ACS Surgery News

SAN DIEGO – Endoscopic and laparoscopic drainage worked about equally well for pancreatic pseudocysts and walled off necrosis in a small randomized trial from India, the first to compare the two options.

Both are in common use, but until now it wasn’t clear if one was better than the other. The findings mean that “in general, one could do either; the choice of treatment depends [largely] on the expertise available. As an endoscopist, I prefer endoscopic drainage,” said gastroenterologist Pramod Garg, of the All India Institute of Medical Sciences, New Delhi.

Laparoscopic drainage was a technical success in 23 of the 30 patients (76.6%) randomized to it, six of whom (20%) had symptomatic pseudocysts larger than 6 cm for more than 6 weeks; the rest had walled off necrosis (WON) containing less than 30% necrotic debris. Five of the other patients were converted to open surgery, and two underwent percutaneous drainage. One of the 30 patients required endoscopic lavage and necrosectomy for secondary infection.

Endoscopic drainage, meanwhile, was technically successful in 22 of 30 patients (73.3%) with similar distributions of pseudocysts and WON. Most of the other patients needed subsequent endoscopic lavage and necrosectomy for secondary infection.

Clinical success – defined as resolution by week 4 – was 100% in the laparoscopic and 97% (29/30) in the endoscopic groups; one endoscopic patient had a splenic artery pseudoaneurysm that required further surgery. The differences in technical and clinical success rates were not statistically significant. There were no recurrences and no deaths in either group after an average follow-up of 22 months.

Although it seems okay to opt for either approach, “it’s very important for us to assess the amount of necrotic debris. If the amount is sizable, say 50% or more of the volume, one should hesitate before doing purely endoscopic drainage.” As seen in the study, “the chances of developing an infection are pretty high, especially if,” like the investigators, “you place only a plastic stent,” Dr. Garg said at the annual Digestive Disease Week.

Laparoscopic drainage would probably be better when there’s a lot of necrotic tissue, and certainly so if patients need their gallbladder removed, because it can be taken out at the same time. If endoscopy is still the choice, “you should be prepared to do repeat procedures for endoscopic lavage and necrosectomy. The chance of infection may be less if you use a metal stent with a wide diameter,” Dr. Garg said. Before tackling WON with endoscopy, he suggested getting input from a radiologist and surgeon.

Laparoscopic cystogastrostomy was done in the usual manner, with an endostapler to create a wide cystogastrostomy, necrotic debris suction, and concomitant cholecystectomies as needed.

Endoscopic drainage was performed under endosonographic guidance in the 13 patients without bulging cysts, and directly in the 17 patients whose cysts bulged. A balloon was used to dilate the cystogastrostomy tract to 12-15 mm, and a 10 F double pigtail plastic stent placed to keep it open.

Patients in both groups received perioperative antibiotics. The demographic, clinical, and laboratory parameters and etiology of acute pancreatitis were comparable between the two groups. Patients tended to be in their mid-30s, and about 75% in both groups were women. Over a third in each group had gallstone disease. The median hospital stay in both groups was about a week. Fever was more common following endoscopic drainage, probably because of the higher incidence of secondary infection.

Patients with complicated pseudocysts, coagulopathies, or organ failure were excluded from the investigation, as well as those otherwise unfit for surgery.

There was no industry funding for the work, and Dr. Garg had no disclosures.

[email protected]

SAN DIEGO – Endoscopic and laparoscopic drainage worked about equally well for pancreatic pseudocysts and walled off necrosis in a small randomized trial from India, the first to compare the two options.

Both are in common use, but until now it wasn’t clear if one was better than the other. The findings mean that “in general, one could do either; the choice of treatment depends [largely] on the expertise available. As an endoscopist, I prefer endoscopic drainage,” said gastroenterologist Pramod Garg, of the All India Institute of Medical Sciences, New Delhi.

Laparoscopic drainage was a technical success in 23 of the 30 patients (76.6%) randomized to it, six of whom (20%) had symptomatic pseudocysts larger than 6 cm for more than 6 weeks; the rest had walled off necrosis (WON) containing less than 30% necrotic debris. Five of the other patients were converted to open surgery, and two underwent percutaneous drainage. One of the 30 patients required endoscopic lavage and necrosectomy for secondary infection.

Endoscopic drainage, meanwhile, was technically successful in 22 of 30 patients (73.3%) with similar distributions of pseudocysts and WON. Most of the other patients needed subsequent endoscopic lavage and necrosectomy for secondary infection.

Clinical success – defined as resolution by week 4 – was 100% in the laparoscopic and 97% (29/30) in the endoscopic groups; one endoscopic patient had a splenic artery pseudoaneurysm that required further surgery. The differences in technical and clinical success rates were not statistically significant. There were no recurrences and no deaths in either group after an average follow-up of 22 months.

Although it seems okay to opt for either approach, “it’s very important for us to assess the amount of necrotic debris. If the amount is sizable, say 50% or more of the volume, one should hesitate before doing purely endoscopic drainage.” As seen in the study, “the chances of developing an infection are pretty high, especially if,” like the investigators, “you place only a plastic stent,” Dr. Garg said at the annual Digestive Disease Week.

Laparoscopic drainage would probably be better when there’s a lot of necrotic tissue, and certainly so if patients need their gallbladder removed, because it can be taken out at the same time. If endoscopy is still the choice, “you should be prepared to do repeat procedures for endoscopic lavage and necrosectomy. The chance of infection may be less if you use a metal stent with a wide diameter,” Dr. Garg said. Before tackling WON with endoscopy, he suggested getting input from a radiologist and surgeon.

Laparoscopic cystogastrostomy was done in the usual manner, with an endostapler to create a wide cystogastrostomy, necrotic debris suction, and concomitant cholecystectomies as needed.

Endoscopic drainage was performed under endosonographic guidance in the 13 patients without bulging cysts, and directly in the 17 patients whose cysts bulged. A balloon was used to dilate the cystogastrostomy tract to 12-15 mm, and a 10 F double pigtail plastic stent placed to keep it open.

Patients in both groups received perioperative antibiotics. The demographic, clinical, and laboratory parameters and etiology of acute pancreatitis were comparable between the two groups. Patients tended to be in their mid-30s, and about 75% in both groups were women. Over a third in each group had gallstone disease. The median hospital stay in both groups was about a week. Fever was more common following endoscopic drainage, probably because of the higher incidence of secondary infection.

Patients with complicated pseudocysts, coagulopathies, or organ failure were excluded from the investigation, as well as those otherwise unfit for surgery.

There was no industry funding for the work, and Dr. Garg had no disclosures.

[email protected]

SAN DIEGO – Endoscopic and laparoscopic drainage worked about equally well for pancreatic pseudocysts and walled off necrosis in a small randomized trial from India, the first to compare the two options.

Both are in common use, but until now it wasn’t clear if one was better than the other. The findings mean that “in general, one could do either; the choice of treatment depends [largely] on the expertise available. As an endoscopist, I prefer endoscopic drainage,” said gastroenterologist Pramod Garg, of the All India Institute of Medical Sciences, New Delhi.

Laparoscopic drainage was a technical success in 23 of the 30 patients (76.6%) randomized to it, six of whom (20%) had symptomatic pseudocysts larger than 6 cm for more than 6 weeks; the rest had walled off necrosis (WON) containing less than 30% necrotic debris. Five of the other patients were converted to open surgery, and two underwent percutaneous drainage. One of the 30 patients required endoscopic lavage and necrosectomy for secondary infection.

Endoscopic drainage, meanwhile, was technically successful in 22 of 30 patients (73.3%) with similar distributions of pseudocysts and WON. Most of the other patients needed subsequent endoscopic lavage and necrosectomy for secondary infection.

Clinical success – defined as resolution by week 4 – was 100% in the laparoscopic and 97% (29/30) in the endoscopic groups; one endoscopic patient had a splenic artery pseudoaneurysm that required further surgery. The differences in technical and clinical success rates were not statistically significant. There were no recurrences and no deaths in either group after an average follow-up of 22 months.

Although it seems okay to opt for either approach, “it’s very important for us to assess the amount of necrotic debris. If the amount is sizable, say 50% or more of the volume, one should hesitate before doing purely endoscopic drainage.” As seen in the study, “the chances of developing an infection are pretty high, especially if,” like the investigators, “you place only a plastic stent,” Dr. Garg said at the annual Digestive Disease Week.

Laparoscopic drainage would probably be better when there’s a lot of necrotic tissue, and certainly so if patients need their gallbladder removed, because it can be taken out at the same time. If endoscopy is still the choice, “you should be prepared to do repeat procedures for endoscopic lavage and necrosectomy. The chance of infection may be less if you use a metal stent with a wide diameter,” Dr. Garg said. Before tackling WON with endoscopy, he suggested getting input from a radiologist and surgeon.

Laparoscopic cystogastrostomy was done in the usual manner, with an endostapler to create a wide cystogastrostomy, necrotic debris suction, and concomitant cholecystectomies as needed.

Endoscopic drainage was performed under endosonographic guidance in the 13 patients without bulging cysts, and directly in the 17 patients whose cysts bulged. A balloon was used to dilate the cystogastrostomy tract to 12-15 mm, and a 10 F double pigtail plastic stent placed to keep it open.

Patients in both groups received perioperative antibiotics. The demographic, clinical, and laboratory parameters and etiology of acute pancreatitis were comparable between the two groups. Patients tended to be in their mid-30s, and about 75% in both groups were women. Over a third in each group had gallstone disease. The median hospital stay in both groups was about a week. Fever was more common following endoscopic drainage, probably because of the higher incidence of secondary infection.

Patients with complicated pseudocysts, coagulopathies, or organ failure were excluded from the investigation, as well as those otherwise unfit for surgery.

There was no industry funding for the work, and Dr. Garg had no disclosures.

[email protected]

NEW ORLEANS – If the yardstick for measuring the cost-effectiveness of an operation or a medical treatment is that it costs less than $50,000 for each quality-adjusted life-year gained, then weight-loss surgery as a treatment for type 2 diabetes is cost-effective.

However, more long-term follow-up is needed to determine the true value of metabolic or bariatric surgery such as gastric bypass, compared with medical treatment for type 2 diabetes. Studies of bariatric surgery in the nondiabetic population found it was most cost-effective in the following scenarios: in women; in the morbidly obese vs. the moderately obese; in patients with obesity-related comorbidities including diabetes; when the procedures were performed laparoscopically; and when the studies themselves received industry support.

In people with diabetes, the results were similar. “Diabetes metabolic surgery is more cost-effective early in the course of type 2 diabetes compared to later in the course, when performed laparoscopically, and again when the study received support from industry,” reported Dr. William H. Herman, professor of epidemiology and internal medicine at the University of Michigan School of Public Health in Ann Arbor and director of the Michigan Center for Diabetes Translational Research.

He reviewed 11 economic analyses of bariatric surgery and concluded that all exceeded the benchmark for cost-effectiveness based on the cost per quality-adjusted life-year (QALY) gained. Six studies evaluated the general population of obese people and found that the cost-effectiveness ratios ranged from $1,600 to $44,000 per QALY gained. The remaining five studies involved obese patients with type 2 diabetes, two of which reported cost-effectiveness ratios of $2,000 to $23,000 per QALY gained; and the remaining three studies actually reporting a cost-savings. “In other words, the money spent on these interventions was more than recouped in the savings resulting from reduced downstream medical costs,” Dr. Herman reported at the American Diabetes Association scientific sessions.

The studies that found gastric bypass cost-saving in diabetes are noteworthy, Dr. Herman said. “If an intervention is more effective and less costly than a comparator intervention, then it is cost-saving, and that really is an unusual finding in health or medicine; perhaps 10% or 15% of interventions turn out to be cost-saving,” he said. “These are interventions that we want to adopt and put into practice pretty much without question.”

By the same measure, if an intervention is more costly and less effective, it’s easy to dismiss “out of hand,” Dr. Herman said. However, interpreting some of the studies he evaluated was more nuanced. “The problem occurs when a new treatment is both more effective but more costly, which was the case with two of the five analyses of metabolic surgery, and all of the analysis of bariatric surgery in the nondiabetic population,” he said

While gastric bypass surgery for type 2 diabetes is a good value, Dr. Herman added a few caveats. “When one looks at other interventions in similar categories, metformin for diabetes prevention has recently been shown to be cost-saving,” he said. He also said surgery is more cost-effective than marginally cost-effective interventions like intensive glycemic management for people with newly diagnosed type 2 diabetes or retinal screening every year vs. every 2 years.

One key issue with the existing evidence on cost-effectiveness of metabolic surgery for type 2 diabetes that Dr. Herman elucidated is how the studies accounted for participants lost to follow-up. “We know that a patient lost to follow-up may have a less favorable outcome than one who returns for follow-up,” he said. There are two ways studies can account for lost patients: the available-case analysis, which assumes that the patients lost to follow-up have the same rates of remission; and the attrition-adjusted available case follow-up, which uses a worst-case imputation. “I would argue that to account for attrition bias, remission rates calculated using the cases available for follow-up should be adjusted using worst-case imputation,” Dr. Herman said.

He pointed out another limitation when calculating the value of gastric bypass surgery for type 2 diabetes: “There are no randomized clinical trials of metabolic surgery that describe its long-term impact on diabetes treatments, complications, comorbidities, and survival. And it really is going be very important to get these data to confirm the cost-effectiveness of metabolic surgery.”

Among the shortcomings of the existing literature he noted are the assumptions that treatment-related adverse events are self-limited, that body mass index (BMI) achieved up to 5 years after surgery will remain stable, and that diabetes will not relapse. “The data are pretty good now on reversal, remission, hernia repair, and those sorts of things, but we need to look at longer downstream costs associated with surgery, including the need for cholecystectomy, joint replacements, and nutritional deficiencies that may occur and do clearly have financial implications,” he said.

