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CMS: SGR repeal equals less pay in long-term
Despite being billed as a permanent solution to the annual threat of Medicare payment cuts to physicians, a bill repealing the Sustainable Growth Rate formula will not ensure adequate physician payments in the long term, according to actuaries at the Centers for Medicare & Medicaid Services.
In an April 9 report outlining the effect of the Medicare Access and CHIP Reauthorization Act (H.R. 2), the CMS Office of the Actuary said it anticipates “that physician payment rates under H.R. 2 would be lower than scheduled under the current SGR formula by 2048 and would continue to worsen thereafter.
“Absent a change in the method or level of update by subsequent legislation, we expect access to Medicare-participating physicians to become a significant issue in the long term under H.R. 2,” the report’s authors noted.
The actuarial report attributes the long-term issues to a number of the bill’s provisions. First, it notes the expiration in 2025 of updates totaling $500 million per year and a 5% annual bonus, which will result in a payment reduction for most physicians.
Second, “this bill specifies the physician payment update amounts for all years in the future, and these amounts do not vary based on underlying economic conditions, nor are they expected to keep pace with the average rate of physician cost increases,” the report warned. That will result in payments that will be inadequate when rates of inflation are higher or when price updates are not enough to cover cost increases.
Compared with costs under current law, the CMS actuaries estimated the legislation’s net cost to the federal government from 2015 through 2025 would be $102.8 billion.
The SGR repeal bill, which also reauthorizes the Children’s Health Insurance Program for 2 more years, passed in the House March 26 with overwhelming bipartisan support. The bill is expected to pass the Senate after members return April 13 from their spring recess.
Despite being billed as a permanent solution to the annual threat of Medicare payment cuts to physicians, a bill repealing the Sustainable Growth Rate formula will not ensure adequate physician payments in the long term, according to actuaries at the Centers for Medicare & Medicaid Services.
In an April 9 report outlining the effect of the Medicare Access and CHIP Reauthorization Act (H.R. 2), the CMS Office of the Actuary said it anticipates “that physician payment rates under H.R. 2 would be lower than scheduled under the current SGR formula by 2048 and would continue to worsen thereafter.
“Absent a change in the method or level of update by subsequent legislation, we expect access to Medicare-participating physicians to become a significant issue in the long term under H.R. 2,” the report’s authors noted.
The actuarial report attributes the long-term issues to a number of the bill’s provisions. First, it notes the expiration in 2025 of updates totaling $500 million per year and a 5% annual bonus, which will result in a payment reduction for most physicians.
Second, “this bill specifies the physician payment update amounts for all years in the future, and these amounts do not vary based on underlying economic conditions, nor are they expected to keep pace with the average rate of physician cost increases,” the report warned. That will result in payments that will be inadequate when rates of inflation are higher or when price updates are not enough to cover cost increases.
Compared with costs under current law, the CMS actuaries estimated the legislation’s net cost to the federal government from 2015 through 2025 would be $102.8 billion.
The SGR repeal bill, which also reauthorizes the Children’s Health Insurance Program for 2 more years, passed in the House March 26 with overwhelming bipartisan support. The bill is expected to pass the Senate after members return April 13 from their spring recess.
Despite being billed as a permanent solution to the annual threat of Medicare payment cuts to physicians, a bill repealing the Sustainable Growth Rate formula will not ensure adequate physician payments in the long term, according to actuaries at the Centers for Medicare & Medicaid Services.
In an April 9 report outlining the effect of the Medicare Access and CHIP Reauthorization Act (H.R. 2), the CMS Office of the Actuary said it anticipates “that physician payment rates under H.R. 2 would be lower than scheduled under the current SGR formula by 2048 and would continue to worsen thereafter.
“Absent a change in the method or level of update by subsequent legislation, we expect access to Medicare-participating physicians to become a significant issue in the long term under H.R. 2,” the report’s authors noted.
The actuarial report attributes the long-term issues to a number of the bill’s provisions. First, it notes the expiration in 2025 of updates totaling $500 million per year and a 5% annual bonus, which will result in a payment reduction for most physicians.
Second, “this bill specifies the physician payment update amounts for all years in the future, and these amounts do not vary based on underlying economic conditions, nor are they expected to keep pace with the average rate of physician cost increases,” the report warned. That will result in payments that will be inadequate when rates of inflation are higher or when price updates are not enough to cover cost increases.
Compared with costs under current law, the CMS actuaries estimated the legislation’s net cost to the federal government from 2015 through 2025 would be $102.8 billion.
The SGR repeal bill, which also reauthorizes the Children’s Health Insurance Program for 2 more years, passed in the House March 26 with overwhelming bipartisan support. The bill is expected to pass the Senate after members return April 13 from their spring recess.
Medicare at 50: High-price therapeutics put Medicare at a crossroad
High-cost advances in diagnosis and treatment are entering medicine each and every month. As Medicare turns 50 this year, how can the program – with its growing number of beneficiaries and their advancing age – cope with the onslaught?
“When we look at the price of something in health care, very often we just look at one bucket,” Amy Miller, Ph.D., executive vice president at the Personalized Medicine Coalition, said in an interview. “We look at the drug bucket or we look at the diagnostic bucket or we look at the hospital bucket or the doctor visit bucket, but when we are talking about the targeted therapy that is more or less known to work for a particular patient with a particular condition, we need to think about the price more broadly. We need to think about the systemic cost savings of getting that drug to the right patient the first time, without failing first on other drugs.”
For some high-priced drugs, that appears to be the case. Take for example the direct-acting antiviral agents (DAA) recently approved to treat hepatitis C (HCV) infection.
“If you have a drug like [sofosbuvir], which is extremely expensive at face value, it may not have such a big long-term effect because [sofosbuvir] is a cure,” said Dr. Soeren Mattke, senior scientist in RAND Corp. in Boston. “So if you take patients with hepatitis C that have a certain trajectory of spending over the next decade or so – treatment, liver transplantation, and the like – it basically wipes out the infection. In the long run, even though the drug is very, very expensive, it may not be such a bad deal for Medicare.”
And while some physicians would like to see these new DAAs prescribed to all appropriate patients with HCV, even they acknowledge that the high price tag can be fiscally constraining in the long run and can handle some restrictions to ease the financial burden.
“If you have a 70-year-old patient who has no evidence of any liver fibrosis and they have lived with hepatitis C for 30 or 40 years, I don’t think it’s unreasonable to suggest that maybe they wait for their therapy until an even less expensive option comes along,” said Dr. Sean Koppe, director of hepatology at University of Illinois at Chicago. “I think if the payer is going to be a little bit restrictive but still allow us to treat the majority of our patients who are showing some signs of fibrosis, I wouldn’t be too bothered by that approach.”
Oncology, another area where high-priced treatments are prevalent, is not as cut and dried in terms of medical outcomes as HCV.
“Some of the oncology drugs [have a cost of] $50,000-$60,000 per treatment course, but you extend life expectancy of a terminal cancer patient by weeks,” Dr. Mattke said. “So while you are looking at this drug, and they cost practically the same [as some DAAs], the impact is quite different.”
But one bright spot that can potentially help alleviate pricing pressures is the growing emphasis on personalized or precision medicine.
“When we talk about a high-priced therapeutic, we have to remember that not too long ago, when a drug came to market, it was marketed to everyone with a particular condition,” Dr. Miller said. “But when [crizotinib] hit the market, it only treated 4% of those with non–small-cell lung cancer initially based on its approved label.”
Identifying the right users will be key to moderating the impact of high-priced therapeutics.
“But if diagnostics aren’t adequately covered or reimbursed or if a particular therapy is on a higher tier or there’s more risk for the physician, giving that drug to a patient, even if diagnostics indicate it’s the right one, then the models might not work,” Dr. Miller said, adding that she is “encouraged” that the federal government is talking about more active use of precision medicine.
But, according to Dr. Mattke, there are pitfalls to precision medicine, too.
“If personalized medicine means that you are able to design a drug that targets the very specific molecular [structure] of a particular cancer and reverses it, this could be a very, very expensive drug, but it could be totally worth it,” he said. “If personalized medicine means there’s a highly differentiated range of drugs out there that all are so-so effective, you may end up with some marginally valuable drugs at extremely high prices, and yet force Medicare to pay for it because they cannot take cost into consideration.”
When it comes to costly medications and treatments, Medicare’s fee-for-service design isn’t helping either.
“We have a payment system that works through a third party payer, so the person who needs the care is not usually the person who is paying for the care,” said Dr. Jeffery Ward, an oncologist who serves on the clinical practice committee of the American Society of Clinical Oncology. “Prices and the fees are set based on what you do. I don’t get paid better for doing a good job than I would get for doing a cruddy job. [Once,] that served medicine and Medicare well, but now we have a health care crisis.”
Dr. Ward added that incentives are misaligned in a manner that rewards doctors for choosing more expensive drugs and procedures for their patients.
As oncologists, “we are going to have get over our addiction to [being compensated on the] margin on drugs,” Dr. Ward said. “We’re going to have to be able to develop a system and have faith in a system that will pay us fairly for what we do instead of paying us based on what drugs we choose.”
However, Dr. Steven Allen, who chairs the American Society of Hematology committee on practice, said that he doesn’t believe that is a key issue.
“I think you are really only referring to a very small percentage of physicians,” Dr. Allen said. “I think the vast majority of physicians do what’s right for their patients. ... They will choose the best drug for their patients regardless of the reimbursement the physician may receive given that drug.”
Dr. Ward said that to address the need to cover these potent, high-cost treatments, “I think what Medicare is going to have to do at its 50th birthday is figure out how to begin to reward physicians for doing the right thing and for providing quality care instead of simply paying for quantity.”
The federal government is moving in that direction. In January, Health and Human Services Secretary Sylvia Burwell announced a new goal for Medicare: Fifty percent of all payments should be value based by 2018 (N. Engl. J. Med. 2015;372:897-9 [doi 10.1056.NEJMp1500445]). But what exactly does value mean? While that point is debated on a broad scale, one thing that is obvious is that it will require a culture shift on a many levels.
High-cost advances in diagnosis and treatment are entering medicine each and every month. As Medicare turns 50 this year, how can the program – with its growing number of beneficiaries and their advancing age – cope with the onslaught?
“When we look at the price of something in health care, very often we just look at one bucket,” Amy Miller, Ph.D., executive vice president at the Personalized Medicine Coalition, said in an interview. “We look at the drug bucket or we look at the diagnostic bucket or we look at the hospital bucket or the doctor visit bucket, but when we are talking about the targeted therapy that is more or less known to work for a particular patient with a particular condition, we need to think about the price more broadly. We need to think about the systemic cost savings of getting that drug to the right patient the first time, without failing first on other drugs.”
For some high-priced drugs, that appears to be the case. Take for example the direct-acting antiviral agents (DAA) recently approved to treat hepatitis C (HCV) infection.
“If you have a drug like [sofosbuvir], which is extremely expensive at face value, it may not have such a big long-term effect because [sofosbuvir] is a cure,” said Dr. Soeren Mattke, senior scientist in RAND Corp. in Boston. “So if you take patients with hepatitis C that have a certain trajectory of spending over the next decade or so – treatment, liver transplantation, and the like – it basically wipes out the infection. In the long run, even though the drug is very, very expensive, it may not be such a bad deal for Medicare.”
And while some physicians would like to see these new DAAs prescribed to all appropriate patients with HCV, even they acknowledge that the high price tag can be fiscally constraining in the long run and can handle some restrictions to ease the financial burden.
“If you have a 70-year-old patient who has no evidence of any liver fibrosis and they have lived with hepatitis C for 30 or 40 years, I don’t think it’s unreasonable to suggest that maybe they wait for their therapy until an even less expensive option comes along,” said Dr. Sean Koppe, director of hepatology at University of Illinois at Chicago. “I think if the payer is going to be a little bit restrictive but still allow us to treat the majority of our patients who are showing some signs of fibrosis, I wouldn’t be too bothered by that approach.”
