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Senate health care proposal already facing uphill battle
Senate Republican leaders are facing pushback from almost every side on their Affordable Care Act repeal/replace proposal – so much so that the current plan is unlikely to gain enough support to pass.
“For a variety of reasons, we are not ready to vote for this bill, but we are open to negotiation and obtaining more information before it is brought to the floor,” Sen. Rand Paul (R-Ky.), Sen. Ted Cruz (R-Texas), Sen. Ron Johnson (R-Wis.), and Sen. Mike Lee (R-Utah) said in a joint statement issued June 22, the day the plan was published. “There are provisions in this draft that represent an improvement to our current health care system, but it does not appear this draft as written will accomplish the most important promise that we made to Americans to repeal Obamacare and lower their health care costs.”
Like the House-passed American Health Care Act (H.R. 1628), the proposed BCRA would reduce Medicaid spending and would address rising premiums in the individual health insurance marketplace; however, BCRA would take a slightly different path to the same destination.
Like the House bill, BCRA also targets funding for Planned Parenthood, although because of Senate procedural rules, it is a more indirect funding ban.
A key difference between BCRA and the House bill is how insurance premium support is calculated. The AHCA would base tax credits on age, providing a lesser benefit for older, but pre–Medicare-age adults. In contrast, BCRA would base tax credits on income while limiting eligibility to households at 350% of the federal poverty line. Further, credits would cover only 58% of the actuarial value of health insurance under BCRA.
The draft Senate plan would not allow states to request a waiver from the ACA’s so-called community waiver provisions – the portion of the law that requires health insurance premiums to be the same regardless of age or preexisting condition; the House-passed AHCA would allow those waivers.
Medicaid expansion would be rolled back under the Senate plan, but at a slower pace than the AHCA would require – by 2023 under BCRA vs. 2020 under AHCA.
The BCRA would establish a per capita funding mechanism for Medicaid going forward, which would base funding on historic Medicaid expenditures and uses an economic index to track inflation and adjust payments accordingly.
To address the needs of people with greater health care needs, the Senate proposal would provide $57 billion over the first 4 years, then another $57 billion over the next 8. The funds would be available for programs such as premium support or high-risk pools to help individuals who are expected to be high users of health care. States would be required to match funds starting in 2022.
Experts were quick to weigh in on the Senate plan.
The BCRA needs to do three things, according to Grace-Marie Turner, president of the Galen Institute: Provide a safety net for those covered through the ACA so that they do not lose coverage in the transition, modernize Medicaid, and give states more authority and options to reform their own health insurance markets.
“We have learned that the federal government is not able to regulate something as local as health insurance,” Ms. Turner said. “They cannot create policies and legislation that works for people in downtown Manhattan and rural Montana and southern New Mexico and the panhandle of Florida. There are too many different populations. The states need to do that, and this bill also would give the states more authority to begin to oversee their health insurance markets but with new funding to provide extra help for the people who have difficulty buying progress.”
She said it could be much better if the Senate did not use the reconciliation process, “but within the confines of that, both the House and Senate bills do the same thing.”
Ms. Turner also stressed that there are more reforms coming later, as the Senate and House address other portions of ACA repeal/replacement.
“I hope that [senators] would see moving this forward as beneficial so that then they can move additional pieces of legislation, hopefully, with 60 votes to go through the regular process, to have additional follow-up bills. This is not the end of the story. This is just rescuing us from Obamacare,” she said. “Then we need to go forward and think about what do we need to do to make our health sector work better in the future by putting doctors and patients, rather than government, in charge of choices.”
Doctors, however, did not agree.
“This bill significantly decreases patients’ ability to access high-quality health care, and affordable coverage for millions of Americans will be in jeopardy if the legislation is passed,” Boyd Buser, MD, a doctor of osteopathy and president of the American Osteopathic Association, said in a statement.
He noted that the Medicaid cuts will have a “devastating impact, especially in areas of our country hardest hit by the ongoing opioid epidemic. ... The Senate bill should have prioritized prevention and care coordination, two measures proven to reduce overall health costs by eliminating waste and addressing health problems at the most treatable stage. Decreasing the number of Americans with coverage as it intends does will not lower costs.”
A vote on the proposal could come as early as June 29 before the Senate breaks for the 4th of July recess.
Republican lawmakers and the Trump administration have vowed to address the ACA in other ways as well, by reviewing and possibly changing all relevant regulations, then using the regular legislative process, which would need 60 votes, to address issues that cannot be handled by the budget reconciliation process.
Senate Republican leaders are facing pushback from almost every side on their Affordable Care Act repeal/replace proposal – so much so that the current plan is unlikely to gain enough support to pass.
“For a variety of reasons, we are not ready to vote for this bill, but we are open to negotiation and obtaining more information before it is brought to the floor,” Sen. Rand Paul (R-Ky.), Sen. Ted Cruz (R-Texas), Sen. Ron Johnson (R-Wis.), and Sen. Mike Lee (R-Utah) said in a joint statement issued June 22, the day the plan was published. “There are provisions in this draft that represent an improvement to our current health care system, but it does not appear this draft as written will accomplish the most important promise that we made to Americans to repeal Obamacare and lower their health care costs.”
Like the House-passed American Health Care Act (H.R. 1628), the proposed BCRA would reduce Medicaid spending and would address rising premiums in the individual health insurance marketplace; however, BCRA would take a slightly different path to the same destination.
Like the House bill, BCRA also targets funding for Planned Parenthood, although because of Senate procedural rules, it is a more indirect funding ban.
A key difference between BCRA and the House bill is how insurance premium support is calculated. The AHCA would base tax credits on age, providing a lesser benefit for older, but pre–Medicare-age adults. In contrast, BCRA would base tax credits on income while limiting eligibility to households at 350% of the federal poverty line. Further, credits would cover only 58% of the actuarial value of health insurance under BCRA.
The draft Senate plan would not allow states to request a waiver from the ACA’s so-called community waiver provisions – the portion of the law that requires health insurance premiums to be the same regardless of age or preexisting condition; the House-passed AHCA would allow those waivers.
Medicaid expansion would be rolled back under the Senate plan, but at a slower pace than the AHCA would require – by 2023 under BCRA vs. 2020 under AHCA.
The BCRA would establish a per capita funding mechanism for Medicaid going forward, which would base funding on historic Medicaid expenditures and uses an economic index to track inflation and adjust payments accordingly.
To address the needs of people with greater health care needs, the Senate proposal would provide $57 billion over the first 4 years, then another $57 billion over the next 8. The funds would be available for programs such as premium support or high-risk pools to help individuals who are expected to be high users of health care. States would be required to match funds starting in 2022.
Experts were quick to weigh in on the Senate plan.
The BCRA needs to do three things, according to Grace-Marie Turner, president of the Galen Institute: Provide a safety net for those covered through the ACA so that they do not lose coverage in the transition, modernize Medicaid, and give states more authority and options to reform their own health insurance markets.
“We have learned that the federal government is not able to regulate something as local as health insurance,” Ms. Turner said. “They cannot create policies and legislation that works for people in downtown Manhattan and rural Montana and southern New Mexico and the panhandle of Florida. There are too many different populations. The states need to do that, and this bill also would give the states more authority to begin to oversee their health insurance markets but with new funding to provide extra help for the people who have difficulty buying progress.”
She said it could be much better if the Senate did not use the reconciliation process, “but within the confines of that, both the House and Senate bills do the same thing.”
Ms. Turner also stressed that there are more reforms coming later, as the Senate and House address other portions of ACA repeal/replacement.
“I hope that [senators] would see moving this forward as beneficial so that then they can move additional pieces of legislation, hopefully, with 60 votes to go through the regular process, to have additional follow-up bills. This is not the end of the story. This is just rescuing us from Obamacare,” she said. “Then we need to go forward and think about what do we need to do to make our health sector work better in the future by putting doctors and patients, rather than government, in charge of choices.”
Doctors, however, did not agree.
“This bill significantly decreases patients’ ability to access high-quality health care, and affordable coverage for millions of Americans will be in jeopardy if the legislation is passed,” Boyd Buser, MD, a doctor of osteopathy and president of the American Osteopathic Association, said in a statement.
He noted that the Medicaid cuts will have a “devastating impact, especially in areas of our country hardest hit by the ongoing opioid epidemic. ... The Senate bill should have prioritized prevention and care coordination, two measures proven to reduce overall health costs by eliminating waste and addressing health problems at the most treatable stage. Decreasing the number of Americans with coverage as it intends does will not lower costs.”
A vote on the proposal could come as early as June 29 before the Senate breaks for the 4th of July recess.
Republican lawmakers and the Trump administration have vowed to address the ACA in other ways as well, by reviewing and possibly changing all relevant regulations, then using the regular legislative process, which would need 60 votes, to address issues that cannot be handled by the budget reconciliation process.
Senate Republican leaders are facing pushback from almost every side on their Affordable Care Act repeal/replace proposal – so much so that the current plan is unlikely to gain enough support to pass.
“For a variety of reasons, we are not ready to vote for this bill, but we are open to negotiation and obtaining more information before it is brought to the floor,” Sen. Rand Paul (R-Ky.), Sen. Ted Cruz (R-Texas), Sen. Ron Johnson (R-Wis.), and Sen. Mike Lee (R-Utah) said in a joint statement issued June 22, the day the plan was published. “There are provisions in this draft that represent an improvement to our current health care system, but it does not appear this draft as written will accomplish the most important promise that we made to Americans to repeal Obamacare and lower their health care costs.”
Like the House-passed American Health Care Act (H.R. 1628), the proposed BCRA would reduce Medicaid spending and would address rising premiums in the individual health insurance marketplace; however, BCRA would take a slightly different path to the same destination.
Like the House bill, BCRA also targets funding for Planned Parenthood, although because of Senate procedural rules, it is a more indirect funding ban.
A key difference between BCRA and the House bill is how insurance premium support is calculated. The AHCA would base tax credits on age, providing a lesser benefit for older, but pre–Medicare-age adults. In contrast, BCRA would base tax credits on income while limiting eligibility to households at 350% of the federal poverty line. Further, credits would cover only 58% of the actuarial value of health insurance under BCRA.
The draft Senate plan would not allow states to request a waiver from the ACA’s so-called community waiver provisions – the portion of the law that requires health insurance premiums to be the same regardless of age or preexisting condition; the House-passed AHCA would allow those waivers.
Medicaid expansion would be rolled back under the Senate plan, but at a slower pace than the AHCA would require – by 2023 under BCRA vs. 2020 under AHCA.
The BCRA would establish a per capita funding mechanism for Medicaid going forward, which would base funding on historic Medicaid expenditures and uses an economic index to track inflation and adjust payments accordingly.
To address the needs of people with greater health care needs, the Senate proposal would provide $57 billion over the first 4 years, then another $57 billion over the next 8. The funds would be available for programs such as premium support or high-risk pools to help individuals who are expected to be high users of health care. States would be required to match funds starting in 2022.
Experts were quick to weigh in on the Senate plan.
The BCRA needs to do three things, according to Grace-Marie Turner, president of the Galen Institute: Provide a safety net for those covered through the ACA so that they do not lose coverage in the transition, modernize Medicaid, and give states more authority and options to reform their own health insurance markets.
“We have learned that the federal government is not able to regulate something as local as health insurance,” Ms. Turner said. “They cannot create policies and legislation that works for people in downtown Manhattan and rural Montana and southern New Mexico and the panhandle of Florida. There are too many different populations. The states need to do that, and this bill also would give the states more authority to begin to oversee their health insurance markets but with new funding to provide extra help for the people who have difficulty buying progress.”
She said it could be much better if the Senate did not use the reconciliation process, “but within the confines of that, both the House and Senate bills do the same thing.”
Ms. Turner also stressed that there are more reforms coming later, as the Senate and House address other portions of ACA repeal/replacement.
“I hope that [senators] would see moving this forward as beneficial so that then they can move additional pieces of legislation, hopefully, with 60 votes to go through the regular process, to have additional follow-up bills. This is not the end of the story. This is just rescuing us from Obamacare,” she said. “Then we need to go forward and think about what do we need to do to make our health sector work better in the future by putting doctors and patients, rather than government, in charge of choices.”
Doctors, however, did not agree.
“This bill significantly decreases patients’ ability to access high-quality health care, and affordable coverage for millions of Americans will be in jeopardy if the legislation is passed,” Boyd Buser, MD, a doctor of osteopathy and president of the American Osteopathic Association, said in a statement.
He noted that the Medicaid cuts will have a “devastating impact, especially in areas of our country hardest hit by the ongoing opioid epidemic. ... The Senate bill should have prioritized prevention and care coordination, two measures proven to reduce overall health costs by eliminating waste and addressing health problems at the most treatable stage. Decreasing the number of Americans with coverage as it intends does will not lower costs.”
A vote on the proposal could come as early as June 29 before the Senate breaks for the 4th of July recess.
Republican lawmakers and the Trump administration have vowed to address the ACA in other ways as well, by reviewing and possibly changing all relevant regulations, then using the regular legislative process, which would need 60 votes, to address issues that cannot be handled by the budget reconciliation process.
Surgeon volume tied to mitral valve surgery outcomes
CHICAGO – A total annual surgeon volume of fewer than 25 operations was associated with increased 1-year mortality and reoperation rates, according to a study presented at the 2017 American Association for Thoracic Surgery Centennial.
Improvements in repair rates, survival, and freedom from reoperation increased with increasing surgeon case volumes, Joanna Chikwe, MD, and her colleagues at the Icahn School of Medicine at Mount Sinai, New York, stated.
The researchers compared repair rates, long-term survival, and risk of postrepair reoperation in patients with degenerative disease according to total annual surgeon volume, which was defined as any mitral valve operation for any cause during the study period. The study was simultaneously published in the Journal of the American College of Cardiology (2017 May 16;69[19]:2397-406).
Mitral valve repair is the preferred treatment, compared with valve replacement, for the treatment of severe mitral valve regurgitation in patients who have degenerative valve disease with mitral valve prolapse, and both U.S. and European guidelines strongly recommend valve repair whenever possible, according to Dr. Chikwe and her colleagues.
But, “mitral valve replacement unfortunately remains relatively common in patients with degenerative valve disease,” they stated.
A total of 313 surgeons from 41 institutions met the study eligibility criteria, according to the researchers. They performed a median of 10 mitral valve operations per year (range, 1-230). The median annual institutional mitral valve volume was 59 mitral valve operations, ranging from a minimum of 6 to a maximum of 310 operations. Repair rates for primary mitral valve operations for any cause at all 41 institutions varied from 15% to 83%, and repair rates for degenerative mitral valve operations varied from 25% to 100%.
In the study cohort, surgeons with a total annual volume of less than 25 operations carried out 25% of procedures.
After multivariable adjustment, total annual surgeon volume was independently associated with the probability of mitral valve repair. The chance of repair increased significantly by 13% for every 10-case increment in total annual surgeon volume (P less than .001).
In addition, compared with patients operated on by surgeons with a total annual surgeon volume of 10 or fewer operations, patients operated on by surgeons with a total annual surgeon volume of greater than 50 operations were more than three times as likely to undergo mitral valve repair rather than replacement.
A total annual surgeon volume of less than 25 operations was associated with lower mitral valve repair rates and with increased 1-year mortality and mitral valve reoperation rates. Improvements in repair rates, survival, and freedom from reoperation increased with increasing surgeon case volumes.
After 1 year of repair or replacement, the actuarial survival of patients with degenerative mitral valve disease who were operated on by surgeons performing greater than 50 operations per year was 97.8%, compared with 94.1% for patients operated on by surgeons performing less than or equal to 10 operations a year.
Compared with replacement, mitral repair was significantly associated with better survival, but total annual surgeon volume still remained a significant independent predictor (P less than .001). In addition, for those patients who underwent mitral valve repair, total annual surgeon volume was a significant independent predictor of late death.
