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Liver transplant waits shorter with DAAs
The rate of wait-listing for liver transplants for patients with hepatitis C and decompensated cirrhosis has decreased by over 30% since the entry of direct-acting antiviral (DAA) therapy and now equals the wait-list rate for nonalcoholic steatohepatitis, according to an abstract of a study that will be presented at the annual meeting of the American Association for the Study of Liver Diseases.
Using the U.S. Scientific Registry of Transplant Recipients (SRTR), Jennifer Flemming, MD, and her coauthors developed a cohort of 47,591 adults who were wait-listed for liver transplant because of HCV or hepatitis B virus infection (HBV), or for nonalcoholic steatohepatitis (NASH).
Dr. Flemming, professor of gastroenterology at Queens University, Kingston, Ont., examined trends in liver transplant wait-listing between 2003 and 2015. The time period was divided into the “interferon era,” from 2003 to 2010, the “protease inhibitor era,” from 2011 to 2013, and the “DAA era,” from 2014 to 2015.
Examining annual standardized incidence rates of wait-listing, Dr. Flemming and her collaborators found that wait-listing for HCV patients with decompensated cirrhosis dropped by 5% during the protease inhibitor era, and by 32% in the DAA era (P = .004 and P less than .001, respectively).
Wait-listing for HBV also dropped, by 17% in the protease inhibitor era and by 24% in the DAA era (P = .002 and P less than .001, respectively). For NASH patients, conversely, wait-listing increased by 41% in the protease inhibitor era, and by 81% in the DAA era (P less than .001 for both). Hepatocellular carcinoma rates also rose during the protease inhibitor and DAA eras.
“Further reductions in [wait-listing] are anticipated with increased testing, linkage to care, and access to DAA therapy,” Dr. Flemming and her coauthors wrote in their study abstract.
Dr. Flemming reported no relevant financial disclosures. Several coauthors reported financial ties to pharmaceutical companies that market DAAs.
[email protected]
On Twitter @karioakes
The rate of wait-listing for liver transplants for patients with hepatitis C and decompensated cirrhosis has decreased by over 30% since the entry of direct-acting antiviral (DAA) therapy and now equals the wait-list rate for nonalcoholic steatohepatitis, according to an abstract of a study that will be presented at the annual meeting of the American Association for the Study of Liver Diseases.
Using the U.S. Scientific Registry of Transplant Recipients (SRTR), Jennifer Flemming, MD, and her coauthors developed a cohort of 47,591 adults who were wait-listed for liver transplant because of HCV or hepatitis B virus infection (HBV), or for nonalcoholic steatohepatitis (NASH).
Dr. Flemming, professor of gastroenterology at Queens University, Kingston, Ont., examined trends in liver transplant wait-listing between 2003 and 2015. The time period was divided into the “interferon era,” from 2003 to 2010, the “protease inhibitor era,” from 2011 to 2013, and the “DAA era,” from 2014 to 2015.
Examining annual standardized incidence rates of wait-listing, Dr. Flemming and her collaborators found that wait-listing for HCV patients with decompensated cirrhosis dropped by 5% during the protease inhibitor era, and by 32% in the DAA era (P = .004 and P less than .001, respectively).
Wait-listing for HBV also dropped, by 17% in the protease inhibitor era and by 24% in the DAA era (P = .002 and P less than .001, respectively). For NASH patients, conversely, wait-listing increased by 41% in the protease inhibitor era, and by 81% in the DAA era (P less than .001 for both). Hepatocellular carcinoma rates also rose during the protease inhibitor and DAA eras.
“Further reductions in [wait-listing] are anticipated with increased testing, linkage to care, and access to DAA therapy,” Dr. Flemming and her coauthors wrote in their study abstract.
Dr. Flemming reported no relevant financial disclosures. Several coauthors reported financial ties to pharmaceutical companies that market DAAs.
[email protected]
On Twitter @karioakes
The rate of wait-listing for liver transplants for patients with hepatitis C and decompensated cirrhosis has decreased by over 30% since the entry of direct-acting antiviral (DAA) therapy and now equals the wait-list rate for nonalcoholic steatohepatitis, according to an abstract of a study that will be presented at the annual meeting of the American Association for the Study of Liver Diseases.
Using the U.S. Scientific Registry of Transplant Recipients (SRTR), Jennifer Flemming, MD, and her coauthors developed a cohort of 47,591 adults who were wait-listed for liver transplant because of HCV or hepatitis B virus infection (HBV), or for nonalcoholic steatohepatitis (NASH).
Dr. Flemming, professor of gastroenterology at Queens University, Kingston, Ont., examined trends in liver transplant wait-listing between 2003 and 2015. The time period was divided into the “interferon era,” from 2003 to 2010, the “protease inhibitor era,” from 2011 to 2013, and the “DAA era,” from 2014 to 2015.
Examining annual standardized incidence rates of wait-listing, Dr. Flemming and her collaborators found that wait-listing for HCV patients with decompensated cirrhosis dropped by 5% during the protease inhibitor era, and by 32% in the DAA era (P = .004 and P less than .001, respectively).
Wait-listing for HBV also dropped, by 17% in the protease inhibitor era and by 24% in the DAA era (P = .002 and P less than .001, respectively). For NASH patients, conversely, wait-listing increased by 41% in the protease inhibitor era, and by 81% in the DAA era (P less than .001 for both). Hepatocellular carcinoma rates also rose during the protease inhibitor and DAA eras.
“Further reductions in [wait-listing] are anticipated with increased testing, linkage to care, and access to DAA therapy,” Dr. Flemming and her coauthors wrote in their study abstract.
Dr. Flemming reported no relevant financial disclosures. Several coauthors reported financial ties to pharmaceutical companies that market DAAs.
[email protected]
On Twitter @karioakes
FROM THE LIVER MEETING 2016
Study finds 19% of Merkel cell carcinomas are virus negative
Nineteen percent of Merkel cell carcinomas are not driven by the Merkel cell polyomavirus and are substantially more aggressive than those that are virus positive, according to a report published online in the Journal of Investigative Dermatology.
This and other findings from a retrospective analysis of samples from 282 Merkel cell carcinomas in a Seattle repository “suggest that it may be clinically indicated to determine tumor viral status at the time of diagnosis, as the results may affect prognosis as well as optimal clinical management,” wrote Ata Moshiri, MD, who was with the University of Washington, Seattle, at the time of the study, and his associates. 
Given that virus-negative Merkel cell carcinomas carry a markedly higher risk of recurrence, progression, and patient mortality, “clinicians may consider larger initial surgical margins, larger radiotherapy fields, and the use of regional nodal therapy even in the absence of documented nodal metastasis. Closer clinical follow-up and more frequent radiologic surveillance may be justified for patients with virus-negative tumors because ... serologic monitoring is not feasible for this patient population,” the investigators noted.
The incidence of Merkel cell carcinoma, a rare and aggressive neuroendocrine skin cancer with an overall disease-related mortality of 40%, has quadrupled during the last 20 years. This is likely because of the increasing prevalence of risk factors for the cancer, including advanced age, increased cumulative exposure to ultraviolet light, and systemic immune suppression.
Data concerning the presence of Merkel cell polyomavirus in these cancers are conflicting, with estimates of virus positivity ranging from 20% all the way to 100% in some studies. Part of the reason for this wide range of estimates is that there is no accepted preferred method for measuring the viral status of these tumors. Moreover, the prognostic significance of that viral status is also debated. Thus, most Merkel cell cancers are not routinely analyzed for the presence of Merkel cell polyomavirus.
To pin down the prevalence of virus positivity and establish whether it impacts clinical outcomes, Dr. Moshiri and his associates analyzed 282 Merkel cell specimens collected since 1980 and stored in a Seattle repository, along with clinical data. They tested each specimen using an immunohistochemical assay to detect one antibody (CM2B4), a different immunohistochemical assay to detect another antibody (Ab3), and a quantitative PCR assay for polyomavirus DNA. To be considered virus positive, each specimen had to show the presence of the virus on at least two of these tests.
By these criteria, 53 tumors (18.8%) were found to be virus negative and 229 (81.2%) to be virus positive.
Virus-negative tumors tended to be smaller than virus-positive tumors at presentation. Despite their smaller size, virus-negative tumors tended to be more advanced at presentation: 66.7% had nodal or distant metastases, compared with 48.3% of virus-positive tumors.
A total of 66.7% of virus-negative carcinomas progressed, compared with only 43.6% of virus-positive carcinomas. The median time to progression was 1.2 years for virus-negative cancers, but was not reached for virus-positive cancers. In a univariate analysis, virus-negative tumors had a nearly twofold higher risk of progression. In a multivariate analysis that adjusted for differences in disease stage at presentation, the HR fell slightly to 1.55.
Cancer-specific mortality was 45.3% for virus-negative tumors, compared with 26.3% for virus-positive tumors. Median time to death from Merkel cell carcinoma was 3.7 years for virus-negative tumors but was not reached for virus-positive tumors. In a univariate analysis, virus-negative tumors carried a nearly twofold higher risk of death from Merkel cell carcinoma. In a multivariate analysis that adjusted for differences in disease stage at presentation, the HR fell somewhat to 1.50.
Median overall survival was 3.3 years for patients with virus-negative tumors, compared with 4.6 years for patients with virus-positive tumors.
These findings indicate that a more advanced cancer stage at diagnosis accounts for some but not all of the poorer clinical outcomes seen with virus-negative tumors, the investigators said.
This study could not assess why virus-negative Merkel cell carcinomas are more aggressive and lethal than virus-positive ones, but previous studies have proposed some plausible biological mechanisms. Virus-negative tumors carry a greater number of chromosomal aberrations, a greater burden of nucleotide mutations, and a greater number of mutations in known oncogenic pathways. They also may be more immunogenic “due to their constitutive expression of oncoproteins that may serve as targets for cytotoxic tumor-infiltrating lymphocytes,” Dr. Moshiri and his associates said.
They added that in this study, the immunohistochemical assay for CM2B4 antibodies was the test that most accurately identified tumors that had worse outcomes. “We believe that the CM2B4 antibody test may be well-suited for routine clinical use” because of its sensitivity and specificity in this application, its commercial availability, “and the ease with which it could be included in the work flow of clinical laboratories accustomed to immunohistochemistry.”
Dr. Moshiri is currently at the University of Pennsylvania, Philadelphia.
The National Institutes of Health, the Colin Johnston Fund, and the Janet Canning Fund supported the study. Dr. Moshiri reported having no relevant financial disclosures; one of his associates reported that her institute received research funding from Valeant and Pfizer unrelated to this work.
Nineteen percent of Merkel cell carcinomas are not driven by the Merkel cell polyomavirus and are substantially more aggressive than those that are virus positive, according to a report published online in the Journal of Investigative Dermatology.
