negative blood cultures, and whether more prosthetic valve endocarditis than we think is actually being caused by P. acnes.”

Dr. Banzon presented a series of 23 cases included in the Cleveland Clinic Infective Endocarditis Registry from the period of 2007-2015. All had P. acnes confirmed as the causative organism. The group comprises 3.3% of the institution’s entire infective endocarditis registry, “making infective carditis with P. acnes already much more common than it is said to be in the literature,” she noted.

All of the cases were confirmed by any of the following standards:

• Two or more blood cultures positive for P. acnes.

• Two or more valve cultures positive for P. acnes.

• Two or more valve sequencing rests positive for P. acnes.

• At least two of the following: a positive blood culture, a positive valve culture or valve sequencing, or histopathologic demonstration of microorganism consistent with P. acnes.

Of the cohort, 22 had prosthetic valve endocarditis. One patient had endocarditis on a native valve. This is an important point, Dr. Banzon said.

The organism is being increasingly recognized for causing infections of prosthetic material, including shoulder joint infections and shunts, but it rarely seems to affect native tissue. The patient who had native valve endocarditis had experienced an episode of Staphylococcus aureus endocarditis about 18 months earlier. He was not treated surgically, and ended up with a damaged valve. After the initial illness, he was readmitted several times with symptoms of endocarditis, but all of his blood cultures were negative. This was attributed to the receipt of antibiotics. “When he was finally operated on, there were three valve sequencing specimens and all were positive for P. acnes,” Dr. Banzon said.

The patients in the cohort were a mean of 74 years old; about 75% were men. All of the cases were left-sided endocarditis, with the majority (74%) involving the aortic valve. Other sites included the mitral valve (18%), aortic plus mitral (4%), and aortic plus tricuspid (4%).

The most common predisposing factor was having a prosthetic valve (96%). Other factors included having a cardiac implantable device (17%), and a prior episode of infective endocarditis (13%). None of the patients had indwelling vascular catheters or used injectable drugs.

The cases presented with severe disease, Dr. Banzon said. Almost half (48%) had a perivalvular abscess at presentation. A third (35%) had valve dehiscence, and 35% had severe valvular regurgitation. There was a vegetation of more than 1 cm in 9% of cases.

Emboli were not uncommon; 17% had emboli in the central nervous system, and 17% had peripheral emboli. Two of these patients had kidney and spleen infarcts and two had acute arterial thromboembolism that required thrombectomy.

All of the patients underwent blood cultures; overall, 30% of the cultures were positive for P. acnes. But there were “striking differences” when the tests were broken down by incubation time, Dr. Banzon said.

Most of the cultures (16) were incubated for the standard of 5 days or less. Among these, 12.5% were positive. However, cultures on seven patients were incubated for more than 5 days and in this group, 71.4% were positive for P. acnes. The median time to positivity overall was 7 days, with a range of 3-9 days.

Other diagnostic methods were important in closing this gap, she said. Valve culturing was positive in 57% of the cases, while valve sequencing was positive in 95%. The median time to positive for valve culture was somewhat shorter than for blood culture (5.5 days).

In nine cases, no organism would have been identified without valve sequencing, Dr. Banzon said.

Because they presented with severe disease, almost all of the patients (22) underwent surgery as their intimal treatment. At the time of surgery, everyone was taking an antibiotic that covered P. acnes. Single-agent therapy was the definitive treatment for most, with vancomycin being most commonly employed (59%), followed by ceftriaxone (25%). A few patients had a combination of both drugs or a combination of vancomycin and rifampin. One patient took penicillin.

The single patient who was medically treated received 6 weeks of intravenous ceftriaxone. After 1 month, he was readmitted with blood cultures positive for P. acnes. He underwent surgery and a valve sequencing confirmed P. acnes as the infective agent.

There were two in-hospital deaths, but the rest of the patients were discharged on antibiotic therapy and recovered with no additional deaths or relapses.

The extended time P. acnes required to show in culture was enough for the Cleveland Clinic to reconsider incubation guidelines for the microorganism, Dr. Banzon said.

“There are enough cases taking 9 or 10 days that we now always hold these cultures for at least 10 days when we’re looking for P. acnes.”

She had no financial disclosures.

[email protected]

AMSTERDAM – Accounting for less than 1% of cases, Propionibacterium acnes has been considered an uncommon cause of infective endocarditis.

But data presented at the annual congress of the European Society of Clinical Microbiology and Infectious Diseases suggest that the common anaerobe may be responsible for many more cases than is now believed. The bacteria are difficult to culture and grow very slowly, Dr. Jona Banzon said at the meeting. Incubating it for the standard 5 days may simply not be long enough.

“Due to this slow-growing nature, the standard incubation period may not be enough to detect it,” said Dr. Banzon, an infectious disease fellow at the Cleveland Clinic. “And since P. acnes is part of our commensal flora, it’s frequently a contaminate in culture, and we might be inappropriately dismissing it as such. In fact, we now wonder if this lack of extended incubation may be accounting for a significant proportion of negative blood cultures, and whether more prosthetic valve endocarditis than we think is actually being caused by P. acnes.”

Dr. Banzon presented a series of 23 cases included in the Cleveland Clinic Infective Endocarditis Registry from the period of 2007-2015. All had P. acnes confirmed as the causative organism. The group comprises 3.3% of the institution’s entire infective endocarditis registry, “making infective carditis with P. acnes already much more common than it is said to be in the literature,” she noted.

All of the cases were confirmed by any of the following standards:

• Two or more blood cultures positive for P. acnes.

• Two or more valve cultures positive for P. acnes.

• Two or more valve sequencing rests positive for P. acnes.

• At least two of the following: a positive blood culture, a positive valve culture or valve sequencing, or histopathologic demonstration of microorganism consistent with P. acnes.

Of the cohort, 22 had prosthetic valve endocarditis. One patient had endocarditis on a native valve. This is an important point, Dr. Banzon said.

The organism is being increasingly recognized for causing infections of prosthetic material, including shoulder joint infections and shunts, but it rarely seems to affect native tissue. The patient who had native valve endocarditis had experienced an episode of Staphylococcus aureus endocarditis about 18 months earlier. He was not treated surgically, and ended up with a damaged valve. After the initial illness, he was readmitted several times with symptoms of endocarditis, but all of his blood cultures were negative. This was attributed to the receipt of antibiotics. “When he was finally operated on, there were three valve sequencing specimens and all were positive for P. acnes,” Dr. Banzon said.

The patients in the cohort were a mean of 74 years old; about 75% were men. All of the cases were left-sided endocarditis, with the majority (74%) involving the aortic valve. Other sites included the mitral valve (18%), aortic plus mitral (4%), and aortic plus tricuspid (4%).