The results are important, the investigators noted, given that the median number of mitral valve operations performed annually by individual surgeons in the United States was five, according to an analysis of the Society of Thoracic Surgeons database – and that, in New York state, most surgeons actually performed less than one mitral operation per month.
There were significant differences seen in the patient characteristics across surgeons’ case volume groups. The prevalence of congestive heart failure was significantly higher in patients operated on by surgeons with lower volumes, and the proportion of patients undergoing urgent surgery was also significantly higher for lower-volume surgeons.
“This leads to a double jeopardy, where sicker patients are adversely affected by the lower repair rates and poorer outcomes seen with lower-volume surgeons, and it underscores the need to refer the highest-risk patients to high-volume surgeons,” said Dr. Chickwe and her colleagues.
However, “even among high-volume surgeons, there was an observed variability of degenerative disease repair rates, ranging from 19% to nearly 100%,” they added. “This finding reflects that surgeon volume is not the only factor for better outcomes, and it emphasizes the need for more transparency of surgeon-related factors and outcomes of degenerative mitral valve surgery for patients and referring cardiologists.
“Considering that there was an incremental improvement in survival and probability of repair with increasing volume over 25 operations, one could make the argument that a minimum volume target of 50, or even more, operations would be optimal,” the researchers noted. “Developing more very high-volume surgeons experienced in mitral valve repair would likely be particularly beneficial for patients with complex but repairable mitral valve disease, and for asymptomatic patients whose repair feasibility would optimally approach 100%.”
Dr. David Adams is the national coprincipal investigator of the Core Valve United States Pivotal Trial, supported by Medtronic. Dr. Chikwe received speaker honoraria from Edwards Lifesciences. The other coauthors had no disclosures to report.
CHICAGO – A total annual surgeon volume of fewer than 25 operations was associated with increased 1-year mortality and reoperation rates, according to a study presented at the 2017 American Association for Thoracic Surgery Centennial.
Improvements in repair rates, survival, and freedom from reoperation increased with increasing surgeon case volumes, Joanna Chikwe, MD, and her colleagues at the Icahn School of Medicine at Mount Sinai, New York, stated.
The researchers compared repair rates, long-term survival, and risk of postrepair reoperation in patients with degenerative disease according to total annual surgeon volume, which was defined as any mitral valve operation for any cause during the study period. The study was simultaneously published in the Journal of the American College of Cardiology (2017 May 16;69[19]:2397-406).
Mitral valve repair is the preferred treatment, compared with valve replacement, for the treatment of severe mitral valve regurgitation in patients who have degenerative valve disease with mitral valve prolapse, and both U.S. and European guidelines strongly recommend valve repair whenever possible, according to Dr. Chikwe and her colleagues.
But, “mitral valve replacement unfortunately remains relatively common in patients with degenerative valve disease,” they stated.
A total of 313 surgeons from 41 institutions met the study eligibility criteria, according to the researchers. They performed a median of 10 mitral valve operations per year (range, 1-230). The median annual institutional mitral valve volume was 59 mitral valve operations, ranging from a minimum of 6 to a maximum of 310 operations. Repair rates for primary mitral valve operations for any cause at all 41 institutions varied from 15% to 83%, and repair rates for degenerative mitral valve operations varied from 25% to 100%.
In the study cohort, surgeons with a total annual volume of less than 25 operations carried out 25% of procedures.
After multivariable adjustment, total annual surgeon volume was independently associated with the probability of mitral valve repair. The chance of repair increased significantly by 13% for every 10-case increment in total annual surgeon volume (P less than .001).
In addition, compared with patients operated on by surgeons with a total annual surgeon volume of 10 or fewer operations, patients operated on by surgeons with a total annual surgeon volume of greater than 50 operations were more than three times as likely to undergo mitral valve repair rather than replacement.
A total annual surgeon volume of less than 25 operations was associated with lower mitral valve repair rates and with increased 1-year mortality and mitral valve reoperation rates. Improvements in repair rates, survival, and freedom from reoperation increased with increasing surgeon case volumes.
After 1 year of repair or replacement, the actuarial survival of patients with degenerative mitral valve disease who were operated on by surgeons performing greater than 50 operations per year was 97.8%, compared with 94.1% for patients operated on by surgeons performing less than or equal to 10 operations a year.
Compared with replacement, mitral repair was significantly associated with better survival, but total annual surgeon volume still remained a significant independent predictor (P less than .001). In addition, for those patients who underwent mitral valve repair, total annual surgeon volume was a significant independent predictor of late death.
The results are important, the investigators noted, given that the median number of mitral valve operations performed annually by individual surgeons in the United States was five, according to an analysis of the Society of Thoracic Surgeons database – and that, in New York state, most surgeons actually performed less than one mitral operation per month.
There were significant differences seen in the patient characteristics across surgeons’ case volume groups. The prevalence of congestive heart failure was significantly higher in patients operated on by surgeons with lower volumes, and the proportion of patients undergoing urgent surgery was also significantly higher for lower-volume surgeons.
“This leads to a double jeopardy, where sicker patients are adversely affected by the lower repair rates and poorer outcomes seen with lower-volume surgeons, and it underscores the need to refer the highest-risk patients to high-volume surgeons,” said Dr. Chickwe and her colleagues.
However, “even among high-volume surgeons, there was an observed variability of degenerative disease repair rates, ranging from 19% to nearly 100%,” they added. “This finding reflects that surgeon volume is not the only factor for better outcomes, and it emphasizes the need for more transparency of surgeon-related factors and outcomes of degenerative mitral valve surgery for patients and referring cardiologists.
“Considering that there was an incremental improvement in survival and probability of repair with increasing volume over 25 operations, one could make the argument that a minimum volume target of 50, or even more, operations would be optimal,” the researchers noted. “Developing more very high-volume surgeons experienced in mitral valve repair would likely be particularly beneficial for patients with complex but repairable mitral valve disease, and for asymptomatic patients whose repair feasibility would optimally approach 100%.”
Dr. David Adams is the national coprincipal investigator of the Core Valve United States Pivotal Trial, supported by Medtronic. Dr. Chikwe received speaker honoraria from Edwards Lifesciences. The other coauthors had no disclosures to report.
CHICAGO – A total annual surgeon volume of fewer than 25 operations was associated with increased 1-year mortality and reoperation rates, according to a study presented at the 2017 American Association for Thoracic Surgery Centennial.
Improvements in repair rates, survival, and freedom from reoperation increased with increasing surgeon case volumes, Joanna Chikwe, MD, and her colleagues at the Icahn School of Medicine at Mount Sinai, New York, stated.
The researchers compared repair rates, long-term survival, and risk of postrepair reoperation in patients with degenerative disease according to total annual surgeon volume, which was defined as any mitral valve operation for any cause during the study period. The study was simultaneously published in the Journal of the American College of Cardiology (2017 May 16;69[19]:2397-406).
Mitral valve repair is the preferred treatment, compared with valve replacement, for the treatment of severe mitral valve regurgitation in patients who have degenerative valve disease with mitral valve prolapse, and both U.S. and European guidelines strongly recommend valve repair whenever possible, according to Dr. Chikwe and her colleagues.
But, “mitral valve replacement unfortunately remains relatively common in patients with degenerative valve disease,” they stated.
A total of 313 surgeons from 41 institutions met the study eligibility criteria, according to the researchers. They performed a median of 10 mitral valve operations per year (range, 1-230). The median annual institutional mitral valve volume was 59 mitral valve operations, ranging from a minimum of 6 to a maximum of 310 operations. Repair rates for primary mitral valve operations for any cause at all 41 institutions varied from 15% to 83%, and repair rates for degenerative mitral valve operations varied from 25% to 100%.
In the study cohort, surgeons with a total annual volume of less than 25 operations carried out 25% of procedures.
After multivariable adjustment, total annual surgeon volume was independently associated with the probability of mitral valve repair. The chance of repair increased significantly by 13% for every 10-case increment in total annual surgeon volume (P less than .001).
In addition, compared with patients operated on by surgeons with a total annual surgeon volume of 10 or fewer operations, patients operated on by surgeons with a total annual surgeon volume of greater than 50 operations were more than three times as likely to undergo mitral valve repair rather than replacement.
A total annual surgeon volume of less than 25 operations was associated with lower mitral valve repair rates and with increased 1-year mortality and mitral valve reoperation rates. Improvements in repair rates, survival, and freedom from reoperation increased with increasing surgeon case volumes.
After 1 year of repair or replacement, the actuarial survival of patients with degenerative mitral valve disease who were operated on by surgeons performing greater than 50 operations per year was 97.8%, compared with 94.1% for patients operated on by surgeons performing less than or equal to 10 operations a year.
Compared with replacement, mitral repair was significantly associated with better survival, but total annual surgeon volume still remained a significant independent predictor (P less than .001). In addition, for those patients who underwent mitral valve repair, total annual surgeon volume was a significant independent predictor of late death.
The results are important, the investigators noted, given that the median number of mitral valve operations performed annually by individual surgeons in the United States was five, according to an analysis of the Society of Thoracic Surgeons database – and that, in New York state, most surgeons actually performed less than one mitral operation per month.
There were significant differences seen in the patient characteristics across surgeons’ case volume groups. The prevalence of congestive heart failure was significantly higher in patients operated on by surgeons with lower volumes, and the proportion of patients undergoing urgent surgery was also significantly higher for lower-volume surgeons.
“This leads to a double jeopardy, where sicker patients are adversely affected by the lower repair rates and poorer outcomes seen with lower-volume surgeons, and it underscores the need to refer the highest-risk patients to high-volume surgeons,” said Dr. Chickwe and her colleagues.
However, “even among high-volume surgeons, there was an observed variability of degenerative disease repair rates, ranging from 19% to nearly 100%,” they added. “This finding reflects that surgeon volume is not the only factor for better outcomes, and it emphasizes the need for more transparency of surgeon-related factors and outcomes of degenerative mitral valve surgery for patients and referring cardiologists.
“Considering that there was an incremental improvement in survival and probability of repair with increasing volume over 25 operations, one could make the argument that a minimum volume target of 50, or even more, operations would be optimal,” the researchers noted. “Developing more very high-volume surgeons experienced in mitral valve repair would likely be particularly beneficial for patients with complex but repairable mitral valve disease, and for asymptomatic patients whose repair feasibility would optimally approach 100%.”
Dr. David Adams is the national coprincipal investigator of the Core Valve United States Pivotal Trial, supported by Medtronic. Dr. Chikwe received speaker honoraria from Edwards Lifesciences. The other coauthors had no disclosures to report.
FROM THE AATS ANNUAL MEETING AND THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Key clinical point:
Major finding: Mitral valve reoperation rates steadily decreased with increasing surgeon volume until 25 operations per year, coupled to an improved 1-year survival for every 10 additional operations more than that.
Data source: A mandatory New York state database containing 5,475 patients who underwent mitral valve repair between 2002 and 2013.
Disclosures: Dr. David Adams is the national coprincipal investigator of the Core Valve United States Pivotal Trial, supported by Medtronic. Dr. Joanna Chikwe received speaker honoraria from Edwards Lifesciences. The other coauthors had no disclosures to report.
CMS proposes exempting more practices from MACRA
The Centers for Medicare & Medicaid Services seeks to exempt more practices participating in Medicare’s Quality Payment Program, the value-based payment program created by Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).
Currently, physicians who receive $30,000 or less in Medicare Part B payments or have 100 or fewer Medicare patients are exempt from QPP but may choose to participate. The proposed rule for the second year of QPP (calendar year 2018) would raise the threshold to $90,000 or less in Part B payments or 200 or fewer Medicare patients. The proposed rule was released June 20.
Under QPP, physicians and practices that are not exempt will choose one of two tracks – the Merit-Based Incentive Payment System (MIPS), which will pay bonuses based on meeting certain quality thresholds, or the advanced alternative payment models (APMs), under which physicians will assume more risk in exchange for greater potential rewards for quality improvement.
“We’ve heard the concerns that too many quality programs, technology requirements, and measures get between the doctor and the patient,” CMS Administrator Seema Verma said in a statement. “That’s why we’re taking a hard look at reducing burdens. By proposing this rule, we aim to improve Medicare by helping doctors and clinicians concentrate on caring for their patients rather than filling out paperwork.”
The proposed rule also introduces the framework for the development of “virtual groups,” a mechanism by which small and solo practices who meet the eligibility requirements for participating in MIPS can pool their reporting into the program to make it easier to share in the bonuses for meeting quality thresholds.
The Centers for Medicare & Medicaid Services seeks to exempt more practices participating in Medicare’s Quality Payment Program, the value-based payment program created by Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).
Currently, physicians who receive $30,000 or less in Medicare Part B payments or have 100 or fewer Medicare patients are exempt from QPP but may choose to participate. The proposed rule for the second year of QPP (calendar year 2018) would raise the threshold to $90,000 or less in Part B payments or 200 or fewer Medicare patients. The proposed rule was released June 20.
Under QPP, physicians and practices that are not exempt will choose one of two tracks – the Merit-Based Incentive Payment System (MIPS), which will pay bonuses based on meeting certain quality thresholds, or the advanced alternative payment models (APMs), under which physicians will assume more risk in exchange for greater potential rewards for quality improvement.
“We’ve heard the concerns that too many quality programs, technology requirements, and measures get between the doctor and the patient,” CMS Administrator Seema Verma said in a statement. “That’s why we’re taking a hard look at reducing burdens. By proposing this rule, we aim to improve Medicare by helping doctors and clinicians concentrate on caring for their patients rather than filling out paperwork.”
The proposed rule also introduces the framework for the development of “virtual groups,” a mechanism by which small and solo practices who meet the eligibility requirements for participating in MIPS can pool their reporting into the program to make it easier to share in the bonuses for meeting quality thresholds.
The Centers for Medicare & Medicaid Services seeks to exempt more practices participating in Medicare’s Quality Payment Program, the value-based payment program created by Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).
Currently, physicians who receive $30,000 or less in Medicare Part B payments or have 100 or fewer Medicare patients are exempt from QPP but may choose to participate. The proposed rule for the second year of QPP (calendar year 2018) would raise the threshold to $90,000 or less in Part B payments or 200 or fewer Medicare patients. The proposed rule was released June 20.
Under QPP, physicians and practices that are not exempt will choose one of two tracks – the Merit-Based Incentive Payment System (MIPS), which will pay bonuses based on meeting certain quality thresholds, or the advanced alternative payment models (APMs), under which physicians will assume more risk in exchange for greater potential rewards for quality improvement.
“We’ve heard the concerns that too many quality programs, technology requirements, and measures get between the doctor and the patient,” CMS Administrator Seema Verma said in a statement. “That’s why we’re taking a hard look at reducing burdens. By proposing this rule, we aim to improve Medicare by helping doctors and clinicians concentrate on caring for their patients rather than filling out paperwork.”
The proposed rule also introduces the framework for the development of “virtual groups,” a mechanism by which small and solo practices who meet the eligibility requirements for participating in MIPS can pool their reporting into the program to make it easier to share in the bonuses for meeting quality thresholds.
FFR stumbles in revascularization deferral decisions for ACS
Paris – One-year outcomes were significantly worse in patients with acute coronary syndrome whose revascularization was deferred based upon the results of fractional flow reserve than with instantaneous wave-free ratio, in the largest-ever study of patients whose revascularization decision was guided by physiologic measurements obtained via a pressure guidewire.
“The hypothesis that some authors have put forth – that in an ACS the hyperemic response of the myocardium is blunted by the ACS, and that this will affect the FFR hyperemic index – is now strengthened,” Javier Escaned, MD, said in presenting the study results at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
The study was a pooled, patient-level meta-analysis of the 4,529 participants with angiographically determined intermediate-risk stenoses in the previously reported randomized DEFINE FLAIR (N Engl J Med. 2017 May 11;376[19]:1824-34) and iFR SWEDEHEART (N Engl J Med. 2017 May 11;376[19]:1813-23) studies. The primary endpoint was the composite of death, nonfatal MI, or unplanned coronary revascularization within 12 months. And while the analysis brought unwelcome news for proponents of FFR with regard to the subset of patients with ACS, such patients comprised only 17% of the total study population.
