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Doctors hail House vote to repeal, replace SGR
Physicians are lauding passage of legislation by the House of Representatives to repeal the Medicare Sustainable Growth Rate formula (SGR) and replace it with an alternative system that would raise physician payments and focus on value-based performance. The bill also reauthorizes the Children’s Health Insurance Program (CHIP) for 2 years.
By a vote of 329-37, the House on March 26 passed H.R. 2, the Medicare Access and CHIP Reauthorization Act. The legislation builds on H.R. 1470, the SGR Repeal and Medicare Provider Payment Modernization Act – reintroduced March 19 – which includes a 0.5% pay increase per year for providers over the next 5 years.
Physician leaders praised the vote and thanked lawmakers for finally passing what they called a critical SGR fix.
“Never before has there been such broad and bipartisan support within and outside of Congress for policies to repeal the Medicare SGR formula and to create a better payment system for physician services provided to patients enrolled in Medicare,” ACP President David A. Fleming said in a statement. “It is imperative that the Senate pass H.R. 2 before it recesses on Friday, March 27, and before a devastating 21% SGR cut is applied cut is applied to all physician services provided to Medicare enrollees.”
If enacted, H.R. 2 also would consolidate existing quality programs – including those regarding the meaningful use of electronic health records – into a single value-based performance program; incentivize physicians to use alternate payment models that focus on care coordination and preventive care; and push for more transparency of Medicare data for physicians, providers, and patients.
The bill also would reauthorize for 2 years CHIP, the Community Health Centers program, the National Health Service Corps, and the Teaching Health Centers program, all are scheduled to expire later this year. Additionally, the legislation continues a partial delay of the Medicare two-midnights ruleuntil Sept. 30.
The Congressional Budget Office estimates that enactment of H.R. 2 will increase the deficit by $141 billion over 10 years. The CBO’s score also found that the legislation would save money compared to the price of continued patches.
A total of $73 billion of the $214 billion cost of package is offset through spending reductions and revenue increases included in the bill, the CBO found. These include income-related premium adjustments for Medicare Parts B and D, Medigap reforms, an increase of levy authority on payments to Medicare providers with delinquent tax debt, adjustments to inpatient hospital payment rates, a delay of Medicaid Disproportionate Share Hospital (DSH) changes until 2018, and a 1% market basket update for postacute care providers
During House debate, Rep. Michael C. Burgess (R-Texas), the bill’s sponsor and a member of the Energy and Commerce Committee’s Health Subcommittee, said the legislation resolves an issue that many lawmakers have worked to repair their entire congressional careers.
“Everyone agrees, the Medicare Sustainable Growth Rate formula has got to go,” said Rep. Burgess, an ob.gyn. “The bill before us provides 5 years of payment transition and allows medicine to concentrate on moving to broad adoption of quality reporting and most importantly, allows congress to move past the distraction of the SGR formula and to begin to identify Medicare reforms that can further benefit our citizens.”
Physician associations commended passage of the bill.
“The American Medical Association applauds the U.S. House of Representatives for overwhelmingly passing a long overdue bill to permanently eliminate the flawed SGR formula and put in place important Medicare payment and delivery reforms that will improve the health of the nation,” AMA President Robert M. Wah said in a statement.
Long-term health security for elderly and disabled patients is closer to reality thanks to the passage of H.R. 2, according to Dr. Robert L. Wergin, president of the American Academy of Family Physicians.
“For the first time in 12 years, true Medicare reform is feasible,” Dr. Wergin said in a statement. “H.R. 2 repeals the disruptive SGR and restructures physician payment to help expand access, encourage quality improvements and spur innovation. The SGR has plagued Medicare patients for far too long. It’s destabilized their access to care and threatened the financial viability of their physicians’ practices for more than a decade.”
By reauthorizing CHIP, the bill will also help ensure millions of children, adolescents, and pregnant women have access to the care that they need, according to a joint statement by the American Academy of Pediatrics, the AMA, and the American Congress of Obstetricians and Gynecologists.
“CHIP is a bipartisan program that works,” the organizations said. “Since its beginning 17 years ago, the program has worked together with Medicaid to cut the child uninsurance rate in half, offering timely access to high-quality, affordable health insurance.”
Enactment of H.R. 2 will allow physicians to focus more fully on patient care rather than face the threat of dramatic cuts that could make caring for Medicare patients unsustainable, according to Dr. Kim Allan Williams Sr., president of the American College of Cardiology.
“Instead of kicking the can down the road one more time, Speaker [John] Boehner and Leader [Nancy] Pelosi demonstrated strong bipartisan leadership to address this problem at last. We urge the Senate to follow suit and quickly take up and pass the provisions of the House measure,” Dr. Williams said in a statement.
President Obama has indicated that he will sign the bill, calling the replacement model a system that offers predictability and accelerates participation in alternative payment models that encourage quality and efficiency.
“The proposal would advance the administration’s goal of moving the nation’s health care delivery system toward one that achieves better care, smarter spending, and healthier people through the expansion of new health care payment models, which could contribute to slowing long-term health care cost growth,” Mr. Obama said in a March 25 statement.
The bill’s passage comes as the latest SGR patch is set to expire on March 31.
The Senate could take up the bill as early as March 27; however, it also could wait until mid-April after a 2-week recess. Without a permanent or temporary SGR fix, doctors can expect a 21% Medicare pay cut come April 1.
Democrats on the Senate Finance Committee have criticized H.R. 2, saying that it unfairly penalizes patients and does not reauthorize CHIP for long enough.
“Any legislation of this magnitude sent to the Senate must be balanced,” according to a joint statement signed by all 12 Democrats who serve on the Finance Committee. “Our current understanding of what the House is negotiating does not sufficiently pass that test....While our concerns vary, we are united by the necessity of extending CHIP funding for 4 years.”
But Finance Committee Chair Sen. Orrin Hatch (R-Utah) has called for swift passage of the bill.
“The time to act is now,” Sen. Hatch said in a March 25 speech on the Senate floor. “I can’t imagine another bipartisan opportunity like this coming around again anytime soon.”
On Twitter @legal_med
Physicians are lauding passage of legislation by the House of Representatives to repeal the Medicare Sustainable Growth Rate formula (SGR) and replace it with an alternative system that would raise physician payments and focus on value-based performance. The bill also reauthorizes the Children’s Health Insurance Program (CHIP) for 2 years.
By a vote of 329-37, the House on March 26 passed H.R. 2, the Medicare Access and CHIP Reauthorization Act. The legislation builds on H.R. 1470, the SGR Repeal and Medicare Provider Payment Modernization Act – reintroduced March 19 – which includes a 0.5% pay increase per year for providers over the next 5 years.
Physician leaders praised the vote and thanked lawmakers for finally passing what they called a critical SGR fix.
“Never before has there been such broad and bipartisan support within and outside of Congress for policies to repeal the Medicare SGR formula and to create a better payment system for physician services provided to patients enrolled in Medicare,” ACP President David A. Fleming said in a statement. “It is imperative that the Senate pass H.R. 2 before it recesses on Friday, March 27, and before a devastating 21% SGR cut is applied cut is applied to all physician services provided to Medicare enrollees.”
If enacted, H.R. 2 also would consolidate existing quality programs – including those regarding the meaningful use of electronic health records – into a single value-based performance program; incentivize physicians to use alternate payment models that focus on care coordination and preventive care; and push for more transparency of Medicare data for physicians, providers, and patients.
The bill also would reauthorize for 2 years CHIP, the Community Health Centers program, the National Health Service Corps, and the Teaching Health Centers program, all are scheduled to expire later this year. Additionally, the legislation continues a partial delay of the Medicare two-midnights ruleuntil Sept. 30.
The Congressional Budget Office estimates that enactment of H.R. 2 will increase the deficit by $141 billion over 10 years. The CBO’s score also found that the legislation would save money compared to the price of continued patches.
A total of $73 billion of the $214 billion cost of package is offset through spending reductions and revenue increases included in the bill, the CBO found. These include income-related premium adjustments for Medicare Parts B and D, Medigap reforms, an increase of levy authority on payments to Medicare providers with delinquent tax debt, adjustments to inpatient hospital payment rates, a delay of Medicaid Disproportionate Share Hospital (DSH) changes until 2018, and a 1% market basket update for postacute care providers
During House debate, Rep. Michael C. Burgess (R-Texas), the bill’s sponsor and a member of the Energy and Commerce Committee’s Health Subcommittee, said the legislation resolves an issue that many lawmakers have worked to repair their entire congressional careers.
“Everyone agrees, the Medicare Sustainable Growth Rate formula has got to go,” said Rep. Burgess, an ob.gyn. “The bill before us provides 5 years of payment transition and allows medicine to concentrate on moving to broad adoption of quality reporting and most importantly, allows congress to move past the distraction of the SGR formula and to begin to identify Medicare reforms that can further benefit our citizens.”
Physician associations commended passage of the bill.
“The American Medical Association applauds the U.S. House of Representatives for overwhelmingly passing a long overdue bill to permanently eliminate the flawed SGR formula and put in place important Medicare payment and delivery reforms that will improve the health of the nation,” AMA President Robert M. Wah said in a statement.
Long-term health security for elderly and disabled patients is closer to reality thanks to the passage of H.R. 2, according to Dr. Robert L. Wergin, president of the American Academy of Family Physicians.