At the same time, the analyses on gastric bypass surgery for type 2 diabetes could be more favorable if they account for improvements in health-related quality-of-life and rely less on cross-sectional data. Dr. Herman said, “I would argue that using cross-sectional data to estimate changes in health-related quality of life as a function of BMI underestimates the improvements on health-related quality-of-life associated with weight loss and will in fact underestimate the cost utility of interventions for obesity treatment,” he said.

Dr. Herman added, “Clearly the evidence to date suggests that metabolic surgery is cost-effective, but I’ll be more assured when I see longer-term follow-up.”

Dr. Herman has no financial relationships to disclose.

NEW ORLEANS – If the yardstick for measuring the cost-effectiveness of an operation or a medical treatment is that it costs less than $50,000 for each quality-adjusted life-year gained, then weight-loss surgery as a treatment for type 2 diabetes is cost-effective.

However, more long-term follow-up is needed to determine the true value of metabolic or bariatric surgery such as gastric bypass, compared with medical treatment for type 2 diabetes. Studies of bariatric surgery in the nondiabetic population found it was most cost-effective in the following scenarios: in women; in the morbidly obese vs. the moderately obese; in patients with obesity-related comorbidities including diabetes; when the procedures were performed laparoscopically; and when the studies themselves received industry support.

In people with diabetes, the results were similar. “Diabetes metabolic surgery is more cost-effective early in the course of type 2 diabetes compared to later in the course, when performed laparoscopically, and again when the study received support from industry,” reported Dr. William H. Herman, professor of epidemiology and internal medicine at the University of Michigan School of Public Health in Ann Arbor and director of the Michigan Center for Diabetes Translational Research.

He reviewed 11 economic analyses of bariatric surgery and concluded that all exceeded the benchmark for cost-effectiveness based on the cost per quality-adjusted life-year (QALY) gained. Six studies evaluated the general population of obese people and found that the cost-effectiveness ratios ranged from $1,600 to $44,000 per QALY gained. The remaining five studies involved obese patients with type 2 diabetes, two of which reported cost-effectiveness ratios of $2,000 to $23,000 per QALY gained; and the remaining three studies actually reporting a cost-savings. “In other words, the money spent on these interventions was more than recouped in the savings resulting from reduced downstream medical costs,” Dr. Herman reported at the American Diabetes Association scientific sessions.

The studies that found gastric bypass cost-saving in diabetes are noteworthy, Dr. Herman said. “If an intervention is more effective and less costly than a comparator intervention, then it is cost-saving, and that really is an unusual finding in health or medicine; perhaps 10% or 15% of interventions turn out to be cost-saving,” he said. “These are interventions that we want to adopt and put into practice pretty much without question.”

By the same measure, if an intervention is more costly and less effective, it’s easy to dismiss “out of hand,” Dr. Herman said. However, interpreting some of the studies he evaluated was more nuanced. “The problem occurs when a new treatment is both more effective but more costly, which was the case with two of the five analyses of metabolic surgery, and all of the analysis of bariatric surgery in the nondiabetic population,” he said

While gastric bypass surgery for type 2 diabetes is a good value, Dr. Herman added a few caveats. “When one looks at other interventions in similar categories, metformin for diabetes prevention has recently been shown to be cost-saving,” he said. He also said surgery is more cost-effective than marginally cost-effective interventions like intensive glycemic management for people with newly diagnosed type 2 diabetes or retinal screening every year vs. every 2 years.

One key issue with the existing evidence on cost-effectiveness of metabolic surgery for type 2 diabetes that Dr. Herman elucidated is how the studies accounted for participants lost to follow-up. “We know that a patient lost to follow-up may have a less favorable outcome than one who returns for follow-up,” he said. There are two ways studies can account for lost patients: the available-case analysis, which assumes that the patients lost to follow-up have the same rates of remission; and the attrition-adjusted available case follow-up, which uses a worst-case imputation. “I would argue that to account for attrition bias, remission rates calculated using the cases available for follow-up should be adjusted using worst-case imputation,” Dr. Herman said.

He pointed out another limitation when calculating the value of gastric bypass surgery for type 2 diabetes: “There are no randomized clinical trials of metabolic surgery that describe its long-term impact on diabetes treatments, complications, comorbidities, and survival. And it really is going be very important to get these data to confirm the cost-effectiveness of metabolic surgery.”

Among the shortcomings of the existing literature he noted are the assumptions that treatment-related adverse events are self-limited, that body mass index (BMI) achieved up to 5 years after surgery will remain stable, and that diabetes will not relapse. “The data are pretty good now on reversal, remission, hernia repair, and those sorts of things, but we need to look at longer downstream costs associated with surgery, including the need for cholecystectomy, joint replacements, and nutritional deficiencies that may occur and do clearly have financial implications,” he said.

At the same time, the analyses on gastric bypass surgery for type 2 diabetes could be more favorable if they account for improvements in health-related quality-of-life and rely less on cross-sectional data. Dr. Herman said, “I would argue that using cross-sectional data to estimate changes in health-related quality of life as a function of BMI underestimates the improvements on health-related quality-of-life associated with weight loss and will in fact underestimate the cost utility of interventions for obesity treatment,” he said.

Dr. Herman added, “Clearly the evidence to date suggests that metabolic surgery is cost-effective, but I’ll be more assured when I see longer-term follow-up.”

Dr. Herman has no financial relationships to disclose.

NEW ORLEANS – If the yardstick for measuring the cost-effectiveness of an operation or a medical treatment is that it costs less than $50,000 for each quality-adjusted life-year gained, then weight-loss surgery as a treatment for type 2 diabetes is cost-effective.

However, more long-term follow-up is needed to determine the true value of metabolic or bariatric surgery such as gastric bypass, compared with medical treatment for type 2 diabetes. Studies of bariatric surgery in the nondiabetic population found it was most cost-effective in the following scenarios: in women; in the morbidly obese vs. the moderately obese; in patients with obesity-related comorbidities including diabetes; when the procedures were performed laparoscopically; and when the studies themselves received industry support.

In people with diabetes, the results were similar. “Diabetes metabolic surgery is more cost-effective early in the course of type 2 diabetes compared to later in the course, when performed laparoscopically, and again when the study received support from industry,” reported Dr. William H. Herman, professor of epidemiology and internal medicine at the University of Michigan School of Public Health in Ann Arbor and director of the Michigan Center for Diabetes Translational Research.

He reviewed 11 economic analyses of bariatric surgery and concluded that all exceeded the benchmark for cost-effectiveness based on the cost per quality-adjusted life-year (QALY) gained. Six studies evaluated the general population of obese people and found that the cost-effectiveness ratios ranged from $1,600 to $44,000 per QALY gained. The remaining five studies involved obese patients with type 2 diabetes, two of which reported cost-effectiveness ratios of $2,000 to $23,000 per QALY gained; and the remaining three studies actually reporting a cost-savings. “In other words, the money spent on these interventions was more than recouped in the savings resulting from reduced downstream medical costs,” Dr. Herman reported at the American Diabetes Association scientific sessions.

The studies that found gastric bypass cost-saving in diabetes are noteworthy, Dr. Herman said. “If an intervention is more effective and less costly than a comparator intervention, then it is cost-saving, and that really is an unusual finding in health or medicine; perhaps 10% or 15% of interventions turn out to be cost-saving,” he said. “These are interventions that we want to adopt and put into practice pretty much without question.”

By the same measure, if an intervention is more costly and less effective, it’s easy to dismiss “out of hand,” Dr. Herman said. However, interpreting some of the studies he evaluated was more nuanced. “The problem occurs when a new treatment is both more effective but more costly, which was the case with two of the five analyses of metabolic surgery, and all of the analysis of bariatric surgery in the nondiabetic population,” he said

While gastric bypass surgery for type 2 diabetes is a good value, Dr. Herman added a few caveats. “When one looks at other interventions in similar categories, metformin for diabetes prevention has recently been shown to be cost-saving,” he said. He also said surgery is more cost-effective than marginally cost-effective interventions like intensive glycemic management for people with newly diagnosed type 2 diabetes or retinal screening every year vs. every 2 years.

One key issue with the existing evidence on cost-effectiveness of metabolic surgery for type 2 diabetes that Dr. Herman elucidated is how the studies accounted for participants lost to follow-up. “We know that a patient lost to follow-up may have a less favorable outcome than one who returns for follow-up,” he said. There are two ways studies can account for lost patients: the available-case analysis, which assumes that the patients lost to follow-up have the same rates of remission; and the attrition-adjusted available case follow-up, which uses a worst-case imputation. “I would argue that to account for attrition bias, remission rates calculated using the cases available for follow-up should be adjusted using worst-case imputation,” Dr. Herman said.

He pointed out another limitation when calculating the value of gastric bypass surgery for type 2 diabetes: “There are no randomized clinical trials of metabolic surgery that describe its long-term impact on diabetes treatments, complications, comorbidities, and survival. And it really is going be very important to get these data to confirm the cost-effectiveness of metabolic surgery.”

Among the shortcomings of the existing literature he noted are the assumptions that treatment-related adverse events are self-limited, that body mass index (BMI) achieved up to 5 years after surgery will remain stable, and that diabetes will not relapse. “The data are pretty good now on reversal, remission, hernia repair, and those sorts of things, but we need to look at longer downstream costs associated with surgery, including the need for cholecystectomy, joint replacements, and nutritional deficiencies that may occur and do clearly have financial implications,” he said.

At the same time, the analyses on gastric bypass surgery for type 2 diabetes could be more favorable if they account for improvements in health-related quality-of-life and rely less on cross-sectional data. Dr. Herman said, “I would argue that using cross-sectional data to estimate changes in health-related quality of life as a function of BMI underestimates the improvements on health-related quality-of-life associated with weight loss and will in fact underestimate the cost utility of interventions for obesity treatment,” he said.

Dr. Herman added, “Clearly the evidence to date suggests that metabolic surgery is cost-effective, but I’ll be more assured when I see longer-term follow-up.”

Dr. Herman has no financial relationships to disclose.

Supreme Court justices have deadlocked on whether protections for undocumented immigrants can be expanded under an executive order by the President.

In a June 23 decision, justices were equally divided on the constitutionality of two of President Obama’s immigration policies: the Deferred Action for Parents of Americans and Lawful Permanent Residents (DAPA) and an expanded version of the Deferred Action for Childhood Arrivals (DACA). The former protects undocumented immigrants who are parents of U.S. citizens from deportation, if they meet certain criteria. The second extends work authorization under the original DACA program from 2 years to 3 years and broadens age requirements.

whitehouse.gov

The 4-to-4 split decision in Texas v. United States mean the policies remain blocked by the lower court, and the expanded programs will not go forward anytime soon. The decision does not affect original DACA, which protects from deportation undocumented immigrants brought to the United States as children and offers access to work authorization.

President Obama expressed disappointment at the lack of agreement, saying the tie vote underscores the need for nine justices on the court.

“As disappointing as it was to be challenged for taking the kind of action that other administrations have taken, the country was looking to the Supreme Court to resolve the important legal questions raised in this case,” President Obama said during a June 23 press conference. “Today, the Supreme Court was unable to reach a decision ... it means the expanded set of common sense deferred action policies that I announced 2 years ago cannot go forward at this stage until there is a ninth justice on the court to break the tie.”

Texas Attorney General Ken Paxton was satisfied with the decision, calling it a victory for the state plaintiffs.

“Today’s decision keeps in place what we have maintained from the very start: one person, even a president, cannot unilaterally change the law,” Mr. Paxton said in a statement. “This is a major setback to President Obama’s attempts to expand executive power, and a victory for those who believe in the separation of powers and the rule of law.”

Texas was 1 of 26 states that sued over DAPA and expanded DACA. The states argued the president does not have the authority to issue the new immigration policies, and that the programs violate the Constitution as well as the Administrative Procedure Act for notice-and-comment rule making. Justices heard oral arguments April 18.

Immigration advocates were worried that if expanded DACA were struck down, a similar fate would follow for the original DACA policy. As it stands, undocumented immigrants who benefit from deportation protection and work authorization under original DACA, including undocumented medical students, will not be affected by the Supreme Court decision.

Marielena Hincapié, executive director for the National Immigration Law Center, vowed to continue fighting for the policies to take effect.

“Immigrants and allies fought for and won these significant policy victories, which would have brought much-needed emotional and economic stability to millions of our community members, and we will not sit back,” she said in a statement. “We urge the Department of Justice to seek a rehearing for when a ninth justice is confirmed for the Supreme Court.”

Federation for American Immigration Reform President Dan Stein said the split decision upholds the rule of law and helps preserve the balance of power in the United States.

“By ruling in favor of the federal court’s injunction, half of the nation’s Supreme Court Justices have shown that they have deep concerns about this president’s attempt at a power grab by his efforts to amend federal laws from the Oval Office,” Mr. Stein said in a statement.

Texas v. United States will be sent back to U.S. District Court Judge Andrew Hanen in Texas who will hear the case on its merits. The case could wind its way back to the U.S. Supreme Court for a rehearing after a ninth justice is confirmed.

[email protected]

On Twitter @legal_med

Supreme Court justices have deadlocked on whether protections for undocumented immigrants can be expanded under an executive order by the President.

In a June 23 decision, justices were equally divided on the constitutionality of two of President Obama’s immigration policies: the Deferred Action for Parents of Americans and Lawful Permanent Residents (DAPA) and an expanded version of the Deferred Action for Childhood Arrivals (DACA). The former protects undocumented immigrants who are parents of U.S. citizens from deportation, if they meet certain criteria. The second extends work authorization under the original DACA program from 2 years to 3 years and broadens age requirements.

whitehouse.gov

The 4-to-4 split decision in Texas v. United States mean the policies remain blocked by the lower court, and the expanded programs will not go forward anytime soon. The decision does not affect original DACA, which protects from deportation undocumented immigrants brought to the United States as children and offers access to work authorization.