Oncology, another area where high-priced treatments are prevalent, is not as cut and dried in terms of medical outcomes as HCV.
“Some of the oncology drugs [have a cost of] $50,000-$60,000 per treatment course, but you extend life expectancy of a terminal cancer patient by weeks,” Dr. Mattke said. “So while you are looking at this drug, and they cost practically the same [as some DAAs], the impact is quite different.”
But one bright spot that can potentially help alleviate pricing pressures is the growing emphasis on personalized or precision medicine.
“When we talk about a high-priced therapeutic, we have to remember that not too long ago, when a drug came to market, it was marketed to everyone with a particular condition,” Dr. Miller said. “But when [crizotinib] hit the market, it only treated 4% of those with non–small-cell lung cancer initially based on its approved label.”
Identifying the right users will be key to moderating the impact of high-priced therapeutics.
“But if diagnostics aren’t adequately covered or reimbursed or if a particular therapy is on a higher tier or there’s more risk for the physician, giving that drug to a patient, even if diagnostics indicate it’s the right one, then the models might not work,” Dr. Miller said, adding that she is “encouraged” that the federal government is talking about more active use of precision medicine.
But, according to Dr. Mattke, there are pitfalls to precision medicine, too.
“If personalized medicine means that you are able to design a drug that targets the very specific molecular [structure] of a particular cancer and reverses it, this could be a very, very expensive drug, but it could be totally worth it,” he said. “If personalized medicine means there’s a highly differentiated range of drugs out there that all are so-so effective, you may end up with some marginally valuable drugs at extremely high prices, and yet force Medicare to pay for it because they cannot take cost into consideration.”
When it comes to costly medications and treatments, Medicare’s fee-for-service design isn’t helping either.
“We have a payment system that works through a third party payer, so the person who needs the care is not usually the person who is paying for the care,” said Dr. Jeffery Ward, an oncologist who serves on the clinical practice committee of the American Society of Clinical Oncology. “Prices and the fees are set based on what you do. I don’t get paid better for doing a good job than I would get for doing a cruddy job. [Once,] that served medicine and Medicare well, but now we have a health care crisis.”
Dr. Ward added that incentives are misaligned in a manner that rewards doctors for choosing more expensive drugs and procedures for their patients.
As oncologists, “we are going to have get over our addiction to [being compensated on the] margin on drugs,” Dr. Ward said. “We’re going to have to be able to develop a system and have faith in a system that will pay us fairly for what we do instead of paying us based on what drugs we choose.”
However, Dr. Steven Allen, who chairs the American Society of Hematology committee on practice, said that he doesn’t believe that is a key issue.
“I think you are really only referring to a very small percentage of physicians,” Dr. Allen said. “I think the vast majority of physicians do what’s right for their patients. ... They will choose the best drug for their patients regardless of the reimbursement the physician may receive given that drug.”
Dr. Ward said that to address the need to cover these potent, high-cost treatments, “I think what Medicare is going to have to do at its 50th birthday is figure out how to begin to reward physicians for doing the right thing and for providing quality care instead of simply paying for quantity.”
The federal government is moving in that direction. In January, Health and Human Services Secretary Sylvia Burwell announced a new goal for Medicare: Fifty percent of all payments should be value based by 2018 (N. Engl. J. Med. 2015;372:897-9 [doi 10.1056.NEJMp1500445]). But what exactly does value mean? While that point is debated on a broad scale, one thing that is obvious is that it will require a culture shift on a many levels.
High-cost advances in diagnosis and treatment are entering medicine each and every month. As Medicare turns 50 this year, how can the program – with its growing number of beneficiaries and their advancing age – cope with the onslaught?
“When we look at the price of something in health care, very often we just look at one bucket,” Amy Miller, Ph.D., executive vice president at the Personalized Medicine Coalition, said in an interview. “We look at the drug bucket or we look at the diagnostic bucket or we look at the hospital bucket or the doctor visit bucket, but when we are talking about the targeted therapy that is more or less known to work for a particular patient with a particular condition, we need to think about the price more broadly. We need to think about the systemic cost savings of getting that drug to the right patient the first time, without failing first on other drugs.”
For some high-priced drugs, that appears to be the case. Take for example the direct-acting antiviral agents (DAA) recently approved to treat hepatitis C (HCV) infection.
“If you have a drug like [sofosbuvir], which is extremely expensive at face value, it may not have such a big long-term effect because [sofosbuvir] is a cure,” said Dr. Soeren Mattke, senior scientist in RAND Corp. in Boston. “So if you take patients with hepatitis C that have a certain trajectory of spending over the next decade or so – treatment, liver transplantation, and the like – it basically wipes out the infection. In the long run, even though the drug is very, very expensive, it may not be such a bad deal for Medicare.”
And while some physicians would like to see these new DAAs prescribed to all appropriate patients with HCV, even they acknowledge that the high price tag can be fiscally constraining in the long run and can handle some restrictions to ease the financial burden.
“If you have a 70-year-old patient who has no evidence of any liver fibrosis and they have lived with hepatitis C for 30 or 40 years, I don’t think it’s unreasonable to suggest that maybe they wait for their therapy until an even less expensive option comes along,” said Dr. Sean Koppe, director of hepatology at University of Illinois at Chicago. “I think if the payer is going to be a little bit restrictive but still allow us to treat the majority of our patients who are showing some signs of fibrosis, I wouldn’t be too bothered by that approach.”
Oncology, another area where high-priced treatments are prevalent, is not as cut and dried in terms of medical outcomes as HCV.
“Some of the oncology drugs [have a cost of] $50,000-$60,000 per treatment course, but you extend life expectancy of a terminal cancer patient by weeks,” Dr. Mattke said. “So while you are looking at this drug, and they cost practically the same [as some DAAs], the impact is quite different.”
But one bright spot that can potentially help alleviate pricing pressures is the growing emphasis on personalized or precision medicine.
“When we talk about a high-priced therapeutic, we have to remember that not too long ago, when a drug came to market, it was marketed to everyone with a particular condition,” Dr. Miller said. “But when [crizotinib] hit the market, it only treated 4% of those with non–small-cell lung cancer initially based on its approved label.”
Identifying the right users will be key to moderating the impact of high-priced therapeutics.
“But if diagnostics aren’t adequately covered or reimbursed or if a particular therapy is on a higher tier or there’s more risk for the physician, giving that drug to a patient, even if diagnostics indicate it’s the right one, then the models might not work,” Dr. Miller said, adding that she is “encouraged” that the federal government is talking about more active use of precision medicine.
But, according to Dr. Mattke, there are pitfalls to precision medicine, too.
“If personalized medicine means that you are able to design a drug that targets the very specific molecular [structure] of a particular cancer and reverses it, this could be a very, very expensive drug, but it could be totally worth it,” he said. “If personalized medicine means there’s a highly differentiated range of drugs out there that all are so-so effective, you may end up with some marginally valuable drugs at extremely high prices, and yet force Medicare to pay for it because they cannot take cost into consideration.”
When it comes to costly medications and treatments, Medicare’s fee-for-service design isn’t helping either.
“We have a payment system that works through a third party payer, so the person who needs the care is not usually the person who is paying for the care,” said Dr. Jeffery Ward, an oncologist who serves on the clinical practice committee of the American Society of Clinical Oncology. “Prices and the fees are set based on what you do. I don’t get paid better for doing a good job than I would get for doing a cruddy job. [Once,] that served medicine and Medicare well, but now we have a health care crisis.”
Dr. Ward added that incentives are misaligned in a manner that rewards doctors for choosing more expensive drugs and procedures for their patients.
As oncologists, “we are going to have get over our addiction to [being compensated on the] margin on drugs,” Dr. Ward said. “We’re going to have to be able to develop a system and have faith in a system that will pay us fairly for what we do instead of paying us based on what drugs we choose.”
However, Dr. Steven Allen, who chairs the American Society of Hematology committee on practice, said that he doesn’t believe that is a key issue.
“I think you are really only referring to a very small percentage of physicians,” Dr. Allen said. “I think the vast majority of physicians do what’s right for their patients. ... They will choose the best drug for their patients regardless of the reimbursement the physician may receive given that drug.”
Dr. Ward said that to address the need to cover these potent, high-cost treatments, “I think what Medicare is going to have to do at its 50th birthday is figure out how to begin to reward physicians for doing the right thing and for providing quality care instead of simply paying for quantity.”
The federal government is moving in that direction. In January, Health and Human Services Secretary Sylvia Burwell announced a new goal for Medicare: Fifty percent of all payments should be value based by 2018 (N. Engl. J. Med. 2015;372:897-9 [doi 10.1056.NEJMp1500445]). But what exactly does value mean? While that point is debated on a broad scale, one thing that is obvious is that it will require a culture shift on a many levels.
Palliative surgery eases pain at end of life
HOUSTON – Palliative surgery can alleviate pain and improve the quality of life for patients dying from advanced cancers, without compromising performance status, a study showed.
Among 202 patients with stage III or IV cancers who underwent surgery with palliation as the goal, pain scores were significantly improved after surgery, while Karnofsky Performance Status (KPS) scores remained unchanged, said Dr. Anne Falor, a surgical oncology fellow at City of Hope in Duarte, Calif.
“Surgical oncology has not been historically involved in palliative care. If a patient is deemed unresectable, his or her treatment is often the purview of medical or radiation oncology,” she said at the annual Society of Surgical Oncology Cancer Symposium.
But for patients who are likely to have prolonged disease-free intervals, palliative surgery can be performed with low morbidity, she said.
Dr. Falor and her colleagues reviewed their center’s experience with palliative surgery in 2011, during which time 202 patients with a predicted 5-year survival of less than 5% underwent a total of 247 palliative procedures.
The patients had malignancies at various sites, including the large intestine, lung, stomach, breast, prostate, lymph nodes, esophagus, pancreas, and ovaries.
The primary indications for the procedure included dysphagia, pain/wound problems, dyspnea, nausea and vomiting, and dysuria.
Most of the patients (83%) had a single procedure, but 13% had two operations, 4% had three operations, 1% had four procedures, and 0.4% had five or more interventions.
The majority of procedures performed were endoscopic interventions characterized as minor in nature, followed by minor genitourinary and thoracic interventions, although a nearly equal proportion of thoracic interventions (about 28%) were major procedures such as diverting ostomy.
When the investigators looked at 30-day outcomes following palliative surgery, they found that only 13% of patients needed an urgent care visit, 2% required a triage call, 22% were readmitted, and 60% had an institutional supportive care referral.
Total 30-day morbidity of any kind was seen in 37% of patients; 15% of patients died within 30 days of surgery.
Looking at quality of life outcomes, the investigators found no differences in the percentage of patients with KPS scores from 80 to 100 between the presurgery and postsurgery periods (78% and 70%, respectively, P = ns).
There were significant improvements, however, in pain scores, which dropped by a mean of 1.2 points from the preoperative period to discharge (P < .0001), and decreased by 0.6 points before surgery to the first follow-up visit (P = .0037).
Dr. Falor said that it’s important for patients and their care team to have a discussion regarding expectations for surgery and the goals of care.
The study was internally funded. Dr. Falor reported having no conflicts of interest.
Over the past decade palliative surgery has been increasingly discussed and scrutinized, as the concept of palliative care has gained greater traction with medical professionals and the public. Not too long ago the designation “palliative” when applied to a surgical procedure had an apologetic connotation because the operation would fail to heal. In some cases the term was even used to describe positive tumor margins at the conclusion of a resection – something totally irrelevant when assessing the direct impact of the operation upon a patient’s self-designated symptoms.
Only recently has a more positive perspective emerged, helped by data such as these researchers have presented. Palliative surgery now is not failing to cure, but succeeding to comfort.