“For the first time in 12 years, true Medicare reform is feasible,” Dr. Wergin said in a statement. “H.R. 2 repeals the disruptive SGR and restructures physician payment to help expand access, encourage quality improvements and spur innovation. The SGR has plagued Medicare patients for far too long. It’s destabilized their access to care and threatened the financial viability of their physicians’ practices for more than a decade.”
By reauthorizing CHIP, the bill will also help ensure millions of children, adolescents, and pregnant women have access to the care that they need, according to a joint statement by the American Academy of Pediatrics, the AMA, and the American Congress of Obstetricians and Gynecologists.
“CHIP is a bipartisan program that works,” the organizations said. “Since its beginning 17 years ago, the program has worked together with Medicaid to cut the child uninsurance rate in half, offering timely access to high-quality, affordable health insurance.”
Enactment of H.R. 2 will allow physicians to focus more fully on patient care rather than face the threat of dramatic cuts that could make caring for Medicare patients unsustainable, according to Dr. Kim Allan Williams Sr., president of the American College of Cardiology.
“Instead of kicking the can down the road one more time, Speaker [John] Boehner and Leader [Nancy] Pelosi demonstrated strong bipartisan leadership to address this problem at last. We urge the Senate to follow suit and quickly take up and pass the provisions of the House measure,” Dr. Williams said in a statement.
President Obama has indicated that he will sign the bill, calling the replacement model a system that offers predictability and accelerates participation in alternative payment models that encourage quality and efficiency.
“The proposal would advance the administration’s goal of moving the nation’s health care delivery system toward one that achieves better care, smarter spending, and healthier people through the expansion of new health care payment models, which could contribute to slowing long-term health care cost growth,” Mr. Obama said in a March 25 statement.
The bill’s passage comes as the latest SGR patch is set to expire on March 31.
The Senate could take up the bill as early as March 27; however, it also could wait until mid-April after a 2-week recess. Without a permanent or temporary SGR fix, doctors can expect a 21% Medicare pay cut come April 1.
Democrats on the Senate Finance Committee have criticized H.R. 2, saying that it unfairly penalizes patients and does not reauthorize CHIP for long enough.
“Any legislation of this magnitude sent to the Senate must be balanced,” according to a joint statement signed by all 12 Democrats who serve on the Finance Committee. “Our current understanding of what the House is negotiating does not sufficiently pass that test....While our concerns vary, we are united by the necessity of extending CHIP funding for 4 years.”
But Finance Committee Chair Sen. Orrin Hatch (R-Utah) has called for swift passage of the bill.
“The time to act is now,” Sen. Hatch said in a March 25 speech on the Senate floor. “I can’t imagine another bipartisan opportunity like this coming around again anytime soon.”
On Twitter @legal_med
Physicians are lauding passage of legislation by the House of Representatives to repeal the Medicare Sustainable Growth Rate formula (SGR) and replace it with an alternative system that would raise physician payments and focus on value-based performance. The bill also reauthorizes the Children’s Health Insurance Program (CHIP) for 2 years.
By a vote of 329-37, the House on March 26 passed H.R. 2, the Medicare Access and CHIP Reauthorization Act. The legislation builds on H.R. 1470, the SGR Repeal and Medicare Provider Payment Modernization Act – reintroduced March 19 – which includes a 0.5% pay increase per year for providers over the next 5 years.
Physician leaders praised the vote and thanked lawmakers for finally passing what they called a critical SGR fix.
“Never before has there been such broad and bipartisan support within and outside of Congress for policies to repeal the Medicare SGR formula and to create a better payment system for physician services provided to patients enrolled in Medicare,” ACP President David A. Fleming said in a statement. “It is imperative that the Senate pass H.R. 2 before it recesses on Friday, March 27, and before a devastating 21% SGR cut is applied cut is applied to all physician services provided to Medicare enrollees.”
If enacted, H.R. 2 also would consolidate existing quality programs – including those regarding the meaningful use of electronic health records – into a single value-based performance program; incentivize physicians to use alternate payment models that focus on care coordination and preventive care; and push for more transparency of Medicare data for physicians, providers, and patients.
The bill also would reauthorize for 2 years CHIP, the Community Health Centers program, the National Health Service Corps, and the Teaching Health Centers program, all are scheduled to expire later this year. Additionally, the legislation continues a partial delay of the Medicare two-midnights ruleuntil Sept. 30.
The Congressional Budget Office estimates that enactment of H.R. 2 will increase the deficit by $141 billion over 10 years. The CBO’s score also found that the legislation would save money compared to the price of continued patches.
A total of $73 billion of the $214 billion cost of package is offset through spending reductions and revenue increases included in the bill, the CBO found. These include income-related premium adjustments for Medicare Parts B and D, Medigap reforms, an increase of levy authority on payments to Medicare providers with delinquent tax debt, adjustments to inpatient hospital payment rates, a delay of Medicaid Disproportionate Share Hospital (DSH) changes until 2018, and a 1% market basket update for postacute care providers
During House debate, Rep. Michael C. Burgess (R-Texas), the bill’s sponsor and a member of the Energy and Commerce Committee’s Health Subcommittee, said the legislation resolves an issue that many lawmakers have worked to repair their entire congressional careers.
“Everyone agrees, the Medicare Sustainable Growth Rate formula has got to go,” said Rep. Burgess, an ob.gyn. “The bill before us provides 5 years of payment transition and allows medicine to concentrate on moving to broad adoption of quality reporting and most importantly, allows congress to move past the distraction of the SGR formula and to begin to identify Medicare reforms that can further benefit our citizens.”
Physician associations commended passage of the bill.
“The American Medical Association applauds the U.S. House of Representatives for overwhelmingly passing a long overdue bill to permanently eliminate the flawed SGR formula and put in place important Medicare payment and delivery reforms that will improve the health of the nation,” AMA President Robert M. Wah said in a statement.
Long-term health security for elderly and disabled patients is closer to reality thanks to the passage of H.R. 2, according to Dr. Robert L. Wergin, president of the American Academy of Family Physicians.
“For the first time in 12 years, true Medicare reform is feasible,” Dr. Wergin said in a statement. “H.R. 2 repeals the disruptive SGR and restructures physician payment to help expand access, encourage quality improvements and spur innovation. The SGR has plagued Medicare patients for far too long. It’s destabilized their access to care and threatened the financial viability of their physicians’ practices for more than a decade.”
By reauthorizing CHIP, the bill will also help ensure millions of children, adolescents, and pregnant women have access to the care that they need, according to a joint statement by the American Academy of Pediatrics, the AMA, and the American Congress of Obstetricians and Gynecologists.
“CHIP is a bipartisan program that works,” the organizations said. “Since its beginning 17 years ago, the program has worked together with Medicaid to cut the child uninsurance rate in half, offering timely access to high-quality, affordable health insurance.”
Enactment of H.R. 2 will allow physicians to focus more fully on patient care rather than face the threat of dramatic cuts that could make caring for Medicare patients unsustainable, according to Dr. Kim Allan Williams Sr., president of the American College of Cardiology.
“Instead of kicking the can down the road one more time, Speaker [John] Boehner and Leader [Nancy] Pelosi demonstrated strong bipartisan leadership to address this problem at last. We urge the Senate to follow suit and quickly take up and pass the provisions of the House measure,” Dr. Williams said in a statement.
President Obama has indicated that he will sign the bill, calling the replacement model a system that offers predictability and accelerates participation in alternative payment models that encourage quality and efficiency.
“The proposal would advance the administration’s goal of moving the nation’s health care delivery system toward one that achieves better care, smarter spending, and healthier people through the expansion of new health care payment models, which could contribute to slowing long-term health care cost growth,” Mr. Obama said in a March 25 statement.
The bill’s passage comes as the latest SGR patch is set to expire on March 31.
The Senate could take up the bill as early as March 27; however, it also could wait until mid-April after a 2-week recess. Without a permanent or temporary SGR fix, doctors can expect a 21% Medicare pay cut come April 1.
Democrats on the Senate Finance Committee have criticized H.R. 2, saying that it unfairly penalizes patients and does not reauthorize CHIP for long enough.
“Any legislation of this magnitude sent to the Senate must be balanced,” according to a joint statement signed by all 12 Democrats who serve on the Finance Committee. “Our current understanding of what the House is negotiating does not sufficiently pass that test....While our concerns vary, we are united by the necessity of extending CHIP funding for 4 years.”
But Finance Committee Chair Sen. Orrin Hatch (R-Utah) has called for swift passage of the bill.
“The time to act is now,” Sen. Hatch said in a March 25 speech on the Senate floor. “I can’t imagine another bipartisan opportunity like this coming around again anytime soon.”
On Twitter @legal_med
House votes to repeal SGR, reauthorize CHIP
After years of failed attempts and temporary fixes, the House of Representatives on March 26 passed H.R. 2, a bill to repeal the Medicare Sustainable Growth Rate formula (SGR) and replace it with an alternative system that temporarily would raise Medicare physician pay and focus on value-based performance. The bill also reauthorizes the Children’s Health Insurance Program (CHIP) for 2 years, as well as other provisions.
Check back for detailed analysis and next steps for the legislation later on March 26.
After years of failed attempts and temporary fixes, the House of Representatives on March 26 passed H.R. 2, a bill to repeal the Medicare Sustainable Growth Rate formula (SGR) and replace it with an alternative system that temporarily would raise Medicare physician pay and focus on value-based performance. The bill also reauthorizes the Children’s Health Insurance Program (CHIP) for 2 years, as well as other provisions.
Check back for detailed analysis and next steps for the legislation later on March 26.