“I think that overall these results are very reassuring. The big finding is that we have dramatically improved the safety of deferral of revascularization using pressure guidewires. If you look at the MACE [major adverse cardiovascular event] rate in the deferred ACS group, it was about 6%, which is much less than the event rate at 1 year with deferral in patients with stable coronary disease in the pivotal DEFER trial [Circulation. 2001 Jun 19;103(24):2928-34], which was our former standard,” observed Dr. Escaned, an interventional cardiologist at San Carlos Hospital in Madrid and a DEFER coinvestigator.
He attributed these greatly improved outcomes of physiologically guided revascularization during the past 15 years to vastly improved stent technology and more effective optimal medical management.
Among the key findings of the combined analysis of DEFINE FLAIR and iFR SWEDEHEART:
• More patients were deferred from PCI when iFR was used for decision-making: 50%, compared with 45% in the FFR arm. Yet 1-year outcomes were as good in the deferred iFR group as in the FFR group overall, and better than with FFR in the deferred ACS patients.
• Event rates were significantly higher in deferred ACS patients overall than in deferred patients with stable coronary disease: 5.9% versus 3.6%. But the deferral tool made a difference: When iFR was utilized, the 1-year event rate was 5.4% in deferred ACS patients, not significantly different from the 3.8% rate in deferred patients with stable coronary disease. In contrast, the event rate in ACS patients with FFR-based deferral was 6.4%, significantly higher than the 3.4% rate in FFR-deferred patients with stable coronary disease.
Dr. Escaned noted that this finding is consistent with the cautionary results of several recent studies, including one, albeit tenfold smaller, in which ACS patients in whom revascularization was deferred based on FFR had a 25% rate of major adverse cardiovascular events at 3.4 years, compared with a 12% rate in patients with stable coronary disease (J Am Coll Cardiol. 2016 Sep 13;68[11]:1181-91).
Discussant Peter Jüni, MD, professor of medicine at the University of Toronto, said “the main results of your study show in a completely waterproof fashion that there is no signal of harm with the experimental strategy” of deferred revascularization based on physiologic measurements, at least in patients with stable ischemic coronary disease.
The results, however, also raise the question of whether physiology-based revascularization decision-making in ACS patients is the best strategy.
“Considering that the event rate in the deferred ACS group was nearly twice as high compared with stable patients, my question to you is: Should we ignore any functional testing in ACS patients and just say, ‘Let’s move forward with revascularization because this clinical presentation is a very good clinical characteristic for risk stratification?’ ”
Dr. Escaned rejected that option. He noted that both the European and U.S. guidelines now state that it’s inappropriate to base a revascularization decision solely on a coronary vessel’s angiographic appearance, because that has been shown to result in unnecessary treatment, which causes harm. Adoption of pressure guidewires to assist in revascularization decision making, whether by FFR or iFR, is still limited in interventional cardiology. The priority in the field now should be to encourage more widespread use of this technology, regardless of which method is selected, he argued.
“The biggest room in the world is the room for improvement,” the cardiologist mused.
“I think one of the real problems that’s impeding adoption of physiologic testing is that many physicians are still afraid of leaving a stenosis without treatment,” he continued. “It’s strange: If you perform angioplasty and it wasn’t indicated and there is a complication, physicians seem to have some type of peace of mind that they did their best and they were trying to help the patient. That’s why it’s so important to establish that deferring revascularization – not treating when it is not needed – is safe.”
The DEFINE FLAIR and iFR SWEDEHEART studies were funded by unrestricted grants from Philips Volcano. Dr. Escaned reported serving as a consultant to Abbott, AstraZeneca, Biosensors, Boston Scientific, Medtronic, OrbusNeich, and Philips Healthcare.
Paris – One-year outcomes were significantly worse in patients with acute coronary syndrome whose revascularization was deferred based upon the results of fractional flow reserve than with instantaneous wave-free ratio, in the largest-ever study of patients whose revascularization decision was guided by physiologic measurements obtained via a pressure guidewire.
“The hypothesis that some authors have put forth – that in an ACS the hyperemic response of the myocardium is blunted by the ACS, and that this will affect the FFR hyperemic index – is now strengthened,” Javier Escaned, MD, said in presenting the study results at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
The study was a pooled, patient-level meta-analysis of the 4,529 participants with angiographically determined intermediate-risk stenoses in the previously reported randomized DEFINE FLAIR (N Engl J Med. 2017 May 11;376[19]:1824-34) and iFR SWEDEHEART (N Engl J Med. 2017 May 11;376[19]:1813-23) studies. The primary endpoint was the composite of death, nonfatal MI, or unplanned coronary revascularization within 12 months. And while the analysis brought unwelcome news for proponents of FFR with regard to the subset of patients with ACS, such patients comprised only 17% of the total study population.
“I think that overall these results are very reassuring. The big finding is that we have dramatically improved the safety of deferral of revascularization using pressure guidewires. If you look at the MACE [major adverse cardiovascular event] rate in the deferred ACS group, it was about 6%, which is much less than the event rate at 1 year with deferral in patients with stable coronary disease in the pivotal DEFER trial [Circulation. 2001 Jun 19;103(24):2928-34], which was our former standard,” observed Dr. Escaned, an interventional cardiologist at San Carlos Hospital in Madrid and a DEFER coinvestigator.
He attributed these greatly improved outcomes of physiologically guided revascularization during the past 15 years to vastly improved stent technology and more effective optimal medical management.
Among the key findings of the combined analysis of DEFINE FLAIR and iFR SWEDEHEART:
• More patients were deferred from PCI when iFR was used for decision-making: 50%, compared with 45% in the FFR arm. Yet 1-year outcomes were as good in the deferred iFR group as in the FFR group overall, and better than with FFR in the deferred ACS patients.
• Event rates were significantly higher in deferred ACS patients overall than in deferred patients with stable coronary disease: 5.9% versus 3.6%. But the deferral tool made a difference: When iFR was utilized, the 1-year event rate was 5.4% in deferred ACS patients, not significantly different from the 3.8% rate in deferred patients with stable coronary disease. In contrast, the event rate in ACS patients with FFR-based deferral was 6.4%, significantly higher than the 3.4% rate in FFR-deferred patients with stable coronary disease.
Dr. Escaned noted that this finding is consistent with the cautionary results of several recent studies, including one, albeit tenfold smaller, in which ACS patients in whom revascularization was deferred based on FFR had a 25% rate of major adverse cardiovascular events at 3.4 years, compared with a 12% rate in patients with stable coronary disease (J Am Coll Cardiol. 2016 Sep 13;68[11]:1181-91).
Discussant Peter Jüni, MD, professor of medicine at the University of Toronto, said “the main results of your study show in a completely waterproof fashion that there is no signal of harm with the experimental strategy” of deferred revascularization based on physiologic measurements, at least in patients with stable ischemic coronary disease.
The results, however, also raise the question of whether physiology-based revascularization decision-making in ACS patients is the best strategy.
“Considering that the event rate in the deferred ACS group was nearly twice as high compared with stable patients, my question to you is: Should we ignore any functional testing in ACS patients and just say, ‘Let’s move forward with revascularization because this clinical presentation is a very good clinical characteristic for risk stratification?’ ”
Dr. Escaned rejected that option. He noted that both the European and U.S. guidelines now state that it’s inappropriate to base a revascularization decision solely on a coronary vessel’s angiographic appearance, because that has been shown to result in unnecessary treatment, which causes harm. Adoption of pressure guidewires to assist in revascularization decision making, whether by FFR or iFR, is still limited in interventional cardiology. The priority in the field now should be to encourage more widespread use of this technology, regardless of which method is selected, he argued.
“The biggest room in the world is the room for improvement,” the cardiologist mused.
“I think one of the real problems that’s impeding adoption of physiologic testing is that many physicians are still afraid of leaving a stenosis without treatment,” he continued. “It’s strange: If you perform angioplasty and it wasn’t indicated and there is a complication, physicians seem to have some type of peace of mind that they did their best and they were trying to help the patient. That’s why it’s so important to establish that deferring revascularization – not treating when it is not needed – is safe.”
The DEFINE FLAIR and iFR SWEDEHEART studies were funded by unrestricted grants from Philips Volcano. Dr. Escaned reported serving as a consultant to Abbott, AstraZeneca, Biosensors, Boston Scientific, Medtronic, OrbusNeich, and Philips Healthcare.
Paris – One-year outcomes were significantly worse in patients with acute coronary syndrome whose revascularization was deferred based upon the results of fractional flow reserve than with instantaneous wave-free ratio, in the largest-ever study of patients whose revascularization decision was guided by physiologic measurements obtained via a pressure guidewire.
“The hypothesis that some authors have put forth – that in an ACS the hyperemic response of the myocardium is blunted by the ACS, and that this will affect the FFR hyperemic index – is now strengthened,” Javier Escaned, MD, said in presenting the study results at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
The study was a pooled, patient-level meta-analysis of the 4,529 participants with angiographically determined intermediate-risk stenoses in the previously reported randomized DEFINE FLAIR (N Engl J Med. 2017 May 11;376[19]:1824-34) and iFR SWEDEHEART (N Engl J Med. 2017 May 11;376[19]:1813-23) studies. The primary endpoint was the composite of death, nonfatal MI, or unplanned coronary revascularization within 12 months. And while the analysis brought unwelcome news for proponents of FFR with regard to the subset of patients with ACS, such patients comprised only 17% of the total study population.
“I think that overall these results are very reassuring. The big finding is that we have dramatically improved the safety of deferral of revascularization using pressure guidewires. If you look at the MACE [major adverse cardiovascular event] rate in the deferred ACS group, it was about 6%, which is much less than the event rate at 1 year with deferral in patients with stable coronary disease in the pivotal DEFER trial [Circulation. 2001 Jun 19;103(24):2928-34], which was our former standard,” observed Dr. Escaned, an interventional cardiologist at San Carlos Hospital in Madrid and a DEFER coinvestigator.
He attributed these greatly improved outcomes of physiologically guided revascularization during the past 15 years to vastly improved stent technology and more effective optimal medical management.
Among the key findings of the combined analysis of DEFINE FLAIR and iFR SWEDEHEART:
• More patients were deferred from PCI when iFR was used for decision-making: 50%, compared with 45% in the FFR arm. Yet 1-year outcomes were as good in the deferred iFR group as in the FFR group overall, and better than with FFR in the deferred ACS patients.
• Event rates were significantly higher in deferred ACS patients overall than in deferred patients with stable coronary disease: 5.9% versus 3.6%. But the deferral tool made a difference: When iFR was utilized, the 1-year event rate was 5.4% in deferred ACS patients, not significantly different from the 3.8% rate in deferred patients with stable coronary disease. In contrast, the event rate in ACS patients with FFR-based deferral was 6.4%, significantly higher than the 3.4% rate in FFR-deferred patients with stable coronary disease.
Dr. Escaned noted that this finding is consistent with the cautionary results of several recent studies, including one, albeit tenfold smaller, in which ACS patients in whom revascularization was deferred based on FFR had a 25% rate of major adverse cardiovascular events at 3.4 years, compared with a 12% rate in patients with stable coronary disease (J Am Coll Cardiol. 2016 Sep 13;68[11]:1181-91).
Discussant Peter Jüni, MD, professor of medicine at the University of Toronto, said “the main results of your study show in a completely waterproof fashion that there is no signal of harm with the experimental strategy” of deferred revascularization based on physiologic measurements, at least in patients with stable ischemic coronary disease.
The results, however, also raise the question of whether physiology-based revascularization decision-making in ACS patients is the best strategy.
“Considering that the event rate in the deferred ACS group was nearly twice as high compared with stable patients, my question to you is: Should we ignore any functional testing in ACS patients and just say, ‘Let’s move forward with revascularization because this clinical presentation is a very good clinical characteristic for risk stratification?’ ”
Dr. Escaned rejected that option. He noted that both the European and U.S. guidelines now state that it’s inappropriate to base a revascularization decision solely on a coronary vessel’s angiographic appearance, because that has been shown to result in unnecessary treatment, which causes harm. Adoption of pressure guidewires to assist in revascularization decision making, whether by FFR or iFR, is still limited in interventional cardiology. The priority in the field now should be to encourage more widespread use of this technology, regardless of which method is selected, he argued.
“The biggest room in the world is the room for improvement,” the cardiologist mused.
“I think one of the real problems that’s impeding adoption of physiologic testing is that many physicians are still afraid of leaving a stenosis without treatment,” he continued. “It’s strange: If you perform angioplasty and it wasn’t indicated and there is a complication, physicians seem to have some type of peace of mind that they did their best and they were trying to help the patient. That’s why it’s so important to establish that deferring revascularization – not treating when it is not needed – is safe.”
The DEFINE FLAIR and iFR SWEDEHEART studies were funded by unrestricted grants from Philips Volcano. Dr. Escaned reported serving as a consultant to Abbott, AstraZeneca, Biosensors, Boston Scientific, Medtronic, OrbusNeich, and Philips Healthcare.
AT EUROPCR
Key clinical point:
Major finding: In patients with acute coronary syndrome, the 1-year adverse event rate in patients with FFR-based deferral was 6.4%, significantly higher than the 3.4% rate in patients with FFR-based deferral with stable coronary disease.
Data source: A pooled patient-level meta-analysis of the 4,529 participants with angiographically intermediate-risk stenoses in two previously reported randomized trials of physiologic assessment of lesions by fractional flow reserve or instantaneous wave-free ratio.
Disclosures: The DEFINE FLAIR and iFR SWEDEHEART studies were funded by unrestricted grants from Philips Volcano. The presenter reported serving as a consultant to Abbott, AstraZeneca, Biosensors, Boston Scientific, Medtronic, OrbusNeich, and Philips Healthcare.
Points/Counterpoint: Should surgeons operate on functional tricuspid regurgitation?
Yes, functional TR is worth repairing (David H. Adams, MD)
Functional tricuspid regurgitation is a common finding in patients undergoing degenerative mitral valve repair. Severe tricuspid regurgitation is unusual, and clearly there is little debate on the merits of concomitant tricuspid repair for these patients. Moderate tricuspid regurgitation is identified preoperatively in around 15% of patients undergoing degenerative mitral repair (J Thorac Cardiovasc Surg. 2011;142:608-13), and concomitant tricuspid repair in these patients is certainly supported by both the American and European guidelines (J Am Coll Cardiol. 2017. doi: 10.1016/j.jacc.2017.03.011; Eur Heart J. 2012;33:2451-96).
What experience and evidence has led us to a more aggressive approach? One of the most important influences on our early adoption of tricuspid repair at the time of mitral surgery was linked to observations that tricuspid regurgitation (TR) sometimes progressed after isolated mitral valve repair (MVR), with some patients developing moderate or worse insufficiency. Certainly, the impact of significant tricuspid regurgitation on the quality and length of patients’ lives and the challenges of reoperation for isolated tricuspid regurgitation are well known to all surgeons.
Consequently, the importance of treating significant annular dilatation, even without significant tricuspid regurgitation, is supported by the guidelines. Our own experience with an aggressive approach to functional tricuspid regurgitation (FTR) at the time of mitral surgery put an exclamation point on this (J Am Coll Cardiol. 2015;65:1931-8). We found that concomitant tricuspid repair in patients who were worse off before surgery with more TR and higher rates of atrial fibrillation and right-sided dysfunction, actually did better during 5 years of follow-up than the isolated mitral repair patients who started with completely normal tricuspid valve anatomy and ventricular function.