This and other findings from a retrospective analysis of samples from 282 Merkel cell carcinomas in a Seattle repository “suggest that it may be clinically indicated to determine tumor viral status at the time of diagnosis, as the results may affect prognosis as well as optimal clinical management,” wrote Ata Moshiri, MD, who was with the University of Washington, Seattle, at the time of the study, and his associates.
Given that virus-negative Merkel cell carcinomas carry a markedly higher risk of recurrence, progression, and patient mortality, “clinicians may consider larger initial surgical margins, larger radiotherapy fields, and the use of regional nodal therapy even in the absence of documented nodal metastasis. Closer clinical follow-up and more frequent radiologic surveillance may be justified for patients with virus-negative tumors because ... serologic monitoring is not feasible for this patient population,” the investigators noted.
The incidence of Merkel cell carcinoma, a rare and aggressive neuroendocrine skin cancer with an overall disease-related mortality of 40%, has quadrupled during the last 20 years. This is likely because of the increasing prevalence of risk factors for the cancer, including advanced age, increased cumulative exposure to ultraviolet light, and systemic immune suppression.
Data concerning the presence of Merkel cell polyomavirus in these cancers are conflicting, with estimates of virus positivity ranging from 20% all the way to 100% in some studies. Part of the reason for this wide range of estimates is that there is no accepted preferred method for measuring the viral status of these tumors. Moreover, the prognostic significance of that viral status is also debated. Thus, most Merkel cell cancers are not routinely analyzed for the presence of Merkel cell polyomavirus.
To pin down the prevalence of virus positivity and establish whether it impacts clinical outcomes, Dr. Moshiri and his associates analyzed 282 Merkel cell specimens collected since 1980 and stored in a Seattle repository, along with clinical data. They tested each specimen using an immunohistochemical assay to detect one antibody (CM2B4), a different immunohistochemical assay to detect another antibody (Ab3), and a quantitative PCR assay for polyomavirus DNA. To be considered virus positive, each specimen had to show the presence of the virus on at least two of these tests.
By these criteria, 53 tumors (18.8%) were found to be virus negative and 229 (81.2%) to be virus positive.
Virus-negative tumors tended to be smaller than virus-positive tumors at presentation. Despite their smaller size, virus-negative tumors tended to be more advanced at presentation: 66.7% had nodal or distant metastases, compared with 48.3% of virus-positive tumors.
A total of 66.7% of virus-negative carcinomas progressed, compared with only 43.6% of virus-positive carcinomas. The median time to progression was 1.2 years for virus-negative cancers, but was not reached for virus-positive cancers. In a univariate analysis, virus-negative tumors had a nearly twofold higher risk of progression. In a multivariate analysis that adjusted for differences in disease stage at presentation, the HR fell slightly to 1.55.
Cancer-specific mortality was 45.3% for virus-negative tumors, compared with 26.3% for virus-positive tumors. Median time to death from Merkel cell carcinoma was 3.7 years for virus-negative tumors but was not reached for virus-positive tumors. In a univariate analysis, virus-negative tumors carried a nearly twofold higher risk of death from Merkel cell carcinoma. In a multivariate analysis that adjusted for differences in disease stage at presentation, the HR fell somewhat to 1.50.
Median overall survival was 3.3 years for patients with virus-negative tumors, compared with 4.6 years for patients with virus-positive tumors.
These findings indicate that a more advanced cancer stage at diagnosis accounts for some but not all of the poorer clinical outcomes seen with virus-negative tumors, the investigators said.
This study could not assess why virus-negative Merkel cell carcinomas are more aggressive and lethal than virus-positive ones, but previous studies have proposed some plausible biological mechanisms. Virus-negative tumors carry a greater number of chromosomal aberrations, a greater burden of nucleotide mutations, and a greater number of mutations in known oncogenic pathways. They also may be more immunogenic “due to their constitutive expression of oncoproteins that may serve as targets for cytotoxic tumor-infiltrating lymphocytes,” Dr. Moshiri and his associates said.
They added that in this study, the immunohistochemical assay for CM2B4 antibodies was the test that most accurately identified tumors that had worse outcomes. “We believe that the CM2B4 antibody test may be well-suited for routine clinical use” because of its sensitivity and specificity in this application, its commercial availability, “and the ease with which it could be included in the work flow of clinical laboratories accustomed to immunohistochemistry.”
Dr. Moshiri is currently at the University of Pennsylvania, Philadelphia.
The National Institutes of Health, the Colin Johnston Fund, and the Janet Canning Fund supported the study. Dr. Moshiri reported having no relevant financial disclosures; one of his associates reported that her institute received research funding from Valeant and Pfizer unrelated to this work.
Nineteen percent of Merkel cell carcinomas are not driven by the Merkel cell polyomavirus and are substantially more aggressive than those that are virus positive, according to a report published online in the Journal of Investigative Dermatology.
This and other findings from a retrospective analysis of samples from 282 Merkel cell carcinomas in a Seattle repository “suggest that it may be clinically indicated to determine tumor viral status at the time of diagnosis, as the results may affect prognosis as well as optimal clinical management,” wrote Ata Moshiri, MD, who was with the University of Washington, Seattle, at the time of the study, and his associates.
Given that virus-negative Merkel cell carcinomas carry a markedly higher risk of recurrence, progression, and patient mortality, “clinicians may consider larger initial surgical margins, larger radiotherapy fields, and the use of regional nodal therapy even in the absence of documented nodal metastasis. Closer clinical follow-up and more frequent radiologic surveillance may be justified for patients with virus-negative tumors because ... serologic monitoring is not feasible for this patient population,” the investigators noted.
The incidence of Merkel cell carcinoma, a rare and aggressive neuroendocrine skin cancer with an overall disease-related mortality of 40%, has quadrupled during the last 20 years. This is likely because of the increasing prevalence of risk factors for the cancer, including advanced age, increased cumulative exposure to ultraviolet light, and systemic immune suppression.
Data concerning the presence of Merkel cell polyomavirus in these cancers are conflicting, with estimates of virus positivity ranging from 20% all the way to 100% in some studies. Part of the reason for this wide range of estimates is that there is no accepted preferred method for measuring the viral status of these tumors. Moreover, the prognostic significance of that viral status is also debated. Thus, most Merkel cell cancers are not routinely analyzed for the presence of Merkel cell polyomavirus.
To pin down the prevalence of virus positivity and establish whether it impacts clinical outcomes, Dr. Moshiri and his associates analyzed 282 Merkel cell specimens collected since 1980 and stored in a Seattle repository, along with clinical data. They tested each specimen using an immunohistochemical assay to detect one antibody (CM2B4), a different immunohistochemical assay to detect another antibody (Ab3), and a quantitative PCR assay for polyomavirus DNA. To be considered virus positive, each specimen had to show the presence of the virus on at least two of these tests.
By these criteria, 53 tumors (18.8%) were found to be virus negative and 229 (81.2%) to be virus positive.
Virus-negative tumors tended to be smaller than virus-positive tumors at presentation. Despite their smaller size, virus-negative tumors tended to be more advanced at presentation: 66.7% had nodal or distant metastases, compared with 48.3% of virus-positive tumors.
A total of 66.7% of virus-negative carcinomas progressed, compared with only 43.6% of virus-positive carcinomas. The median time to progression was 1.2 years for virus-negative cancers, but was not reached for virus-positive cancers. In a univariate analysis, virus-negative tumors had a nearly twofold higher risk of progression. In a multivariate analysis that adjusted for differences in disease stage at presentation, the HR fell slightly to 1.55.
Cancer-specific mortality was 45.3% for virus-negative tumors, compared with 26.3% for virus-positive tumors. Median time to death from Merkel cell carcinoma was 3.7 years for virus-negative tumors but was not reached for virus-positive tumors. In a univariate analysis, virus-negative tumors carried a nearly twofold higher risk of death from Merkel cell carcinoma. In a multivariate analysis that adjusted for differences in disease stage at presentation, the HR fell somewhat to 1.50.
Median overall survival was 3.3 years for patients with virus-negative tumors, compared with 4.6 years for patients with virus-positive tumors.
These findings indicate that a more advanced cancer stage at diagnosis accounts for some but not all of the poorer clinical outcomes seen with virus-negative tumors, the investigators said.
This study could not assess why virus-negative Merkel cell carcinomas are more aggressive and lethal than virus-positive ones, but previous studies have proposed some plausible biological mechanisms. Virus-negative tumors carry a greater number of chromosomal aberrations, a greater burden of nucleotide mutations, and a greater number of mutations in known oncogenic pathways. They also may be more immunogenic “due to their constitutive expression of oncoproteins that may serve as targets for cytotoxic tumor-infiltrating lymphocytes,” Dr. Moshiri and his associates said.
They added that in this study, the immunohistochemical assay for CM2B4 antibodies was the test that most accurately identified tumors that had worse outcomes. “We believe that the CM2B4 antibody test may be well-suited for routine clinical use” because of its sensitivity and specificity in this application, its commercial availability, “and the ease with which it could be included in the work flow of clinical laboratories accustomed to immunohistochemistry.”
Dr. Moshiri is currently at the University of Pennsylvania, Philadelphia.
The National Institutes of Health, the Colin Johnston Fund, and the Janet Canning Fund supported the study. Dr. Moshiri reported having no relevant financial disclosures; one of his associates reported that her institute received research funding from Valeant and Pfizer unrelated to this work.
FROM THE JOURNAL OF INVESTIGATIVE DERMATOLOGY
Key clinical point: Nineteen percent of Merkel cell carcinomas are not driven by the Merkel cell polyomavirus and are substantially more aggressive than those that are virus positive.
Major finding: The 53 virus-negative tumors carried a cancer-specific mortality of 45.3%, while the 229 virus-positive tumors carried a cancer-specific mortality of 26.2%.
Data source: A retrospective molecular analysis of samples from 282 Merkel cell carcinomas in a Seattle repository for the presence of Merkel cell polyomavirus.
Disclosures: The National Institutes of Health, the Colin Johnston Fund, and the Janet Canning Fund supported the study. Dr. Moshiri reported having no relevant financial disclosures; one of his associates reported that her institute received research funding from Valeant and Pfizer unrelated to this work.
What will the Trump administration mean for medicine?
The Affordable Care Act is in the crosshairs as the transition to the Trump administration begins Nov. 9.
The primary tenet of Donald J. Trump’s health care platform calls for Congress to repeal the ACA.
In fact, Mr. Trump has called for ACA repeal efforts to begin on his administration’s first day.
The Trump administration is likely to find plentiful allies in Congress as both the House and the Senate were projected at press time to have Republican majorities, albeit slim ones. Since the ACA’s passage in 2010, House Republicans have put forward repeal legislation scores of times.
While many medical specialty societies have supported the ACA and other major health care reforms enacted over the last 8 years – Meaningful Use from the HITECH ACT and value-based payment from MACRA among them – large numbers of physicians have chafed under the myriad reporting requirements and administrative hassles.