After years of failed attempts and temporary fixes, the House of Representatives on March 26 passed H.R. 2, a bill to repeal the Medicare Sustainable Growth Rate formula (SGR) and replace it with an alternative system that temporarily would raise Medicare physician pay and focus on value-based performance. The bill also reauthorizes the Children’s Health Insurance Program (CHIP) for 2 years, as well as other provisions.
Check back for detailed analysis and next steps for the legislation later on March 26.
CMS: Stage 3 meaningful use by 2018
All physicians and hospitals would need to meet stage 3 meaningful use beginning in 2018, according to a recent proposal by the Centers for Medicare & Medicaid Services.
In the agency’s Stage 3 proposed rule, there would be no transition period from earlier stages for those just starting or those who were in an earlier stage. CMS said that this is “expected to be the final stage” and will incorporate elements of the previous two stages.
That change comes along with the proposal beginning in 2017 to permanently make the attestation period a full year, with a few exceptions. A full-year attestation period was supposed to go into effect for 2015 with Stage 2, but CMS announced that it would reduce attestation to a 90-day period because of low participation.
The final year in which participants in the EHR Incentive Programs can receive bonus payments for meeting meaningful use criteria is 2017; penalties for failing to meet criteria have already begun.
The American College of Cardiology said in a statement that it is “concerned” by the proposal that even new physicians and practices will have to jump immediately to stage 3 in 2018 without a transition period.
“Implementing an EHR system in a physician or a hospital is not as simple as flipping a switch; it takes time, financial investment, careful consideration and planning, as well as education for all staff. The program must take this learning curve into consideration,” Dr. Kim Allan Williams Sr., ACC president, said in a statement.
The proposed rule also contains a number of more stringent requirements. On the patient engagement front, the proposed rule calls for 25% of patients to access their data, although it also allows for third-party providers to access a patient’s account as a means of satisfying the requirement. Patient-generated data also are highlighted, with a proposed requirement that physicians collect information via mobile devices or apps from 15% of their patients.Under the proposed Stage 3 of meaningful use, physicians and eligible hospitals must meet two of three criteria: that more than 50% of referrals or transitions of care involve the passing of information by the referring provider; that more than 40% of transitions or referrals received by a provider seeing a patient for the first time include information imported into that new provider’s EHR; or that for more than 80% of those new patients seen in transition or by referral for the first time, a clinical reconciliation be done on the information received during the health information exchange, including a review of current medications, medication allergies, and current and active diagnoses.
The proposed rule is scheduled to be published in the Federal Register on March 30; comments will be accepted at www.regulations.gov until May 29.
All physicians and hospitals would need to meet stage 3 meaningful use beginning in 2018, according to a recent proposal by the Centers for Medicare & Medicaid Services.
In the agency’s Stage 3 proposed rule, there would be no transition period from earlier stages for those just starting or those who were in an earlier stage. CMS said that this is “expected to be the final stage” and will incorporate elements of the previous two stages.
That change comes along with the proposal beginning in 2017 to permanently make the attestation period a full year, with a few exceptions. A full-year attestation period was supposed to go into effect for 2015 with Stage 2, but CMS announced that it would reduce attestation to a 90-day period because of low participation.
The final year in which participants in the EHR Incentive Programs can receive bonus payments for meeting meaningful use criteria is 2017; penalties for failing to meet criteria have already begun.
The American College of Cardiology said in a statement that it is “concerned” by the proposal that even new physicians and practices will have to jump immediately to stage 3 in 2018 without a transition period.
“Implementing an EHR system in a physician or a hospital is not as simple as flipping a switch; it takes time, financial investment, careful consideration and planning, as well as education for all staff. The program must take this learning curve into consideration,” Dr. Kim Allan Williams Sr., ACC president, said in a statement.
The proposed rule also contains a number of more stringent requirements. On the patient engagement front, the proposed rule calls for 25% of patients to access their data, although it also allows for third-party providers to access a patient’s account as a means of satisfying the requirement. Patient-generated data also are highlighted, with a proposed requirement that physicians collect information via mobile devices or apps from 15% of their patients.Under the proposed Stage 3 of meaningful use, physicians and eligible hospitals must meet two of three criteria: that more than 50% of referrals or transitions of care involve the passing of information by the referring provider; that more than 40% of transitions or referrals received by a provider seeing a patient for the first time include information imported into that new provider’s EHR; or that for more than 80% of those new patients seen in transition or by referral for the first time, a clinical reconciliation be done on the information received during the health information exchange, including a review of current medications, medication allergies, and current and active diagnoses.
The proposed rule is scheduled to be published in the Federal Register on March 30; comments will be accepted at www.regulations.gov until May 29.
All physicians and hospitals would need to meet stage 3 meaningful use beginning in 2018, according to a recent proposal by the Centers for Medicare & Medicaid Services.
In the agency’s Stage 3 proposed rule, there would be no transition period from earlier stages for those just starting or those who were in an earlier stage. CMS said that this is “expected to be the final stage” and will incorporate elements of the previous two stages.
That change comes along with the proposal beginning in 2017 to permanently make the attestation period a full year, with a few exceptions. A full-year attestation period was supposed to go into effect for 2015 with Stage 2, but CMS announced that it would reduce attestation to a 90-day period because of low participation.
The final year in which participants in the EHR Incentive Programs can receive bonus payments for meeting meaningful use criteria is 2017; penalties for failing to meet criteria have already begun.
The American College of Cardiology said in a statement that it is “concerned” by the proposal that even new physicians and practices will have to jump immediately to stage 3 in 2018 without a transition period.
“Implementing an EHR system in a physician or a hospital is not as simple as flipping a switch; it takes time, financial investment, careful consideration and planning, as well as education for all staff. The program must take this learning curve into consideration,” Dr. Kim Allan Williams Sr., ACC president, said in a statement.
The proposed rule also contains a number of more stringent requirements. On the patient engagement front, the proposed rule calls for 25% of patients to access their data, although it also allows for third-party providers to access a patient’s account as a means of satisfying the requirement. Patient-generated data also are highlighted, with a proposed requirement that physicians collect information via mobile devices or apps from 15% of their patients.Under the proposed Stage 3 of meaningful use, physicians and eligible hospitals must meet two of three criteria: that more than 50% of referrals or transitions of care involve the passing of information by the referring provider; that more than 40% of transitions or referrals received by a provider seeing a patient for the first time include information imported into that new provider’s EHR; or that for more than 80% of those new patients seen in transition or by referral for the first time, a clinical reconciliation be done on the information received during the health information exchange, including a review of current medications, medication allergies, and current and active diagnoses.
The proposed rule is scheduled to be published in the Federal Register on March 30; comments will be accepted at www.regulations.gov until May 29.
FDA approves miniature heart pump for use during high risk PCI
A miniature heart pump has been approved by the Food and Drug Administration to “help certain patients maintain stable heart function and circulation during certain high-risk percutaneous coronary intervention (HRPCI) procedures,” the agency has announced.
The Impella 2.5 System, manufactured by Abiomed, is “intended for temporary use by patients with severe symptomatic CAD [coronary artery disease] and diminished (but stable) heart function who are undergoing HRPCI but are not candidates for surgical coronary bypass treatment,” according to the FDA’s statement.
“Use of the Impella 2.5 System is intended to prevent episodes of unstable heart function, including unstable blood pressure and poor circulation, in patients who are at high risk for its occurrence,” Dr. William Maisel, acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in the statement.
Approval was based on the PROTECT II study and observational data from the USpella Registry.
“The overall data provided evidence that, for patients with severe CAD and diminished heart function, the temporary circulatory support provided by the Impella 2.5 System during an HRPCI procedure may allow a longer and more thorough procedure by preventing episodes of hemodynamic instability ... due to temporary abnormalities in heart function,” the FDA statement said. In addition, “fewer later adverse events” such as the need for repeat HRPCI procedures, “may occur in patients undergoing HRPCI with the pump compared to patients undergoing HRPCI with an intra-aortic balloon pump,” according to the FDA.
The FDA statement also noted that the system can be used as an alternative to the intra-aortic balloon pump “without significantly increasing the safety risks of the HRPCI procedure.”
As a postmarketing requirement, the manufacturer will conduct a single arm study of the device in high-risk PCI patients, according to the company’s statement announcing approval.
The wording of the approved indication is as follows, according to Abiomed: “The Impella 2.5 is a temporary (less than or equal to 6 hours) ventricular support device indicated for use during high-risk PCI performed in elective or urgent hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction, when a heart team, including a cardiac surgeon, has determined high-risk PCI is the appropriate therapeutic option. Use of the Impella 2.5 in these patients may prevent hemodynamic instability that may occur during planned temporary coronary occlusions and may reduce peri- and postprocedural adverse events.”
A miniature heart pump has been approved by the Food and Drug Administration to “help certain patients maintain stable heart function and circulation during certain high-risk percutaneous coronary intervention (HRPCI) procedures,” the agency has announced.
The Impella 2.5 System, manufactured by Abiomed, is “intended for temporary use by patients with severe symptomatic CAD [coronary artery disease] and diminished (but stable) heart function who are undergoing HRPCI but are not candidates for surgical coronary bypass treatment,” according to the FDA’s statement.
“Use of the Impella 2.5 System is intended to prevent episodes of unstable heart function, including unstable blood pressure and poor circulation, in patients who are at high risk for its occurrence,” Dr. William Maisel, acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in the statement.
Approval was based on the PROTECT II study and observational data from the USpella Registry.
