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House barely passes ACA repeal/replace bill
A few additional tweaks to the American Health Care Act helped garner just enough Republican votes to pass the first phase of the party’s three-part effort to repeal and replace the Affordable Care Act.
The bill passed May 4 by a 217-213 margin, with one Republican member not voting. The vote came after a false start in March when House Speaker Paul Ryan (R-Wisc.) canceled consideration because Republicans could not muster enough votes to pass it. All votes in favor of the bill came from GOP members, while all House Democrats plus 20 Republicans voted against passage.
Two amendments helped to make the bill palatable enough to gain enough votes for passage. New amendments from Rep. Gary Palmer (R-Ala.) and Rep. Fred Upton (R-Mich.) targeted high-risk pools. They were added to an April amendment from Rep. Tom MacArthur (R-N.J.) that would allow states to seek waivers for coverage of the essential health benefits and from community rating provisions to allow for higher premiums for those who are sicker or older.
The American Health Care Act (H.R. 1629) in its amended form has not been yet been scored by the Congressional Budget Office (CBO) to determine its effects on the federal budget. However, an earlier CBO analysis of the original, unamended bill predicted an estimated 58 million people would be uninsured by 2026, compared with 28 million under the Affordable Care Act. It is also predicting large premium increases for some groups of patients.
A CBO score is required of all legislation because, under Senate rules, anything that adds to the budget must be offset by additional revenue-generating provisions or cuts elsewhere in the federal budget. The bill, if passed and sent to the president’s desk for signature, is at minimum budget neutral if not deficit reducing.
The amended AHCA was roundly rejected by most physician organizations, including the American Medical Association and many specialty societies.
“The bill passed by the House today will result in millions of Americans losing access to quality, affordable health insurance and those with preexisting health conditions face the possibility of going back to the time when insurers could charge them premiums that made access to coverage out of the question,” AMA President Andrew Gurman, MD, said in a statement. “The AMA urges the Senate and the Administration to work with physician, patient, hospital, and other provider groups to craft bipartisan solutions so all American families can access affordable and meaningful coverage, while preserving the safety net for vulnerable patients.”
House Minority Leader Nancy Pelosi (D-Calif.), in addition to criticizing the bill for its predicted effects in increasing premiums and decreasing coverage for those with preexisting conditions, called out the bill for being nothing more than a means to help cover the cost of a separate tax bill when she described the AHCA as providing “tax cuts for the rich at the expense of health insurance for tens of millions of working families across America” during the debate prior to passage. “Trumpcare is a billionaire’s tax cut disguised as a health care bill.”
Speaker Ryan continued to highlight the continual coverage issues that have been growing in the individual health insurance marketplace, spotlighting Iowa, where insurer Medica has announced that it will likely discontinue providing coverage in 2018, leaving most counties in the state with no option to purchase coverage following the announced withdrawal of Aetna and Wellmark Blue Cross Blue Shield.
“This is a crisis,” Speaker Ryan said during the debate. “What protection is Obamacare if there is no health care plan to purchase in your state? This is the direction Obamacare is rapidly heading.”
In helping to get the AHCA barely over the final hurdle, the Palmer amendment creates an “invisible risk-sharing program” under which the federal government would subsidize insurers to the tune of $15 billion over 9 years. The program would allow insurers to make a prospective determination of who might be a cost-intensive user and move them to the high-risk pool with the federal funding joining insurer funding to help pay for coverage. The amendment also would change the ACA’s reinsurance provisions, which retroactively reimburse insurers for high-utilizing customers.
Neither invisible risk sharing nor retroactive reinsurance are “inherently superior at reducing premiums,” according to an April 12 blog post by the journal Health Affairs. “Premium reductions depend entirely on how much funding the program receives in relation to the risks being insured. Rep. Palmer’s amendment leaves all the critical details of this new, invisible program unspecified, making it hard to generate precise estimate.”
Authors Mark Hall, senior fellow at Brookings Institute, and Nicholas Bagely, law professor at the University of Michigan, Ann Arbor, note that the funding in the amendment “is no more than 2% of total premiums in the market.”
The Upton amendment would add an additional $8 billion in funding for high-risk pools, bringing the total amount potentially available to help cover people with preexisting conditions to $123 billion.
Analysis from Avalere finds that the funding specifically allocated to assist those with preexisting conditions ($23 billion, including the additional $8 billion from the Upton amendment) “will only cover 110,000 individuals with preexisting, chronic condition. If states were to allocate all the other funds [available in the AHCA] toward providing insurance to people with preexisting conditions ... 600,000 with preexisting chronic conditions could be covered.” The analysis notes approximately “2.2 million enrollees in the individual market today have some sort of preexisting chronic condition.”
“Given the amount of funding in the bill, the program can only afford a few small states to opt into medical underwriting,” Caroline Pearson, senior vice president at Avalere, said in a statement. “If any large states receive a waiver, many chronically ill individuals could be left without access to insurance.”
Because the AHCA focuses solely on reforming revenue-related aspects of the ACA and was passed using budget reconciliation procedures, it will need only a simple majority to pass the Senate. However, keeping the bill budget neutral will make it difficult to pass in its current form, even though Republicans hold 52 of the chamber’s 100 seats.
Phase two of the repeal and replace plan will be a full examination of federal regulations and phase three, which will require at least 60 votes in the Senate, will be changes to other provisions in the health care law that are not directly revenue generating. President Donald Trump in the past has suggested that this will include his goals of opening the sale of insurance across state lines and other key priorities.
A few additional tweaks to the American Health Care Act helped garner just enough Republican votes to pass the first phase of the party’s three-part effort to repeal and replace the Affordable Care Act.
The bill passed May 4 by a 217-213 margin, with one Republican member not voting. The vote came after a false start in March when House Speaker Paul Ryan (R-Wisc.) canceled consideration because Republicans could not muster enough votes to pass it. All votes in favor of the bill came from GOP members, while all House Democrats plus 20 Republicans voted against passage.
Two amendments helped to make the bill palatable enough to gain enough votes for passage. New amendments from Rep. Gary Palmer (R-Ala.) and Rep. Fred Upton (R-Mich.) targeted high-risk pools. They were added to an April amendment from Rep. Tom MacArthur (R-N.J.) that would allow states to seek waivers for coverage of the essential health benefits and from community rating provisions to allow for higher premiums for those who are sicker or older.
The American Health Care Act (H.R. 1629) in its amended form has not been yet been scored by the Congressional Budget Office (CBO) to determine its effects on the federal budget. However, an earlier CBO analysis of the original, unamended bill predicted an estimated 58 million people would be uninsured by 2026, compared with 28 million under the Affordable Care Act. It is also predicting large premium increases for some groups of patients.
A CBO score is required of all legislation because, under Senate rules, anything that adds to the budget must be offset by additional revenue-generating provisions or cuts elsewhere in the federal budget. The bill, if passed and sent to the president’s desk for signature, is at minimum budget neutral if not deficit reducing.
The amended AHCA was roundly rejected by most physician organizations, including the American Medical Association and many specialty societies.
“The bill passed by the House today will result in millions of Americans losing access to quality, affordable health insurance and those with preexisting health conditions face the possibility of going back to the time when insurers could charge them premiums that made access to coverage out of the question,” AMA President Andrew Gurman, MD, said in a statement. “The AMA urges the Senate and the Administration to work with physician, patient, hospital, and other provider groups to craft bipartisan solutions so all American families can access affordable and meaningful coverage, while preserving the safety net for vulnerable patients.”
House Minority Leader Nancy Pelosi (D-Calif.), in addition to criticizing the bill for its predicted effects in increasing premiums and decreasing coverage for those with preexisting conditions, called out the bill for being nothing more than a means to help cover the cost of a separate tax bill when she described the AHCA as providing “tax cuts for the rich at the expense of health insurance for tens of millions of working families across America” during the debate prior to passage. “Trumpcare is a billionaire’s tax cut disguised as a health care bill.”
Speaker Ryan continued to highlight the continual coverage issues that have been growing in the individual health insurance marketplace, spotlighting Iowa, where insurer Medica has announced that it will likely discontinue providing coverage in 2018, leaving most counties in the state with no option to purchase coverage following the announced withdrawal of Aetna and Wellmark Blue Cross Blue Shield.
“This is a crisis,” Speaker Ryan said during the debate. “What protection is Obamacare if there is no health care plan to purchase in your state? This is the direction Obamacare is rapidly heading.”
In helping to get the AHCA barely over the final hurdle, the Palmer amendment creates an “invisible risk-sharing program” under which the federal government would subsidize insurers to the tune of $15 billion over 9 years. The program would allow insurers to make a prospective determination of who might be a cost-intensive user and move them to the high-risk pool with the federal funding joining insurer funding to help pay for coverage. The amendment also would change the ACA’s reinsurance provisions, which retroactively reimburse insurers for high-utilizing customers.
Neither invisible risk sharing nor retroactive reinsurance are “inherently superior at reducing premiums,” according to an April 12 blog post by the journal Health Affairs. “Premium reductions depend entirely on how much funding the program receives in relation to the risks being insured. Rep. Palmer’s amendment leaves all the critical details of this new, invisible program unspecified, making it hard to generate precise estimate.”
Authors Mark Hall, senior fellow at Brookings Institute, and Nicholas Bagely, law professor at the University of Michigan, Ann Arbor, note that the funding in the amendment “is no more than 2% of total premiums in the market.”
The Upton amendment would add an additional $8 billion in funding for high-risk pools, bringing the total amount potentially available to help cover people with preexisting conditions to $123 billion.
Analysis from Avalere finds that the funding specifically allocated to assist those with preexisting conditions ($23 billion, including the additional $8 billion from the Upton amendment) “will only cover 110,000 individuals with preexisting, chronic condition. If states were to allocate all the other funds [available in the AHCA] toward providing insurance to people with preexisting conditions ... 600,000 with preexisting chronic conditions could be covered.” The analysis notes approximately “2.2 million enrollees in the individual market today have some sort of preexisting chronic condition.”
“Given the amount of funding in the bill, the program can only afford a few small states to opt into medical underwriting,” Caroline Pearson, senior vice president at Avalere, said in a statement. “If any large states receive a waiver, many chronically ill individuals could be left without access to insurance.”
Because the AHCA focuses solely on reforming revenue-related aspects of the ACA and was passed using budget reconciliation procedures, it will need only a simple majority to pass the Senate. However, keeping the bill budget neutral will make it difficult to pass in its current form, even though Republicans hold 52 of the chamber’s 100 seats.
Phase two of the repeal and replace plan will be a full examination of federal regulations and phase three, which will require at least 60 votes in the Senate, will be changes to other provisions in the health care law that are not directly revenue generating. President Donald Trump in the past has suggested that this will include his goals of opening the sale of insurance across state lines and other key priorities.
A few additional tweaks to the American Health Care Act helped garner just enough Republican votes to pass the first phase of the party’s three-part effort to repeal and replace the Affordable Care Act.
The bill passed May 4 by a 217-213 margin, with one Republican member not voting. The vote came after a false start in March when House Speaker Paul Ryan (R-Wisc.) canceled consideration because Republicans could not muster enough votes to pass it. All votes in favor of the bill came from GOP members, while all House Democrats plus 20 Republicans voted against passage.
Two amendments helped to make the bill palatable enough to gain enough votes for passage. New amendments from Rep. Gary Palmer (R-Ala.) and Rep. Fred Upton (R-Mich.) targeted high-risk pools. They were added to an April amendment from Rep. Tom MacArthur (R-N.J.) that would allow states to seek waivers for coverage of the essential health benefits and from community rating provisions to allow for higher premiums for those who are sicker or older.