A recent survey commissioned by the Physicians Foundation and conducted by Merritt Hawkins found that nearly half (48%) of physicians are considering a change of practice – including leaving medicine – in the next 1-3 years. Reasons cited by survey respondents included the MACRA (Medicare Access and CHIP Reauthorization Act of 2015) transition to value-based care, the increased coding required by ICD-10, the growth of physician employment, the continued sale of private practices to hospitals and health systems, the increased number of patients in the system because of the ACA coupled with a shortage of physicians, and the “businessification” of heath care.
“If any of these [changes] occurred in a period of time, it would be impactful,” Walker Ray, MD, president of the Physicians Foundation, said in an interview. “But to have all occur simultaneously, we say now that to be a physician is to feel the ground shaking under your feet. This is the landscape in which the survey was taken.”
Mr. Trump supports several free market reforms to replace repealed provisions of the ACA, as well as address other issues in the health care system. The proposals include the following:
• Foster interstate insurance sales.
• Reinstate the tax deductibility of health insurance premiums.
• Promote the more widespread use of health savings accounts.
• Require price transparency so that patients can shop for medical procedures, exams, and tests.
• Block grant Medicaid to the states.
• Allow patients to import drugs from outside of the United States.
The Trump platform also promises to reduce fraud and waste, as well as save approximately $11 billion annually by not providing health care to illegal immigrants.
Speculation has also begun regarding who might lead health care agencies and policy for the Trump administration. Among the names that have been floated for secretary of Health and Human Services are Ben Carson, MD, the former presidential candidate and retired neurosurgeon; former House Speaker Newt Gingrich (who also has been suggested as a potential secretary of State); as well as Florida Gov. Rick Scott, former chief executive of Columbia/HCA, according to Politico.com.
[email protected]
On Twitter @denisefulton
Gregory Twachtman contributed to this story.
The Affordable Care Act is in the crosshairs as the transition to the Trump administration begins Nov. 9.
The primary tenet of Donald J. Trump’s health care platform calls for Congress to repeal the ACA.
In fact, Mr. Trump has called for ACA repeal efforts to begin on his administration’s first day.
The Trump administration is likely to find plentiful allies in Congress as both the House and the Senate were projected at press time to have Republican majorities, albeit slim ones. Since the ACA’s passage in 2010, House Republicans have put forward repeal legislation scores of times.
While many medical specialty societies have supported the ACA and other major health care reforms enacted over the last 8 years – Meaningful Use from the HITECH ACT and value-based payment from MACRA among them – large numbers of physicians have chafed under the myriad reporting requirements and administrative hassles.
A recent survey commissioned by the Physicians Foundation and conducted by Merritt Hawkins found that nearly half (48%) of physicians are considering a change of practice – including leaving medicine – in the next 1-3 years. Reasons cited by survey respondents included the MACRA (Medicare Access and CHIP Reauthorization Act of 2015) transition to value-based care, the increased coding required by ICD-10, the growth of physician employment, the continued sale of private practices to hospitals and health systems, the increased number of patients in the system because of the ACA coupled with a shortage of physicians, and the “businessification” of heath care.
“If any of these [changes] occurred in a period of time, it would be impactful,” Walker Ray, MD, president of the Physicians Foundation, said in an interview. “But to have all occur simultaneously, we say now that to be a physician is to feel the ground shaking under your feet. This is the landscape in which the survey was taken.”
Mr. Trump supports several free market reforms to replace repealed provisions of the ACA, as well as address other issues in the health care system. The proposals include the following:
• Foster interstate insurance sales.
• Reinstate the tax deductibility of health insurance premiums.
• Promote the more widespread use of health savings accounts.
• Require price transparency so that patients can shop for medical procedures, exams, and tests.
• Block grant Medicaid to the states.
• Allow patients to import drugs from outside of the United States.
The Trump platform also promises to reduce fraud and waste, as well as save approximately $11 billion annually by not providing health care to illegal immigrants.
Speculation has also begun regarding who might lead health care agencies and policy for the Trump administration. Among the names that have been floated for secretary of Health and Human Services are Ben Carson, MD, the former presidential candidate and retired neurosurgeon; former House Speaker Newt Gingrich (who also has been suggested as a potential secretary of State); as well as Florida Gov. Rick Scott, former chief executive of Columbia/HCA, according to Politico.com.
[email protected]
On Twitter @denisefulton
Gregory Twachtman contributed to this story.
The Affordable Care Act is in the crosshairs as the transition to the Trump administration begins Nov. 9.
The primary tenet of Donald J. Trump’s health care platform calls for Congress to repeal the ACA.
In fact, Mr. Trump has called for ACA repeal efforts to begin on his administration’s first day.
The Trump administration is likely to find plentiful allies in Congress as both the House and the Senate were projected at press time to have Republican majorities, albeit slim ones. Since the ACA’s passage in 2010, House Republicans have put forward repeal legislation scores of times.
While many medical specialty societies have supported the ACA and other major health care reforms enacted over the last 8 years – Meaningful Use from the HITECH ACT and value-based payment from MACRA among them – large numbers of physicians have chafed under the myriad reporting requirements and administrative hassles.
A recent survey commissioned by the Physicians Foundation and conducted by Merritt Hawkins found that nearly half (48%) of physicians are considering a change of practice – including leaving medicine – in the next 1-3 years. Reasons cited by survey respondents included the MACRA (Medicare Access and CHIP Reauthorization Act of 2015) transition to value-based care, the increased coding required by ICD-10, the growth of physician employment, the continued sale of private practices to hospitals and health systems, the increased number of patients in the system because of the ACA coupled with a shortage of physicians, and the “businessification” of heath care.
“If any of these [changes] occurred in a period of time, it would be impactful,” Walker Ray, MD, president of the Physicians Foundation, said in an interview. “But to have all occur simultaneously, we say now that to be a physician is to feel the ground shaking under your feet. This is the landscape in which the survey was taken.”
Mr. Trump supports several free market reforms to replace repealed provisions of the ACA, as well as address other issues in the health care system. The proposals include the following:
• Foster interstate insurance sales.
• Reinstate the tax deductibility of health insurance premiums.
• Promote the more widespread use of health savings accounts.
• Require price transparency so that patients can shop for medical procedures, exams, and tests.
• Block grant Medicaid to the states.
• Allow patients to import drugs from outside of the United States.
The Trump platform also promises to reduce fraud and waste, as well as save approximately $11 billion annually by not providing health care to illegal immigrants.
Speculation has also begun regarding who might lead health care agencies and policy for the Trump administration. Among the names that have been floated for secretary of Health and Human Services are Ben Carson, MD, the former presidential candidate and retired neurosurgeon; former House Speaker Newt Gingrich (who also has been suggested as a potential secretary of State); as well as Florida Gov. Rick Scott, former chief executive of Columbia/HCA, according to Politico.com.
[email protected]
On Twitter @denisefulton
Gregory Twachtman contributed to this story.
In era of infliximab, ulcerative colitis surgical outcomes worsen
WASHINGTON – The era of powerful biologics has led to unforeseen surgical outcomes in patients with ulcerative colitis.
Patients undergoing surgery for ulcerative colitis now are 38% more likely to die in the hospital than they were 15 years ago, before infliximab and other biologics were adopted as medical therapy for the disease. A database review covering 18 years found that other surgical outcomes are worse, too, Jonathan Abelson, MD, said at the annual clinical congress of the American College of Surgeons.
“These very powerful agents could be completely eliminating the need for surgery in patients with mild disease, leaving surgery for those who have very advanced disease and didn’t respond well to medical therapy,” said Dr. Abelson, a clinical research fellow at New York–Presbyterian Hospital, N.Y. “We are operating now only on patients with very severe disease, not the wider range of patients we had 15 years ago, when there weren’t as effective medical options.”
He and his colleagues used the New York Statewide Planning and Research Cooperative System (SPARCS) database to identify 7,070 patients who had undergone bowel resection for ulcerative colitis during two epochs: prebiologics (1995-2005) and postbiologics (2006-2013). The cohorts were about evenly split in numbers.
There were some statistically significant differences in baseline characteristics. Patients in epoch 2 were about a year older (51 vs. 50 years). Significantly more of them had at least two major comorbidities (28% vs. 18%). Minimally invasive surgery was significantly more common in epoch 2 (28% vs. 3%).
Significantly more surgeries in epoch 2 were staged into three or more procedures (14% vs. 9%). This finding probably reflects the level of disease severity in those presenting for surgery or the fact that they underwent surgery after recently receiving biologics, Dr. Abelson said.
“One of the limits of this study is that we don’t know exactly the reasons for these one-, two-, or three-stage surgeries. The theory is that patients who were more ill at presentation are more likely to have a multistaged surgery. Another reason could be that if they are on these powerful immunosuppressive regimens, the surgeon might be concerned about not healing well from a definitive one- or two-stage surgery.”
He then conducted a multivariate analysis that controlled for baseline factors, including a variety of individual comorbid conditions. In this analysis, patients in epoch 2 were 38% more likely to die in the hospital and 51% more likely to experience a major postoperative event, like shock, pulmonary embolism, stroke, or heart attack. The chance of a surgical complication was increased by 39%, and these patients were 25% more likely to need a transfusion during surgery than those from epoch 1.
The poorer outcomes held for an at least an entire year after surgery, Dr. Abelson said. At 1 year, patients in epoch 2 were 36% more likely to have a readmission than those in epoch 1. Major events and procedural complications were both 46% more likely. Patients were also 36% more likely to require an additional procedure.
“These are not the outcomes we want to see, especially in this era when our surgical techniques have improved so much,” Dr. Abelson said. “If what this represents, though, is that we are now operating on a higher-risk population, we can’t just say, ‘Well, that’s how it’s going to be.’ We need to figure out how to minimize morbidity and mortality in this high-risk patient population.”
One goal, he suggested, would be to assess response to a biologic regimen earlier in the hopes of determining who will respond well, and moving ahead with surgery in those who don’t.
This is a tough sell for patients, he said.
“There is a big fear of this surgery. It usually requires a temporary ileostomy and a stoma bag, and patients are terrified of that. There have been a few studies demonstrating that earlier referral to surgery improves quality of life; living with advanced ulcerative colitis can be extremely difficult and patients often feel a lot better after we remove their diseased colon. But getting there is a challenge.”
Dr. Abelson had no financial disclosures.
[email protected]
On Twitter @Alz_Gal
WASHINGTON – The era of powerful biologics has led to unforeseen surgical outcomes in patients with ulcerative colitis.
Patients undergoing surgery for ulcerative colitis now are 38% more likely to die in the hospital than they were 15 years ago, before infliximab and other biologics were adopted as medical therapy for the disease. A database review covering 18 years found that other surgical outcomes are worse, too, Jonathan Abelson, MD, said at the annual clinical congress of the American College of Surgeons.