The most common predisposing factor was having a prosthetic valve (96%). Other factors included having a cardiac implantable device (17%), and a prior episode of infective endocarditis (13%). None of the patients had indwelling vascular catheters or used injectable drugs.

The cases presented with severe disease, Dr. Banzon said. Almost half (48%) had a perivalvular abscess at presentation. A third (35%) had valve dehiscence, and 35% had severe valvular regurgitation. There was a vegetation of more than 1 cm in 9% of cases.

Emboli were not uncommon; 17% had emboli in the central nervous system, and 17% had peripheral emboli. Two of these patients had kidney and spleen infarcts and two had acute arterial thromboembolism that required thrombectomy.

All of the patients underwent blood cultures; overall, 30% of the cultures were positive for P. acnes. But there were “striking differences” when the tests were broken down by incubation time, Dr. Banzon said.

Most of the cultures (16) were incubated for the standard of 5 days or less. Among these, 12.5% were positive. However, cultures on seven patients were incubated for more than 5 days and in this group, 71.4% were positive for P. acnes. The median time to positivity overall was 7 days, with a range of 3-9 days.

Other diagnostic methods were important in closing this gap, she said. Valve culturing was positive in 57% of the cases, while valve sequencing was positive in 95%. The median time to positive for valve culture was somewhat shorter than for blood culture (5.5 days).

In nine cases, no organism would have been identified without valve sequencing, Dr. Banzon said.

Because they presented with severe disease, almost all of the patients (22) underwent surgery as their intimal treatment. At the time of surgery, everyone was taking an antibiotic that covered P. acnes. Single-agent therapy was the definitive treatment for most, with vancomycin being most commonly employed (59%), followed by ceftriaxone (25%). A few patients had a combination of both drugs or a combination of vancomycin and rifampin. One patient took penicillin.

The single patient who was medically treated received 6 weeks of intravenous ceftriaxone. After 1 month, he was readmitted with blood cultures positive for P. acnes. He underwent surgery and a valve sequencing confirmed P. acnes as the infective agent.

There were two in-hospital deaths, but the rest of the patients were discharged on antibiotic therapy and recovered with no additional deaths or relapses.

The extended time P. acnes required to show in culture was enough for the Cleveland Clinic to reconsider incubation guidelines for the microorganism, Dr. Banzon said.

“There are enough cases taking 9 or 10 days that we now always hold these cultures for at least 10 days when we’re looking for P. acnes.”

She had no financial disclosures.

[email protected]

AMSTERDAM – Accounting for less than 1% of cases, Propionibacterium acnes has been considered an uncommon cause of infective endocarditis.

But data presented at the annual congress of the European Society of Clinical Microbiology and Infectious Diseases suggest that the common anaerobe may be responsible for many more cases than is now believed. The bacteria are difficult to culture and grow very slowly, Dr. Jona Banzon said at the meeting. Incubating it for the standard 5 days may simply not be long enough.

“Due to this slow-growing nature, the standard incubation period may not be enough to detect it,” said Dr. Banzon, an infectious disease fellow at the Cleveland Clinic. “And since P. acnes is part of our commensal flora, it’s frequently a contaminate in culture, and we might be inappropriately dismissing it as such. In fact, we now wonder if this lack of extended incubation may be accounting for a significant proportion of negative blood cultures, and whether more prosthetic valve endocarditis than we think is actually being caused by P. acnes.”

Dr. Banzon presented a series of 23 cases included in the Cleveland Clinic Infective Endocarditis Registry from the period of 2007-2015. All had P. acnes confirmed as the causative organism. The group comprises 3.3% of the institution’s entire infective endocarditis registry, “making infective carditis with P. acnes already much more common than it is said to be in the literature,” she noted.

All of the cases were confirmed by any of the following standards:

• Two or more blood cultures positive for P. acnes.

• Two or more valve cultures positive for P. acnes.

• Two or more valve sequencing rests positive for P. acnes.

• At least two of the following: a positive blood culture, a positive valve culture or valve sequencing, or histopathologic demonstration of microorganism consistent with P. acnes.

Of the cohort, 22 had prosthetic valve endocarditis. One patient had endocarditis on a native valve. This is an important point, Dr. Banzon said.

The organism is being increasingly recognized for causing infections of prosthetic material, including shoulder joint infections and shunts, but it rarely seems to affect native tissue. The patient who had native valve endocarditis had experienced an episode of Staphylococcus aureus endocarditis about 18 months earlier. He was not treated surgically, and ended up with a damaged valve. After the initial illness, he was readmitted several times with symptoms of endocarditis, but all of his blood cultures were negative. This was attributed to the receipt of antibiotics. “When he was finally operated on, there were three valve sequencing specimens and all were positive for P. acnes,” Dr. Banzon said.

The patients in the cohort were a mean of 74 years old; about 75% were men. All of the cases were left-sided endocarditis, with the majority (74%) involving the aortic valve. Other sites included the mitral valve (18%), aortic plus mitral (4%), and aortic plus tricuspid (4%).

The most common predisposing factor was having a prosthetic valve (96%). Other factors included having a cardiac implantable device (17%), and a prior episode of infective endocarditis (13%). None of the patients had indwelling vascular catheters or used injectable drugs.

The cases presented with severe disease, Dr. Banzon said. Almost half (48%) had a perivalvular abscess at presentation. A third (35%) had valve dehiscence, and 35% had severe valvular regurgitation. There was a vegetation of more than 1 cm in 9% of cases.

Emboli were not uncommon; 17% had emboli in the central nervous system, and 17% had peripheral emboli. Two of these patients had kidney and spleen infarcts and two had acute arterial thromboembolism that required thrombectomy.

All of the patients underwent blood cultures; overall, 30% of the cultures were positive for P. acnes. But there were “striking differences” when the tests were broken down by incubation time, Dr. Banzon said.

Most of the cultures (16) were incubated for the standard of 5 days or less. Among these, 12.5% were positive. However, cultures on seven patients were incubated for more than 5 days and in this group, 71.4% were positive for P. acnes. The median time to positivity overall was 7 days, with a range of 3-9 days.

Other diagnostic methods were important in closing this gap, she said. Valve culturing was positive in 57% of the cases, while valve sequencing was positive in 95%. The median time to positive for valve culture was somewhat shorter than for blood culture (5.5 days).

In nine cases, no organism would have been identified without valve sequencing, Dr. Banzon said.

Because they presented with severe disease, almost all of the patients (22) underwent surgery as their intimal treatment. At the time of surgery, everyone was taking an antibiotic that covered P. acnes. Single-agent therapy was the definitive treatment for most, with vancomycin being most commonly employed (59%), followed by ceftriaxone (25%). A few patients had a combination of both drugs or a combination of vancomycin and rifampin. One patient took penicillin.