The American Health Care Act (H.R. 1629) in its amended form has not been yet been scored by the Congressional Budget Office (CBO) to determine its effects on the federal budget. However, an earlier CBO analysis of the original, unamended bill predicted an estimated 58 million people would be uninsured by 2026, compared with 28 million under the Affordable Care Act. It is also predicting large premium increases for some groups of patients.
A CBO score is required of all legislation because, under Senate rules, anything that adds to the budget must be offset by additional revenue-generating provisions or cuts elsewhere in the federal budget. The bill, if passed and sent to the president’s desk for signature, is at minimum budget neutral if not deficit reducing.
The amended AHCA was roundly rejected by most physician organizations, including the American Medical Association and many specialty societies.
“The bill passed by the House today will result in millions of Americans losing access to quality, affordable health insurance and those with preexisting health conditions face the possibility of going back to the time when insurers could charge them premiums that made access to coverage out of the question,” AMA President Andrew Gurman, MD, said in a statement. “The AMA urges the Senate and the Administration to work with physician, patient, hospital, and other provider groups to craft bipartisan solutions so all American families can access affordable and meaningful coverage, while preserving the safety net for vulnerable patients.”
House Minority Leader Nancy Pelosi (D-Calif.), in addition to criticizing the bill for its predicted effects in increasing premiums and decreasing coverage for those with preexisting conditions, called out the bill for being nothing more than a means to help cover the cost of a separate tax bill when she described the AHCA as providing “tax cuts for the rich at the expense of health insurance for tens of millions of working families across America” during the debate prior to passage. “Trumpcare is a billionaire’s tax cut disguised as a health care bill.”
Speaker Ryan continued to highlight the continual coverage issues that have been growing in the individual health insurance marketplace, spotlighting Iowa, where insurer Medica has announced that it will likely discontinue providing coverage in 2018, leaving most counties in the state with no option to purchase coverage following the announced withdrawal of Aetna and Wellmark Blue Cross Blue Shield.
“This is a crisis,” Speaker Ryan said during the debate. “What protection is Obamacare if there is no health care plan to purchase in your state? This is the direction Obamacare is rapidly heading.”
In helping to get the AHCA barely over the final hurdle, the Palmer amendment creates an “invisible risk-sharing program” under which the federal government would subsidize insurers to the tune of $15 billion over 9 years. The program would allow insurers to make a prospective determination of who might be a cost-intensive user and move them to the high-risk pool with the federal funding joining insurer funding to help pay for coverage. The amendment also would change the ACA’s reinsurance provisions, which retroactively reimburse insurers for high-utilizing customers.
Neither invisible risk sharing nor retroactive reinsurance are “inherently superior at reducing premiums,” according to an April 12 blog post by the journal Health Affairs. “Premium reductions depend entirely on how much funding the program receives in relation to the risks being insured. Rep. Palmer’s amendment leaves all the critical details of this new, invisible program unspecified, making it hard to generate precise estimate.”
Authors Mark Hall, senior fellow at Brookings Institute, and Nicholas Bagely, law professor at the University of Michigan, Ann Arbor, note that the funding in the amendment “is no more than 2% of total premiums in the market.”
The Upton amendment would add an additional $8 billion in funding for high-risk pools, bringing the total amount potentially available to help cover people with preexisting conditions to $123 billion.
Analysis from Avalere finds that the funding specifically allocated to assist those with preexisting conditions ($23 billion, including the additional $8 billion from the Upton amendment) “will only cover 110,000 individuals with preexisting, chronic condition. If states were to allocate all the other funds [available in the AHCA] toward providing insurance to people with preexisting conditions ... 600,000 with preexisting chronic conditions could be covered.” The analysis notes approximately “2.2 million enrollees in the individual market today have some sort of preexisting chronic condition.”
“Given the amount of funding in the bill, the program can only afford a few small states to opt into medical underwriting,” Caroline Pearson, senior vice president at Avalere, said in a statement. “If any large states receive a waiver, many chronically ill individuals could be left without access to insurance.”
Because the AHCA focuses solely on reforming revenue-related aspects of the ACA and was passed using budget reconciliation procedures, it will need only a simple majority to pass the Senate. However, keeping the bill budget neutral will make it difficult to pass in its current form, even though Republicans hold 52 of the chamber’s 100 seats.
Phase two of the repeal and replace plan will be a full examination of federal regulations and phase three, which will require at least 60 votes in the Senate, will be changes to other provisions in the health care law that are not directly revenue generating. President Donald Trump in the past has suggested that this will include his goals of opening the sale of insurance across state lines and other key priorities.
Point/Counterpoint: Should all suspected mucinous cystic neoplasms be resected?
Dr. Pawlik is a pretty clever guy and a strong adversary. Mucinous cystic neoplasm is literally the only topic in hepato-pancreato-biliary surgery he has not written about – yet.1
But I will argue that all suspected mucinous cystic neoplasms (MCNs) should be surgically removed. Reasons include: the natural history of a benign MCN in a typical 45-year-old remains unknown, clinical features are not always reliable, and it’s difficult to distinguish benign from malignant neoplasms without surgery.
Although many MCNs are benign when resected, all have malignant potential.
The prevalence of cancer at time of diagnosis with an MCN is fairly low, about 15%. This means most of these cysts are benign when resected. However, discrimination between benign and malignant is difficult without surgery, and the degree of epithelial dysplasia at time of resection ranges from mild to severe with invasive carcinoma.
When cancer is present, patients tend to do poorly. In one study where 44 out of 344 patients developed invasive cancer, the group with cancer had a 3-year overall survival rate of 59%.2
In addition, aspiration of cyst fluid is often of limited utility. It is poor at distinguishing whether a cyst is benign or malignant. For example, in a series of 55 patients with MCNs that underwent fine-needle aspiration of cyst epithelium, 71% of assays were nondiagnostic.3 So this diagnostic test is very insensitive and may miss at least half of cancers – another point in favor of surgical resection for all MCNs.
It is true that evidence in the literature associates certain clinical factors with a higher risk for malignancy in suspected MCNs. These include male gender, larger cysts, and location in the pancreatic head or neck or larger cyst diameter and presence of nodules.2,4 However, use of clinical features is not perfect.
In another study, of 163 resected MCNs, those with invasive cancer were often – but not always – larger than 4 cm with nodules.5 These same series revealed that those with invasive cancer were often, but again not always, larger than 4 cm.
We see this in our practice as well – that a large cyst or presence of nodules is not a foolproof indicator of malignancy. We had a 38-year-old woman with a large cyst and nodules who did not have cancer. In contrast, a 45-year-old woman at our institution presented with small cysts and no cancer on fine-needle aspiration. However, final pathology in her case revealed high-grade dysplasia.
Also, we only know what happens to cysts that have been resected. We know nothing about duration or other best practices for following patients who do not undergo surgery. For this reason, we really don’t know what these tumors will do if left alone.
Surgery is curative and carries a pretty low risk. Following resection, these patients do well. We’re talking about curative operations.
Dr. Katz is an Associate Professor, Department of Surgical Oncology, Division of Surgery at the University of Texas MD Anderson Cancer Center in Houston. He is also Chief of the Pancreas Surgery Service at MD Anderson. Dr. Katz noted he was asked to provide the pro side of the argument, and he may not necessarily uphold these positions in his own practice. Dr. Katz had no relevant financial disclosures.
References:
1. Dr. Pawlik’s list of selected publications: http://pathology.jhu.edu/liver/pawlik.cfm.
2. JAMA Surg. 2017;152:19-25.
3. Cancer. 2017;125:169-77.
4. Pancreas. 2011;40:67-71.
5. Ann Surg. 2008;247:571-9.
Some mucinous cystic neoplasms can be safely followed.
Data in the literature suggest some of these suspected mucinous cystic neoplasms can be followed; surgery may not be indicated solely because “as surgeons we tend to take all masses out” and because operative complications occur. Therefore, resection is not a benign procedure.
Dr. Katz, you were done before you got started. The evidence shows that some of the MCNs can be followed rather than resected.
Most of the published studies focus on IPMN, but I think the topic of MCNs is becoming increasingly important; they follow IPMNs as the second most common type of cystic neoplasms. So we’re going to be finding more small MCNs. In this debate, we are not talking about an 8-cm MCN, but rather what do we do when we see a 2- to 3-cm MCN. Do these patients all need to undergo resection?
What Dr. Katz is concerned about is that we are going to miss a cancer. We should operate on all patients because – at least as Dr. Katz’s argues – the surgery can always be done without complications.
However, even at the very, very experienced centers, morbidity was 30%-50%, and a pancreatic fistula developed for 1 in 10 patients. So it’s not a benign procedure.1
As surgeons, we tend to take every mass out. Although operative mortality is low, it is still in a measurable range, 1%-2%, and that is even at expert centers. Many of these small cysts are being found at smaller and community hospitals, and undue morbidity and mortality may weigh more heavily in these settings.2
Rather than “being a hammer and seeing everything as a nail,” we need a more rational approach. For example, we should identify a subgroup that will the most benefit from resection.
Investigators from Memorial Sloan Kettering Cancer Center reported that certain clinical factors identify patients at higher risk for mortality, such as nodules.3 Patients with invasive cancer almost all had nodules. And all patients with invasive cancer without nodules had a tumor larger than 4 cm.
Maybe using both presence of nodules and size is the right approach to identifying underling malignancy in suspected MCNs. Again, size is important, as is male gender, presence of solid nodules, and duct dilatation.4
We are arguing whether all MCNs should be resected. I’m positing that many 2-cm to 3-cm MCNs can be followed. There is only a small chance they will grow over time, and it’s unlikely they are harboring a malignancy.
Dr. Pawlik is Chair of Surgery at the Ohio State Wexner Medical Center in Columbus. He is also the Urban Meyer III and Shelley Meyer Chair for Cancer Research at Ohio State. He has no disclosures.
References
1. HPB (Oxford). 2007;9:8-15.
2. Diagnosis and Management of Cystic Lesions of the Pancreas. Diagnostic and Therapeutic Endoscopy Volume 2011 (2011), Article ID 478913.
3. JAMA Surg. 2017;152:19-25.
4. Ann Surg. 2006;244:572-82.
This Point/Counterpoint feature is based on comments Dr. Katz and Dr. Pawlik made during a debate at AHPBA 2017, the annual meeting of the Americas Hepato-Pancreato-Biliary Association.
Dr. Pawlik is a pretty clever guy and a strong adversary. Mucinous cystic neoplasm is literally the only topic in hepato-pancreato-biliary surgery he has not written about – yet.1
But I will argue that all suspected mucinous cystic neoplasms (MCNs) should be surgically removed. Reasons include: the natural history of a benign MCN in a typical 45-year-old remains unknown, clinical features are not always reliable, and it’s difficult to distinguish benign from malignant neoplasms without surgery.
Although many MCNs are benign when resected, all have malignant potential.
The prevalence of cancer at time of diagnosis with an MCN is fairly low, about 15%. This means most of these cysts are benign when resected. However, discrimination between benign and malignant is difficult without surgery, and the degree of epithelial dysplasia at time of resection ranges from mild to severe with invasive carcinoma.
When cancer is present, patients tend to do poorly. In one study where 44 out of 344 patients developed invasive cancer, the group with cancer had a 3-year overall survival rate of 59%.2
In addition, aspiration of cyst fluid is often of limited utility. It is poor at distinguishing whether a cyst is benign or malignant. For example, in a series of 55 patients with MCNs that underwent fine-needle aspiration of cyst epithelium, 71% of assays were nondiagnostic.3 So this diagnostic test is very insensitive and may miss at least half of cancers – another point in favor of surgical resection for all MCNs.