“These very powerful agents could be completely eliminating the need for surgery in patients with mild disease, leaving surgery for those who have very advanced disease and didn’t respond well to medical therapy,” said Dr. Abelson, a clinical research fellow at New York–Presbyterian Hospital, N.Y. “We are operating now only on patients with very severe disease, not the wider range of patients we had 15 years ago, when there weren’t as effective medical options.”
He and his colleagues used the New York Statewide Planning and Research Cooperative System (SPARCS) database to identify 7,070 patients who had undergone bowel resection for ulcerative colitis during two epochs: prebiologics (1995-2005) and postbiologics (2006-2013). The cohorts were about evenly split in numbers.
There were some statistically significant differences in baseline characteristics. Patients in epoch 2 were about a year older (51 vs. 50 years). Significantly more of them had at least two major comorbidities (28% vs. 18%). Minimally invasive surgery was significantly more common in epoch 2 (28% vs. 3%).
Significantly more surgeries in epoch 2 were staged into three or more procedures (14% vs. 9%). This finding probably reflects the level of disease severity in those presenting for surgery or the fact that they underwent surgery after recently receiving biologics, Dr. Abelson said.
“One of the limits of this study is that we don’t know exactly the reasons for these one-, two-, or three-stage surgeries. The theory is that patients who were more ill at presentation are more likely to have a multistaged surgery. Another reason could be that if they are on these powerful immunosuppressive regimens, the surgeon might be concerned about not healing well from a definitive one- or two-stage surgery.”
He then conducted a multivariate analysis that controlled for baseline factors, including a variety of individual comorbid conditions. In this analysis, patients in epoch 2 were 38% more likely to die in the hospital and 51% more likely to experience a major postoperative event, like shock, pulmonary embolism, stroke, or heart attack. The chance of a surgical complication was increased by 39%, and these patients were 25% more likely to need a transfusion during surgery than those from epoch 1.
The poorer outcomes held for an at least an entire year after surgery, Dr. Abelson said. At 1 year, patients in epoch 2 were 36% more likely to have a readmission than those in epoch 1. Major events and procedural complications were both 46% more likely. Patients were also 36% more likely to require an additional procedure.
“These are not the outcomes we want to see, especially in this era when our surgical techniques have improved so much,” Dr. Abelson said. “If what this represents, though, is that we are now operating on a higher-risk population, we can’t just say, ‘Well, that’s how it’s going to be.’ We need to figure out how to minimize morbidity and mortality in this high-risk patient population.”
One goal, he suggested, would be to assess response to a biologic regimen earlier in the hopes of determining who will respond well, and moving ahead with surgery in those who don’t.
This is a tough sell for patients, he said.
“There is a big fear of this surgery. It usually requires a temporary ileostomy and a stoma bag, and patients are terrified of that. There have been a few studies demonstrating that earlier referral to surgery improves quality of life; living with advanced ulcerative colitis can be extremely difficult and patients often feel a lot better after we remove their diseased colon. But getting there is a challenge.”
Dr. Abelson had no financial disclosures.
[email protected]
On Twitter @Alz_Gal
WASHINGTON – The era of powerful biologics has led to unforeseen surgical outcomes in patients with ulcerative colitis.
Patients undergoing surgery for ulcerative colitis now are 38% more likely to die in the hospital than they were 15 years ago, before infliximab and other biologics were adopted as medical therapy for the disease. A database review covering 18 years found that other surgical outcomes are worse, too, Jonathan Abelson, MD, said at the annual clinical congress of the American College of Surgeons.
“These very powerful agents could be completely eliminating the need for surgery in patients with mild disease, leaving surgery for those who have very advanced disease and didn’t respond well to medical therapy,” said Dr. Abelson, a clinical research fellow at New York–Presbyterian Hospital, N.Y. “We are operating now only on patients with very severe disease, not the wider range of patients we had 15 years ago, when there weren’t as effective medical options.”
He and his colleagues used the New York Statewide Planning and Research Cooperative System (SPARCS) database to identify 7,070 patients who had undergone bowel resection for ulcerative colitis during two epochs: prebiologics (1995-2005) and postbiologics (2006-2013). The cohorts were about evenly split in numbers.
There were some statistically significant differences in baseline characteristics. Patients in epoch 2 were about a year older (51 vs. 50 years). Significantly more of them had at least two major comorbidities (28% vs. 18%). Minimally invasive surgery was significantly more common in epoch 2 (28% vs. 3%).
Significantly more surgeries in epoch 2 were staged into three or more procedures (14% vs. 9%). This finding probably reflects the level of disease severity in those presenting for surgery or the fact that they underwent surgery after recently receiving biologics, Dr. Abelson said.
“One of the limits of this study is that we don’t know exactly the reasons for these one-, two-, or three-stage surgeries. The theory is that patients who were more ill at presentation are more likely to have a multistaged surgery. Another reason could be that if they are on these powerful immunosuppressive regimens, the surgeon might be concerned about not healing well from a definitive one- or two-stage surgery.”
He then conducted a multivariate analysis that controlled for baseline factors, including a variety of individual comorbid conditions. In this analysis, patients in epoch 2 were 38% more likely to die in the hospital and 51% more likely to experience a major postoperative event, like shock, pulmonary embolism, stroke, or heart attack. The chance of a surgical complication was increased by 39%, and these patients were 25% more likely to need a transfusion during surgery than those from epoch 1.
The poorer outcomes held for an at least an entire year after surgery, Dr. Abelson said. At 1 year, patients in epoch 2 were 36% more likely to have a readmission than those in epoch 1. Major events and procedural complications were both 46% more likely. Patients were also 36% more likely to require an additional procedure.
“These are not the outcomes we want to see, especially in this era when our surgical techniques have improved so much,” Dr. Abelson said. “If what this represents, though, is that we are now operating on a higher-risk population, we can’t just say, ‘Well, that’s how it’s going to be.’ We need to figure out how to minimize morbidity and mortality in this high-risk patient population.”
One goal, he suggested, would be to assess response to a biologic regimen earlier in the hopes of determining who will respond well, and moving ahead with surgery in those who don’t.
This is a tough sell for patients, he said.
“There is a big fear of this surgery. It usually requires a temporary ileostomy and a stoma bag, and patients are terrified of that. There have been a few studies demonstrating that earlier referral to surgery improves quality of life; living with advanced ulcerative colitis can be extremely difficult and patients often feel a lot better after we remove their diseased colon. But getting there is a challenge.”
Dr. Abelson had no financial disclosures.
[email protected]
On Twitter @Alz_Gal
AT THE ACS CLINICAL CONGRESS
Key clinical point:
Major finding: Patients are 38% more likely to die in the hospital than they were 15 years ago.
Data source: The 18-year database review comprised more than 7,000 surgeries.
Disclosures: Dr. Abelson had no financial disclosures.
Is regional anesthesia safer in CEA?
COLUMBUS, OHIO – General anesthesia during carotid endarterectomy carries almost twice the risk of complications and unplanned intubation as regional anesthesia, but the latter approach, which is not available in all hospitals, has its own issues, an analysis of procedures from a statewide database in Michigan found.
“This study is timely because of CMS [Center for Medicare & Medicaid Services] initiatives tying reimbursement to specific quality measures,” Ahmad S Hussain, MD, of Wayne State University in Detroit said in reporting the study results at the annual meeting of the Midwestern Vascular Surgery Society.
Regional anesthesia in CEA emerged in the 1990s, Dr. Hussain said, and allows for more reliable neurologic monitoring and more direct evaluation of the need for stenting during CEA than general anesthesia, which requires continuous monitoring of cerebral perfusion with carotid stump pressures, electroencephalogram, and transcranial doppler.
The researchers retrospectively analyzed 4,558 patients who had CEA at hospitals participating in the Michigan Surgical Quality Cooperative from 2012 to 2014 – 4,008 of whom had general anesthesia and 550 regional anesthesia.
“Advocates for carotid endarterectomy with regional anesthesia cite a reduction in hemodynamic instability and the ability for neurological monitoring, but many still prefer general anesthesia because the benefits of regional anesthesia have not been clearly demonstrated, allowing that regional anesthesia may not be available in all centers and allowing that a certain amount of patient movement during the procedure may not be uniformly tolerated,” Dr. Hussain said.
General anesthesia patients in the study had more than twice the rate of any morbidity at 30 days than those who had regional, 8.7% vs. 4.2%, and significantly higher rates of unplanned intervention, 2.1% vs. 0.6%. Dr. Hussain said. However, the study could not determine differences in 30-day mortality or other key outcomes, such as rates of pneumonia, sepsis, deep vein thrombosis, or pulmonary embolism, becauseof insufficient sample sizes, Dr. Hussain said
The study found less significant differences between general and regional anesthesia techniques, respectively, in rates of extended length of stay, 12.1% vs. 9.5%; readmissions, 9.2% vs. 6.1%; and reoperation, 4.5% vs. 3%.
The retrospective study used two models to analyze odds ratios: Model 1 adjusted for case mix; and model 2 adjusted for case mix as fixed effects and site as a random effect. While the retrospective nature of the study may be a limitation, the findings support the use of regional anesthesia for CEA when available, Dr. Hussain said.
Dr. Hussain had no relationships to disclose.
COLUMBUS, OHIO – General anesthesia during carotid endarterectomy carries almost twice the risk of complications and unplanned intubation as regional anesthesia, but the latter approach, which is not available in all hospitals, has its own issues, an analysis of procedures from a statewide database in Michigan found.
“This study is timely because of CMS [Center for Medicare & Medicaid Services] initiatives tying reimbursement to specific quality measures,” Ahmad S Hussain, MD, of Wayne State University in Detroit said in reporting the study results at the annual meeting of the Midwestern Vascular Surgery Society.
Regional anesthesia in CEA emerged in the 1990s, Dr. Hussain said, and allows for more reliable neurologic monitoring and more direct evaluation of the need for stenting during CEA than general anesthesia, which requires continuous monitoring of cerebral perfusion with carotid stump pressures, electroencephalogram, and transcranial doppler.
The researchers retrospectively analyzed 4,558 patients who had CEA at hospitals participating in the Michigan Surgical Quality Cooperative from 2012 to 2014 – 4,008 of whom had general anesthesia and 550 regional anesthesia.
“Advocates for carotid endarterectomy with regional anesthesia cite a reduction in hemodynamic instability and the ability for neurological monitoring, but many still prefer general anesthesia because the benefits of regional anesthesia have not been clearly demonstrated, allowing that regional anesthesia may not be available in all centers and allowing that a certain amount of patient movement during the procedure may not be uniformly tolerated,” Dr. Hussain said.