New perspectives, however, will raise new and necessary questions to better define the role of surgery in the greater context of relief of suffering in all its manifestations. In our wish to respond surgically to pain and other symptoms we must be vigilant against the temptation to “do something” when surgery for cure or palliation is unlikely to help in order to assuage our feelings of hopelessness. Hopelessness is not an indication for surgery – pain, obstruction, and saving life are. Indications for surgery must be more specific, as this article points out, and it is more likely to help with localized and pressing symptoms. A rule of thumb passed down to me from my surgeon grandfather who practiced in an era when the vast majority of operations were palliative, the more pressing and clear the indication for surgery, the better the result.
Dr. Geoffrey Dunn, an ACS Fellow based in Erie, Pa.
Over the past decade palliative surgery has been increasingly discussed and scrutinized, as the concept of palliative care has gained greater traction with medical professionals and the public. Not too long ago the designation “palliative” when applied to a surgical procedure had an apologetic connotation because the operation would fail to heal. In some cases the term was even used to describe positive tumor margins at the conclusion of a resection – something totally irrelevant when assessing the direct impact of the operation upon a patient’s self-designated symptoms.
Only recently has a more positive perspective emerged, helped by data such as these researchers have presented. Palliative surgery now is not failing to cure, but succeeding to comfort.
New perspectives, however, will raise new and necessary questions to better define the role of surgery in the greater context of relief of suffering in all its manifestations. In our wish to respond surgically to pain and other symptoms we must be vigilant against the temptation to “do something” when surgery for cure or palliation is unlikely to help in order to assuage our feelings of hopelessness. Hopelessness is not an indication for surgery – pain, obstruction, and saving life are. Indications for surgery must be more specific, as this article points out, and it is more likely to help with localized and pressing symptoms. A rule of thumb passed down to me from my surgeon grandfather who practiced in an era when the vast majority of operations were palliative, the more pressing and clear the indication for surgery, the better the result.
Dr. Geoffrey Dunn, an ACS Fellow based in Erie, Pa.
Over the past decade palliative surgery has been increasingly discussed and scrutinized, as the concept of palliative care has gained greater traction with medical professionals and the public. Not too long ago the designation “palliative” when applied to a surgical procedure had an apologetic connotation because the operation would fail to heal. In some cases the term was even used to describe positive tumor margins at the conclusion of a resection – something totally irrelevant when assessing the direct impact of the operation upon a patient’s self-designated symptoms.
Only recently has a more positive perspective emerged, helped by data such as these researchers have presented. Palliative surgery now is not failing to cure, but succeeding to comfort.
New perspectives, however, will raise new and necessary questions to better define the role of surgery in the greater context of relief of suffering in all its manifestations. In our wish to respond surgically to pain and other symptoms we must be vigilant against the temptation to “do something” when surgery for cure or palliation is unlikely to help in order to assuage our feelings of hopelessness. Hopelessness is not an indication for surgery – pain, obstruction, and saving life are. Indications for surgery must be more specific, as this article points out, and it is more likely to help with localized and pressing symptoms. A rule of thumb passed down to me from my surgeon grandfather who practiced in an era when the vast majority of operations were palliative, the more pressing and clear the indication for surgery, the better the result.
Dr. Geoffrey Dunn, an ACS Fellow based in Erie, Pa.
HOUSTON – Palliative surgery can alleviate pain and improve the quality of life for patients dying from advanced cancers, without compromising performance status, a study showed.
Among 202 patients with stage III or IV cancers who underwent surgery with palliation as the goal, pain scores were significantly improved after surgery, while Karnofsky Performance Status (KPS) scores remained unchanged, said Dr. Anne Falor, a surgical oncology fellow at City of Hope in Duarte, Calif.
“Surgical oncology has not been historically involved in palliative care. If a patient is deemed unresectable, his or her treatment is often the purview of medical or radiation oncology,” she said at the annual Society of Surgical Oncology Cancer Symposium.
But for patients who are likely to have prolonged disease-free intervals, palliative surgery can be performed with low morbidity, she said.
Dr. Falor and her colleagues reviewed their center’s experience with palliative surgery in 2011, during which time 202 patients with a predicted 5-year survival of less than 5% underwent a total of 247 palliative procedures.
The patients had malignancies at various sites, including the large intestine, lung, stomach, breast, prostate, lymph nodes, esophagus, pancreas, and ovaries.
The primary indications for the procedure included dysphagia, pain/wound problems, dyspnea, nausea and vomiting, and dysuria.
Most of the patients (83%) had a single procedure, but 13% had two operations, 4% had three operations, 1% had four procedures, and 0.4% had five or more interventions.
The majority of procedures performed were endoscopic interventions characterized as minor in nature, followed by minor genitourinary and thoracic interventions, although a nearly equal proportion of thoracic interventions (about 28%) were major procedures such as diverting ostomy.
When the investigators looked at 30-day outcomes following palliative surgery, they found that only 13% of patients needed an urgent care visit, 2% required a triage call, 22% were readmitted, and 60% had an institutional supportive care referral.
Total 30-day morbidity of any kind was seen in 37% of patients; 15% of patients died within 30 days of surgery.
Looking at quality of life outcomes, the investigators found no differences in the percentage of patients with KPS scores from 80 to 100 between the presurgery and postsurgery periods (78% and 70%, respectively, P = ns).
There were significant improvements, however, in pain scores, which dropped by a mean of 1.2 points from the preoperative period to discharge (P < .0001), and decreased by 0.6 points before surgery to the first follow-up visit (P = .0037).
Dr. Falor said that it’s important for patients and their care team to have a discussion regarding expectations for surgery and the goals of care.
The study was internally funded. Dr. Falor reported having no conflicts of interest.
HOUSTON – Palliative surgery can alleviate pain and improve the quality of life for patients dying from advanced cancers, without compromising performance status, a study showed.
Among 202 patients with stage III or IV cancers who underwent surgery with palliation as the goal, pain scores were significantly improved after surgery, while Karnofsky Performance Status (KPS) scores remained unchanged, said Dr. Anne Falor, a surgical oncology fellow at City of Hope in Duarte, Calif.
“Surgical oncology has not been historically involved in palliative care. If a patient is deemed unresectable, his or her treatment is often the purview of medical or radiation oncology,” she said at the annual Society of Surgical Oncology Cancer Symposium.
But for patients who are likely to have prolonged disease-free intervals, palliative surgery can be performed with low morbidity, she said.
Dr. Falor and her colleagues reviewed their center’s experience with palliative surgery in 2011, during which time 202 patients with a predicted 5-year survival of less than 5% underwent a total of 247 palliative procedures.
The patients had malignancies at various sites, including the large intestine, lung, stomach, breast, prostate, lymph nodes, esophagus, pancreas, and ovaries.
The primary indications for the procedure included dysphagia, pain/wound problems, dyspnea, nausea and vomiting, and dysuria.
Most of the patients (83%) had a single procedure, but 13% had two operations, 4% had three operations, 1% had four procedures, and 0.4% had five or more interventions.
The majority of procedures performed were endoscopic interventions characterized as minor in nature, followed by minor genitourinary and thoracic interventions, although a nearly equal proportion of thoracic interventions (about 28%) were major procedures such as diverting ostomy.
When the investigators looked at 30-day outcomes following palliative surgery, they found that only 13% of patients needed an urgent care visit, 2% required a triage call, 22% were readmitted, and 60% had an institutional supportive care referral.
Total 30-day morbidity of any kind was seen in 37% of patients; 15% of patients died within 30 days of surgery.
Looking at quality of life outcomes, the investigators found no differences in the percentage of patients with KPS scores from 80 to 100 between the presurgery and postsurgery periods (78% and 70%, respectively, P = ns).
There were significant improvements, however, in pain scores, which dropped by a mean of 1.2 points from the preoperative period to discharge (P < .0001), and decreased by 0.6 points before surgery to the first follow-up visit (P = .0037).
Dr. Falor said that it’s important for patients and their care team to have a discussion regarding expectations for surgery and the goals of care.
The study was internally funded. Dr. Falor reported having no conflicts of interest.
Key clinical point: Palliative surgery in patients with advanced cancers can relieve pain with minimal morbidity.
Major finding: Pain scores improved significantly from the pre- to postoperative periods, without a significant decline in performance status scores.
Data source: Case series of 202 patients with stage III or IV malignancies who underwent 247 palliative procedures.
Disclosures: The study was internally funded. Dr. Falor reported having no conflicts of interest.
The April issue of Thoracic Surgery News is now available online
Be sure to visit our online PDF version of the April issue of Thoracic Surgery News, now available online. This month we are focusing on the potential of 3-D printing for cardiothoracic surgery education and practice, the new privacy issues arising from the development of genomic medicine, and the apparent end of the SGR era.
Also, in our News from AATS section there is further information on the upcoming 95th AATS Annual Meeting, the 2015 Mitral Conclave, and new fellowship and training opportunities available through the AATS.
Click here to view our April PDF.
Be sure to visit our online PDF version of the April issue of Thoracic Surgery News, now available online. This month we are focusing on the potential of 3-D printing for cardiothoracic surgery education and practice, the new privacy issues arising from the development of genomic medicine, and the apparent end of the SGR era.
Also, in our News from AATS section there is further information on the upcoming 95th AATS Annual Meeting, the 2015 Mitral Conclave, and new fellowship and training opportunities available through the AATS.
Click here to view our April PDF.
Be sure to visit our online PDF version of the April issue of Thoracic Surgery News, now available online. This month we are focusing on the potential of 3-D printing for cardiothoracic surgery education and practice, the new privacy issues arising from the development of genomic medicine, and the apparent end of the SGR era.
Also, in our News from AATS section there is further information on the upcoming 95th AATS Annual Meeting, the 2015 Mitral Conclave, and new fellowship and training opportunities available through the AATS.
Click here to view our April PDF.
SGR cuts pay by 21%; CMS to hold checks for 2 weeks
Medicare physician pay was cut by approximately 21% effective April 1, due to the expiration of the last temporary fix to the Sustainable Growth Rate formula.
Because legislation to repeal the SGR has passed the House and awaits action in the Senate, the Centers for Medicare & Medicaid Services announced it will hold Medicare payments for 2 weeks, allowing Congress to complete action on the issue.
Without a legislative fix, beginning April 15, “CMS will begin processing claims received on or after April 1 with a 21% reduction in the physician’s rate to limit the impact on Medicare providers and beneficiaries,” the agency said in a statement.
The House on March 26 overwhelming passed H.R.2, the Medicare Access and CHIP Reauthorization Act, which would repeal the SGR, reauthorize the Children’s Health Insurance Program for 2 years, and reform Medicare. The Senate did not address the bill before taking a recess until April 13.
Should SGR repeal legislation pass Congress and be signed by the President – something he has indicated he will do – CMS will reprocess any claims processed at the lower rate.
Medicare physician pay was cut by approximately 21% effective April 1, due to the expiration of the last temporary fix to the Sustainable Growth Rate formula.
Because legislation to repeal the SGR has passed the House and awaits action in the Senate, the Centers for Medicare & Medicaid Services announced it will hold Medicare payments for 2 weeks, allowing Congress to complete action on the issue.
Without a legislative fix, beginning April 15, “CMS will begin processing claims received on or after April 1 with a 21% reduction in the physician’s rate to limit the impact on Medicare providers and beneficiaries,” the agency said in a statement.
The House on March 26 overwhelming passed H.R.2, the Medicare Access and CHIP Reauthorization Act, which would repeal the SGR, reauthorize the Children’s Health Insurance Program for 2 years, and reform Medicare. The Senate did not address the bill before taking a recess until April 13.
Should SGR repeal legislation pass Congress and be signed by the President – something he has indicated he will do – CMS will reprocess any claims processed at the lower rate.
Medicare physician pay was cut by approximately 21% effective April 1, due to the expiration of the last temporary fix to the Sustainable Growth Rate formula.
Because legislation to repeal the SGR has passed the House and awaits action in the Senate, the Centers for Medicare & Medicaid Services announced it will hold Medicare payments for 2 weeks, allowing Congress to complete action on the issue.
Without a legislative fix, beginning April 15, “CMS will begin processing claims received on or after April 1 with a 21% reduction in the physician’s rate to limit the impact on Medicare providers and beneficiaries,” the agency said in a statement.
