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The Official Newspaper of the American Association for Thoracic Surgery
Inaugural Innovation Summit Addressed CTS Creativity and Development
The first AATS Innovation Summit was launched on Saturday morning. The Summit was designed to assist cardiothoracic surgeons in developing new clinically applicable technology by giving them information on how to protect intellectual property, obtain funding, and conduct clinical trials. Attendees also got the latest updates on regulatory pathways and advice on building industry relationships needed to forge a novel product.
Pedro J. del Nido, MD, who was instrumental in coming up with the original idea for the Summit, introduced former AATS President W. Randolph Chitwood Jr., MD, who served as Program Director.
“The most fun part of this meeting,” Dr. Chitwood promised, would be the Commercialization Workshop at the end of the day “where we develop a fictitious product and carry it all the way to commercialization.”
Michael J. Mack, MD, a famous innovator in his own right, opened the didactic portion of the program by outlining the Summit Challenges.
“The whole field of cardiac surgery is moving to a catheter-based approach,” he declared.
He pointed out the tremendous growth in the invention of catheter-based products in the mitral regurgitation space. “The field is fertile with innovators,” he added.
In order to be innovative, he said, quoting what he called the Bavaria Rules, after Joseph E. Bavaria, MD, “You’ve got to have a vision; you’ve got to have a strategy; you need the tactics to implement that strategy, and at the end of the day, you have to execute that strategy.”
He concluded his talk saying, “Our field has a legacy of innovation. Our challenge is to adopt the tools to move that innovation field forward that our specialty has always been known for.”
He listed some of the major innovations in the cardiac space over the past 60+ years, from the beginning of aortic surgery, to mitral valve surgery, the Maze procedure, and even TAVR, pointing out that historically at least 10-20 years has been the lag time between the development of the innovation and its more-or-less widespread adoption, following the so-called S-curve.
The next stage of innovation is not starting from scratch, he said, but rather the recognition that the previous innovation can be improved upon, and the beginning of a new innovation S-curve at the peak of the old, a process of continual development and refinement.
Dr. Cox stressed that for innovation to be adopted, it couldn’t be overly complex, citing the Maze procedure for atrial fibrillation, which was highly superior to the alternatives for treating AF, but has still lagged behind pulmonary vein isolation, a much less effective, but much easier technique used by interventional cardiologists.
He showed data demonstrating that when it came to innovative techniques, cure rate effectively did not matter to adoption, compared to the level of complexity of the new procedure.
He added that it was important for any new innovation to not “get too far away” from nature and its lessons, and that it should not be too complex to be routinely trained for and adopted.
Dr. Cox concluded with an admonition to new innovators to “listen to what your peers say. They have ideas, experiences, and imaginations of their own.”
He added that “they may or may not have anything to say that will change your course, but you have to listen to them.”
The first AATS Innovation Summit was launched on Saturday morning. The Summit was designed to assist cardiothoracic surgeons in developing new clinically applicable technology by giving them information on how to protect intellectual property, obtain funding, and conduct clinical trials. Attendees also got the latest updates on regulatory pathways and advice on building industry relationships needed to forge a novel product.
Pedro J. del Nido, MD, who was instrumental in coming up with the original idea for the Summit, introduced former AATS President W. Randolph Chitwood Jr., MD, who served as Program Director.
“The most fun part of this meeting,” Dr. Chitwood promised, would be the Commercialization Workshop at the end of the day “where we develop a fictitious product and carry it all the way to commercialization.”
Michael J. Mack, MD, a famous innovator in his own right, opened the didactic portion of the program by outlining the Summit Challenges.
“The whole field of cardiac surgery is moving to a catheter-based approach,” he declared.
He pointed out the tremendous growth in the invention of catheter-based products in the mitral regurgitation space. “The field is fertile with innovators,” he added.
In order to be innovative, he said, quoting what he called the Bavaria Rules, after Joseph E. Bavaria, MD, “You’ve got to have a vision; you’ve got to have a strategy; you need the tactics to implement that strategy, and at the end of the day, you have to execute that strategy.”
He concluded his talk saying, “Our field has a legacy of innovation. Our challenge is to adopt the tools to move that innovation field forward that our specialty has always been known for.”
He listed some of the major innovations in the cardiac space over the past 60+ years, from the beginning of aortic surgery, to mitral valve surgery, the Maze procedure, and even TAVR, pointing out that historically at least 10-20 years has been the lag time between the development of the innovation and its more-or-less widespread adoption, following the so-called S-curve.
The next stage of innovation is not starting from scratch, he said, but rather the recognition that the previous innovation can be improved upon, and the beginning of a new innovation S-curve at the peak of the old, a process of continual development and refinement.
Dr. Cox stressed that for innovation to be adopted, it couldn’t be overly complex, citing the Maze procedure for atrial fibrillation, which was highly superior to the alternatives for treating AF, but has still lagged behind pulmonary vein isolation, a much less effective, but much easier technique used by interventional cardiologists.
He showed data demonstrating that when it came to innovative techniques, cure rate effectively did not matter to adoption, compared to the level of complexity of the new procedure.
He added that it was important for any new innovation to not “get too far away” from nature and its lessons, and that it should not be too complex to be routinely trained for and adopted.
Dr. Cox concluded with an admonition to new innovators to “listen to what your peers say. They have ideas, experiences, and imaginations of their own.”
He added that “they may or may not have anything to say that will change your course, but you have to listen to them.”
The first AATS Innovation Summit was launched on Saturday morning. The Summit was designed to assist cardiothoracic surgeons in developing new clinically applicable technology by giving them information on how to protect intellectual property, obtain funding, and conduct clinical trials. Attendees also got the latest updates on regulatory pathways and advice on building industry relationships needed to forge a novel product.
Pedro J. del Nido, MD, who was instrumental in coming up with the original idea for the Summit, introduced former AATS President W. Randolph Chitwood Jr., MD, who served as Program Director.
“The most fun part of this meeting,” Dr. Chitwood promised, would be the Commercialization Workshop at the end of the day “where we develop a fictitious product and carry it all the way to commercialization.”
Michael J. Mack, MD, a famous innovator in his own right, opened the didactic portion of the program by outlining the Summit Challenges.
“The whole field of cardiac surgery is moving to a catheter-based approach,” he declared.
He pointed out the tremendous growth in the invention of catheter-based products in the mitral regurgitation space. “The field is fertile with innovators,” he added.
In order to be innovative, he said, quoting what he called the Bavaria Rules, after Joseph E. Bavaria, MD, “You’ve got to have a vision; you’ve got to have a strategy; you need the tactics to implement that strategy, and at the end of the day, you have to execute that strategy.”
He concluded his talk saying, “Our field has a legacy of innovation. Our challenge is to adopt the tools to move that innovation field forward that our specialty has always been known for.”
He listed some of the major innovations in the cardiac space over the past 60+ years, from the beginning of aortic surgery, to mitral valve surgery, the Maze procedure, and even TAVR, pointing out that historically at least 10-20 years has been the lag time between the development of the innovation and its more-or-less widespread adoption, following the so-called S-curve.
The next stage of innovation is not starting from scratch, he said, but rather the recognition that the previous innovation can be improved upon, and the beginning of a new innovation S-curve at the peak of the old, a process of continual development and refinement.
Dr. Cox stressed that for innovation to be adopted, it couldn’t be overly complex, citing the Maze procedure for atrial fibrillation, which was highly superior to the alternatives for treating AF, but has still lagged behind pulmonary vein isolation, a much less effective, but much easier technique used by interventional cardiologists.
He showed data demonstrating that when it came to innovative techniques, cure rate effectively did not matter to adoption, compared to the level of complexity of the new procedure.
He added that it was important for any new innovation to not “get too far away” from nature and its lessons, and that it should not be too complex to be routinely trained for and adopted.
Dr. Cox concluded with an admonition to new innovators to “listen to what your peers say. They have ideas, experiences, and imaginations of their own.”
He added that “they may or may not have anything to say that will change your course, but you have to listen to them.”
VIDEO: Surgery use declines for non–small cell lung cancer
BOSTON – The use of surgical therapy for early stage lung cancer in the United States has declined as other nonsurgical treatment options have become available, according to a study reported at the annual meeting of the American Association for Thoracic Surgery.
Most notably, the study finds that surgery for early stage non–small cell lung cancer decreased by 12% from 2004 to 2013.
In a video interview, Keith Naunheim, MD, a professor of surgery at Saint Louis University, discusses the study findings and the potential reasons behind declining surgery use for lung cancer. Dr. Naunheim also addresses why physicians should keep an open mind about alternative therapy options for lung cancer, while ensuring that the treatments are safe and effective for patients.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @legal_med
BOSTON – The use of surgical therapy for early stage lung cancer in the United States has declined as other nonsurgical treatment options have become available, according to a study reported at the annual meeting of the American Association for Thoracic Surgery.