General anesthesia patients in the study had more than twice the rate of any morbidity at 30 days than those who had regional, 8.7% vs. 4.2%, and significantly higher rates of unplanned intervention, 2.1% vs. 0.6%. Dr. Hussain said. However, the study could not determine differences in 30-day mortality or other key outcomes, such as rates of pneumonia, sepsis, deep vein thrombosis, or pulmonary embolism, becauseof insufficient sample sizes, Dr. Hussain said
The study found less significant differences between general and regional anesthesia techniques, respectively, in rates of extended length of stay, 12.1% vs. 9.5%; readmissions, 9.2% vs. 6.1%; and reoperation, 4.5% vs. 3%.
The retrospective study used two models to analyze odds ratios: Model 1 adjusted for case mix; and model 2 adjusted for case mix as fixed effects and site as a random effect. While the retrospective nature of the study may be a limitation, the findings support the use of regional anesthesia for CEA when available, Dr. Hussain said.
Dr. Hussain had no relationships to disclose.
COLUMBUS, OHIO – General anesthesia during carotid endarterectomy carries almost twice the risk of complications and unplanned intubation as regional anesthesia, but the latter approach, which is not available in all hospitals, has its own issues, an analysis of procedures from a statewide database in Michigan found.
“This study is timely because of CMS [Center for Medicare & Medicaid Services] initiatives tying reimbursement to specific quality measures,” Ahmad S Hussain, MD, of Wayne State University in Detroit said in reporting the study results at the annual meeting of the Midwestern Vascular Surgery Society.
Regional anesthesia in CEA emerged in the 1990s, Dr. Hussain said, and allows for more reliable neurologic monitoring and more direct evaluation of the need for stenting during CEA than general anesthesia, which requires continuous monitoring of cerebral perfusion with carotid stump pressures, electroencephalogram, and transcranial doppler.
The researchers retrospectively analyzed 4,558 patients who had CEA at hospitals participating in the Michigan Surgical Quality Cooperative from 2012 to 2014 – 4,008 of whom had general anesthesia and 550 regional anesthesia.
“Advocates for carotid endarterectomy with regional anesthesia cite a reduction in hemodynamic instability and the ability for neurological monitoring, but many still prefer general anesthesia because the benefits of regional anesthesia have not been clearly demonstrated, allowing that regional anesthesia may not be available in all centers and allowing that a certain amount of patient movement during the procedure may not be uniformly tolerated,” Dr. Hussain said.
General anesthesia patients in the study had more than twice the rate of any morbidity at 30 days than those who had regional, 8.7% vs. 4.2%, and significantly higher rates of unplanned intervention, 2.1% vs. 0.6%. Dr. Hussain said. However, the study could not determine differences in 30-day mortality or other key outcomes, such as rates of pneumonia, sepsis, deep vein thrombosis, or pulmonary embolism, becauseof insufficient sample sizes, Dr. Hussain said
The study found less significant differences between general and regional anesthesia techniques, respectively, in rates of extended length of stay, 12.1% vs. 9.5%; readmissions, 9.2% vs. 6.1%; and reoperation, 4.5% vs. 3%.
The retrospective study used two models to analyze odds ratios: Model 1 adjusted for case mix; and model 2 adjusted for case mix as fixed effects and site as a random effect. While the retrospective nature of the study may be a limitation, the findings support the use of regional anesthesia for CEA when available, Dr. Hussain said.
Dr. Hussain had no relationships to disclose.
AT MIDWESTERN VASCULAR 2016
Key clinical point: General anesthesia for carotid endarterectomy carries a higher risk of complications and readmissions than regional anesthesia.
Major finding: Any morbidity after CEA with general anesthesia was 8.7% vs. 4.2% for regional anesthesia, and readmissions rates were 9.2% vs. 6.1%.
Data source: Retrospective analysis of 4,558 patients who had CEA between 2012 and 2014 at hospitals participating in the Michigan Surgical Quality Collaborative database.
Disclosures: Dr. Hussain reported having no financial disclosures.
Delayed bleeding possible with EBUS-TBNA on antiplatelets
LOS ANGELES – There might be a slight increase in delayed bleeding when patients have endobronchial ultrasound with transbronchial needle aspiration within 5 days of taking oral antiplatelets, according to a review of 404 patients at Riverside Methodist Hospital in Columbus, Ohio.
This study is unusual in that it looked at the 48 hour mark. Previous studies have tended to focus on immediate bleeding events that require the procedure to be stopped; only some of that research has found an increased bleeding risk with antiplatelet therapy.
In the study at Riverside Methodist, none of the 20 patients on dual antiplatelet therapy – clopidogrel (Plavix) plus aspirin – bled during the procedure, but one (5%) had a hemoglobin drop of more than 2 g within 48 hours and another was readmitted to the hospital within 48 hours for procedure-related hemoptysis. Overall, the delayed bleeding event rate for patients using the dual antiplatelet therapy was 10%. Additionally, one of the 13 patients (7.7%) on clopidogrel alone experienced a greater than 2 g drop in hemoglobin.
Among the 270 patients not exposed to antiplatelets, the overall bleeding event rate was 2.6%, and the event rate for delayed bleeding was 1.1%. Four patients (1.5%) bled during the procedure, two (0.7%) had hemoglobin drops greater than 2 g within 48 hours, and one (0.4%) was readmitted for hemoptysis.
There were no bleeding events in the 101 patients who only took aspirin.
“There was a trend toward delayed bleeding events in patients” on clopidogrel or dual antiplatelets. “It’s worth considering a thoughtful pause in decision making. Maybe with the bleeding events we’re seeing, it would be worthwhile, if possible, to defer” endobronchial ultrasound with transbronchial needle aspiration “until after the antiplatelet therapy,” said Kevin Swiatek, DO, a medicine resident at Riverside.
Patients were excluded from the study if they had histories of bleeding or clotting disorders; low platelet counts; or if they were on anticoagulation. Subjects on antiplatelets were about 10 years older, on average, than those who were not (about 68 versus 59 years old), and more likely to have had a heart attack or stroke, and to be hypertensive.
There was no industry funding for the work, and the investigators had no disclosures.
LOS ANGELES – There might be a slight increase in delayed bleeding when patients have endobronchial ultrasound with transbronchial needle aspiration within 5 days of taking oral antiplatelets, according to a review of 404 patients at Riverside Methodist Hospital in Columbus, Ohio.
This study is unusual in that it looked at the 48 hour mark. Previous studies have tended to focus on immediate bleeding events that require the procedure to be stopped; only some of that research has found an increased bleeding risk with antiplatelet therapy.
In the study at Riverside Methodist, none of the 20 patients on dual antiplatelet therapy – clopidogrel (Plavix) plus aspirin – bled during the procedure, but one (5%) had a hemoglobin drop of more than 2 g within 48 hours and another was readmitted to the hospital within 48 hours for procedure-related hemoptysis. Overall, the delayed bleeding event rate for patients using the dual antiplatelet therapy was 10%. Additionally, one of the 13 patients (7.7%) on clopidogrel alone experienced a greater than 2 g drop in hemoglobin.
Among the 270 patients not exposed to antiplatelets, the overall bleeding event rate was 2.6%, and the event rate for delayed bleeding was 1.1%. Four patients (1.5%) bled during the procedure, two (0.7%) had hemoglobin drops greater than 2 g within 48 hours, and one (0.4%) was readmitted for hemoptysis.
There were no bleeding events in the 101 patients who only took aspirin.
“There was a trend toward delayed bleeding events in patients” on clopidogrel or dual antiplatelets. “It’s worth considering a thoughtful pause in decision making. Maybe with the bleeding events we’re seeing, it would be worthwhile, if possible, to defer” endobronchial ultrasound with transbronchial needle aspiration “until after the antiplatelet therapy,” said Kevin Swiatek, DO, a medicine resident at Riverside.
Patients were excluded from the study if they had histories of bleeding or clotting disorders; low platelet counts; or if they were on anticoagulation. Subjects on antiplatelets were about 10 years older, on average, than those who were not (about 68 versus 59 years old), and more likely to have had a heart attack or stroke, and to be hypertensive.
There was no industry funding for the work, and the investigators had no disclosures.
LOS ANGELES – There might be a slight increase in delayed bleeding when patients have endobronchial ultrasound with transbronchial needle aspiration within 5 days of taking oral antiplatelets, according to a review of 404 patients at Riverside Methodist Hospital in Columbus, Ohio.
This study is unusual in that it looked at the 48 hour mark. Previous studies have tended to focus on immediate bleeding events that require the procedure to be stopped; only some of that research has found an increased bleeding risk with antiplatelet therapy.
In the study at Riverside Methodist, none of the 20 patients on dual antiplatelet therapy – clopidogrel (Plavix) plus aspirin – bled during the procedure, but one (5%) had a hemoglobin drop of more than 2 g within 48 hours and another was readmitted to the hospital within 48 hours for procedure-related hemoptysis. Overall, the delayed bleeding event rate for patients using the dual antiplatelet therapy was 10%. Additionally, one of the 13 patients (7.7%) on clopidogrel alone experienced a greater than 2 g drop in hemoglobin.
Among the 270 patients not exposed to antiplatelets, the overall bleeding event rate was 2.6%, and the event rate for delayed bleeding was 1.1%. Four patients (1.5%) bled during the procedure, two (0.7%) had hemoglobin drops greater than 2 g within 48 hours, and one (0.4%) was readmitted for hemoptysis.
There were no bleeding events in the 101 patients who only took aspirin.
“There was a trend toward delayed bleeding events in patients” on clopidogrel or dual antiplatelets. “It’s worth considering a thoughtful pause in decision making. Maybe with the bleeding events we’re seeing, it would be worthwhile, if possible, to defer” endobronchial ultrasound with transbronchial needle aspiration “until after the antiplatelet therapy,” said Kevin Swiatek, DO, a medicine resident at Riverside.
Patients were excluded from the study if they had histories of bleeding or clotting disorders; low platelet counts; or if they were on anticoagulation. Subjects on antiplatelets were about 10 years older, on average, than those who were not (about 68 versus 59 years old), and more likely to have had a heart attack or stroke, and to be hypertensive.
There was no industry funding for the work, and the investigators had no disclosures.
AT CHEST 2016
Key clinical point:
Major finding: Ten percent of patients on dual antiplatelet therapy bled within 48 hours, versus 1.1% of those not on antiplatelet therapy.
Data source: Single-center review of 404 patients.
Disclosures: There was no industry funding for the work, and the investigators had no disclosures.
Most infective endocarditis calls for early surgery
CHICAGO - Turning to surgery earlier in infective endocarditis may hold the key to a cure for some patients. Upcoming guidelines for surgical treatment of infective endocarditis lend evidence-based support to early surgical intervention in this high-mortality condition.
“Infective endocarditis is the most severe and potentially devastating complication for heart valve disease,” said Joseph Coselli, MD, in a presentation that reviewed current trends in incidence of infective endocarditis (IE) and laid out a rationale and strategy for early surgical intervention in some patients.