The House on March 26 overwhelming passed H.R.2, the Medicare Access and CHIP Reauthorization Act, which would repeal the SGR, reauthorize the Children’s Health Insurance Program for 2 years, and reform Medicare. The Senate did not address the bill before taking a recess until April 13.
Should SGR repeal legislation pass Congress and be signed by the President – something he has indicated he will do – CMS will reprocess any claims processed at the lower rate.
Poor control of CVD risk factors raises morbidity, mortality risk in diabetes
Optimal control of glucose, blood pressure, LDL cholesterol, and smoking in adults with diabetes could result in substantial reductions of cardiovascular risk, according to results from a large cohort study of diabetes patients with and without underlying cardiovascular disease.
CV events and deaths associated with inadequate control of any of these four modifiable risk factors were about 11% and 3%, respectively, for subjects with baseline CVD, and 34% and 7%, respectively, for those without it.
Though risk was much higher for those with CVD, as expected, more attention to these traditional CVD risk factors in all diabetic patients – with or without CVD – would significantly reduce CVD-related morbidity and mortality, investigators concluded.
For their research, published online in Diabetes Care, epidemiologist Gabriela Vasquez-Benitez, Ph.D., of the Health Partners Institute for Education and Research in Minneapolis and her associates identified 859,617 patients with diabetes (31% with CVD) receiving treatment at a network of 11 U.S. health centers for 6 months or more, with mean follow-up of 5 years. About half of patients were female, and 45% were white. Risk factors were defined as LDL-C ≥100 mg/dL, glycosylated hemoglobin (HbA1c) ≥7%, blood pressure ≥140/90 mm Hg, or smoking.
Dr. Vasquez-Benitez and associates used a regression analysis to quantify the contributions each risk factor made to CVD risk and type of CV event in both patient groups.
In patients without CVD (n = 593,167), the vast majority had HbA1c, BP, and LDL-C not at goal or were current smokers. Inadequately controlled LDL cholesterol was associated with 19.6% of myocardial infarction or acute coronary syndrome (95% confidence interval, 18.7-20.5), and 13.7% of strokes. Smoking was associated with 3.8% of all CV events, while inadequately controlled blood pressure was associated with 11.6% of strokes. Dr. Vasquez-Benitez and colleagues found an increased CV risk for HbA1c above 9%, but no increased risk for HbA1c of 7%-7.9%, compared with 6.5%-6.9%. This finding supports current guidelines recommending HbA1c targets below 7% or 8% for patients with diabetes, according to the investigators (Diab. Care 2015 Feb. 20 [doi:10.2337/dc14-1877]).
In subjects with diabetes and CVD, 7% of stroke was found attributable to inadequate blood pressure control and 5.9% to poor glycemic control. Smoking was the only factor seen associated with an increase in all-cause mortality in this patient group, with 2.6% of deaths seen linked to smoking.
Dr. Vasquez-Benitez and her colleagues noted in their analysis that a substantial share of risk could not be attributed to the modifiable factors investigated in their study, raising the possibility that “unidentified genetic, metabolic, or psychosocial risk factors may affect risk.”
The investigators noted as limitations of their study the fact that risk factors and comorbidities were assessed at baseline and may have changed during follow-up, and that data were obtained from routine care settings with varying time intervals. Patients with type I diabetes may have been included in the cohort due to difficulties distinguishing diabetes types in patient records, they said.
The study was funded by the Agency for Healthcare Research & Quality. None of its authors reported conflicts of interest.
Optimal control of glucose, blood pressure, LDL cholesterol, and smoking in adults with diabetes could result in substantial reductions of cardiovascular risk, according to results from a large cohort study of diabetes patients with and without underlying cardiovascular disease.
CV events and deaths associated with inadequate control of any of these four modifiable risk factors were about 11% and 3%, respectively, for subjects with baseline CVD, and 34% and 7%, respectively, for those without it.
Though risk was much higher for those with CVD, as expected, more attention to these traditional CVD risk factors in all diabetic patients – with or without CVD – would significantly reduce CVD-related morbidity and mortality, investigators concluded.
For their research, published online in Diabetes Care, epidemiologist Gabriela Vasquez-Benitez, Ph.D., of the Health Partners Institute for Education and Research in Minneapolis and her associates identified 859,617 patients with diabetes (31% with CVD) receiving treatment at a network of 11 U.S. health centers for 6 months or more, with mean follow-up of 5 years. About half of patients were female, and 45% were white. Risk factors were defined as LDL-C ≥100 mg/dL, glycosylated hemoglobin (HbA1c) ≥7%, blood pressure ≥140/90 mm Hg, or smoking.
Dr. Vasquez-Benitez and associates used a regression analysis to quantify the contributions each risk factor made to CVD risk and type of CV event in both patient groups.
In patients without CVD (n = 593,167), the vast majority had HbA1c, BP, and LDL-C not at goal or were current smokers. Inadequately controlled LDL cholesterol was associated with 19.6% of myocardial infarction or acute coronary syndrome (95% confidence interval, 18.7-20.5), and 13.7% of strokes. Smoking was associated with 3.8% of all CV events, while inadequately controlled blood pressure was associated with 11.6% of strokes. Dr. Vasquez-Benitez and colleagues found an increased CV risk for HbA1c above 9%, but no increased risk for HbA1c of 7%-7.9%, compared with 6.5%-6.9%. This finding supports current guidelines recommending HbA1c targets below 7% or 8% for patients with diabetes, according to the investigators (Diab. Care 2015 Feb. 20 [doi:10.2337/dc14-1877]).
In subjects with diabetes and CVD, 7% of stroke was found attributable to inadequate blood pressure control and 5.9% to poor glycemic control. Smoking was the only factor seen associated with an increase in all-cause mortality in this patient group, with 2.6% of deaths seen linked to smoking.
Dr. Vasquez-Benitez and her colleagues noted in their analysis that a substantial share of risk could not be attributed to the modifiable factors investigated in their study, raising the possibility that “unidentified genetic, metabolic, or psychosocial risk factors may affect risk.”
The investigators noted as limitations of their study the fact that risk factors and comorbidities were assessed at baseline and may have changed during follow-up, and that data were obtained from routine care settings with varying time intervals. Patients with type I diabetes may have been included in the cohort due to difficulties distinguishing diabetes types in patient records, they said.
The study was funded by the Agency for Healthcare Research & Quality. None of its authors reported conflicts of interest.
Optimal control of glucose, blood pressure, LDL cholesterol, and smoking in adults with diabetes could result in substantial reductions of cardiovascular risk, according to results from a large cohort study of diabetes patients with and without underlying cardiovascular disease.
CV events and deaths associated with inadequate control of any of these four modifiable risk factors were about 11% and 3%, respectively, for subjects with baseline CVD, and 34% and 7%, respectively, for those without it.
Though risk was much higher for those with CVD, as expected, more attention to these traditional CVD risk factors in all diabetic patients – with or without CVD – would significantly reduce CVD-related morbidity and mortality, investigators concluded.
For their research, published online in Diabetes Care, epidemiologist Gabriela Vasquez-Benitez, Ph.D., of the Health Partners Institute for Education and Research in Minneapolis and her associates identified 859,617 patients with diabetes (31% with CVD) receiving treatment at a network of 11 U.S. health centers for 6 months or more, with mean follow-up of 5 years. About half of patients were female, and 45% were white. Risk factors were defined as LDL-C ≥100 mg/dL, glycosylated hemoglobin (HbA1c) ≥7%, blood pressure ≥140/90 mm Hg, or smoking.
Dr. Vasquez-Benitez and associates used a regression analysis to quantify the contributions each risk factor made to CVD risk and type of CV event in both patient groups.
In patients without CVD (n = 593,167), the vast majority had HbA1c, BP, and LDL-C not at goal or were current smokers. Inadequately controlled LDL cholesterol was associated with 19.6% of myocardial infarction or acute coronary syndrome (95% confidence interval, 18.7-20.5), and 13.7% of strokes. Smoking was associated with 3.8% of all CV events, while inadequately controlled blood pressure was associated with 11.6% of strokes. Dr. Vasquez-Benitez and colleagues found an increased CV risk for HbA1c above 9%, but no increased risk for HbA1c of 7%-7.9%, compared with 6.5%-6.9%. This finding supports current guidelines recommending HbA1c targets below 7% or 8% for patients with diabetes, according to the investigators (Diab. Care 2015 Feb. 20 [doi:10.2337/dc14-1877]).
In subjects with diabetes and CVD, 7% of stroke was found attributable to inadequate blood pressure control and 5.9% to poor glycemic control. Smoking was the only factor seen associated with an increase in all-cause mortality in this patient group, with 2.6% of deaths seen linked to smoking.
Dr. Vasquez-Benitez and her colleagues noted in their analysis that a substantial share of risk could not be attributed to the modifiable factors investigated in their study, raising the possibility that “unidentified genetic, metabolic, or psychosocial risk factors may affect risk.”
The investigators noted as limitations of their study the fact that risk factors and comorbidities were assessed at baseline and may have changed during follow-up, and that data were obtained from routine care settings with varying time intervals. Patients with type I diabetes may have been included in the cohort due to difficulties distinguishing diabetes types in patient records, they said.
The study was funded by the Agency for Healthcare Research & Quality. None of its authors reported conflicts of interest.
FROM DIABETES CARE
Key clinical point: Optimal control of cardiac risk factors in patients with diabetes can substantially lower their CV risks.
Major finding: Traditional cardiovascular risk factors contribute to more than one-third of CV morbidity in patients with diabetes without known underlying cardiovascular disease.
Data source: More than 850,000 patients with diabetes treated at 11 linked healthcare centers between 2005 and 2011, of whom nearly 600,000 had no CVD at baseline.
Disclosures: Dr. Vasquez-Benitez and her associates reported no relevant conflicts of interest.
CoreValve receives first TAVR valve-in-valve indication
The U.S. Food and Drug Administration on March 30 expanded its approved use of the CoreValve transcatheter aortic-valve replacement (TAVR) system to include patients who already have undergone aortic valve replacement and need a second valve replacement done as a valve-in-valve placement.
With this action, CoreValve became the first TAVR system to receive U.S. approval for valve-in-valve use. The CoreValve System received FDA approval for TAVR performed on native aortic valves in January 2014 in patients at “extreme risk,” and in June 2014 for those at “high risk,” for surgical aortic valve replacement.* Valve-in-valve TAVR is only feasible in patients with a failing bioprosthetic aortic valve: It is not an option for patients with a failing mechanical aortic valve.
“The CoreValve System offers a less-invasive treatment option for a significant number of patients with failed tissue aortic valves whose medical teams determine that the risks associated with repeat open-heart surgery are high or extremely high,” Dr. William H. Maisel, deputy center director for science and chief scientist in the FDA’s Center for Devices and Radiological Health, said in a written statement. “The approval is an important expansion of the authorized use of the transcatheter aortic valve replacement technology.”
The CoreValve, which is designed to sit in a supra-annular location 12 mm above the aortic valve annulus, is well suited for valve-in-valve replacement because the only portion of the CoreValve that actually fills the annular space and the ring of the existing valve is the CoreValve’s sealer. This results in a tight seal that produces less paravalvular leak than when the sealer sits in a native annulus that is often deformed with calcium, noted Dr. Michael J. Reardon, professor of cardiothoracic surgery at Methodist Hospital in Houston.
In addition, because the sealer exerts pressure on the old valve ring in the annulus instead of on myocardium, placing the CoreValve as a valve-in-valve produces much less conduction disruption and results in fewer patients who need a pacemaker following TAVR, he said.
The CoreValve as a valve-in-valve “works quite well, and is not hard to position,” said Dr. Reardon, who added that he has now performed several valve-in-valve TAVRs using the CoreValve.
Similar TAVR procedures are usually not possible using the balloon-expandable SAPIEN System because the SAPIEN valve is designed to sit directly in the annulus and, in most patients, the existing valve ring does not provide enough space to accommodate a SAPIEN valve.