The single patient who was medically treated received 6 weeks of intravenous ceftriaxone. After 1 month, he was readmitted with blood cultures positive for P. acnes. He underwent surgery and a valve sequencing confirmed P. acnes as the infective agent.

There were two in-hospital deaths, but the rest of the patients were discharged on antibiotic therapy and recovered with no additional deaths or relapses.

The extended time P. acnes required to show in culture was enough for the Cleveland Clinic to reconsider incubation guidelines for the microorganism, Dr. Banzon said.

“There are enough cases taking 9 or 10 days that we now always hold these cultures for at least 10 days when we’re looking for P. acnes.”

She had no financial disclosures.

[email protected]

CHICAGO – Current U.S. and European guidelines recommending postponement of noncardiac surgery for 6-12 months after drug-eluting stent implantation appear to be excessive, Dr. Gro Egholm reported at the annual meeting of the American College of Cardiology.

She presented a large retrospective observational study of outcomes in patients undergoing various types of noncardiac surgery in western Denmark during 2005-2012. Among 4,303 patients who had noncardiac surgery within 12 months after receiving a drug-eluting stent (DES), only those whose operations took place during the first month post stenting had increased risks of acute MI and cardiac death within 30 days post surgery.

Bruce Jancin/Frontline Medical News

Risks of major adverse cardiac events among the DES recipients who had noncardiac surgery within that first month post–percutaneous coronary intervention were increased roughly 7.5-fold compared with controls, but for surgery performed after that the risks of MI and cardiac death dropped off abruptly and were no different from rates in 20,232 controls without ischemic heart disease or stents who were matched for age, gender, surgical procedure, and Charlson Comorbidity Index, according to Dr. Egholm of Aarhus (Denmark) University.

Moreover, even in DES recipients undergoing noncardiac surgery during the first month post stenting, all-cause mortality was no greater than in controls.

“Surgery could be performed much earlier than recommended,” she concluded.

Her study was carried out by linking data from comprehensive regional and national Danish health care registries. Most patients with DES remained on dual antiplatelet therapy periprocedurally. The exceptions were neurosurgical operations and others where it’s standard that dual antiplatelet therapy must be stopped.

“If you can continue only one antiplatelet agent, aspirin would be the most appealing,” she said.

Of the DES participants, 56% received their device as treatment for an acute coronary syndrome. The average time from stent placement to noncardiac surgery in this large series was 147 days.

Session co-chair Dr. Sunil V. Rao of Duke University in Durham, N.C., called this work “a very important study that’s relevant to daily practice.” However, he found the 23% incidence of noncardiac surgery within 12 months following DES implantation reported in Dr. Egholm’s study to be “shockingly high.” She agreed, noting that rates in some non-Danish registries she’s looked at are more in the 8%-15% range. But Denmark’s health care registries are known for rigorous accuracy and completeness.

Dr. Egholm reported having no financial conflicts regarding her study.

[email protected]

CHICAGO – Current U.S. and European guidelines recommending postponement of noncardiac surgery for 6-12 months after drug-eluting stent implantation appear to be excessive, Dr. Gro Egholm reported at the annual meeting of the American College of Cardiology.

She presented a large retrospective observational study of outcomes in patients undergoing various types of noncardiac surgery in western Denmark during 2005-2012. Among 4,303 patients who had noncardiac surgery within 12 months after receiving a drug-eluting stent (DES), only those whose operations took place during the first month post stenting had increased risks of acute MI and cardiac death within 30 days post surgery.

Bruce Jancin/Frontline Medical News

Risks of major adverse cardiac events among the DES recipients who had noncardiac surgery within that first month post–percutaneous coronary intervention were increased roughly 7.5-fold compared with controls, but for surgery performed after that the risks of MI and cardiac death dropped off abruptly and were no different from rates in 20,232 controls without ischemic heart disease or stents who were matched for age, gender, surgical procedure, and Charlson Comorbidity Index, according to Dr. Egholm of Aarhus (Denmark) University.

Moreover, even in DES recipients undergoing noncardiac surgery during the first month post stenting, all-cause mortality was no greater than in controls.

“Surgery could be performed much earlier than recommended,” she concluded.

Her study was carried out by linking data from comprehensive regional and national Danish health care registries. Most patients with DES remained on dual antiplatelet therapy periprocedurally. The exceptions were neurosurgical operations and others where it’s standard that dual antiplatelet therapy must be stopped.

“If you can continue only one antiplatelet agent, aspirin would be the most appealing,” she said.

Of the DES participants, 56% received their device as treatment for an acute coronary syndrome. The average time from stent placement to noncardiac surgery in this large series was 147 days.

Session co-chair Dr. Sunil V. Rao of Duke University in Durham, N.C., called this work “a very important study that’s relevant to daily practice.” However, he found the 23% incidence of noncardiac surgery within 12 months following DES implantation reported in Dr. Egholm’s study to be “shockingly high.” She agreed, noting that rates in some non-Danish registries she’s looked at are more in the 8%-15% range. But Denmark’s health care registries are known for rigorous accuracy and completeness.

Dr. Egholm reported having no financial conflicts regarding her study.

[email protected]

CHICAGO – Current U.S. and European guidelines recommending postponement of noncardiac surgery for 6-12 months after drug-eluting stent implantation appear to be excessive, Dr. Gro Egholm reported at the annual meeting of the American College of Cardiology.

She presented a large retrospective observational study of outcomes in patients undergoing various types of noncardiac surgery in western Denmark during 2005-2012. Among 4,303 patients who had noncardiac surgery within 12 months after receiving a drug-eluting stent (DES), only those whose operations took place during the first month post stenting had increased risks of acute MI and cardiac death within 30 days post surgery.

Bruce Jancin/Frontline Medical News

Risks of major adverse cardiac events among the DES recipients who had noncardiac surgery within that first month post–percutaneous coronary intervention were increased roughly 7.5-fold compared with controls, but for surgery performed after that the risks of MI and cardiac death dropped off abruptly and were no different from rates in 20,232 controls without ischemic heart disease or stents who were matched for age, gender, surgical procedure, and Charlson Comorbidity Index, according to Dr. Egholm of Aarhus (Denmark) University.

Moreover, even in DES recipients undergoing noncardiac surgery during the first month post stenting, all-cause mortality was no greater than in controls.

“Surgery could be performed much earlier than recommended,” she concluded.

Her study was carried out by linking data from comprehensive regional and national Danish health care registries. Most patients with DES remained on dual antiplatelet therapy periprocedurally. The exceptions were neurosurgical operations and others where it’s standard that dual antiplatelet therapy must be stopped.