It is true that evidence in the literature associates certain clinical factors with a higher risk for malignancy in suspected MCNs. These include male gender, larger cysts, and location in the pancreatic head or neck or larger cyst diameter and presence of nodules.2,4 However, use of clinical features is not perfect.
In another study, of 163 resected MCNs, those with invasive cancer were often – but not always – larger than 4 cm with nodules.5 These same series revealed that those with invasive cancer were often, but again not always, larger than 4 cm.
We see this in our practice as well – that a large cyst or presence of nodules is not a foolproof indicator of malignancy. We had a 38-year-old woman with a large cyst and nodules who did not have cancer. In contrast, a 45-year-old woman at our institution presented with small cysts and no cancer on fine-needle aspiration. However, final pathology in her case revealed high-grade dysplasia.
Also, we only know what happens to cysts that have been resected. We know nothing about duration or other best practices for following patients who do not undergo surgery. For this reason, we really don’t know what these tumors will do if left alone.
Surgery is curative and carries a pretty low risk. Following resection, these patients do well. We’re talking about curative operations.
Dr. Katz is an Associate Professor, Department of Surgical Oncology, Division of Surgery at the University of Texas MD Anderson Cancer Center in Houston. He is also Chief of the Pancreas Surgery Service at MD Anderson. Dr. Katz noted he was asked to provide the pro side of the argument, and he may not necessarily uphold these positions in his own practice. Dr. Katz had no relevant financial disclosures.
References:
1. Dr. Pawlik’s list of selected publications: http://pathology.jhu.edu/liver/pawlik.cfm.
2. JAMA Surg. 2017;152:19-25.
3. Cancer. 2017;125:169-77.
4. Pancreas. 2011;40:67-71.
5. Ann Surg. 2008;247:571-9.
Some mucinous cystic neoplasms can be safely followed.
Data in the literature suggest some of these suspected mucinous cystic neoplasms can be followed; surgery may not be indicated solely because “as surgeons we tend to take all masses out” and because operative complications occur. Therefore, resection is not a benign procedure.
Dr. Katz, you were done before you got started. The evidence shows that some of the MCNs can be followed rather than resected.
Most of the published studies focus on IPMN, but I think the topic of MCNs is becoming increasingly important; they follow IPMNs as the second most common type of cystic neoplasms. So we’re going to be finding more small MCNs. In this debate, we are not talking about an 8-cm MCN, but rather what do we do when we see a 2- to 3-cm MCN. Do these patients all need to undergo resection?
What Dr. Katz is concerned about is that we are going to miss a cancer. We should operate on all patients because – at least as Dr. Katz’s argues – the surgery can always be done without complications.
However, even at the very, very experienced centers, morbidity was 30%-50%, and a pancreatic fistula developed for 1 in 10 patients. So it’s not a benign procedure.1
As surgeons, we tend to take every mass out. Although operative mortality is low, it is still in a measurable range, 1%-2%, and that is even at expert centers. Many of these small cysts are being found at smaller and community hospitals, and undue morbidity and mortality may weigh more heavily in these settings.2
Rather than “being a hammer and seeing everything as a nail,” we need a more rational approach. For example, we should identify a subgroup that will the most benefit from resection.
Investigators from Memorial Sloan Kettering Cancer Center reported that certain clinical factors identify patients at higher risk for mortality, such as nodules.3 Patients with invasive cancer almost all had nodules. And all patients with invasive cancer without nodules had a tumor larger than 4 cm.
Maybe using both presence of nodules and size is the right approach to identifying underling malignancy in suspected MCNs. Again, size is important, as is male gender, presence of solid nodules, and duct dilatation.4
We are arguing whether all MCNs should be resected. I’m positing that many 2-cm to 3-cm MCNs can be followed. There is only a small chance they will grow over time, and it’s unlikely they are harboring a malignancy.
Dr. Pawlik is Chair of Surgery at the Ohio State Wexner Medical Center in Columbus. He is also the Urban Meyer III and Shelley Meyer Chair for Cancer Research at Ohio State. He has no disclosures.
References
1. HPB (Oxford). 2007;9:8-15.
2. Diagnosis and Management of Cystic Lesions of the Pancreas. Diagnostic and Therapeutic Endoscopy Volume 2011 (2011), Article ID 478913.
3. JAMA Surg. 2017;152:19-25.
4. Ann Surg. 2006;244:572-82.
This Point/Counterpoint feature is based on comments Dr. Katz and Dr. Pawlik made during a debate at AHPBA 2017, the annual meeting of the Americas Hepato-Pancreato-Biliary Association.
Dr. Pawlik is a pretty clever guy and a strong adversary. Mucinous cystic neoplasm is literally the only topic in hepato-pancreato-biliary surgery he has not written about – yet.1
But I will argue that all suspected mucinous cystic neoplasms (MCNs) should be surgically removed. Reasons include: the natural history of a benign MCN in a typical 45-year-old remains unknown, clinical features are not always reliable, and it’s difficult to distinguish benign from malignant neoplasms without surgery.
Although many MCNs are benign when resected, all have malignant potential.
The prevalence of cancer at time of diagnosis with an MCN is fairly low, about 15%. This means most of these cysts are benign when resected. However, discrimination between benign and malignant is difficult without surgery, and the degree of epithelial dysplasia at time of resection ranges from mild to severe with invasive carcinoma.
When cancer is present, patients tend to do poorly. In one study where 44 out of 344 patients developed invasive cancer, the group with cancer had a 3-year overall survival rate of 59%.2
In addition, aspiration of cyst fluid is often of limited utility. It is poor at distinguishing whether a cyst is benign or malignant. For example, in a series of 55 patients with MCNs that underwent fine-needle aspiration of cyst epithelium, 71% of assays were nondiagnostic.3 So this diagnostic test is very insensitive and may miss at least half of cancers – another point in favor of surgical resection for all MCNs.
It is true that evidence in the literature associates certain clinical factors with a higher risk for malignancy in suspected MCNs. These include male gender, larger cysts, and location in the pancreatic head or neck or larger cyst diameter and presence of nodules.2,4 However, use of clinical features is not perfect.
In another study, of 163 resected MCNs, those with invasive cancer were often – but not always – larger than 4 cm with nodules.5 These same series revealed that those with invasive cancer were often, but again not always, larger than 4 cm.
We see this in our practice as well – that a large cyst or presence of nodules is not a foolproof indicator of malignancy. We had a 38-year-old woman with a large cyst and nodules who did not have cancer. In contrast, a 45-year-old woman at our institution presented with small cysts and no cancer on fine-needle aspiration. However, final pathology in her case revealed high-grade dysplasia.
Also, we only know what happens to cysts that have been resected. We know nothing about duration or other best practices for following patients who do not undergo surgery. For this reason, we really don’t know what these tumors will do if left alone.
Surgery is curative and carries a pretty low risk. Following resection, these patients do well. We’re talking about curative operations.
Dr. Katz is an Associate Professor, Department of Surgical Oncology, Division of Surgery at the University of Texas MD Anderson Cancer Center in Houston. He is also Chief of the Pancreas Surgery Service at MD Anderson. Dr. Katz noted he was asked to provide the pro side of the argument, and he may not necessarily uphold these positions in his own practice. Dr. Katz had no relevant financial disclosures.
References:
1. Dr. Pawlik’s list of selected publications: http://pathology.jhu.edu/liver/pawlik.cfm.
2. JAMA Surg. 2017;152:19-25.
3. Cancer. 2017;125:169-77.
4. Pancreas. 2011;40:67-71.
5. Ann Surg. 2008;247:571-9.
Some mucinous cystic neoplasms can be safely followed.
Data in the literature suggest some of these suspected mucinous cystic neoplasms can be followed; surgery may not be indicated solely because “as surgeons we tend to take all masses out” and because operative complications occur. Therefore, resection is not a benign procedure.
Dr. Katz, you were done before you got started. The evidence shows that some of the MCNs can be followed rather than resected.
Most of the published studies focus on IPMN, but I think the topic of MCNs is becoming increasingly important; they follow IPMNs as the second most common type of cystic neoplasms. So we’re going to be finding more small MCNs. In this debate, we are not talking about an 8-cm MCN, but rather what do we do when we see a 2- to 3-cm MCN. Do these patients all need to undergo resection?
What Dr. Katz is concerned about is that we are going to miss a cancer. We should operate on all patients because – at least as Dr. Katz’s argues – the surgery can always be done without complications.
However, even at the very, very experienced centers, morbidity was 30%-50%, and a pancreatic fistula developed for 1 in 10 patients. So it’s not a benign procedure.1
As surgeons, we tend to take every mass out. Although operative mortality is low, it is still in a measurable range, 1%-2%, and that is even at expert centers. Many of these small cysts are being found at smaller and community hospitals, and undue morbidity and mortality may weigh more heavily in these settings.2
Rather than “being a hammer and seeing everything as a nail,” we need a more rational approach. For example, we should identify a subgroup that will the most benefit from resection.
Investigators from Memorial Sloan Kettering Cancer Center reported that certain clinical factors identify patients at higher risk for mortality, such as nodules.3 Patients with invasive cancer almost all had nodules. And all patients with invasive cancer without nodules had a tumor larger than 4 cm.
Maybe using both presence of nodules and size is the right approach to identifying underling malignancy in suspected MCNs. Again, size is important, as is male gender, presence of solid nodules, and duct dilatation.4
We are arguing whether all MCNs should be resected. I’m positing that many 2-cm to 3-cm MCNs can be followed. There is only a small chance they will grow over time, and it’s unlikely they are harboring a malignancy.
Dr. Pawlik is Chair of Surgery at the Ohio State Wexner Medical Center in Columbus. He is also the Urban Meyer III and Shelley Meyer Chair for Cancer Research at Ohio State. He has no disclosures.
References
1. HPB (Oxford). 2007;9:8-15.
2. Diagnosis and Management of Cystic Lesions of the Pancreas. Diagnostic and Therapeutic Endoscopy Volume 2011 (2011), Article ID 478913.
3. JAMA Surg. 2017;152:19-25.
4. Ann Surg. 2006;244:572-82.
This Point/Counterpoint feature is based on comments Dr. Katz and Dr. Pawlik made during a debate at AHPBA 2017, the annual meeting of the Americas Hepato-Pancreato-Biliary Association.
Mastectomy unnecessary for some breast cancer recurrences
LAS VEGAS – Although mastectomy is the standard of care for tumor recurrence following lumpectomy and whole breast irradiation, a second lumpectomy with partial breast irradiation is a sound alternative under certain circumstances, according to Manjeet Chadha, MD, professor of radiation oncology and director of the department of radiation oncology at Icahn School of Medicine at Mount Sinai, New York.
It depends on whether the new lesion is a true recurrence, or simply another primary tumor. In the absence of a genetic footprint to compare the two, Dr. Chadha and her colleagues use several of what she called “soft criteria” to make the call and counsel women.
True ipsilateral recurrence of an aggressive tumor tends to happen early, and in the same quadrant. However, if breast cancer recurs more than 3 years after treatment of the primary tumor and in a different quadrant, and if the patient is negative for BRCA mutation, and if the new growth is small, localized on MRI, histologically different from the primary tumor, and likely to be resected with clean margins, Dr. Chadha said she is comfortable offering a second lumpectomy and partial breast radiation – usually multicatheter brachytherapy – to women who do not want a mastectomy.