“The overall data provided evidence that, for patients with severe CAD and diminished heart function, the temporary circulatory support provided by the Impella 2.5 System during an HRPCI procedure may allow a longer and more thorough procedure by preventing episodes of hemodynamic instability ... due to temporary abnormalities in heart function,” the FDA statement said. In addition, “fewer later adverse events” such as the need for repeat HRPCI procedures, “may occur in patients undergoing HRPCI with the pump compared to patients undergoing HRPCI with an intra-aortic balloon pump,” according to the FDA.
The FDA statement also noted that the system can be used as an alternative to the intra-aortic balloon pump “without significantly increasing the safety risks of the HRPCI procedure.”
As a postmarketing requirement, the manufacturer will conduct a single arm study of the device in high-risk PCI patients, according to the company’s statement announcing approval.
The wording of the approved indication is as follows, according to Abiomed: “The Impella 2.5 is a temporary (less than or equal to 6 hours) ventricular support device indicated for use during high-risk PCI performed in elective or urgent hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction, when a heart team, including a cardiac surgeon, has determined high-risk PCI is the appropriate therapeutic option. Use of the Impella 2.5 in these patients may prevent hemodynamic instability that may occur during planned temporary coronary occlusions and may reduce peri- and postprocedural adverse events.”
A miniature heart pump has been approved by the Food and Drug Administration to “help certain patients maintain stable heart function and circulation during certain high-risk percutaneous coronary intervention (HRPCI) procedures,” the agency has announced.
The Impella 2.5 System, manufactured by Abiomed, is “intended for temporary use by patients with severe symptomatic CAD [coronary artery disease] and diminished (but stable) heart function who are undergoing HRPCI but are not candidates for surgical coronary bypass treatment,” according to the FDA’s statement.
“Use of the Impella 2.5 System is intended to prevent episodes of unstable heart function, including unstable blood pressure and poor circulation, in patients who are at high risk for its occurrence,” Dr. William Maisel, acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in the statement.
Approval was based on the PROTECT II study and observational data from the USpella Registry.
“The overall data provided evidence that, for patients with severe CAD and diminished heart function, the temporary circulatory support provided by the Impella 2.5 System during an HRPCI procedure may allow a longer and more thorough procedure by preventing episodes of hemodynamic instability ... due to temporary abnormalities in heart function,” the FDA statement said. In addition, “fewer later adverse events” such as the need for repeat HRPCI procedures, “may occur in patients undergoing HRPCI with the pump compared to patients undergoing HRPCI with an intra-aortic balloon pump,” according to the FDA.
The FDA statement also noted that the system can be used as an alternative to the intra-aortic balloon pump “without significantly increasing the safety risks of the HRPCI procedure.”
As a postmarketing requirement, the manufacturer will conduct a single arm study of the device in high-risk PCI patients, according to the company’s statement announcing approval.
The wording of the approved indication is as follows, according to Abiomed: “The Impella 2.5 is a temporary (less than or equal to 6 hours) ventricular support device indicated for use during high-risk PCI performed in elective or urgent hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction, when a heart team, including a cardiac surgeon, has determined high-risk PCI is the appropriate therapeutic option. Use of the Impella 2.5 in these patients may prevent hemodynamic instability that may occur during planned temporary coronary occlusions and may reduce peri- and postprocedural adverse events.”
New bill consolidates SGR fix, CHIP reauthorization
Bipartisan lawmakers have introduced a bill that would repeal the Medicare Sustainable Growth Rate (SGR) formula, this time with language that would reauthorize the Children’s Health Insurance Program (CHIP) for 2 years.
Leaders on the House Energy and Commerce and House Ways and Means committees on March 24 announced H.R. 2, the Medicare Access and CHIP Reauthorization Act. The proposal builds on H.R. 1470, the SGR Repeal and Medicare Provider Payment Modernization Act – reintroduced March 19 – by extending CHIP funding through fiscal 2017. Funding for the program expires in September. The Medicare Access and CHIP Reauthorization Act also includes 2-year reauthorization of the Community Health Centers program, the National Health Service Corps, and the Teaching Health Centers program, all of which would expire in 2015.
The changes would be paid for by income-related premium adjustments for Medicare parts B and D, Medigap reforms, an increase of levy authority on payments to Medicare providers with delinquent tax debt, adjustments to inpatient hospital payment rates, a delay of Medicaid Disproportionate Share Hospital (DSH) changes until 2018, and a 1% market basket update for post–acute care providers.
The payment proposals of the bill reflect a working framework released by committee members March 20. A vote on the SGR package is expected this week.
The bill culminates years of efforts by lawmakers and stakeholders and will strengthen Medicare over the long term, according to Energy and Commerce Committee Chairman Fred Upton (R-Mich.).
“We can see the light at the end of the SGR tunnel – finally,” Rep. Upton said in a statement. “This responsible legislative package reflects years of bipartisan work, is a good deal for seniors, and a good deal for children, too. It’s time to put a stop once and for all to the repeated SGR crises and start to put Medicare on a stronger path forward for our seniors.”
The committee’s ranking member, Rep. Frank Pallone (D-N.J.) agreed.
“Finally, after a decade of trying, we have a bipartisan bill that will permanently repeal the flawed SGR and move Medicare to a health care system based on quality and efficiency, that is good for seniors and doctors alike,” Rep. Pallone said.
“As with any bipartisan effort, this legislation reflects give and take on both sides. However, we have come to a balanced compromise that will end uncertainty in the system, extend CHIP, fund Community Health Centers, and make permanent the Qualifying Individual (QI) program that helps low income seniors pay their Medicare premiums,” he added.
In addition to repealing the SGR, the final bill includes a 0.5% pay increase per year for the next 5 years; consolidates existing quality programs into a single value-based performance program; incentivizes physicians to use alternate payment models that focus on care coordination and preventive care; and pushes for more transparency of Medicare data for physicians, providers, and patients.
The latest bill comes a week before the current SGR patch expires on March 31. Without legislative action, physicians will see a 21% cut in Medicare pay.
Bipartisan lawmakers have introduced a bill that would repeal the Medicare Sustainable Growth Rate (SGR) formula, this time with language that would reauthorize the Children’s Health Insurance Program (CHIP) for 2 years.
Leaders on the House Energy and Commerce and House Ways and Means committees on March 24 announced H.R. 2, the Medicare Access and CHIP Reauthorization Act. The proposal builds on H.R. 1470, the SGR Repeal and Medicare Provider Payment Modernization Act – reintroduced March 19 – by extending CHIP funding through fiscal 2017. Funding for the program expires in September. The Medicare Access and CHIP Reauthorization Act also includes 2-year reauthorization of the Community Health Centers program, the National Health Service Corps, and the Teaching Health Centers program, all of which would expire in 2015.
The changes would be paid for by income-related premium adjustments for Medicare parts B and D, Medigap reforms, an increase of levy authority on payments to Medicare providers with delinquent tax debt, adjustments to inpatient hospital payment rates, a delay of Medicaid Disproportionate Share Hospital (DSH) changes until 2018, and a 1% market basket update for post–acute care providers.
The payment proposals of the bill reflect a working framework released by committee members March 20. A vote on the SGR package is expected this week.
The bill culminates years of efforts by lawmakers and stakeholders and will strengthen Medicare over the long term, according to Energy and Commerce Committee Chairman Fred Upton (R-Mich.).
“We can see the light at the end of the SGR tunnel – finally,” Rep. Upton said in a statement. “This responsible legislative package reflects years of bipartisan work, is a good deal for seniors, and a good deal for children, too. It’s time to put a stop once and for all to the repeated SGR crises and start to put Medicare on a stronger path forward for our seniors.”
The committee’s ranking member, Rep. Frank Pallone (D-N.J.) agreed.
“Finally, after a decade of trying, we have a bipartisan bill that will permanently repeal the flawed SGR and move Medicare to a health care system based on quality and efficiency, that is good for seniors and doctors alike,” Rep. Pallone said.
“As with any bipartisan effort, this legislation reflects give and take on both sides. However, we have come to a balanced compromise that will end uncertainty in the system, extend CHIP, fund Community Health Centers, and make permanent the Qualifying Individual (QI) program that helps low income seniors pay their Medicare premiums,” he added.
In addition to repealing the SGR, the final bill includes a 0.5% pay increase per year for the next 5 years; consolidates existing quality programs into a single value-based performance program; incentivizes physicians to use alternate payment models that focus on care coordination and preventive care; and pushes for more transparency of Medicare data for physicians, providers, and patients.
The latest bill comes a week before the current SGR patch expires on March 31. Without legislative action, physicians will see a 21% cut in Medicare pay.
Bipartisan lawmakers have introduced a bill that would repeal the Medicare Sustainable Growth Rate (SGR) formula, this time with language that would reauthorize the Children’s Health Insurance Program (CHIP) for 2 years.
Leaders on the House Energy and Commerce and House Ways and Means committees on March 24 announced H.R. 2, the Medicare Access and CHIP Reauthorization Act. The proposal builds on H.R. 1470, the SGR Repeal and Medicare Provider Payment Modernization Act – reintroduced March 19 – by extending CHIP funding through fiscal 2017. Funding for the program expires in September. The Medicare Access and CHIP Reauthorization Act also includes 2-year reauthorization of the Community Health Centers program, the National Health Service Corps, and the Teaching Health Centers program, all of which would expire in 2015.