President Obama expressed disappointment at the lack of agreement, saying the tie vote underscores the need for nine justices on the court.

“As disappointing as it was to be challenged for taking the kind of action that other administrations have taken, the country was looking to the Supreme Court to resolve the important legal questions raised in this case,” President Obama said during a June 23 press conference. “Today, the Supreme Court was unable to reach a decision ... it means the expanded set of common sense deferred action policies that I announced 2 years ago cannot go forward at this stage until there is a ninth justice on the court to break the tie.”

Texas Attorney General Ken Paxton was satisfied with the decision, calling it a victory for the state plaintiffs.

“Today’s decision keeps in place what we have maintained from the very start: one person, even a president, cannot unilaterally change the law,” Mr. Paxton said in a statement. “This is a major setback to President Obama’s attempts to expand executive power, and a victory for those who believe in the separation of powers and the rule of law.”

Texas was 1 of 26 states that sued over DAPA and expanded DACA. The states argued the president does not have the authority to issue the new immigration policies, and that the programs violate the Constitution as well as the Administrative Procedure Act for notice-and-comment rule making. Justices heard oral arguments April 18.

Immigration advocates were worried that if expanded DACA were struck down, a similar fate would follow for the original DACA policy. As it stands, undocumented immigrants who benefit from deportation protection and work authorization under original DACA, including undocumented medical students, will not be affected by the Supreme Court decision.

Marielena Hincapié, executive director for the National Immigration Law Center, vowed to continue fighting for the policies to take effect.

“Immigrants and allies fought for and won these significant policy victories, which would have brought much-needed emotional and economic stability to millions of our community members, and we will not sit back,” she said in a statement. “We urge the Department of Justice to seek a rehearing for when a ninth justice is confirmed for the Supreme Court.”

Federation for American Immigration Reform President Dan Stein said the split decision upholds the rule of law and helps preserve the balance of power in the United States.

“By ruling in favor of the federal court’s injunction, half of the nation’s Supreme Court Justices have shown that they have deep concerns about this president’s attempt at a power grab by his efforts to amend federal laws from the Oval Office,” Mr. Stein said in a statement.

Texas v. United States will be sent back to U.S. District Court Judge Andrew Hanen in Texas who will hear the case on its merits. The case could wind its way back to the U.S. Supreme Court for a rehearing after a ninth justice is confirmed.

[email protected]

On Twitter @legal_med

Supreme Court justices have deadlocked on whether protections for undocumented immigrants can be expanded under an executive order by the President.

In a June 23 decision, justices were equally divided on the constitutionality of two of President Obama’s immigration policies: the Deferred Action for Parents of Americans and Lawful Permanent Residents (DAPA) and an expanded version of the Deferred Action for Childhood Arrivals (DACA). The former protects undocumented immigrants who are parents of U.S. citizens from deportation, if they meet certain criteria. The second extends work authorization under the original DACA program from 2 years to 3 years and broadens age requirements.

whitehouse.gov

The 4-to-4 split decision in Texas v. United States mean the policies remain blocked by the lower court, and the expanded programs will not go forward anytime soon. The decision does not affect original DACA, which protects from deportation undocumented immigrants brought to the United States as children and offers access to work authorization.

President Obama expressed disappointment at the lack of agreement, saying the tie vote underscores the need for nine justices on the court.

“As disappointing as it was to be challenged for taking the kind of action that other administrations have taken, the country was looking to the Supreme Court to resolve the important legal questions raised in this case,” President Obama said during a June 23 press conference. “Today, the Supreme Court was unable to reach a decision ... it means the expanded set of common sense deferred action policies that I announced 2 years ago cannot go forward at this stage until there is a ninth justice on the court to break the tie.”

Texas Attorney General Ken Paxton was satisfied with the decision, calling it a victory for the state plaintiffs.

“Today’s decision keeps in place what we have maintained from the very start: one person, even a president, cannot unilaterally change the law,” Mr. Paxton said in a statement. “This is a major setback to President Obama’s attempts to expand executive power, and a victory for those who believe in the separation of powers and the rule of law.”

Texas was 1 of 26 states that sued over DAPA and expanded DACA. The states argued the president does not have the authority to issue the new immigration policies, and that the programs violate the Constitution as well as the Administrative Procedure Act for notice-and-comment rule making. Justices heard oral arguments April 18.

Immigration advocates were worried that if expanded DACA were struck down, a similar fate would follow for the original DACA policy. As it stands, undocumented immigrants who benefit from deportation protection and work authorization under original DACA, including undocumented medical students, will not be affected by the Supreme Court decision.

Marielena Hincapié, executive director for the National Immigration Law Center, vowed to continue fighting for the policies to take effect.

“Immigrants and allies fought for and won these significant policy victories, which would have brought much-needed emotional and economic stability to millions of our community members, and we will not sit back,” she said in a statement. “We urge the Department of Justice to seek a rehearing for when a ninth justice is confirmed for the Supreme Court.”

Federation for American Immigration Reform President Dan Stein said the split decision upholds the rule of law and helps preserve the balance of power in the United States.

“By ruling in favor of the federal court’s injunction, half of the nation’s Supreme Court Justices have shown that they have deep concerns about this president’s attempt at a power grab by his efforts to amend federal laws from the Oval Office,” Mr. Stein said in a statement.

Texas v. United States will be sent back to U.S. District Court Judge Andrew Hanen in Texas who will hear the case on its merits. The case could wind its way back to the U.S. Supreme Court for a rehearing after a ninth justice is confirmed.

[email protected]

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Yes: MRI should be considered in the preoperative setting for specific clinical indications.

MRI, like any technology, has its strengths and weaknesses, with high sensitivity but low specificity. Importantly, MRI provides excellent soft tissue contrast with anatomic 3-D detail, and is not impeded by high breast density.

Admittedly, MRI only incrementally increases cancer detection rates in either the ipsilateral or contralateral breasts of all patients, and when used in the preoperative setting does not affect short-term surgical outcomes for all patients. Therefore, MRI should not be used for routine screening or routine preoperative screening.

That said, there are specific clinical situations where preoperative MRI may provide surgeons with valuable information. These include patients who have:

• Invasive lobular carcinoma.

• Neoadjuvant chemotherapy.

• Occult primaries in extremely dense breasts.

Invasive lobular carcinomas are more likely to be multi-centric, multi-focal, and/or bilateral than other breast cancer types, and they are more difficult to diagnose because they infiltrate into tissue, making it extremely difficult to determine the extent of disease. In this setting, MRI can more accurately determine tumor size than mammography. Mammography underestimates the tumor size significantly more frequently than does MRI. In addition, among women with this cancer subtype, MRI can significantly reduce the rate of excision (Breast Cancer Res Treat. 2010;119;415-22).

We know that women at risk for systemic recurrence will not be cured with surgery alone. Neoadjuvant therapies give us the opportunity to refine local therapy options, better understand the patient’s response to therapy and prognosis, and accelerate targeted drug development to improve outcomes. To accomplish all of these goals, we need a noninvasive way to assess tumors before, during, and after neoadjuvant treatment. MRI is unsurpassed for evaluating the extent of tumors, showing in larger tumors, for example, the complexity of tumor and stroma.

MRI is also a biomarker for response to therapy and has been shown to be an independent predictor of event-free survival. In addition, MRI is more accurate than either clinical exam, mammography, or ultrasound for determining residual tumor size following neoadjuvant chemotherapy (Radiology. 2012;263:663-72).

Lastly, for patients with an occult primary (by imaging) breast cancer or primary presentation of axillary node involvement, MRI has been found to have an approximately 90% sensitivity for identifying a primary tumor, and a 95% accuracy at locating the tumor in patients who undergo surgical excision. Mammography cannot distinguish a tumor mass that is dense relative to surrounding tissue. However, MRI can distinguish a tumor which is obscured by dense breast tissue because tumors are visualized on MRI by rapid contrast uptake and washout.

MRI is a catalyst for change, but you have to use it and all technology wisely: At the time of diagnosis for select patients, for screening only those patients with very breast dense tissue and very high risk for developing breast cancer, and, perhaps most importantly, for postcancer surveillance only in women at very high risk of recurrence where standard tools such as mammography are expected to have lower performance (for example, very dense breast tissue). Overuse of MRI will increase false positives, anxiety, and cost. However, used appropriately, MRI can be used to help usher in a change in practice through the evaluation of response to neoadjuvant therapy and novel therapeutic approaches to both invasive and in situ lesions.

With improvements in technology and techniques such as diffusion-weighted imaging, the value of MRI in the preoperative setting can only continue to grow. We can also expect greater performance for presurgical staging with more refined technologies for breast imaging, localization, and biopsy, but the costs have to come down. Breast-dedicated MRI technologies may address this need.

Laura Esserman, MD, is a professor of surgery and radiology at the University of California, San Francisco, and Director of the Carol Franc Buck Breast Care Center at the UCSF Mount Zion campus.

No: MRI leads to unnecessary surgeries and does not improve short-term surgical outcomes.

The key word in this debate is “routinely.” I agree that preoperative MRI may have a role in about 5% of all cases – namely in women with occult primaries and those who undergo neoadjuvant chemotherapy. But for the vast majority of patients, the 95%, I would argue that preoperative MRI has the potential to do more harm than good.

Thirty years of experience providing breast conserving therapies without MRI has taught us several important lessons:

• Selection of patients for breast-conserving therapy is not a big problem.

• The incidences of local recurrence and contralateral breast cancers have decreased over time, antedating the use of MRI.

• Surgical excision of all microscopic subclinical disease is not necessary to achieve good long-term outcomes.

In National Surgical Adjuvant Breast and Bowel Project studies from the 1990s, in the era before the use of aromatase inhibitors or HER-2 blockade, the 10-year incidence of ipsilateral breast tumor recurrence ranged from 3.5% to 6.5% in the breast cancer population at large.

In addition, the incidence of contralateral breast cancers has been declining at a rate of approximately 3% per year, thanks to the use of adjuvant systemic therapies.

We have known since the 1960s, thanks to our colleagues in pathology, that somewhere between 30% and 60% of breast cancers that appear to be localized have microscopic subclinical disease which is treated with breast irradiation. More recently, we have recognized that we can leave behind cancer in the axilla in anywhere from 13% to 27% of patients who are not receiving direct axillary radiation, and see failure rates of 1% or less.

In the context, then, of our current understanding of breast cancer biology, what outcomes could MRI be expected to improve, since the purpose of a test is to improve patient outcomes?

We know that MRI will not improve survival, because 30 years ago randomized trials showed us that survival was equal between breast conservation and mastectomy.

MRI has no apparent effect on reducing local recurrences either, as shown in an analysis of data on 3,180 patients published in 2014 (J Clin Oncol. 2014;32:292).

Regarding contralateral breast cancer, a 2007 study (N Engl J Med. 2007;356:1295-303) showed that among 969 women, MRI found unsuspected cancer in the contralateral breast within 1 year of diagnosis in 3.1%, a finding used to support the argument that all women with breast cancer should have an MRI. But a second study using Surveillance, Epidemiology and End Results (SEER) data on 339,790 women with 2.5 million person-years of follow-up found that the 10-year rate of contralateral cancers was 2%-3% of women with estrogen-receptor–positive tumors, and in 5%-6% of those with estrogen-receptor–negative tumors, strongly suggesting that MRI leads to detection and treatment of disease that would never become clinically evident.

Finally, I would point to evidence that MRI does not improve short-term surgical outcomes, as shown in a meta-analysis my colleagues and I conducted of two randomized controlled trials and seven cohort studies, involving a total of 3,112 patients (Ann Surg. 2013;257:249-55).

We found that after adjustment for age, having an MRI was associated with a three-fold greater chance of having a mastectomy, and MRI did not significantly reduce either the need for re-excision or unexpected conversion to mastectomy. We also performed a subanalysis of infiltrating lobular cancers, and found that there was no statistically significant benefit for MRI in these patients.

The overall rate of mastectomy was 25.5% among patients who had an MRI, vs. 18.2% for those who did not.

So to summarize: MRI finds two to three times more cancer than observed rates of local recurrence, leading to unnecessary mastectomies and does not improve short-term surgical outcomes, and there is no evidence indicating that MRI decreases local recurrence.

Monica Morrow, MD, FACS, is chief of the breast service in the department of surgery and holds the Anne Burnett Windfohr Chair of Clinical Oncology at Memorial Sloan Kettering Cancer Center in New York.

Yes: MRI should be considered in the preoperative setting for specific clinical indications.

MRI, like any technology, has its strengths and weaknesses, with high sensitivity but low specificity. Importantly, MRI provides excellent soft tissue contrast with anatomic 3-D detail, and is not impeded by high breast density.

Admittedly, MRI only incrementally increases cancer detection rates in either the ipsilateral or contralateral breasts of all patients, and when used in the preoperative setting does not affect short-term surgical outcomes for all patients. Therefore, MRI should not be used for routine screening or routine preoperative screening.

That said, there are specific clinical situations where preoperative MRI may provide surgeons with valuable information. These include patients who have:

• Invasive lobular carcinoma.

• Neoadjuvant chemotherapy.

• Occult primaries in extremely dense breasts.

Invasive lobular carcinomas are more likely to be multi-centric, multi-focal, and/or bilateral than other breast cancer types, and they are more difficult to diagnose because they infiltrate into tissue, making it extremely difficult to determine the extent of disease. In this setting, MRI can more accurately determine tumor size than mammography. Mammography underestimates the tumor size significantly more frequently than does MRI. In addition, among women with this cancer subtype, MRI can significantly reduce the rate of excision (Breast Cancer Res Treat. 2010;119;415-22).