“If you can continue only one antiplatelet agent, aspirin would be the most appealing,” she said.

Of the DES participants, 56% received their device as treatment for an acute coronary syndrome. The average time from stent placement to noncardiac surgery in this large series was 147 days.

Session co-chair Dr. Sunil V. Rao of Duke University in Durham, N.C., called this work “a very important study that’s relevant to daily practice.” However, he found the 23% incidence of noncardiac surgery within 12 months following DES implantation reported in Dr. Egholm’s study to be “shockingly high.” She agreed, noting that rates in some non-Danish registries she’s looked at are more in the 8%-15% range. But Denmark’s health care registries are known for rigorous accuracy and completeness.

Dr. Egholm reported having no financial conflicts regarding her study.

[email protected]

Men on androgen deprivation therapy for prostate cancer are at significantly increased risk for depression, a risk that increases with duration of therapy, investigators report.

A review of Surveillance, Epidemiology, and End Results (SEER) Medicare data on nearly 79,000 men older than 65 years with a diagnosis of prostate cancer showed that those who received androgen deprivation therapy (ADT) had a 23% increased risk for depression, compared with men who were not on ADT, reported Kathryn T. Dinh of Harvard Medical School, Boston, and her colleagues.

“We observed a significantly increased risk of depression and inpatient psychiatric treatment in men treated with ADT for prostate cancer, as well as a duration-response effect such that more ADT was linked to an increasing risk of depression and inpatient and outpatient psychiatric treatment. The possible psychiatric effects of ADT should be recognized by physicians and discussed with patients before initiating treatment,” they wrote (J Clin Oncol. 2016 Apr 11. doi: 10.1200/JCO.2015.64.1969).

Although ADT has been identified in some studies as a risk factor for clinical depression, evidence for such a relationship has been spotty, the investigators said, prompting them to conduct a population-based retrospective study to get a better handle on the issue.

They reviewed SEER Medicare data on 78,552 men older than 65 years with a diagnosis of stage I-III prostate cancer treated with ADT from 1992 through 2006, excluding from the sample those patients who had a psychiatric diagnosis within the past 12 months.

Ms. Dinh and her associates found that the 33,882 patients (43%) who received ADT had a significantly higher 3-year cumulative incidence of depression than patients who did not have ADT (7.1% vs. 5.2%, P less than .001), and a significantly higher proportion had either inpatient psychiatric treatment (2.8% vs. 1.9%, P less than .001) or outpatient psychiatric therapy (3.4% vs. 2.5%, P less than .001).

In proportional hazard models controlling for demographic and clinical factors, receipt of ADT was associated with adjusted hazard ratios of 1.23 for depression and 1.29 (P less than .001 for both) for inpatient psychiatric treatment. There was no significant increase in risk for outpatient psychiatric treatment in this analysis, however.

In addition, the longer patients that were on ADT, the greater the risk for depression. The risk of depression was 12% for patients treated for 6 months or less, 26% for those on ADT for 7-11 months, and 37% for those on ADT for at least 1 year.

“The impact of ADT on depression may plausibly occur via deregulation of neurochemicals, such as serotonin, in addition to the well-described physical effects,” Ms. Dinh and her associates wrote.

Side effects of ADT that can impair quality of life also may contribute to clinical depression, they noted.

The study was supported by charitable grants and internal institutional sources. One investigator reported consulting or advisory roles with Medivation, GenomeDx, and Ferring. Three of the other ten coauthors also reported financial disclosures.

Men on androgen deprivation therapy for prostate cancer are at significantly increased risk for depression, a risk that increases with duration of therapy, investigators report.

A review of Surveillance, Epidemiology, and End Results (SEER) Medicare data on nearly 79,000 men older than 65 years with a diagnosis of prostate cancer showed that those who received androgen deprivation therapy (ADT) had a 23% increased risk for depression, compared with men who were not on ADT, reported Kathryn T. Dinh of Harvard Medical School, Boston, and her colleagues.

“We observed a significantly increased risk of depression and inpatient psychiatric treatment in men treated with ADT for prostate cancer, as well as a duration-response effect such that more ADT was linked to an increasing risk of depression and inpatient and outpatient psychiatric treatment. The possible psychiatric effects of ADT should be recognized by physicians and discussed with patients before initiating treatment,” they wrote (J Clin Oncol. 2016 Apr 11. doi: 10.1200/JCO.2015.64.1969).

Although ADT has been identified in some studies as a risk factor for clinical depression, evidence for such a relationship has been spotty, the investigators said, prompting them to conduct a population-based retrospective study to get a better handle on the issue.

They reviewed SEER Medicare data on 78,552 men older than 65 years with a diagnosis of stage I-III prostate cancer treated with ADT from 1992 through 2006, excluding from the sample those patients who had a psychiatric diagnosis within the past 12 months.

Ms. Dinh and her associates found that the 33,882 patients (43%) who received ADT had a significantly higher 3-year cumulative incidence of depression than patients who did not have ADT (7.1% vs. 5.2%, P less than .001), and a significantly higher proportion had either inpatient psychiatric treatment (2.8% vs. 1.9%, P less than .001) or outpatient psychiatric therapy (3.4% vs. 2.5%, P less than .001).

In proportional hazard models controlling for demographic and clinical factors, receipt of ADT was associated with adjusted hazard ratios of 1.23 for depression and 1.29 (P less than .001 for both) for inpatient psychiatric treatment. There was no significant increase in risk for outpatient psychiatric treatment in this analysis, however.

In addition, the longer patients that were on ADT, the greater the risk for depression. The risk of depression was 12% for patients treated for 6 months or less, 26% for those on ADT for 7-11 months, and 37% for those on ADT for at least 1 year.

“The impact of ADT on depression may plausibly occur via deregulation of neurochemicals, such as serotonin, in addition to the well-described physical effects,” Ms. Dinh and her associates wrote.

Side effects of ADT that can impair quality of life also may contribute to clinical depression, they noted.

The study was supported by charitable grants and internal institutional sources. One investigator reported consulting or advisory roles with Medivation, GenomeDx, and Ferring. Three of the other ten coauthors also reported financial disclosures.

Men on androgen deprivation therapy for prostate cancer are at significantly increased risk for depression, a risk that increases with duration of therapy, investigators report.

A review of Surveillance, Epidemiology, and End Results (SEER) Medicare data on nearly 79,000 men older than 65 years with a diagnosis of prostate cancer showed that those who received androgen deprivation therapy (ADT) had a 23% increased risk for depression, compared with men who were not on ADT, reported Kathryn T. Dinh of Harvard Medical School, Boston, and her colleagues.

