Thoracic Surgery News (Archived)

MIAMI BEACH – Researchers have developed a way to quickly and objectively assess the risk for aortic valve regurgitation based on the measurement of aortic blood pressures immediately after transcatheter valvevale replacement (TAVR). This new measure, the "aortic regurgitation index," showed significant correlation with periprocedural aortic regurgitation as well as with patients’ 1-year survival following their procedure, Dr. Eberhard Grube said at the ISET 2012 meeting.

Until now, "there has been no way to quantify aortic regurgitation; it’s subjective," said Dr. Grube, professor and chief of cardiology and angiology at the Helios Heart Centre in Siegburg, Germany. The aortic regurgitation index (ARI) allows physicians "to quantify aortic regurgitation periprocedurally by objectively looking at the patient’s hemodynamics, regardless of the subjective evaluation of aortic insufficiency by angiography or by echo," he said. "We can see the ARI and know what we need to do for post-deployment treatment."

Dr. Grube and his associates set the ARI as equal to the patient’s diastolic aortic pressure minus the left ventricular end diastolic pressure, all divided by the aortic systolic pressure, andthen multiplied by 100.

For example, a patient with mild periprocedural aortic regurgitation might have an aortic diastolic pressure of 60 mm Hg, a left ventricular end diastolic pressure of 15 mm Hg, and an aortic systolic pressure of 150 mm Hg, which would produce an ARI of 30, showing that the patient had a low risk for dying during the subsequent year. In contrast, a patient with moderate or severe periprocedural aortic regurgitation could have an aortic diastolic pressure of 40 mm Hg, a left ventricular end diastolic pressure of 20 mm Hg, and an aortic systolic pressure of 120 mm Hg, which would produce an ARI of 16.7, flagging a higher mortality risk in the following year.

His group assessed the prognostic ability of the ARI in a series of 146 patients who underwent TAVR. The group included 124 patients with no or mild aortic regurgitation following TAVR and 22 who showed moderate or severe regurgitation. During 1-year follow-up, the 96 patients with a periprocedural ARI of 25 or greater had an 83% survival rate; the 50 patients with a periprocedural ARI of less than 25 had a survival rate of 54%, a statistically significant difference. The analysis also showed a significant correlation between the ARI and the severity of aortic regurgitation. Among patients with no discerniable regurgitation, the average ARI was about 30, in those with mild regurgitation the average ARI was about 25, in patients with moderate regurgitation the average was about 18, and in patients with severe regurgitation the ARI averaged about 10.

One recently identified key to limiting aortic regurgitation following TAVR is proper valve sizing relative to the patient’s aortic annulus. "Appropriate valve sizing is likely the most important factor that will influence both the degree of perivalvular regurgitation and pacemaker need after TAVR," said Dr. Jeffrey J. Popma in a separate talk at the meeting.

Until recently, many operators used transthoracic echocardiography for annulus sizing, but recently published evidence showed that imaging by CT or by MRI provides superior information, said Dr. Popma, director of interventional cardiology at Beth Israel Deaconess Medical Center in Boston. He cited a British report published last November that compared transthoracic echo, CT, and MRI in 202 patients who underwent TAVR, which found both CT and MRI superior to echo for annulus measurement prior to TAVR (J. Am. Coll. Cardiol. 2011;58:2165-73).

Dr. Grube and Dr. Popma disclosed financial relationships with several medical device manufacturers including Boston Scientific, Medtronic, and Cordis.

MIAMI BEACH – Researchers have developed a way to quickly and objectively assess the risk for aortic valve regurgitation based on the measurement of aortic blood pressures immediately after transcatheter valvevale replacement (TAVR). This new measure, the "aortic regurgitation index," showed significant correlation with periprocedural aortic regurgitation as well as with patients’ 1-year survival following their procedure, Dr. Eberhard Grube said at the ISET 2012 meeting.

Until now, "there has been no way to quantify aortic regurgitation; it’s subjective," said Dr. Grube, professor and chief of cardiology and angiology at the Helios Heart Centre in Siegburg, Germany. The aortic regurgitation index (ARI) allows physicians "to quantify aortic regurgitation periprocedurally by objectively looking at the patient’s hemodynamics, regardless of the subjective evaluation of aortic insufficiency by angiography or by echo," he said. "We can see the ARI and know what we need to do for post-deployment treatment."