Benign neglect is always an option (J Thorac Cardiovasc Surg. 2017;154:125-6), but we agree with Roberto Dion, MD – despite our friends’ opinions in Toronto and Rochester – we would much prefer to have minimal TR and a normal sized tricuspid valve after MVR. Ask yourself: would you rather have no TR and a normal sized tricuspid valve after you undergo a mitral operation, or a very dilated annulus and perhaps moderate FTR? I am pretty sure I know the answer, but if you are not sure, read our paper.
Dr. Adams is cardiac surgeon-in-chief, Mount Sinai Health System, and Marie-Josée and Henry R. Kravis Professor and Chairman, department of cardiovascular surgery, Icahn School of Medicine at Mount Sinai and The Mount Sinai Hospital, and president-elect of the American Association for Thoracic Surgery. He disclosed he is the national co-principal investigator for the Medtronic NeoChord trial, and receives royalties from Medtronic and Edwards Lifesciences. The Icahn School of Medicine at Mount Sinai receives royalty payments from Edwards Lifesciences and Medtronic for intellectual property related to Dr. Adams’ involvement in the development of 2 mitral valve repair rings and 1 tricuspid valve repair ring.
No, a patient with FTR does not necessarily need repair (Tirone David, MD)
In our clinic, a patient who undergoes MVR and has FTR generally goes home without an annuloplasty. We now have 12 years or more of follow-up in these patients, and they do not develop TR if their MVR is competent. We have reported that preoperative TR in patients who had MVR is associated with mitral valve disease and often improves after the operation (J Thorac Cardiovasc Surg. 2017;154:110-22). New postoperative TR is uncommon.
Ninety percent of my mitral valve repair patients today have no symptoms. Of those patients, a small proportion have moderate TR.
Dr. David is a professor of surgery at Toronto General Hospital. He reported no financial relationships.
Yes, but repair of FTR requires caution (Gilles Dreyfus, MD)
The controversy surrounding the legitimacy of concomitant tricuspid annuloplasty for functional TR during MVR begs for a clinical trial, but before we can conduct a clinical trial, we must define the primary and secondary endpoints. We’ve seen recent prospective, randomized trials that have reported faulty conclusions because the primary endpoints were wrong.
We need a strong debate to agree on those endpoints. Mortality as an endpoint will probably take a very long time to arrive at.
We’re mixing up many different factors. We’re mixing up TR grading, and we know that grading is unreliable. We have all seen patients with full-fledged TR, and after we put them on Lasix (furosemide, Sanofi), 3 days later they have mild TR. So the same patient with no treatment becomes let’s say a “Dreyfus indication,” and then suddenly in 3 days the patient doesn’t need surgery. At any further stage of his life this patient can experience severe TR again; tricuspid annuloplasty will prevent that from happening.
Moderate TR according to the common definition does not exist. If you look at the reports in echocardiography and if you ask any cardiologist, everything between no TR and severe TR is considered moderate. We have proposed a new staging system for evaluating FTR that uses three factors: TR severity; annular dilatation; and extent of tethering, or mode of leaflet coaptation (J Am Coll Cardiol. 2015;65:2331-6).
Dr. Dreyfus is director of the medical and surgical team at the Cardiothoracic Centre of Monaco in Monte Carlo and professor of cardiothoracic surgery at Paris V University and the Imperial College of London. He disclosed receiving speaker fees from Edwards Lifesciences, LivaNova, and Medtronic.
No, few FTR patients at risk after MVR (Hartzell Schaff, MD)
Echocardiography can provide a great deal of information about when concomitant repair for TR is indicated during MVR. We’ve found that if the patient has no right-sided signs, has normal right atrial pressure, and has mild or mild/moderate TR at the time of repair to the journey mitral valve, the chance of him returning for a tricuspid valve procedure is near zero.
A few patients do return after MVR. They develop atrial fibrillation and may need a pacemaker, but we see very few patients return for tricuspid surgery.
It’s fair to say we cannot demonstrate any benefit of correcting functional mitral regurgitation. Why would we think there’s a benefit of correcting FTR? We can say we’re going to look at grade of TR down the road, or we could look at some other endpoint, but think about it this way: If we cannot prove that correcting functional mitral regurgitation is helpful, why is correcting FTR going to help?
Dr. Schaff is a cardiothoracic surgeon at Mayo Clinic Foundation, Rochester, Minn. He reported no financial relationships.
Yes, functional TR is worth repairing (David H. Adams, MD)
Functional tricuspid regurgitation is a common finding in patients undergoing degenerative mitral valve repair. Severe tricuspid regurgitation is unusual, and clearly there is little debate on the merits of concomitant tricuspid repair for these patients. Moderate tricuspid regurgitation is identified preoperatively in around 15% of patients undergoing degenerative mitral repair (J Thorac Cardiovasc Surg. 2011;142:608-13), and concomitant tricuspid repair in these patients is certainly supported by both the American and European guidelines (J Am Coll Cardiol. 2017. doi: 10.1016/j.jacc.2017.03.011; Eur Heart J. 2012;33:2451-96).
What experience and evidence has led us to a more aggressive approach? One of the most important influences on our early adoption of tricuspid repair at the time of mitral surgery was linked to observations that tricuspid regurgitation (TR) sometimes progressed after isolated mitral valve repair (MVR), with some patients developing moderate or worse insufficiency. Certainly, the impact of significant tricuspid regurgitation on the quality and length of patients’ lives and the challenges of reoperation for isolated tricuspid regurgitation are well known to all surgeons.
Consequently, the importance of treating significant annular dilatation, even without significant tricuspid regurgitation, is supported by the guidelines. Our own experience with an aggressive approach to functional tricuspid regurgitation (FTR) at the time of mitral surgery put an exclamation point on this (J Am Coll Cardiol. 2015;65:1931-8). We found that concomitant tricuspid repair in patients who were worse off before surgery with more TR and higher rates of atrial fibrillation and right-sided dysfunction, actually did better during 5 years of follow-up than the isolated mitral repair patients who started with completely normal tricuspid valve anatomy and ventricular function.
Benign neglect is always an option (J Thorac Cardiovasc Surg. 2017;154:125-6), but we agree with Roberto Dion, MD – despite our friends’ opinions in Toronto and Rochester – we would much prefer to have minimal TR and a normal sized tricuspid valve after MVR. Ask yourself: would you rather have no TR and a normal sized tricuspid valve after you undergo a mitral operation, or a very dilated annulus and perhaps moderate FTR? I am pretty sure I know the answer, but if you are not sure, read our paper.
Dr. Adams is cardiac surgeon-in-chief, Mount Sinai Health System, and Marie-Josée and Henry R. Kravis Professor and Chairman, department of cardiovascular surgery, Icahn School of Medicine at Mount Sinai and The Mount Sinai Hospital, and president-elect of the American Association for Thoracic Surgery. He disclosed he is the national co-principal investigator for the Medtronic NeoChord trial, and receives royalties from Medtronic and Edwards Lifesciences. The Icahn School of Medicine at Mount Sinai receives royalty payments from Edwards Lifesciences and Medtronic for intellectual property related to Dr. Adams’ involvement in the development of 2 mitral valve repair rings and 1 tricuspid valve repair ring.
No, a patient with FTR does not necessarily need repair (Tirone David, MD)
In our clinic, a patient who undergoes MVR and has FTR generally goes home without an annuloplasty. We now have 12 years or more of follow-up in these patients, and they do not develop TR if their MVR is competent. We have reported that preoperative TR in patients who had MVR is associated with mitral valve disease and often improves after the operation (J Thorac Cardiovasc Surg. 2017;154:110-22). New postoperative TR is uncommon.
Ninety percent of my mitral valve repair patients today have no symptoms. Of those patients, a small proportion have moderate TR.
Dr. David is a professor of surgery at Toronto General Hospital. He reported no financial relationships.
Yes, but repair of FTR requires caution (Gilles Dreyfus, MD)
The controversy surrounding the legitimacy of concomitant tricuspid annuloplasty for functional TR during MVR begs for a clinical trial, but before we can conduct a clinical trial, we must define the primary and secondary endpoints. We’ve seen recent prospective, randomized trials that have reported faulty conclusions because the primary endpoints were wrong.
We need a strong debate to agree on those endpoints. Mortality as an endpoint will probably take a very long time to arrive at.
We’re mixing up many different factors. We’re mixing up TR grading, and we know that grading is unreliable. We have all seen patients with full-fledged TR, and after we put them on Lasix (furosemide, Sanofi), 3 days later they have mild TR. So the same patient with no treatment becomes let’s say a “Dreyfus indication,” and then suddenly in 3 days the patient doesn’t need surgery. At any further stage of his life this patient can experience severe TR again; tricuspid annuloplasty will prevent that from happening.
Moderate TR according to the common definition does not exist. If you look at the reports in echocardiography and if you ask any cardiologist, everything between no TR and severe TR is considered moderate. We have proposed a new staging system for evaluating FTR that uses three factors: TR severity; annular dilatation; and extent of tethering, or mode of leaflet coaptation (J Am Coll Cardiol. 2015;65:2331-6).
Dr. Dreyfus is director of the medical and surgical team at the Cardiothoracic Centre of Monaco in Monte Carlo and professor of cardiothoracic surgery at Paris V University and the Imperial College of London. He disclosed receiving speaker fees from Edwards Lifesciences, LivaNova, and Medtronic.
No, few FTR patients at risk after MVR (Hartzell Schaff, MD)
Echocardiography can provide a great deal of information about when concomitant repair for TR is indicated during MVR. We’ve found that if the patient has no right-sided signs, has normal right atrial pressure, and has mild or mild/moderate TR at the time of repair to the journey mitral valve, the chance of him returning for a tricuspid valve procedure is near zero.
A few patients do return after MVR. They develop atrial fibrillation and may need a pacemaker, but we see very few patients return for tricuspid surgery.
It’s fair to say we cannot demonstrate any benefit of correcting functional mitral regurgitation. Why would we think there’s a benefit of correcting FTR? We can say we’re going to look at grade of TR down the road, or we could look at some other endpoint, but think about it this way: If we cannot prove that correcting functional mitral regurgitation is helpful, why is correcting FTR going to help?
Dr. Schaff is a cardiothoracic surgeon at Mayo Clinic Foundation, Rochester, Minn. He reported no financial relationships.
Yes, functional TR is worth repairing (David H. Adams, MD)
Functional tricuspid regurgitation is a common finding in patients undergoing degenerative mitral valve repair. Severe tricuspid regurgitation is unusual, and clearly there is little debate on the merits of concomitant tricuspid repair for these patients. Moderate tricuspid regurgitation is identified preoperatively in around 15% of patients undergoing degenerative mitral repair (J Thorac Cardiovasc Surg. 2011;142:608-13), and concomitant tricuspid repair in these patients is certainly supported by both the American and European guidelines (J Am Coll Cardiol. 2017. doi: 10.1016/j.jacc.2017.03.011; Eur Heart J. 2012;33:2451-96).
What experience and evidence has led us to a more aggressive approach? One of the most important influences on our early adoption of tricuspid repair at the time of mitral surgery was linked to observations that tricuspid regurgitation (TR) sometimes progressed after isolated mitral valve repair (MVR), with some patients developing moderate or worse insufficiency. Certainly, the impact of significant tricuspid regurgitation on the quality and length of patients’ lives and the challenges of reoperation for isolated tricuspid regurgitation are well known to all surgeons.
Consequently, the importance of treating significant annular dilatation, even without significant tricuspid regurgitation, is supported by the guidelines. Our own experience with an aggressive approach to functional tricuspid regurgitation (FTR) at the time of mitral surgery put an exclamation point on this (J Am Coll Cardiol. 2015;65:1931-8). We found that concomitant tricuspid repair in patients who were worse off before surgery with more TR and higher rates of atrial fibrillation and right-sided dysfunction, actually did better during 5 years of follow-up than the isolated mitral repair patients who started with completely normal tricuspid valve anatomy and ventricular function.
Benign neglect is always an option (J Thorac Cardiovasc Surg. 2017;154:125-6), but we agree with Roberto Dion, MD – despite our friends’ opinions in Toronto and Rochester – we would much prefer to have minimal TR and a normal sized tricuspid valve after MVR. Ask yourself: would you rather have no TR and a normal sized tricuspid valve after you undergo a mitral operation, or a very dilated annulus and perhaps moderate FTR? I am pretty sure I know the answer, but if you are not sure, read our paper.
Dr. Adams is cardiac surgeon-in-chief, Mount Sinai Health System, and Marie-Josée and Henry R. Kravis Professor and Chairman, department of cardiovascular surgery, Icahn School of Medicine at Mount Sinai and The Mount Sinai Hospital, and president-elect of the American Association for Thoracic Surgery. He disclosed he is the national co-principal investigator for the Medtronic NeoChord trial, and receives royalties from Medtronic and Edwards Lifesciences. The Icahn School of Medicine at Mount Sinai receives royalty payments from Edwards Lifesciences and Medtronic for intellectual property related to Dr. Adams’ involvement in the development of 2 mitral valve repair rings and 1 tricuspid valve repair ring.
No, a patient with FTR does not necessarily need repair (Tirone David, MD)
In our clinic, a patient who undergoes MVR and has FTR generally goes home without an annuloplasty. We now have 12 years or more of follow-up in these patients, and they do not develop TR if their MVR is competent. We have reported that preoperative TR in patients who had MVR is associated with mitral valve disease and often improves after the operation (J Thorac Cardiovasc Surg. 2017;154:110-22). New postoperative TR is uncommon.
Ninety percent of my mitral valve repair patients today have no symptoms. Of those patients, a small proportion have moderate TR.
Dr. David is a professor of surgery at Toronto General Hospital. He reported no financial relationships.
Yes, but repair of FTR requires caution (Gilles Dreyfus, MD)
The controversy surrounding the legitimacy of concomitant tricuspid annuloplasty for functional TR during MVR begs for a clinical trial, but before we can conduct a clinical trial, we must define the primary and secondary endpoints. We’ve seen recent prospective, randomized trials that have reported faulty conclusions because the primary endpoints were wrong.
We need a strong debate to agree on those endpoints. Mortality as an endpoint will probably take a very long time to arrive at.
We’re mixing up many different factors. We’re mixing up TR grading, and we know that grading is unreliable. We have all seen patients with full-fledged TR, and after we put them on Lasix (furosemide, Sanofi), 3 days later they have mild TR. So the same patient with no treatment becomes let’s say a “Dreyfus indication,” and then suddenly in 3 days the patient doesn’t need surgery. At any further stage of his life this patient can experience severe TR again; tricuspid annuloplasty will prevent that from happening.
Moderate TR according to the common definition does not exist. If you look at the reports in echocardiography and if you ask any cardiologist, everything between no TR and severe TR is considered moderate. We have proposed a new staging system for evaluating FTR that uses three factors: TR severity; annular dilatation; and extent of tethering, or mode of leaflet coaptation (J Am Coll Cardiol. 2015;65:2331-6).
Dr. Dreyfus is director of the medical and surgical team at the Cardiothoracic Centre of Monaco in Monte Carlo and professor of cardiothoracic surgery at Paris V University and the Imperial College of London. He disclosed receiving speaker fees from Edwards Lifesciences, LivaNova, and Medtronic.
No, few FTR patients at risk after MVR (Hartzell Schaff, MD)
Echocardiography can provide a great deal of information about when concomitant repair for TR is indicated during MVR. We’ve found that if the patient has no right-sided signs, has normal right atrial pressure, and has mild or mild/moderate TR at the time of repair to the journey mitral valve, the chance of him returning for a tricuspid valve procedure is near zero.
A few patients do return after MVR. They develop atrial fibrillation and may need a pacemaker, but we see very few patients return for tricuspid surgery.
It’s fair to say we cannot demonstrate any benefit of correcting functional mitral regurgitation. Why would we think there’s a benefit of correcting FTR? We can say we’re going to look at grade of TR down the road, or we could look at some other endpoint, but think about it this way: If we cannot prove that correcting functional mitral regurgitation is helpful, why is correcting FTR going to help?