“Untreated infective endocarditis is universally fatal,” said Dr. Coselli. Even with current treatments, however, overall mortality for infective endocarditis is 20%-25%, he said.
Speaking at the joint AATS-ACC Heart Valve Summit, Dr. Coselli, chief of the division of cardiothoracic surgery at Baylor College of Medicine, Houston, reviewed the key points in the upcoming guideline and the evidence that backs up the guidelines.
Dr. Coselli served on the writing committee for the 2016 AATS consensus guidelines for the surgical treatment of infective endocarditis; the guidelines are currently in press.
The guidelines propose that “at the time of surgery, the patient should be on an effective antimicrobial regimen to which the causative agent is sensitive,” he said. This is a level I recommendation, as is the recommendation that the surgeon should understand the pathology as well as possible before the procedure. Usually, say the guidelines, this is obtained by means of a transesophageal echocardiogram (TEE), assigning level I status to this recommendation as well.
According to the guidelines, patients with IE who may be surgical candidates during their hospitalization, regardless of whether their antimicrobial course is complete, include those who present with valve dysfunction that results in symptoms of heart failure. Surgery should also be considered in patients with left-sided IE with S. aureus, fungi, or other highly resistant organisms as the causative pathogen. If heart block, an aortic or annular abscess, or destructive penetrating lesions are present, surgery is also indicated. Finally, the guidelines recommend considering surgery if patients have persistent bacteremia or fevers at 5 to 7 days after initiation of appropriate antimicrobial therapy. All of these are class I indications in the upcoming guidelines, he said.
The patient who has relapsing infection, defined by the guidelines as recurrent bacteremia “after a complete course of appropriate antibiotics and subsequently negative blood culture,” who has no other identifiable source of infection, may also be a candidate.
Given the dearth of randomized trials in the area, no recommendation for intervention is backed by a level of evidence greater than B, said Dr. Coselli. And knowledge gaps persist in many areas, such as the appropriate timing of surgery in IE when there are neurological complications. Also, he said, “embolism risk needs to be better understood.” Imaging improvements would help guide decision-making, as would better data about contemporary rates of IE relapse and recurrence, said Dr. Coselli.
Though these surgeries should be done at centers that can field a complete team, and by experience valve surgeons, early intervention may be a key to success: “Operate before a devastating complication occurs,” said Dr. Coselli. “Understand what you see; don’t be afraid of radical debridement, and master alternative options to reconstruction” depending on the heart’s appearance in the OR, he said.
Surgeons can run into trouble in IE cases if they wait too long. “A patient who’s already had an embolic stroke may be too sick,” said Dr. Coselli. Insensitive organisms and ineffective antimicrobial therapy set the patient up for recurrent IE or treatment failure as well.
Having guidance for surgical intervention is important because cardiologists and surgeons will be seeing more infective endocarditis patients as heroin and other illicit intravenous drug use continues to rise, said Dr. Coselli. IE in intravenous drug users now accounts for up to 30% of all patients who seek treatment for IE, he said, citing a study that tracked characteristics of endocarditis patients undergoing surgery at a single institution from 2002-2014 (J Thorac Cardiovasc Surg. 2016 Sep;152:832-41). Incidence in intravenous drug users can range to 2,000 cases per 100,000 patient-years, he said.
The study, conducted by Joon Bum Kim, MD, PhD, and his colleagues at Massachusetts General and Brigham and Women’s hospitals, both in Boston, followed 436 patients with IE, 78 of whom were intravenous drug users (IVDUs) at the time of diagnosis. Overall, the IVDUs were younger (mean age, 36 plus or minus 10 years) when compared with the non-IVDU group (mean age, 58 plus or minus 14 years; P less than 0.001). The non-IVDU cohort were also significantly more likely to have hypertension and diabetes, but less likely to smoke. However, IVDUs were more likely to have embolic events, and to have right-sided valve involvement.
Though early mortality was better in the IVDU group post-surgically, late complications, including reinfection and reoperation, were significantly more likely to occur in the IVDUs, with reinfection more than four times as frequent in IVDUs (aggregate valve-related complications, 41% in IVDUs vs. 10% in non-IVDUs; P = 0.001).
Despite the additional morbidity seen in IVDU-associated endocarditis, the 10-year survival rate was virtually identical between the two groups.
For many IE patients, said Dr. Coselli, “the arguments against surgery have lost strength.” Active systemic infections are treatable, sicker patients can be operated on earlier, and surgeons will gain experience with this sometimes technically challenging surgery, he said. Finally, Dr. Coselli said, even though the best available data support early surgical intervention in select IE patients, “final cure of IE is always the result of antimicrobial treatment and the patient’s own defense.”
[email protected]
On Twitter @karioakes
CHICAGO - Turning to surgery earlier in infective endocarditis may hold the key to a cure for some patients. Upcoming guidelines for surgical treatment of infective endocarditis lend evidence-based support to early surgical intervention in this high-mortality condition.
“Infective endocarditis is the most severe and potentially devastating complication for heart valve disease,” said Joseph Coselli, MD, in a presentation that reviewed current trends in incidence of infective endocarditis (IE) and laid out a rationale and strategy for early surgical intervention in some patients.
“Untreated infective endocarditis is universally fatal,” said Dr. Coselli. Even with current treatments, however, overall mortality for infective endocarditis is 20%-25%, he said.
Speaking at the joint AATS-ACC Heart Valve Summit, Dr. Coselli, chief of the division of cardiothoracic surgery at Baylor College of Medicine, Houston, reviewed the key points in the upcoming guideline and the evidence that backs up the guidelines.
Dr. Coselli served on the writing committee for the 2016 AATS consensus guidelines for the surgical treatment of infective endocarditis; the guidelines are currently in press.
The guidelines propose that “at the time of surgery, the patient should be on an effective antimicrobial regimen to which the causative agent is sensitive,” he said. This is a level I recommendation, as is the recommendation that the surgeon should understand the pathology as well as possible before the procedure. Usually, say the guidelines, this is obtained by means of a transesophageal echocardiogram (TEE), assigning level I status to this recommendation as well.
According to the guidelines, patients with IE who may be surgical candidates during their hospitalization, regardless of whether their antimicrobial course is complete, include those who present with valve dysfunction that results in symptoms of heart failure. Surgery should also be considered in patients with left-sided IE with S. aureus, fungi, or other highly resistant organisms as the causative pathogen. If heart block, an aortic or annular abscess, or destructive penetrating lesions are present, surgery is also indicated. Finally, the guidelines recommend considering surgery if patients have persistent bacteremia or fevers at 5 to 7 days after initiation of appropriate antimicrobial therapy. All of these are class I indications in the upcoming guidelines, he said.
The patient who has relapsing infection, defined by the guidelines as recurrent bacteremia “after a complete course of appropriate antibiotics and subsequently negative blood culture,” who has no other identifiable source of infection, may also be a candidate.
Given the dearth of randomized trials in the area, no recommendation for intervention is backed by a level of evidence greater than B, said Dr. Coselli. And knowledge gaps persist in many areas, such as the appropriate timing of surgery in IE when there are neurological complications. Also, he said, “embolism risk needs to be better understood.” Imaging improvements would help guide decision-making, as would better data about contemporary rates of IE relapse and recurrence, said Dr. Coselli.
Though these surgeries should be done at centers that can field a complete team, and by experience valve surgeons, early intervention may be a key to success: “Operate before a devastating complication occurs,” said Dr. Coselli. “Understand what you see; don’t be afraid of radical debridement, and master alternative options to reconstruction” depending on the heart’s appearance in the OR, he said.
Surgeons can run into trouble in IE cases if they wait too long. “A patient who’s already had an embolic stroke may be too sick,” said Dr. Coselli. Insensitive organisms and ineffective antimicrobial therapy set the patient up for recurrent IE or treatment failure as well.
Having guidance for surgical intervention is important because cardiologists and surgeons will be seeing more infective endocarditis patients as heroin and other illicit intravenous drug use continues to rise, said Dr. Coselli. IE in intravenous drug users now accounts for up to 30% of all patients who seek treatment for IE, he said, citing a study that tracked characteristics of endocarditis patients undergoing surgery at a single institution from 2002-2014 (J Thorac Cardiovasc Surg. 2016 Sep;152:832-41). Incidence in intravenous drug users can range to 2,000 cases per 100,000 patient-years, he said.
The study, conducted by Joon Bum Kim, MD, PhD, and his colleagues at Massachusetts General and Brigham and Women’s hospitals, both in Boston, followed 436 patients with IE, 78 of whom were intravenous drug users (IVDUs) at the time of diagnosis. Overall, the IVDUs were younger (mean age, 36 plus or minus 10 years) when compared with the non-IVDU group (mean age, 58 plus or minus 14 years; P less than 0.001). The non-IVDU cohort were also significantly more likely to have hypertension and diabetes, but less likely to smoke. However, IVDUs were more likely to have embolic events, and to have right-sided valve involvement.
Though early mortality was better in the IVDU group post-surgically, late complications, including reinfection and reoperation, were significantly more likely to occur in the IVDUs, with reinfection more than four times as frequent in IVDUs (aggregate valve-related complications, 41% in IVDUs vs. 10% in non-IVDUs; P = 0.001).
Despite the additional morbidity seen in IVDU-associated endocarditis, the 10-year survival rate was virtually identical between the two groups.
For many IE patients, said Dr. Coselli, “the arguments against surgery have lost strength.” Active systemic infections are treatable, sicker patients can be operated on earlier, and surgeons will gain experience with this sometimes technically challenging surgery, he said. Finally, Dr. Coselli said, even though the best available data support early surgical intervention in select IE patients, “final cure of IE is always the result of antimicrobial treatment and the patient’s own defense.”
[email protected]
On Twitter @karioakes
CHICAGO - Turning to surgery earlier in infective endocarditis may hold the key to a cure for some patients. Upcoming guidelines for surgical treatment of infective endocarditis lend evidence-based support to early surgical intervention in this high-mortality condition.
“Infective endocarditis is the most severe and potentially devastating complication for heart valve disease,” said Joseph Coselli, MD, in a presentation that reviewed current trends in incidence of infective endocarditis (IE) and laid out a rationale and strategy for early surgical intervention in some patients.
“Untreated infective endocarditis is universally fatal,” said Dr. Coselli. Even with current treatments, however, overall mortality for infective endocarditis is 20%-25%, he said.
Speaking at the joint AATS-ACC Heart Valve Summit, Dr. Coselli, chief of the division of cardiothoracic surgery at Baylor College of Medicine, Houston, reviewed the key points in the upcoming guideline and the evidence that backs up the guidelines.
Dr. Coselli served on the writing committee for the 2016 AATS consensus guidelines for the surgical treatment of infective endocarditis; the guidelines are currently in press.