Dr. Grube and his associates set the ARI as equal to the patient’s diastolic aortic pressure minus the left ventricular end diastolic pressure, all divided by the aortic systolic pressure, andthen multiplied by 100.

For example, a patient with mild periprocedural aortic regurgitation might have an aortic diastolic pressure of 60 mm Hg, a left ventricular end diastolic pressure of 15 mm Hg, and an aortic systolic pressure of 150 mm Hg, which would produce an ARI of 30, showing that the patient had a low risk for dying during the subsequent year. In contrast, a patient with moderate or severe periprocedural aortic regurgitation could have an aortic diastolic pressure of 40 mm Hg, a left ventricular end diastolic pressure of 20 mm Hg, and an aortic systolic pressure of 120 mm Hg, which would produce an ARI of 16.7, flagging a higher mortality risk in the following year.

His group assessed the prognostic ability of the ARI in a series of 146 patients who underwent TAVR. The group included 124 patients with no or mild aortic regurgitation following TAVR and 22 who showed moderate or severe regurgitation. During 1-year follow-up, the 96 patients with a periprocedural ARI of 25 or greater had an 83% survival rate; the 50 patients with a periprocedural ARI of less than 25 had a survival rate of 54%, a statistically significant difference. The analysis also showed a significant correlation between the ARI and the severity of aortic regurgitation. Among patients with no discerniable regurgitation, the average ARI was about 30, in those with mild regurgitation the average ARI was about 25, in patients with moderate regurgitation the average was about 18, and in patients with severe regurgitation the ARI averaged about 10.

One recently identified key to limiting aortic regurgitation following TAVR is proper valve sizing relative to the patient’s aortic annulus. "Appropriate valve sizing is likely the most important factor that will influence both the degree of perivalvular regurgitation and pacemaker need after TAVR," said Dr. Jeffrey J. Popma in a separate talk at the meeting.

Until recently, many operators used transthoracic echocardiography for annulus sizing, but recently published evidence showed that imaging by CT or by MRI provides superior information, said Dr. Popma, director of interventional cardiology at Beth Israel Deaconess Medical Center in Boston. He cited a British report published last November that compared transthoracic echo, CT, and MRI in 202 patients who underwent TAVR, which found both CT and MRI superior to echo for annulus measurement prior to TAVR (J. Am. Coll. Cardiol. 2011;58:2165-73).

Dr. Grube and Dr. Popma disclosed financial relationships with several medical device manufacturers including Boston Scientific, Medtronic, and Cordis.

MIAMI BEACH – Researchers have developed a way to quickly and objectively assess the risk for aortic valve regurgitation based on the measurement of aortic blood pressures immediately after transcatheter valvevale replacement (TAVR). This new measure, the "aortic regurgitation index," showed significant correlation with periprocedural aortic regurgitation as well as with patients’ 1-year survival following their procedure, Dr. Eberhard Grube said at the ISET 2012 meeting.

Until now, "there has been no way to quantify aortic regurgitation; it’s subjective," said Dr. Grube, professor and chief of cardiology and angiology at the Helios Heart Centre in Siegburg, Germany. The aortic regurgitation index (ARI) allows physicians "to quantify aortic regurgitation periprocedurally by objectively looking at the patient’s hemodynamics, regardless of the subjective evaluation of aortic insufficiency by angiography or by echo," he said. "We can see the ARI and know what we need to do for post-deployment treatment."

Dr. Grube and his associates set the ARI as equal to the patient’s diastolic aortic pressure minus the left ventricular end diastolic pressure, all divided by the aortic systolic pressure, andthen multiplied by 100.

For example, a patient with mild periprocedural aortic regurgitation might have an aortic diastolic pressure of 60 mm Hg, a left ventricular end diastolic pressure of 15 mm Hg, and an aortic systolic pressure of 150 mm Hg, which would produce an ARI of 30, showing that the patient had a low risk for dying during the subsequent year. In contrast, a patient with moderate or severe periprocedural aortic regurgitation could have an aortic diastolic pressure of 40 mm Hg, a left ventricular end diastolic pressure of 20 mm Hg, and an aortic systolic pressure of 120 mm Hg, which would produce an ARI of 16.7, flagging a higher mortality risk in the following year.