Dr. Schaff is a cardiothoracic surgeon at Mayo Clinic Foundation, Rochester, Minn. He reported no financial relationships.
AT THE AATS MITRAL CONCLAVE 2017
Survey: Most doctors would pick single payer over ACA, ACHA
CHICAGO – If given the option, the majority of physicians would scrap both the Affordable Care Act and the proposed American Health Care Act (AHCA) and opt for a single payer health care system, according to a survey of 1,059 doctors by the Chicago Medical Society (CMS).
When asked their preferred health care structure, 53% of physician said they would prefer a single payer health system, while 26% preferred the Affordable Care Act, and 13% said they would like to see the ACA repealed and replaced with the AHCA. Another 8% of doctors stated they would prefer repeal of the ACA but did not offer a replacement option.
The high percentage of physicians who favored a single payer system was surprising, said A. Jay Chauhan, DO, secretary and chair of public health for the Chicago Medical Society.
“That is a shift from past surveys,” Dr. Chauhan said during an interview at a conference held by the American Bar Association. “It certainly speaks to the frustration that physicians are [feeling] and how difficult it is to practice. I think they’re trying to reach out for other alternatives because the current manner in which we’re practicing doesn’t seem to fulfill our desires to better take care of patients.”
Respondents also choose a single payer system as their top preference when asked which health care system they believed would provide “the best care to the greatest number of people for a given amount of funding.”
A primary takeaway from the survey is that physicians want to see better access to health care for their patients and more affordable insurance coverage, said Katherine M. Tynus, MD, immediate past president of the Chicago Medical Society and president-elect of the Illinois State Medical Society.
“I think what the Affordable Care Act did was raise expectations as far as access to care and people being able to afford their health care,” Dr. Tynus said in an interview at the meeting. “Since that system seems to be failing, the expectation remains. Now, we need to find an alternative solution to achieve that.”
The online survey, released at the Physicians Legal Issues Conference held by the American Bar Association, was conducted between March 2017 and May 2017 and featured questions about health reform. Survey participants were physicians primarily based in the Chicago area or within Illinois and the majority practiced in an urban area. Respondents represented a variety of political affiliations and medical specialties. The majority said they identifying as independent (43%), and the most common specialty was general medicine (19%).
[email protected]
On Twitter @legal_med
CHICAGO – If given the option, the majority of physicians would scrap both the Affordable Care Act and the proposed American Health Care Act (AHCA) and opt for a single payer health care system, according to a survey of 1,059 doctors by the Chicago Medical Society (CMS).
When asked their preferred health care structure, 53% of physician said they would prefer a single payer health system, while 26% preferred the Affordable Care Act, and 13% said they would like to see the ACA repealed and replaced with the AHCA. Another 8% of doctors stated they would prefer repeal of the ACA but did not offer a replacement option.
The high percentage of physicians who favored a single payer system was surprising, said A. Jay Chauhan, DO, secretary and chair of public health for the Chicago Medical Society.
“That is a shift from past surveys,” Dr. Chauhan said during an interview at a conference held by the American Bar Association. “It certainly speaks to the frustration that physicians are [feeling] and how difficult it is to practice. I think they’re trying to reach out for other alternatives because the current manner in which we’re practicing doesn’t seem to fulfill our desires to better take care of patients.”
Respondents also choose a single payer system as their top preference when asked which health care system they believed would provide “the best care to the greatest number of people for a given amount of funding.”
A primary takeaway from the survey is that physicians want to see better access to health care for their patients and more affordable insurance coverage, said Katherine M. Tynus, MD, immediate past president of the Chicago Medical Society and president-elect of the Illinois State Medical Society.
“I think what the Affordable Care Act did was raise expectations as far as access to care and people being able to afford their health care,” Dr. Tynus said in an interview at the meeting. “Since that system seems to be failing, the expectation remains. Now, we need to find an alternative solution to achieve that.”
The online survey, released at the Physicians Legal Issues Conference held by the American Bar Association, was conducted between March 2017 and May 2017 and featured questions about health reform. Survey participants were physicians primarily based in the Chicago area or within Illinois and the majority practiced in an urban area. Respondents represented a variety of political affiliations and medical specialties. The majority said they identifying as independent (43%), and the most common specialty was general medicine (19%).
[email protected]
On Twitter @legal_med
CHICAGO – If given the option, the majority of physicians would scrap both the Affordable Care Act and the proposed American Health Care Act (AHCA) and opt for a single payer health care system, according to a survey of 1,059 doctors by the Chicago Medical Society (CMS).
When asked their preferred health care structure, 53% of physician said they would prefer a single payer health system, while 26% preferred the Affordable Care Act, and 13% said they would like to see the ACA repealed and replaced with the AHCA. Another 8% of doctors stated they would prefer repeal of the ACA but did not offer a replacement option.
The high percentage of physicians who favored a single payer system was surprising, said A. Jay Chauhan, DO, secretary and chair of public health for the Chicago Medical Society.
“That is a shift from past surveys,” Dr. Chauhan said during an interview at a conference held by the American Bar Association. “It certainly speaks to the frustration that physicians are [feeling] and how difficult it is to practice. I think they’re trying to reach out for other alternatives because the current manner in which we’re practicing doesn’t seem to fulfill our desires to better take care of patients.”
Respondents also choose a single payer system as their top preference when asked which health care system they believed would provide “the best care to the greatest number of people for a given amount of funding.”
A primary takeaway from the survey is that physicians want to see better access to health care for their patients and more affordable insurance coverage, said Katherine M. Tynus, MD, immediate past president of the Chicago Medical Society and president-elect of the Illinois State Medical Society.
“I think what the Affordable Care Act did was raise expectations as far as access to care and people being able to afford their health care,” Dr. Tynus said in an interview at the meeting. “Since that system seems to be failing, the expectation remains. Now, we need to find an alternative solution to achieve that.”
The online survey, released at the Physicians Legal Issues Conference held by the American Bar Association, was conducted between March 2017 and May 2017 and featured questions about health reform. Survey participants were physicians primarily based in the Chicago area or within Illinois and the majority practiced in an urban area. Respondents represented a variety of political affiliations and medical specialties. The majority said they identifying as independent (43%), and the most common specialty was general medicine (19%).
[email protected]
On Twitter @legal_med
AT THE PHYSICIANS LEGAL ISSUES CONFERENCE
KHN Exclusive: White House task force echoes Pharma proposals
President Donald Trump repeatedly talks tough about reining in the pharmaceutical industry, but his administration’s efforts to lower drug prices are shrouded in secrecy.
Senior administrative officials met Friday to discuss an executive order on the cost of pharmaceuticals, a roundtable informed by Trump’s “Drug Pricing and Innovation Working Group.” Kaiser Health News examined documents that shed light on the workings of this working group.
The documents reveal behind-the-scenes discussions that are influenced by the pharmaceutical industry. Joe Grogan, associate director of health programs for the Office of Management and Budget (OMB), has led the group. Until March, Grogan served as a lobbyist for Gilead Sciences, the pharmaceutical company that priced its hepatitis C drugs at $1,000 per pill.
To solve the crisis of high drug prices, the group discussed strengthening the monopoly rights of pharmaceuticals overseas, ending discounts for low-income hospitals and accelerating drug approvals by the Food and Drug Administration. The White House declined to comment on the working group.
The group initially met May 4 in the Eisenhower Executive Office Building and has since met every two weeks. In addition to OMB, the working group includes officials from the White House National Economic Council, the Domestic Policy Council, Health and Human Services, the FDA, the Federal Trade Commission, the Department of Commerce, the Office of the U.S. Trade Representative and the Department of Justice.
According to the documents – the latest of which is dated June 1– the working group focused on the following “principles” and “talking points”:
1. Extending the patent life of drugs in foreign markets to “provide for protection and enforcement of intellectual property rights.” This will ensure “that American consumers do not unfairly subsidize research and development for people throughout the globe.” Extending monopoly protections for drugs overseas has been one of the pharmaceutical industry’s top priorities since the Trans-Pacific Partnership was defeated last year. That policy would push up global drug prices, according to Médecins Sans Frontières.
2. Promoting competition in the U.S. drug market – both by “modernizing our regulatory and reimbursement systems” and limiting “barrier to entry, including the cost of research and development,” according to the documents. The working group also discussed two broad policy ideas that have been championed by the pharmaceutical industry, according to sources familiar with the process:
3. Value-based pricing, under which pharmaceutical companies keep the list prices of drugs unchanged but offer rebates if patients don’t improve, is one option. It’s unclear who would audit the effectiveness of the drugs, what criteria they would use to evaluate them, and who would receive the rebates. Grogan invited Robert Shapiro – an adviser for Gilead and former secretary of Commerce under President Bill Clinton – to brief the working group on value-based pricing on May 18. Shapiro is the chairman and cofounder of Sonecon, a Washington, D.C., firm that consulted with Gilead, Amgen, and PhRMA, according to his curriculum vitae.
4. Grogan and Shapiro also discussed issuing 10-year U.S. Treasury bonds to drug manufacturers to pay for expensive hepatitis C drugs like Sovaldi and Harvoni under Medicare and Medicaid, to avoid rationing drugs to the sickest patients. The 2015 Senate investigation, for example, found that, though Medicaid spent more than $1 billion on Sovaldi, just 2.4% of Medicaid patients with hepatitis C were treated.
After the working group’s first meeting on May 4, Grogan distributed detailed policy recommendations on options for expediting generic drug approvals, creating a new tax credit “of up to 50%” for investments in generic drug manufacturing, distribution, and research and development. The documents also propose scaling back the 340B program, which requires drug manufacturers to provide some medicines at a discount to hospitals that treat low-income patients.
Most of these policies would not ease patient costs, and at least one would increase prices, said experts who reviewed the documents at the request of Kaiser Health News.
“This six-page document contains the kinds of solutions to the cost-of-drugs problem that you would get if you gathered together all the executives of pharma and asked them ‘What sort of token gestures can we do?’ ” said Vinay Prasad, MD, a professor of medicine at Oregon Health and Sciences University who studies the costs of cancer drugs.
The pharma-friendly recommendations appear to clash with earlier press reports indicating that OMB Director Mick Mulvaney was considering requiring drug makers to pay rebates to Medicare patients, a measure the pharmaceutical lobby fiercely opposes.
Brand-name drug prices – which account for 72% of drug spending – go untouched in the handouts, said Fiona Scott Morton, PhD, a Yale economics professor and former attorney with the Justice Department’s antitrust division.
“The changes to generic markets to promote competition look helpful, but there need to be some more ideas to create more competition for branded drugs or consumers aren’t really going to notice this,” Scott Morton said.
Some of the text in the document is cribbed directly from policy papers published by the pharmaceutical industry’s powerful lobby – Pharmaceutical Research and Manufacturers Association (PhRMA).
Under the subtitle, “Encourage Use of 21st Century Tools for Drug Evaluation, Review, and Approval,” one handout proposes the FDA use less rigorous clinical trial standards to speed drug approvals.
The handout cites a PhRMA paper from March 2016 that includes an identical subtitle, “Encourage Use of 21st Century Tools for Drug Evaluation, Review, and Approval” and recommends the FDA implement less rigorous clinical trial standards.
These recommendations would not lower drug prices, experts say. Such measures “would be like a firefighter spraying gasoline on your burning garage,” Prasad said.
Another section – which recommends giving the FDA more discretion to evaluate generic copies of complex drugs – closely resembles a National Law Review article written by two lobbyists in the pharmaceutical division of Foley & Lardner, whose clients include generic drug makers.
The handouts further recommend allowing drug makers to supply data and off-label information to insurers and pharmacy benefit managers during the clinical trial period, before they secure FDA approval.
That’s a “terrible idea,” said Jerry Avorn, MD, a professor at Harvard Medical School and the chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital. “That’s why we have the whole approval process, to determine what’s actually true,” he said.
KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation. Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
President Donald Trump repeatedly talks tough about reining in the pharmaceutical industry, but his administration’s efforts to lower drug prices are shrouded in secrecy.
Senior administrative officials met Friday to discuss an executive order on the cost of pharmaceuticals, a roundtable informed by Trump’s “Drug Pricing and Innovation Working Group.” Kaiser Health News examined documents that shed light on the workings of this working group.
The documents reveal behind-the-scenes discussions that are influenced by the pharmaceutical industry. Joe Grogan, associate director of health programs for the Office of Management and Budget (OMB), has led the group. Until March, Grogan served as a lobbyist for Gilead Sciences, the pharmaceutical company that priced its hepatitis C drugs at $1,000 per pill.
To solve the crisis of high drug prices, the group discussed strengthening the monopoly rights of pharmaceuticals overseas, ending discounts for low-income hospitals and accelerating drug approvals by the Food and Drug Administration. The White House declined to comment on the working group.
The group initially met May 4 in the Eisenhower Executive Office Building and has since met every two weeks. In addition to OMB, the working group includes officials from the White House National Economic Council, the Domestic Policy Council, Health and Human Services, the FDA, the Federal Trade Commission, the Department of Commerce, the Office of the U.S. Trade Representative and the Department of Justice.
According to the documents – the latest of which is dated June 1– the working group focused on the following “principles” and “talking points”:
1. Extending the patent life of drugs in foreign markets to “provide for protection and enforcement of intellectual property rights.” This will ensure “that American consumers do not unfairly subsidize research and development for people throughout the globe.” Extending monopoly protections for drugs overseas has been one of the pharmaceutical industry’s top priorities since the Trans-Pacific Partnership was defeated last year. That policy would push up global drug prices, according to Médecins Sans Frontières.
2. Promoting competition in the U.S. drug market – both by “modernizing our regulatory and reimbursement systems” and limiting “barrier to entry, including the cost of research and development,” according to the documents. The working group also discussed two broad policy ideas that have been championed by the pharmaceutical industry, according to sources familiar with the process:
3. Value-based pricing, under which pharmaceutical companies keep the list prices of drugs unchanged but offer rebates if patients don’t improve, is one option. It’s unclear who would audit the effectiveness of the drugs, what criteria they would use to evaluate them, and who would receive the rebates. Grogan invited Robert Shapiro – an adviser for Gilead and former secretary of Commerce under President Bill Clinton – to brief the working group on value-based pricing on May 18. Shapiro is the chairman and cofounder of Sonecon, a Washington, D.C., firm that consulted with Gilead, Amgen, and PhRMA, according to his curriculum vitae.
4. Grogan and Shapiro also discussed issuing 10-year U.S. Treasury bonds to drug manufacturers to pay for expensive hepatitis C drugs like Sovaldi and Harvoni under Medicare and Medicaid, to avoid rationing drugs to the sickest patients. The 2015 Senate investigation, for example, found that, though Medicaid spent more than $1 billion on Sovaldi, just 2.4% of Medicaid patients with hepatitis C were treated.
After the working group’s first meeting on May 4, Grogan distributed detailed policy recommendations on options for expediting generic drug approvals, creating a new tax credit “of up to 50%” for investments in generic drug manufacturing, distribution, and research and development. The documents also propose scaling back the 340B program, which requires drug manufacturers to provide some medicines at a discount to hospitals that treat low-income patients.
Most of these policies would not ease patient costs, and at least one would increase prices, said experts who reviewed the documents at the request of Kaiser Health News.
“This six-page document contains the kinds of solutions to the cost-of-drugs problem that you would get if you gathered together all the executives of pharma and asked them ‘What sort of token gestures can we do?’ ” said Vinay Prasad, MD, a professor of medicine at Oregon Health and Sciences University who studies the costs of cancer drugs.
The pharma-friendly recommendations appear to clash with earlier press reports indicating that OMB Director Mick Mulvaney was considering requiring drug makers to pay rebates to Medicare patients, a measure the pharmaceutical lobby fiercely opposes.