The changes would be paid for by income-related premium adjustments for Medicare parts B and D, Medigap reforms, an increase of levy authority on payments to Medicare providers with delinquent tax debt, adjustments to inpatient hospital payment rates, a delay of Medicaid Disproportionate Share Hospital (DSH) changes until 2018, and a 1% market basket update for post–acute care providers.
The payment proposals of the bill reflect a working framework released by committee members March 20. A vote on the SGR package is expected this week.
The bill culminates years of efforts by lawmakers and stakeholders and will strengthen Medicare over the long term, according to Energy and Commerce Committee Chairman Fred Upton (R-Mich.).
“We can see the light at the end of the SGR tunnel – finally,” Rep. Upton said in a statement. “This responsible legislative package reflects years of bipartisan work, is a good deal for seniors, and a good deal for children, too. It’s time to put a stop once and for all to the repeated SGR crises and start to put Medicare on a stronger path forward for our seniors.”
The committee’s ranking member, Rep. Frank Pallone (D-N.J.) agreed.
“Finally, after a decade of trying, we have a bipartisan bill that will permanently repeal the flawed SGR and move Medicare to a health care system based on quality and efficiency, that is good for seniors and doctors alike,” Rep. Pallone said.
“As with any bipartisan effort, this legislation reflects give and take on both sides. However, we have come to a balanced compromise that will end uncertainty in the system, extend CHIP, fund Community Health Centers, and make permanent the Qualifying Individual (QI) program that helps low income seniors pay their Medicare premiums,” he added.
In addition to repealing the SGR, the final bill includes a 0.5% pay increase per year for the next 5 years; consolidates existing quality programs into a single value-based performance program; incentivizes physicians to use alternate payment models that focus on care coordination and preventive care; and pushes for more transparency of Medicare data for physicians, providers, and patients.
The latest bill comes a week before the current SGR patch expires on March 31. Without legislative action, physicians will see a 21% cut in Medicare pay.
AATS Mitral Conclave Program Now Online
Don’t miss the AATS Mitral Conclave, the benchmark meeting about mitral valve disease. The event precedes the AATS Annual Meeting and lasts from Thursday, April 23 to Friday, April 24, 2015, and is being held at the Hilton New York Midtown, New York City, N.Y.
With a faculty of over 70 international leaders in the field, the conference features more than 100 invited lectures and video presentations, as well as 100 submitted abstracts and video offerings.
The two-day Conclave will cover a wide-range of topic areas including guidelines, imaging, surgical approaches, reconstructive techniques, replacement options, catheter based approaches, heart failure strategies, and long term outcomes.
The schedule includes:
** Five plenary lecture sessions
** Over 20 breakout sessions
** Eight sponsored luncheons
** Three expert video/technique demonstrations
** Debates
** Moderated panel discussions
** Special lectures
** Breakfast breakout sessions
** Case-based discussions
View the complete preliminary program here.
Program Director
David H. Adams
Program Committee
Anelechi C. Anyanwu
Tirone E. David
Pedro J. del Nido
Gilles D. Dreyfus
Volkmar Falk
Rakesh M. Suri
Hugo K. I. Vanermen
Francis C. Wells
CME Credits
The American Association for Thoracic Surgery is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
This activity has been approved for AMA PRA Category 1 Credit(s)™.
Don’t miss the AATS Mitral Conclave, the benchmark meeting about mitral valve disease. The event precedes the AATS Annual Meeting and lasts from Thursday, April 23 to Friday, April 24, 2015, and is being held at the Hilton New York Midtown, New York City, N.Y.
With a faculty of over 70 international leaders in the field, the conference features more than 100 invited lectures and video presentations, as well as 100 submitted abstracts and video offerings.
The two-day Conclave will cover a wide-range of topic areas including guidelines, imaging, surgical approaches, reconstructive techniques, replacement options, catheter based approaches, heart failure strategies, and long term outcomes.
The schedule includes:
** Five plenary lecture sessions
** Over 20 breakout sessions
** Eight sponsored luncheons
** Three expert video/technique demonstrations
** Debates
** Moderated panel discussions
** Special lectures
** Breakfast breakout sessions
** Case-based discussions
View the complete preliminary program here.
Program Director
David H. Adams
Program Committee
Anelechi C. Anyanwu
Tirone E. David
Pedro J. del Nido
Gilles D. Dreyfus
Volkmar Falk
Rakesh M. Suri
Hugo K. I. Vanermen
Francis C. Wells
CME Credits
The American Association for Thoracic Surgery is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
This activity has been approved for AMA PRA Category 1 Credit(s)™.
Don’t miss the AATS Mitral Conclave, the benchmark meeting about mitral valve disease. The event precedes the AATS Annual Meeting and lasts from Thursday, April 23 to Friday, April 24, 2015, and is being held at the Hilton New York Midtown, New York City, N.Y.
With a faculty of over 70 international leaders in the field, the conference features more than 100 invited lectures and video presentations, as well as 100 submitted abstracts and video offerings.
The two-day Conclave will cover a wide-range of topic areas including guidelines, imaging, surgical approaches, reconstructive techniques, replacement options, catheter based approaches, heart failure strategies, and long term outcomes.
The schedule includes:
** Five plenary lecture sessions
** Over 20 breakout sessions
** Eight sponsored luncheons
** Three expert video/technique demonstrations
** Debates
** Moderated panel discussions
** Special lectures
** Breakfast breakout sessions
** Case-based discussions
View the complete preliminary program here.
Program Director
David H. Adams
Program Committee
Anelechi C. Anyanwu
Tirone E. David
Pedro J. del Nido
Gilles D. Dreyfus
Volkmar Falk
Rakesh M. Suri
Hugo K. I. Vanermen
Francis C. Wells
CME Credits
The American Association for Thoracic Surgery is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
This activity has been approved for AMA PRA Category 1 Credit(s)™.
Midlife blood pressure patterns predict CVD, mortality risk
BALTIMORE – Distinct patterns of blood pressure changes in midlife are associated with varying degrees of risk for cardiovascular disease and death, according to a multisite study.
These patterns of change contributed to risk for both CVD and mortality, separate from the known association of absolute elevation of systolic blood pressure with CVD and death. Natalia Petruski-Ivleva of the University of North Carolina, Chapel Hill, and colleagues identified SBP patterns emerging from the biracial, multisite Atherosclerosis Risk in Communities (ARIC) study and presented the results at the American Heart Association Epidemiology and Prevention, Lifestyle and Cardiometabolic Health 2015 Scientific Sessions.
The study included 9,882 patients from the ARIC population who had recorded BPs at four study visits between 1987 and 1998, and whose outcomes were tracked over the period from 1987 to 2011. Median follow-up after the last study visit was 13.2 years. Participants were grouped by patterns of change in SBP over time using a latent class growth model; this analytic model allowed for the discovery of similar groups of cases within the data.
Results were adjusted for age and demographic characteristics, as well as for self-reported hypertension medication use. In addition to all-cause mortality, outcomes included coronary heart disease, heart failure, and stroke.
In all, six distinct patterns emerged of change in SBP over the study visit period, with three groups having SBPs consistently below the threshold of 140 mm Hg, and three other groups showing varying patterns of elevation. About 84% of participants fell into one of the three groups that showed parallel patterns of SBP change, with pressures slowly rising over time, but never exceeding 140 mm Hg. The remainder of participants were grouped into three other patterns. One showed a steep increase over time from an initial SBP just under 140 mm Hg to a final reading just over 160 mm Hg; a second showed high and sustained SBPs of more than 160 mm Hg at all study visits. Finally, some participants had initially elevated SBPs that fell to the normal range by the end of the study.
Overall, analysis showed a gradient of risk, with lower SBP associated with lower risk of CVD and death. This was true even for those participants in the first three groups, whose SBPs stayed below 140 mm Hg throughout. Notably, the pattern of steep increase of already elevated SBP, as well as that of sustained elevated blood pressures, were both associated with the highest all-cause mortality. Reducing SBP to less than 140 mm Hg was not associated with reduced risk of CHD in the final group.
The three higher-risk groups were more likely to be obese, black, on hypertension medication, and have diabetes. They were also older on average than participants with the three nonelevated patterns.
These patterns of change, said Ms. Petruski-Ivleva, “contribute varying amounts of risk of CVD and mortality in addition to the risk imparted by the absolute SBP level.” Though the clinical significance of these patterns of blood pressure change needs more examination, she said that the results underscore the cumulative impact of elevated SBP through midlife.
BALTIMORE – Distinct patterns of blood pressure changes in midlife are associated with varying degrees of risk for cardiovascular disease and death, according to a multisite study.
These patterns of change contributed to risk for both CVD and mortality, separate from the known association of absolute elevation of systolic blood pressure with CVD and death. Natalia Petruski-Ivleva of the University of North Carolina, Chapel Hill, and colleagues identified SBP patterns emerging from the biracial, multisite Atherosclerosis Risk in Communities (ARIC) study and presented the results at the American Heart Association Epidemiology and Prevention, Lifestyle and Cardiometabolic Health 2015 Scientific Sessions.
The study included 9,882 patients from the ARIC population who had recorded BPs at four study visits between 1987 and 1998, and whose outcomes were tracked over the period from 1987 to 2011. Median follow-up after the last study visit was 13.2 years. Participants were grouped by patterns of change in SBP over time using a latent class growth model; this analytic model allowed for the discovery of similar groups of cases within the data.
Results were adjusted for age and demographic characteristics, as well as for self-reported hypertension medication use. In addition to all-cause mortality, outcomes included coronary heart disease, heart failure, and stroke.