Dr. Reardon anticipates that many U.S. patients now in their 80s with a failing bioprosthetic aortic valve will be interested in nonsurgical TAVR replacement. These patients often do not want conventional open-heart surgery, he said in an interview.
To evaluate the safety and efficacy of the CoreValve System for aortic valve-in-valve replacement, the FDA reviewed clinical data collected from a U.S. clinical trial with 143 patients, an agency representative said in the statement. In the clinical trial, the estimated rate of 30-day survival without major stroke was 96%, and 89% after 6 months. “This compares well to the corresponding rates reported previously for trial participants who received the same device to replace their own, native diseased or damaged aortic valve,” the agency’s statement said.
According to the agency, aortic valve-in-valve use of the CoreValve System should be limited to patients who need replacement of a failed tissue aortic valve but are at extreme or high risk of death or serious complications from traditional open-heart surgery. A decision as to whether the product and procedure are appropriate for a patient “should involve careful evaluation by the patient’s heart medical team, including a cardiologist and a cardiac surgeon.”
The FDA said that the CoreValve System should not be used in patients who have any infection, have a mechanical aortic heart valve, cannot tolerate anticoagulant drugs, or have sensitivity to titanium, nickel, or contrast media.
Dr. Maisel had no disclosures. Dr. Reardon has served as an advisor to Medtronic, the company that markets the CoreValve.
On Twitter @mitchelzoler
*Correction, 4/1/2015: An earlier version of this article misstated the device’s approval history.
The U.S. Food and Drug Administration on March 30 expanded its approved use of the CoreValve transcatheter aortic-valve replacement (TAVR) system to include patients who already have undergone aortic valve replacement and need a second valve replacement done as a valve-in-valve placement.
With this action, CoreValve became the first TAVR system to receive U.S. approval for valve-in-valve use. The CoreValve System received FDA approval for TAVR performed on native aortic valves in January 2014 in patients at “extreme risk,” and in June 2014 for those at “high risk,” for surgical aortic valve replacement.* Valve-in-valve TAVR is only feasible in patients with a failing bioprosthetic aortic valve: It is not an option for patients with a failing mechanical aortic valve.
“The CoreValve System offers a less-invasive treatment option for a significant number of patients with failed tissue aortic valves whose medical teams determine that the risks associated with repeat open-heart surgery are high or extremely high,” Dr. William H. Maisel, deputy center director for science and chief scientist in the FDA’s Center for Devices and Radiological Health, said in a written statement. “The approval is an important expansion of the authorized use of the transcatheter aortic valve replacement technology.”
The CoreValve, which is designed to sit in a supra-annular location 12 mm above the aortic valve annulus, is well suited for valve-in-valve replacement because the only portion of the CoreValve that actually fills the annular space and the ring of the existing valve is the CoreValve’s sealer. This results in a tight seal that produces less paravalvular leak than when the sealer sits in a native annulus that is often deformed with calcium, noted Dr. Michael J. Reardon, professor of cardiothoracic surgery at Methodist Hospital in Houston.
In addition, because the sealer exerts pressure on the old valve ring in the annulus instead of on myocardium, placing the CoreValve as a valve-in-valve produces much less conduction disruption and results in fewer patients who need a pacemaker following TAVR, he said.
The CoreValve as a valve-in-valve “works quite well, and is not hard to position,” said Dr. Reardon, who added that he has now performed several valve-in-valve TAVRs using the CoreValve.
Similar TAVR procedures are usually not possible using the balloon-expandable SAPIEN System because the SAPIEN valve is designed to sit directly in the annulus and, in most patients, the existing valve ring does not provide enough space to accommodate a SAPIEN valve.
Dr. Reardon anticipates that many U.S. patients now in their 80s with a failing bioprosthetic aortic valve will be interested in nonsurgical TAVR replacement. These patients often do not want conventional open-heart surgery, he said in an interview.
To evaluate the safety and efficacy of the CoreValve System for aortic valve-in-valve replacement, the FDA reviewed clinical data collected from a U.S. clinical trial with 143 patients, an agency representative said in the statement. In the clinical trial, the estimated rate of 30-day survival without major stroke was 96%, and 89% after 6 months. “This compares well to the corresponding rates reported previously for trial participants who received the same device to replace their own, native diseased or damaged aortic valve,” the agency’s statement said.
According to the agency, aortic valve-in-valve use of the CoreValve System should be limited to patients who need replacement of a failed tissue aortic valve but are at extreme or high risk of death or serious complications from traditional open-heart surgery. A decision as to whether the product and procedure are appropriate for a patient “should involve careful evaluation by the patient’s heart medical team, including a cardiologist and a cardiac surgeon.”
The FDA said that the CoreValve System should not be used in patients who have any infection, have a mechanical aortic heart valve, cannot tolerate anticoagulant drugs, or have sensitivity to titanium, nickel, or contrast media.
Dr. Maisel had no disclosures. Dr. Reardon has served as an advisor to Medtronic, the company that markets the CoreValve.
On Twitter @mitchelzoler
*Correction, 4/1/2015: An earlier version of this article misstated the device’s approval history.
The U.S. Food and Drug Administration on March 30 expanded its approved use of the CoreValve transcatheter aortic-valve replacement (TAVR) system to include patients who already have undergone aortic valve replacement and need a second valve replacement done as a valve-in-valve placement.
With this action, CoreValve became the first TAVR system to receive U.S. approval for valve-in-valve use. The CoreValve System received FDA approval for TAVR performed on native aortic valves in January 2014 in patients at “extreme risk,” and in June 2014 for those at “high risk,” for surgical aortic valve replacement.* Valve-in-valve TAVR is only feasible in patients with a failing bioprosthetic aortic valve: It is not an option for patients with a failing mechanical aortic valve.
“The CoreValve System offers a less-invasive treatment option for a significant number of patients with failed tissue aortic valves whose medical teams determine that the risks associated with repeat open-heart surgery are high or extremely high,” Dr. William H. Maisel, deputy center director for science and chief scientist in the FDA’s Center for Devices and Radiological Health, said in a written statement. “The approval is an important expansion of the authorized use of the transcatheter aortic valve replacement technology.”
The CoreValve, which is designed to sit in a supra-annular location 12 mm above the aortic valve annulus, is well suited for valve-in-valve replacement because the only portion of the CoreValve that actually fills the annular space and the ring of the existing valve is the CoreValve’s sealer. This results in a tight seal that produces less paravalvular leak than when the sealer sits in a native annulus that is often deformed with calcium, noted Dr. Michael J. Reardon, professor of cardiothoracic surgery at Methodist Hospital in Houston.
In addition, because the sealer exerts pressure on the old valve ring in the annulus instead of on myocardium, placing the CoreValve as a valve-in-valve produces much less conduction disruption and results in fewer patients who need a pacemaker following TAVR, he said.
The CoreValve as a valve-in-valve “works quite well, and is not hard to position,” said Dr. Reardon, who added that he has now performed several valve-in-valve TAVRs using the CoreValve.
Similar TAVR procedures are usually not possible using the balloon-expandable SAPIEN System because the SAPIEN valve is designed to sit directly in the annulus and, in most patients, the existing valve ring does not provide enough space to accommodate a SAPIEN valve.
Dr. Reardon anticipates that many U.S. patients now in their 80s with a failing bioprosthetic aortic valve will be interested in nonsurgical TAVR replacement. These patients often do not want conventional open-heart surgery, he said in an interview.
To evaluate the safety and efficacy of the CoreValve System for aortic valve-in-valve replacement, the FDA reviewed clinical data collected from a U.S. clinical trial with 143 patients, an agency representative said in the statement. In the clinical trial, the estimated rate of 30-day survival without major stroke was 96%, and 89% after 6 months. “This compares well to the corresponding rates reported previously for trial participants who received the same device to replace their own, native diseased or damaged aortic valve,” the agency’s statement said.
According to the agency, aortic valve-in-valve use of the CoreValve System should be limited to patients who need replacement of a failed tissue aortic valve but are at extreme or high risk of death or serious complications from traditional open-heart surgery. A decision as to whether the product and procedure are appropriate for a patient “should involve careful evaluation by the patient’s heart medical team, including a cardiologist and a cardiac surgeon.”
The FDA said that the CoreValve System should not be used in patients who have any infection, have a mechanical aortic heart valve, cannot tolerate anticoagulant drugs, or have sensitivity to titanium, nickel, or contrast media.
Dr. Maisel had no disclosures. Dr. Reardon has served as an advisor to Medtronic, the company that markets the CoreValve.
On Twitter @mitchelzoler
*Correction, 4/1/2015: An earlier version of this article misstated the device’s approval history.
AHA/ACC updates hypertension guidelines for CAD patients
The first update to U.S. guidelines for managing hypertension in adult patients with coronary artery disease in 8 years reset the target blood pressure for most of these patients to less than 140/90 mm Hg, and highlighted beta-blockers, renin-angiotensin-aldosterone system blockers, and thiazide diuretics as the mainstays of drug treatment for these patients.
The main messages in the new scientific statement from the American Heart Association, American College of Cardiology, and American Society of Hypertension, released on March 31 in an article published online (Hypertension 2015 [doi:10.116/HYP.0000000000000018]) are the blood pressure targets set for patients with coronary artery disease (CAD) and the designations of the preferred drugs to use to achieve the blood pressure goals when lifestyle measures alone prove inadequate, said Dr. Clive Rosendorff, chair of the panel that wrote the new statement.
But the statement also highlighted that a blood pressure target of less than 130/80 mm Hg “could be considered” and was reasonable for selected CAD patients whom physicians judge capable of achieving this lower blood pressure level safely and who are at especially high risk for cerebrovascular events.
“We felt the best evidence [to prevent future cardiovascular events] was to reduce pressure below 140/90 mm Hg, but a goal pressure of less than 130/80 mm Hg may be appropriate in some cases; we left it to the discretion of physicians to decide which blood pressure target to choose,” said Dr. Rosendorff, professor of medicine at Mount Sinai Hospital in New York.
The default blood pressure goal of less than 140/90 for most CAD patients represented an increase from the less than 130/80 mm Hg goal set by the prior edition of this guideline, issued in 2007 (Circulation 2007;115:2761-88). Current evidence for the lower blood pressure target of less than 130/80 mm Hg “was not as strong,” Dr. Rosendorff said in an interview. He suggested that physicians consider using the lower target for patients who are younger, reasonably healthy, able to tolerate a regimen that brings them to a lower blood pressure without an increase in angina or other significant effects caused by the drugs themselves, do not experience compromised renal function with reduced blood pressure, and have an increased risk for cerebrovascular events.
“These guidelines are not rigid, and should involve a discussion with the patient of the benefits and risks,” he said.
The new statement targets a blood pressure goal of less than 150/90 mm Hg for CAD patients who are more than 80 years old.
The new target for CAD patients represents something of a response to the blood pressure target of less than 150/90 mm Hg for people at least 60 years old recommended last year in recommendations made by the panel originally assembled as the Eighth Joint National Committee (JNC 8) (JAMA 2014;311:507-20). Although the JNC 8 recommendations aimed at the general population in a primary prevention setting, as opposed to CAD patients for whom secondary prevention is the goal, the target of less than 150/90 mm Hg became “highly controversial” and was a factor in composing the new recommendation, Dr. Rosendorff said. He also stressed that the AHA, ACC, and ASH have assembled a group that is formulating new recommendations for diagnosing and managing hypertension for the general population in a primary prevention setting that will come out sometime in the future.
The new hypertension guideline for CAD patients and the 2014 statement from the JNC 8 panel should be seen as distinct recommendations because they targeted different patient populations and because they were based on different ground rules for evidence, said Dr. Suzanne Oparil, one of three people who served on both writing groups. The JNC 8 group focused exclusively on findings from randomized, controlled trials that used hard cardiovascular disease endpoints. The writing committee for the new guidelines targeted specifically at CAD patients also considered evidence from epidemiologic studies. In addition, the new guidelines is targeted at primarily a cardiologist audience, while the 2014 JNC 8 guidelines were written primarily for primary care physicians, she said in an interview.