Brand-name drug prices – which account for 72% of drug spending – go untouched in the handouts, said Fiona Scott Morton, PhD, a Yale economics professor and former attorney with the Justice Department’s antitrust division.
“The changes to generic markets to promote competition look helpful, but there need to be some more ideas to create more competition for branded drugs or consumers aren’t really going to notice this,” Scott Morton said.
Some of the text in the document is cribbed directly from policy papers published by the pharmaceutical industry’s powerful lobby – Pharmaceutical Research and Manufacturers Association (PhRMA).
Under the subtitle, “Encourage Use of 21st Century Tools for Drug Evaluation, Review, and Approval,” one handout proposes the FDA use less rigorous clinical trial standards to speed drug approvals.
The handout cites a PhRMA paper from March 2016 that includes an identical subtitle, “Encourage Use of 21st Century Tools for Drug Evaluation, Review, and Approval” and recommends the FDA implement less rigorous clinical trial standards.
These recommendations would not lower drug prices, experts say. Such measures “would be like a firefighter spraying gasoline on your burning garage,” Prasad said.
Another section – which recommends giving the FDA more discretion to evaluate generic copies of complex drugs – closely resembles a National Law Review article written by two lobbyists in the pharmaceutical division of Foley & Lardner, whose clients include generic drug makers.
The handouts further recommend allowing drug makers to supply data and off-label information to insurers and pharmacy benefit managers during the clinical trial period, before they secure FDA approval.
That’s a “terrible idea,” said Jerry Avorn, MD, a professor at Harvard Medical School and the chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital. “That’s why we have the whole approval process, to determine what’s actually true,” he said.
KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation. Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
President Donald Trump repeatedly talks tough about reining in the pharmaceutical industry, but his administration’s efforts to lower drug prices are shrouded in secrecy.
Senior administrative officials met Friday to discuss an executive order on the cost of pharmaceuticals, a roundtable informed by Trump’s “Drug Pricing and Innovation Working Group.” Kaiser Health News examined documents that shed light on the workings of this working group.
The documents reveal behind-the-scenes discussions that are influenced by the pharmaceutical industry. Joe Grogan, associate director of health programs for the Office of Management and Budget (OMB), has led the group. Until March, Grogan served as a lobbyist for Gilead Sciences, the pharmaceutical company that priced its hepatitis C drugs at $1,000 per pill.
To solve the crisis of high drug prices, the group discussed strengthening the monopoly rights of pharmaceuticals overseas, ending discounts for low-income hospitals and accelerating drug approvals by the Food and Drug Administration. The White House declined to comment on the working group.
The group initially met May 4 in the Eisenhower Executive Office Building and has since met every two weeks. In addition to OMB, the working group includes officials from the White House National Economic Council, the Domestic Policy Council, Health and Human Services, the FDA, the Federal Trade Commission, the Department of Commerce, the Office of the U.S. Trade Representative and the Department of Justice.
According to the documents – the latest of which is dated June 1– the working group focused on the following “principles” and “talking points”:
1. Extending the patent life of drugs in foreign markets to “provide for protection and enforcement of intellectual property rights.” This will ensure “that American consumers do not unfairly subsidize research and development for people throughout the globe.” Extending monopoly protections for drugs overseas has been one of the pharmaceutical industry’s top priorities since the Trans-Pacific Partnership was defeated last year. That policy would push up global drug prices, according to Médecins Sans Frontières.
2. Promoting competition in the U.S. drug market – both by “modernizing our regulatory and reimbursement systems” and limiting “barrier to entry, including the cost of research and development,” according to the documents. The working group also discussed two broad policy ideas that have been championed by the pharmaceutical industry, according to sources familiar with the process:
3. Value-based pricing, under which pharmaceutical companies keep the list prices of drugs unchanged but offer rebates if patients don’t improve, is one option. It’s unclear who would audit the effectiveness of the drugs, what criteria they would use to evaluate them, and who would receive the rebates. Grogan invited Robert Shapiro – an adviser for Gilead and former secretary of Commerce under President Bill Clinton – to brief the working group on value-based pricing on May 18. Shapiro is the chairman and cofounder of Sonecon, a Washington, D.C., firm that consulted with Gilead, Amgen, and PhRMA, according to his curriculum vitae.
4. Grogan and Shapiro also discussed issuing 10-year U.S. Treasury bonds to drug manufacturers to pay for expensive hepatitis C drugs like Sovaldi and Harvoni under Medicare and Medicaid, to avoid rationing drugs to the sickest patients. The 2015 Senate investigation, for example, found that, though Medicaid spent more than $1 billion on Sovaldi, just 2.4% of Medicaid patients with hepatitis C were treated.
After the working group’s first meeting on May 4, Grogan distributed detailed policy recommendations on options for expediting generic drug approvals, creating a new tax credit “of up to 50%” for investments in generic drug manufacturing, distribution, and research and development. The documents also propose scaling back the 340B program, which requires drug manufacturers to provide some medicines at a discount to hospitals that treat low-income patients.
Most of these policies would not ease patient costs, and at least one would increase prices, said experts who reviewed the documents at the request of Kaiser Health News.
“This six-page document contains the kinds of solutions to the cost-of-drugs problem that you would get if you gathered together all the executives of pharma and asked them ‘What sort of token gestures can we do?’ ” said Vinay Prasad, MD, a professor of medicine at Oregon Health and Sciences University who studies the costs of cancer drugs.
The pharma-friendly recommendations appear to clash with earlier press reports indicating that OMB Director Mick Mulvaney was considering requiring drug makers to pay rebates to Medicare patients, a measure the pharmaceutical lobby fiercely opposes.
Brand-name drug prices – which account for 72% of drug spending – go untouched in the handouts, said Fiona Scott Morton, PhD, a Yale economics professor and former attorney with the Justice Department’s antitrust division.
“The changes to generic markets to promote competition look helpful, but there need to be some more ideas to create more competition for branded drugs or consumers aren’t really going to notice this,” Scott Morton said.
Some of the text in the document is cribbed directly from policy papers published by the pharmaceutical industry’s powerful lobby – Pharmaceutical Research and Manufacturers Association (PhRMA).
Under the subtitle, “Encourage Use of 21st Century Tools for Drug Evaluation, Review, and Approval,” one handout proposes the FDA use less rigorous clinical trial standards to speed drug approvals.
The handout cites a PhRMA paper from March 2016 that includes an identical subtitle, “Encourage Use of 21st Century Tools for Drug Evaluation, Review, and Approval” and recommends the FDA implement less rigorous clinical trial standards.
These recommendations would not lower drug prices, experts say. Such measures “would be like a firefighter spraying gasoline on your burning garage,” Prasad said.
Another section – which recommends giving the FDA more discretion to evaluate generic copies of complex drugs – closely resembles a National Law Review article written by two lobbyists in the pharmaceutical division of Foley & Lardner, whose clients include generic drug makers.
The handouts further recommend allowing drug makers to supply data and off-label information to insurers and pharmacy benefit managers during the clinical trial period, before they secure FDA approval.
That’s a “terrible idea,” said Jerry Avorn, MD, a professor at Harvard Medical School and the chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital. “That’s why we have the whole approval process, to determine what’s actually true,” he said.
KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation. Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
Ear to the door: Five things being weighed in secret health bill also weigh it down
Anyone following the debate over the “repeal and replace” of the Affordable Care Act knows that the 13 Republican senators writing the bill are meeting behind closed doors.
While Senate Majority Leader Mitch McConnell (R-Ky.) continues to push for a vote before the July 4 Senate recess, Washington’s favorite parlor game has become guessing what is, or will be, in the Senate bill.
Spoiler: No one knows what the final Senate bill will look like – not even those writing it.
“It’s an iterative process,” Senate Majority Whip John Cornyn (R-Texas) told Politico, adding that senators in the room are sending options to the Congressional Budget Office to try to figure out, in general, how much they would cost. Those conversations between senators and the CBO – common for lawmakers working on major, complex pieces of legislation – sometimes prompt members to press through and other times to change course.
Although specifics, to the extent there are any, have largely stayed secret, some of the policies under consideration have slipped out, and pressure points of the debate are fairly clear. Anything can happen, but here’s what we know so far:
1. Medicaid expansion
The Republicans are determined to roll back the expansion of Medicaid under the Affordable Care Act. The question is, How to do it? The ACA called for an expansion of the Medicaid program for those with low incomes to everyone who earns less than 133% of poverty (around $16,000 a year for an individual), with the federal government footing much of the bill. The Supreme Court ruled in 2012 that the expansion was optional for states, but 31 have done so, providing new coverage to an estimated 14 million people.
The Republican bill passed by the House on May 4 would phase out the federal funding for those made eligible by the ACA over 2 years, beginning in 2020. But, Republican moderates in the Senate want a much slower end to the additional federal aid. Several have suggested that they could accept a 7-year phaseout.
Keeping the federal expansion money flowing that long, however, would cut into the bill’s budget savings. That matters: In order to protect the Senate’s ability to pass the bill under budget rules that require only a simple majority rather than 60 votes, the bill’s savings must at least match those of the House version. Any extra money spent on Medicaid expansion would have to be cut elsewhere.
2. Medicaid caps
A related issue is whether and at what level to cap federal Medicaid spending. Medicaid currently covers more than 70 million low-income people. Medicaid covers half of all births and half of the nation’s bill for long-term care, including nursing home stays. Right now, the federal government matches whatever states spend at least 50-50 and provides more matching funds for less wealthy states.
The House bill would, for the first time, cap the amount the federal government provides to states for their Medicaid programs. The CBO estimated that the caps would put more of the financial burden for the program on states, which would respond by a combination of cutting payments to health care providers like doctors and hospitals, eliminating benefits for patients, and restricting eligibility.
The Medicaid cap may or may not be included in the Senate bill, depending on whom you ask. However, sources with direct knowledge of the negotiations say the real sticking point is not whether or not to impose a cap – they want to do that. The hurdles are how to be fair to states that get less federal money and how fast the caps should rise.
Again, if the Senate proposal is more generous than the House’s version, it will be harder to meet the bill’s required budget targets.
3. Restrictions on abortion coverage
The senators are actively considering two measures that would limit funding for abortions, though it is not clear if either would be allowed to remain in the bill according to the Senate’s rules. The Senate Parliamentarian, who must review the bill after the senators complete it but before it comes to the floor, will decide.
The House-passed bill would ban the use of federal tax credits to purchase private coverage that includes abortion as a benefit. This is a key demand for a large portion of the Republican base. However, the Senate version of the bill must abide by strict rules that limit its content to provisions that directly impact the federal budget. In the past, abortion language in budget bills has been ruled out of order.
4. Reading between the lines
A related issue is whether House language to temporarily bar Planned Parenthood from participating in the Medicaid program will be allowed in the Senate.
While the Parliamentarian allowed identical language defunding Planned Parenthood to remain in a similar budget bill in 2015, it was not clear at the time that Planned Parenthood would have been the only provider affected by the language. Planned Parenthood backers say they will argue to the Parliamentarian that the budget impact of the language is “merely incidental” to the policy aim and, therefore, should not be allowed in the Senate bill.
5. Insurance market reforms
Senators are also struggling with provisions of the House-passed bill that would allow states to waive certain insurance requirements in the Affordable Care Act, including those laying out “essential” benefits that policies must cover and those banning insurers from charging sicker people higher premiums. That language, as well as an amendment seeking to ensure more funding to help people with preexisting conditions, was instrumental in gaining enough votes for the bill to pass the House.
Eliminating insurance regulations imposed by the ACA is a top priority for conservatives. “Conservatives would like to clear the books of Obamacare’s most costly regulations and free the states to regulate their markets how they wish,” wrote Sen. Mike Lee (R-Utah), who is one of the 13 senators negotiating the details of the bill, in an op-ed in May.
However, budget experts suggest that none of the insurance market provisions is likely to clear the Parliamentarian hurdle as being primarily budget-related.
Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
Anyone following the debate over the “repeal and replace” of the Affordable Care Act knows that the 13 Republican senators writing the bill are meeting behind closed doors.
While Senate Majority Leader Mitch McConnell (R-Ky.) continues to push for a vote before the July 4 Senate recess, Washington’s favorite parlor game has become guessing what is, or will be, in the Senate bill.
Spoiler: No one knows what the final Senate bill will look like – not even those writing it.
“It’s an iterative process,” Senate Majority Whip John Cornyn (R-Texas) told Politico, adding that senators in the room are sending options to the Congressional Budget Office to try to figure out, in general, how much they would cost. Those conversations between senators and the CBO – common for lawmakers working on major, complex pieces of legislation – sometimes prompt members to press through and other times to change course.
Although specifics, to the extent there are any, have largely stayed secret, some of the policies under consideration have slipped out, and pressure points of the debate are fairly clear. Anything can happen, but here’s what we know so far:
1. Medicaid expansion
The Republicans are determined to roll back the expansion of Medicaid under the Affordable Care Act. The question is, How to do it? The ACA called for an expansion of the Medicaid program for those with low incomes to everyone who earns less than 133% of poverty (around $16,000 a year for an individual), with the federal government footing much of the bill. The Supreme Court ruled in 2012 that the expansion was optional for states, but 31 have done so, providing new coverage to an estimated 14 million people.
The Republican bill passed by the House on May 4 would phase out the federal funding for those made eligible by the ACA over 2 years, beginning in 2020. But, Republican moderates in the Senate want a much slower end to the additional federal aid. Several have suggested that they could accept a 7-year phaseout.
Keeping the federal expansion money flowing that long, however, would cut into the bill’s budget savings. That matters: In order to protect the Senate’s ability to pass the bill under budget rules that require only a simple majority rather than 60 votes, the bill’s savings must at least match those of the House version. Any extra money spent on Medicaid expansion would have to be cut elsewhere.
2. Medicaid caps
A related issue is whether and at what level to cap federal Medicaid spending. Medicaid currently covers more than 70 million low-income people. Medicaid covers half of all births and half of the nation’s bill for long-term care, including nursing home stays. Right now, the federal government matches whatever states spend at least 50-50 and provides more matching funds for less wealthy states.
The House bill would, for the first time, cap the amount the federal government provides to states for their Medicaid programs. The CBO estimated that the caps would put more of the financial burden for the program on states, which would respond by a combination of cutting payments to health care providers like doctors and hospitals, eliminating benefits for patients, and restricting eligibility.
The Medicaid cap may or may not be included in the Senate bill, depending on whom you ask. However, sources with direct knowledge of the negotiations say the real sticking point is not whether or not to impose a cap – they want to do that. The hurdles are how to be fair to states that get less federal money and how fast the caps should rise.
Again, if the Senate proposal is more generous than the House’s version, it will be harder to meet the bill’s required budget targets.
3. Restrictions on abortion coverage
The senators are actively considering two measures that would limit funding for abortions, though it is not clear if either would be allowed to remain in the bill according to the Senate’s rules. The Senate Parliamentarian, who must review the bill after the senators complete it but before it comes to the floor, will decide.
The House-passed bill would ban the use of federal tax credits to purchase private coverage that includes abortion as a benefit. This is a key demand for a large portion of the Republican base. However, the Senate version of the bill must abide by strict rules that limit its content to provisions that directly impact the federal budget. In the past, abortion language in budget bills has been ruled out of order.
4. Reading between the lines
A related issue is whether House language to temporarily bar Planned Parenthood from participating in the Medicaid program will be allowed in the Senate.
While the Parliamentarian allowed identical language defunding Planned Parenthood to remain in a similar budget bill in 2015, it was not clear at the time that Planned Parenthood would have been the only provider affected by the language. Planned Parenthood backers say they will argue to the Parliamentarian that the budget impact of the language is “merely incidental” to the policy aim and, therefore, should not be allowed in the Senate bill.