“Second cancer in a previously irradiated breast is not an uncommon clinical entity. Based on patient preference, the option of repeat breast conservation and reirradiation may be offered selectively as an alternative to mastectomy,” followed by systemic therapy, she said at the annual meeting of the American Society of Breast Surgeons.
“I think all of us across the country are discussing presentations like this in tumor boards,” but it’s not always offered as an option. Sometimes, “the mindset of the treating surgeon is ‘oh, this breast has had radiation; I can’t give radiation again.’ Clearly, whole breast reirradiation is not recommended,” but it seems possible based on a growing body of literature to differentiate new primaries with new biology from true recurrences, and to treat them safely with breast conserving surgery and partial irradiation, she said.
The largest series to date of salvage lumpectomy with multicatheter brachytherapy followed 217 women for a median of 3.9 years. Median tumor size was 1.2 cm. The 5-year local control rate – effectively, the mastectomy-free survival – was 94.4%, and the overall survival was 88.7%, which mirrors the success of first-time lumpectomy with whole breast irradiation, and lends support to the notion that some recurrences are, in fact, entirely new disease. The European team reported excellent or good cosmetic results in 85% of women (Radiother Oncol. 2013 Aug;108[2]:226-31).
The series used high-dose radiation. Dr. Chadha said she and her colleagues have had similar success with low-dose multicatheter brachytherapy, with similarly good aesthetic results. To avoid cosmetic impact, however, she noted it’s important to work with radiation oncologists “mindful of the nuances of what’s needed,” including how far to separate the skin from the radiation.
Brachytherapy has the most support in the literature, but external beam therapy is also an option. “Whatever technique you use, the delineation of the target and the geometric coverage of the lumpectomy cavity [must be] complete in all cases,” she said.
Dr. Chadha had no financial conflicts of interest.
LAS VEGAS – Although mastectomy is the standard of care for tumor recurrence following lumpectomy and whole breast irradiation, a second lumpectomy with partial breast irradiation is a sound alternative under certain circumstances, according to Manjeet Chadha, MD, professor of radiation oncology and director of the department of radiation oncology at Icahn School of Medicine at Mount Sinai, New York.
It depends on whether the new lesion is a true recurrence, or simply another primary tumor. In the absence of a genetic footprint to compare the two, Dr. Chadha and her colleagues use several of what she called “soft criteria” to make the call and counsel women.
True ipsilateral recurrence of an aggressive tumor tends to happen early, and in the same quadrant. However, if breast cancer recurs more than 3 years after treatment of the primary tumor and in a different quadrant, and if the patient is negative for BRCA mutation, and if the new growth is small, localized on MRI, histologically different from the primary tumor, and likely to be resected with clean margins, Dr. Chadha said she is comfortable offering a second lumpectomy and partial breast radiation – usually multicatheter brachytherapy – to women who do not want a mastectomy.
“Second cancer in a previously irradiated breast is not an uncommon clinical entity. Based on patient preference, the option of repeat breast conservation and reirradiation may be offered selectively as an alternative to mastectomy,” followed by systemic therapy, she said at the annual meeting of the American Society of Breast Surgeons.
“I think all of us across the country are discussing presentations like this in tumor boards,” but it’s not always offered as an option. Sometimes, “the mindset of the treating surgeon is ‘oh, this breast has had radiation; I can’t give radiation again.’ Clearly, whole breast reirradiation is not recommended,” but it seems possible based on a growing body of literature to differentiate new primaries with new biology from true recurrences, and to treat them safely with breast conserving surgery and partial irradiation, she said.
The largest series to date of salvage lumpectomy with multicatheter brachytherapy followed 217 women for a median of 3.9 years. Median tumor size was 1.2 cm. The 5-year local control rate – effectively, the mastectomy-free survival – was 94.4%, and the overall survival was 88.7%, which mirrors the success of first-time lumpectomy with whole breast irradiation, and lends support to the notion that some recurrences are, in fact, entirely new disease. The European team reported excellent or good cosmetic results in 85% of women (Radiother Oncol. 2013 Aug;108[2]:226-31).
The series used high-dose radiation. Dr. Chadha said she and her colleagues have had similar success with low-dose multicatheter brachytherapy, with similarly good aesthetic results. To avoid cosmetic impact, however, she noted it’s important to work with radiation oncologists “mindful of the nuances of what’s needed,” including how far to separate the skin from the radiation.
Brachytherapy has the most support in the literature, but external beam therapy is also an option. “Whatever technique you use, the delineation of the target and the geometric coverage of the lumpectomy cavity [must be] complete in all cases,” she said.
Dr. Chadha had no financial conflicts of interest.
LAS VEGAS – Although mastectomy is the standard of care for tumor recurrence following lumpectomy and whole breast irradiation, a second lumpectomy with partial breast irradiation is a sound alternative under certain circumstances, according to Manjeet Chadha, MD, professor of radiation oncology and director of the department of radiation oncology at Icahn School of Medicine at Mount Sinai, New York.
It depends on whether the new lesion is a true recurrence, or simply another primary tumor. In the absence of a genetic footprint to compare the two, Dr. Chadha and her colleagues use several of what she called “soft criteria” to make the call and counsel women.
True ipsilateral recurrence of an aggressive tumor tends to happen early, and in the same quadrant. However, if breast cancer recurs more than 3 years after treatment of the primary tumor and in a different quadrant, and if the patient is negative for BRCA mutation, and if the new growth is small, localized on MRI, histologically different from the primary tumor, and likely to be resected with clean margins, Dr. Chadha said she is comfortable offering a second lumpectomy and partial breast radiation – usually multicatheter brachytherapy – to women who do not want a mastectomy.
“Second cancer in a previously irradiated breast is not an uncommon clinical entity. Based on patient preference, the option of repeat breast conservation and reirradiation may be offered selectively as an alternative to mastectomy,” followed by systemic therapy, she said at the annual meeting of the American Society of Breast Surgeons.
“I think all of us across the country are discussing presentations like this in tumor boards,” but it’s not always offered as an option. Sometimes, “the mindset of the treating surgeon is ‘oh, this breast has had radiation; I can’t give radiation again.’ Clearly, whole breast reirradiation is not recommended,” but it seems possible based on a growing body of literature to differentiate new primaries with new biology from true recurrences, and to treat them safely with breast conserving surgery and partial irradiation, she said.
The largest series to date of salvage lumpectomy with multicatheter brachytherapy followed 217 women for a median of 3.9 years. Median tumor size was 1.2 cm. The 5-year local control rate – effectively, the mastectomy-free survival – was 94.4%, and the overall survival was 88.7%, which mirrors the success of first-time lumpectomy with whole breast irradiation, and lends support to the notion that some recurrences are, in fact, entirely new disease. The European team reported excellent or good cosmetic results in 85% of women (Radiother Oncol. 2013 Aug;108[2]:226-31).
The series used high-dose radiation. Dr. Chadha said she and her colleagues have had similar success with low-dose multicatheter brachytherapy, with similarly good aesthetic results. To avoid cosmetic impact, however, she noted it’s important to work with radiation oncologists “mindful of the nuances of what’s needed,” including how far to separate the skin from the radiation.
Brachytherapy has the most support in the literature, but external beam therapy is also an option. “Whatever technique you use, the delineation of the target and the geometric coverage of the lumpectomy cavity [must be] complete in all cases,” she said.
Dr. Chadha had no financial conflicts of interest.
EXPERT ANALYSIS FROM ASBS 2017
Study identifies gaps in surgical trainees’ readiness
PHILADELPHIA – The question of how prepared general surgery residents are to operate independently after their training is longstanding, but clear definitions of competency and readiness have been elusive. A consortium of general surgery residencies has developed a metric for assessing surgeon readiness, but what the metric revealed may be a cause for concern for the surgical profession.
Brian C. George, MD, of the University of Michigan, Ann Arbor, reported at the annual meeting of the American Surgical Association on results of a study designed to measure the autonomy and readiness for independent practice of residents at 14 general surgery programs.
The study found that in the final 6 months of training, 96% of residents were rated competent by their observers to perform a straightforward appendectomy on their own, but only 71% were rated the same for partial colectomy, Dr. George said.
The participating general surgery attendings rated residents according to three scales (J Surg Educ. 2016;73:e118-130):
•“Performance” scale to measure readiness for independent practice, with competence defined as practice-ready and exceptional performance.
• “Zwisch” scale, named after Jay Zwischenberger, MD, FACS, of the University of Kentucky, to assess the amount of autonomy granted to a resident by the supervising surgical attending.
• “Complexity” scale to measure the patient-related complexity of the case at hand.
The study used a smartphone-based app, SIMPL, to collect data from September 2015 through December 2016. In evaluating performance, 437 observers provided 8,526 different ratings of 522 residents.
In a subset analysis, the study authors focused on the 132 operations the Surgical Council on Resident Education considers the core procedures of general surgery and found that 77% of fifth-year residents were rated as competent. Further restricting the analysis to residents in their final 6 months of training performing the five most commonly rated core procedures – appendectomy, cholecystectomy, ventral hernia repair, inguinal/femoral hernia repair, and partial colectomy – the researchers found that competency ranged from a high of 96% for appendectomy to a low of 71% for partial colectomy.
“If you combine all five procedures into one category, on average the residents are rated competent 84% of the time during the last 6 months of training,” Dr. George said. “But what’s really interesting – and I think this is probably the most important result for this study – is that looking at just the less-frequently rated core procedures and excluding the top five, residents are deemed competent in the last 6 months of training for 74% of those observed procedures.”
According to the Zwisch” scale to measure autonomy, residents in their last 6 months of training displayed what Dr. George termed “meaningful autonomy” in 77% of their observed operations for the core procedures. “Interestingly,” he added, “they were observed to have maximum autonomy, which is the supervision-only level, for 33% of all observed procedures.”
The researchers did an adjusted analysis to account for confounding factors such as the stringency of individual raters and patient complexity. “Using this type of analysis, the likelihood that a typical trainee rated by a typical attendee would be deemed competent by the end of training for a relatively straightforward laparoscopy appendectomy is 97%,” Dr. George said. “For a difficult laparoscopic appendectomy, by the end of training, they’re likely to be deemed competent 92% of time.” In the adjusted analysis, for a straightforward partial colectomy the raters predicted trainees to be competent 91.8% of time, but only 81.8% of the time for a complicated partial colectomy. “For less-frequently performed core procedures, there are many for which residents are likely to be deemed competent at a much lower level,” Dr. George added.
In discussing the study, Ara Darzi, MD, of St. Mary’s Hospital, London, called the methodology “unique and commendable,” and asked “Would you make the case to say we should increase the number of years of trainees from PG5 to PG6 or at least make your fellowships compulsory?”
Dr. George answered that 80% of general surgery residents already go into fellowships. “Whether it’s required or not is above my pay grade,” he said. “I hope not. Five years is already a big ask for a lot of medical students who are considering this profession. If we increase the training requirements, we’re going to have a supply problem that we will then need to address. We will be trading one problem for another.” He later added “The 20,000 hours of surgical residency should be enough to train a general surgeon to competence – its up to us to figure out how.”
The following organizations supported the research: American Board of Surgery, Association for Surgical Education, Association for Program Directors in Surgery, Massachusetts General Hospital, Northwestern University, Indiana University, and the members of the Procedural Learning and Safety Collaborative.
Neither Dr. George nor Dr. Darzi had any relevant financial disclosures.