We know that women at risk for systemic recurrence will not be cured with surgery alone. Neoadjuvant therapies give us the opportunity to refine local therapy options, better understand the patient’s response to therapy and prognosis, and accelerate targeted drug development to improve outcomes. To accomplish all of these goals, we need a noninvasive way to assess tumors before, during, and after neoadjuvant treatment. MRI is unsurpassed for evaluating the extent of tumors, showing in larger tumors, for example, the complexity of tumor and stroma.

MRI is also a biomarker for response to therapy and has been shown to be an independent predictor of event-free survival. In addition, MRI is more accurate than either clinical exam, mammography, or ultrasound for determining residual tumor size following neoadjuvant chemotherapy (Radiology. 2012;263:663-72).

Lastly, for patients with an occult primary (by imaging) breast cancer or primary presentation of axillary node involvement, MRI has been found to have an approximately 90% sensitivity for identifying a primary tumor, and a 95% accuracy at locating the tumor in patients who undergo surgical excision. Mammography cannot distinguish a tumor mass that is dense relative to surrounding tissue. However, MRI can distinguish a tumor which is obscured by dense breast tissue because tumors are visualized on MRI by rapid contrast uptake and washout.

MRI is a catalyst for change, but you have to use it and all technology wisely: At the time of diagnosis for select patients, for screening only those patients with very breast dense tissue and very high risk for developing breast cancer, and, perhaps most importantly, for postcancer surveillance only in women at very high risk of recurrence where standard tools such as mammography are expected to have lower performance (for example, very dense breast tissue). Overuse of MRI will increase false positives, anxiety, and cost. However, used appropriately, MRI can be used to help usher in a change in practice through the evaluation of response to neoadjuvant therapy and novel therapeutic approaches to both invasive and in situ lesions.

With improvements in technology and techniques such as diffusion-weighted imaging, the value of MRI in the preoperative setting can only continue to grow. We can also expect greater performance for presurgical staging with more refined technologies for breast imaging, localization, and biopsy, but the costs have to come down. Breast-dedicated MRI technologies may address this need.

Laura Esserman, MD, is a professor of surgery and radiology at the University of California, San Francisco, and Director of the Carol Franc Buck Breast Care Center at the UCSF Mount Zion campus.

No: MRI leads to unnecessary surgeries and does not improve short-term surgical outcomes.

The key word in this debate is “routinely.” I agree that preoperative MRI may have a role in about 5% of all cases – namely in women with occult primaries and those who undergo neoadjuvant chemotherapy. But for the vast majority of patients, the 95%, I would argue that preoperative MRI has the potential to do more harm than good.

Thirty years of experience providing breast conserving therapies without MRI has taught us several important lessons:

• Selection of patients for breast-conserving therapy is not a big problem.

• The incidences of local recurrence and contralateral breast cancers have decreased over time, antedating the use of MRI.

• Surgical excision of all microscopic subclinical disease is not necessary to achieve good long-term outcomes.

In National Surgical Adjuvant Breast and Bowel Project studies from the 1990s, in the era before the use of aromatase inhibitors or HER-2 blockade, the 10-year incidence of ipsilateral breast tumor recurrence ranged from 3.5% to 6.5% in the breast cancer population at large.

In addition, the incidence of contralateral breast cancers has been declining at a rate of approximately 3% per year, thanks to the use of adjuvant systemic therapies.

We have known since the 1960s, thanks to our colleagues in pathology, that somewhere between 30% and 60% of breast cancers that appear to be localized have microscopic subclinical disease which is treated with breast irradiation. More recently, we have recognized that we can leave behind cancer in the axilla in anywhere from 13% to 27% of patients who are not receiving direct axillary radiation, and see failure rates of 1% or less.

In the context, then, of our current understanding of breast cancer biology, what outcomes could MRI be expected to improve, since the purpose of a test is to improve patient outcomes?

We know that MRI will not improve survival, because 30 years ago randomized trials showed us that survival was equal between breast conservation and mastectomy.

MRI has no apparent effect on reducing local recurrences either, as shown in an analysis of data on 3,180 patients published in 2014 (J Clin Oncol. 2014;32:292).

Regarding contralateral breast cancer, a 2007 study (N Engl J Med. 2007;356:1295-303) showed that among 969 women, MRI found unsuspected cancer in the contralateral breast within 1 year of diagnosis in 3.1%, a finding used to support the argument that all women with breast cancer should have an MRI. But a second study using Surveillance, Epidemiology and End Results (SEER) data on 339,790 women with 2.5 million person-years of follow-up found that the 10-year rate of contralateral cancers was 2%-3% of women with estrogen-receptor–positive tumors, and in 5%-6% of those with estrogen-receptor–negative tumors, strongly suggesting that MRI leads to detection and treatment of disease that would never become clinically evident.

Finally, I would point to evidence that MRI does not improve short-term surgical outcomes, as shown in a meta-analysis my colleagues and I conducted of two randomized controlled trials and seven cohort studies, involving a total of 3,112 patients (Ann Surg. 2013;257:249-55).

We found that after adjustment for age, having an MRI was associated with a three-fold greater chance of having a mastectomy, and MRI did not significantly reduce either the need for re-excision or unexpected conversion to mastectomy. We also performed a subanalysis of infiltrating lobular cancers, and found that there was no statistically significant benefit for MRI in these patients.

The overall rate of mastectomy was 25.5% among patients who had an MRI, vs. 18.2% for those who did not.

So to summarize: MRI finds two to three times more cancer than observed rates of local recurrence, leading to unnecessary mastectomies and does not improve short-term surgical outcomes, and there is no evidence indicating that MRI decreases local recurrence.

Monica Morrow, MD, FACS, is chief of the breast service in the department of surgery and holds the Anne Burnett Windfohr Chair of Clinical Oncology at Memorial Sloan Kettering Cancer Center in New York.

Yes: MRI should be considered in the preoperative setting for specific clinical indications.

MRI, like any technology, has its strengths and weaknesses, with high sensitivity but low specificity. Importantly, MRI provides excellent soft tissue contrast with anatomic 3-D detail, and is not impeded by high breast density.

Admittedly, MRI only incrementally increases cancer detection rates in either the ipsilateral or contralateral breasts of all patients, and when used in the preoperative setting does not affect short-term surgical outcomes for all patients. Therefore, MRI should not be used for routine screening or routine preoperative screening.

That said, there are specific clinical situations where preoperative MRI may provide surgeons with valuable information. These include patients who have:

• Invasive lobular carcinoma.

• Neoadjuvant chemotherapy.

• Occult primaries in extremely dense breasts.

Invasive lobular carcinomas are more likely to be multi-centric, multi-focal, and/or bilateral than other breast cancer types, and they are more difficult to diagnose because they infiltrate into tissue, making it extremely difficult to determine the extent of disease. In this setting, MRI can more accurately determine tumor size than mammography. Mammography underestimates the tumor size significantly more frequently than does MRI. In addition, among women with this cancer subtype, MRI can significantly reduce the rate of excision (Breast Cancer Res Treat. 2010;119;415-22).

We know that women at risk for systemic recurrence will not be cured with surgery alone. Neoadjuvant therapies give us the opportunity to refine local therapy options, better understand the patient’s response to therapy and prognosis, and accelerate targeted drug development to improve outcomes. To accomplish all of these goals, we need a noninvasive way to assess tumors before, during, and after neoadjuvant treatment. MRI is unsurpassed for evaluating the extent of tumors, showing in larger tumors, for example, the complexity of tumor and stroma.

MRI is also a biomarker for response to therapy and has been shown to be an independent predictor of event-free survival. In addition, MRI is more accurate than either clinical exam, mammography, or ultrasound for determining residual tumor size following neoadjuvant chemotherapy (Radiology. 2012;263:663-72).

Lastly, for patients with an occult primary (by imaging) breast cancer or primary presentation of axillary node involvement, MRI has been found to have an approximately 90% sensitivity for identifying a primary tumor, and a 95% accuracy at locating the tumor in patients who undergo surgical excision. Mammography cannot distinguish a tumor mass that is dense relative to surrounding tissue. However, MRI can distinguish a tumor which is obscured by dense breast tissue because tumors are visualized on MRI by rapid contrast uptake and washout.

MRI is a catalyst for change, but you have to use it and all technology wisely: At the time of diagnosis for select patients, for screening only those patients with very breast dense tissue and very high risk for developing breast cancer, and, perhaps most importantly, for postcancer surveillance only in women at very high risk of recurrence where standard tools such as mammography are expected to have lower performance (for example, very dense breast tissue). Overuse of MRI will increase false positives, anxiety, and cost. However, used appropriately, MRI can be used to help usher in a change in practice through the evaluation of response to neoadjuvant therapy and novel therapeutic approaches to both invasive and in situ lesions.

With improvements in technology and techniques such as diffusion-weighted imaging, the value of MRI in the preoperative setting can only continue to grow. We can also expect greater performance for presurgical staging with more refined technologies for breast imaging, localization, and biopsy, but the costs have to come down. Breast-dedicated MRI technologies may address this need.

Laura Esserman, MD, is a professor of surgery and radiology at the University of California, San Francisco, and Director of the Carol Franc Buck Breast Care Center at the UCSF Mount Zion campus.

No: MRI leads to unnecessary surgeries and does not improve short-term surgical outcomes.

The key word in this debate is “routinely.” I agree that preoperative MRI may have a role in about 5% of all cases – namely in women with occult primaries and those who undergo neoadjuvant chemotherapy. But for the vast majority of patients, the 95%, I would argue that preoperative MRI has the potential to do more harm than good.

Thirty years of experience providing breast conserving therapies without MRI has taught us several important lessons:

• Selection of patients for breast-conserving therapy is not a big problem.

• The incidences of local recurrence and contralateral breast cancers have decreased over time, antedating the use of MRI.

• Surgical excision of all microscopic subclinical disease is not necessary to achieve good long-term outcomes.

In National Surgical Adjuvant Breast and Bowel Project studies from the 1990s, in the era before the use of aromatase inhibitors or HER-2 blockade, the 10-year incidence of ipsilateral breast tumor recurrence ranged from 3.5% to 6.5% in the breast cancer population at large.

In addition, the incidence of contralateral breast cancers has been declining at a rate of approximately 3% per year, thanks to the use of adjuvant systemic therapies.

We have known since the 1960s, thanks to our colleagues in pathology, that somewhere between 30% and 60% of breast cancers that appear to be localized have microscopic subclinical disease which is treated with breast irradiation. More recently, we have recognized that we can leave behind cancer in the axilla in anywhere from 13% to 27% of patients who are not receiving direct axillary radiation, and see failure rates of 1% or less.

In the context, then, of our current understanding of breast cancer biology, what outcomes could MRI be expected to improve, since the purpose of a test is to improve patient outcomes?

We know that MRI will not improve survival, because 30 years ago randomized trials showed us that survival was equal between breast conservation and mastectomy.

MRI has no apparent effect on reducing local recurrences either, as shown in an analysis of data on 3,180 patients published in 2014 (J Clin Oncol. 2014;32:292).

Regarding contralateral breast cancer, a 2007 study (N Engl J Med. 2007;356:1295-303) showed that among 969 women, MRI found unsuspected cancer in the contralateral breast within 1 year of diagnosis in 3.1%, a finding used to support the argument that all women with breast cancer should have an MRI. But a second study using Surveillance, Epidemiology and End Results (SEER) data on 339,790 women with 2.5 million person-years of follow-up found that the 10-year rate of contralateral cancers was 2%-3% of women with estrogen-receptor–positive tumors, and in 5%-6% of those with estrogen-receptor–negative tumors, strongly suggesting that MRI leads to detection and treatment of disease that would never become clinically evident.

Finally, I would point to evidence that MRI does not improve short-term surgical outcomes, as shown in a meta-analysis my colleagues and I conducted of two randomized controlled trials and seven cohort studies, involving a total of 3,112 patients (Ann Surg. 2013;257:249-55).

We found that after adjustment for age, having an MRI was associated with a three-fold greater chance of having a mastectomy, and MRI did not significantly reduce either the need for re-excision or unexpected conversion to mastectomy. We also performed a subanalysis of infiltrating lobular cancers, and found that there was no statistically significant benefit for MRI in these patients.

The overall rate of mastectomy was 25.5% among patients who had an MRI, vs. 18.2% for those who did not.

So to summarize: MRI finds two to three times more cancer than observed rates of local recurrence, leading to unnecessary mastectomies and does not improve short-term surgical outcomes, and there is no evidence indicating that MRI decreases local recurrence.

Monica Morrow, MD, FACS, is chief of the breast service in the department of surgery and holds the Anne Burnett Windfohr Chair of Clinical Oncology at Memorial Sloan Kettering Cancer Center in New York.

Six years after promising a plan to “repeal and replace” the federal health law, House Republicans are finally ready to deliver.

The 37-page white paper, called “A Better Way,” includes virtually every idea on health care proposed by Republicans going back at least 2 decades. It would bring back “high-risk pools” for people with very high medical expenses, end open-ended funding for the Medicaid program, and encourage small businesses to band together to get better bargaining power in “Association Health Plans.”

What the plan does not include, however, is any idea of how much it would cost, or how it would be financed. Also unclear is how many of the 20 million Americans who have gained coverage since the law took effect would be able to remain insured.

“It’s a framework,” a senior House Republican leadership aide said on a conference call with reporters Tuesday, with the specifics to be determined next year by congressional committees, assuming the GOP maintains its majority. He likened the document to the white paper issued just after President Barack Obama’s election by then–Senate Finance Committee Chairman Max Baucus (D-Mont.). That document foreshadowed many of the key elements of the Affordable Care Act.