“We observed a significantly increased risk of depression and inpatient psychiatric treatment in men treated with ADT for prostate cancer, as well as a duration-response effect such that more ADT was linked to an increasing risk of depression and inpatient and outpatient psychiatric treatment. The possible psychiatric effects of ADT should be recognized by physicians and discussed with patients before initiating treatment,” they wrote (J Clin Oncol. 2016 Apr 11. doi: 10.1200/JCO.2015.64.1969).

Although ADT has been identified in some studies as a risk factor for clinical depression, evidence for such a relationship has been spotty, the investigators said, prompting them to conduct a population-based retrospective study to get a better handle on the issue.

They reviewed SEER Medicare data on 78,552 men older than 65 years with a diagnosis of stage I-III prostate cancer treated with ADT from 1992 through 2006, excluding from the sample those patients who had a psychiatric diagnosis within the past 12 months.

Ms. Dinh and her associates found that the 33,882 patients (43%) who received ADT had a significantly higher 3-year cumulative incidence of depression than patients who did not have ADT (7.1% vs. 5.2%, P less than .001), and a significantly higher proportion had either inpatient psychiatric treatment (2.8% vs. 1.9%, P less than .001) or outpatient psychiatric therapy (3.4% vs. 2.5%, P less than .001).

In proportional hazard models controlling for demographic and clinical factors, receipt of ADT was associated with adjusted hazard ratios of 1.23 for depression and 1.29 (P less than .001 for both) for inpatient psychiatric treatment. There was no significant increase in risk for outpatient psychiatric treatment in this analysis, however.

In addition, the longer patients that were on ADT, the greater the risk for depression. The risk of depression was 12% for patients treated for 6 months or less, 26% for those on ADT for 7-11 months, and 37% for those on ADT for at least 1 year.

“The impact of ADT on depression may plausibly occur via deregulation of neurochemicals, such as serotonin, in addition to the well-described physical effects,” Ms. Dinh and her associates wrote.

Side effects of ADT that can impair quality of life also may contribute to clinical depression, they noted.

The study was supported by charitable grants and internal institutional sources. One investigator reported consulting or advisory roles with Medivation, GenomeDx, and Ferring. Three of the other ten coauthors also reported financial disclosures.

The Food and Drug Administration has approved the first leadless pacemaker, the Micra transcatheter pacing system, the FDA stated in a release accompanying its approval.

The Micra pacemaker eliminates the need for wired leads and the risk of associated complications. The single-chamber ventricular pacemaker is 93% smaller than traditional pacemakers, according to a summary document submitted to the FDA by Medtronic, which makes the device. Like other ventricular pacemakers, Micra provides rate-adaptive pacing, with automated pacing capture threshold management to maximize battery life, which the company estimates at about 10 years.

Courtesy Medtronic plc

The pacemaker is inserted directly into the right ventricle through the femoral vein by means of a steerable catheter. Pressing a button on the distal end of the catheter releases four flexible, electrically inactive nitinol tines that hook into the myocardium to secure the device. Engagement by two tines exerts 15 times the amount of force needed to secure the device in place, according to Medtronic.

The device’s approval was based on a pivotal prospective, nonrandomized uncontrolled study of 719 patients at 56 investigational sites in North America, Europe, Asia, Australia, and Africa. The primary efficacy endpoint, low and stable pacing capture thresholds at 6 months (up to 2.0 V at a pulse width of 0.24 milliseconds and an increase of up to 1.5 V from the time of implantation) was achieved for 98% of patients (95% confidence interval, 96%-99.5%), reported Dr. Dwight Reynolds of the University of Oklahoma Health Sciences Center in Oklahoma City and his associates (N Engl J Med. 2016 Feb. 11. doi: 10.1056/NEJMoa1511643).

The researchers also compared safety outcomes among Micra recipients and 2,667 historical controls from six previously published studies. The Micra pacemaker was associated with significantly lower hospitalization and system revision rates, with “no systemic infections, no pneumothoraxes, and no radiographically visible dislodgements or device emboli,” they said. In all, 4% of Micra recipients had complications leading to death or requiring invasive revision, treatment cessation, or hospitalization, which resembled recent reports of transvenous systems and was significantly lower than the rate for historical controls, according to the investigators. However, the rate of cardiac perforation or effusion was 1.6%, slightly higher than the rate of 1.1% for historical controls. Other major complications included cardiac failure (0.9% of study patients), atrioventricular fistula or pseudoaneurysm at the groin puncture site (0.7%), and deep vein thrombosis or pulmonary thromboembolism (0.3%).

Medtronic funded the pivotal study on which approval of the Micra pacemaker was based. Dr. Reynolds had no relevant financial disclosures. Several coinvestigators reported financial relationships with Medtronic and several other cardiac device manufacturers.

The Food and Drug Administration has approved the first leadless pacemaker, the Micra transcatheter pacing system, the FDA stated in a release accompanying its approval.

The Micra pacemaker eliminates the need for wired leads and the risk of associated complications. The single-chamber ventricular pacemaker is 93% smaller than traditional pacemakers, according to a summary document submitted to the FDA by Medtronic, which makes the device. Like other ventricular pacemakers, Micra provides rate-adaptive pacing, with automated pacing capture threshold management to maximize battery life, which the company estimates at about 10 years.

Courtesy Medtronic plc

The pacemaker is inserted directly into the right ventricle through the femoral vein by means of a steerable catheter. Pressing a button on the distal end of the catheter releases four flexible, electrically inactive nitinol tines that hook into the myocardium to secure the device. Engagement by two tines exerts 15 times the amount of force needed to secure the device in place, according to Medtronic.

The device’s approval was based on a pivotal prospective, nonrandomized uncontrolled study of 719 patients at 56 investigational sites in North America, Europe, Asia, Australia, and Africa. The primary efficacy endpoint, low and stable pacing capture thresholds at 6 months (up to 2.0 V at a pulse width of 0.24 milliseconds and an increase of up to 1.5 V from the time of implantation) was achieved for 98% of patients (95% confidence interval, 96%-99.5%), reported Dr. Dwight Reynolds of the University of Oklahoma Health Sciences Center in Oklahoma City and his associates (N Engl J Med. 2016 Feb. 11. doi: 10.1056/NEJMoa1511643).

The researchers also compared safety outcomes among Micra recipients and 2,667 historical controls from six previously published studies. The Micra pacemaker was associated with significantly lower hospitalization and system revision rates, with “no systemic infections, no pneumothoraxes, and no radiographically visible dislodgements or device emboli,” they said. In all, 4% of Micra recipients had complications leading to death or requiring invasive revision, treatment cessation, or hospitalization, which resembled recent reports of transvenous systems and was significantly lower than the rate for historical controls, according to the investigators. However, the rate of cardiac perforation or effusion was 1.6%, slightly higher than the rate of 1.1% for historical controls. Other major complications included cardiac failure (0.9% of study patients), atrioventricular fistula or pseudoaneurysm at the groin puncture site (0.7%), and deep vein thrombosis or pulmonary thromboembolism (0.3%).