Most notably, the study finds that surgery for early stage non–small cell lung cancer decreased by 12% from 2004 to 2013.
In a video interview, Keith Naunheim, MD, a professor of surgery at Saint Louis University, discusses the study findings and the potential reasons behind declining surgery use for lung cancer. Dr. Naunheim also addresses why physicians should keep an open mind about alternative therapy options for lung cancer, while ensuring that the treatments are safe and effective for patients.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @legal_med
BOSTON – The use of surgical therapy for early stage lung cancer in the United States has declined as other nonsurgical treatment options have become available, according to a study reported at the annual meeting of the American Association for Thoracic Surgery.
Most notably, the study finds that surgery for early stage non–small cell lung cancer decreased by 12% from 2004 to 2013.
In a video interview, Keith Naunheim, MD, a professor of surgery at Saint Louis University, discusses the study findings and the potential reasons behind declining surgery use for lung cancer. Dr. Naunheim also addresses why physicians should keep an open mind about alternative therapy options for lung cancer, while ensuring that the treatments are safe and effective for patients.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @legal_med
AT THE AATS ANNUAL MEETING
FDA approves brigatinib for second-line advanced ALK-positive NSCLC
The Food and Drug Administration has granted accelerated approval to brigatinib for the treatment of patients with metastatic anaplastic lymphoma kinase (ALK)–positive non–small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.
Approval was based on a meaningful and durable overall response rate in a two-arm, open-label, multicenter trial of 222 patients with locally advanced or metastatic ALK-positive NSCLC who had progressed on crizotinib. Patients were randomized to brigatinib orally either 90 mg once daily (112 patients) or 180 mg once daily following a 7-day lead-in at 90 mg once daily (110 patients).
The median duration of response was 13.8 months in both arms.
The most common adverse reactions in 219 patients who received at least one dose were nausea, diarrhea, fatigue, cough, and headache. The most common serious adverse reactions were pneumonia and interstitial lung disease/pneumonitis. The rate of fatal adverse reactions was 3.7%; they were pneumonia in two patients and sudden death, dyspnea, respiratory failure, pulmonary embolism, bacterial meningitis, and urosepsis in one patient each. Visual disturbances also occurred in patients receiving brigatinib. The FDA cautions that patients receiving brigatinib should be monitored for new or worsening respiratory symptoms; hypertension; bradycardia; visual symptoms; and elevations in amylase, lipase, blood glucose, and creatine phosphokinase.
The recommended dosing of brigatinib, marketed as Alunbrig by Takeda Pharmaceutical, is 90 mg orally once daily for the first 7 days then, if tolerated, increase to 180 mg orally once daily.
Full prescribing information is available here.
The Food and Drug Administration has granted accelerated approval to brigatinib for the treatment of patients with metastatic anaplastic lymphoma kinase (ALK)–positive non–small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.
Approval was based on a meaningful and durable overall response rate in a two-arm, open-label, multicenter trial of 222 patients with locally advanced or metastatic ALK-positive NSCLC who had progressed on crizotinib. Patients were randomized to brigatinib orally either 90 mg once daily (112 patients) or 180 mg once daily following a 7-day lead-in at 90 mg once daily (110 patients).
The median duration of response was 13.8 months in both arms.
The most common adverse reactions in 219 patients who received at least one dose were nausea, diarrhea, fatigue, cough, and headache. The most common serious adverse reactions were pneumonia and interstitial lung disease/pneumonitis. The rate of fatal adverse reactions was 3.7%; they were pneumonia in two patients and sudden death, dyspnea, respiratory failure, pulmonary embolism, bacterial meningitis, and urosepsis in one patient each. Visual disturbances also occurred in patients receiving brigatinib. The FDA cautions that patients receiving brigatinib should be monitored for new or worsening respiratory symptoms; hypertension; bradycardia; visual symptoms; and elevations in amylase, lipase, blood glucose, and creatine phosphokinase.
The recommended dosing of brigatinib, marketed as Alunbrig by Takeda Pharmaceutical, is 90 mg orally once daily for the first 7 days then, if tolerated, increase to 180 mg orally once daily.
Full prescribing information is available here.
The Food and Drug Administration has granted accelerated approval to brigatinib for the treatment of patients with metastatic anaplastic lymphoma kinase (ALK)–positive non–small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.
Approval was based on a meaningful and durable overall response rate in a two-arm, open-label, multicenter trial of 222 patients with locally advanced or metastatic ALK-positive NSCLC who had progressed on crizotinib. Patients were randomized to brigatinib orally either 90 mg once daily (112 patients) or 180 mg once daily following a 7-day lead-in at 90 mg once daily (110 patients).
The median duration of response was 13.8 months in both arms.
The most common adverse reactions in 219 patients who received at least one dose were nausea, diarrhea, fatigue, cough, and headache. The most common serious adverse reactions were pneumonia and interstitial lung disease/pneumonitis. The rate of fatal adverse reactions was 3.7%; they were pneumonia in two patients and sudden death, dyspnea, respiratory failure, pulmonary embolism, bacterial meningitis, and urosepsis in one patient each. Visual disturbances also occurred in patients receiving brigatinib. The FDA cautions that patients receiving brigatinib should be monitored for new or worsening respiratory symptoms; hypertension; bradycardia; visual symptoms; and elevations in amylase, lipase, blood glucose, and creatine phosphokinase.
The recommended dosing of brigatinib, marketed as Alunbrig by Takeda Pharmaceutical, is 90 mg orally once daily for the first 7 days then, if tolerated, increase to 180 mg orally once daily.
Full prescribing information is available here.
Digoxin and heart failure mortality: The Swedes weigh in
WASHINGTON – The use of digoxin by Swedish Heart Failure Registry participants with heart failure with reduced ejection fraction was associated with significantly increased risk of all-cause mortality if they had concomitant paroxysmal atrial fibrillation or were in normal sinus rhythm, Gianluigi Savarese, MD, reported at the annual meeting of the American College of Cardiology.
In contrast, digoxin in Swedish patients with heart failure with reduced ejection fraction (HFrEF) and permanent atrial fibrillation (AF) was associated with a reduced risk of heart failure hospitalization but had no impact on mortality, added Dr. Savarese of the Karolinska Institute in Stockholm.
The Swedish Heart Failure Registry includes the majority of heart failure patients in that country. Data on 80 variables gets collected for each participant.
Dr. Savarese reported on 23,708 Swedes with HFrEF, 18% of whom were on digoxin. In a multivariate Cox regression analysis adjusted for numerous potential confounders, the use of digoxin was associated with an 8% increased risk of all-cause mortality and a 10% lower risk of heart failure hospitalizations during up to 11 years of follow-up.
In the 12,162 patients with HFrEF and comorbid AF, 30% of whom were on digoxin, the drug was associated with a 12% reduction in heart failure hospitalizations and had no effect on all-cause mortality.
In contrast, among patients with HFrEF without AF, 5% of whom were taking digoxin, use of the drug was associated with an adjusted 31% increase in mortality risk. But digoxin didn’t affect the risk of heart failure hospitalization one way or the other in this group.
Stratifying subjects by their type of AF, the use of digoxin in patients with HFrEF and permanent AF was associated with a 16% reduction in risk of heart failure hospitalization with no impact on mortality. In contrast, among the 2,723 patients with HFrEF and paroxysmal AF, digoxin was associated with a 29% increase in the risk of mortality and no effect on hospitalization.
Current ACC/American Heart Association heart failure guidelines give digoxin a strong Class IIa recommendation for reducing heart failure hospitalizations in patients with HFrEF. European Society of Cardiology guidelines provide a Class IIb recommendation for digoxin to reduce the risk of hospitalization in patients with symptomatic HFrEF in normal sinus rhythm.
Dr. Savarese said he and his coinvestigators decided to examine the impact of digoxin in the Swedish Heart Failure Registry because despite the guideline support for the drug’s use, recent years have brought conflicting data regarding digoxin’s impact on mortality. For example, a meta-analysis of nine studies in more than 235,000 AF patients, seven studies in patients with heart failure, and three in patients with both disorders showed that digoxin was associated with a 29% increased mortality risk in AF patients and a 14% increase in those with heart failure (Eur Heart J. 2015 Jul 21;36[28]:1831-8).
Moreover, at a late-breaking clinical trial session elsewhere at ACC 17, a secondary analysis of the roughly 18,000-patient ARISTOTLE trial came down emphatically on the side of avoiding the venerable drug in patients with AF, where it was found to be associated with a fourfold increased risk of sudden death.
Session comoderator Lee R. Goldberg, MD, medical director of the University of Pennsylvania Heart Failure and Transplantation Program in Philadelphia, observed that the use of digoxin has become quite controversial. He posed a question to Dr. Savarese: “Every few months someone writes the last paper on digoxin as they look at thousands of patients, and then there’s always a new paper. If you were to rewrite the guidelines now, what would you recommend for digoxin?”