“I do not believe that the new CAD guidelines will change practice. They reflect what most cardiologists already do,” said Dr. Oparil, professor of medicine and director of the vascular biology and hypertension program at the University of Alabama, Birmingham.
Regarding antihypertensive drug selection the new statement endorses a focus on treating hypertensive patients with established CAD with a beta-blocker, a renin-angiotensin-aldosterone system blocker such as an ACE inhibitor or angiotensin-receptor blocker, and a thiazide or thiazide-like diuretic. Hypertensive patients with CAD should immediately start on all three drug classes, Dr. Rosendorff said.
“For patients with established CAD, a treatment with a beta-blocker moves from the limbo they are in for treating uncomplicated hypertension to center stage,” he said. The statement gives more detailed guidance on which specific drugs from the beta-blocker class have the best evidence for efficacy in various types of patients with CAD.
Dr. Rosendorff had no disclosures. Dr. Oparil has been a consultant to Bayer, Daiichi Sankyo, and Pfizer, and has received research grants from Medtronic, Merck, Novartis, and Takeda.
On Twitter @mitchelzoler
The new statement on treating hypertension in patients with established coronary artery disease clears up what had been a confusing situation for U.S. physicians during the past year.
In early 2014, the panel that had originally been assembled as the Eighth Joint National Committee (JNC 8) issued a statement that called for a blood pressure target of less than 150/90 mm Hg for people 60 years or older (JAMA 2014;311:507-20). People were very confused about that, and may have erroneously believed that this recommendation applied to patients with CAD. I and many of my colleagues believe that having a recommendation to treat to just less than 150/90 mm Hg potentially put millions of CAD patients at risk, especially at risk for stroke. The new statement highlights the high risk faced by CAD patients who need special attention to their blood pressure.
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| Mitchel L. Zoler/Fronbtline Medical News Dr. Elliott M. Antman |
The epidemiologic evidence clearly shows that increased blood pressure relates to an increased risk for cardiovascular events across a blood pressure range from 115/75 mm Hg to 185/115 mm Hg.
The new recommendations for CAD patients also say that a target blood pressure of less than 130/80 mm Hg may be preferred for selected patients, although the statement does not offer clear steps on how to identify these patients. Physicians must use their clinical judgment.
In my practice, I make sure not to drop a patient’s creatinine clearance to an unacceptably low level, and I would especially consider the lower target for patients with a history of heart failure or left ventricular dilatation or hypertrophy. I believe that in the past, physicians have been too conservative about blood pressure reduction in CAD patients, in part out of a concern about reducing perfusion pressure too much. I believe that if a CAD patient can tolerate a lower blood pressure and the treatment it takes to achieve it, then it is better to be more aggressive.
We also must always remember that the lifestyle modifications, including less dietary sodium, weight loss, and exercise, are the first steps to reducing blood pressure.
Dr. Elliott M. Antman is professor of medicine at Harvard University in Boston and president of the American Heart Association. He had no relevant disclosures. He made these comments in an interview.
The new statement on treating hypertension in patients with established coronary artery disease clears up what had been a confusing situation for U.S. physicians during the past year.
In early 2014, the panel that had originally been assembled as the Eighth Joint National Committee (JNC 8) issued a statement that called for a blood pressure target of less than 150/90 mm Hg for people 60 years or older (JAMA 2014;311:507-20). People were very confused about that, and may have erroneously believed that this recommendation applied to patients with CAD. I and many of my colleagues believe that having a recommendation to treat to just less than 150/90 mm Hg potentially put millions of CAD patients at risk, especially at risk for stroke. The new statement highlights the high risk faced by CAD patients who need special attention to their blood pressure.
|
|
| Mitchel L. Zoler/Fronbtline Medical News Dr. Elliott M. Antman |
The epidemiologic evidence clearly shows that increased blood pressure relates to an increased risk for cardiovascular events across a blood pressure range from 115/75 mm Hg to 185/115 mm Hg.
The new recommendations for CAD patients also say that a target blood pressure of less than 130/80 mm Hg may be preferred for selected patients, although the statement does not offer clear steps on how to identify these patients. Physicians must use their clinical judgment.
In my practice, I make sure not to drop a patient’s creatinine clearance to an unacceptably low level, and I would especially consider the lower target for patients with a history of heart failure or left ventricular dilatation or hypertrophy. I believe that in the past, physicians have been too conservative about blood pressure reduction in CAD patients, in part out of a concern about reducing perfusion pressure too much. I believe that if a CAD patient can tolerate a lower blood pressure and the treatment it takes to achieve it, then it is better to be more aggressive.
We also must always remember that the lifestyle modifications, including less dietary sodium, weight loss, and exercise, are the first steps to reducing blood pressure.
Dr. Elliott M. Antman is professor of medicine at Harvard University in Boston and president of the American Heart Association. He had no relevant disclosures. He made these comments in an interview.
The new statement on treating hypertension in patients with established coronary artery disease clears up what had been a confusing situation for U.S. physicians during the past year.
In early 2014, the panel that had originally been assembled as the Eighth Joint National Committee (JNC 8) issued a statement that called for a blood pressure target of less than 150/90 mm Hg for people 60 years or older (JAMA 2014;311:507-20). People were very confused about that, and may have erroneously believed that this recommendation applied to patients with CAD. I and many of my colleagues believe that having a recommendation to treat to just less than 150/90 mm Hg potentially put millions of CAD patients at risk, especially at risk for stroke. The new statement highlights the high risk faced by CAD patients who need special attention to their blood pressure.
|
|
| Mitchel L. Zoler/Fronbtline Medical News Dr. Elliott M. Antman |
The epidemiologic evidence clearly shows that increased blood pressure relates to an increased risk for cardiovascular events across a blood pressure range from 115/75 mm Hg to 185/115 mm Hg.
The new recommendations for CAD patients also say that a target blood pressure of less than 130/80 mm Hg may be preferred for selected patients, although the statement does not offer clear steps on how to identify these patients. Physicians must use their clinical judgment.
In my practice, I make sure not to drop a patient’s creatinine clearance to an unacceptably low level, and I would especially consider the lower target for patients with a history of heart failure or left ventricular dilatation or hypertrophy. I believe that in the past, physicians have been too conservative about blood pressure reduction in CAD patients, in part out of a concern about reducing perfusion pressure too much. I believe that if a CAD patient can tolerate a lower blood pressure and the treatment it takes to achieve it, then it is better to be more aggressive.
We also must always remember that the lifestyle modifications, including less dietary sodium, weight loss, and exercise, are the first steps to reducing blood pressure.
Dr. Elliott M. Antman is professor of medicine at Harvard University in Boston and president of the American Heart Association. He had no relevant disclosures. He made these comments in an interview.
The first update to U.S. guidelines for managing hypertension in adult patients with coronary artery disease in 8 years reset the target blood pressure for most of these patients to less than 140/90 mm Hg, and highlighted beta-blockers, renin-angiotensin-aldosterone system blockers, and thiazide diuretics as the mainstays of drug treatment for these patients.
The main messages in the new scientific statement from the American Heart Association, American College of Cardiology, and American Society of Hypertension, released on March 31 in an article published online (Hypertension 2015 [doi:10.116/HYP.0000000000000018]) are the blood pressure targets set for patients with coronary artery disease (CAD) and the designations of the preferred drugs to use to achieve the blood pressure goals when lifestyle measures alone prove inadequate, said Dr. Clive Rosendorff, chair of the panel that wrote the new statement.
But the statement also highlighted that a blood pressure target of less than 130/80 mm Hg “could be considered” and was reasonable for selected CAD patients whom physicians judge capable of achieving this lower blood pressure level safely and who are at especially high risk for cerebrovascular events.
“We felt the best evidence [to prevent future cardiovascular events] was to reduce pressure below 140/90 mm Hg, but a goal pressure of less than 130/80 mm Hg may be appropriate in some cases; we left it to the discretion of physicians to decide which blood pressure target to choose,” said Dr. Rosendorff, professor of medicine at Mount Sinai Hospital in New York.
The default blood pressure goal of less than 140/90 for most CAD patients represented an increase from the less than 130/80 mm Hg goal set by the prior edition of this guideline, issued in 2007 (Circulation 2007;115:2761-88). Current evidence for the lower blood pressure target of less than 130/80 mm Hg “was not as strong,” Dr. Rosendorff said in an interview. He suggested that physicians consider using the lower target for patients who are younger, reasonably healthy, able to tolerate a regimen that brings them to a lower blood pressure without an increase in angina or other significant effects caused by the drugs themselves, do not experience compromised renal function with reduced blood pressure, and have an increased risk for cerebrovascular events.
“These guidelines are not rigid, and should involve a discussion with the patient of the benefits and risks,” he said.
The new statement targets a blood pressure goal of less than 150/90 mm Hg for CAD patients who are more than 80 years old.
The new target for CAD patients represents something of a response to the blood pressure target of less than 150/90 mm Hg for people at least 60 years old recommended last year in recommendations made by the panel originally assembled as the Eighth Joint National Committee (JNC 8) (JAMA 2014;311:507-20). Although the JNC 8 recommendations aimed at the general population in a primary prevention setting, as opposed to CAD patients for whom secondary prevention is the goal, the target of less than 150/90 mm Hg became “highly controversial” and was a factor in composing the new recommendation, Dr. Rosendorff said. He also stressed that the AHA, ACC, and ASH have assembled a group that is formulating new recommendations for diagnosing and managing hypertension for the general population in a primary prevention setting that will come out sometime in the future.
The new hypertension guideline for CAD patients and the 2014 statement from the JNC 8 panel should be seen as distinct recommendations because they targeted different patient populations and because they were based on different ground rules for evidence, said Dr. Suzanne Oparil, one of three people who served on both writing groups. The JNC 8 group focused exclusively on findings from randomized, controlled trials that used hard cardiovascular disease endpoints. The writing committee for the new guidelines targeted specifically at CAD patients also considered evidence from epidemiologic studies. In addition, the new guidelines is targeted at primarily a cardiologist audience, while the 2014 JNC 8 guidelines were written primarily for primary care physicians, she said in an interview.
“I do not believe that the new CAD guidelines will change practice. They reflect what most cardiologists already do,” said Dr. Oparil, professor of medicine and director of the vascular biology and hypertension program at the University of Alabama, Birmingham.
Regarding antihypertensive drug selection the new statement endorses a focus on treating hypertensive patients with established CAD with a beta-blocker, a renin-angiotensin-aldosterone system blocker such as an ACE inhibitor or angiotensin-receptor blocker, and a thiazide or thiazide-like diuretic. Hypertensive patients with CAD should immediately start on all three drug classes, Dr. Rosendorff said.
“For patients with established CAD, a treatment with a beta-blocker moves from the limbo they are in for treating uncomplicated hypertension to center stage,” he said. The statement gives more detailed guidance on which specific drugs from the beta-blocker class have the best evidence for efficacy in various types of patients with CAD.
Dr. Rosendorff had no disclosures. Dr. Oparil has been a consultant to Bayer, Daiichi Sankyo, and Pfizer, and has received research grants from Medtronic, Merck, Novartis, and Takeda.
On Twitter @mitchelzoler
The first update to U.S. guidelines for managing hypertension in adult patients with coronary artery disease in 8 years reset the target blood pressure for most of these patients to less than 140/90 mm Hg, and highlighted beta-blockers, renin-angiotensin-aldosterone system blockers, and thiazide diuretics as the mainstays of drug treatment for these patients.
The main messages in the new scientific statement from the American Heart Association, American College of Cardiology, and American Society of Hypertension, released on March 31 in an article published online (Hypertension 2015 [doi:10.116/HYP.0000000000000018]) are the blood pressure targets set for patients with coronary artery disease (CAD) and the designations of the preferred drugs to use to achieve the blood pressure goals when lifestyle measures alone prove inadequate, said Dr. Clive Rosendorff, chair of the panel that wrote the new statement.