His group assessed the prognostic ability of the ARI in a series of 146 patients who underwent TAVR. The group included 124 patients with no or mild aortic regurgitation following TAVR and 22 who showed moderate or severe regurgitation. During 1-year follow-up, the 96 patients with a periprocedural ARI of 25 or greater had an 83% survival rate; the 50 patients with a periprocedural ARI of less than 25 had a survival rate of 54%, a statistically significant difference. The analysis also showed a significant correlation between the ARI and the severity of aortic regurgitation. Among patients with no discerniable regurgitation, the average ARI was about 30, in those with mild regurgitation the average ARI was about 25, in patients with moderate regurgitation the average was about 18, and in patients with severe regurgitation the ARI averaged about 10.

One recently identified key to limiting aortic regurgitation following TAVR is proper valve sizing relative to the patient’s aortic annulus. "Appropriate valve sizing is likely the most important factor that will influence both the degree of perivalvular regurgitation and pacemaker need after TAVR," said Dr. Jeffrey J. Popma in a separate talk at the meeting.

Until recently, many operators used transthoracic echocardiography for annulus sizing, but recently published evidence showed that imaging by CT or by MRI provides superior information, said Dr. Popma, director of interventional cardiology at Beth Israel Deaconess Medical Center in Boston. He cited a British report published last November that compared transthoracic echo, CT, and MRI in 202 patients who underwent TAVR, which found both CT and MRI superior to echo for annulus measurement prior to TAVR (J. Am. Coll. Cardiol. 2011;58:2165-73).

Dr. Grube and Dr. Popma disclosed financial relationships with several medical device manufacturers including Boston Scientific, Medtronic, and Cordis.

New federal regulations aim to accelerate the use of electronic payments to health care providers while reducing administrative costs and saving resources.

The interim final regulations – part of a series of regulations coming from the Department of Health and Human Services – standardize the format and content of the transmissions that health plans send to banks when paying claims via electronic funds transfer (EFT) and will require plans to use a trace number to match the EFT with the remittance advice sent to providers. Currently the EFT and the remittance documents are sent to providers separately, and matching them is difficult.

The new standards took effect on Jan. 1; full compliance will be required by Jan. 1, 2014, according to the agency.

Under the new rules, "health care professionals will spend less time filling out paperwork and more time focusing on delivering the best care for patients," HHS Secretary Kathleen Sebelius said in a statement.

Further, the rules will cost physicians, hospitals, and other providers little or nothing, since "providers are the receivers of the standardized transactions and not the senders," according to HHS.

The agency also estimated that widespread use of EFT should save physician practices and hospitals between $3 billion and $4.5 billion over the next 10 years. The most common savings from implementation of electronic fund transfers are in paper, printing, and postage, as well as staff time for processing paper payments and depositing checks.

The cost to implement the new standards across all commercial health plans is estimated at between $18 million and $28 million. Implementation in Medicaid, the Children’s Health Insurance Plan, and the Indian Health Service is estimated at $400,000-$600,000. Meanwhile, the savings for commercial health plans could be as much as $40 million over 10 years, and $31 million for Medicaid, CHIP, and IHS, according to an HHS fact sheet.

Use of EFT, while widespread in many industries – has been slow in health care, partly due to lack of standardization of transactions, HHS officials said.

The new standards are required by the Affordable Care Act, and fall under the Health Insurance Portability and Accountability Act (HIPAA). They are second in a series of regulations that aim to streamline health care administrative transactions within the next 5 years. Future efforts are slated to include a standard unique identifier for health plans and standardized claim attachments.

New federal regulations aim to accelerate the use of electronic payments to health care providers while reducing administrative costs and saving resources.

The interim final regulations – part of a series of regulations coming from the Department of Health and Human Services – standardize the format and content of the transmissions that health plans send to banks when paying claims via electronic funds transfer (EFT) and will require plans to use a trace number to match the EFT with the remittance advice sent to providers. Currently the EFT and the remittance documents are sent to providers separately, and matching them is difficult.

The new standards took effect on Jan. 1; full compliance will be required by Jan. 1, 2014, according to the agency.

Under the new rules, "health care professionals will spend less time filling out paperwork and more time focusing on delivering the best care for patients," HHS Secretary Kathleen Sebelius said in a statement.

Further, the rules will cost physicians, hospitals, and other providers little or nothing, since "providers are the receivers of the standardized transactions and not the senders," according to HHS.

The agency also estimated that widespread use of EFT should save physician practices and hospitals between $3 billion and $4.5 billion over the next 10 years. The most common savings from implementation of electronic fund transfers are in paper, printing, and postage, as well as staff time for processing paper payments and depositing checks.