Dr. Savarese replied that the current guidelines rely heavily upon the results of a 20-year-old randomized, double-blind, placebo-controlled trial of digoxin in heart failure (N Engl J Med. 1997 Feb 20;336[8]:525-33). Those study participants look nothing at all like the heart failure patients physicians see today in clinical practice. Hardly any of them were on what today is guideline-directed medical therapy with a beta-blocker or mineralocorticoid receptor antagonist. So the trial’s applicability is dubious.
“Our Swedish data are observational. They are hypothesis-generating. They should drive trialists to design a new trial of digoxin. But I think we all know that’s not going to happen. So actually I don’t think there is still space for a IIb or IIa recommendation for digoxin in the guidelines,” Dr. Savarese said.
He reported having no financial conflicts.
WASHINGTON – The use of digoxin by Swedish Heart Failure Registry participants with heart failure with reduced ejection fraction was associated with significantly increased risk of all-cause mortality if they had concomitant paroxysmal atrial fibrillation or were in normal sinus rhythm, Gianluigi Savarese, MD, reported at the annual meeting of the American College of Cardiology.
In contrast, digoxin in Swedish patients with heart failure with reduced ejection fraction (HFrEF) and permanent atrial fibrillation (AF) was associated with a reduced risk of heart failure hospitalization but had no impact on mortality, added Dr. Savarese of the Karolinska Institute in Stockholm.
The Swedish Heart Failure Registry includes the majority of heart failure patients in that country. Data on 80 variables gets collected for each participant.
Dr. Savarese reported on 23,708 Swedes with HFrEF, 18% of whom were on digoxin. In a multivariate Cox regression analysis adjusted for numerous potential confounders, the use of digoxin was associated with an 8% increased risk of all-cause mortality and a 10% lower risk of heart failure hospitalizations during up to 11 years of follow-up.
In the 12,162 patients with HFrEF and comorbid AF, 30% of whom were on digoxin, the drug was associated with a 12% reduction in heart failure hospitalizations and had no effect on all-cause mortality.
In contrast, among patients with HFrEF without AF, 5% of whom were taking digoxin, use of the drug was associated with an adjusted 31% increase in mortality risk. But digoxin didn’t affect the risk of heart failure hospitalization one way or the other in this group.
Stratifying subjects by their type of AF, the use of digoxin in patients with HFrEF and permanent AF was associated with a 16% reduction in risk of heart failure hospitalization with no impact on mortality. In contrast, among the 2,723 patients with HFrEF and paroxysmal AF, digoxin was associated with a 29% increase in the risk of mortality and no effect on hospitalization.
Current ACC/American Heart Association heart failure guidelines give digoxin a strong Class IIa recommendation for reducing heart failure hospitalizations in patients with HFrEF. European Society of Cardiology guidelines provide a Class IIb recommendation for digoxin to reduce the risk of hospitalization in patients with symptomatic HFrEF in normal sinus rhythm.
Dr. Savarese said he and his coinvestigators decided to examine the impact of digoxin in the Swedish Heart Failure Registry because despite the guideline support for the drug’s use, recent years have brought conflicting data regarding digoxin’s impact on mortality. For example, a meta-analysis of nine studies in more than 235,000 AF patients, seven studies in patients with heart failure, and three in patients with both disorders showed that digoxin was associated with a 29% increased mortality risk in AF patients and a 14% increase in those with heart failure (Eur Heart J. 2015 Jul 21;36[28]:1831-8).
Moreover, at a late-breaking clinical trial session elsewhere at ACC 17, a secondary analysis of the roughly 18,000-patient ARISTOTLE trial came down emphatically on the side of avoiding the venerable drug in patients with AF, where it was found to be associated with a fourfold increased risk of sudden death.
Session comoderator Lee R. Goldberg, MD, medical director of the University of Pennsylvania Heart Failure and Transplantation Program in Philadelphia, observed that the use of digoxin has become quite controversial. He posed a question to Dr. Savarese: “Every few months someone writes the last paper on digoxin as they look at thousands of patients, and then there’s always a new paper. If you were to rewrite the guidelines now, what would you recommend for digoxin?”
Dr. Savarese replied that the current guidelines rely heavily upon the results of a 20-year-old randomized, double-blind, placebo-controlled trial of digoxin in heart failure (N Engl J Med. 1997 Feb 20;336[8]:525-33). Those study participants look nothing at all like the heart failure patients physicians see today in clinical practice. Hardly any of them were on what today is guideline-directed medical therapy with a beta-blocker or mineralocorticoid receptor antagonist. So the trial’s applicability is dubious.
“Our Swedish data are observational. They are hypothesis-generating. They should drive trialists to design a new trial of digoxin. But I think we all know that’s not going to happen. So actually I don’t think there is still space for a IIb or IIa recommendation for digoxin in the guidelines,” Dr. Savarese said.
He reported having no financial conflicts.
WASHINGTON – The use of digoxin by Swedish Heart Failure Registry participants with heart failure with reduced ejection fraction was associated with significantly increased risk of all-cause mortality if they had concomitant paroxysmal atrial fibrillation or were in normal sinus rhythm, Gianluigi Savarese, MD, reported at the annual meeting of the American College of Cardiology.
In contrast, digoxin in Swedish patients with heart failure with reduced ejection fraction (HFrEF) and permanent atrial fibrillation (AF) was associated with a reduced risk of heart failure hospitalization but had no impact on mortality, added Dr. Savarese of the Karolinska Institute in Stockholm.
The Swedish Heart Failure Registry includes the majority of heart failure patients in that country. Data on 80 variables gets collected for each participant.
Dr. Savarese reported on 23,708 Swedes with HFrEF, 18% of whom were on digoxin. In a multivariate Cox regression analysis adjusted for numerous potential confounders, the use of digoxin was associated with an 8% increased risk of all-cause mortality and a 10% lower risk of heart failure hospitalizations during up to 11 years of follow-up.
In the 12,162 patients with HFrEF and comorbid AF, 30% of whom were on digoxin, the drug was associated with a 12% reduction in heart failure hospitalizations and had no effect on all-cause mortality.
In contrast, among patients with HFrEF without AF, 5% of whom were taking digoxin, use of the drug was associated with an adjusted 31% increase in mortality risk. But digoxin didn’t affect the risk of heart failure hospitalization one way or the other in this group.
Stratifying subjects by their type of AF, the use of digoxin in patients with HFrEF and permanent AF was associated with a 16% reduction in risk of heart failure hospitalization with no impact on mortality. In contrast, among the 2,723 patients with HFrEF and paroxysmal AF, digoxin was associated with a 29% increase in the risk of mortality and no effect on hospitalization.
Current ACC/American Heart Association heart failure guidelines give digoxin a strong Class IIa recommendation for reducing heart failure hospitalizations in patients with HFrEF. European Society of Cardiology guidelines provide a Class IIb recommendation for digoxin to reduce the risk of hospitalization in patients with symptomatic HFrEF in normal sinus rhythm.
Dr. Savarese said he and his coinvestigators decided to examine the impact of digoxin in the Swedish Heart Failure Registry because despite the guideline support for the drug’s use, recent years have brought conflicting data regarding digoxin’s impact on mortality. For example, a meta-analysis of nine studies in more than 235,000 AF patients, seven studies in patients with heart failure, and three in patients with both disorders showed that digoxin was associated with a 29% increased mortality risk in AF patients and a 14% increase in those with heart failure (Eur Heart J. 2015 Jul 21;36[28]:1831-8).
Moreover, at a late-breaking clinical trial session elsewhere at ACC 17, a secondary analysis of the roughly 18,000-patient ARISTOTLE trial came down emphatically on the side of avoiding the venerable drug in patients with AF, where it was found to be associated with a fourfold increased risk of sudden death.
Session comoderator Lee R. Goldberg, MD, medical director of the University of Pennsylvania Heart Failure and Transplantation Program in Philadelphia, observed that the use of digoxin has become quite controversial. He posed a question to Dr. Savarese: “Every few months someone writes the last paper on digoxin as they look at thousands of patients, and then there’s always a new paper. If you were to rewrite the guidelines now, what would you recommend for digoxin?”
Dr. Savarese replied that the current guidelines rely heavily upon the results of a 20-year-old randomized, double-blind, placebo-controlled trial of digoxin in heart failure (N Engl J Med. 1997 Feb 20;336[8]:525-33). Those study participants look nothing at all like the heart failure patients physicians see today in clinical practice. Hardly any of them were on what today is guideline-directed medical therapy with a beta-blocker or mineralocorticoid receptor antagonist. So the trial’s applicability is dubious.
“Our Swedish data are observational. They are hypothesis-generating. They should drive trialists to design a new trial of digoxin. But I think we all know that’s not going to happen. So actually I don’t think there is still space for a IIb or IIa recommendation for digoxin in the guidelines,” Dr. Savarese said.
He reported having no financial conflicts.