Medtronic funded the pivotal study on which approval of the Micra pacemaker was based. Dr. Reynolds had no relevant financial disclosures. Several coinvestigators reported financial relationships with Medtronic and several other cardiac device manufacturers.

The Food and Drug Administration has approved the first leadless pacemaker, the Micra transcatheter pacing system, the FDA stated in a release accompanying its approval.

The Micra pacemaker eliminates the need for wired leads and the risk of associated complications. The single-chamber ventricular pacemaker is 93% smaller than traditional pacemakers, according to a summary document submitted to the FDA by Medtronic, which makes the device. Like other ventricular pacemakers, Micra provides rate-adaptive pacing, with automated pacing capture threshold management to maximize battery life, which the company estimates at about 10 years.

Courtesy Medtronic plc

The pacemaker is inserted directly into the right ventricle through the femoral vein by means of a steerable catheter. Pressing a button on the distal end of the catheter releases four flexible, electrically inactive nitinol tines that hook into the myocardium to secure the device. Engagement by two tines exerts 15 times the amount of force needed to secure the device in place, according to Medtronic.

The device’s approval was based on a pivotal prospective, nonrandomized uncontrolled study of 719 patients at 56 investigational sites in North America, Europe, Asia, Australia, and Africa. The primary efficacy endpoint, low and stable pacing capture thresholds at 6 months (up to 2.0 V at a pulse width of 0.24 milliseconds and an increase of up to 1.5 V from the time of implantation) was achieved for 98% of patients (95% confidence interval, 96%-99.5%), reported Dr. Dwight Reynolds of the University of Oklahoma Health Sciences Center in Oklahoma City and his associates (N Engl J Med. 2016 Feb. 11. doi: 10.1056/NEJMoa1511643).

The researchers also compared safety outcomes among Micra recipients and 2,667 historical controls from six previously published studies. The Micra pacemaker was associated with significantly lower hospitalization and system revision rates, with “no systemic infections, no pneumothoraxes, and no radiographically visible dislodgements or device emboli,” they said. In all, 4% of Micra recipients had complications leading to death or requiring invasive revision, treatment cessation, or hospitalization, which resembled recent reports of transvenous systems and was significantly lower than the rate for historical controls, according to the investigators. However, the rate of cardiac perforation or effusion was 1.6%, slightly higher than the rate of 1.1% for historical controls. Other major complications included cardiac failure (0.9% of study patients), atrioventricular fistula or pseudoaneurysm at the groin puncture site (0.7%), and deep vein thrombosis or pulmonary thromboembolism (0.3%).

Medtronic funded the pivotal study on which approval of the Micra pacemaker was based. Dr. Reynolds had no relevant financial disclosures. Several coinvestigators reported financial relationships with Medtronic and several other cardiac device manufacturers.

MONTREAL – Surgeons, nurses, and anesthesia providers were all pretty bad at estimating surgical blood loss in a small study. And more experience doesn’t improve accuracy, though experienced providers were more confident in their estimates.

These were the findings from a study that simulated operating room scenarios and asked providers to estimate blood loss. “Estimation of blood loss is inaccurate and unreliable,” Dr. Luke Rothermel said at the Central Surgical Association’s annual meeting.

Dr. Rothermel, a resident at Case Western Reserve University, Cleveland, noted that although the Joint Commission requires operative notes to contain estimated blood loss, “no study in the United States has compared the characteristics of operating room personnel or conditions associated with improved accuracy or reliability of blood loss estimation.”

©Svisio/Thinkstock

Beyond the required reporting, estimating blood loss (EBL) also provides important guidance in perioperative care. Still, said Dr. Rothermel, previous studies have shown that EBL is typically inaccurate.

To assess providers’ ability to be accurate and reliable in estimating blood loss, Dr. Rothermel and his collaborator, Dr. Jeremy Lipman, assistant residency director at MetroHealth, Cleveland, designed a study to simulate three different operating room scenarios, involving high, medium, and low blood loss volumes. The materials used, such as blood-soaked sponges and suction canisters, were identical to what’s actually used in the operating room (porcine blood was used in the simulations).

Before the study, Dr. Rothermel said that he and Dr. Lipman hypothesized that those providers who had more experience and those who were working at the operating field would be more accurate in estimating blood loss. They also hypothesized that estimations in procedures with lower volumes of blood loss would be more accurate.

The study recruited providers from the surgery, anesthesia, and nursing services at an urban level 1 trauma center. Each scenario included a written description of the procedure performed and the course of surgery, and participants could handle study materials for each scenario under the supervision of study staff.

A total of 60 participants (22 from surgery, 17 from anesthesia, and 21 from nursing) participated; they had an average of 12.8 years of experience. The surgical participants included surgical scrub techs, trainees, and attending physicians. Anesthesia participants included anesthesia assistants, CRNAs, trainees, and attending physicians. Nursing participants were all RNs.

The findings? All over the board: “There was no association between specialty, years of experience, or confidence in ability with the consistency or accuracy of estimated blood loss,” said Dr. Rothermel.

Most participants were far shy of the mark, with just 5% of study participants overall able to come within 25% accuracy in judging EBL in all scenarios. Just over a quarter were consistent in over- or underestimating blood loss.

These findings held true across scenarios, across disciplines, and regardless of the number of years of experience. “Increased years of experience trended toward increased error,” said Dr. Rothermel, though the difference was not statistically significant. However, those with more years of experience tended to be more confident of their judgments.

Dr. Rothermel noted the small study size and single institution studied as limitations. Also, “this model was not a high fidelity representation of the OR experience, “ he said, explaining that during surgery, caregivers continually assess intraoperative blood loss and may form an estimate in a different – and potentially more accurate – manner than occurs when presented with the contrived presentation of a scenario.

The study calls into question the validity of using EBL as a quality indicator in assessing physician performance and patient outcomes, said Dr. Rothermel, who had no financial disclosures.

[email protected]

On Twitter @karioakes

MONTREAL – Surgeons, nurses, and anesthesia providers were all pretty bad at estimating surgical blood loss in a small study. And more experience doesn’t improve accuracy, though experienced providers were more confident in their estimates.

These were the findings from a study that simulated operating room scenarios and asked providers to estimate blood loss. “Estimation of blood loss is inaccurate and unreliable,” Dr. Luke Rothermel said at the Central Surgical Association’s annual meeting.