The cost to implement the new standards across all commercial health plans is estimated at between $18 million and $28 million. Implementation in Medicaid, the Children’s Health Insurance Plan, and the Indian Health Service is estimated at $400,000-$600,000. Meanwhile, the savings for commercial health plans could be as much as $40 million over 10 years, and $31 million for Medicaid, CHIP, and IHS, according to an HHS fact sheet.

Use of EFT, while widespread in many industries – has been slow in health care, partly due to lack of standardization of transactions, HHS officials said.

The new standards are required by the Affordable Care Act, and fall under the Health Insurance Portability and Accountability Act (HIPAA). They are second in a series of regulations that aim to streamline health care administrative transactions within the next 5 years. Future efforts are slated to include a standard unique identifier for health plans and standardized claim attachments.

New federal regulations aim to accelerate the use of electronic payments to health care providers while reducing administrative costs and saving resources.

The interim final regulations – part of a series of regulations coming from the Department of Health and Human Services – standardize the format and content of the transmissions that health plans send to banks when paying claims via electronic funds transfer (EFT) and will require plans to use a trace number to match the EFT with the remittance advice sent to providers. Currently the EFT and the remittance documents are sent to providers separately, and matching them is difficult.

The new standards took effect on Jan. 1; full compliance will be required by Jan. 1, 2014, according to the agency.

Under the new rules, "health care professionals will spend less time filling out paperwork and more time focusing on delivering the best care for patients," HHS Secretary Kathleen Sebelius said in a statement.

Further, the rules will cost physicians, hospitals, and other providers little or nothing, since "providers are the receivers of the standardized transactions and not the senders," according to HHS.

The agency also estimated that widespread use of EFT should save physician practices and hospitals between $3 billion and $4.5 billion over the next 10 years. The most common savings from implementation of electronic fund transfers are in paper, printing, and postage, as well as staff time for processing paper payments and depositing checks.

The cost to implement the new standards across all commercial health plans is estimated at between $18 million and $28 million. Implementation in Medicaid, the Children’s Health Insurance Plan, and the Indian Health Service is estimated at $400,000-$600,000. Meanwhile, the savings for commercial health plans could be as much as $40 million over 10 years, and $31 million for Medicaid, CHIP, and IHS, according to an HHS fact sheet.

Use of EFT, while widespread in many industries – has been slow in health care, partly due to lack of standardization of transactions, HHS officials said.

The new standards are required by the Affordable Care Act, and fall under the Health Insurance Portability and Accountability Act (HIPAA). They are second in a series of regulations that aim to streamline health care administrative transactions within the next 5 years. Future efforts are slated to include a standard unique identifier for health plans and standardized claim attachments.

New credentialing recommendations for TAVR programs released by four leading cardiovascular organizations, serve as a starting point for programs and institutions that want to assess their potential for implementing or maintaining a TAVR program.

"As new technologies begin to be incorporated into cardiovascular practice, it is the responsibility of the medical societies to work together to develop standards for optimal patient care," Dr. Carl L. Tommaso, chair of the writing committee, said in a statement.

The 48-page document, prepared jointly by the American College of Cardiology Foundation, the Society for Cardiovascular Angiography and Interventions, the AATS, and the Society of Thoracic Surgeons, defines operator and institutional requirements for the procedure, and emphasizes the use of multidisciplinary teams, which go beyond the collaboration between interventional cardiologists and cardiac surgeons (www.jtcvs.com/webfiles/images/journals/ymtc/ExpertConsensus.pdf).

"A TAVR program that uses only one specialty is fundamentally deficient, and valve therapy programs should not be established without this multidisciplinary partnership," they wrote.

The document also recommends that irrespective of their specialty, physicians in TAVR programs should all have extensive knowledge of valvular heart disease, and they should be able to interpret images. Meanwhile, facilities should contain a full range of diagnostic imaging, in addition to an active valvular heart disease surgical program and "at least two institutionally based cardiac surgeons experienced in valvular surgery."

The role of an invested hospital administration is also emphasized. "There must be dedication on the part of the hospital to provide these services and support, both financially and with no time constraints on the personnel involved," the authors write.

While they lay out minimum case number requirements for surgeons and interventionalists, the authors predict that simulators are "likely to play a significant role in technical training and proficiency maintenance for these evolving procedures," and the training strategy will evolve as the procedure becomes mainstream. Therefore, there "is the need for this to be a dynamic document that we will revisit in the future as the technology evolves, experience grows, and data accumulate," Dr. R. Morton Bolman, cochair of the document writing committee said in a statement.