AT ACC 17
Key clinical point:
Major finding: The use of digoxin in patients with heart failure with reduced ejection fraction was associated with significantly increased risk of all-cause mortality if they had concomitant paroxysmal atrial fibrillation or were in normal sinus rhythm.
Data source: An observational study of nearly 24,000 patients enrolled in the Swedish Heart Failure Registry, 18% of whom were on digoxin.
Disclosures: The study presenter reported having no financial conflicts.
HHS Secretary Price promises reduced health IT burden for physicians
WASHINGTON – Reducing IT burden for doctors and fostering interoperability are two top tech priorities for Health and Human Services Secretary Tom Price, MD.
“We simply have to do a better job of reducing the burden of health IT on physicians and all health care providers,” Dr. Price said April 27 at Health Datapalooza, an annual conference on health data transparency. “The promise of big data and health information technology is so great and absolutely remarkable but we must not, we cannot continue to get this wrong.”
“Now we are seeing physicians leaving the practice of medicine when they are 60 or 55,” he said. “Many of my colleagues, my personal friends who have been practicing, right now they are looking for the exit doors. They are trying to figure out how to get out of practicing medicine and I think it is incredibly important for us as a society to step back and ask, why?”
A significant factor is the shift to electronic health records, which has caused doctors to spend much more time looking at screens and feeling more like data entry clerks than health care providers, he said.
“I know that we have lost more than one physician to retirement because of the kinds of burdens that have been placed on a lot of them and that simply ought to be unacceptable to us,” he said. “You think of the intellectual capital that has been lost by this nation because of the kinds of burdens that clinicians have seen.”
That said, “data is absolutely crucial,” Dr. Price said. “Don’t misunderstand me. It is absolutely critical that we have all the data that we can and that we use it in an evidence-based manner so that we can provide better care and better quality of care to patients.”
He challenged the health IT professionals at the meeting to make their products more user friendly.
“We will work on reducing the burdens at the federal level, but we also need clinicians and IT folks on the ground to help make certain that technology implementation is done in a way that it enhances usability and increases efficiency,” Dr. Price said.
He also called for true interoperability, a common goal that has persisted since electronic health records were mandated under the HITECH Act but remains an elusive target.
“This has always been the goal and it just seems so simple,” he said. “Somehow something has happened between the idea of interoperability and now that has made it so much more challenging.”
He placed that fault on current federal regulation around interoperability and pledged to create an environment that reduces regulatory roadblocks and allows the technology sector to innovate and foster the free flow of data.
“From my perspective it seems that what we ought to be doing is deciding the rules of the road,” Dr. Price said. “We are going to drive on the right side. We are going to stop at the red light. This is the language we are going to do. This is what a triangular sign looks like, as opposed to stipulating every single dot... all the way down the line.”
WASHINGTON – Reducing IT burden for doctors and fostering interoperability are two top tech priorities for Health and Human Services Secretary Tom Price, MD.
“We simply have to do a better job of reducing the burden of health IT on physicians and all health care providers,” Dr. Price said April 27 at Health Datapalooza, an annual conference on health data transparency. “The promise of big data and health information technology is so great and absolutely remarkable but we must not, we cannot continue to get this wrong.”
“Now we are seeing physicians leaving the practice of medicine when they are 60 or 55,” he said. “Many of my colleagues, my personal friends who have been practicing, right now they are looking for the exit doors. They are trying to figure out how to get out of practicing medicine and I think it is incredibly important for us as a society to step back and ask, why?”
A significant factor is the shift to electronic health records, which has caused doctors to spend much more time looking at screens and feeling more like data entry clerks than health care providers, he said.
“I know that we have lost more than one physician to retirement because of the kinds of burdens that have been placed on a lot of them and that simply ought to be unacceptable to us,” he said. “You think of the intellectual capital that has been lost by this nation because of the kinds of burdens that clinicians have seen.”
That said, “data is absolutely crucial,” Dr. Price said. “Don’t misunderstand me. It is absolutely critical that we have all the data that we can and that we use it in an evidence-based manner so that we can provide better care and better quality of care to patients.”
He challenged the health IT professionals at the meeting to make their products more user friendly.
“We will work on reducing the burdens at the federal level, but we also need clinicians and IT folks on the ground to help make certain that technology implementation is done in a way that it enhances usability and increases efficiency,” Dr. Price said.
He also called for true interoperability, a common goal that has persisted since electronic health records were mandated under the HITECH Act but remains an elusive target.
“This has always been the goal and it just seems so simple,” he said. “Somehow something has happened between the idea of interoperability and now that has made it so much more challenging.”
He placed that fault on current federal regulation around interoperability and pledged to create an environment that reduces regulatory roadblocks and allows the technology sector to innovate and foster the free flow of data.
“From my perspective it seems that what we ought to be doing is deciding the rules of the road,” Dr. Price said. “We are going to drive on the right side. We are going to stop at the red light. This is the language we are going to do. This is what a triangular sign looks like, as opposed to stipulating every single dot... all the way down the line.”
WASHINGTON – Reducing IT burden for doctors and fostering interoperability are two top tech priorities for Health and Human Services Secretary Tom Price, MD.
“We simply have to do a better job of reducing the burden of health IT on physicians and all health care providers,” Dr. Price said April 27 at Health Datapalooza, an annual conference on health data transparency. “The promise of big data and health information technology is so great and absolutely remarkable but we must not, we cannot continue to get this wrong.”
“Now we are seeing physicians leaving the practice of medicine when they are 60 or 55,” he said. “Many of my colleagues, my personal friends who have been practicing, right now they are looking for the exit doors. They are trying to figure out how to get out of practicing medicine and I think it is incredibly important for us as a society to step back and ask, why?”
A significant factor is the shift to electronic health records, which has caused doctors to spend much more time looking at screens and feeling more like data entry clerks than health care providers, he said.
“I know that we have lost more than one physician to retirement because of the kinds of burdens that have been placed on a lot of them and that simply ought to be unacceptable to us,” he said. “You think of the intellectual capital that has been lost by this nation because of the kinds of burdens that clinicians have seen.”
That said, “data is absolutely crucial,” Dr. Price said. “Don’t misunderstand me. It is absolutely critical that we have all the data that we can and that we use it in an evidence-based manner so that we can provide better care and better quality of care to patients.”
He challenged the health IT professionals at the meeting to make their products more user friendly.
“We will work on reducing the burdens at the federal level, but we also need clinicians and IT folks on the ground to help make certain that technology implementation is done in a way that it enhances usability and increases efficiency,” Dr. Price said.
He also called for true interoperability, a common goal that has persisted since electronic health records were mandated under the HITECH Act but remains an elusive target.
“This has always been the goal and it just seems so simple,” he said. “Somehow something has happened between the idea of interoperability and now that has made it so much more challenging.”
He placed that fault on current federal regulation around interoperability and pledged to create an environment that reduces regulatory roadblocks and allows the technology sector to innovate and foster the free flow of data.
“From my perspective it seems that what we ought to be doing is deciding the rules of the road,” Dr. Price said. “We are going to drive on the right side. We are going to stop at the red light. This is the language we are going to do. This is what a triangular sign looks like, as opposed to stipulating every single dot... all the way down the line.”
AT HEALTH DATAPALOOZA 2017
ASCO updates NSCLC guidelines for adjuvant therapy
Adjuvant cisplatin-based chemotherapy is recommended for routine use in non–small cell lung cancer patients with stage IIA, IIB, or IIIA disease who have undergone complete surgical resections, according to updated guidelines from the American Society of Clinical Oncology.
In patients with stage IA disease, the guidelines recommend against cisplatin-based chemotherapy. The new guidelines are based on a systematic review current to January 2016 and an American Society for Radiation Oncology guideline and systematic review, which ASCO had already endorsed, which formed the basis for recommendations on adjuvant radiation therapy, Mark G. Kris, MD, and panel authors said (J Clin Oncol. 2017 April 26. doi: 10.1200/JCO.2017.72.4401).
The guidelines, available online, also recommend against routine cisplatin-based chemotherapy in patients with stage IB disease, but they suggest an evaluation of these patients to explore the pros and cons of adjuvant chemotherapy.
With respect to radiation, the authors recommend against it for patients with resected stage I or stage II disease, and they recommend against it for routine use in patients with stage IIIA. However, in patients with IIIA N2 disease, patients should be evaluated postoperatively, in consultation with a medical oncologist, for the potential risks and benefits of adjuvant radiation.
The authors also provide some recommendations for communicating with patients regarding treatment decisions. There are few studies examining this question, so the recommendations are based on low-quality evidence.
Non–small cell lung cancer patients may have complex social, psychological, and medical issues, and discussions should be carried out with this in mind. Pain, impaired breathing, and fatigue are common after surgery, and smoking cessation can lead to short-term stress as a result of nicotine withdrawal. Older patients may have a range of comorbidities.