In all, six distinct patterns emerged of change in SBP over the study visit period, with three groups having SBPs consistently below the threshold of 140 mm Hg, and three other groups showing varying patterns of elevation. About 84% of participants fell into one of the three groups that showed parallel patterns of SBP change, with pressures slowly rising over time, but never exceeding 140 mm Hg. The remainder of participants were grouped into three other patterns. One showed a steep increase over time from an initial SBP just under 140 mm Hg to a final reading just over 160 mm Hg; a second showed high and sustained SBPs of more than 160 mm Hg at all study visits. Finally, some participants had initially elevated SBPs that fell to the normal range by the end of the study.
Overall, analysis showed a gradient of risk, with lower SBP associated with lower risk of CVD and death. This was true even for those participants in the first three groups, whose SBPs stayed below 140 mm Hg throughout. Notably, the pattern of steep increase of already elevated SBP, as well as that of sustained elevated blood pressures, were both associated with the highest all-cause mortality. Reducing SBP to less than 140 mm Hg was not associated with reduced risk of CHD in the final group.
The three higher-risk groups were more likely to be obese, black, on hypertension medication, and have diabetes. They were also older on average than participants with the three nonelevated patterns.
These patterns of change, said Ms. Petruski-Ivleva, “contribute varying amounts of risk of CVD and mortality in addition to the risk imparted by the absolute SBP level.” Though the clinical significance of these patterns of blood pressure change needs more examination, she said that the results underscore the cumulative impact of elevated SBP through midlife.
BALTIMORE – Distinct patterns of blood pressure changes in midlife are associated with varying degrees of risk for cardiovascular disease and death, according to a multisite study.
These patterns of change contributed to risk for both CVD and mortality, separate from the known association of absolute elevation of systolic blood pressure with CVD and death. Natalia Petruski-Ivleva of the University of North Carolina, Chapel Hill, and colleagues identified SBP patterns emerging from the biracial, multisite Atherosclerosis Risk in Communities (ARIC) study and presented the results at the American Heart Association Epidemiology and Prevention, Lifestyle and Cardiometabolic Health 2015 Scientific Sessions.
The study included 9,882 patients from the ARIC population who had recorded BPs at four study visits between 1987 and 1998, and whose outcomes were tracked over the period from 1987 to 2011. Median follow-up after the last study visit was 13.2 years. Participants were grouped by patterns of change in SBP over time using a latent class growth model; this analytic model allowed for the discovery of similar groups of cases within the data.
Results were adjusted for age and demographic characteristics, as well as for self-reported hypertension medication use. In addition to all-cause mortality, outcomes included coronary heart disease, heart failure, and stroke.
In all, six distinct patterns emerged of change in SBP over the study visit period, with three groups having SBPs consistently below the threshold of 140 mm Hg, and three other groups showing varying patterns of elevation. About 84% of participants fell into one of the three groups that showed parallel patterns of SBP change, with pressures slowly rising over time, but never exceeding 140 mm Hg. The remainder of participants were grouped into three other patterns. One showed a steep increase over time from an initial SBP just under 140 mm Hg to a final reading just over 160 mm Hg; a second showed high and sustained SBPs of more than 160 mm Hg at all study visits. Finally, some participants had initially elevated SBPs that fell to the normal range by the end of the study.
Overall, analysis showed a gradient of risk, with lower SBP associated with lower risk of CVD and death. This was true even for those participants in the first three groups, whose SBPs stayed below 140 mm Hg throughout. Notably, the pattern of steep increase of already elevated SBP, as well as that of sustained elevated blood pressures, were both associated with the highest all-cause mortality. Reducing SBP to less than 140 mm Hg was not associated with reduced risk of CHD in the final group.
The three higher-risk groups were more likely to be obese, black, on hypertension medication, and have diabetes. They were also older on average than participants with the three nonelevated patterns.
These patterns of change, said Ms. Petruski-Ivleva, “contribute varying amounts of risk of CVD and mortality in addition to the risk imparted by the absolute SBP level.” Though the clinical significance of these patterns of blood pressure change needs more examination, she said that the results underscore the cumulative impact of elevated SBP through midlife.
AT AHA EPI/LIFESTYLE 2015
Key clinical point: Systolic blood pressures at midlife fall into patterns associated with varying degrees of CVD risk.
Major finding: Lower SBP was associated with lower risk of CVD and death, and a pattern of steep increase of already elevated SBP was associated with higher all-cause mortality.
Data source: Analysis of longitudinal change in SBP of nearly 10,000 participants in the multiracial, multisite ARIC study.
Disclosures: ARIC is supported by the National Heart, Lung, and Blood Institute. No authors reported financial disclosures.
Novel Watchman device approved as warfarin alternative in atrial fib
The Watchman left atrial appendage (LAA) closure device has been approved in the United States as an alternative to warfarin for patients with nonvalvular atrial fibrillation, for a narrower indication than the one submitted for approval to the Food and Drug Administration.
The device is a percutaneously delivered permanent cardiac implant placed in the LAA to prevent the embolization of thrombi formed in the LAA, and is manufactured by Boston Scientific. The FDA approved the Watchman for reducing the risk of thromboembolism from the LAA in patients with nonvalvular atrial fibrillation “who are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores, are deemed by their physicians to be suitable for warfarin; and have an appropriate rationale to seek a nonpharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device, compared to warfarin,” according to a statement issued by the company on March 13.
The approved indication is worded differently than the proposed indication that was submitted to the FDA for approval and discussed at an FDA panel meeting in October, to “prevent thromboembolism from the left atrial appendage.” The changes in the indication include the replacement of “prevent” with “reduce the risk” of thromboembolism, and the addition of the following qualifiers: In patients who “are deemed by their physicians to be suitable for warfarin,” and who have “an appropriate rationale to seek a nonpharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device compared to warfarin.”
“These changes were made to more accurately reflect the appropriate patient population for this device,” according to an FDA spokesperson.
At a meeting in October 2014, the FDA’s Circulatory System Devices Panel voted 6-5 with one abstention that the benefits of the device outweighed its risks for the proposed indication, but several panelists who voted no said they would support approval of a second-line indication. In addition, panelists voting on both sides of this question said that the indication was too broad and should be revised to describe the device as a second-line alternative to warfarin, making clear it is not appropriate for all warfarin-eligible patients. (At the meeting, the panel unanimously agreed that there was “reasonable assurance” that the device was safe for use in this population.)
At the first advisory panel meeting on the device, in December 2013, the panel voted 13-1 to recommend approval, based on data from the PREVAIL and PROTECT-AF studies, which compared the device to chronic warfarin, and information from the Continued Access to PREVAIL (CAP2) registry.PREVAIL compared implantation of the device – with 45 days of warfarin plus 81 mg of aspirin for 45 days, followed by 325 mg of aspirin and 75 mg of clopidogrel through 6 months, followed by 325 mg of aspirin a day indefinitely – to chronic warfarin.
The October meeting was convened by the FDA to review longer follow-up data from PREVAIL, which found additional cases of ischemic strokes in the Watchman group and none in the warfarin-treated group.
The Watchman device has been available outside of the United States since 2009, is registered in 75 countries, and has been used to treat more than 10,000 patients, according to Boston Scientific.
The Watchman left atrial appendage (LAA) closure device has been approved in the United States as an alternative to warfarin for patients with nonvalvular atrial fibrillation, for a narrower indication than the one submitted for approval to the Food and Drug Administration.
The device is a percutaneously delivered permanent cardiac implant placed in the LAA to prevent the embolization of thrombi formed in the LAA, and is manufactured by Boston Scientific. The FDA approved the Watchman for reducing the risk of thromboembolism from the LAA in patients with nonvalvular atrial fibrillation “who are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores, are deemed by their physicians to be suitable for warfarin; and have an appropriate rationale to seek a nonpharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device, compared to warfarin,” according to a statement issued by the company on March 13.
The approved indication is worded differently than the proposed indication that was submitted to the FDA for approval and discussed at an FDA panel meeting in October, to “prevent thromboembolism from the left atrial appendage.” The changes in the indication include the replacement of “prevent” with “reduce the risk” of thromboembolism, and the addition of the following qualifiers: In patients who “are deemed by their physicians to be suitable for warfarin,” and who have “an appropriate rationale to seek a nonpharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device compared to warfarin.”
“These changes were made to more accurately reflect the appropriate patient population for this device,” according to an FDA spokesperson.
At a meeting in October 2014, the FDA’s Circulatory System Devices Panel voted 6-5 with one abstention that the benefits of the device outweighed its risks for the proposed indication, but several panelists who voted no said they would support approval of a second-line indication. In addition, panelists voting on both sides of this question said that the indication was too broad and should be revised to describe the device as a second-line alternative to warfarin, making clear it is not appropriate for all warfarin-eligible patients. (At the meeting, the panel unanimously agreed that there was “reasonable assurance” that the device was safe for use in this population.)
At the first advisory panel meeting on the device, in December 2013, the panel voted 13-1 to recommend approval, based on data from the PREVAIL and PROTECT-AF studies, which compared the device to chronic warfarin, and information from the Continued Access to PREVAIL (CAP2) registry.PREVAIL compared implantation of the device – with 45 days of warfarin plus 81 mg of aspirin for 45 days, followed by 325 mg of aspirin and 75 mg of clopidogrel through 6 months, followed by 325 mg of aspirin a day indefinitely – to chronic warfarin.