Dr. Tommaso and Dr. Bolman had no relevant disclosures.

New credentialing recommendations for TAVR programs released by four leading cardiovascular organizations, serve as a starting point for programs and institutions that want to assess their potential for implementing or maintaining a TAVR program.

"As new technologies begin to be incorporated into cardiovascular practice, it is the responsibility of the medical societies to work together to develop standards for optimal patient care," Dr. Carl L. Tommaso, chair of the writing committee, said in a statement.

The 48-page document, prepared jointly by the American College of Cardiology Foundation, the Society for Cardiovascular Angiography and Interventions, the AATS, and the Society of Thoracic Surgeons, defines operator and institutional requirements for the procedure, and emphasizes the use of multidisciplinary teams, which go beyond the collaboration between interventional cardiologists and cardiac surgeons (www.jtcvs.com/webfiles/images/journals/ymtc/ExpertConsensus.pdf).

"A TAVR program that uses only one specialty is fundamentally deficient, and valve therapy programs should not be established without this multidisciplinary partnership," they wrote.

The document also recommends that irrespective of their specialty, physicians in TAVR programs should all have extensive knowledge of valvular heart disease, and they should be able to interpret images. Meanwhile, facilities should contain a full range of diagnostic imaging, in addition to an active valvular heart disease surgical program and "at least two institutionally based cardiac surgeons experienced in valvular surgery."

The role of an invested hospital administration is also emphasized. "There must be dedication on the part of the hospital to provide these services and support, both financially and with no time constraints on the personnel involved," the authors write.

While they lay out minimum case number requirements for surgeons and interventionalists, the authors predict that simulators are "likely to play a significant role in technical training and proficiency maintenance for these evolving procedures," and the training strategy will evolve as the procedure becomes mainstream. Therefore, there "is the need for this to be a dynamic document that we will revisit in the future as the technology evolves, experience grows, and data accumulate," Dr. R. Morton Bolman, cochair of the document writing committee said in a statement.

Dr. Tommaso and Dr. Bolman had no relevant disclosures.

New credentialing recommendations for TAVR programs released by four leading cardiovascular organizations, serve as a starting point for programs and institutions that want to assess their potential for implementing or maintaining a TAVR program.

"As new technologies begin to be incorporated into cardiovascular practice, it is the responsibility of the medical societies to work together to develop standards for optimal patient care," Dr. Carl L. Tommaso, chair of the writing committee, said in a statement.

The 48-page document, prepared jointly by the American College of Cardiology Foundation, the Society for Cardiovascular Angiography and Interventions, the AATS, and the Society of Thoracic Surgeons, defines operator and institutional requirements for the procedure, and emphasizes the use of multidisciplinary teams, which go beyond the collaboration between interventional cardiologists and cardiac surgeons (www.jtcvs.com/webfiles/images/journals/ymtc/ExpertConsensus.pdf).

"A TAVR program that uses only one specialty is fundamentally deficient, and valve therapy programs should not be established without this multidisciplinary partnership," they wrote.

The document also recommends that irrespective of their specialty, physicians in TAVR programs should all have extensive knowledge of valvular heart disease, and they should be able to interpret images. Meanwhile, facilities should contain a full range of diagnostic imaging, in addition to an active valvular heart disease surgical program and "at least two institutionally based cardiac surgeons experienced in valvular surgery."

The role of an invested hospital administration is also emphasized. "There must be dedication on the part of the hospital to provide these services and support, both financially and with no time constraints on the personnel involved," the authors write.

While they lay out minimum case number requirements for surgeons and interventionalists, the authors predict that simulators are "likely to play a significant role in technical training and proficiency maintenance for these evolving procedures," and the training strategy will evolve as the procedure becomes mainstream. Therefore, there "is the need for this to be a dynamic document that we will revisit in the future as the technology evolves, experience grows, and data accumulate," Dr. R. Morton Bolman, cochair of the document writing committee said in a statement.

Dr. Tommaso and Dr. Bolman had no relevant disclosures.

New credentialing recommendations for TAVR programs released by four leading cardiovascular organizations, serve as a starting point for programs and institutions that want to assess their potential for implementing or maintaining a TAVR program.