Studies show that patients are most satisfied if they feel that physicians allow them to share in the decision making, and if they are given sufficient time to choose. To that end, the authors recommend a session dedicated to discussion of adjuvant therapy.
Communicating risk of death is challenging for many reasons. Patients should be asked how they would like to hear about their risks: some prefer general terms, while others may opt for numbers, charts, or graphs. The guidelines include a risk chart that can help patients understand the potential benefits and risks of chemotherapy.
The study authors report financial relationships with numerous pharmaceutical companies.
Adjuvant cisplatin-based chemotherapy is recommended for routine use in non–small cell lung cancer patients with stage IIA, IIB, or IIIA disease who have undergone complete surgical resections, according to updated guidelines from the American Society of Clinical Oncology.
In patients with stage IA disease, the guidelines recommend against cisplatin-based chemotherapy. The new guidelines are based on a systematic review current to January 2016 and an American Society for Radiation Oncology guideline and systematic review, which ASCO had already endorsed, which formed the basis for recommendations on adjuvant radiation therapy, Mark G. Kris, MD, and panel authors said (J Clin Oncol. 2017 April 26. doi: 10.1200/JCO.2017.72.4401).
The guidelines, available online, also recommend against routine cisplatin-based chemotherapy in patients with stage IB disease, but they suggest an evaluation of these patients to explore the pros and cons of adjuvant chemotherapy.
With respect to radiation, the authors recommend against it for patients with resected stage I or stage II disease, and they recommend against it for routine use in patients with stage IIIA. However, in patients with IIIA N2 disease, patients should be evaluated postoperatively, in consultation with a medical oncologist, for the potential risks and benefits of adjuvant radiation.
The authors also provide some recommendations for communicating with patients regarding treatment decisions. There are few studies examining this question, so the recommendations are based on low-quality evidence.
Non–small cell lung cancer patients may have complex social, psychological, and medical issues, and discussions should be carried out with this in mind. Pain, impaired breathing, and fatigue are common after surgery, and smoking cessation can lead to short-term stress as a result of nicotine withdrawal. Older patients may have a range of comorbidities.
Studies show that patients are most satisfied if they feel that physicians allow them to share in the decision making, and if they are given sufficient time to choose. To that end, the authors recommend a session dedicated to discussion of adjuvant therapy.
Communicating risk of death is challenging for many reasons. Patients should be asked how they would like to hear about their risks: some prefer general terms, while others may opt for numbers, charts, or graphs. The guidelines include a risk chart that can help patients understand the potential benefits and risks of chemotherapy.
The study authors report financial relationships with numerous pharmaceutical companies.
Adjuvant cisplatin-based chemotherapy is recommended for routine use in non–small cell lung cancer patients with stage IIA, IIB, or IIIA disease who have undergone complete surgical resections, according to updated guidelines from the American Society of Clinical Oncology.
In patients with stage IA disease, the guidelines recommend against cisplatin-based chemotherapy. The new guidelines are based on a systematic review current to January 2016 and an American Society for Radiation Oncology guideline and systematic review, which ASCO had already endorsed, which formed the basis for recommendations on adjuvant radiation therapy, Mark G. Kris, MD, and panel authors said (J Clin Oncol. 2017 April 26. doi: 10.1200/JCO.2017.72.4401).
The guidelines, available online, also recommend against routine cisplatin-based chemotherapy in patients with stage IB disease, but they suggest an evaluation of these patients to explore the pros and cons of adjuvant chemotherapy.
With respect to radiation, the authors recommend against it for patients with resected stage I or stage II disease, and they recommend against it for routine use in patients with stage IIIA. However, in patients with IIIA N2 disease, patients should be evaluated postoperatively, in consultation with a medical oncologist, for the potential risks and benefits of adjuvant radiation.
The authors also provide some recommendations for communicating with patients regarding treatment decisions. There are few studies examining this question, so the recommendations are based on low-quality evidence.
Non–small cell lung cancer patients may have complex social, psychological, and medical issues, and discussions should be carried out with this in mind. Pain, impaired breathing, and fatigue are common after surgery, and smoking cessation can lead to short-term stress as a result of nicotine withdrawal. Older patients may have a range of comorbidities.
Studies show that patients are most satisfied if they feel that physicians allow them to share in the decision making, and if they are given sufficient time to choose. To that end, the authors recommend a session dedicated to discussion of adjuvant therapy.
Communicating risk of death is challenging for many reasons. Patients should be asked how they would like to hear about their risks: some prefer general terms, while others may opt for numbers, charts, or graphs. The guidelines include a risk chart that can help patients understand the potential benefits and risks of chemotherapy.
The study authors report financial relationships with numerous pharmaceutical companies.
GOP health reform: Essential health benefits, community rating under fire
Republicans are targeting two key consumer protections in their latest attempt to gain enough votes to pass the American Health Care Act, phase 1 of their Affordable Care Act repeal and replace plan.
On the chopping block are the essential health care benefits package and so-called community rating provisions – which prevent insurers from charging significantly more for older patients and those with preexisting conditions.
“Obamacare is already in a race to the bottom in terms of quality coverage for the sick and that’s because of the law’s community rating provisions, which penalize high-quality coverage for the sick,” Michael F. Cannon, director of health policy studies at the Cato Institute, said in an interview. “The [AHCA] would arguably accelerate that race to the bottom. The waiver provision in this amendment definitely would and it would because the bill would allow states to waive the community rating provisions, but only for people who were not previously insured.”
The waiver provisions would “increase premiums for the previously uninsured and discourage them from enrolling,” Mr. Cannon predicted.
David Anderson, research associate at the Margolis Center for Health Policy at Duke University, Durham, N.C., said that, if a state elects to take a waiver, so-called high-cost patients “such as individuals with cancer, individuals with cystic fibrosis, individuals with coagulation disorders, [would be] shrugged to the side into a high-cost risk pool or some kind of risk sharing ... with their own premium pool.” This could lower premium costs for healthy patients, he added.
This could be enhanced by narrowing the essential health benefits. For example, Mr. Anderson said that a state could keep the drug benefit, but apply for a waiver to narrow its coverage for all generics plus a limited list of brand names.
“Someone with cystic fibrosis with a $300,000-a-year medication will not have that covered and will be put in the high-cost risk pool,” Mr. Anderson said. “What it does is that it makes insurance cheaper for individuals who are highly unlikely to be high cost, and it makes it much more expensive for any individuals with known high-cost conditions.”
The draft amendment also would make it easier a whole lot easier to get such waivers approved: If enacted, the legislation would give default approval of such waivers and allow just 60 days for the Department of Health & Human Services to deny waiver request.
States would be able to apply for a waiver from the essential health benefits requirements for the 2020 plan year and a waiver to charge higher premiums to certain individuals for the 2019 plan year.
Waivers to change the essential health benefits package would need to meet one or more of the following conditions:
- Reduce average premiums.
- Increase enrollment.
- Stabilize the health insurance market.
- Stabilize premiums for individuals with preexisting conditions.
- Increase consumer choice.
For a state to change community rating provisions, its waiver also would need to create a mechanism, such as high-risk pools, to help those patients. Funding for these pools is provided for in the AHCA, but has been criticized as being inadequate on a national level.
Mr. Cannon of the Cato Institute predicted that such waivers ultimately would lead to more adverse selections for people needing comprehensive coverage and could force more people to lose coverage than to gain access to affordable, high-quality plans.
“If you waive essential health benefits in a community-rated market, you get even more adverse selection against comprehensive plans that sick people want, so those plans disappear,” Mr. Cannon said. “They either disappear because the insurers stop offering them or they disappear because insurers try to make the coverage worse, because Obamacare penalizes them if they don’t make coverage worse.”
He said these waivers provide little incentive for health insurers to stay in the individual markets and they could, as they are already, flee the individual markets.
The AHCA is phase 1 of the GOP repeal and replace plan. Congressional Republicans want to use the budget reconciliation process for the AHCA, so that they need only a simple majority to change revenue-generating provisions of the ACA. Phase 2 is a comprehensive review of all federal health care regulations and phase 3 is slated to be new legislation to replace the ACA with a new health care reform plan, which will require a two-thirds majority in the Senate to pass.
Republicans are targeting two key consumer protections in their latest attempt to gain enough votes to pass the American Health Care Act, phase 1 of their Affordable Care Act repeal and replace plan.
On the chopping block are the essential health care benefits package and so-called community rating provisions – which prevent insurers from charging significantly more for older patients and those with preexisting conditions.
“Obamacare is already in a race to the bottom in terms of quality coverage for the sick and that’s because of the law’s community rating provisions, which penalize high-quality coverage for the sick,” Michael F. Cannon, director of health policy studies at the Cato Institute, said in an interview. “The [AHCA] would arguably accelerate that race to the bottom. The waiver provision in this amendment definitely would and it would because the bill would allow states to waive the community rating provisions, but only for people who were not previously insured.”