The October meeting was convened by the FDA to review longer follow-up data from PREVAIL, which found additional cases of ischemic strokes in the Watchman group and none in the warfarin-treated group.
The Watchman device has been available outside of the United States since 2009, is registered in 75 countries, and has been used to treat more than 10,000 patients, according to Boston Scientific.
The Watchman left atrial appendage (LAA) closure device has been approved in the United States as an alternative to warfarin for patients with nonvalvular atrial fibrillation, for a narrower indication than the one submitted for approval to the Food and Drug Administration.
The device is a percutaneously delivered permanent cardiac implant placed in the LAA to prevent the embolization of thrombi formed in the LAA, and is manufactured by Boston Scientific. The FDA approved the Watchman for reducing the risk of thromboembolism from the LAA in patients with nonvalvular atrial fibrillation “who are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores, are deemed by their physicians to be suitable for warfarin; and have an appropriate rationale to seek a nonpharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device, compared to warfarin,” according to a statement issued by the company on March 13.
The approved indication is worded differently than the proposed indication that was submitted to the FDA for approval and discussed at an FDA panel meeting in October, to “prevent thromboembolism from the left atrial appendage.” The changes in the indication include the replacement of “prevent” with “reduce the risk” of thromboembolism, and the addition of the following qualifiers: In patients who “are deemed by their physicians to be suitable for warfarin,” and who have “an appropriate rationale to seek a nonpharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device compared to warfarin.”
“These changes were made to more accurately reflect the appropriate patient population for this device,” according to an FDA spokesperson.
At a meeting in October 2014, the FDA’s Circulatory System Devices Panel voted 6-5 with one abstention that the benefits of the device outweighed its risks for the proposed indication, but several panelists who voted no said they would support approval of a second-line indication. In addition, panelists voting on both sides of this question said that the indication was too broad and should be revised to describe the device as a second-line alternative to warfarin, making clear it is not appropriate for all warfarin-eligible patients. (At the meeting, the panel unanimously agreed that there was “reasonable assurance” that the device was safe for use in this population.)
At the first advisory panel meeting on the device, in December 2013, the panel voted 13-1 to recommend approval, based on data from the PREVAIL and PROTECT-AF studies, which compared the device to chronic warfarin, and information from the Continued Access to PREVAIL (CAP2) registry.PREVAIL compared implantation of the device – with 45 days of warfarin plus 81 mg of aspirin for 45 days, followed by 325 mg of aspirin and 75 mg of clopidogrel through 6 months, followed by 325 mg of aspirin a day indefinitely – to chronic warfarin.
The October meeting was convened by the FDA to review longer follow-up data from PREVAIL, which found additional cases of ischemic strokes in the Watchman group and none in the warfarin-treated group.
The Watchman device has been available outside of the United States since 2009, is registered in 75 countries, and has been used to treat more than 10,000 patients, according to Boston Scientific.
Cost comparison favors minimally invasive over conventional AVR
Outcomes were similar, but hospital costs improved with use of mini-aortic valve replacement, compared with conventional AVR, according to the results of a Society of Thoracic Surgeons (STS) database study of 1,341 patients who underwent primary AVR at 17 hospitals.
A propensity match cohort analysis was done to compare patients who had conventional (67%) vs. mini-AVR (33%) performed using either partial sternotomy or right thoracotomy.
Mortality, stroke, renal failure, atrial fibrillation, reoperation for bleeding, and respiratory insufficiency were not statistically significantly different between the two groups. There was also no significant difference in ICU or hospital length of stay between the two groups. However, mini-AVR was associated with both significantly decreased ventilator time (5 vs. 6 hours) and blood product transfusion (25% vs. 32%), according to the report, which was published online and scheduled for the April issue of the Journal of Thoracic and Cardiovascular Surgery (doi:10.1016/j/jtcvs.2015.01.014).
Total hospital cost was significantly lower in the mini-AVR group ($36,348) vs. the conventional repair group ($38,239, P = .02), wrote Dr. Ravi Kiran Ghanta of the University of Virginia, Charlottesville, and his colleagues.
The authors discussed the previously raised issue of longer cross-clamp and bypass times seen in earlier studies of mini-AVR. In their current study, such was not the case, with mini-AVR appearing equivalent with conventional operations. The authors suggested that surgeons have now adopted techniques to reduce bypass and cross-clamp times with mini-AVR.
Data were limited to in-hospital costs. Other costs, such as those of rehabilitation and lost productivity, were not included in the analysis. “Including these health-care costs may have increased overall savings with mini-AVR compared to conventional AVR,” the authors noted.
“Mini-AVR is associated with decreased ventilator time, blood product utilization, early discharge, and reduced total hospital cost. In contemporary clinical practice, mini-AVR is safe and cost-effective,” the researchers concluded.
The authors reported that they had no conflicts.
“Measurement of cost and outcome, the determinant of ‘value’ in health care, is assuming increasing importance in the evaluation of all medial interventions, especially those surgical procedures done frequently and at higher cost,” wrote Dr. Verdi J. DiSesa in his invited commentary (J. Thorac. Cardiovasc. Surg. 2015 [doi:10.1016/j.jtcvs.2015.01.049]).
Although applauding the timeliness and importance of analyzing the costs and outcomes in propensity-matched patients undergoing aortic valve replacement via full sternotomy of mini-AVR using a partial sternotomy or limited thoracotomy incision, he questioned some of the methodology. The cost-to-charge ratio used, which provides an estimate of the cost of services, is not uniform throughout departments in a single hospital, and differs from hospital to hospital, although the latter was accounted for. He suggested that “activity-based costing” would have been a better approach, although more labor intensive. In this approach, every encounter with a caregiver is assigned a unit cost and the cost of a patient encounter is calculated by estimating the number of units of service and multiplying by the unit cost for service.
“This method is demanding of resources but has the potential to become the most accurate and therefore the preferred way to determine the costs of medical services,” he wrote. In addition, the authors included but did not separately analyze patients having AVR via minithoracotomy.
“What might be the conclusions of this research were these patients excluded or analyzed separately?” he asked.
In terms of the propensity model, the matching procedure included only three clinical factors – STS Predicted Rate of Mortality (PROM) score, the operative year, and the surgeon who performed the procedure – resulting in 35% of patients remaining unmatched, which may have biased the results.
This analysis, Dr. DiSesa concluded, is “perhaps an early version of the kind of analyses, which increasingly will be required for the evaluation of the services provided by all health care providers, not only cardiac surgeons.”
Dr. DiSesa is professor of surgery at Temple University, Philadelphia.
“Measurement of cost and outcome, the determinant of ‘value’ in health care, is assuming increasing importance in the evaluation of all medial interventions, especially those surgical procedures done frequently and at higher cost,” wrote Dr. Verdi J. DiSesa in his invited commentary (J. Thorac. Cardiovasc. Surg. 2015 [doi:10.1016/j.jtcvs.2015.01.049]).
Although applauding the timeliness and importance of analyzing the costs and outcomes in propensity-matched patients undergoing aortic valve replacement via full sternotomy of mini-AVR using a partial sternotomy or limited thoracotomy incision, he questioned some of the methodology. The cost-to-charge ratio used, which provides an estimate of the cost of services, is not uniform throughout departments in a single hospital, and differs from hospital to hospital, although the latter was accounted for. He suggested that “activity-based costing” would have been a better approach, although more labor intensive. In this approach, every encounter with a caregiver is assigned a unit cost and the cost of a patient encounter is calculated by estimating the number of units of service and multiplying by the unit cost for service.
“This method is demanding of resources but has the potential to become the most accurate and therefore the preferred way to determine the costs of medical services,” he wrote. In addition, the authors included but did not separately analyze patients having AVR via minithoracotomy.
“What might be the conclusions of this research were these patients excluded or analyzed separately?” he asked.
In terms of the propensity model, the matching procedure included only three clinical factors – STS Predicted Rate of Mortality (PROM) score, the operative year, and the surgeon who performed the procedure – resulting in 35% of patients remaining unmatched, which may have biased the results.
This analysis, Dr. DiSesa concluded, is “perhaps an early version of the kind of analyses, which increasingly will be required for the evaluation of the services provided by all health care providers, not only cardiac surgeons.”
Dr. DiSesa is professor of surgery at Temple University, Philadelphia.
“Measurement of cost and outcome, the determinant of ‘value’ in health care, is assuming increasing importance in the evaluation of all medial interventions, especially those surgical procedures done frequently and at higher cost,” wrote Dr. Verdi J. DiSesa in his invited commentary (J. Thorac. Cardiovasc. Surg. 2015 [doi:10.1016/j.jtcvs.2015.01.049]).
Although applauding the timeliness and importance of analyzing the costs and outcomes in propensity-matched patients undergoing aortic valve replacement via full sternotomy of mini-AVR using a partial sternotomy or limited thoracotomy incision, he questioned some of the methodology. The cost-to-charge ratio used, which provides an estimate of the cost of services, is not uniform throughout departments in a single hospital, and differs from hospital to hospital, although the latter was accounted for. He suggested that “activity-based costing” would have been a better approach, although more labor intensive. In this approach, every encounter with a caregiver is assigned a unit cost and the cost of a patient encounter is calculated by estimating the number of units of service and multiplying by the unit cost for service.
“This method is demanding of resources but has the potential to become the most accurate and therefore the preferred way to determine the costs of medical services,” he wrote. In addition, the authors included but did not separately analyze patients having AVR via minithoracotomy.
“What might be the conclusions of this research were these patients excluded or analyzed separately?” he asked.