"As new technologies begin to be incorporated into cardiovascular practice, it is the responsibility of the medical societies to work together to develop standards for optimal patient care," Dr. Carl L. Tommaso, chair of the writing committee, said in a statement.

The 48-page document, prepared jointly by the American College of Cardiology Foundation, the Society for Cardiovascular Angiography and Interventions, the AATS, and the Society of Thoracic Surgeons, defines operator and institutional requirements for the procedure, and emphasizes the use of multidisciplinary teams, which go beyond the collaboration between interventional cardiologists and cardiac surgeons (www.jtcvs.com/webfiles/images/journals/ymtc/ExpertConsensus.pdf).

"A TAVR program that uses only one specialty is fundamentally deficient, and valve therapy programs should not be established without this multidisciplinary partnership," they wrote.

The document also recommends that irrespective of their specialty, physicians in TAVR programs should all have extensive knowledge of valvular heart disease, and they should be able to interpret images. Meanwhile, facilities should contain a full range of diagnostic imaging, in addition to an active valvular heart disease surgical program and "at least two institutionally based cardiac surgeons experienced in valvular surgery."

The role of an invested hospital administration is also emphasized. "There must be dedication on the part of the hospital to provide these services and support, both financially and with no time constraints on the personnel involved," the authors write.

While they lay out minimum case number requirements for surgeons and interventionalists, the authors predict that simulators are "likely to play a significant role in technical training and proficiency maintenance for these evolving procedures," and the training strategy will evolve as the procedure becomes mainstream. Therefore, there "is the need for this to be a dynamic document that we will revisit in the future as the technology evolves, experience grows, and data accumulate," Dr. R. Morton Bolman, cochair of the document writing committee said in a statement.

Dr. Tommaso and Dr. Bolman had no relevant disclosures.

New credentialing recommendations for TAVR programs released by four leading cardiovascular organizations, serve as a starting point for programs and institutions that want to assess their potential for implementing or maintaining a TAVR program.

"As new technologies begin to be incorporated into cardiovascular practice, it is the responsibility of the medical societies to work together to develop standards for optimal patient care," Dr. Carl L. Tommaso, chair of the writing committee, said in a statement.

The 48-page document, prepared jointly by the American College of Cardiology Foundation, the Society for Cardiovascular Angiography and Interventions, the AATS, and the Society of Thoracic Surgeons, defines operator and institutional requirements for the procedure, and emphasizes the use of multidisciplinary teams, which go beyond the collaboration between interventional cardiologists and cardiac surgeons (www.jtcvs.com/webfiles/images/journals/ymtc/ExpertConsensus.pdf).

"A TAVR program that uses only one specialty is fundamentally deficient, and valve therapy programs should not be established without this multidisciplinary partnership," they wrote.

The document also recommends that irrespective of their specialty, physicians in TAVR programs should all have extensive knowledge of valvular heart disease, and they should be able to interpret images. Meanwhile, facilities should contain a full range of diagnostic imaging, in addition to an active valvular heart disease surgical program and "at least two institutionally based cardiac surgeons experienced in valvular surgery."

The role of an invested hospital administration is also emphasized. "There must be dedication on the part of the hospital to provide these services and support, both financially and with no time constraints on the personnel involved," the authors write.

While they lay out minimum case number requirements for surgeons and interventionalists, the authors predict that simulators are "likely to play a significant role in technical training and proficiency maintenance for these evolving procedures," and the training strategy will evolve as the procedure becomes mainstream. Therefore, there "is the need for this to be a dynamic document that we will revisit in the future as the technology evolves, experience grows, and data accumulate," Dr. R. Morton Bolman, cochair of the document writing committee said in a statement.

Dr. Tommaso and Dr. Bolman had no relevant disclosures.

New credentialing recommendations for TAVR programs released by four leading cardiovascular organizations, serve as a starting point for programs and institutions that want to assess their potential for implementing or maintaining a TAVR program.

"As new technologies begin to be incorporated into cardiovascular practice, it is the responsibility of the medical societies to work together to develop standards for optimal patient care," Dr. Carl L. Tommaso, chair of the writing committee, said in a statement.

The 48-page document, prepared jointly by the American College of Cardiology Foundation, the Society for Cardiovascular Angiography and Interventions, the AATS, and the Society of Thoracic Surgeons, defines operator and institutional requirements for the procedure, and emphasizes the use of multidisciplinary teams, which go beyond the collaboration between interventional cardiologists and cardiac surgeons (www.jtcvs.com/webfiles/images/journals/ymtc/ExpertConsensus.pdf).