The plan starts with repeal of the health law and its requirements and taxes, but it would then put back many of its most popular elements: Allowing young adults to stay on their parents’ health plan to age 26; banning insurers from charging people with preexisting health problems higher premiums; and forbidding insurers from dropping coverage if a policyholder gets sick.

It would repeal the current scheme of exchanges where consumers buy insurance and government tax credits to help moderate-income Americans pay their premiums if they don’t have an employer to help. Instead, everyone buying policies in the individual market would receive tax credits. Older people charged more by insurers would receive larger credits, though the House Republicans don’t specify how much.

But the GOP plan also would likely make insurance more expensive for older people by proposing a broader range for premiums based on age. Current premiums can vary only threefold based on age, which is “driving out younger and healthier patients” who can’t afford them, the GOP aide said.

Under the plan, insurance companies could not charge higher rates to people with preexisting conditions so long as they maintain continuous coverage, whether from an employer or in a policy they purchase themselves. The new high-risk pools would be available for those who have a break in coverage, or who fail to purchase during a one-time open enrollment under the plan.

The plan would get rid of most of the coverage requirements under the Medicaid program for the poor, so states could make them more or less generous than they are currently. It would also limit funding. States could opt for either a per-person cap or a block grant to spend much as they wish.

On Medicare, the proposal would encourage the existing movement of patients from the program’s traditional fee-for-service program to managed care plans, and would transition from the existing financing structure based on benefits to a controversial structure called “premium support” that puts cost-controlling responsibilities more on private insurance companies. That change has been pushed by House Speaker Paul Ryan (R-Wisc.) for nearly a decade.

Backers of the existing health law were quick to criticize the GOP outline.

“The proposal introduced by Speaker Ryan is nothing more than vague and recycled ideas to take health insurance away from millions and increase costs for seniors and hardworking families,” said White House Assistant Press Secretary Katie Hill.

Families USA Executive Director Ron Pollack, who pushed hard for passage of the Affordable Care Act, said: “Make no mistake, Ryan’s approach is not a better way forward, but a bitter path backward that returns us to the bad old days when vast swaths of Americans were left to the tender mercies of the insurance industry and could not afford needed care.”

This story appears courtesy of Kaiser Health News, a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Six years after promising a plan to “repeal and replace” the federal health law, House Republicans are finally ready to deliver.

The 37-page white paper, called “A Better Way,” includes virtually every idea on health care proposed by Republicans going back at least 2 decades. It would bring back “high-risk pools” for people with very high medical expenses, end open-ended funding for the Medicaid program, and encourage small businesses to band together to get better bargaining power in “Association Health Plans.”

What the plan does not include, however, is any idea of how much it would cost, or how it would be financed. Also unclear is how many of the 20 million Americans who have gained coverage since the law took effect would be able to remain insured.

“It’s a framework,” a senior House Republican leadership aide said on a conference call with reporters Tuesday, with the specifics to be determined next year by congressional committees, assuming the GOP maintains its majority. He likened the document to the white paper issued just after President Barack Obama’s election by then–Senate Finance Committee Chairman Max Baucus (D-Mont.). That document foreshadowed many of the key elements of the Affordable Care Act.

The plan starts with repeal of the health law and its requirements and taxes, but it would then put back many of its most popular elements: Allowing young adults to stay on their parents’ health plan to age 26; banning insurers from charging people with preexisting health problems higher premiums; and forbidding insurers from dropping coverage if a policyholder gets sick.

It would repeal the current scheme of exchanges where consumers buy insurance and government tax credits to help moderate-income Americans pay their premiums if they don’t have an employer to help. Instead, everyone buying policies in the individual market would receive tax credits. Older people charged more by insurers would receive larger credits, though the House Republicans don’t specify how much.

But the GOP plan also would likely make insurance more expensive for older people by proposing a broader range for premiums based on age. Current premiums can vary only threefold based on age, which is “driving out younger and healthier patients” who can’t afford them, the GOP aide said.

Under the plan, insurance companies could not charge higher rates to people with preexisting conditions so long as they maintain continuous coverage, whether from an employer or in a policy they purchase themselves. The new high-risk pools would be available for those who have a break in coverage, or who fail to purchase during a one-time open enrollment under the plan.

The plan would get rid of most of the coverage requirements under the Medicaid program for the poor, so states could make them more or less generous than they are currently. It would also limit funding. States could opt for either a per-person cap or a block grant to spend much as they wish.

On Medicare, the proposal would encourage the existing movement of patients from the program’s traditional fee-for-service program to managed care plans, and would transition from the existing financing structure based on benefits to a controversial structure called “premium support” that puts cost-controlling responsibilities more on private insurance companies. That change has been pushed by House Speaker Paul Ryan (R-Wisc.) for nearly a decade.

Backers of the existing health law were quick to criticize the GOP outline.

“The proposal introduced by Speaker Ryan is nothing more than vague and recycled ideas to take health insurance away from millions and increase costs for seniors and hardworking families,” said White House Assistant Press Secretary Katie Hill.

Families USA Executive Director Ron Pollack, who pushed hard for passage of the Affordable Care Act, said: “Make no mistake, Ryan’s approach is not a better way forward, but a bitter path backward that returns us to the bad old days when vast swaths of Americans were left to the tender mercies of the insurance industry and could not afford needed care.”

This story appears courtesy of Kaiser Health News, a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Six years after promising a plan to “repeal and replace” the federal health law, House Republicans are finally ready to deliver.

The 37-page white paper, called “A Better Way,” includes virtually every idea on health care proposed by Republicans going back at least 2 decades. It would bring back “high-risk pools” for people with very high medical expenses, end open-ended funding for the Medicaid program, and encourage small businesses to band together to get better bargaining power in “Association Health Plans.”

What the plan does not include, however, is any idea of how much it would cost, or how it would be financed. Also unclear is how many of the 20 million Americans who have gained coverage since the law took effect would be able to remain insured.

“It’s a framework,” a senior House Republican leadership aide said on a conference call with reporters Tuesday, with the specifics to be determined next year by congressional committees, assuming the GOP maintains its majority. He likened the document to the white paper issued just after President Barack Obama’s election by then–Senate Finance Committee Chairman Max Baucus (D-Mont.). That document foreshadowed many of the key elements of the Affordable Care Act.

The plan starts with repeal of the health law and its requirements and taxes, but it would then put back many of its most popular elements: Allowing young adults to stay on their parents’ health plan to age 26; banning insurers from charging people with preexisting health problems higher premiums; and forbidding insurers from dropping coverage if a policyholder gets sick.

It would repeal the current scheme of exchanges where consumers buy insurance and government tax credits to help moderate-income Americans pay their premiums if they don’t have an employer to help. Instead, everyone buying policies in the individual market would receive tax credits. Older people charged more by insurers would receive larger credits, though the House Republicans don’t specify how much.

But the GOP plan also would likely make insurance more expensive for older people by proposing a broader range for premiums based on age. Current premiums can vary only threefold based on age, which is “driving out younger and healthier patients” who can’t afford them, the GOP aide said.

Under the plan, insurance companies could not charge higher rates to people with preexisting conditions so long as they maintain continuous coverage, whether from an employer or in a policy they purchase themselves. The new high-risk pools would be available for those who have a break in coverage, or who fail to purchase during a one-time open enrollment under the plan.

The plan would get rid of most of the coverage requirements under the Medicaid program for the poor, so states could make them more or less generous than they are currently. It would also limit funding. States could opt for either a per-person cap or a block grant to spend much as they wish.

On Medicare, the proposal would encourage the existing movement of patients from the program’s traditional fee-for-service program to managed care plans, and would transition from the existing financing structure based on benefits to a controversial structure called “premium support” that puts cost-controlling responsibilities more on private insurance companies. That change has been pushed by House Speaker Paul Ryan (R-Wisc.) for nearly a decade.

Backers of the existing health law were quick to criticize the GOP outline.

“The proposal introduced by Speaker Ryan is nothing more than vague and recycled ideas to take health insurance away from millions and increase costs for seniors and hardworking families,” said White House Assistant Press Secretary Katie Hill.

Families USA Executive Director Ron Pollack, who pushed hard for passage of the Affordable Care Act, said: “Make no mistake, Ryan’s approach is not a better way forward, but a bitter path backward that returns us to the bad old days when vast swaths of Americans were left to the tender mercies of the insurance industry and could not afford needed care.”

This story appears courtesy of Kaiser Health News, a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

The Medicare Trust Fund is projected to become insolvent in 2028, 2 years earlier than projected this time last year.

The change is based on two key factors: an expected reduction in payroll taxes and a slowdown in declining rate of inpatient utilization, Andy Slavitt, acting administrator of the Centers for Medicare & Medicaid Services said at a June 22 press conference to review the annual Medicare Trustees report.

©MADDRAT/thinkstockphotos.com

“The good news is inpatient utilization is still declining, it’s just declining at a slightly lower rate,” Mr. Slavitt said.

He also highlighted the continuing rising cost of prescription medications, which he called “a major driver” in Medicare spending growth.

“For the second year in a row, we saw spending growth for prescription drugs dramatically outpace cost growth for other Medicare services,” Mr. Slavitt said. “Through 2025, Medicare Part D expenditures per enrollee are estimated to increase nearly 50% higher than the estimated increase in GDP per capita and higher than the combined per enrollee growth rate of Medicare Part A and Medicare Part B combined.”

Overall, total Medicare expenditures “are slightly lower than estimated last year,” Mr. Slavitt said, adding that over the next decade, “Medicare per-enrollee spending is projected to continue to grow slower than historical rates, at 4.3%, lower than the growth in overall per capita national health expenditures.”

The growth rate is not projected to trigger the activation of the Independent Payment Advisory Board, according to the report.

In 2015, Medicare covered 55.3 million people, including 46.3 million aged 65 and older, and 9 million disabled individuals.

[email protected]

The Medicare Trust Fund is projected to become insolvent in 2028, 2 years earlier than projected this time last year.

The change is based on two key factors: an expected reduction in payroll taxes and a slowdown in declining rate of inpatient utilization, Andy Slavitt, acting administrator of the Centers for Medicare & Medicaid Services said at a June 22 press conference to review the annual Medicare Trustees report.

©MADDRAT/thinkstockphotos.com

“The good news is inpatient utilization is still declining, it’s just declining at a slightly lower rate,” Mr. Slavitt said.

He also highlighted the continuing rising cost of prescription medications, which he called “a major driver” in Medicare spending growth.

“For the second year in a row, we saw spending growth for prescription drugs dramatically outpace cost growth for other Medicare services,” Mr. Slavitt said. “Through 2025, Medicare Part D expenditures per enrollee are estimated to increase nearly 50% higher than the estimated increase in GDP per capita and higher than the combined per enrollee growth rate of Medicare Part A and Medicare Part B combined.”

Overall, total Medicare expenditures “are slightly lower than estimated last year,” Mr. Slavitt said, adding that over the next decade, “Medicare per-enrollee spending is projected to continue to grow slower than historical rates, at 4.3%, lower than the growth in overall per capita national health expenditures.”

The growth rate is not projected to trigger the activation of the Independent Payment Advisory Board, according to the report.

In 2015, Medicare covered 55.3 million people, including 46.3 million aged 65 and older, and 9 million disabled individuals.

[email protected]

The Medicare Trust Fund is projected to become insolvent in 2028, 2 years earlier than projected this time last year.

The change is based on two key factors: an expected reduction in payroll taxes and a slowdown in declining rate of inpatient utilization, Andy Slavitt, acting administrator of the Centers for Medicare & Medicaid Services said at a June 22 press conference to review the annual Medicare Trustees report.

©MADDRAT/thinkstockphotos.com

“The good news is inpatient utilization is still declining, it’s just declining at a slightly lower rate,” Mr. Slavitt said.

He also highlighted the continuing rising cost of prescription medications, which he called “a major driver” in Medicare spending growth.

“For the second year in a row, we saw spending growth for prescription drugs dramatically outpace cost growth for other Medicare services,” Mr. Slavitt said. “Through 2025, Medicare Part D expenditures per enrollee are estimated to increase nearly 50% higher than the estimated increase in GDP per capita and higher than the combined per enrollee growth rate of Medicare Part A and Medicare Part B combined.”

Overall, total Medicare expenditures “are slightly lower than estimated last year,” Mr. Slavitt said, adding that over the next decade, “Medicare per-enrollee spending is projected to continue to grow slower than historical rates, at 4.3%, lower than the growth in overall per capita national health expenditures.”

The growth rate is not projected to trigger the activation of the Independent Payment Advisory Board, according to the report.

In 2015, Medicare covered 55.3 million people, including 46.3 million aged 65 and older, and 9 million disabled individuals.

[email protected]

CHICAGO – Dealing with disruptive behavior by staff and colleagues isn’t just about knowing what to do – it’s also about knowing what not to do.

Often, mishandling disruptive behavior can make matters worse and lead to further conflict among physicians and employees, health law experts warn. At a conference held by the American Bar Association, attorneys offered guidance on the dos and don’ts of disruptive behavior management.

Don’t discipline for the wrong reasons

Know what disruptive behavior is not, advised Margo S. Struthers, a Minneapolis-based health law attorney. Criticism offered in good faith with the aim of improving patient care should not be considered disruptive, she said.

Courtesy Margo Struthers

“This is a problem that comes up a lot because, often, there is some element of criticism that is offered by the supposed disruptive physician, which may or may not be justified, may or may have been done in good faith, and may or may not have been in a respectful manner.”

An isolated incident of behavior that is not reflective of a pattern of inappropriate, deep-seated, and habitual behavior should not be construed as disruptive, Ms. Struthers added. In addition, disruptive behavior is not respectful disagreement with leadership, presentation of controversial ideas, or the respectful complaining about processes that endanger patient care.