In terms of the propensity model, the matching procedure included only three clinical factors – STS Predicted Rate of Mortality (PROM) score, the operative year, and the surgeon who performed the procedure – resulting in 35% of patients remaining unmatched, which may have biased the results.
This analysis, Dr. DiSesa concluded, is “perhaps an early version of the kind of analyses, which increasingly will be required for the evaluation of the services provided by all health care providers, not only cardiac surgeons.”
Dr. DiSesa is professor of surgery at Temple University, Philadelphia.
Outcomes were similar, but hospital costs improved with use of mini-aortic valve replacement, compared with conventional AVR, according to the results of a Society of Thoracic Surgeons (STS) database study of 1,341 patients who underwent primary AVR at 17 hospitals.
A propensity match cohort analysis was done to compare patients who had conventional (67%) vs. mini-AVR (33%) performed using either partial sternotomy or right thoracotomy.
Mortality, stroke, renal failure, atrial fibrillation, reoperation for bleeding, and respiratory insufficiency were not statistically significantly different between the two groups. There was also no significant difference in ICU or hospital length of stay between the two groups. However, mini-AVR was associated with both significantly decreased ventilator time (5 vs. 6 hours) and blood product transfusion (25% vs. 32%), according to the report, which was published online and scheduled for the April issue of the Journal of Thoracic and Cardiovascular Surgery (doi:10.1016/j/jtcvs.2015.01.014).
Total hospital cost was significantly lower in the mini-AVR group ($36,348) vs. the conventional repair group ($38,239, P = .02), wrote Dr. Ravi Kiran Ghanta of the University of Virginia, Charlottesville, and his colleagues.
The authors discussed the previously raised issue of longer cross-clamp and bypass times seen in earlier studies of mini-AVR. In their current study, such was not the case, with mini-AVR appearing equivalent with conventional operations. The authors suggested that surgeons have now adopted techniques to reduce bypass and cross-clamp times with mini-AVR.
Data were limited to in-hospital costs. Other costs, such as those of rehabilitation and lost productivity, were not included in the analysis. “Including these health-care costs may have increased overall savings with mini-AVR compared to conventional AVR,” the authors noted.
“Mini-AVR is associated with decreased ventilator time, blood product utilization, early discharge, and reduced total hospital cost. In contemporary clinical practice, mini-AVR is safe and cost-effective,” the researchers concluded.
The authors reported that they had no conflicts.
Outcomes were similar, but hospital costs improved with use of mini-aortic valve replacement, compared with conventional AVR, according to the results of a Society of Thoracic Surgeons (STS) database study of 1,341 patients who underwent primary AVR at 17 hospitals.
A propensity match cohort analysis was done to compare patients who had conventional (67%) vs. mini-AVR (33%) performed using either partial sternotomy or right thoracotomy.
Mortality, stroke, renal failure, atrial fibrillation, reoperation for bleeding, and respiratory insufficiency were not statistically significantly different between the two groups. There was also no significant difference in ICU or hospital length of stay between the two groups. However, mini-AVR was associated with both significantly decreased ventilator time (5 vs. 6 hours) and blood product transfusion (25% vs. 32%), according to the report, which was published online and scheduled for the April issue of the Journal of Thoracic and Cardiovascular Surgery (doi:10.1016/j/jtcvs.2015.01.014).
Total hospital cost was significantly lower in the mini-AVR group ($36,348) vs. the conventional repair group ($38,239, P = .02), wrote Dr. Ravi Kiran Ghanta of the University of Virginia, Charlottesville, and his colleagues.
The authors discussed the previously raised issue of longer cross-clamp and bypass times seen in earlier studies of mini-AVR. In their current study, such was not the case, with mini-AVR appearing equivalent with conventional operations. The authors suggested that surgeons have now adopted techniques to reduce bypass and cross-clamp times with mini-AVR.
Data were limited to in-hospital costs. Other costs, such as those of rehabilitation and lost productivity, were not included in the analysis. “Including these health-care costs may have increased overall savings with mini-AVR compared to conventional AVR,” the authors noted.
“Mini-AVR is associated with decreased ventilator time, blood product utilization, early discharge, and reduced total hospital cost. In contemporary clinical practice, mini-AVR is safe and cost-effective,” the researchers concluded.
The authors reported that they had no conflicts.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: Mortality, stroke, renal failure, and other complications were not significantly different between mini-aortic valve replacement and conventional replacement.
Major finding: Total hospital costs were significantly lower with mini-AVR, compared with conventional replacement ($36,348 vs. $38,239).
Data source: A retrospective data analysis of patient records for isolated AVR repair, extracted from a regional, multi-institutional Society of Thoracic Surgeons database.
Disclosures: The authors reported that they had no relevant conflicts of interest.
Perioperative treatment with diuretic linked with lower lung cancer recurrence
Patients with lung cancer who underwent surgery to remove solid tumors and who were treated with atrial natriuretic peptide (ANP) had significantly lower cancer recurrence than did untreated patients, according to a report published in the Proceedings of the National Academy of Sciences.
Investigators retrospectively evaluated patients with lung cancer who underwent surgical removal of tumors; 77 patients received perioperative treatment with ANP and 390 patients did not receive ANP treatment.
ANP-treated patients had significantly greater 2-year relapse-free survival (RFS) after surgery than did those who did not receive ANP (91% vs. 75%, P = .018). Analysis of propensity-matched patients also showed significantly greater 2-year RFS in the ANP group (91% vs. 67%, P = .0013), reported Dr. Takashi Nojiri of Osaka (Japan) University Graduate School of Medicine, and his associates.
“We demonstrated that cancer recurrence after curative surgery was significantly lower in ANP-treated patients than in control patients, suggesting that ANP could potentially be used to prevent cancer recurrence after surgery,” wrote Dr. Nojiri and colleagues (Proc. Natl. Acad. Sci. USA 2015 March 16 [doi:10.1073/pnas.1417273112]).
Atrial natriuretic peptide is a vasodilating hormone from the human heart and acts as a diuretic; previous studies have shown that administration during the perioperative period reduces inflammatory responses and has a prophylactic effect on postoperative cardiopulmonary complications in lung cancer surgery.
Patients with lung cancer who underwent surgery to remove solid tumors and who were treated with atrial natriuretic peptide (ANP) had significantly lower cancer recurrence than did untreated patients, according to a report published in the Proceedings of the National Academy of Sciences.
Investigators retrospectively evaluated patients with lung cancer who underwent surgical removal of tumors; 77 patients received perioperative treatment with ANP and 390 patients did not receive ANP treatment.
ANP-treated patients had significantly greater 2-year relapse-free survival (RFS) after surgery than did those who did not receive ANP (91% vs. 75%, P = .018). Analysis of propensity-matched patients also showed significantly greater 2-year RFS in the ANP group (91% vs. 67%, P = .0013), reported Dr. Takashi Nojiri of Osaka (Japan) University Graduate School of Medicine, and his associates.
“We demonstrated that cancer recurrence after curative surgery was significantly lower in ANP-treated patients than in control patients, suggesting that ANP could potentially be used to prevent cancer recurrence after surgery,” wrote Dr. Nojiri and colleagues (Proc. Natl. Acad. Sci. USA 2015 March 16 [doi:10.1073/pnas.1417273112]).
Atrial natriuretic peptide is a vasodilating hormone from the human heart and acts as a diuretic; previous studies have shown that administration during the perioperative period reduces inflammatory responses and has a prophylactic effect on postoperative cardiopulmonary complications in lung cancer surgery.
Patients with lung cancer who underwent surgery to remove solid tumors and who were treated with atrial natriuretic peptide (ANP) had significantly lower cancer recurrence than did untreated patients, according to a report published in the Proceedings of the National Academy of Sciences.
Investigators retrospectively evaluated patients with lung cancer who underwent surgical removal of tumors; 77 patients received perioperative treatment with ANP and 390 patients did not receive ANP treatment.
ANP-treated patients had significantly greater 2-year relapse-free survival (RFS) after surgery than did those who did not receive ANP (91% vs. 75%, P = .018). Analysis of propensity-matched patients also showed significantly greater 2-year RFS in the ANP group (91% vs. 67%, P = .0013), reported Dr. Takashi Nojiri of Osaka (Japan) University Graduate School of Medicine, and his associates.
“We demonstrated that cancer recurrence after curative surgery was significantly lower in ANP-treated patients than in control patients, suggesting that ANP could potentially be used to prevent cancer recurrence after surgery,” wrote Dr. Nojiri and colleagues (Proc. Natl. Acad. Sci. USA 2015 March 16 [doi:10.1073/pnas.1417273112]).
Atrial natriuretic peptide is a vasodilating hormone from the human heart and acts as a diuretic; previous studies have shown that administration during the perioperative period reduces inflammatory responses and has a prophylactic effect on postoperative cardiopulmonary complications in lung cancer surgery.
FROM PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES
Key clinical point: After surgical removal of tumors, lung cancer patients treated with atrial natriuretic peptide had a significantly lower recurrence rate than did patients who had not received atrial natriuretic peptide.
Major finding: Patients treated with atrial natriuretic peptide had significantly greater 2-year relapse-free survival than did untreated patients (91% vs. 75%, P = .018).
Data source: The retrospective study included 390 patients who were not treated with atrial natriuretic peptide and 77 patients who were.
Disclosures: Dr. Nojiri and two other authors have filed a patent related to atrial natriuretic peptide treatment for cancer metastasis with Daiichi-Sankyo Pharmaceutical Inc.