The guidelines propose that “at the time of surgery, the patient should be on an effective antimicrobial regimen to which the causative agent is sensitive,” he said. This is a level I recommendation, as is the recommendation that the surgeon should understand the pathology as well as possible before the procedure. Usually, say the guidelines, this is obtained by means of a transesophageal echocardiogram (TEE), assigning level I status to this recommendation as well.
According to the guidelines, patients with IE who may be surgical candidates during their hospitalization, regardless of whether their antimicrobial course is complete, include those who present with valve dysfunction that results in symptoms of heart failure. Surgery should also be considered in patients with left-sided IE with S. aureus, fungi, or other highly resistant organisms as the causative pathogen. If heart block, an aortic or annular abscess, or destructive penetrating lesions are present, surgery is also indicated. Finally, the guidelines recommend considering surgery if patients have persistent bacteremia or fevers at 5 to 7 days after initiation of appropriate antimicrobial therapy. All of these are class I indications in the upcoming guidelines, he said.
The patient who has relapsing infection, defined by the guidelines as recurrent bacteremia “after a complete course of appropriate antibiotics and subsequently negative blood culture,” who has no other identifiable source of infection, may also be a candidate.
Given the dearth of randomized trials in the area, no recommendation for intervention is backed by a level of evidence greater than B, said Dr. Coselli. And knowledge gaps persist in many areas, such as the appropriate timing of surgery in IE when there are neurological complications. Also, he said, “embolism risk needs to be better understood.” Imaging improvements would help guide decision-making, as would better data about contemporary rates of IE relapse and recurrence, said Dr. Coselli.
Though these surgeries should be done at centers that can field a complete team, and by experience valve surgeons, early intervention may be a key to success: “Operate before a devastating complication occurs,” said Dr. Coselli. “Understand what you see; don’t be afraid of radical debridement, and master alternative options to reconstruction” depending on the heart’s appearance in the OR, he said.
Surgeons can run into trouble in IE cases if they wait too long. “A patient who’s already had an embolic stroke may be too sick,” said Dr. Coselli. Insensitive organisms and ineffective antimicrobial therapy set the patient up for recurrent IE or treatment failure as well.
Having guidance for surgical intervention is important because cardiologists and surgeons will be seeing more infective endocarditis patients as heroin and other illicit intravenous drug use continues to rise, said Dr. Coselli. IE in intravenous drug users now accounts for up to 30% of all patients who seek treatment for IE, he said, citing a study that tracked characteristics of endocarditis patients undergoing surgery at a single institution from 2002-2014 (J Thorac Cardiovasc Surg. 2016 Sep;152:832-41). Incidence in intravenous drug users can range to 2,000 cases per 100,000 patient-years, he said.
The study, conducted by Joon Bum Kim, MD, PhD, and his colleagues at Massachusetts General and Brigham and Women’s hospitals, both in Boston, followed 436 patients with IE, 78 of whom were intravenous drug users (IVDUs) at the time of diagnosis. Overall, the IVDUs were younger (mean age, 36 plus or minus 10 years) when compared with the non-IVDU group (mean age, 58 plus or minus 14 years; P less than 0.001). The non-IVDU cohort were also significantly more likely to have hypertension and diabetes, but less likely to smoke. However, IVDUs were more likely to have embolic events, and to have right-sided valve involvement.
Though early mortality was better in the IVDU group post-surgically, late complications, including reinfection and reoperation, were significantly more likely to occur in the IVDUs, with reinfection more than four times as frequent in IVDUs (aggregate valve-related complications, 41% in IVDUs vs. 10% in non-IVDUs; P = 0.001).
Despite the additional morbidity seen in IVDU-associated endocarditis, the 10-year survival rate was virtually identical between the two groups.
For many IE patients, said Dr. Coselli, “the arguments against surgery have lost strength.” Active systemic infections are treatable, sicker patients can be operated on earlier, and surgeons will gain experience with this sometimes technically challenging surgery, he said. Finally, Dr. Coselli said, even though the best available data support early surgical intervention in select IE patients, “final cure of IE is always the result of antimicrobial treatment and the patient’s own defense.”
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EXPERT ANALYSIS FROM THE HEART VALVE SUMMIT 2016
CEA risk models fit for an app
COLUMBUS, OHIO – Carotid endarterectomy is an effective treatment for people with asymptomatic carotid artery disease when stroke rates are low and they survive long enough to benefit from the treatment. But determining who those patients are can be a challenge for vascular surgeons. A team of vascular specialists from around the country have developed risk prediction models to help surgeons better select asymptomatic patients for the procedure, Randall DeMartino, MD, said at the annual meeting of the Midwestern Vascular Surgical Society.
“These models will be used for mobile apps and web-based applications for point of care patient risk assessment,” said Dr. DeMartino of the Mayo Clinic in Rochester, Minn. He is the lead researcher for the study, which uses data from the Vascular Quality Initiative (VQI).
In developing the models, the researchers sampled asymptomatic patients in the VQI who had first-time elective CEA. There were 31,939 patients in the stroke analysis who had CEA from 2010-2015, and 24,086 patients in the mortality analysis who had procedures from 2010-2014. Dr. DeMartino and his colleagues evaluated all preoperative patient and surgeon characteristics, then used an algorithm to optimize the variables that were selected for the final logistic model.
The researchers also evaluated 30-day stroke rates and 1-year mortality at participating centers and found wide variability: an average of 0.9% for stroke, with a range of 0-8.3%; and 3.2% for mortality, with a range of 0-20%. “Actually, 22% of centers had a 1-year mortality rate that exceeded 5%,” Dr. DeMartino said.
The model for 1-year mortality identified the following variables associated with the highest risk of death 1 year after CEA: age greater than or equal to 80 years; a preoperative hemoglobin less than 10 mg/dL; oxygen-dependent chronic obstructive pulmonary disease; mild to severe congestive heart failure; American Society of Anesthesiologists classification of IV or V; stage 4 or 5 chronic kidney disease; and a contralateral occlusion.
“Conversely, a normal stress test, when performed, and preoperative statin use were associated with reduced risk of death over a year,” Dr. DeMartino said.
“These data have been used to provide Center Opportunity for Improvement reports through VQI where centers can identify if they are selecting patients with risk factors for stroke or mortality more often compared to other centers,” Dr. DeMartino said. “This allows centers to see where opportunities for improvement exist.”
Also, physicians can see the proportion of patients they select with a predicted mortality risk over 5% at one year – “a group of patients who may gain little benefit from prophylactic CEA,” he said. “Physicians can compare their patient selection to those in their region or nationally.”
Dr. DeMartino had no relationships to disclose.
COLUMBUS, OHIO – Carotid endarterectomy is an effective treatment for people with asymptomatic carotid artery disease when stroke rates are low and they survive long enough to benefit from the treatment. But determining who those patients are can be a challenge for vascular surgeons. A team of vascular specialists from around the country have developed risk prediction models to help surgeons better select asymptomatic patients for the procedure, Randall DeMartino, MD, said at the annual meeting of the Midwestern Vascular Surgical Society.
“These models will be used for mobile apps and web-based applications for point of care patient risk assessment,” said Dr. DeMartino of the Mayo Clinic in Rochester, Minn. He is the lead researcher for the study, which uses data from the Vascular Quality Initiative (VQI).
In developing the models, the researchers sampled asymptomatic patients in the VQI who had first-time elective CEA. There were 31,939 patients in the stroke analysis who had CEA from 2010-2015, and 24,086 patients in the mortality analysis who had procedures from 2010-2014. Dr. DeMartino and his colleagues evaluated all preoperative patient and surgeon characteristics, then used an algorithm to optimize the variables that were selected for the final logistic model.
The researchers also evaluated 30-day stroke rates and 1-year mortality at participating centers and found wide variability: an average of 0.9% for stroke, with a range of 0-8.3%; and 3.2% for mortality, with a range of 0-20%. “Actually, 22% of centers had a 1-year mortality rate that exceeded 5%,” Dr. DeMartino said.
The model for 1-year mortality identified the following variables associated with the highest risk of death 1 year after CEA: age greater than or equal to 80 years; a preoperative hemoglobin less than 10 mg/dL; oxygen-dependent chronic obstructive pulmonary disease; mild to severe congestive heart failure; American Society of Anesthesiologists classification of IV or V; stage 4 or 5 chronic kidney disease; and a contralateral occlusion.
“Conversely, a normal stress test, when performed, and preoperative statin use were associated with reduced risk of death over a year,” Dr. DeMartino said.
“These data have been used to provide Center Opportunity for Improvement reports through VQI where centers can identify if they are selecting patients with risk factors for stroke or mortality more often compared to other centers,” Dr. DeMartino said. “This allows centers to see where opportunities for improvement exist.”
Also, physicians can see the proportion of patients they select with a predicted mortality risk over 5% at one year – “a group of patients who may gain little benefit from prophylactic CEA,” he said. “Physicians can compare their patient selection to those in their region or nationally.”
Dr. DeMartino had no relationships to disclose.
COLUMBUS, OHIO – Carotid endarterectomy is an effective treatment for people with asymptomatic carotid artery disease when stroke rates are low and they survive long enough to benefit from the treatment. But determining who those patients are can be a challenge for vascular surgeons. A team of vascular specialists from around the country have developed risk prediction models to help surgeons better select asymptomatic patients for the procedure, Randall DeMartino, MD, said at the annual meeting of the Midwestern Vascular Surgical Society.
“These models will be used for mobile apps and web-based applications for point of care patient risk assessment,” said Dr. DeMartino of the Mayo Clinic in Rochester, Minn. He is the lead researcher for the study, which uses data from the Vascular Quality Initiative (VQI).
In developing the models, the researchers sampled asymptomatic patients in the VQI who had first-time elective CEA. There were 31,939 patients in the stroke analysis who had CEA from 2010-2015, and 24,086 patients in the mortality analysis who had procedures from 2010-2014. Dr. DeMartino and his colleagues evaluated all preoperative patient and surgeon characteristics, then used an algorithm to optimize the variables that were selected for the final logistic model.
The researchers also evaluated 30-day stroke rates and 1-year mortality at participating centers and found wide variability: an average of 0.9% for stroke, with a range of 0-8.3%; and 3.2% for mortality, with a range of 0-20%. “Actually, 22% of centers had a 1-year mortality rate that exceeded 5%,” Dr. DeMartino said.
The model for 1-year mortality identified the following variables associated with the highest risk of death 1 year after CEA: age greater than or equal to 80 years; a preoperative hemoglobin less than 10 mg/dL; oxygen-dependent chronic obstructive pulmonary disease; mild to severe congestive heart failure; American Society of Anesthesiologists classification of IV or V; stage 4 or 5 chronic kidney disease; and a contralateral occlusion.
“Conversely, a normal stress test, when performed, and preoperative statin use were associated with reduced risk of death over a year,” Dr. DeMartino said.
“These data have been used to provide Center Opportunity for Improvement reports through VQI where centers can identify if they are selecting patients with risk factors for stroke or mortality more often compared to other centers,” Dr. DeMartino said. “This allows centers to see where opportunities for improvement exist.”