Dr. Rothermel, a resident at Case Western Reserve University, Cleveland, noted that although the Joint Commission requires operative notes to contain estimated blood loss, “no study in the United States has compared the characteristics of operating room personnel or conditions associated with improved accuracy or reliability of blood loss estimation.”

©Svisio/Thinkstock

Beyond the required reporting, estimating blood loss (EBL) also provides important guidance in perioperative care. Still, said Dr. Rothermel, previous studies have shown that EBL is typically inaccurate.

To assess providers’ ability to be accurate and reliable in estimating blood loss, Dr. Rothermel and his collaborator, Dr. Jeremy Lipman, assistant residency director at MetroHealth, Cleveland, designed a study to simulate three different operating room scenarios, involving high, medium, and low blood loss volumes. The materials used, such as blood-soaked sponges and suction canisters, were identical to what’s actually used in the operating room (porcine blood was used in the simulations).

Before the study, Dr. Rothermel said that he and Dr. Lipman hypothesized that those providers who had more experience and those who were working at the operating field would be more accurate in estimating blood loss. They also hypothesized that estimations in procedures with lower volumes of blood loss would be more accurate.

The study recruited providers from the surgery, anesthesia, and nursing services at an urban level 1 trauma center. Each scenario included a written description of the procedure performed and the course of surgery, and participants could handle study materials for each scenario under the supervision of study staff.

A total of 60 participants (22 from surgery, 17 from anesthesia, and 21 from nursing) participated; they had an average of 12.8 years of experience. The surgical participants included surgical scrub techs, trainees, and attending physicians. Anesthesia participants included anesthesia assistants, CRNAs, trainees, and attending physicians. Nursing participants were all RNs.

The findings? All over the board: “There was no association between specialty, years of experience, or confidence in ability with the consistency or accuracy of estimated blood loss,” said Dr. Rothermel.

Most participants were far shy of the mark, with just 5% of study participants overall able to come within 25% accuracy in judging EBL in all scenarios. Just over a quarter were consistent in over- or underestimating blood loss.

These findings held true across scenarios, across disciplines, and regardless of the number of years of experience. “Increased years of experience trended toward increased error,” said Dr. Rothermel, though the difference was not statistically significant. However, those with more years of experience tended to be more confident of their judgments.

Dr. Rothermel noted the small study size and single institution studied as limitations. Also, “this model was not a high fidelity representation of the OR experience, “ he said, explaining that during surgery, caregivers continually assess intraoperative blood loss and may form an estimate in a different – and potentially more accurate – manner than occurs when presented with the contrived presentation of a scenario.

The study calls into question the validity of using EBL as a quality indicator in assessing physician performance and patient outcomes, said Dr. Rothermel, who had no financial disclosures.

[email protected]

On Twitter @karioakes

MONTREAL – Surgeons, nurses, and anesthesia providers were all pretty bad at estimating surgical blood loss in a small study. And more experience doesn’t improve accuracy, though experienced providers were more confident in their estimates.

These were the findings from a study that simulated operating room scenarios and asked providers to estimate blood loss. “Estimation of blood loss is inaccurate and unreliable,” Dr. Luke Rothermel said at the Central Surgical Association’s annual meeting.

Dr. Rothermel, a resident at Case Western Reserve University, Cleveland, noted that although the Joint Commission requires operative notes to contain estimated blood loss, “no study in the United States has compared the characteristics of operating room personnel or conditions associated with improved accuracy or reliability of blood loss estimation.”

©Svisio/Thinkstock

Beyond the required reporting, estimating blood loss (EBL) also provides important guidance in perioperative care. Still, said Dr. Rothermel, previous studies have shown that EBL is typically inaccurate.

To assess providers’ ability to be accurate and reliable in estimating blood loss, Dr. Rothermel and his collaborator, Dr. Jeremy Lipman, assistant residency director at MetroHealth, Cleveland, designed a study to simulate three different operating room scenarios, involving high, medium, and low blood loss volumes. The materials used, such as blood-soaked sponges and suction canisters, were identical to what’s actually used in the operating room (porcine blood was used in the simulations).

Before the study, Dr. Rothermel said that he and Dr. Lipman hypothesized that those providers who had more experience and those who were working at the operating field would be more accurate in estimating blood loss. They also hypothesized that estimations in procedures with lower volumes of blood loss would be more accurate.

The study recruited providers from the surgery, anesthesia, and nursing services at an urban level 1 trauma center. Each scenario included a written description of the procedure performed and the course of surgery, and participants could handle study materials for each scenario under the supervision of study staff.

A total of 60 participants (22 from surgery, 17 from anesthesia, and 21 from nursing) participated; they had an average of 12.8 years of experience. The surgical participants included surgical scrub techs, trainees, and attending physicians. Anesthesia participants included anesthesia assistants, CRNAs, trainees, and attending physicians. Nursing participants were all RNs.

The findings? All over the board: “There was no association between specialty, years of experience, or confidence in ability with the consistency or accuracy of estimated blood loss,” said Dr. Rothermel.

Most participants were far shy of the mark, with just 5% of study participants overall able to come within 25% accuracy in judging EBL in all scenarios. Just over a quarter were consistent in over- or underestimating blood loss.

These findings held true across scenarios, across disciplines, and regardless of the number of years of experience. “Increased years of experience trended toward increased error,” said Dr. Rothermel, though the difference was not statistically significant. However, those with more years of experience tended to be more confident of their judgments.

Dr. Rothermel noted the small study size and single institution studied as limitations. Also, “this model was not a high fidelity representation of the OR experience, “ he said, explaining that during surgery, caregivers continually assess intraoperative blood loss and may form an estimate in a different – and potentially more accurate – manner than occurs when presented with the contrived presentation of a scenario.

The study calls into question the validity of using EBL as a quality indicator in assessing physician performance and patient outcomes, said Dr. Rothermel, who had no financial disclosures.

[email protected]

On Twitter @karioakes

Patient-controlled epidural analgesia achieves pain control similar to that of patient-controlled intravenous analgesia after spinal fusion surgery, but is associated with a higher incidence of pruritus and paresthesia, a meta-analysis published in BMC Musculoskeletal Disorders has found.

The analysis of eight randomized controlled trials involving 482 patients found that patient-controlled epidural analgesia was associated with significantly better analgesic effects on day 1 and 2 after surgery (mean difference in visual analog scale scores of −0.47 and −0.66, respectively), but this difference was no longer statistically significant on day 3.

Thomas Northcut/ ©Thinkstock

The study, conducted by Dr. Peng Tian of Tianjin (China) Hospital and colleagues showed that patient-controlled epidural analgesia was associated with a significant 53% higher incidence of pruritus and a threefold increase in paresthesia, compared with patient-controlled intravenous analgesia, although there were no significant differences in the rates of nausea or vomiting (BMC Musculoskeletal Disorders 2015 Dec 15. doi: 10.1186/s12891-015-0849-y).