The complete manuscript of this study and its presentation at the American Surgical Association’s 137th Annual Meeting, April 2017, in Philadelphia, Pennsylvania, is to be published in Annals of Surgery pending editorial review.
PHILADELPHIA – The question of how prepared general surgery residents are to operate independently after their training is longstanding, but clear definitions of competency and readiness have been elusive. A consortium of general surgery residencies has developed a metric for assessing surgeon readiness, but what the metric revealed may be a cause for concern for the surgical profession.
Brian C. George, MD, of the University of Michigan, Ann Arbor, reported at the annual meeting of the American Surgical Association on results of a study designed to measure the autonomy and readiness for independent practice of residents at 14 general surgery programs.
The study found that in the final 6 months of training, 96% of residents were rated competent by their observers to perform a straightforward appendectomy on their own, but only 71% were rated the same for partial colectomy, Dr. George said.
The participating general surgery attendings rated residents according to three scales (J Surg Educ. 2016;73:e118-130):
•“Performance” scale to measure readiness for independent practice, with competence defined as practice-ready and exceptional performance.
• “Zwisch” scale, named after Jay Zwischenberger, MD, FACS, of the University of Kentucky, to assess the amount of autonomy granted to a resident by the supervising surgical attending.
• “Complexity” scale to measure the patient-related complexity of the case at hand.
The study used a smartphone-based app, SIMPL, to collect data from September 2015 through December 2016. In evaluating performance, 437 observers provided 8,526 different ratings of 522 residents.
In a subset analysis, the study authors focused on the 132 operations the Surgical Council on Resident Education considers the core procedures of general surgery and found that 77% of fifth-year residents were rated as competent. Further restricting the analysis to residents in their final 6 months of training performing the five most commonly rated core procedures – appendectomy, cholecystectomy, ventral hernia repair, inguinal/femoral hernia repair, and partial colectomy – the researchers found that competency ranged from a high of 96% for appendectomy to a low of 71% for partial colectomy.
“If you combine all five procedures into one category, on average the residents are rated competent 84% of the time during the last 6 months of training,” Dr. George said. “But what’s really interesting – and I think this is probably the most important result for this study – is that looking at just the less-frequently rated core procedures and excluding the top five, residents are deemed competent in the last 6 months of training for 74% of those observed procedures.”
According to the Zwisch” scale to measure autonomy, residents in their last 6 months of training displayed what Dr. George termed “meaningful autonomy” in 77% of their observed operations for the core procedures. “Interestingly,” he added, “they were observed to have maximum autonomy, which is the supervision-only level, for 33% of all observed procedures.”
The researchers did an adjusted analysis to account for confounding factors such as the stringency of individual raters and patient complexity. “Using this type of analysis, the likelihood that a typical trainee rated by a typical attendee would be deemed competent by the end of training for a relatively straightforward laparoscopy appendectomy is 97%,” Dr. George said. “For a difficult laparoscopic appendectomy, by the end of training, they’re likely to be deemed competent 92% of time.” In the adjusted analysis, for a straightforward partial colectomy the raters predicted trainees to be competent 91.8% of time, but only 81.8% of the time for a complicated partial colectomy. “For less-frequently performed core procedures, there are many for which residents are likely to be deemed competent at a much lower level,” Dr. George added.
In discussing the study, Ara Darzi, MD, of St. Mary’s Hospital, London, called the methodology “unique and commendable,” and asked “Would you make the case to say we should increase the number of years of trainees from PG5 to PG6 or at least make your fellowships compulsory?”
Dr. George answered that 80% of general surgery residents already go into fellowships. “Whether it’s required or not is above my pay grade,” he said. “I hope not. Five years is already a big ask for a lot of medical students who are considering this profession. If we increase the training requirements, we’re going to have a supply problem that we will then need to address. We will be trading one problem for another.” He later added “The 20,000 hours of surgical residency should be enough to train a general surgeon to competence – its up to us to figure out how.”
The following organizations supported the research: American Board of Surgery, Association for Surgical Education, Association for Program Directors in Surgery, Massachusetts General Hospital, Northwestern University, Indiana University, and the members of the Procedural Learning and Safety Collaborative.
Neither Dr. George nor Dr. Darzi had any relevant financial disclosures.
The complete manuscript of this study and its presentation at the American Surgical Association’s 137th Annual Meeting, April 2017, in Philadelphia, Pennsylvania, is to be published in Annals of Surgery pending editorial review.
PHILADELPHIA – The question of how prepared general surgery residents are to operate independently after their training is longstanding, but clear definitions of competency and readiness have been elusive. A consortium of general surgery residencies has developed a metric for assessing surgeon readiness, but what the metric revealed may be a cause for concern for the surgical profession.
Brian C. George, MD, of the University of Michigan, Ann Arbor, reported at the annual meeting of the American Surgical Association on results of a study designed to measure the autonomy and readiness for independent practice of residents at 14 general surgery programs.
The study found that in the final 6 months of training, 96% of residents were rated competent by their observers to perform a straightforward appendectomy on their own, but only 71% were rated the same for partial colectomy, Dr. George said.
The participating general surgery attendings rated residents according to three scales (J Surg Educ. 2016;73:e118-130):
•“Performance” scale to measure readiness for independent practice, with competence defined as practice-ready and exceptional performance.
• “Zwisch” scale, named after Jay Zwischenberger, MD, FACS, of the University of Kentucky, to assess the amount of autonomy granted to a resident by the supervising surgical attending.
• “Complexity” scale to measure the patient-related complexity of the case at hand.
The study used a smartphone-based app, SIMPL, to collect data from September 2015 through December 2016. In evaluating performance, 437 observers provided 8,526 different ratings of 522 residents.
In a subset analysis, the study authors focused on the 132 operations the Surgical Council on Resident Education considers the core procedures of general surgery and found that 77% of fifth-year residents were rated as competent. Further restricting the analysis to residents in their final 6 months of training performing the five most commonly rated core procedures – appendectomy, cholecystectomy, ventral hernia repair, inguinal/femoral hernia repair, and partial colectomy – the researchers found that competency ranged from a high of 96% for appendectomy to a low of 71% for partial colectomy.
“If you combine all five procedures into one category, on average the residents are rated competent 84% of the time during the last 6 months of training,” Dr. George said. “But what’s really interesting – and I think this is probably the most important result for this study – is that looking at just the less-frequently rated core procedures and excluding the top five, residents are deemed competent in the last 6 months of training for 74% of those observed procedures.”
According to the Zwisch” scale to measure autonomy, residents in their last 6 months of training displayed what Dr. George termed “meaningful autonomy” in 77% of their observed operations for the core procedures. “Interestingly,” he added, “they were observed to have maximum autonomy, which is the supervision-only level, for 33% of all observed procedures.”
The researchers did an adjusted analysis to account for confounding factors such as the stringency of individual raters and patient complexity. “Using this type of analysis, the likelihood that a typical trainee rated by a typical attendee would be deemed competent by the end of training for a relatively straightforward laparoscopy appendectomy is 97%,” Dr. George said. “For a difficult laparoscopic appendectomy, by the end of training, they’re likely to be deemed competent 92% of time.” In the adjusted analysis, for a straightforward partial colectomy the raters predicted trainees to be competent 91.8% of time, but only 81.8% of the time for a complicated partial colectomy. “For less-frequently performed core procedures, there are many for which residents are likely to be deemed competent at a much lower level,” Dr. George added.
In discussing the study, Ara Darzi, MD, of St. Mary’s Hospital, London, called the methodology “unique and commendable,” and asked “Would you make the case to say we should increase the number of years of trainees from PG5 to PG6 or at least make your fellowships compulsory?”
Dr. George answered that 80% of general surgery residents already go into fellowships. “Whether it’s required or not is above my pay grade,” he said. “I hope not. Five years is already a big ask for a lot of medical students who are considering this profession. If we increase the training requirements, we’re going to have a supply problem that we will then need to address. We will be trading one problem for another.” He later added “The 20,000 hours of surgical residency should be enough to train a general surgeon to competence – its up to us to figure out how.”
The following organizations supported the research: American Board of Surgery, Association for Surgical Education, Association for Program Directors in Surgery, Massachusetts General Hospital, Northwestern University, Indiana University, and the members of the Procedural Learning and Safety Collaborative.
Neither Dr. George nor Dr. Darzi had any relevant financial disclosures.
The complete manuscript of this study and its presentation at the American Surgical Association’s 137th Annual Meeting, April 2017, in Philadelphia, Pennsylvania, is to be published in Annals of Surgery pending editorial review.
AT THE ASA ANNUAL MEETING
Key clinical point: General surgery residents are often but not universally ready to independently perform core surgical procedures upon completion of surgical training.
Major finding: In the last 6 months of training, residents were rated competent 84% of the time in performing the five leading core procedures and 64% of the time for less-frequently performed procedures.
Data source: Ratings of 437 of 8,526 different observations of 522 residents at 14 institutions of the Procedural Learning and Safety Collaborative.
Disclosures: Dr. George and his coauthors reported having no financial disclosures.
Hot Threads in ACS Communities
Here are the top discussion threads in ACS Communities just prior to press time (all of these threads are from the General Surgery community):
1. Potential Florida legislation prohibiting maintenance of certification requirements
2. My proposal for changing MOC
3. Surgical training and ethics in the ’50s/’60s
4. Timing of cholecystectomy in severe gallstone pancreatitis
5. GOO (Gastric Outlet Obstruction) – What would you do?
6. Transv colon cancer, abdominal aortic aneurysm
7. Catheter migration
8. Cholecystectomy after endoscopic retrograde cholangiopancreatography for choledocholithiasis
9. Cecal mass and concomitant distal sigmoid large polyp
10. Feeding after perforated ulcer/Graham patch
To join communities, log in to ACS Communities at http://acscommunities.facs.org/home, go to “Browse All Communities” near the top of any page, and click the blue “Join” button next to the community you’d like to join. If you have any questions, please send them to [email protected].
Here are the top discussion threads in ACS Communities just prior to press time (all of these threads are from the General Surgery community):
1. Potential Florida legislation prohibiting maintenance of certification requirements
2. My proposal for changing MOC
3. Surgical training and ethics in the ’50s/’60s
4. Timing of cholecystectomy in severe gallstone pancreatitis
5. GOO (Gastric Outlet Obstruction) – What would you do?
6. Transv colon cancer, abdominal aortic aneurysm
7. Catheter migration
8. Cholecystectomy after endoscopic retrograde cholangiopancreatography for choledocholithiasis
9. Cecal mass and concomitant distal sigmoid large polyp
10. Feeding after perforated ulcer/Graham patch
To join communities, log in to ACS Communities at http://acscommunities.facs.org/home, go to “Browse All Communities” near the top of any page, and click the blue “Join” button next to the community you’d like to join. If you have any questions, please send them to [email protected].
Here are the top discussion threads in ACS Communities just prior to press time (all of these threads are from the General Surgery community):
1. Potential Florida legislation prohibiting maintenance of certification requirements
2. My proposal for changing MOC
3. Surgical training and ethics in the ’50s/’60s
4. Timing of cholecystectomy in severe gallstone pancreatitis
5. GOO (Gastric Outlet Obstruction) – What would you do?
6. Transv colon cancer, abdominal aortic aneurysm
7. Catheter migration
8. Cholecystectomy after endoscopic retrograde cholangiopancreatography for choledocholithiasis
9. Cecal mass and concomitant distal sigmoid large polyp
10. Feeding after perforated ulcer/Graham patch
To join communities, log in to ACS Communities at http://acscommunities.facs.org/home, go to “Browse All Communities” near the top of any page, and click the blue “Join” button next to the community you’d like to join. If you have any questions, please send them to [email protected].