But the statement also highlighted that a blood pressure target of less than 130/80 mm Hg “could be considered” and was reasonable for selected CAD patients whom physicians judge capable of achieving this lower blood pressure level safely and who are at especially high risk for cerebrovascular events.
“We felt the best evidence [to prevent future cardiovascular events] was to reduce pressure below 140/90 mm Hg, but a goal pressure of less than 130/80 mm Hg may be appropriate in some cases; we left it to the discretion of physicians to decide which blood pressure target to choose,” said Dr. Rosendorff, professor of medicine at Mount Sinai Hospital in New York.
The default blood pressure goal of less than 140/90 for most CAD patients represented an increase from the less than 130/80 mm Hg goal set by the prior edition of this guideline, issued in 2007 (Circulation 2007;115:2761-88). Current evidence for the lower blood pressure target of less than 130/80 mm Hg “was not as strong,” Dr. Rosendorff said in an interview. He suggested that physicians consider using the lower target for patients who are younger, reasonably healthy, able to tolerate a regimen that brings them to a lower blood pressure without an increase in angina or other significant effects caused by the drugs themselves, do not experience compromised renal function with reduced blood pressure, and have an increased risk for cerebrovascular events.
“These guidelines are not rigid, and should involve a discussion with the patient of the benefits and risks,” he said.
The new statement targets a blood pressure goal of less than 150/90 mm Hg for CAD patients who are more than 80 years old.
The new target for CAD patients represents something of a response to the blood pressure target of less than 150/90 mm Hg for people at least 60 years old recommended last year in recommendations made by the panel originally assembled as the Eighth Joint National Committee (JNC 8) (JAMA 2014;311:507-20). Although the JNC 8 recommendations aimed at the general population in a primary prevention setting, as opposed to CAD patients for whom secondary prevention is the goal, the target of less than 150/90 mm Hg became “highly controversial” and was a factor in composing the new recommendation, Dr. Rosendorff said. He also stressed that the AHA, ACC, and ASH have assembled a group that is formulating new recommendations for diagnosing and managing hypertension for the general population in a primary prevention setting that will come out sometime in the future.
The new hypertension guideline for CAD patients and the 2014 statement from the JNC 8 panel should be seen as distinct recommendations because they targeted different patient populations and because they were based on different ground rules for evidence, said Dr. Suzanne Oparil, one of three people who served on both writing groups. The JNC 8 group focused exclusively on findings from randomized, controlled trials that used hard cardiovascular disease endpoints. The writing committee for the new guidelines targeted specifically at CAD patients also considered evidence from epidemiologic studies. In addition, the new guidelines is targeted at primarily a cardiologist audience, while the 2014 JNC 8 guidelines were written primarily for primary care physicians, she said in an interview.
“I do not believe that the new CAD guidelines will change practice. They reflect what most cardiologists already do,” said Dr. Oparil, professor of medicine and director of the vascular biology and hypertension program at the University of Alabama, Birmingham.
Regarding antihypertensive drug selection the new statement endorses a focus on treating hypertensive patients with established CAD with a beta-blocker, a renin-angiotensin-aldosterone system blocker such as an ACE inhibitor or angiotensin-receptor blocker, and a thiazide or thiazide-like diuretic. Hypertensive patients with CAD should immediately start on all three drug classes, Dr. Rosendorff said.
“For patients with established CAD, a treatment with a beta-blocker moves from the limbo they are in for treating uncomplicated hypertension to center stage,” he said. The statement gives more detailed guidance on which specific drugs from the beta-blocker class have the best evidence for efficacy in various types of patients with CAD.
Dr. Rosendorff had no disclosures. Dr. Oparil has been a consultant to Bayer, Daiichi Sankyo, and Pfizer, and has received research grants from Medtronic, Merck, Novartis, and Takeda.
On Twitter @mitchelzoler
FROM HYPERTENSION
Advanced age no barrier to aggressive heart attack treatment
SAN DIEGO – Patients aged 80 years and older benefit from more invasive early treatment after non-ST-elevation myocardial infarction or unstable angina, the After Eighty Trial showed.
After a median follow-up of 1.5 years, an invasive strategy that included coronary angiography significantly reduced the primary endpoint of myocardial infarction (MI), need for urgent revascularization, stroke, and death from 61% with optimal medical treatment to 41% (risk ratio, 0.48; P value < .00001).
That drop was driven primarily by significantly fewer MIs (17% vs. 30%; RR, 0.50; P = .0003) and urgent revascularizations (2% vs. 11%; RR, 0.19; P = .0001), lead author Dr. Nicolai Tegn reported at the American College of Cardiology/Cardiovascular Research Foundation Innovation in Intervention Summit.
There were no significant differences between the invasive and conservative strategy groups in rates of stroke (3% vs. 6%; RR, 0.61; P = .26) or all-cause death (25% vs. 27%; RR, 0.87; P = .53).
The composite of death and MI, however, significantly favored the invasive group (35% vs. 48%; RR, 0.54; P < .0001), he said during a latebreaking clinical trial session.
After Eighty randomly assigned 457 patients, aged 80 years or older, to either optimal medical therapy with no invasive treatments or coronary angiography at a percutaneous coronary intervention (PCI) center the day after inclusion, plus optimal medical therapy after about 4-5 hours if PCI was not performed or about 6-18 hours if it was. Of the 225 patients receiving angiography, 48% went on to balloon angioplasty and/or coronary stenting, and 3% had bypass surgery.
Patients 80 years or older account for roughly one-third of all patients with non-STEMI and unstable angina, but they are underrepresented in clinical trials. As a result, the role of an early invasive strategy, and even an invasive strategy at all, in those elderly patients is still a subject of debate, observed Dr. Tegn, a cardiologist from Rikshospitalet, Oslo University Hospital, Oslo.
The study demonstrated that an invasive strategy is superior to a conservative strategy in patients at least 80 years with NSTEMI or unstable angina, he concluded.
After Eighty is a welcome study because of the under-representation of the elderly in clinical trials, Dr. David Kandzari, director of interventional cardiology at the Piedmont Heart Center in Atlanta, said during a press briefing at the meeting. But it raises the challenge of identifying patients in clinical practice with the same qualifying characteristics, he added, given that the study population represents only 10% of the entire screened population,
There was also a fairly high prevalence of patients who angiographically did not have significant coronary artery disease, yet MI and stroke rates were quite considerable.
That said, “the study in other ways reminds us that the coronary anatomy does not know the age of the patient, meaning that the findings of a benefit of an early invasive strategy seem consistent with previous studies we know across the management of patients with acute coronary syndromes,” Dr. Kandzari said.
After Eighty investigators screened 4,187 elderly patients presenting at 17 community hospitals in Norway with non-STEMI or unstable angina, with or without ST-segment depression in ECG, and normal or elevated troponin T or I levels. Patients had to have no chest pain or other ischemic symptoms after medical treatment and mobilization.
In all, 3,730 patients were excluded for life expectancy less than 12 months because of a serious comorbidity; ongoing or recent bleeding; inability to comply with protocol; clinically unstable including ongoing ischemia; refusal to participate; logistic reasons; or other reasons.
The average age was 84.7 years in the invasive group (range 80-93 years) and 84.9 years in the conservative group (range 80-94 years).
Medical treatment during the index admission included 75 mg aspirin in 97% of both the invasive and conservative groups, clopidogrel (85% vs. 82%), ticagrelor (both 5%), angiotensin-converting enzyme (ACE) inhibitor/angiotensin receptor blockers (ARB) (43% vs. 50%), beta blocker (83% vs. 85%), statins (90% vs. 85%), loop or thiazide diuretics (41% vs. 33%), calcium channel blocker (20% vs. 21%), nitrates (45% vs. 55%), warfarin (17% vs. 9%), low molecular-weight heparin (both 76% ), and dabigatran in one patient in each group.
Medical therapy at discharge in the invasive and conservative groups was aspirin (both 93%), clopidogrel (both 72%), ticagrelor (both 4%), ACE inhibitor/ARB (52% vs. 54%), beta blockers (both 84%), statins (90% vs. 86%), diuretics (45% vs. 38%), calcium channel blocker (24% vs. 23%), nitrates (34% vs. 48%), warfarin (21% vs. 14%), rivaroxaban (three patients in both groups), and dabigatran (one patient vs. six patients).
There were no differences in bleeding rates between the two groups, Dr. Tegn said. Four major bleeding events were reported in both groups, while 23 patients in the invasive group and 16 patients in the conservative group had minor bleeds.
The Norwegian Health Association sponsored the study. Dr. Tegn reported nothing to disclose. Dr. Kandazari reported research and grant support from Abbott Vascular, Biotronic, Boston Scientific, and Medtronic, and minor consulting honoraria from Boston Scientific and Medtronic.
SAN DIEGO – Patients aged 80 years and older benefit from more invasive early treatment after non-ST-elevation myocardial infarction or unstable angina, the After Eighty Trial showed.
After a median follow-up of 1.5 years, an invasive strategy that included coronary angiography significantly reduced the primary endpoint of myocardial infarction (MI), need for urgent revascularization, stroke, and death from 61% with optimal medical treatment to 41% (risk ratio, 0.48; P value < .00001).
That drop was driven primarily by significantly fewer MIs (17% vs. 30%; RR, 0.50; P = .0003) and urgent revascularizations (2% vs. 11%; RR, 0.19; P = .0001), lead author Dr. Nicolai Tegn reported at the American College of Cardiology/Cardiovascular Research Foundation Innovation in Intervention Summit.
There were no significant differences between the invasive and conservative strategy groups in rates of stroke (3% vs. 6%; RR, 0.61; P = .26) or all-cause death (25% vs. 27%; RR, 0.87; P = .53).
The composite of death and MI, however, significantly favored the invasive group (35% vs. 48%; RR, 0.54; P < .0001), he said during a latebreaking clinical trial session.
After Eighty randomly assigned 457 patients, aged 80 years or older, to either optimal medical therapy with no invasive treatments or coronary angiography at a percutaneous coronary intervention (PCI) center the day after inclusion, plus optimal medical therapy after about 4-5 hours if PCI was not performed or about 6-18 hours if it was. Of the 225 patients receiving angiography, 48% went on to balloon angioplasty and/or coronary stenting, and 3% had bypass surgery.
Patients 80 years or older account for roughly one-third of all patients with non-STEMI and unstable angina, but they are underrepresented in clinical trials. As a result, the role of an early invasive strategy, and even an invasive strategy at all, in those elderly patients is still a subject of debate, observed Dr. Tegn, a cardiologist from Rikshospitalet, Oslo University Hospital, Oslo.
The study demonstrated that an invasive strategy is superior to a conservative strategy in patients at least 80 years with NSTEMI or unstable angina, he concluded.
After Eighty is a welcome study because of the under-representation of the elderly in clinical trials, Dr. David Kandzari, director of interventional cardiology at the Piedmont Heart Center in Atlanta, said during a press briefing at the meeting. But it raises the challenge of identifying patients in clinical practice with the same qualifying characteristics, he added, given that the study population represents only 10% of the entire screened population,
There was also a fairly high prevalence of patients who angiographically did not have significant coronary artery disease, yet MI and stroke rates were quite considerable.
That said, “the study in other ways reminds us that the coronary anatomy does not know the age of the patient, meaning that the findings of a benefit of an early invasive strategy seem consistent with previous studies we know across the management of patients with acute coronary syndromes,” Dr. Kandzari said.
After Eighty investigators screened 4,187 elderly patients presenting at 17 community hospitals in Norway with non-STEMI or unstable angina, with or without ST-segment depression in ECG, and normal or elevated troponin T or I levels. Patients had to have no chest pain or other ischemic symptoms after medical treatment and mobilization.
In all, 3,730 patients were excluded for life expectancy less than 12 months because of a serious comorbidity; ongoing or recent bleeding; inability to comply with protocol; clinically unstable including ongoing ischemia; refusal to participate; logistic reasons; or other reasons.