The waiver provisions would “increase premiums for the previously uninsured and discourage them from enrolling,” Mr. Cannon predicted.
David Anderson, research associate at the Margolis Center for Health Policy at Duke University, Durham, N.C., said that, if a state elects to take a waiver, so-called high-cost patients “such as individuals with cancer, individuals with cystic fibrosis, individuals with coagulation disorders, [would be] shrugged to the side into a high-cost risk pool or some kind of risk sharing ... with their own premium pool.” This could lower premium costs for healthy patients, he added.
This could be enhanced by narrowing the essential health benefits. For example, Mr. Anderson said that a state could keep the drug benefit, but apply for a waiver to narrow its coverage for all generics plus a limited list of brand names.
“Someone with cystic fibrosis with a $300,000-a-year medication will not have that covered and will be put in the high-cost risk pool,” Mr. Anderson said. “What it does is that it makes insurance cheaper for individuals who are highly unlikely to be high cost, and it makes it much more expensive for any individuals with known high-cost conditions.”
The draft amendment also would make it easier a whole lot easier to get such waivers approved: If enacted, the legislation would give default approval of such waivers and allow just 60 days for the Department of Health & Human Services to deny waiver request.
States would be able to apply for a waiver from the essential health benefits requirements for the 2020 plan year and a waiver to charge higher premiums to certain individuals for the 2019 plan year.
Waivers to change the essential health benefits package would need to meet one or more of the following conditions:
- Reduce average premiums.
- Increase enrollment.
- Stabilize the health insurance market.
- Stabilize premiums for individuals with preexisting conditions.
- Increase consumer choice.
For a state to change community rating provisions, its waiver also would need to create a mechanism, such as high-risk pools, to help those patients. Funding for these pools is provided for in the AHCA, but has been criticized as being inadequate on a national level.
Mr. Cannon of the Cato Institute predicted that such waivers ultimately would lead to more adverse selections for people needing comprehensive coverage and could force more people to lose coverage than to gain access to affordable, high-quality plans.
“If you waive essential health benefits in a community-rated market, you get even more adverse selection against comprehensive plans that sick people want, so those plans disappear,” Mr. Cannon said. “They either disappear because the insurers stop offering them or they disappear because insurers try to make the coverage worse, because Obamacare penalizes them if they don’t make coverage worse.”
He said these waivers provide little incentive for health insurers to stay in the individual markets and they could, as they are already, flee the individual markets.
The AHCA is phase 1 of the GOP repeal and replace plan. Congressional Republicans want to use the budget reconciliation process for the AHCA, so that they need only a simple majority to change revenue-generating provisions of the ACA. Phase 2 is a comprehensive review of all federal health care regulations and phase 3 is slated to be new legislation to replace the ACA with a new health care reform plan, which will require a two-thirds majority in the Senate to pass.
Republicans are targeting two key consumer protections in their latest attempt to gain enough votes to pass the American Health Care Act, phase 1 of their Affordable Care Act repeal and replace plan.
On the chopping block are the essential health care benefits package and so-called community rating provisions – which prevent insurers from charging significantly more for older patients and those with preexisting conditions.
“Obamacare is already in a race to the bottom in terms of quality coverage for the sick and that’s because of the law’s community rating provisions, which penalize high-quality coverage for the sick,” Michael F. Cannon, director of health policy studies at the Cato Institute, said in an interview. “The [AHCA] would arguably accelerate that race to the bottom. The waiver provision in this amendment definitely would and it would because the bill would allow states to waive the community rating provisions, but only for people who were not previously insured.”
The waiver provisions would “increase premiums for the previously uninsured and discourage them from enrolling,” Mr. Cannon predicted.
David Anderson, research associate at the Margolis Center for Health Policy at Duke University, Durham, N.C., said that, if a state elects to take a waiver, so-called high-cost patients “such as individuals with cancer, individuals with cystic fibrosis, individuals with coagulation disorders, [would be] shrugged to the side into a high-cost risk pool or some kind of risk sharing ... with their own premium pool.” This could lower premium costs for healthy patients, he added.
This could be enhanced by narrowing the essential health benefits. For example, Mr. Anderson said that a state could keep the drug benefit, but apply for a waiver to narrow its coverage for all generics plus a limited list of brand names.
“Someone with cystic fibrosis with a $300,000-a-year medication will not have that covered and will be put in the high-cost risk pool,” Mr. Anderson said. “What it does is that it makes insurance cheaper for individuals who are highly unlikely to be high cost, and it makes it much more expensive for any individuals with known high-cost conditions.”
The draft amendment also would make it easier a whole lot easier to get such waivers approved: If enacted, the legislation would give default approval of such waivers and allow just 60 days for the Department of Health & Human Services to deny waiver request.
States would be able to apply for a waiver from the essential health benefits requirements for the 2020 plan year and a waiver to charge higher premiums to certain individuals for the 2019 plan year.
Waivers to change the essential health benefits package would need to meet one or more of the following conditions:
- Reduce average premiums.
- Increase enrollment.
- Stabilize the health insurance market.
- Stabilize premiums for individuals with preexisting conditions.
- Increase consumer choice.
For a state to change community rating provisions, its waiver also would need to create a mechanism, such as high-risk pools, to help those patients. Funding for these pools is provided for in the AHCA, but has been criticized as being inadequate on a national level.
Mr. Cannon of the Cato Institute predicted that such waivers ultimately would lead to more adverse selections for people needing comprehensive coverage and could force more people to lose coverage than to gain access to affordable, high-quality plans.
“If you waive essential health benefits in a community-rated market, you get even more adverse selection against comprehensive plans that sick people want, so those plans disappear,” Mr. Cannon said. “They either disappear because the insurers stop offering them or they disappear because insurers try to make the coverage worse, because Obamacare penalizes them if they don’t make coverage worse.”
He said these waivers provide little incentive for health insurers to stay in the individual markets and they could, as they are already, flee the individual markets.
The AHCA is phase 1 of the GOP repeal and replace plan. Congressional Republicans want to use the budget reconciliation process for the AHCA, so that they need only a simple majority to change revenue-generating provisions of the ACA. Phase 2 is a comprehensive review of all federal health care regulations and phase 3 is slated to be new legislation to replace the ACA with a new health care reform plan, which will require a two-thirds majority in the Senate to pass.
What drives readmissions within 90 days after MI hospitalization
WASHINGTON – In a large population of Medicare patients hospitalized for acute MI, four factors stood out as predictors of increased likelihood of readmission within 90 days, Aaron D. Kugelmass, MD, reported at the annual meeting of the American College of Cardiology.
These four predictors of 90-day readmission were end-stage renal disease at the time of the initial admission for MI, which in a logistic regression model was independently associated with an 88% relative increase in readmission risk; no percutaneous coronary intervention (PCI) during the index hospitalization, which carried a 64% increase in risk; type 1 diabetes, with a 57% increased readmission rate; and heart failure at the initial hospitalization, with an associated 34% greater risk, according to Dr. Kugelmass, chief of cardiology and medical director of the heart and vascular center at Baystate Medical Center in Springfield, Mass.
“This is going to be a learning curve for everyone,” he said.
“The best way to deal with this change is to understand the factors driving costs and morbidity and mortality,” Dr. Kugelmass said, in explaining why he conducted a retrospective study of readmissions within 90 days in a population of 143,286 Medicare beneficiaries hospitalized for acute MI in 2014. The study focus was on readmissions because they add so much to total cost of care for a 90-day episode.
Twenty-eight percent of patients were readmitted at least once within 90 days of discharge following their acute MI. The Medicare bundled payment plan divides MI patients into two separate groups: those who undergo PCI during their initial hospitalization and those who receive medical management only. Thirty-one percent of the readmitted patients in Dr. Kugelmass’s study had undergone PCI during their index hospitalization, while the other 69% were managed medically.
Heart failure was the No. 1 reason for readmission within 90 days in patients who had PCI during the index hospitalization. It was the primary reason for 17.6% of readmissions. Next came recurrent angina or chest pain, which accounted for 6.6% of readmissions; chronic obstructive pulmonary disease or pneumonia, 6.3%; and GI bleeding with hemorrhage, which was the primary reason for 6.0% of readmissions. Together these four causes accounted for more than 36% of all readmissions in the PCI group.
“The GI bleeding data were really interesting,” the cardiologist said. “There’s a lot of talk now about reducing the duration of dual-antiplatelet therapy [DAPT] after PCI. This is an administrative data set that’s quite large, and it shows that GI bleeding in a post-PCI group early in the duration of DAPT is in fact a significant cause of readmission and poses significant hazard.”
Among patients who were medically managed during their index hospitalization, the top four reasons for readmission were heart failure, accounting for 20.6% of readmissions; cardiac surgery, 13.5%; sepsis, 7.8%; and chronic obstructive pulmonary disease/pneumonia, 6.3%. GI bleeding wasn’t a significant cause of readmission in this group.