5. Insurance market reforms
Senators are also struggling with provisions of the House-passed bill that would allow states to waive certain insurance requirements in the Affordable Care Act, including those laying out “essential” benefits that policies must cover and those banning insurers from charging sicker people higher premiums. That language, as well as an amendment seeking to ensure more funding to help people with preexisting conditions, was instrumental in gaining enough votes for the bill to pass the House.
Eliminating insurance regulations imposed by the ACA is a top priority for conservatives. “Conservatives would like to clear the books of Obamacare’s most costly regulations and free the states to regulate their markets how they wish,” wrote Sen. Mike Lee (R-Utah), who is one of the 13 senators negotiating the details of the bill, in an op-ed in May.
However, budget experts suggest that none of the insurance market provisions is likely to clear the Parliamentarian hurdle as being primarily budget-related.
Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
Anyone following the debate over the “repeal and replace” of the Affordable Care Act knows that the 13 Republican senators writing the bill are meeting behind closed doors.
While Senate Majority Leader Mitch McConnell (R-Ky.) continues to push for a vote before the July 4 Senate recess, Washington’s favorite parlor game has become guessing what is, or will be, in the Senate bill.
Spoiler: No one knows what the final Senate bill will look like – not even those writing it.
“It’s an iterative process,” Senate Majority Whip John Cornyn (R-Texas) told Politico, adding that senators in the room are sending options to the Congressional Budget Office to try to figure out, in general, how much they would cost. Those conversations between senators and the CBO – common for lawmakers working on major, complex pieces of legislation – sometimes prompt members to press through and other times to change course.
Although specifics, to the extent there are any, have largely stayed secret, some of the policies under consideration have slipped out, and pressure points of the debate are fairly clear. Anything can happen, but here’s what we know so far:
1. Medicaid expansion
The Republicans are determined to roll back the expansion of Medicaid under the Affordable Care Act. The question is, How to do it? The ACA called for an expansion of the Medicaid program for those with low incomes to everyone who earns less than 133% of poverty (around $16,000 a year for an individual), with the federal government footing much of the bill. The Supreme Court ruled in 2012 that the expansion was optional for states, but 31 have done so, providing new coverage to an estimated 14 million people.
The Republican bill passed by the House on May 4 would phase out the federal funding for those made eligible by the ACA over 2 years, beginning in 2020. But, Republican moderates in the Senate want a much slower end to the additional federal aid. Several have suggested that they could accept a 7-year phaseout.
Keeping the federal expansion money flowing that long, however, would cut into the bill’s budget savings. That matters: In order to protect the Senate’s ability to pass the bill under budget rules that require only a simple majority rather than 60 votes, the bill’s savings must at least match those of the House version. Any extra money spent on Medicaid expansion would have to be cut elsewhere.
2. Medicaid caps
A related issue is whether and at what level to cap federal Medicaid spending. Medicaid currently covers more than 70 million low-income people. Medicaid covers half of all births and half of the nation’s bill for long-term care, including nursing home stays. Right now, the federal government matches whatever states spend at least 50-50 and provides more matching funds for less wealthy states.
The House bill would, for the first time, cap the amount the federal government provides to states for their Medicaid programs. The CBO estimated that the caps would put more of the financial burden for the program on states, which would respond by a combination of cutting payments to health care providers like doctors and hospitals, eliminating benefits for patients, and restricting eligibility.
The Medicaid cap may or may not be included in the Senate bill, depending on whom you ask. However, sources with direct knowledge of the negotiations say the real sticking point is not whether or not to impose a cap – they want to do that. The hurdles are how to be fair to states that get less federal money and how fast the caps should rise.
Again, if the Senate proposal is more generous than the House’s version, it will be harder to meet the bill’s required budget targets.
3. Restrictions on abortion coverage
The senators are actively considering two measures that would limit funding for abortions, though it is not clear if either would be allowed to remain in the bill according to the Senate’s rules. The Senate Parliamentarian, who must review the bill after the senators complete it but before it comes to the floor, will decide.
The House-passed bill would ban the use of federal tax credits to purchase private coverage that includes abortion as a benefit. This is a key demand for a large portion of the Republican base. However, the Senate version of the bill must abide by strict rules that limit its content to provisions that directly impact the federal budget. In the past, abortion language in budget bills has been ruled out of order.
4. Reading between the lines
A related issue is whether House language to temporarily bar Planned Parenthood from participating in the Medicaid program will be allowed in the Senate.
While the Parliamentarian allowed identical language defunding Planned Parenthood to remain in a similar budget bill in 2015, it was not clear at the time that Planned Parenthood would have been the only provider affected by the language. Planned Parenthood backers say they will argue to the Parliamentarian that the budget impact of the language is “merely incidental” to the policy aim and, therefore, should not be allowed in the Senate bill.
5. Insurance market reforms
Senators are also struggling with provisions of the House-passed bill that would allow states to waive certain insurance requirements in the Affordable Care Act, including those laying out “essential” benefits that policies must cover and those banning insurers from charging sicker people higher premiums. That language, as well as an amendment seeking to ensure more funding to help people with preexisting conditions, was instrumental in gaining enough votes for the bill to pass the House.
Eliminating insurance regulations imposed by the ACA is a top priority for conservatives. “Conservatives would like to clear the books of Obamacare’s most costly regulations and free the states to regulate their markets how they wish,” wrote Sen. Mike Lee (R-Utah), who is one of the 13 senators negotiating the details of the bill, in an op-ed in May.
However, budget experts suggest that none of the insurance market provisions is likely to clear the Parliamentarian hurdle as being primarily budget-related.
Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
Age, anticoagulation prime issues in choice of mechanical valves
NEW YORK – While bioprosthetic valves have become the predominant choice for cardiothoracic surgeons performing heart valve replacement, situations exist in which a mechanical valve may be a better choice. Young and middle-aged adults are the ideal candidates for mechanical valves, but achieving long-term success with mechanical valves also depends on a patient’s circumstances, according to an expert panel at the American Association for Thoracic Surgery Mitral Conclave 2017 here.
“I think we should put in more mechanical valves,” said panel chair Thoralf M. Sundt III, MD, of Massachusetts General Hospital, Boston and former AATS president. “I think mechanical valves have gotten a bad rap. If patients have a supportive, stable social structure and they can manage their anticoagulation, I don’t think there’s anything wrong with a mechanical valve. I think the pendulum has swung too far.”
Anelechi C. Anyanwu, MD, of Mount Sinai Health System, New York, acknowledged another patient factor that would enter his calculus for recommending a mechanical mitral valve. “We would consider a mechanical valve in the patient who is compliant [and] well informed and understands well the requirements and implications of long-term anticoagulation,” he said. In another scenario – “the patient who’s had multiple reoperations – we may consider a mechanical valve.” Particularly, the patient who has had a reoperation for a bioprosthetic valve resulting from early degeneration will merit consideration of a mechanical prosthesis, Dr. Anyanwu said.
Michael A. Borger, MD, of Columbia University Medical Center, New York, agreed that the younger patient who has had a series of operations is a good candidate for a mechanical mitral valve. “In addition, the mechanical valve does have some hemodynamic advantages over bioprosthetic valves,” Dr. Borger said. “If a surgeon implants a 25-mm tissue valve with a plan for the patient to undergo a series of valve-in-valve operations in the future, mitral stenosis will definitely become a factor at some point.”
Pedro J. del Nido, MD, a pediatric cardiac surgeon at Children’s Hospital, Boston, expanded on that point. “We very, very rarely use mechanical valves in young patients,” Dr. del Nido said. “In very young patients, the reoperation rates for mechanical or biological valves are not much different. We still have to reoperate on both sets of patients. But, the reoperation itself for a mechanical valve is more difficult, and there is the need for full anticoagulation.”
Instead, Dr. del Nido has used the bovine Melody valve (Medtronic) in the mitral position for these patients because it accommodates some growth. Typically, the only time Dr. del Nido considers a mechanical valve in these young patients is for an aortic valve replacement.
Another younger patient that may be a good candidate for a mechanical valve is the 25-year-old male with rheumatic mitral stenosis. “I would err on the side of the mechanical valve in this patient if I were to make a choice, but I would present the patient with informed data on the outcomes of both mechanical valve and bioprosthesis,” according to Dr. Anyanwu
For even younger patients, Dr. del Nido bases his valve choice on their activity level. “I have a lot of young teenagers, and my decision is entirely based on what their background is like – what their regular life is like,” he said. “If they have a support structure than can help them manage anticoagulation, absolutely the mechanical valve is probably the best thing.”
However, there are exceptions because the couching of the device can change over time. “Eventually that 12-year-old [or] that 15-year-old is going to decide he can still snowboard or ride a motorcycle, and that’s when he’s going to get into trouble,” Dr. del Nido said. “If a reoperation is not problematic, I would still say it’s a tossup between the mechanical and biological valve. I would still offer the possibility of a bioprosthesis knowing that they’ll be back in 6, 8, or 10 years.”
Bleeding risk is another factor that can influence valve choice, as mechanical valve recipients must stay on anticoagulation. “The bleeding complication rates are very low when patients are younger, in their 40s or 50s, but the bleeding rates increase exponentially with warfarin for patients in their 80s and 90s,” Dr. Borger said. “The older you are, the more difficult it is to manage anticoagulation. In addition, the ability to stop anticoagulants because of bleeding is different for the two types of prostheses. If a patient develops bleeding during anticoagulation for leaflet immobility after a tissue valve-in-valve procedure, the physician can simply stop the warfarin. But, if you have a mechanical mitral valve in place that’s not an option.”
That’s not necessarily a bad problem to have, Dr. Sundt said, quoting Steven Bolling, MD, of the University of Michigan. “If you’re 25 and you’ve had your valve replaced and you’re worried about bleeding at the age of 80, I call that a success.”
Dr. Borger disclosed he is a speaker for and consultant to Edwards Lifesciences, Medtronic, and CryoLife; a speaker for St. Jude; and a recipient of research support from NeoChord. Dr. Lange disclosed he is a consultant and speaker for Medtronic, St. Jude/Abbott, LivaNova and NeoChord and cofounder of HighLife. Dr. Anyanwu, Dr. del Nido, and Dr. Sundt reported no relevant financial relationships.
NEW YORK – While bioprosthetic valves have become the predominant choice for cardiothoracic surgeons performing heart valve replacement, situations exist in which a mechanical valve may be a better choice. Young and middle-aged adults are the ideal candidates for mechanical valves, but achieving long-term success with mechanical valves also depends on a patient’s circumstances, according to an expert panel at the American Association for Thoracic Surgery Mitral Conclave 2017 here.
“I think we should put in more mechanical valves,” said panel chair Thoralf M. Sundt III, MD, of Massachusetts General Hospital, Boston and former AATS president. “I think mechanical valves have gotten a bad rap. If patients have a supportive, stable social structure and they can manage their anticoagulation, I don’t think there’s anything wrong with a mechanical valve. I think the pendulum has swung too far.”
Anelechi C. Anyanwu, MD, of Mount Sinai Health System, New York, acknowledged another patient factor that would enter his calculus for recommending a mechanical mitral valve. “We would consider a mechanical valve in the patient who is compliant [and] well informed and understands well the requirements and implications of long-term anticoagulation,” he said. In another scenario – “the patient who’s had multiple reoperations – we may consider a mechanical valve.” Particularly, the patient who has had a reoperation for a bioprosthetic valve resulting from early degeneration will merit consideration of a mechanical prosthesis, Dr. Anyanwu said.
Michael A. Borger, MD, of Columbia University Medical Center, New York, agreed that the younger patient who has had a series of operations is a good candidate for a mechanical mitral valve. “In addition, the mechanical valve does have some hemodynamic advantages over bioprosthetic valves,” Dr. Borger said. “If a surgeon implants a 25-mm tissue valve with a plan for the patient to undergo a series of valve-in-valve operations in the future, mitral stenosis will definitely become a factor at some point.”
Pedro J. del Nido, MD, a pediatric cardiac surgeon at Children’s Hospital, Boston, expanded on that point. “We very, very rarely use mechanical valves in young patients,” Dr. del Nido said. “In very young patients, the reoperation rates for mechanical or biological valves are not much different. We still have to reoperate on both sets of patients. But, the reoperation itself for a mechanical valve is more difficult, and there is the need for full anticoagulation.”
Instead, Dr. del Nido has used the bovine Melody valve (Medtronic) in the mitral position for these patients because it accommodates some growth. Typically, the only time Dr. del Nido considers a mechanical valve in these young patients is for an aortic valve replacement.
Another younger patient that may be a good candidate for a mechanical valve is the 25-year-old male with rheumatic mitral stenosis. “I would err on the side of the mechanical valve in this patient if I were to make a choice, but I would present the patient with informed data on the outcomes of both mechanical valve and bioprosthesis,” according to Dr. Anyanwu
For even younger patients, Dr. del Nido bases his valve choice on their activity level. “I have a lot of young teenagers, and my decision is entirely based on what their background is like – what their regular life is like,” he said. “If they have a support structure than can help them manage anticoagulation, absolutely the mechanical valve is probably the best thing.”
However, there are exceptions because the couching of the device can change over time. “Eventually that 12-year-old [or] that 15-year-old is going to decide he can still snowboard or ride a motorcycle, and that’s when he’s going to get into trouble,” Dr. del Nido said. “If a reoperation is not problematic, I would still say it’s a tossup between the mechanical and biological valve. I would still offer the possibility of a bioprosthesis knowing that they’ll be back in 6, 8, or 10 years.”
Bleeding risk is another factor that can influence valve choice, as mechanical valve recipients must stay on anticoagulation. “The bleeding complication rates are very low when patients are younger, in their 40s or 50s, but the bleeding rates increase exponentially with warfarin for patients in their 80s and 90s,” Dr. Borger said. “The older you are, the more difficult it is to manage anticoagulation. In addition, the ability to stop anticoagulants because of bleeding is different for the two types of prostheses. If a patient develops bleeding during anticoagulation for leaflet immobility after a tissue valve-in-valve procedure, the physician can simply stop the warfarin. But, if you have a mechanical mitral valve in place that’s not an option.”
That’s not necessarily a bad problem to have, Dr. Sundt said, quoting Steven Bolling, MD, of the University of Michigan. “If you’re 25 and you’ve had your valve replaced and you’re worried about bleeding at the age of 80, I call that a success.”
Dr. Borger disclosed he is a speaker for and consultant to Edwards Lifesciences, Medtronic, and CryoLife; a speaker for St. Jude; and a recipient of research support from NeoChord. Dr. Lange disclosed he is a consultant and speaker for Medtronic, St. Jude/Abbott, LivaNova and NeoChord and cofounder of HighLife. Dr. Anyanwu, Dr. del Nido, and Dr. Sundt reported no relevant financial relationships.
NEW YORK – While bioprosthetic valves have become the predominant choice for cardiothoracic surgeons performing heart valve replacement, situations exist in which a mechanical valve may be a better choice. Young and middle-aged adults are the ideal candidates for mechanical valves, but achieving long-term success with mechanical valves also depends on a patient’s circumstances, according to an expert panel at the American Association for Thoracic Surgery Mitral Conclave 2017 here.
“I think we should put in more mechanical valves,” said panel chair Thoralf M. Sundt III, MD, of Massachusetts General Hospital, Boston and former AATS president. “I think mechanical valves have gotten a bad rap. If patients have a supportive, stable social structure and they can manage their anticoagulation, I don’t think there’s anything wrong with a mechanical valve. I think the pendulum has swung too far.”
Anelechi C. Anyanwu, MD, of Mount Sinai Health System, New York, acknowledged another patient factor that would enter his calculus for recommending a mechanical mitral valve. “We would consider a mechanical valve in the patient who is compliant [and] well informed and understands well the requirements and implications of long-term anticoagulation,” he said. In another scenario – “the patient who’s had multiple reoperations – we may consider a mechanical valve.” Particularly, the patient who has had a reoperation for a bioprosthetic valve resulting from early degeneration will merit consideration of a mechanical prosthesis, Dr. Anyanwu said.