Do address behavior that is truly disruptive

According to the American Medical Association, disruptive behavior is defined as personal conduct, whether verbal or physical, that negatively affects or that potentially may negatively affect patient care, including conduct that interferes the ability to work with members of the health care team. Such behavior can be passive, such as ignoring calls or frequently missing meetings; passive-aggressive, such as excessive sarcasm or veiled threats; or aggressive, such as yelling or bullying.

Don’t focus solely on the behavior

Most disruptive behavior has a root cause, and efforts should be made to get to the bottom of the conduct, according to Sidney Welch, an Atlanta-based health law attorney.

“Often, there’s an underlying frustration in terms of clinical care or what they’re being told to do or the systems and processes [in play],” she said “Where is the sources of the tension that is creating the behavior?”

Do identify contributing factors

Personality characteristics that could lead to hostile behavior include self-centeredness, immaturity, resentfulness, or a need for power and control. Systemic factors could include increased productivity demands, cost-containment requirements, embedded hierarchies, fear of litigation, ineffective or absent conflict-resolution processes, competition between hospitals and medical staff, new care settings, and marketplace demands. Shortages of staff and high work burdens also could fuel disruptive behavior, Ms. Welch said.

“There are situations where there [is] a psychiatric disorder or a personality disorder that’s the root cause of the disruption,” she said. But “sometimes it’s just a stressful situation. A lot of these cases [in which] the physician is the disruption, we’re seeing them in high stakes emergency departments or situations where decisions have to be made very quickly, or fatigue and external stresses may be the source.”

Don’t apply corrective actions inconsistently

Make expectations clear by having a code of conduct supported by policies that apply to every employee, Ms. Welch noted. A lack of fairness among employees can create greater tension and generate increased conflict during a disruptive situation. Ensure that physicians are not be treated differently than nurses or administrators when addressing complaints, she said.

Do implement a graduated set of responses

A tiered response system (informal, formal, disciplinary, regulatory) helps manage disruptive situations based on the extent of conduct, Ms. Welch said.

“The process and disciplinary process [should] to be multileveled so that people know the rules of the road, and the parameters and the bumpers so to speak, are defined.”

Don’t necessarily involve HR

Be cautious of allowing human resource (HR) departments to direct potential disruptive physician issues, Ms. Struthers said.

“I have some concerns about HR getting involved for a couple of reasons,” she said. “If you get nonphysicians involved, it seems to exacerbate the level of tension.”

In addition, if a hospital has a significant number of both employed and independent physicians, HR can sometimes apply different standards and varied courses of action depending on employment status, she said. Of course, if the alleged disrupter is a nonphysician, HR is generally the only route for remedy within a hospital setting, Ms. Welch noted.

Do address the issue through internal processes

Every medical staff should develop and adopt bylaw provisions or policies for intervening in situations in which a physician’s behavior is identified as disruptive, according to AMA policy. Medical staff bylaw provisions or policies should contain procedural safeguards that protect due process.

For doctors in groups or small practices, employment policies and procedures should address protocols when disruption matters arise, Ms. Struthers said.

“The dynamics in a small clinic is that some doctors may more have power than others, so it may be harder in some contexts to treat everyone the same,” she said in an interview. “But that’s a really important thing to do. Any well-advised clinics would have a code of conduct or conduct policy, really to protect the clinic from employee lawsuits.”

Don’t let policies collect dust

“As we all know, you can write the policies, you can put them on the shelf, but if people aren’t reading them and understanding them and aren’t educated on them, then it really does no good,” Ms. Welch said.

Do ensure everyone knows how disruptive behavior is handled

Make certain that all staff review disruptive behavior policies and are adequately trained in how the process works, Ms. Welch added. Employees should know where to seek help if experiencing a disruption matter. Consider having staff members sign or acknowledge a code of conduct upon credentialing or hiring.

“Obviously, disruptive behavior can impact patient care, and it can come from a lot of differ directions; It’s not just physicians,” Ms. Struthers said. “Hospitals [and practices] like other places of business, need to have comprehensive polices and procedures, and they need to follow them.”

[email protected]

On Twitter @legal_med

CHICAGO – Dealing with disruptive behavior by staff and colleagues isn’t just about knowing what to do – it’s also about knowing what not to do.

Often, mishandling disruptive behavior can make matters worse and lead to further conflict among physicians and employees, health law experts warn. At a conference held by the American Bar Association, attorneys offered guidance on the dos and don’ts of disruptive behavior management.

Don’t discipline for the wrong reasons

Know what disruptive behavior is not, advised Margo S. Struthers, a Minneapolis-based health law attorney. Criticism offered in good faith with the aim of improving patient care should not be considered disruptive, she said.

Courtesy Margo Struthers

“This is a problem that comes up a lot because, often, there is some element of criticism that is offered by the supposed disruptive physician, which may or may not be justified, may or may have been done in good faith, and may or may not have been in a respectful manner.”

An isolated incident of behavior that is not reflective of a pattern of inappropriate, deep-seated, and habitual behavior should not be construed as disruptive, Ms. Struthers added. In addition, disruptive behavior is not respectful disagreement with leadership, presentation of controversial ideas, or the respectful complaining about processes that endanger patient care.

Do address behavior that is truly disruptive

According to the American Medical Association, disruptive behavior is defined as personal conduct, whether verbal or physical, that negatively affects or that potentially may negatively affect patient care, including conduct that interferes the ability to work with members of the health care team. Such behavior can be passive, such as ignoring calls or frequently missing meetings; passive-aggressive, such as excessive sarcasm or veiled threats; or aggressive, such as yelling or bullying.

Don’t focus solely on the behavior

Most disruptive behavior has a root cause, and efforts should be made to get to the bottom of the conduct, according to Sidney Welch, an Atlanta-based health law attorney.

“Often, there’s an underlying frustration in terms of clinical care or what they’re being told to do or the systems and processes [in play],” she said “Where is the sources of the tension that is creating the behavior?”

Do identify contributing factors

Personality characteristics that could lead to hostile behavior include self-centeredness, immaturity, resentfulness, or a need for power and control. Systemic factors could include increased productivity demands, cost-containment requirements, embedded hierarchies, fear of litigation, ineffective or absent conflict-resolution processes, competition between hospitals and medical staff, new care settings, and marketplace demands. Shortages of staff and high work burdens also could fuel disruptive behavior, Ms. Welch said.

“There are situations where there [is] a psychiatric disorder or a personality disorder that’s the root cause of the disruption,” she said. But “sometimes it’s just a stressful situation. A lot of these cases [in which] the physician is the disruption, we’re seeing them in high stakes emergency departments or situations where decisions have to be made very quickly, or fatigue and external stresses may be the source.”

Don’t apply corrective actions inconsistently

Make expectations clear by having a code of conduct supported by policies that apply to every employee, Ms. Welch noted. A lack of fairness among employees can create greater tension and generate increased conflict during a disruptive situation. Ensure that physicians are not be treated differently than nurses or administrators when addressing complaints, she said.

Do implement a graduated set of responses

A tiered response system (informal, formal, disciplinary, regulatory) helps manage disruptive situations based on the extent of conduct, Ms. Welch said.

“The process and disciplinary process [should] to be multileveled so that people know the rules of the road, and the parameters and the bumpers so to speak, are defined.”

Don’t necessarily involve HR

Be cautious of allowing human resource (HR) departments to direct potential disruptive physician issues, Ms. Struthers said.

“I have some concerns about HR getting involved for a couple of reasons,” she said. “If you get nonphysicians involved, it seems to exacerbate the level of tension.”

In addition, if a hospital has a significant number of both employed and independent physicians, HR can sometimes apply different standards and varied courses of action depending on employment status, she said. Of course, if the alleged disrupter is a nonphysician, HR is generally the only route for remedy within a hospital setting, Ms. Welch noted.

Do address the issue through internal processes

Every medical staff should develop and adopt bylaw provisions or policies for intervening in situations in which a physician’s behavior is identified as disruptive, according to AMA policy. Medical staff bylaw provisions or policies should contain procedural safeguards that protect due process.

For doctors in groups or small practices, employment policies and procedures should address protocols when disruption matters arise, Ms. Struthers said.

“The dynamics in a small clinic is that some doctors may more have power than others, so it may be harder in some contexts to treat everyone the same,” she said in an interview. “But that’s a really important thing to do. Any well-advised clinics would have a code of conduct or conduct policy, really to protect the clinic from employee lawsuits.”

Don’t let policies collect dust

“As we all know, you can write the policies, you can put them on the shelf, but if people aren’t reading them and understanding them and aren’t educated on them, then it really does no good,” Ms. Welch said.

Do ensure everyone knows how disruptive behavior is handled

Make certain that all staff review disruptive behavior policies and are adequately trained in how the process works, Ms. Welch added. Employees should know where to seek help if experiencing a disruption matter. Consider having staff members sign or acknowledge a code of conduct upon credentialing or hiring.

“Obviously, disruptive behavior can impact patient care, and it can come from a lot of differ directions; It’s not just physicians,” Ms. Struthers said. “Hospitals [and practices] like other places of business, need to have comprehensive polices and procedures, and they need to follow them.”

[email protected]

On Twitter @legal_med

CHICAGO – Dealing with disruptive behavior by staff and colleagues isn’t just about knowing what to do – it’s also about knowing what not to do.

Often, mishandling disruptive behavior can make matters worse and lead to further conflict among physicians and employees, health law experts warn. At a conference held by the American Bar Association, attorneys offered guidance on the dos and don’ts of disruptive behavior management.

Don’t discipline for the wrong reasons

Know what disruptive behavior is not, advised Margo S. Struthers, a Minneapolis-based health law attorney. Criticism offered in good faith with the aim of improving patient care should not be considered disruptive, she said.

Courtesy Margo Struthers

“This is a problem that comes up a lot because, often, there is some element of criticism that is offered by the supposed disruptive physician, which may or may not be justified, may or may have been done in good faith, and may or may not have been in a respectful manner.”

An isolated incident of behavior that is not reflective of a pattern of inappropriate, deep-seated, and habitual behavior should not be construed as disruptive, Ms. Struthers added. In addition, disruptive behavior is not respectful disagreement with leadership, presentation of controversial ideas, or the respectful complaining about processes that endanger patient care.

Do address behavior that is truly disruptive

According to the American Medical Association, disruptive behavior is defined as personal conduct, whether verbal or physical, that negatively affects or that potentially may negatively affect patient care, including conduct that interferes the ability to work with members of the health care team. Such behavior can be passive, such as ignoring calls or frequently missing meetings; passive-aggressive, such as excessive sarcasm or veiled threats; or aggressive, such as yelling or bullying.

Don’t focus solely on the behavior

Most disruptive behavior has a root cause, and efforts should be made to get to the bottom of the conduct, according to Sidney Welch, an Atlanta-based health law attorney.

“Often, there’s an underlying frustration in terms of clinical care or what they’re being told to do or the systems and processes [in play],” she said “Where is the sources of the tension that is creating the behavior?”

Do identify contributing factors

Personality characteristics that could lead to hostile behavior include self-centeredness, immaturity, resentfulness, or a need for power and control. Systemic factors could include increased productivity demands, cost-containment requirements, embedded hierarchies, fear of litigation, ineffective or absent conflict-resolution processes, competition between hospitals and medical staff, new care settings, and marketplace demands. Shortages of staff and high work burdens also could fuel disruptive behavior, Ms. Welch said.

“There are situations where there [is] a psychiatric disorder or a personality disorder that’s the root cause of the disruption,” she said. But “sometimes it’s just a stressful situation. A lot of these cases [in which] the physician is the disruption, we’re seeing them in high stakes emergency departments or situations where decisions have to be made very quickly, or fatigue and external stresses may be the source.”

Don’t apply corrective actions inconsistently

Make expectations clear by having a code of conduct supported by policies that apply to every employee, Ms. Welch noted. A lack of fairness among employees can create greater tension and generate increased conflict during a disruptive situation. Ensure that physicians are not be treated differently than nurses or administrators when addressing complaints, she said.

Do implement a graduated set of responses

A tiered response system (informal, formal, disciplinary, regulatory) helps manage disruptive situations based on the extent of conduct, Ms. Welch said.

“The process and disciplinary process [should] to be multileveled so that people know the rules of the road, and the parameters and the bumpers so to speak, are defined.”

Don’t necessarily involve HR

Be cautious of allowing human resource (HR) departments to direct potential disruptive physician issues, Ms. Struthers said.

“I have some concerns about HR getting involved for a couple of reasons,” she said. “If you get nonphysicians involved, it seems to exacerbate the level of tension.”

In addition, if a hospital has a significant number of both employed and independent physicians, HR can sometimes apply different standards and varied courses of action depending on employment status, she said. Of course, if the alleged disrupter is a nonphysician, HR is generally the only route for remedy within a hospital setting, Ms. Welch noted.

Do address the issue through internal processes

Every medical staff should develop and adopt bylaw provisions or policies for intervening in situations in which a physician’s behavior is identified as disruptive, according to AMA policy. Medical staff bylaw provisions or policies should contain procedural safeguards that protect due process.

For doctors in groups or small practices, employment policies and procedures should address protocols when disruption matters arise, Ms. Struthers said.

“The dynamics in a small clinic is that some doctors may more have power than others, so it may be harder in some contexts to treat everyone the same,” she said in an interview. “But that’s a really important thing to do. Any well-advised clinics would have a code of conduct or conduct policy, really to protect the clinic from employee lawsuits.”

Don’t let policies collect dust

“As we all know, you can write the policies, you can put them on the shelf, but if people aren’t reading them and understanding them and aren’t educated on them, then it really does no good,” Ms. Welch said.

Do ensure everyone knows how disruptive behavior is handled

Make certain that all staff review disruptive behavior policies and are adequately trained in how the process works, Ms. Welch added. Employees should know where to seek help if experiencing a disruption matter. Consider having staff members sign or acknowledge a code of conduct upon credentialing or hiring.