Executive order aims to reform specialized visa program
A recent executive order by President Trump that aims to overhaul a specialized visa program for foreign workers appears to have more bark than bite, immigration experts say.
The order, published April 21 in the Federal Register, calls upon federal agencies to propose new rules, guidance, and reforms to ensure that H-1B visas are granted only to fill the most highly skilled positions. The H-1B visa program allows U.S. employers to temporarily employ highly skilled foreign workers in specialty occupations; foreign physicians and medical students regularly use the program to practice and train in the United States.
In a statement, the White House said the order is intended to prevent companies from abusing the H-1B visa program by replacing American workers with lower-paid foreign workers. While the program is designed to bring in skilled workers, the majority of approved applications are for the two lowest wage levels allowed, according to a White House statement.
“This executive order targets the abusive use of waivers and exceptions that undermine ‘Buy American’ laws meant to promote taxpayer money going to American companies,” according to the statement. “President Trump is making sure the immigration system isn’t abused to displace hard-working American workers for cheaper foreign labor.”
But the executive order will have no immediate effect on the H-1B program or foreign physicians applying for such visas, said Jennifer A. Minear, a Richmond, Va.–based attorney and national treasurer for the American Immigration Lawyers Association.
“[There is] no immediate impact on the H-1B at all, just a promise to look at the program and ‘crack down’ on the alleged abuse and fraud,” Ms. Minear said in an interview. “I view this as a way of scaring people and looking to sound tough while actually doing nothing to change the system.”
Many of the changes proposed by the Trump administration would require legislation or a lengthy rule-making process, according to Adam Cohen, a Memphis immigration attorney. Some of the proposed changes have included changing the H-1B lottery system, altering the way prevailing wages are calculated, and charging higher processing fees.
“[The executive order] reflects a desire to move toward H-1B reforms but does not signal any immediate or concrete change,” Mr. Cohen said in an interview.
It remains to be seen what the new toughness on potential fraud and abuse may look like, Ms. Minear said. Added enforcement could include additional hurdles during visa processing due to heightened suspicion and review of all H-1B applicants. Depending on the extent of enforcement, it’s possible the changes could end up before a court, she said.
“If the administration oversteps in terms of enforcements and inappropriate scrutinizing of the program, there will be litigation in a heartbeat,” she predicted.
Meanwhile, there is still no word whether U.S. Citizenship and Immigration Services (USCIS) may exempt physicians from the
On April 3, USCIS temporarily suspended its expedited processing of H-1B visas, a program by which applicants could pay for expedited processing and a response within 15 days. Standard processing of H-1B applications takes 6-10 months. USCIS is terminating the expedited reviews for up to 6 months to address long-standing H-1B petitions and to reduce backlogs, according to a March announcement by the agency.
The International Medical Graduate Taskforce and a group of U.S. senators have urged USCIS to exempt physicians from the premium processing ban.
USCIS officials have not said whether the agency will exempt physicians. In an interview, a spokeswoman said the agency will be monitoring the situation during the coming months and will evaluate any time-sensitive impacts prior to the resumption of premium processing services.
[email protected]
On Twitter @legal_med
A recent executive order by President Trump that aims to overhaul a specialized visa program for foreign workers appears to have more bark than bite, immigration experts say.
The order, published April 21 in the Federal Register, calls upon federal agencies to propose new rules, guidance, and reforms to ensure that H-1B visas are granted only to fill the most highly skilled positions. The H-1B visa program allows U.S. employers to temporarily employ highly skilled foreign workers in specialty occupations; foreign physicians and medical students regularly use the program to practice and train in the United States.
In a statement, the White House said the order is intended to prevent companies from abusing the H-1B visa program by replacing American workers with lower-paid foreign workers. While the program is designed to bring in skilled workers, the majority of approved applications are for the two lowest wage levels allowed, according to a White House statement.
“This executive order targets the abusive use of waivers and exceptions that undermine ‘Buy American’ laws meant to promote taxpayer money going to American companies,” according to the statement. “President Trump is making sure the immigration system isn’t abused to displace hard-working American workers for cheaper foreign labor.”
But the executive order will have no immediate effect on the H-1B program or foreign physicians applying for such visas, said Jennifer A. Minear, a Richmond, Va.–based attorney and national treasurer for the American Immigration Lawyers Association.
“[There is] no immediate impact on the H-1B at all, just a promise to look at the program and ‘crack down’ on the alleged abuse and fraud,” Ms. Minear said in an interview. “I view this as a way of scaring people and looking to sound tough while actually doing nothing to change the system.”
Many of the changes proposed by the Trump administration would require legislation or a lengthy rule-making process, according to Adam Cohen, a Memphis immigration attorney. Some of the proposed changes have included changing the H-1B lottery system, altering the way prevailing wages are calculated, and charging higher processing fees.
“[The executive order] reflects a desire to move toward H-1B reforms but does not signal any immediate or concrete change,” Mr. Cohen said in an interview.
It remains to be seen what the new toughness on potential fraud and abuse may look like, Ms. Minear said. Added enforcement could include additional hurdles during visa processing due to heightened suspicion and review of all H-1B applicants. Depending on the extent of enforcement, it’s possible the changes could end up before a court, she said.
“If the administration oversteps in terms of enforcements and inappropriate scrutinizing of the program, there will be litigation in a heartbeat,” she predicted.
Meanwhile, there is still no word whether U.S. Citizenship and Immigration Services (USCIS) may exempt physicians from the
On April 3, USCIS temporarily suspended its expedited processing of H-1B visas, a program by which applicants could pay for expedited processing and a response within 15 days. Standard processing of H-1B applications takes 6-10 months. USCIS is terminating the expedited reviews for up to 6 months to address long-standing H-1B petitions and to reduce backlogs, according to a March announcement by the agency.
The International Medical Graduate Taskforce and a group of U.S. senators have urged USCIS to exempt physicians from the premium processing ban.
USCIS officials have not said whether the agency will exempt physicians. In an interview, a spokeswoman said the agency will be monitoring the situation during the coming months and will evaluate any time-sensitive impacts prior to the resumption of premium processing services.
[email protected]
On Twitter @legal_med
A recent executive order by President Trump that aims to overhaul a specialized visa program for foreign workers appears to have more bark than bite, immigration experts say.
The order, published April 21 in the Federal Register, calls upon federal agencies to propose new rules, guidance, and reforms to ensure that H-1B visas are granted only to fill the most highly skilled positions. The H-1B visa program allows U.S. employers to temporarily employ highly skilled foreign workers in specialty occupations; foreign physicians and medical students regularly use the program to practice and train in the United States.
In a statement, the White House said the order is intended to prevent companies from abusing the H-1B visa program by replacing American workers with lower-paid foreign workers. While the program is designed to bring in skilled workers, the majority of approved applications are for the two lowest wage levels allowed, according to a White House statement.
“This executive order targets the abusive use of waivers and exceptions that undermine ‘Buy American’ laws meant to promote taxpayer money going to American companies,” according to the statement. “President Trump is making sure the immigration system isn’t abused to displace hard-working American workers for cheaper foreign labor.”
But the executive order will have no immediate effect on the H-1B program or foreign physicians applying for such visas, said Jennifer A. Minear, a Richmond, Va.–based attorney and national treasurer for the American Immigration Lawyers Association.
“[There is] no immediate impact on the H-1B at all, just a promise to look at the program and ‘crack down’ on the alleged abuse and fraud,” Ms. Minear said in an interview. “I view this as a way of scaring people and looking to sound tough while actually doing nothing to change the system.”
Many of the changes proposed by the Trump administration would require legislation or a lengthy rule-making process, according to Adam Cohen, a Memphis immigration attorney. Some of the proposed changes have included changing the H-1B lottery system, altering the way prevailing wages are calculated, and charging higher processing fees.
“[The executive order] reflects a desire to move toward H-1B reforms but does not signal any immediate or concrete change,” Mr. Cohen said in an interview.
It remains to be seen what the new toughness on potential fraud and abuse may look like, Ms. Minear said. Added enforcement could include additional hurdles during visa processing due to heightened suspicion and review of all H-1B applicants. Depending on the extent of enforcement, it’s possible the changes could end up before a court, she said.
“If the administration oversteps in terms of enforcements and inappropriate scrutinizing of the program, there will be litigation in a heartbeat,” she predicted.
Meanwhile, there is still no word whether U.S. Citizenship and Immigration Services (USCIS) may exempt physicians from the
On April 3, USCIS temporarily suspended its expedited processing of H-1B visas, a program by which applicants could pay for expedited processing and a response within 15 days. Standard processing of H-1B applications takes 6-10 months. USCIS is terminating the expedited reviews for up to 6 months to address long-standing H-1B petitions and to reduce backlogs, according to a March announcement by the agency.
The International Medical Graduate Taskforce and a group of U.S. senators have urged USCIS to exempt physicians from the premium processing ban.
USCIS officials have not said whether the agency will exempt physicians. In an interview, a spokeswoman said the agency will be monitoring the situation during the coming months and will evaluate any time-sensitive impacts prior to the resumption of premium processing services.
[email protected]
On Twitter @legal_med
For bone and joint infections, oral antibiotics match IV, cost less
VIENNA – Oral antibiotic therapy is just as effective as intravenous treatment in curing bone and joint infections, but costs about $3,500 less.
Treating these infections with oral agents also “improves patient autonomy, as it’s not necessary to have IV lines at home,” and represents a generally wiser use of powerful antibiotics, Matthew Scarborough, MD, said at the European Society of Clinical Microbiology and Infectious Diseases annual congress.
OVIVA (Oral vs. Intravenous Antibiotics for Bone and Joint Infection) was conducted at 26 sites in the United Kingdom. It randomized 1,054 adults with bone or joint infections to 6 weeks of either oral or intravenous treatment.
An important aspect of the trial was that both oral and IV treatment choices were made before randomization, Dr. Scarborough said. However, the decisions on what drug to use were left up to the treating physician and depended on the infection site and pathogen.
The primary outcome was definite treatment failure (bacteriologic, histologic, and clinical). Patients were followed for 1 year.
Patients were a median of 60 years old. All had surgical treatment before antibiotic therapy, including debridement and, in those with implants, removal of infected devices. The lower limb was involved in 81%, including hip, knee, and foot. The infection was in an upper limb in 10% and in the spine in 7%.
Staphylococcus aureus was present in 38% of cases, coagulase-negative staphylococci in 27%, and streptococci in 15%. Gram-negative bacteria were found in 22%.
For those patients randomized to IV therapy, glycopeptides and cephalosporins were most commonly employed (41% and 33%, respectively). For oral therapy, quinolones and penicillins were most common (37% and 16%). Most patients (74%) continued antibiotic treatment for more than 6 weeks. Forty patients were lost to follow-up.
In the primary intent-to-treat analysis, the failure rate was 13% for oral therapy and 14% for IV therapy, not a significant difference. Results were similar in the other analyses, including a modified intent to treat with only patients who had complete 1-year data, and a per-protocol analysis. All of the point prevalence numbers favored oral therapy, but crossed the null. Curves in the time-to-treatment-failure analysis were virtually superimposable, as were curves in time to discontinuation of therapy.
Another subgroup analysis examined treatment failure by infective organism; again, there were no significant treatment differences in any of the pathogen subgroups examined (S. aureus, coagulase-negative staph, streptococci species, and other gram-negative bacteria).