The average age was 84.7 years in the invasive group (range 80-93 years) and 84.9 years in the conservative group (range 80-94 years).
Medical treatment during the index admission included 75 mg aspirin in 97% of both the invasive and conservative groups, clopidogrel (85% vs. 82%), ticagrelor (both 5%), angiotensin-converting enzyme (ACE) inhibitor/angiotensin receptor blockers (ARB) (43% vs. 50%), beta blocker (83% vs. 85%), statins (90% vs. 85%), loop or thiazide diuretics (41% vs. 33%), calcium channel blocker (20% vs. 21%), nitrates (45% vs. 55%), warfarin (17% vs. 9%), low molecular-weight heparin (both 76% ), and dabigatran in one patient in each group.
Medical therapy at discharge in the invasive and conservative groups was aspirin (both 93%), clopidogrel (both 72%), ticagrelor (both 4%), ACE inhibitor/ARB (52% vs. 54%), beta blockers (both 84%), statins (90% vs. 86%), diuretics (45% vs. 38%), calcium channel blocker (24% vs. 23%), nitrates (34% vs. 48%), warfarin (21% vs. 14%), rivaroxaban (three patients in both groups), and dabigatran (one patient vs. six patients).
There were no differences in bleeding rates between the two groups, Dr. Tegn said. Four major bleeding events were reported in both groups, while 23 patients in the invasive group and 16 patients in the conservative group had minor bleeds.
The Norwegian Health Association sponsored the study. Dr. Tegn reported nothing to disclose. Dr. Kandazari reported research and grant support from Abbott Vascular, Biotronic, Boston Scientific, and Medtronic, and minor consulting honoraria from Boston Scientific and Medtronic.
SAN DIEGO – Patients aged 80 years and older benefit from more invasive early treatment after non-ST-elevation myocardial infarction or unstable angina, the After Eighty Trial showed.
After a median follow-up of 1.5 years, an invasive strategy that included coronary angiography significantly reduced the primary endpoint of myocardial infarction (MI), need for urgent revascularization, stroke, and death from 61% with optimal medical treatment to 41% (risk ratio, 0.48; P value < .00001).
That drop was driven primarily by significantly fewer MIs (17% vs. 30%; RR, 0.50; P = .0003) and urgent revascularizations (2% vs. 11%; RR, 0.19; P = .0001), lead author Dr. Nicolai Tegn reported at the American College of Cardiology/Cardiovascular Research Foundation Innovation in Intervention Summit.
There were no significant differences between the invasive and conservative strategy groups in rates of stroke (3% vs. 6%; RR, 0.61; P = .26) or all-cause death (25% vs. 27%; RR, 0.87; P = .53).
The composite of death and MI, however, significantly favored the invasive group (35% vs. 48%; RR, 0.54; P < .0001), he said during a latebreaking clinical trial session.
After Eighty randomly assigned 457 patients, aged 80 years or older, to either optimal medical therapy with no invasive treatments or coronary angiography at a percutaneous coronary intervention (PCI) center the day after inclusion, plus optimal medical therapy after about 4-5 hours if PCI was not performed or about 6-18 hours if it was. Of the 225 patients receiving angiography, 48% went on to balloon angioplasty and/or coronary stenting, and 3% had bypass surgery.
Patients 80 years or older account for roughly one-third of all patients with non-STEMI and unstable angina, but they are underrepresented in clinical trials. As a result, the role of an early invasive strategy, and even an invasive strategy at all, in those elderly patients is still a subject of debate, observed Dr. Tegn, a cardiologist from Rikshospitalet, Oslo University Hospital, Oslo.
The study demonstrated that an invasive strategy is superior to a conservative strategy in patients at least 80 years with NSTEMI or unstable angina, he concluded.
After Eighty is a welcome study because of the under-representation of the elderly in clinical trials, Dr. David Kandzari, director of interventional cardiology at the Piedmont Heart Center in Atlanta, said during a press briefing at the meeting. But it raises the challenge of identifying patients in clinical practice with the same qualifying characteristics, he added, given that the study population represents only 10% of the entire screened population,
There was also a fairly high prevalence of patients who angiographically did not have significant coronary artery disease, yet MI and stroke rates were quite considerable.
That said, “the study in other ways reminds us that the coronary anatomy does not know the age of the patient, meaning that the findings of a benefit of an early invasive strategy seem consistent with previous studies we know across the management of patients with acute coronary syndromes,” Dr. Kandzari said.
After Eighty investigators screened 4,187 elderly patients presenting at 17 community hospitals in Norway with non-STEMI or unstable angina, with or without ST-segment depression in ECG, and normal or elevated troponin T or I levels. Patients had to have no chest pain or other ischemic symptoms after medical treatment and mobilization.
In all, 3,730 patients were excluded for life expectancy less than 12 months because of a serious comorbidity; ongoing or recent bleeding; inability to comply with protocol; clinically unstable including ongoing ischemia; refusal to participate; logistic reasons; or other reasons.
The average age was 84.7 years in the invasive group (range 80-93 years) and 84.9 years in the conservative group (range 80-94 years).
Medical treatment during the index admission included 75 mg aspirin in 97% of both the invasive and conservative groups, clopidogrel (85% vs. 82%), ticagrelor (both 5%), angiotensin-converting enzyme (ACE) inhibitor/angiotensin receptor blockers (ARB) (43% vs. 50%), beta blocker (83% vs. 85%), statins (90% vs. 85%), loop or thiazide diuretics (41% vs. 33%), calcium channel blocker (20% vs. 21%), nitrates (45% vs. 55%), warfarin (17% vs. 9%), low molecular-weight heparin (both 76% ), and dabigatran in one patient in each group.
Medical therapy at discharge in the invasive and conservative groups was aspirin (both 93%), clopidogrel (both 72%), ticagrelor (both 4%), ACE inhibitor/ARB (52% vs. 54%), beta blockers (both 84%), statins (90% vs. 86%), diuretics (45% vs. 38%), calcium channel blocker (24% vs. 23%), nitrates (34% vs. 48%), warfarin (21% vs. 14%), rivaroxaban (three patients in both groups), and dabigatran (one patient vs. six patients).
There were no differences in bleeding rates between the two groups, Dr. Tegn said. Four major bleeding events were reported in both groups, while 23 patients in the invasive group and 16 patients in the conservative group had minor bleeds.
The Norwegian Health Association sponsored the study. Dr. Tegn reported nothing to disclose. Dr. Kandazari reported research and grant support from Abbott Vascular, Biotronic, Boston Scientific, and Medtronic, and minor consulting honoraria from Boston Scientific and Medtronic.
AT ACC/CRF i2 SUMMIT
Key clinical point: An early invasive treatment strategy improved most outcomes in patients aged 80 years and older with acute coronary syndromes.
Major finding: Myocardial infarction, need for urgent revascularization, stroke, and death were significantly lower with invasive vs. conservative care (41% vs. 61%; risk ratio, 0.48; P < .00001).
Data source: Randomized study in 457 patients aged 80 years or older with non-STEMI or unstable angina.
Disclosures: The Norwegian Health Association sponsored the study. Dr. Tegn reported nothing to disclose. Dr. Kandzari reported research and grant support from Abbott Vascular, Biotronic, Boston Scientific, and Medtronic, and minor consulting honoraria from Boston Scientific and Medtronic.
Senate recesses without addressing SGR repeal bill
The Senate adjourned for a 2-week recess early on March 27, leaving without taking action on House-passed legislation to repeal the Medicare Sustainable Growth Rate formula and reauthorize the Children’s Health Insurance Program.
The Senate will not convene again until April 13, nearly 2 weeks after a temporary SGR patch expires. Doctors will see their Medicare pay cut by 21% on April 1.
As has happened in the SGR’s troubled past and for other reasons, doctors and legislators expect the Centers for Medicare & Medicaid Services to hold Medicare payments for a while until the Senate can act.
“We’ve seen CMS hold checks for 2 weeks. We know that can happen,” Rep. Michael Burgess (R-Texas), lead sponsor of H.R. 2, the Medicare Access and CHIP Reauthorization Act, told reporters. “If it doesn’t pass this week, the world wouldn’t come to an end.”
A 2-week hold generally does not impact physicians’ practices too harshly, Dr. Robert Wergin, president of the American Academy of Family Physicians, said regarding an administrative hold CMS announced in January 2015. “It does affect your cash flow, but it has happened in the past, particularly around the time with SGR patches.”
The American Medical Association called for the Senate to address H.R. 2 as soon as it returns.
“Physicians are always working to provide the highest quality of care for their patients and the bipartisan bill passed by the House provides a clear pathway for them to do that,” Dr. Robert Wah, president of the AMA, said in a statement. “We urge the Senate to immediately address this issue upon their return and once-and-for-all lay this destructive issue to rest by building the stable and sustainable Medicare program that our nation’s patients and physicians need and deserve.”
On Twitter @denisefulton
The Senate adjourned for a 2-week recess early on March 27, leaving without taking action on House-passed legislation to repeal the Medicare Sustainable Growth Rate formula and reauthorize the Children’s Health Insurance Program.
The Senate will not convene again until April 13, nearly 2 weeks after a temporary SGR patch expires. Doctors will see their Medicare pay cut by 21% on April 1.
As has happened in the SGR’s troubled past and for other reasons, doctors and legislators expect the Centers for Medicare & Medicaid Services to hold Medicare payments for a while until the Senate can act.
“We’ve seen CMS hold checks for 2 weeks. We know that can happen,” Rep. Michael Burgess (R-Texas), lead sponsor of H.R. 2, the Medicare Access and CHIP Reauthorization Act, told reporters. “If it doesn’t pass this week, the world wouldn’t come to an end.”
A 2-week hold generally does not impact physicians’ practices too harshly, Dr. Robert Wergin, president of the American Academy of Family Physicians, said regarding an administrative hold CMS announced in January 2015. “It does affect your cash flow, but it has happened in the past, particularly around the time with SGR patches.”
The American Medical Association called for the Senate to address H.R. 2 as soon as it returns.
“Physicians are always working to provide the highest quality of care for their patients and the bipartisan bill passed by the House provides a clear pathway for them to do that,” Dr. Robert Wah, president of the AMA, said in a statement. “We urge the Senate to immediately address this issue upon their return and once-and-for-all lay this destructive issue to rest by building the stable and sustainable Medicare program that our nation’s patients and physicians need and deserve.”
On Twitter @denisefulton
The Senate adjourned for a 2-week recess early on March 27, leaving without taking action on House-passed legislation to repeal the Medicare Sustainable Growth Rate formula and reauthorize the Children’s Health Insurance Program.
The Senate will not convene again until April 13, nearly 2 weeks after a temporary SGR patch expires. Doctors will see their Medicare pay cut by 21% on April 1.
As has happened in the SGR’s troubled past and for other reasons, doctors and legislators expect the Centers for Medicare & Medicaid Services to hold Medicare payments for a while until the Senate can act.
“We’ve seen CMS hold checks for 2 weeks. We know that can happen,” Rep. Michael Burgess (R-Texas), lead sponsor of H.R. 2, the Medicare Access and CHIP Reauthorization Act, told reporters. “If it doesn’t pass this week, the world wouldn’t come to an end.”
A 2-week hold generally does not impact physicians’ practices too harshly, Dr. Robert Wergin, president of the American Academy of Family Physicians, said regarding an administrative hold CMS announced in January 2015. “It does affect your cash flow, but it has happened in the past, particularly around the time with SGR patches.”
The American Medical Association called for the Senate to address H.R. 2 as soon as it returns.
“Physicians are always working to provide the highest quality of care for their patients and the bipartisan bill passed by the House provides a clear pathway for them to do that,” Dr. Robert Wah, president of the AMA, said in a statement. “We urge the Senate to immediately address this issue upon their return and once-and-for-all lay this destructive issue to rest by building the stable and sustainable Medicare program that our nation’s patients and physicians need and deserve.”
On Twitter @denisefulton