“Obviously, disruptive behavior can impact patient care, and it can come from a lot of differ directions; It’s not just physicians,” Ms. Struthers said. “Hospitals [and practices] like other places of business, need to have comprehensive polices and procedures, and they need to follow them.”

[email protected]

On Twitter @legal_med

BALTIMORE – Wedge resection was associated with significantly improved overall 5-year survival, compared with stereotactic body radiation therapy (SBRT) in patients with operable clinical Stage IA non–small cell lung cancer, according to a study of more than 8,000 patients.

Despite the fact that surgical resection has been the standard of care for early-stage non–small cell lung cancer (NSCLC), an increasing number of patients with potentially operable early-stage NSCLC are now being treated with SBRT, study investigator Dr. Babatunde A. Yerokun said at the annual meeting of the American Association for Thoracic Surgery.

“Our data show that thoracic surgeons should be included in the evaluation of these patients, and operative candidates with ct1A NO MO NSCLC should continue to receive a wedge resection vs. SBRT when technically feasible,” said Dr. Yerokun of Duke University, Durham, N.C. “Prospective studies are needed to determine the appropriate role of SBRT in management of these patients,” he concluded.

Dr. Yerokun and his colleagues examined overall survival of patients with cT1N0 lung cancer who underwent SBRT or wedge resection as reported in the National Cancer Data Base from 2003 to 2011. Survival was assessed using Kaplan-Meier and propensity-score matched analysis. The researchers matched groups according to common prognostic covariates, including age, sex, race, education, insurance status, facility type, and Charlson/Deyo comorbidity score, as well as tumor histology, size, and location.

Patients identified as having cT1N0 NSCLC with a tumor less than 2 cm underwent SBRT (1,514 patients) or wedge resection (6,923). Compared with the wedge resection cohort, the SBRT patients were significantly older (74 vs. 69 years) and significantly more likely to be treated at an academic comprehensive cancer program (47% vs. 37%). The median Charlson/Deyo score was lower in the SBRT patients (0 vs. 1).

In unmatched analysis, SBRT was associated with significantly lower survival than wedge resection (5-year overall survival: 32% vs. 55%). In the propensity matching, all baseline covariates, including co-morbidity scores, facility type, and tumor size, were well balanced between the SBRT and wedge groups, with 1,398 patients in each group.

However, even in the matched groups, SBRT was associated with significantly lower 5-year overall survival than wedge (33% vs. 52%). When the investigators performed a propensity matched subgroup analysis in younger patients (age less than 60 years) who had a Charlson/Deyo score of 0, SBRT was associated with worse survival with a 5-year overall survival of 59% vs. 82% for SBRT and wedge resection, respectively.

Additionally, Dr. Yerokun and his colleagues conducted a sensitivity analysis comparing centers that performed predominately wedge resection with centers that performed predominately SBRT. After the exclusion of centers with low-volume and centers that conducted either 100% wedge resection or 100% SBRT only, centers that performed predominately wedge resection were more likely to have significantly better 3-year survival.

A video of the original presentation from the AATS Annual Meeting is available online.

Dr. Yerokun reported that he had no disclosures related to this presentation.

[email protected]

On Twitter @ThoracicTweets

BALTIMORE – Wedge resection was associated with significantly improved overall 5-year survival, compared with stereotactic body radiation therapy (SBRT) in patients with operable clinical Stage IA non–small cell lung cancer, according to a study of more than 8,000 patients.

Despite the fact that surgical resection has been the standard of care for early-stage non–small cell lung cancer (NSCLC), an increasing number of patients with potentially operable early-stage NSCLC are now being treated with SBRT, study investigator Dr. Babatunde A. Yerokun said at the annual meeting of the American Association for Thoracic Surgery.

“Our data show that thoracic surgeons should be included in the evaluation of these patients, and operative candidates with ct1A NO MO NSCLC should continue to receive a wedge resection vs. SBRT when technically feasible,” said Dr. Yerokun of Duke University, Durham, N.C. “Prospective studies are needed to determine the appropriate role of SBRT in management of these patients,” he concluded.

Dr. Yerokun and his colleagues examined overall survival of patients with cT1N0 lung cancer who underwent SBRT or wedge resection as reported in the National Cancer Data Base from 2003 to 2011. Survival was assessed using Kaplan-Meier and propensity-score matched analysis. The researchers matched groups according to common prognostic covariates, including age, sex, race, education, insurance status, facility type, and Charlson/Deyo comorbidity score, as well as tumor histology, size, and location.

Patients identified as having cT1N0 NSCLC with a tumor less than 2 cm underwent SBRT (1,514 patients) or wedge resection (6,923). Compared with the wedge resection cohort, the SBRT patients were significantly older (74 vs. 69 years) and significantly more likely to be treated at an academic comprehensive cancer program (47% vs. 37%). The median Charlson/Deyo score was lower in the SBRT patients (0 vs. 1).

In unmatched analysis, SBRT was associated with significantly lower survival than wedge resection (5-year overall survival: 32% vs. 55%). In the propensity matching, all baseline covariates, including co-morbidity scores, facility type, and tumor size, were well balanced between the SBRT and wedge groups, with 1,398 patients in each group.

However, even in the matched groups, SBRT was associated with significantly lower 5-year overall survival than wedge (33% vs. 52%). When the investigators performed a propensity matched subgroup analysis in younger patients (age less than 60 years) who had a Charlson/Deyo score of 0, SBRT was associated with worse survival with a 5-year overall survival of 59% vs. 82% for SBRT and wedge resection, respectively.

Additionally, Dr. Yerokun and his colleagues conducted a sensitivity analysis comparing centers that performed predominately wedge resection with centers that performed predominately SBRT. After the exclusion of centers with low-volume and centers that conducted either 100% wedge resection or 100% SBRT only, centers that performed predominately wedge resection were more likely to have significantly better 3-year survival.

A video of the original presentation from the AATS Annual Meeting is available online.

Dr. Yerokun reported that he had no disclosures related to this presentation.

[email protected]

On Twitter @ThoracicTweets

BALTIMORE – Wedge resection was associated with significantly improved overall 5-year survival, compared with stereotactic body radiation therapy (SBRT) in patients with operable clinical Stage IA non–small cell lung cancer, according to a study of more than 8,000 patients.

Despite the fact that surgical resection has been the standard of care for early-stage non–small cell lung cancer (NSCLC), an increasing number of patients with potentially operable early-stage NSCLC are now being treated with SBRT, study investigator Dr. Babatunde A. Yerokun said at the annual meeting of the American Association for Thoracic Surgery.

“Our data show that thoracic surgeons should be included in the evaluation of these patients, and operative candidates with ct1A NO MO NSCLC should continue to receive a wedge resection vs. SBRT when technically feasible,” said Dr. Yerokun of Duke University, Durham, N.C. “Prospective studies are needed to determine the appropriate role of SBRT in management of these patients,” he concluded.

Dr. Yerokun and his colleagues examined overall survival of patients with cT1N0 lung cancer who underwent SBRT or wedge resection as reported in the National Cancer Data Base from 2003 to 2011. Survival was assessed using Kaplan-Meier and propensity-score matched analysis. The researchers matched groups according to common prognostic covariates, including age, sex, race, education, insurance status, facility type, and Charlson/Deyo comorbidity score, as well as tumor histology, size, and location.

Patients identified as having cT1N0 NSCLC with a tumor less than 2 cm underwent SBRT (1,514 patients) or wedge resection (6,923). Compared with the wedge resection cohort, the SBRT patients were significantly older (74 vs. 69 years) and significantly more likely to be treated at an academic comprehensive cancer program (47% vs. 37%). The median Charlson/Deyo score was lower in the SBRT patients (0 vs. 1).

In unmatched analysis, SBRT was associated with significantly lower survival than wedge resection (5-year overall survival: 32% vs. 55%). In the propensity matching, all baseline covariates, including co-morbidity scores, facility type, and tumor size, were well balanced between the SBRT and wedge groups, with 1,398 patients in each group.

However, even in the matched groups, SBRT was associated with significantly lower 5-year overall survival than wedge (33% vs. 52%). When the investigators performed a propensity matched subgroup analysis in younger patients (age less than 60 years) who had a Charlson/Deyo score of 0, SBRT was associated with worse survival with a 5-year overall survival of 59% vs. 82% for SBRT and wedge resection, respectively.

Additionally, Dr. Yerokun and his colleagues conducted a sensitivity analysis comparing centers that performed predominately wedge resection with centers that performed predominately SBRT. After the exclusion of centers with low-volume and centers that conducted either 100% wedge resection or 100% SBRT only, centers that performed predominately wedge resection were more likely to have significantly better 3-year survival.

A video of the original presentation from the AATS Annual Meeting is available online.

Dr. Yerokun reported that he had no disclosures related to this presentation.

[email protected]

On Twitter @ThoracicTweets

BALTIMORE – Approximately one in five patients is readmitted after esophagectomy, and leading risk factors for readmission are longer operative time, post-surgical ICU admission, and preoperative blood transfusions, according to a single-center study of 86 patients.

As one of the first reports on readmissions following esophagectomy with complete follow-up, this study, conducted at the Mayo Clinic in Rochester, Minn., demonstrates that even in a high volume center with specialization in esophageal and foregut surgery, readmission after esophagectomy is not uncommon, researchers reported at the annual meeting of the American Association for Thoracic Surgery.

“In the context of increasing pressures to reduce length of stay, we must also put in the effort to better understand our readmission rates and the important factors that affect them,” said study investigator Dr. Stephen Cassivi. “Reporting on ‘improved’ lengths of stay without accompanying data on readmission rates is not telling the whole story.”

According to the Mayo Clinic research team, identifying risk factors that predict readmissions might permit improved patient management and outcomes.

“Careful collection of data regarding patient outcomes, including unplanned hospital readmissions is essential to improve the quality of patient care since national databases can leave gaps in data regarding follow-up of these patients by failing to identify all readmissions after their surgery,” said Dr. Karen J. Dickinson, who presented the study at the meeting.

The study was designed such that all patients undergoing an elective esophagectomy between August 2013 and July 2014 were contacted directly to follow up on whether they had been readmitted to any medical institution within 30 days of dismissal from the Mayo Clinic. Among all patients who underwent esophagectomy during the one-year study period, 86 patients met the study inclusion criteria. Follow-up was complete in 100% of patients, according to Dr. Dickinson.

Median age of the patients at the time of surgery was 63 years, and the majority of patients were men (70 patients). The most common operative approach was transthoracic (Ivor Lewis) esophagectomy (72%); 7% of cases were performed using a minimally invasive approach. Overall 30-day mortality was 2% (2/86), and anastomotic leak occurred in 8% of the patients.

Median length of stay was 9 days, and the rate of unplanned 30-day readmission was 19% (16 patients). Of these patients, 88% were readmitted to the Mayo Clinic and 12% were readmitted to other medical institutions.

The most common reasons for readmission were due to respiratory causes such as dyspnea, pleural effusions or pneumonia and gastrointestinal causes, including bowel obstruction and anastomotic complications.

Using multivariable analysis, the researchers found that the factors significantly associated with unplanned readmission were postoperative ICU admission (13% in non-readmitted, 38% in admitted), perioperative blood transfusion (12% vs. 38%), and operative length (368 vs. 460 minutes). Importantly, initial hospital length of stay was not associated with the need for readmission. Furthermore, ASA score, sex, BMI, neoadjuvant therapy, and postoperative pain scores also were not associated with unplanned readmission.

“Identifying these risk factors in the perioperative and postoperative setting may provide opportunities for decreasing morbidity, improving readmission rates, and enhancing overall patient outcomes,” Dr. Dickinson concluded.

A video of this presentation at the AATS Annual Meeting is available online.

Dr. Dickinson and her colleagues reported having no relevant disclosures.

[email protected]

On Twitter @ThoracicTweets

BALTIMORE – Approximately one in five patients is readmitted after esophagectomy, and leading risk factors for readmission are longer operative time, post-surgical ICU admission, and preoperative blood transfusions, according to a single-center study of 86 patients.

As one of the first reports on readmissions following esophagectomy with complete follow-up, this study, conducted at the Mayo Clinic in Rochester, Minn., demonstrates that even in a high volume center with specialization in esophageal and foregut surgery, readmission after esophagectomy is not uncommon, researchers reported at the annual meeting of the American Association for Thoracic Surgery.

“In the context of increasing pressures to reduce length of stay, we must also put in the effort to better understand our readmission rates and the important factors that affect them,” said study investigator Dr. Stephen Cassivi. “Reporting on ‘improved’ lengths of stay without accompanying data on readmission rates is not telling the whole story.”

According to the Mayo Clinic research team, identifying risk factors that predict readmissions might permit improved patient management and outcomes.

“Careful collection of data regarding patient outcomes, including unplanned hospital readmissions is essential to improve the quality of patient care since national databases can leave gaps in data regarding follow-up of these patients by failing to identify all readmissions after their surgery,” said Dr. Karen J. Dickinson, who presented the study at the meeting.

The study was designed such that all patients undergoing an elective esophagectomy between August 2013 and July 2014 were contacted directly to follow up on whether they had been readmitted to any medical institution within 30 days of dismissal from the Mayo Clinic. Among all patients who underwent esophagectomy during the one-year study period, 86 patients met the study inclusion criteria. Follow-up was complete in 100% of patients, according to Dr. Dickinson.

Median age of the patients at the time of surgery was 63 years, and the majority of patients were men (70 patients). The most common operative approach was transthoracic (Ivor Lewis) esophagectomy (72%); 7% of cases were performed using a minimally invasive approach. Overall 30-day mortality was 2% (2/86), and anastomotic leak occurred in 8% of the patients.

Median length of stay was 9 days, and the rate of unplanned 30-day readmission was 19% (16 patients). Of these patients, 88% were readmitted to the Mayo Clinic and 12% were readmitted to other medical institutions.