Nor did the type of antibiotic significantly affect failure rate, Dr. Scarborough noted. The median length of stay was 14 days for patients on IV treatment and 11 days for those taking oral medications. The incidence of serious adverse events was very similar – about 86% in each group.
On a visual analog scale that assessed health-related quality of life, patients taking oral treatment reported better mobility, self-care, and activity level, and less pain, discomfort, anxiety, and depression than those taking IV medications.
Cost represented the other significant difference between the groups. Over 1 year, the mean IV treatment cost was the equivalent of $17,152, and the mean oral treatment cost was $13,611 – a significant difference of $3,541.
“This represents a potential savings to the National Health Service of 16-25 million pounds sterling ($20.6 million-$32.3 million) per year,” Dr. Scarborough said. “All coming at no expense of good clinical outcomes.”
OVIVA was sponsored by the U.K. National Institute of Health Research. Dr. Scarborough had no financial disclosures.
[email protected]
On Twitter @alz_gal
VIENNA – Oral antibiotic therapy is just as effective as intravenous treatment in curing bone and joint infections, but costs about $3,500 less.
Treating these infections with oral agents also “improves patient autonomy, as it’s not necessary to have IV lines at home,” and represents a generally wiser use of powerful antibiotics, Matthew Scarborough, MD, said at the European Society of Clinical Microbiology and Infectious Diseases annual congress.
OVIVA (Oral vs. Intravenous Antibiotics for Bone and Joint Infection) was conducted at 26 sites in the United Kingdom. It randomized 1,054 adults with bone or joint infections to 6 weeks of either oral or intravenous treatment.
An important aspect of the trial was that both oral and IV treatment choices were made before randomization, Dr. Scarborough said. However, the decisions on what drug to use were left up to the treating physician and depended on the infection site and pathogen.
The primary outcome was definite treatment failure (bacteriologic, histologic, and clinical). Patients were followed for 1 year.
Patients were a median of 60 years old. All had surgical treatment before antibiotic therapy, including debridement and, in those with implants, removal of infected devices. The lower limb was involved in 81%, including hip, knee, and foot. The infection was in an upper limb in 10% and in the spine in 7%.
Staphylococcus aureus was present in 38% of cases, coagulase-negative staphylococci in 27%, and streptococci in 15%. Gram-negative bacteria were found in 22%.
For those patients randomized to IV therapy, glycopeptides and cephalosporins were most commonly employed (41% and 33%, respectively). For oral therapy, quinolones and penicillins were most common (37% and 16%). Most patients (74%) continued antibiotic treatment for more than 6 weeks. Forty patients were lost to follow-up.
In the primary intent-to-treat analysis, the failure rate was 13% for oral therapy and 14% for IV therapy, not a significant difference. Results were similar in the other analyses, including a modified intent to treat with only patients who had complete 1-year data, and a per-protocol analysis. All of the point prevalence numbers favored oral therapy, but crossed the null. Curves in the time-to-treatment-failure analysis were virtually superimposable, as were curves in time to discontinuation of therapy.
Another subgroup analysis examined treatment failure by infective organism; again, there were no significant treatment differences in any of the pathogen subgroups examined (S. aureus, coagulase-negative staph, streptococci species, and other gram-negative bacteria).
Nor did the type of antibiotic significantly affect failure rate, Dr. Scarborough noted. The median length of stay was 14 days for patients on IV treatment and 11 days for those taking oral medications. The incidence of serious adverse events was very similar – about 86% in each group.
On a visual analog scale that assessed health-related quality of life, patients taking oral treatment reported better mobility, self-care, and activity level, and less pain, discomfort, anxiety, and depression than those taking IV medications.
Cost represented the other significant difference between the groups. Over 1 year, the mean IV treatment cost was the equivalent of $17,152, and the mean oral treatment cost was $13,611 – a significant difference of $3,541.
“This represents a potential savings to the National Health Service of 16-25 million pounds sterling ($20.6 million-$32.3 million) per year,” Dr. Scarborough said. “All coming at no expense of good clinical outcomes.”
OVIVA was sponsored by the U.K. National Institute of Health Research. Dr. Scarborough had no financial disclosures.
[email protected]
On Twitter @alz_gal
VIENNA – Oral antibiotic therapy is just as effective as intravenous treatment in curing bone and joint infections, but costs about $3,500 less.
Treating these infections with oral agents also “improves patient autonomy, as it’s not necessary to have IV lines at home,” and represents a generally wiser use of powerful antibiotics, Matthew Scarborough, MD, said at the European Society of Clinical Microbiology and Infectious Diseases annual congress.
OVIVA (Oral vs. Intravenous Antibiotics for Bone and Joint Infection) was conducted at 26 sites in the United Kingdom. It randomized 1,054 adults with bone or joint infections to 6 weeks of either oral or intravenous treatment.
An important aspect of the trial was that both oral and IV treatment choices were made before randomization, Dr. Scarborough said. However, the decisions on what drug to use were left up to the treating physician and depended on the infection site and pathogen.
The primary outcome was definite treatment failure (bacteriologic, histologic, and clinical). Patients were followed for 1 year.
Patients were a median of 60 years old. All had surgical treatment before antibiotic therapy, including debridement and, in those with implants, removal of infected devices. The lower limb was involved in 81%, including hip, knee, and foot. The infection was in an upper limb in 10% and in the spine in 7%.
Staphylococcus aureus was present in 38% of cases, coagulase-negative staphylococci in 27%, and streptococci in 15%. Gram-negative bacteria were found in 22%.
For those patients randomized to IV therapy, glycopeptides and cephalosporins were most commonly employed (41% and 33%, respectively). For oral therapy, quinolones and penicillins were most common (37% and 16%). Most patients (74%) continued antibiotic treatment for more than 6 weeks. Forty patients were lost to follow-up.
In the primary intent-to-treat analysis, the failure rate was 13% for oral therapy and 14% for IV therapy, not a significant difference. Results were similar in the other analyses, including a modified intent to treat with only patients who had complete 1-year data, and a per-protocol analysis. All of the point prevalence numbers favored oral therapy, but crossed the null. Curves in the time-to-treatment-failure analysis were virtually superimposable, as were curves in time to discontinuation of therapy.
Another subgroup analysis examined treatment failure by infective organism; again, there were no significant treatment differences in any of the pathogen subgroups examined (S. aureus, coagulase-negative staph, streptococci species, and other gram-negative bacteria).
Nor did the type of antibiotic significantly affect failure rate, Dr. Scarborough noted. The median length of stay was 14 days for patients on IV treatment and 11 days for those taking oral medications. The incidence of serious adverse events was very similar – about 86% in each group.
On a visual analog scale that assessed health-related quality of life, patients taking oral treatment reported better mobility, self-care, and activity level, and less pain, discomfort, anxiety, and depression than those taking IV medications.
Cost represented the other significant difference between the groups. Over 1 year, the mean IV treatment cost was the equivalent of $17,152, and the mean oral treatment cost was $13,611 – a significant difference of $3,541.
“This represents a potential savings to the National Health Service of 16-25 million pounds sterling ($20.6 million-$32.3 million) per year,” Dr. Scarborough said. “All coming at no expense of good clinical outcomes.”
OVIVA was sponsored by the U.K. National Institute of Health Research. Dr. Scarborough had no financial disclosures.
[email protected]
On Twitter @alz_gal
AT ECCMID 2017
Key clinical point:
Major finding: At 1 year, cure rates were identical, but oral treatment cost about $3,500 less than IV treatment.
Data source: The study randomized 1,054 patients.
Disclosures: OVIVA was sponsored by the U.K. National Institute of Health Research. Dr. Scarborough had no financial disclosures.
Sutureless, guided lumpectomy produced clean margins in majority
LAS VEGAS – An automated, minimally invasive, stereotactic-guided lumpectomy performed well in an outpatient setting, with no sutures required, potentially decreasing patient morbidity, according to Pat Whitworth, MD.
Pain scores were low, and all high-risk lesions were successfully removed.
The new technology is part of the natural progression of cancer resection, said Dr. Whitworth, director of the Nashville (Tenn.) Breast Center, at the annual meeting of the American Society of Breast Surgeons.
“We went from radical mastectomy, to modified radical mastectomy, to lumpectomy. This is just part of that progression where we match what we do to what the patient really needs,” he said.
Dr. Whitworth said he believes that radiologists will soon be using such technology to treat breast cancer, which puts the onus on breast cancer surgeons to adopt it themselves. “I think it’s important for breast surgeons to acquire the necessary skill and techniques to use the same tools and work collaboratively with radiologists, because this is coming,” he said.
To see if it were possible to achieve results similar to those with lumpectomy, Dr. Whitworth analyzed data from 279 women who had a small ductal carcinoma in situ (DCIS), invasive carcinoma, or high-risk lesion removed using a 15- or 20-mm radiofrequency basket capture with imaging guidance (lumpectomy). Patients who received a cancer diagnosis underwent a second, 20-mm basket capture to obtain shaved margins.
The procedure was conducted under local anesthesia and sedation, and the incisions were closed using Steri-Strip skin closures. The average pain score was 1.55 out of 10 (range, 0-7).
Of 125 patients found to have DCIS (n = 52) and invasive lesions (n = 73), the first capture achieved clear margins in 69 cases, and the shaved margin capture achieved clean margins in another 33 cases.
The remaining 23 patients (18%) had a positive margin by histologic standards following lumpectomy and shaved margin. Of the 22 with reported results, 17 (77%) had no residual lesion following open surgery.
The results convinced Dr. Wentworth of the technique’s utility, particularly in patients who may have a heightened surgical risk, he said. “We think this can replace open lumpectomy in selected patients, with favorable margin clearance.”
The approach is fairly simple, but Dr. Wentworth recommended beginning with stereotactic-guided technology before attempting the ultrasound-guided version, which requires a little more skill. “The biggest challenge is learning that you have to use a lot more local anesthetic. When this technology first came out, people tried to use the same amount of local anesthetic that they used for standard vacuum-assisted core biopsy, and it’s very painful unless you put 30 or 40 cc of dilute anesthetic in there,” said Dr. Wentworth.
The study was funded by Medtronic, which markets the technology. Dr. Whitworth is a principal at Targeted Medical Education, which receives funding from Medtronic.
LAS VEGAS – An automated, minimally invasive, stereotactic-guided lumpectomy performed well in an outpatient setting, with no sutures required, potentially decreasing patient morbidity, according to Pat Whitworth, MD.
Pain scores were low, and all high-risk lesions were successfully removed.
The new technology is part of the natural progression of cancer resection, said Dr. Whitworth, director of the Nashville (Tenn.) Breast Center, at the annual meeting of the American Society of Breast Surgeons.
“We went from radical mastectomy, to modified radical mastectomy, to lumpectomy. This is just part of that progression where we match what we do to what the patient really needs,” he said.
Dr. Whitworth said he believes that radiologists will soon be using such technology to treat breast cancer, which puts the onus on breast cancer surgeons to adopt it themselves. “I think it’s important for breast surgeons to acquire the necessary skill and techniques to use the same tools and work collaboratively with radiologists, because this is coming,” he said.
To see if it were possible to achieve results similar to those with lumpectomy, Dr. Whitworth analyzed data from 279 women who had a small ductal carcinoma in situ (DCIS), invasive carcinoma, or high-risk lesion removed using a 15- or 20-mm radiofrequency basket capture with imaging guidance (lumpectomy). Patients who received a cancer diagnosis underwent a second, 20-mm basket capture to obtain shaved margins.
The procedure was conducted under local anesthesia and sedation, and the incisions were closed using Steri-Strip skin closures. The average pain score was 1.55 out of 10 (range, 0-7).