Michael A. Borger, MD, of Columbia University Medical Center, New York, agreed that the younger patient who has had a series of operations is a good candidate for a mechanical mitral valve. “In addition, the mechanical valve does have some hemodynamic advantages over bioprosthetic valves,” Dr. Borger said. “If a surgeon implants a 25-mm tissue valve with a plan for the patient to undergo a series of valve-in-valve operations in the future, mitral stenosis will definitely become a factor at some point.”
Pedro J. del Nido, MD, a pediatric cardiac surgeon at Children’s Hospital, Boston, expanded on that point. “We very, very rarely use mechanical valves in young patients,” Dr. del Nido said. “In very young patients, the reoperation rates for mechanical or biological valves are not much different. We still have to reoperate on both sets of patients. But, the reoperation itself for a mechanical valve is more difficult, and there is the need for full anticoagulation.”
Instead, Dr. del Nido has used the bovine Melody valve (Medtronic) in the mitral position for these patients because it accommodates some growth. Typically, the only time Dr. del Nido considers a mechanical valve in these young patients is for an aortic valve replacement.
Another younger patient that may be a good candidate for a mechanical valve is the 25-year-old male with rheumatic mitral stenosis. “I would err on the side of the mechanical valve in this patient if I were to make a choice, but I would present the patient with informed data on the outcomes of both mechanical valve and bioprosthesis,” according to Dr. Anyanwu
For even younger patients, Dr. del Nido bases his valve choice on their activity level. “I have a lot of young teenagers, and my decision is entirely based on what their background is like – what their regular life is like,” he said. “If they have a support structure than can help them manage anticoagulation, absolutely the mechanical valve is probably the best thing.”
However, there are exceptions because the couching of the device can change over time. “Eventually that 12-year-old [or] that 15-year-old is going to decide he can still snowboard or ride a motorcycle, and that’s when he’s going to get into trouble,” Dr. del Nido said. “If a reoperation is not problematic, I would still say it’s a tossup between the mechanical and biological valve. I would still offer the possibility of a bioprosthesis knowing that they’ll be back in 6, 8, or 10 years.”
Bleeding risk is another factor that can influence valve choice, as mechanical valve recipients must stay on anticoagulation. “The bleeding complication rates are very low when patients are younger, in their 40s or 50s, but the bleeding rates increase exponentially with warfarin for patients in their 80s and 90s,” Dr. Borger said. “The older you are, the more difficult it is to manage anticoagulation. In addition, the ability to stop anticoagulants because of bleeding is different for the two types of prostheses. If a patient develops bleeding during anticoagulation for leaflet immobility after a tissue valve-in-valve procedure, the physician can simply stop the warfarin. But, if you have a mechanical mitral valve in place that’s not an option.”
That’s not necessarily a bad problem to have, Dr. Sundt said, quoting Steven Bolling, MD, of the University of Michigan. “If you’re 25 and you’ve had your valve replaced and you’re worried about bleeding at the age of 80, I call that a success.”
Dr. Borger disclosed he is a speaker for and consultant to Edwards Lifesciences, Medtronic, and CryoLife; a speaker for St. Jude; and a recipient of research support from NeoChord. Dr. Lange disclosed he is a consultant and speaker for Medtronic, St. Jude/Abbott, LivaNova and NeoChord and cofounder of HighLife. Dr. Anyanwu, Dr. del Nido, and Dr. Sundt reported no relevant financial relationships.
EXPERT ANALYSIS FROM THE 2017 MITRAL VALVE CONCLAVE
Shift to minimally invasive MV surgery picks up
NEW YORK – An analysis of a Society of Thoracic Surgeons database has identified a significant increase in volumes for isolated mitral valve surgery and leaflet prolapse this decade, with a shift toward minimally invasive approaches, according to a study of trends in mitral valve surgery in the United States presented here at the American Association for Thoracic Surgery Mitral Conclave 2017.
James Gammie, MD, of the University of Maryland School of Medicine, Baltimore, reported on the analysis of the STS Adult Cardiac Surgery Database in which more than 90% of the adult cardiac surgery centers in North America participate.
“Degenerative disease remains the most common reason patients are referred for surgery,” Dr. Gammie said, noting that 60.7% of patients with an identified etiology had degenerative leaflet prolapse (etiology was unknown in 31% of the patients in the dataset).
“The operative approach has changed and continues to shift toward a less invasive approach,” Dr. Gammie said. Overall, 74.1% of operations involved sternotomy, but only 67.5% of those in the leaflet prolapse subgroup, with less invasive operations comprising 23% of all operations and 29.1% of those in the leaflet prolapse subgroup. From 2011 to 2016, total mitral surgical volume grew at a rate of 1.1% annually, but the volume for isolated MV operations grew 4.4% annually while leaflet prolapse procedures increased 7.6% annually, Dr. Gammie said.
Dr. Gammie described surgeons’ decision to perform ablation for preoperative AF during MV surgery a “coin toss.” One-third (34%) had AF, but only 51.2% of patients with AF in the total cohort and 54.4% of those in the leaflet prolapse subgroup got ablation. The overall MV repair rate was 65% for the total cohort but 83% for those with leaflet prolapse. For those who had MV replacement, the share of bioprosthetic devices increased steadily through the study period, from around 65% to 75.8%, Dr. Gammie said.
In the leaflet prolapse subgroup, 96.1% had annuloplasty and 29.2% had artificial chords implanted, with an average of two chords per operation. “There’s an increasing use of artificial ePTFE chords,” Dr. Gammie said. He noted the leaflet prolapse subgroup was composed of low-risk healthy patients. The mean ejection fraction (EF) for the cohort was 57%, and 47% of patients had EF of less than 60%. The overwhelming majority of patients (88%) had Class I indications for surgery with the remainder having Class IIa indications.
Dr. Gammie noted a few other emerging trends of MV surgery during the study period. “Patients with functional mitral regurgitation are rarely referred for operation: these patients made up fewer than 5% of patients undergoing mitral valve operations during the study period,” he said.;
With regard to outcomes, Dr. Gammie said, “There remain substantial differences between repair and replacement.” Replacement had almost twice the rate of reoperation for bleeding than repair (4.1% vs. 2.1%) and renal failure (3.4% vs. 1.4%).
“We observed that a substantial number of patients have an unsuccessful attempt at mitral valve repair before undergoing replacement – 16 % of the overall replacement group and 27% of patients having replacement for degenerative leaflet prolapse,” he said. “This does not appear to penalize patients in terms of outcome.”
The rate of permanent pacemaker was also significantly higher in the replacement cohort, 9.8% vs. 3.8% for repair operations, as was operative mortality, 3.7% vs. 1.1%. Said Dr. Gammie.
“This is something to think about as we move to less invasive approaches and overall operative mortality remains over threefold higher for replacement than repair.”
The leaflet prolapse subgroup showed similar disparities between replacement and repair groups. “The increased application of repair when feasible will be of value to improve outcomes, as will referral of patients earlier in the disease process ,” Dr. Gammie said.
“In our own STS database, about one-third of patients who were coded as having AF had no evidence of it, and that’s why in our institution they don’t get treated.” He added, “I’m not that surprised at the low repair rate when the average surgeon in the United States does five mitral repairs a year.”
Dr. Gammie disclosed that he is a consultant to Edwards Lifesciences and has an ownership interest in Harpoon Medical. Dr. Damiano disclosed that he is a speaker for LivaNova and a consultant to and a research grant recipient of Atricure.
NEW YORK – An analysis of a Society of Thoracic Surgeons database has identified a significant increase in volumes for isolated mitral valve surgery and leaflet prolapse this decade, with a shift toward minimally invasive approaches, according to a study of trends in mitral valve surgery in the United States presented here at the American Association for Thoracic Surgery Mitral Conclave 2017.
James Gammie, MD, of the University of Maryland School of Medicine, Baltimore, reported on the analysis of the STS Adult Cardiac Surgery Database in which more than 90% of the adult cardiac surgery centers in North America participate.
“Degenerative disease remains the most common reason patients are referred for surgery,” Dr. Gammie said, noting that 60.7% of patients with an identified etiology had degenerative leaflet prolapse (etiology was unknown in 31% of the patients in the dataset).
“The operative approach has changed and continues to shift toward a less invasive approach,” Dr. Gammie said. Overall, 74.1% of operations involved sternotomy, but only 67.5% of those in the leaflet prolapse subgroup, with less invasive operations comprising 23% of all operations and 29.1% of those in the leaflet prolapse subgroup. From 2011 to 2016, total mitral surgical volume grew at a rate of 1.1% annually, but the volume for isolated MV operations grew 4.4% annually while leaflet prolapse procedures increased 7.6% annually, Dr. Gammie said.
Dr. Gammie described surgeons’ decision to perform ablation for preoperative AF during MV surgery a “coin toss.” One-third (34%) had AF, but only 51.2% of patients with AF in the total cohort and 54.4% of those in the leaflet prolapse subgroup got ablation. The overall MV repair rate was 65% for the total cohort but 83% for those with leaflet prolapse. For those who had MV replacement, the share of bioprosthetic devices increased steadily through the study period, from around 65% to 75.8%, Dr. Gammie said.
In the leaflet prolapse subgroup, 96.1% had annuloplasty and 29.2% had artificial chords implanted, with an average of two chords per operation. “There’s an increasing use of artificial ePTFE chords,” Dr. Gammie said. He noted the leaflet prolapse subgroup was composed of low-risk healthy patients. The mean ejection fraction (EF) for the cohort was 57%, and 47% of patients had EF of less than 60%. The overwhelming majority of patients (88%) had Class I indications for surgery with the remainder having Class IIa indications.
Dr. Gammie noted a few other emerging trends of MV surgery during the study period. “Patients with functional mitral regurgitation are rarely referred for operation: these patients made up fewer than 5% of patients undergoing mitral valve operations during the study period,” he said.;
With regard to outcomes, Dr. Gammie said, “There remain substantial differences between repair and replacement.” Replacement had almost twice the rate of reoperation for bleeding than repair (4.1% vs. 2.1%) and renal failure (3.4% vs. 1.4%).
“We observed that a substantial number of patients have an unsuccessful attempt at mitral valve repair before undergoing replacement – 16 % of the overall replacement group and 27% of patients having replacement for degenerative leaflet prolapse,” he said. “This does not appear to penalize patients in terms of outcome.”
The rate of permanent pacemaker was also significantly higher in the replacement cohort, 9.8% vs. 3.8% for repair operations, as was operative mortality, 3.7% vs. 1.1%. Said Dr. Gammie.
“This is something to think about as we move to less invasive approaches and overall operative mortality remains over threefold higher for replacement than repair.”
The leaflet prolapse subgroup showed similar disparities between replacement and repair groups. “The increased application of repair when feasible will be of value to improve outcomes, as will referral of patients earlier in the disease process ,” Dr. Gammie said.
“In our own STS database, about one-third of patients who were coded as having AF had no evidence of it, and that’s why in our institution they don’t get treated.” He added, “I’m not that surprised at the low repair rate when the average surgeon in the United States does five mitral repairs a year.”
Dr. Gammie disclosed that he is a consultant to Edwards Lifesciences and has an ownership interest in Harpoon Medical. Dr. Damiano disclosed that he is a speaker for LivaNova and a consultant to and a research grant recipient of Atricure.
NEW YORK – An analysis of a Society of Thoracic Surgeons database has identified a significant increase in volumes for isolated mitral valve surgery and leaflet prolapse this decade, with a shift toward minimally invasive approaches, according to a study of trends in mitral valve surgery in the United States presented here at the American Association for Thoracic Surgery Mitral Conclave 2017.
James Gammie, MD, of the University of Maryland School of Medicine, Baltimore, reported on the analysis of the STS Adult Cardiac Surgery Database in which more than 90% of the adult cardiac surgery centers in North America participate.
“Degenerative disease remains the most common reason patients are referred for surgery,” Dr. Gammie said, noting that 60.7% of patients with an identified etiology had degenerative leaflet prolapse (etiology was unknown in 31% of the patients in the dataset).
“The operative approach has changed and continues to shift toward a less invasive approach,” Dr. Gammie said. Overall, 74.1% of operations involved sternotomy, but only 67.5% of those in the leaflet prolapse subgroup, with less invasive operations comprising 23% of all operations and 29.1% of those in the leaflet prolapse subgroup. From 2011 to 2016, total mitral surgical volume grew at a rate of 1.1% annually, but the volume for isolated MV operations grew 4.4% annually while leaflet prolapse procedures increased 7.6% annually, Dr. Gammie said.
Dr. Gammie described surgeons’ decision to perform ablation for preoperative AF during MV surgery a “coin toss.” One-third (34%) had AF, but only 51.2% of patients with AF in the total cohort and 54.4% of those in the leaflet prolapse subgroup got ablation. The overall MV repair rate was 65% for the total cohort but 83% for those with leaflet prolapse. For those who had MV replacement, the share of bioprosthetic devices increased steadily through the study period, from around 65% to 75.8%, Dr. Gammie said.
In the leaflet prolapse subgroup, 96.1% had annuloplasty and 29.2% had artificial chords implanted, with an average of two chords per operation. “There’s an increasing use of artificial ePTFE chords,” Dr. Gammie said. He noted the leaflet prolapse subgroup was composed of low-risk healthy patients. The mean ejection fraction (EF) for the cohort was 57%, and 47% of patients had EF of less than 60%. The overwhelming majority of patients (88%) had Class I indications for surgery with the remainder having Class IIa indications.
Dr. Gammie noted a few other emerging trends of MV surgery during the study period. “Patients with functional mitral regurgitation are rarely referred for operation: these patients made up fewer than 5% of patients undergoing mitral valve operations during the study period,” he said.;
With regard to outcomes, Dr. Gammie said, “There remain substantial differences between repair and replacement.” Replacement had almost twice the rate of reoperation for bleeding than repair (4.1% vs. 2.1%) and renal failure (3.4% vs. 1.4%).
“We observed that a substantial number of patients have an unsuccessful attempt at mitral valve repair before undergoing replacement – 16 % of the overall replacement group and 27% of patients having replacement for degenerative leaflet prolapse,” he said. “This does not appear to penalize patients in terms of outcome.”
The rate of permanent pacemaker was also significantly higher in the replacement cohort, 9.8% vs. 3.8% for repair operations, as was operative mortality, 3.7% vs. 1.1%. Said Dr. Gammie.
“This is something to think about as we move to less invasive approaches and overall operative mortality remains over threefold higher for replacement than repair.”
The leaflet prolapse subgroup showed similar disparities between replacement and repair groups. “The increased application of repair when feasible will be of value to improve outcomes, as will referral of patients earlier in the disease process ,” Dr. Gammie said.
“In our own STS database, about one-third of patients who were coded as having AF had no evidence of it, and that’s why in our institution they don’t get treated.” He added, “I’m not that surprised at the low repair rate when the average surgeon in the United States does five mitral repairs a year.”
Dr. Gammie disclosed that he is a consultant to Edwards Lifesciences and has an ownership interest in Harpoon Medical. Dr. Damiano disclosed that he is a speaker for LivaNova and a consultant to and a research grant recipient of Atricure.
AT THE AATS MITRAL CONCLAVE 2017
Key clinical point: The volume of mitral valve surgery has increased substantially, according to an analysis of the Society for Thoracic Surgery database, and an increasing percentage of procedures are minimally invasive in nature.
Major finding: Sternotomy continues to be the most widely used approach for mitral valve surgery, but less invasive options most recently comprised 23% of the overall group and 29.1% of those with isolated leaflet prolapse.
Data source: Retrospective study of 15,360 isolated mitral valve operations performed from July 2011 to September 2016 in the Society of Thoracic Surgeons database.
Disclosures: Dr. Gammie reported being a consultant to Edwards Lifesciences and having an ownership interest in Harpoon Medical.