The most common reasons for readmission were due to respiratory causes such as dyspnea, pleural effusions or pneumonia and gastrointestinal causes, including bowel obstruction and anastomotic complications.

Using multivariable analysis, the researchers found that the factors significantly associated with unplanned readmission were postoperative ICU admission (13% in non-readmitted, 38% in admitted), perioperative blood transfusion (12% vs. 38%), and operative length (368 vs. 460 minutes). Importantly, initial hospital length of stay was not associated with the need for readmission. Furthermore, ASA score, sex, BMI, neoadjuvant therapy, and postoperative pain scores also were not associated with unplanned readmission.

“Identifying these risk factors in the perioperative and postoperative setting may provide opportunities for decreasing morbidity, improving readmission rates, and enhancing overall patient outcomes,” Dr. Dickinson concluded.

A video of this presentation at the AATS Annual Meeting is available online.

Dr. Dickinson and her colleagues reported having no relevant disclosures.

[email protected]

On Twitter @ThoracicTweets

BALTIMORE – Approximately one in five patients is readmitted after esophagectomy, and leading risk factors for readmission are longer operative time, post-surgical ICU admission, and preoperative blood transfusions, according to a single-center study of 86 patients.

As one of the first reports on readmissions following esophagectomy with complete follow-up, this study, conducted at the Mayo Clinic in Rochester, Minn., demonstrates that even in a high volume center with specialization in esophageal and foregut surgery, readmission after esophagectomy is not uncommon, researchers reported at the annual meeting of the American Association for Thoracic Surgery.

“In the context of increasing pressures to reduce length of stay, we must also put in the effort to better understand our readmission rates and the important factors that affect them,” said study investigator Dr. Stephen Cassivi. “Reporting on ‘improved’ lengths of stay without accompanying data on readmission rates is not telling the whole story.”

According to the Mayo Clinic research team, identifying risk factors that predict readmissions might permit improved patient management and outcomes.

“Careful collection of data regarding patient outcomes, including unplanned hospital readmissions is essential to improve the quality of patient care since national databases can leave gaps in data regarding follow-up of these patients by failing to identify all readmissions after their surgery,” said Dr. Karen J. Dickinson, who presented the study at the meeting.

The study was designed such that all patients undergoing an elective esophagectomy between August 2013 and July 2014 were contacted directly to follow up on whether they had been readmitted to any medical institution within 30 days of dismissal from the Mayo Clinic. Among all patients who underwent esophagectomy during the one-year study period, 86 patients met the study inclusion criteria. Follow-up was complete in 100% of patients, according to Dr. Dickinson.

Median age of the patients at the time of surgery was 63 years, and the majority of patients were men (70 patients). The most common operative approach was transthoracic (Ivor Lewis) esophagectomy (72%); 7% of cases were performed using a minimally invasive approach. Overall 30-day mortality was 2% (2/86), and anastomotic leak occurred in 8% of the patients.

Median length of stay was 9 days, and the rate of unplanned 30-day readmission was 19% (16 patients). Of these patients, 88% were readmitted to the Mayo Clinic and 12% were readmitted to other medical institutions.

The most common reasons for readmission were due to respiratory causes such as dyspnea, pleural effusions or pneumonia and gastrointestinal causes, including bowel obstruction and anastomotic complications.

Using multivariable analysis, the researchers found that the factors significantly associated with unplanned readmission were postoperative ICU admission (13% in non-readmitted, 38% in admitted), perioperative blood transfusion (12% vs. 38%), and operative length (368 vs. 460 minutes). Importantly, initial hospital length of stay was not associated with the need for readmission. Furthermore, ASA score, sex, BMI, neoadjuvant therapy, and postoperative pain scores also were not associated with unplanned readmission.

“Identifying these risk factors in the perioperative and postoperative setting may provide opportunities for decreasing morbidity, improving readmission rates, and enhancing overall patient outcomes,” Dr. Dickinson concluded.

A video of this presentation at the AATS Annual Meeting is available online.

Dr. Dickinson and her colleagues reported having no relevant disclosures.

[email protected]

On Twitter @ThoracicTweets

Infections of aortic prosthetic grafts can be a devastating complication, and while cryopreserved human allografts (CHA) can continue to possess antibacterial activity even after 5 years or more in storage, cardiac surgeons may want to apply additional antibiotic agents during implantation to boost bacterial resistance, investigators from Germany reported in the May issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151:1251-9).

The researchers compared three different antibiotic regimens used in processing CHA aortic tissue and valves to determine the impact each can have on long-term bacterial resistance.

©CDC/Janice Haney Carr

“Antibiotic combinations applied during CHA processing have a significant influence on their infection resistance,” said Dr. Viola Steffen of Hannover (Germany) Medical School and her colleagues. The average storage time of CHAs was 8.5 years, with the longest having been stored for 10 years.

The study involved microbiologic tests in vitro of three different antibiotic regimens used in processing CHA: gentamicin-piperacillin-vancomycin-metronidazole-amphotericin B (group A); gentamicin-piperacillin-flucloxacillin-metronidazole-amphotericin B (group B); and meropenem-vancomycin-tobramycin-colistin-amphotericin B (group C). The combinations are used to counteract Staphylococcus epidermidis and Staphylococcus aureus.

The study exposed pieces of 10 CHAs to different microbes and determined that regimen groups B and C were more effective than group A in eradicating gram-positive organisms. Specifically, group C was most resistant to Escherichia coli, whereas group B was most effective against Pseudomonas aeruginosa. Aortic tissue showed significantly less contamination with staphylococcal bacteria than valve grafts, the study reported.

Dr. Steffen and her colleagues said that tissue banks use antibiotic protocols during CHA processing, but they differ substantially. “Our results support the hypothesis that infection resistance of CHAs depends on the antibiotic pretreatment during processing and their residual activity,” they said.

The study had four key findings:

• The infection resistance of aortic wall and valve tissue differed significantly.

• In aortic wall specimens, group A specimens exhibited increased adherence of S. epidermidis, with vancomycin in group A and flucloxacillin in group B being the only differentiating agents between the two.

• Cryopreserved aortic vessels had a propensity toward reduced infection resistance against P. aeruginosa.

• Morphologic changes occurred in the microorganisms, especially rod-shaped E. coli, indicating that regional antibiotic release alters bacterial growth without eliminating all adherent bacteria.

Dr. Steffen and her colleagues noted that while previous studies determined that residual concentrations of antibiotics used in processing CHA heart valves and blood vessels are still present after they are prepared for implantation, they neither measured the antibacterial affect, clarified the period of cryopreservation nor differentiated between valve and vessel tissue (PLoS One. 2014;9:e112679; Transfus Med Hemother. 2011;38:379-86).

The Hannover researchers found that only a few gram-positive microorganisms adhered to aortic wall specimens, although they found “extensive adherence” of S. epidermidis in group A specimens. Valves, however, “were completely colonized” with both strains of staphylococcal bacteria, although the severity of contamination varied depending on the regimen used.

The findings raise some questions about the antibiotic properties of CHAs. “Because their infection resistance depends on the antibiotic combination selected during processing, further investigations concerning this treatment are necessary to improve the antimicrobial activity against frequent and highly virulent infection-causing bacteria,” Dr. Steffen and her colleagues said.

Dr. Steffen and her coauthors had no financial relationships to disclose.

Infections of aortic prosthetic grafts can be a devastating complication, and while cryopreserved human allografts (CHA) can continue to possess antibacterial activity even after 5 years or more in storage, cardiac surgeons may want to apply additional antibiotic agents during implantation to boost bacterial resistance, investigators from Germany reported in the May issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151:1251-9).

The researchers compared three different antibiotic regimens used in processing CHA aortic tissue and valves to determine the impact each can have on long-term bacterial resistance.

©CDC/Janice Haney Carr

“Antibiotic combinations applied during CHA processing have a significant influence on their infection resistance,” said Dr. Viola Steffen of Hannover (Germany) Medical School and her colleagues. The average storage time of CHAs was 8.5 years, with the longest having been stored for 10 years.

The study involved microbiologic tests in vitro of three different antibiotic regimens used in processing CHA: gentamicin-piperacillin-vancomycin-metronidazole-amphotericin B (group A); gentamicin-piperacillin-flucloxacillin-metronidazole-amphotericin B (group B); and meropenem-vancomycin-tobramycin-colistin-amphotericin B (group C). The combinations are used to counteract Staphylococcus epidermidis and Staphylococcus aureus.

The study exposed pieces of 10 CHAs to different microbes and determined that regimen groups B and C were more effective than group A in eradicating gram-positive organisms. Specifically, group C was most resistant to Escherichia coli, whereas group B was most effective against Pseudomonas aeruginosa. Aortic tissue showed significantly less contamination with staphylococcal bacteria than valve grafts, the study reported.

Dr. Steffen and her colleagues said that tissue banks use antibiotic protocols during CHA processing, but they differ substantially. “Our results support the hypothesis that infection resistance of CHAs depends on the antibiotic pretreatment during processing and their residual activity,” they said.

The study had four key findings:

• The infection resistance of aortic wall and valve tissue differed significantly.

• In aortic wall specimens, group A specimens exhibited increased adherence of S. epidermidis, with vancomycin in group A and flucloxacillin in group B being the only differentiating agents between the two.

• Cryopreserved aortic vessels had a propensity toward reduced infection resistance against P. aeruginosa.

• Morphologic changes occurred in the microorganisms, especially rod-shaped E. coli, indicating that regional antibiotic release alters bacterial growth without eliminating all adherent bacteria.

Dr. Steffen and her colleagues noted that while previous studies determined that residual concentrations of antibiotics used in processing CHA heart valves and blood vessels are still present after they are prepared for implantation, they neither measured the antibacterial affect, clarified the period of cryopreservation nor differentiated between valve and vessel tissue (PLoS One. 2014;9:e112679; Transfus Med Hemother. 2011;38:379-86).

The Hannover researchers found that only a few gram-positive microorganisms adhered to aortic wall specimens, although they found “extensive adherence” of S. epidermidis in group A specimens. Valves, however, “were completely colonized” with both strains of staphylococcal bacteria, although the severity of contamination varied depending on the regimen used.

The findings raise some questions about the antibiotic properties of CHAs. “Because their infection resistance depends on the antibiotic combination selected during processing, further investigations concerning this treatment are necessary to improve the antimicrobial activity against frequent and highly virulent infection-causing bacteria,” Dr. Steffen and her colleagues said.

Dr. Steffen and her coauthors had no financial relationships to disclose.

Infections of aortic prosthetic grafts can be a devastating complication, and while cryopreserved human allografts (CHA) can continue to possess antibacterial activity even after 5 years or more in storage, cardiac surgeons may want to apply additional antibiotic agents during implantation to boost bacterial resistance, investigators from Germany reported in the May issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151:1251-9).

The researchers compared three different antibiotic regimens used in processing CHA aortic tissue and valves to determine the impact each can have on long-term bacterial resistance.

©CDC/Janice Haney Carr

“Antibiotic combinations applied during CHA processing have a significant influence on their infection resistance,” said Dr. Viola Steffen of Hannover (Germany) Medical School and her colleagues. The average storage time of CHAs was 8.5 years, with the longest having been stored for 10 years.

The study involved microbiologic tests in vitro of three different antibiotic regimens used in processing CHA: gentamicin-piperacillin-vancomycin-metronidazole-amphotericin B (group A); gentamicin-piperacillin-flucloxacillin-metronidazole-amphotericin B (group B); and meropenem-vancomycin-tobramycin-colistin-amphotericin B (group C). The combinations are used to counteract Staphylococcus epidermidis and Staphylococcus aureus.

The study exposed pieces of 10 CHAs to different microbes and determined that regimen groups B and C were more effective than group A in eradicating gram-positive organisms. Specifically, group C was most resistant to Escherichia coli, whereas group B was most effective against Pseudomonas aeruginosa. Aortic tissue showed significantly less contamination with staphylococcal bacteria than valve grafts, the study reported.

Dr. Steffen and her colleagues said that tissue banks use antibiotic protocols during CHA processing, but they differ substantially. “Our results support the hypothesis that infection resistance of CHAs depends on the antibiotic pretreatment during processing and their residual activity,” they said.

The study had four key findings:

• The infection resistance of aortic wall and valve tissue differed significantly.

• In aortic wall specimens, group A specimens exhibited increased adherence of S. epidermidis, with vancomycin in group A and flucloxacillin in group B being the only differentiating agents between the two.

• Cryopreserved aortic vessels had a propensity toward reduced infection resistance against P. aeruginosa.

• Morphologic changes occurred in the microorganisms, especially rod-shaped E. coli, indicating that regional antibiotic release alters bacterial growth without eliminating all adherent bacteria.

Dr. Steffen and her colleagues noted that while previous studies determined that residual concentrations of antibiotics used in processing CHA heart valves and blood vessels are still present after they are prepared for implantation, they neither measured the antibacterial affect, clarified the period of cryopreservation nor differentiated between valve and vessel tissue (PLoS One. 2014;9:e112679; Transfus Med Hemother. 2011;38:379-86).

The Hannover researchers found that only a few gram-positive microorganisms adhered to aortic wall specimens, although they found “extensive adherence” of S. epidermidis in group A specimens. Valves, however, “were completely colonized” with both strains of staphylococcal bacteria, although the severity of contamination varied depending on the regimen used.

The findings raise some questions about the antibiotic properties of CHAs. “Because their infection resistance depends on the antibiotic combination selected during processing, further investigations concerning this treatment are necessary to improve the antimicrobial activity against frequent and highly virulent infection-causing bacteria,” Dr. Steffen and her colleagues said.

Dr. Steffen and her coauthors had no financial relationships to disclose.