Also, physicians can see the proportion of patients they select with a predicted mortality risk over 5% at one year – “a group of patients who may gain little benefit from prophylactic CEA,” he said. “Physicians can compare their patient selection to those in their region or nationally.”
Dr. DeMartino had no relationships to disclose.
AT MIDWESTERN VASCULAR 2016
Key clinical point: Risk-prediction models may identify patients at greatest risk of stroke and 1-year death after carotid endarterectomy (CEA).
Major finding: Contralateral occlusion has odds ratios of 2.5 for 30-day stroke after CEA and 1.7 for death at 1 year.
Data source: Sampling of patients from the Vascular Quality Initiative who had first-time CEA: 31,939 in the stroke analysis and 24,086 in the mortality analysis.
Disclosures: Dr. DeMartino reported having no financial disclosures.
Infection, readmission linked after open lower-extremity procedures
COLUMBUS, OHIO – Infections account for more than one-third of readmissions after endovascular lower-extremity procedures, but an analysis of these procedures over a 6-year period has identified a handful of factors, including an extended hospital stay, that may help vascular surgeons identify patients at greatest risk and reduce infection-related readmissions.
“Of a little over 7,000 patients that we evaluated with peripheral artery disease who underwent an elective lower-extremity procedure, we found an overall readmission rate of 10.9%; about 9.5% for those who underwent an open procedure and just over 12% for those who underwent an endovascular procedure,” Joseph C. Melvin, MD, of the University of Missouri Hospitals & Clinics in Columbia said at the annual meeting of the Midwestern Vascular Surgery Society.
While the readmission rate for open operations was lower, the infection rate at readmission was higher for open procedures: 45.5% (157 of 345 readmissions) vs. 31.1% (132 of 425 readmissions), Dr. Melvin said.
“The risk factors for diagnosis of infection at readmission we found to be significant were anemia, chronic kidney disease, and end-stage renal disease, any infection at the time of the index admission, specifically cellulitis or abscess of the lower extremity given the patient’s peripheral artery disease status, diabetes, and then complications including posthemorrhagic anemia,” Dr. Melvin said. Laboratory testing values at the time of index admissions confirmed the risk factors.
The investigators also used multivariable logistic regression models in the analysis and found that factors most predictive of an infection-related readmission were length of stay, having the procedure at a teaching facility, anemia, and infection at the index admission, Dr. Melvin said.
The surgical site was the most common source of the infection, and Staphylococcus “not surprisingly” accounted for 25% of pathogens, Dr. Melvin said. “But what we did find to be interesting was that just over 40% of patients were found to have a gram-negative bacteria isolated, which would come into play with our decision with regards to antibiotic treatment,” he said.
The data suggest that further evaluation of ways to decrease postoperative infections and use of broad-spectrum antibiotics during readmissions may improve outcomes after open lower-extremity procedures, Dr. Melvin said.
Dr. Melvin had no financial relationships to disclose.
COLUMBUS, OHIO – Infections account for more than one-third of readmissions after endovascular lower-extremity procedures, but an analysis of these procedures over a 6-year period has identified a handful of factors, including an extended hospital stay, that may help vascular surgeons identify patients at greatest risk and reduce infection-related readmissions.
“Of a little over 7,000 patients that we evaluated with peripheral artery disease who underwent an elective lower-extremity procedure, we found an overall readmission rate of 10.9%; about 9.5% for those who underwent an open procedure and just over 12% for those who underwent an endovascular procedure,” Joseph C. Melvin, MD, of the University of Missouri Hospitals & Clinics in Columbia said at the annual meeting of the Midwestern Vascular Surgery Society.
While the readmission rate for open operations was lower, the infection rate at readmission was higher for open procedures: 45.5% (157 of 345 readmissions) vs. 31.1% (132 of 425 readmissions), Dr. Melvin said.
“The risk factors for diagnosis of infection at readmission we found to be significant were anemia, chronic kidney disease, and end-stage renal disease, any infection at the time of the index admission, specifically cellulitis or abscess of the lower extremity given the patient’s peripheral artery disease status, diabetes, and then complications including posthemorrhagic anemia,” Dr. Melvin said. Laboratory testing values at the time of index admissions confirmed the risk factors.
The investigators also used multivariable logistic regression models in the analysis and found that factors most predictive of an infection-related readmission were length of stay, having the procedure at a teaching facility, anemia, and infection at the index admission, Dr. Melvin said.
The surgical site was the most common source of the infection, and Staphylococcus “not surprisingly” accounted for 25% of pathogens, Dr. Melvin said. “But what we did find to be interesting was that just over 40% of patients were found to have a gram-negative bacteria isolated, which would come into play with our decision with regards to antibiotic treatment,” he said.
The data suggest that further evaluation of ways to decrease postoperative infections and use of broad-spectrum antibiotics during readmissions may improve outcomes after open lower-extremity procedures, Dr. Melvin said.
Dr. Melvin had no financial relationships to disclose.
COLUMBUS, OHIO – Infections account for more than one-third of readmissions after endovascular lower-extremity procedures, but an analysis of these procedures over a 6-year period has identified a handful of factors, including an extended hospital stay, that may help vascular surgeons identify patients at greatest risk and reduce infection-related readmissions.
“Of a little over 7,000 patients that we evaluated with peripheral artery disease who underwent an elective lower-extremity procedure, we found an overall readmission rate of 10.9%; about 9.5% for those who underwent an open procedure and just over 12% for those who underwent an endovascular procedure,” Joseph C. Melvin, MD, of the University of Missouri Hospitals & Clinics in Columbia said at the annual meeting of the Midwestern Vascular Surgery Society.
While the readmission rate for open operations was lower, the infection rate at readmission was higher for open procedures: 45.5% (157 of 345 readmissions) vs. 31.1% (132 of 425 readmissions), Dr. Melvin said.
“The risk factors for diagnosis of infection at readmission we found to be significant were anemia, chronic kidney disease, and end-stage renal disease, any infection at the time of the index admission, specifically cellulitis or abscess of the lower extremity given the patient’s peripheral artery disease status, diabetes, and then complications including posthemorrhagic anemia,” Dr. Melvin said. Laboratory testing values at the time of index admissions confirmed the risk factors.
The investigators also used multivariable logistic regression models in the analysis and found that factors most predictive of an infection-related readmission were length of stay, having the procedure at a teaching facility, anemia, and infection at the index admission, Dr. Melvin said.
The surgical site was the most common source of the infection, and Staphylococcus “not surprisingly” accounted for 25% of pathogens, Dr. Melvin said. “But what we did find to be interesting was that just over 40% of patients were found to have a gram-negative bacteria isolated, which would come into play with our decision with regards to antibiotic treatment,” he said.
The data suggest that further evaluation of ways to decrease postoperative infections and use of broad-spectrum antibiotics during readmissions may improve outcomes after open lower-extremity procedures, Dr. Melvin said.
Dr. Melvin had no financial relationships to disclose.
AT MIDWESTERN VASCULAR 2016
Key clinical point: Extended hospital stay and other factors can help identify patients at greatest risk for readmission due to infection.
Major finding: More than one-third of readmissions from lower-extremity procedures are the result of infections.
Data source: 7,089 elective lower extremity procedures selected from the Cerner Health Facts database.
Disclosures: Dr. Melvin reported having no financial disclosures.
Meaningful use: CMS extends 90-day reporting period to 2016, 2017
Physicians who already participate in the EHR incentive program for meaningful use will have to demonstrate they are meaningful users for only 90 days in 2016 and 2017.
The Centers for Medicare & Medicaid Services finalized the 90-day reporting period in its annual update to the hospital outpatient prospective payment system, scheduled for publication in the Federal Register on Nov. 14.
The CMS was preparing to require a full year of reporting in 2017 to be eligible for bonuses under the EHR Incentive Program; but instead extended the 90-day reporting requirement to address concerns about technical functionalities and to help ease the transition to the Merit-based Incentive Payment System (MIPS) created by the 2015 MACRA law, according to an agency fact sheet.
The Outpatient Prospective Payment System (OPPS) final rule also eliminated clinical decision support and computerized order entry objectives and measures for eligible hospitals and critical access hospitals.
Instead of requiring that eligible professionals and hospitals new to the EHR Incentive Program in 2017 to meet Stage 3 requirements, the CMS has provided modified Stage 2 requirements.
Physicians who are new to the EHR Incentive Program in 2017 but are transitioning their practice to MIPS next year can apply for a significant hardship exemption to avoid any penalties to their 2018 Medicare payments.
Physicians who already participate in the EHR incentive program for meaningful use will have to demonstrate they are meaningful users for only 90 days in 2016 and 2017.
The Centers for Medicare & Medicaid Services finalized the 90-day reporting period in its annual update to the hospital outpatient prospective payment system, scheduled for publication in the Federal Register on Nov. 14.
The CMS was preparing to require a full year of reporting in 2017 to be eligible for bonuses under the EHR Incentive Program; but instead extended the 90-day reporting requirement to address concerns about technical functionalities and to help ease the transition to the Merit-based Incentive Payment System (MIPS) created by the 2015 MACRA law, according to an agency fact sheet.
The Outpatient Prospective Payment System (OPPS) final rule also eliminated clinical decision support and computerized order entry objectives and measures for eligible hospitals and critical access hospitals.
Instead of requiring that eligible professionals and hospitals new to the EHR Incentive Program in 2017 to meet Stage 3 requirements, the CMS has provided modified Stage 2 requirements.
Physicians who are new to the EHR Incentive Program in 2017 but are transitioning their practice to MIPS next year can apply for a significant hardship exemption to avoid any penalties to their 2018 Medicare payments.
Physicians who already participate in the EHR incentive program for meaningful use will have to demonstrate they are meaningful users for only 90 days in 2016 and 2017.
The Centers for Medicare & Medicaid Services finalized the 90-day reporting period in its annual update to the hospital outpatient prospective payment system, scheduled for publication in the Federal Register on Nov. 14.
The CMS was preparing to require a full year of reporting in 2017 to be eligible for bonuses under the EHR Incentive Program; but instead extended the 90-day reporting requirement to address concerns about technical functionalities and to help ease the transition to the Merit-based Incentive Payment System (MIPS) created by the 2015 MACRA law, according to an agency fact sheet.
The Outpatient Prospective Payment System (OPPS) final rule also eliminated clinical decision support and computerized order entry objectives and measures for eligible hospitals and critical access hospitals.
Instead of requiring that eligible professionals and hospitals new to the EHR Incentive Program in 2017 to meet Stage 3 requirements, the CMS has provided modified Stage 2 requirements.
Physicians who are new to the EHR Incentive Program in 2017 but are transitioning their practice to MIPS next year can apply for a significant hardship exemption to avoid any penalties to their 2018 Medicare payments.