Of 125 patients found to have DCIS (n = 52) and invasive lesions (n = 73), the first capture achieved clear margins in 69 cases, and the shaved margin capture achieved clean margins in another 33 cases.
The remaining 23 patients (18%) had a positive margin by histologic standards following lumpectomy and shaved margin. Of the 22 with reported results, 17 (77%) had no residual lesion following open surgery.
The results convinced Dr. Wentworth of the technique’s utility, particularly in patients who may have a heightened surgical risk, he said. “We think this can replace open lumpectomy in selected patients, with favorable margin clearance.”
The approach is fairly simple, but Dr. Wentworth recommended beginning with stereotactic-guided technology before attempting the ultrasound-guided version, which requires a little more skill. “The biggest challenge is learning that you have to use a lot more local anesthetic. When this technology first came out, people tried to use the same amount of local anesthetic that they used for standard vacuum-assisted core biopsy, and it’s very painful unless you put 30 or 40 cc of dilute anesthetic in there,” said Dr. Wentworth.
The study was funded by Medtronic, which markets the technology. Dr. Whitworth is a principal at Targeted Medical Education, which receives funding from Medtronic.
LAS VEGAS – An automated, minimally invasive, stereotactic-guided lumpectomy performed well in an outpatient setting, with no sutures required, potentially decreasing patient morbidity, according to Pat Whitworth, MD.
Pain scores were low, and all high-risk lesions were successfully removed.
The new technology is part of the natural progression of cancer resection, said Dr. Whitworth, director of the Nashville (Tenn.) Breast Center, at the annual meeting of the American Society of Breast Surgeons.
“We went from radical mastectomy, to modified radical mastectomy, to lumpectomy. This is just part of that progression where we match what we do to what the patient really needs,” he said.
Dr. Whitworth said he believes that radiologists will soon be using such technology to treat breast cancer, which puts the onus on breast cancer surgeons to adopt it themselves. “I think it’s important for breast surgeons to acquire the necessary skill and techniques to use the same tools and work collaboratively with radiologists, because this is coming,” he said.
To see if it were possible to achieve results similar to those with lumpectomy, Dr. Whitworth analyzed data from 279 women who had a small ductal carcinoma in situ (DCIS), invasive carcinoma, or high-risk lesion removed using a 15- or 20-mm radiofrequency basket capture with imaging guidance (lumpectomy). Patients who received a cancer diagnosis underwent a second, 20-mm basket capture to obtain shaved margins.
The procedure was conducted under local anesthesia and sedation, and the incisions were closed using Steri-Strip skin closures. The average pain score was 1.55 out of 10 (range, 0-7).
Of 125 patients found to have DCIS (n = 52) and invasive lesions (n = 73), the first capture achieved clear margins in 69 cases, and the shaved margin capture achieved clean margins in another 33 cases.
The remaining 23 patients (18%) had a positive margin by histologic standards following lumpectomy and shaved margin. Of the 22 with reported results, 17 (77%) had no residual lesion following open surgery.
The results convinced Dr. Wentworth of the technique’s utility, particularly in patients who may have a heightened surgical risk, he said. “We think this can replace open lumpectomy in selected patients, with favorable margin clearance.”
The approach is fairly simple, but Dr. Wentworth recommended beginning with stereotactic-guided technology before attempting the ultrasound-guided version, which requires a little more skill. “The biggest challenge is learning that you have to use a lot more local anesthetic. When this technology first came out, people tried to use the same amount of local anesthetic that they used for standard vacuum-assisted core biopsy, and it’s very painful unless you put 30 or 40 cc of dilute anesthetic in there,” said Dr. Wentworth.
The study was funded by Medtronic, which markets the technology. Dr. Whitworth is a principal at Targeted Medical Education, which receives funding from Medtronic.
AT ASBS 2017
Key clinical point: The technique could replace standard lumpectomy in patients at high surgical risk.
Major finding: Clean margins were obtained in 102 of 125 women with diagnosed cancer.
Data source: A retrospective analysis of 279 patients.
Disclosures: The study was funded by Medtronic, which markets the technology. Dr. Whitworth is a principal at Targeted Medical Education, which receives funding from Medtronic.
VIDEO: Dr. Lisa Newman on triple negative breast cancer in African American women
LAS VEGAS – The heavy burden of triple negative and other aggressive breast cancers among African American women cannot be simplified to socioeconomic factors alone.
International investigations by Lisa Newman, MD, director of the Breast Oncology Program at the Henry Ford Health System, Detroit, and other researchers are making it clear that genetic factors play a significant role.
She explained the latest findings and what they mean for screening, genetic referral, and treatment in an interview at the American Society of Breast Surgeons annual meeting.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
LAS VEGAS – The heavy burden of triple negative and other aggressive breast cancers among African American women cannot be simplified to socioeconomic factors alone.
International investigations by Lisa Newman, MD, director of the Breast Oncology Program at the Henry Ford Health System, Detroit, and other researchers are making it clear that genetic factors play a significant role.
She explained the latest findings and what they mean for screening, genetic referral, and treatment in an interview at the American Society of Breast Surgeons annual meeting.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
LAS VEGAS – The heavy burden of triple negative and other aggressive breast cancers among African American women cannot be simplified to socioeconomic factors alone.
International investigations by Lisa Newman, MD, director of the Breast Oncology Program at the Henry Ford Health System, Detroit, and other researchers are making it clear that genetic factors play a significant role.
She explained the latest findings and what they mean for screening, genetic referral, and treatment in an interview at the American Society of Breast Surgeons annual meeting.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT ASBS 2017
DCIS tool IDs axillary node biopsy candidates
LAS VEGAS – A new tool identifies patients with ductal carcinoma in situ (DCIS) who are at high risk for being upstaged as a result of the pathology report. The screen could encourage patients to undergo axillary nodal staging during the core needle biopsy (CNB), thus avoiding a second procedure.
“The risk factors have been well described, but they haven’t helped give individual risk or individual percentages. Our goal was to try to individualize that risk so that we could counsel patients,” said lead researcher James Jakub, MD, chair of the division of breast endocrine and metabolic surgery at Mayo Clinic Rochester, at the annual meeting of the American Society of Breast Surgeons.
The researchers found that grade on CNB, mass lesion on imaging, multifocal/centric disease, and linear dimension combined to predict the likelihood of being upstaged to invasive disease (C statistic, 0.71; 95% confidence interval, 0.66-0.77).
They then combined those characteristics to create a nomogram and tested it against the validation set. In that group, 11% of patients were upstaged to invasive disease. The nomogram performed almost identically in the external validation set (C statistic, 0.71; 95% CI, 0.63-0.79). The model predicted 56 upstages, and 46 occurred.
This wasn’t the first attempt to create a nomogram to predict upstaging in DCIS patients, but others were not tested against external datasets. “That’s a weakness with other studies. Unless it’s validated externally, you don’t really know if you can apply it to your population. That was a very large plus: having colleagues who were willing to collaborate to validate it,” said Dr. Jakub.
The team is working on posting the nomogram online for widespread use.
It remains to be seen whether the availability of the nomogram will, in fact, change patients’ decision-making and result in more axillary nodal biopsies during CNB procedures in high risk patients.
“We haven’t looked into that. It will be interesting to see how it influences [sentinel lymph node] biopsy rate at our institution, and we’d love to hear from institutions who apply it. My sense is that patients who are at high risk are going to be interested in doing that. I think it will definitely change their management,” said Dr. Jakub.
LAS VEGAS – A new tool identifies patients with ductal carcinoma in situ (DCIS) who are at high risk for being upstaged as a result of the pathology report. The screen could encourage patients to undergo axillary nodal staging during the core needle biopsy (CNB), thus avoiding a second procedure.
“The risk factors have been well described, but they haven’t helped give individual risk or individual percentages. Our goal was to try to individualize that risk so that we could counsel patients,” said lead researcher James Jakub, MD, chair of the division of breast endocrine and metabolic surgery at Mayo Clinic Rochester, at the annual meeting of the American Society of Breast Surgeons.
The researchers found that grade on CNB, mass lesion on imaging, multifocal/centric disease, and linear dimension combined to predict the likelihood of being upstaged to invasive disease (C statistic, 0.71; 95% confidence interval, 0.66-0.77).
They then combined those characteristics to create a nomogram and tested it against the validation set. In that group, 11% of patients were upstaged to invasive disease. The nomogram performed almost identically in the external validation set (C statistic, 0.71; 95% CI, 0.63-0.79). The model predicted 56 upstages, and 46 occurred.
This wasn’t the first attempt to create a nomogram to predict upstaging in DCIS patients, but others were not tested against external datasets. “That’s a weakness with other studies. Unless it’s validated externally, you don’t really know if you can apply it to your population. That was a very large plus: having colleagues who were willing to collaborate to validate it,” said Dr. Jakub.
The team is working on posting the nomogram online for widespread use.
It remains to be seen whether the availability of the nomogram will, in fact, change patients’ decision-making and result in more axillary nodal biopsies during CNB procedures in high risk patients.
“We haven’t looked into that. It will be interesting to see how it influences [sentinel lymph node] biopsy rate at our institution, and we’d love to hear from institutions who apply it. My sense is that patients who are at high risk are going to be interested in doing that. I think it will definitely change their management,” said Dr. Jakub.
LAS VEGAS – A new tool identifies patients with ductal carcinoma in situ (DCIS) who are at high risk for being upstaged as a result of the pathology report. The screen could encourage patients to undergo axillary nodal staging during the core needle biopsy (CNB), thus avoiding a second procedure.
“The risk factors have been well described, but they haven’t helped give individual risk or individual percentages. Our goal was to try to individualize that risk so that we could counsel patients,” said lead researcher James Jakub, MD, chair of the division of breast endocrine and metabolic surgery at Mayo Clinic Rochester, at the annual meeting of the American Society of Breast Surgeons.
The researchers found that grade on CNB, mass lesion on imaging, multifocal/centric disease, and linear dimension combined to predict the likelihood of being upstaged to invasive disease (C statistic, 0.71; 95% confidence interval, 0.66-0.77).
They then combined those characteristics to create a nomogram and tested it against the validation set. In that group, 11% of patients were upstaged to invasive disease. The nomogram performed almost identically in the external validation set (C statistic, 0.71; 95% CI, 0.63-0.79). The model predicted 56 upstages, and 46 occurred.
This wasn’t the first attempt to create a nomogram to predict upstaging in DCIS patients, but others were not tested against external datasets. “That’s a weakness with other studies. Unless it’s validated externally, you don’t really know if you can apply it to your population. That was a very large plus: having colleagues who were willing to collaborate to validate it,” said Dr. Jakub.
The team is working on posting the nomogram online for widespread use.
It remains to be seen whether the availability of the nomogram will, in fact, change patients’ decision-making and result in more axillary nodal biopsies during CNB procedures in high risk patients.
“We haven’t looked into that. It will be interesting to see how it influences [sentinel lymph node] biopsy rate at our institution, and we’d love to hear from institutions who apply it. My sense is that patients who are at high risk are going to be interested in doing that. I think it will definitely change their management,” said Dr. Jakub.
AT ASBS 2017
Key clinical point: High risk patients who choose axillary biopsy could avoid a second procedure.
Major finding: The 4-item nomogram predicted upstaging with a C statistic of 0.71.
Data source: A retrospective sample (n = 827) and validation study (n = 579).
Disclosures: The source of funding was not disclosed. Dr. Jakub reported having no financial disclosures.