Researchers noted that patient-controlled epidural analgesia achieves a faster analgesic effect than does patient-controlled intravenous analgesia because it acts directly on the near-operative region, but the analgesic effect of the intravenous administration lasts longer.

“The most important findings of the present meta-analysis are that the application of PCEA [patient-controlled epidural analgesia] does not more effectively relieve” pain in 3 postoperative days compared with patient-controlled intravenous analgesia, “meanwhile increasing the incidence of some complications such as pruritus and paresthesia,” wrote the investigators.

The National Natural Science Foundation of China supported the study. No conflicts of interest were declared.

Patient-controlled epidural analgesia achieves pain control similar to that of patient-controlled intravenous analgesia after spinal fusion surgery, but is associated with a higher incidence of pruritus and paresthesia, a meta-analysis published in BMC Musculoskeletal Disorders has found.

The analysis of eight randomized controlled trials involving 482 patients found that patient-controlled epidural analgesia was associated with significantly better analgesic effects on day 1 and 2 after surgery (mean difference in visual analog scale scores of −0.47 and −0.66, respectively), but this difference was no longer statistically significant on day 3.

Thomas Northcut/ ©Thinkstock

The study, conducted by Dr. Peng Tian of Tianjin (China) Hospital and colleagues showed that patient-controlled epidural analgesia was associated with a significant 53% higher incidence of pruritus and a threefold increase in paresthesia, compared with patient-controlled intravenous analgesia, although there were no significant differences in the rates of nausea or vomiting (BMC Musculoskeletal Disorders 2015 Dec 15. doi: 10.1186/s12891-015-0849-y).

Researchers noted that patient-controlled epidural analgesia achieves a faster analgesic effect than does patient-controlled intravenous analgesia because it acts directly on the near-operative region, but the analgesic effect of the intravenous administration lasts longer.

“The most important findings of the present meta-analysis are that the application of PCEA [patient-controlled epidural analgesia] does not more effectively relieve” pain in 3 postoperative days compared with patient-controlled intravenous analgesia, “meanwhile increasing the incidence of some complications such as pruritus and paresthesia,” wrote the investigators.

The National Natural Science Foundation of China supported the study. No conflicts of interest were declared.

Patient-controlled epidural analgesia achieves pain control similar to that of patient-controlled intravenous analgesia after spinal fusion surgery, but is associated with a higher incidence of pruritus and paresthesia, a meta-analysis published in BMC Musculoskeletal Disorders has found.

The analysis of eight randomized controlled trials involving 482 patients found that patient-controlled epidural analgesia was associated with significantly better analgesic effects on day 1 and 2 after surgery (mean difference in visual analog scale scores of −0.47 and −0.66, respectively), but this difference was no longer statistically significant on day 3.

Thomas Northcut/ ©Thinkstock

The study, conducted by Dr. Peng Tian of Tianjin (China) Hospital and colleagues showed that patient-controlled epidural analgesia was associated with a significant 53% higher incidence of pruritus and a threefold increase in paresthesia, compared with patient-controlled intravenous analgesia, although there were no significant differences in the rates of nausea or vomiting (BMC Musculoskeletal Disorders 2015 Dec 15. doi: 10.1186/s12891-015-0849-y).

Researchers noted that patient-controlled epidural analgesia achieves a faster analgesic effect than does patient-controlled intravenous analgesia because it acts directly on the near-operative region, but the analgesic effect of the intravenous administration lasts longer.

“The most important findings of the present meta-analysis are that the application of PCEA [patient-controlled epidural analgesia] does not more effectively relieve” pain in 3 postoperative days compared with patient-controlled intravenous analgesia, “meanwhile increasing the incidence of some complications such as pruritus and paresthesia,” wrote the investigators.

The National Natural Science Foundation of China supported the study. No conflicts of interest were declared.

The failure of the first U.S. uterus transplant may have been due a complication triggered by an infection of Candida, according to the Cleveland Clinic.

Courtesy the Cleveland Clinic

“Preliminary results suggest that the complication was due to an infection caused by an organism that is commonly found in a woman’s reproductive system,” officials at the Cleveland Clinic said in an April 8 statement. “The infection appears to have compromised the blood supply to the uterus, causing the need for its removal. There is an ongoing review of all the data and the team is modifying the protocol to reduce the chances of this complication occurring again in the future. The health of our patient is and has always been our primary concern.”

A team of surgeons at the Cleveland Clinic performed the first U.S. uterus transplant on a 26-year-old woman with uterine factor infertility on Feb. 24, but had to remove the transplanted uterus several days later following a sudden complication. The transplant is part of a study aimed at achieving pregnancy in women with uterine factor infertility. The study is still ongoing.

[email protected]

On Twitter @maryellenny

The failure of the first U.S. uterus transplant may have been due a complication triggered by an infection of Candida, according to the Cleveland Clinic.

Courtesy the Cleveland Clinic

“Preliminary results suggest that the complication was due to an infection caused by an organism that is commonly found in a woman’s reproductive system,” officials at the Cleveland Clinic said in an April 8 statement. “The infection appears to have compromised the blood supply to the uterus, causing the need for its removal. There is an ongoing review of all the data and the team is modifying the protocol to reduce the chances of this complication occurring again in the future. The health of our patient is and has always been our primary concern.”

A team of surgeons at the Cleveland Clinic performed the first U.S. uterus transplant on a 26-year-old woman with uterine factor infertility on Feb. 24, but had to remove the transplanted uterus several days later following a sudden complication. The transplant is part of a study aimed at achieving pregnancy in women with uterine factor infertility. The study is still ongoing.

[email protected]

On Twitter @maryellenny

The failure of the first U.S. uterus transplant may have been due a complication triggered by an infection of Candida, according to the Cleveland Clinic.

Courtesy the Cleveland Clinic

“Preliminary results suggest that the complication was due to an infection caused by an organism that is commonly found in a woman’s reproductive system,” officials at the Cleveland Clinic said in an April 8 statement. “The infection appears to have compromised the blood supply to the uterus, causing the need for its removal. There is an ongoing review of all the data and the team is modifying the protocol to reduce the chances of this complication occurring again in the future. The health of our patient is and has always been our primary concern.”

A team of surgeons at the Cleveland Clinic performed the first U.S. uterus transplant on a 26-year-old woman with uterine factor infertility on Feb. 24, but had to remove the transplanted uterus several days later following a sudden complication. The transplant is part of a study aimed at achieving pregnancy in women with uterine factor infertility. The study is still ongoing.

[email protected]

On Twitter @maryellenny