“I think what we need to do next is dive deeper into the medically managed group. There is a cohort in there that’s incredibly sick and are likely to drive costs and be prone to readmission. And there’s another component of the medically managed group that had to be fairly healthy because they were able to undergo coronary artery bypass surgery within 90 days,” Dr. Kugelmass said.
He reported having no financial conflicts regarding his study.
WASHINGTON – In a large population of Medicare patients hospitalized for acute MI, four factors stood out as predictors of increased likelihood of readmission within 90 days, Aaron D. Kugelmass, MD, reported at the annual meeting of the American College of Cardiology.
These four predictors of 90-day readmission were end-stage renal disease at the time of the initial admission for MI, which in a logistic regression model was independently associated with an 88% relative increase in readmission risk; no percutaneous coronary intervention (PCI) during the index hospitalization, which carried a 64% increase in risk; type 1 diabetes, with a 57% increased readmission rate; and heart failure at the initial hospitalization, with an associated 34% greater risk, according to Dr. Kugelmass, chief of cardiology and medical director of the heart and vascular center at Baystate Medical Center in Springfield, Mass.
“This is going to be a learning curve for everyone,” he said.
“The best way to deal with this change is to understand the factors driving costs and morbidity and mortality,” Dr. Kugelmass said, in explaining why he conducted a retrospective study of readmissions within 90 days in a population of 143,286 Medicare beneficiaries hospitalized for acute MI in 2014. The study focus was on readmissions because they add so much to total cost of care for a 90-day episode.
Twenty-eight percent of patients were readmitted at least once within 90 days of discharge following their acute MI. The Medicare bundled payment plan divides MI patients into two separate groups: those who undergo PCI during their initial hospitalization and those who receive medical management only. Thirty-one percent of the readmitted patients in Dr. Kugelmass’s study had undergone PCI during their index hospitalization, while the other 69% were managed medically.
Heart failure was the No. 1 reason for readmission within 90 days in patients who had PCI during the index hospitalization. It was the primary reason for 17.6% of readmissions. Next came recurrent angina or chest pain, which accounted for 6.6% of readmissions; chronic obstructive pulmonary disease or pneumonia, 6.3%; and GI bleeding with hemorrhage, which was the primary reason for 6.0% of readmissions. Together these four causes accounted for more than 36% of all readmissions in the PCI group.
“The GI bleeding data were really interesting,” the cardiologist said. “There’s a lot of talk now about reducing the duration of dual-antiplatelet therapy [DAPT] after PCI. This is an administrative data set that’s quite large, and it shows that GI bleeding in a post-PCI group early in the duration of DAPT is in fact a significant cause of readmission and poses significant hazard.”
Among patients who were medically managed during their index hospitalization, the top four reasons for readmission were heart failure, accounting for 20.6% of readmissions; cardiac surgery, 13.5%; sepsis, 7.8%; and chronic obstructive pulmonary disease/pneumonia, 6.3%. GI bleeding wasn’t a significant cause of readmission in this group.
“I think what we need to do next is dive deeper into the medically managed group. There is a cohort in there that’s incredibly sick and are likely to drive costs and be prone to readmission. And there’s another component of the medically managed group that had to be fairly healthy because they were able to undergo coronary artery bypass surgery within 90 days,” Dr. Kugelmass said.
He reported having no financial conflicts regarding his study.
WASHINGTON – In a large population of Medicare patients hospitalized for acute MI, four factors stood out as predictors of increased likelihood of readmission within 90 days, Aaron D. Kugelmass, MD, reported at the annual meeting of the American College of Cardiology.
These four predictors of 90-day readmission were end-stage renal disease at the time of the initial admission for MI, which in a logistic regression model was independently associated with an 88% relative increase in readmission risk; no percutaneous coronary intervention (PCI) during the index hospitalization, which carried a 64% increase in risk; type 1 diabetes, with a 57% increased readmission rate; and heart failure at the initial hospitalization, with an associated 34% greater risk, according to Dr. Kugelmass, chief of cardiology and medical director of the heart and vascular center at Baystate Medical Center in Springfield, Mass.
“This is going to be a learning curve for everyone,” he said.
“The best way to deal with this change is to understand the factors driving costs and morbidity and mortality,” Dr. Kugelmass said, in explaining why he conducted a retrospective study of readmissions within 90 days in a population of 143,286 Medicare beneficiaries hospitalized for acute MI in 2014. The study focus was on readmissions because they add so much to total cost of care for a 90-day episode.
Twenty-eight percent of patients were readmitted at least once within 90 days of discharge following their acute MI. The Medicare bundled payment plan divides MI patients into two separate groups: those who undergo PCI during their initial hospitalization and those who receive medical management only. Thirty-one percent of the readmitted patients in Dr. Kugelmass’s study had undergone PCI during their index hospitalization, while the other 69% were managed medically.
Heart failure was the No. 1 reason for readmission within 90 days in patients who had PCI during the index hospitalization. It was the primary reason for 17.6% of readmissions. Next came recurrent angina or chest pain, which accounted for 6.6% of readmissions; chronic obstructive pulmonary disease or pneumonia, 6.3%; and GI bleeding with hemorrhage, which was the primary reason for 6.0% of readmissions. Together these four causes accounted for more than 36% of all readmissions in the PCI group.
“The GI bleeding data were really interesting,” the cardiologist said. “There’s a lot of talk now about reducing the duration of dual-antiplatelet therapy [DAPT] after PCI. This is an administrative data set that’s quite large, and it shows that GI bleeding in a post-PCI group early in the duration of DAPT is in fact a significant cause of readmission and poses significant hazard.”
Among patients who were medically managed during their index hospitalization, the top four reasons for readmission were heart failure, accounting for 20.6% of readmissions; cardiac surgery, 13.5%; sepsis, 7.8%; and chronic obstructive pulmonary disease/pneumonia, 6.3%. GI bleeding wasn’t a significant cause of readmission in this group.
“I think what we need to do next is dive deeper into the medically managed group. There is a cohort in there that’s incredibly sick and are likely to drive costs and be prone to readmission. And there’s another component of the medically managed group that had to be fairly healthy because they were able to undergo coronary artery bypass surgery within 90 days,” Dr. Kugelmass said.
He reported having no financial conflicts regarding his study.
Key clinical point:
Major finding: Twenty-eight percent of Medicare patients hospitalized for acute MI were readmitted within 90 days.
Data source: A retrospective study of readmissions within 90 days among more than 143,000 Medicare beneficiaries hospitalized for acute MI in 2014.
Disclosures: The study presenter reported having no financial conflicts.
CRT-D beneficial in mild HF with ejection fraction above 30%
WASHINGTON – Patients with mild heart failure symptoms, left bundle branch block, and a left ventricular ejection fraction of 31% to 44% who received cardiac resynchronization therapy with a built-in defibrillator experienced a significant reduction in all-cause mortality, compared with those randomized to an implantable cardioverter-defibrillator alone during 7 years of follow-up.
These results from a new MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy) long-term follow-up substudy “suggest that patients with a relatively preserved ejection fraction greater than 30% benefit from CRT-D [cardiac resynchronization therapy defibrillator] and could potentially be considered for this therapy,” said Katherine Vermilye, MD, at the annual meeting of the American College of Cardiology.
In a subsequent publication, the MADIT-CRT investigators reported that, with extension of follow-up to 7 years, CRT-D also provided a significant benefit in terms of all-cause mortality in addition to the reduced rate of heart failure events (N Engl J Med. 2014 May 1;370[18]:1694-701).
However, even though an LVEF of 30% or less was a requirement for participation in MADIT-CRT, it turned out that, when the initial screening echocardiograms were eventually analyzed in a central core laboratory, one-third of study participants actually had a baseline LVEF of 31% to 44%, with the majority of excessive values being in the 31%-35% range.
Dr. Vermilye, of the University of Rochester in New York, presented a post hoc analysis of long-term outcomes in the subgroup having a baseline LVEF greater than 30%. They totaled 450 of 1,224 MADIT-CRT participants with left bundle branch block. They were significantly older and more likely to be female than the 824 subjects with an LVEF of 30% or less. They also had a shorter QRS duration – an average of 160 ms, versus 165 ms in patients with an LVEF of 30% or lower – and a smaller baseline left ventricular end systolic volume of 151 mL, compared with 196 mL in patients with a lower LVEF.
In a multivariate Cox regression analysis adjusted for potential confounders, CRT-D in patients with a baseline LVEF greater than 30% was associated with a 54% reduction in the risk of all-cause mortality at 7 years of follow-up, compared with receipt of an ICD-only device and with a smaller yet significant 31% reduction in risk in those with an LVEF of 30% or less. Worsening heart failure events were reduced by 64% in patients with a baseline LVEF greater than 30% who received CRT-D, compared with ICD-only, and by 54% in those with a lower baseline LVEF.
The reduction in all-cause mortality seen with CRT-D was confined to patients who were high responders to CRT as defined echocardiographically by at least a 35% change in left ventricular end systolic volume 1 year post implantation. They had an 85% reduction in the risk of death during 7 years of follow-up with CRT-D if their baseline LVEF was greater than 30% and a 58% relative risk reduction if their LVEF was 30% or less.
In contrast, CRT-D brought a significantly reduced risk of heart failure events regardless of whether a patient was a low or high responder, although the magnitude of benefit was greater in the high responders. Among patients with a baseline LVEF greater than 30%, CRT-D low responders had a 52% reduction in risk of heart failure events, compared with ICD recipients, while CRT-D high responders had an 81% relative risk reduction. Similarly, in patients with a baseline LVEF of 30% or less, CRT-D low responders had 48% reduction in heart failure events and high responders had a 79% risk reduction, compared with the ICD-only group.
Because this is a post hoc analysis, these new MADIT-CRT findings require validation in future studies, Dr. Vermilye observed.
MADIT-CRT was supported by Boston Scientific. Dr.. Vermilye reported having no financial conflicts.
The authors demonstrate the benefit of cardiac resynchronization therapy in patients with a defibrillator. The reduction in mortality at 5 years was greater in high responders to CRT-D, although overall mortality was significantly reduced in all comers.
The authors demonstrate the benefit of cardiac resynchronization therapy in patients with a defibrillator. The reduction in mortality at 5 years was greater in high responders to CRT-D, although overall mortality was significantly reduced in all comers.
The authors demonstrate the benefit of cardiac resynchronization therapy in patients with a defibrillator. The reduction in mortality at 5 years was greater in high responders to CRT-D, although overall mortality was significantly reduced in all comers.
WASHINGTON – Patients with mild heart failure symptoms, left bundle branch block, and a left ventricular ejection fraction of 31% to 44% who received cardiac resynchronization therapy with a built-in defibrillator experienced a significant reduction in all-cause mortality, compared with those randomized to an implantable cardioverter-defibrillator alone during 7 years of follow-up.
These results from a new MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy) long-term follow-up substudy “suggest that patients with a relatively preserved ejection fraction greater than 30% benefit from CRT-D [cardiac resynchronization therapy defibrillator] and could potentially be considered for this therapy,” said Katherine Vermilye, MD, at the annual meeting of the American College of Cardiology.
In a subsequent publication, the MADIT-CRT investigators reported that, with extension of follow-up to 7 years, CRT-D also provided a significant benefit in terms of all-cause mortality in addition to the reduced rate of heart failure events (N Engl J Med. 2014 May 1;370[18]:1694-701).
However, even though an LVEF of 30% or less was a requirement for participation in MADIT-CRT, it turned out that, when the initial screening echocardiograms were eventually analyzed in a central core laboratory, one-third of study participants actually had a baseline LVEF of 31% to 44%, with the majority of excessive values being in the 31%-35% range.
Dr. Vermilye, of the University of Rochester in New York, presented a post hoc analysis of long-term outcomes in the subgroup having a baseline LVEF greater than 30%. They totaled 450 of 1,224 MADIT-CRT participants with left bundle branch block. They were significantly older and more likely to be female than the 824 subjects with an LVEF of 30% or less. They also had a shorter QRS duration – an average of 160 ms, versus 165 ms in patients with an LVEF of 30% or lower – and a smaller baseline left ventricular end systolic volume of 151 mL, compared with 196 mL in patients with a lower LVEF.
In a multivariate Cox regression analysis adjusted for potential confounders, CRT-D in patients with a baseline LVEF greater than 30% was associated with a 54% reduction in the risk of all-cause mortality at 7 years of follow-up, compared with receipt of an ICD-only device and with a smaller yet significant 31% reduction in risk in those with an LVEF of 30% or less. Worsening heart failure events were reduced by 64% in patients with a baseline LVEF greater than 30% who received CRT-D, compared with ICD-only, and by 54% in those with a lower baseline LVEF.
The reduction in all-cause mortality seen with CRT-D was confined to patients who were high responders to CRT as defined echocardiographically by at least a 35% change in left ventricular end systolic volume 1 year post implantation. They had an 85% reduction in the risk of death during 7 years of follow-up with CRT-D if their baseline LVEF was greater than 30% and a 58% relative risk reduction if their LVEF was 30% or less.
In contrast, CRT-D brought a significantly reduced risk of heart failure events regardless of whether a patient was a low or high responder, although the magnitude of benefit was greater in the high responders. Among patients with a baseline LVEF greater than 30%, CRT-D low responders had a 52% reduction in risk of heart failure events, compared with ICD recipients, while CRT-D high responders had an 81% relative risk reduction. Similarly, in patients with a baseline LVEF of 30% or less, CRT-D low responders had 48% reduction in heart failure events and high responders had a 79% risk reduction, compared with the ICD-only group.
Because this is a post hoc analysis, these new MADIT-CRT findings require validation in future studies, Dr. Vermilye observed.
MADIT-CRT was supported by Boston Scientific. Dr.. Vermilye reported having no financial conflicts.
WASHINGTON – Patients with mild heart failure symptoms, left bundle branch block, and a left ventricular ejection fraction of 31% to 44% who received cardiac resynchronization therapy with a built-in defibrillator experienced a significant reduction in all-cause mortality, compared with those randomized to an implantable cardioverter-defibrillator alone during 7 years of follow-up.
These results from a new MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy) long-term follow-up substudy “suggest that patients with a relatively preserved ejection fraction greater than 30% benefit from CRT-D [cardiac resynchronization therapy defibrillator] and could potentially be considered for this therapy,” said Katherine Vermilye, MD, at the annual meeting of the American College of Cardiology.
In a subsequent publication, the MADIT-CRT investigators reported that, with extension of follow-up to 7 years, CRT-D also provided a significant benefit in terms of all-cause mortality in addition to the reduced rate of heart failure events (N Engl J Med. 2014 May 1;370[18]:1694-701).
However, even though an LVEF of 30% or less was a requirement for participation in MADIT-CRT, it turned out that, when the initial screening echocardiograms were eventually analyzed in a central core laboratory, one-third of study participants actually had a baseline LVEF of 31% to 44%, with the majority of excessive values being in the 31%-35% range.
Dr. Vermilye, of the University of Rochester in New York, presented a post hoc analysis of long-term outcomes in the subgroup having a baseline LVEF greater than 30%. They totaled 450 of 1,224 MADIT-CRT participants with left bundle branch block. They were significantly older and more likely to be female than the 824 subjects with an LVEF of 30% or less. They also had a shorter QRS duration – an average of 160 ms, versus 165 ms in patients with an LVEF of 30% or lower – and a smaller baseline left ventricular end systolic volume of 151 mL, compared with 196 mL in patients with a lower LVEF.
In a multivariate Cox regression analysis adjusted for potential confounders, CRT-D in patients with a baseline LVEF greater than 30% was associated with a 54% reduction in the risk of all-cause mortality at 7 years of follow-up, compared with receipt of an ICD-only device and with a smaller yet significant 31% reduction in risk in those with an LVEF of 30% or less. Worsening heart failure events were reduced by 64% in patients with a baseline LVEF greater than 30% who received CRT-D, compared with ICD-only, and by 54% in those with a lower baseline LVEF.
The reduction in all-cause mortality seen with CRT-D was confined to patients who were high responders to CRT as defined echocardiographically by at least a 35% change in left ventricular end systolic volume 1 year post implantation. They had an 85% reduction in the risk of death during 7 years of follow-up with CRT-D if their baseline LVEF was greater than 30% and a 58% relative risk reduction if their LVEF was 30% or less.
In contrast, CRT-D brought a significantly reduced risk of heart failure events regardless of whether a patient was a low or high responder, although the magnitude of benefit was greater in the high responders. Among patients with a baseline LVEF greater than 30%, CRT-D low responders had a 52% reduction in risk of heart failure events, compared with ICD recipients, while CRT-D high responders had an 81% relative risk reduction. Similarly, in patients with a baseline LVEF of 30% or less, CRT-D low responders had 48% reduction in heart failure events and high responders had a 79% risk reduction, compared with the ICD-only group.
Because this is a post hoc analysis, these new MADIT-CRT findings require validation in future studies, Dr. Vermilye observed.
MADIT-CRT was supported by Boston Scientific. Dr.. Vermilye reported having no financial conflicts.
AT ACC 2017
Key clinical point:
Major finding: The risk of all-cause mortality was reduced by 54% with CRT-D as compared with an ICD alone in MADIT-CRT participants with a baseline LVEF greater than 30% and by 31% in those with an LVEF of 30% or lower.
Data source: An analysis of 7-year rates of all-cause mortality and worsening heart failure events in 1,224 MADIT-CRT participants with left bundle branch block, 450 of whom had a baseline LVEF greater than 30%.
Disclosures: The MADIT-CRT study was supported by Boston Scientific. The presenter reported having no financial conflicts.