"A TAVR program that uses only one specialty is fundamentally deficient, and valve therapy programs should not be established without this multidisciplinary partnership," they wrote.

The document also recommends that irrespective of their specialty, physicians in TAVR programs should all have extensive knowledge of valvular heart disease, and they should be able to interpret images. Meanwhile, facilities should contain a full range of diagnostic imaging, in addition to an active valvular heart disease surgical program and "at least two institutionally based cardiac surgeons experienced in valvular surgery."

The role of an invested hospital administration is also emphasized. "There must be dedication on the part of the hospital to provide these services and support, both financially and with no time constraints on the personnel involved," the authors write.

While they lay out minimum case number requirements for surgeons and interventionalists, the authors predict that simulators are "likely to play a significant role in technical training and proficiency maintenance for these evolving procedures," and the training strategy will evolve as the procedure becomes mainstream. Therefore, there "is the need for this to be a dynamic document that we will revisit in the future as the technology evolves, experience grows, and data accumulate," Dr. R. Morton Bolman, cochair of the document writing committee said in a statement.

Dr. Tommaso and Dr. Bolman had no relevant disclosures.

FT. LAUDERDALE, FLA. – Coronary artery bypass graft surgery shows a clear long-term survival advantage in certain high-risk groups over percutaneous coronary intervention, based on results of the largest study of real-world data so far.

The survival advantage for a composite high-risk group – including patients aged 75 years and older, patients with diabetes, those with ejection fractions (EF) less than 50%, and those with a glomerular filtration rate (GFR) less than 60 mL/min per 1.73 m² – was 28% at 4 years, Dr. Fred H. Edwards reported at the annual meeting of the Society of Thoracic Surgeons.

The findings come from the ASCERT (The American College of Cardiology Foundation – The Society of Thoracic Surgeons Collaboration on the Comparative Effectiveness of Revascularization Strategies) study, in which researchers compared catheter- and surgery-based procedures using the existing ACC and STS databases, as well as the Centers for Medicare and Medicaid Services 100% denominator file data. The study was designed to identify specific patient characteristics that favor one mode of treatment over the other.

The ACC and the STS both have large registries containing detailed clinical information on millions of procedures. However, the information in these databases extends to only 1 month after the procedure. The researchers linked this short-term clinical information with the administrative data registry from the CMS to provide long-term mortality, rehospitalization, and resource utilization outcomes. The 3- to 5-year outcomes after coronary artery bypass graft (CABG) surgery are being compared with those after percutaneous coronary intervention (PCI) – primarily using drug-eluting coronary stents, from the STS and ACC databases, respectively. In addition to survival, researchers are assessing the need for additional procedures and hospitalizations, new cardiac disease conditions, and the medications being taken at various points in time after the coronary artery procedure.

Patients in this CMS population were at least 65 years of age with two- to three-vessel disease. Patients with either single-vessel disease or left-main disease were excluded.

"[This study has] a population that is actually 10 times greater than the sum total of all patients ever having been enrolled in randomized [revascularization] trials," said Dr. Edwards, who is medical director of cardiothoracic surgery at the University of Florida/Shands Jacksonville,and chairman of the STS National Database.

Data from both the STS and ACC databases were linked to data from the CMS. A propensity score – the probability of having CABG – was calculated for each patient, and clinically important subgroups were identified before the files were linked. The propensity scores and inverse weighting were used to calculate adjusted survival curves. "Then we compared the survival for coronary bypass and percutaneous intervention for groups having very similar characteristics," said Dr. Edwards.

High- and Low-Risk Groups Identified

This analysis included a total of 189,793 patients, of which 103,549 received PCI. Dr. Edwards presented the survival results for high-risk subgroups; the overall results will be presented at the ACC’s Annual Scientific Session in March, he said.

High-risk subgroups include patients who were aged 75 years and older, had diabetes, had EFs less than 50%, and had a GFR less than 60 mL/min per 1.73 m².

For those aged 75 years and older, the mortality risk ratio at 4 years was 0.78 favoring surgery. Correspondingly, the survival advantage in this group for surgery was 22%. For patients with three-vessel disease, the survival advantage at 4 years was 25%. Patients with insulin-dependent diabetes had a 28% survival advantage at 4 years with CABG, compared with PCI. For patients with EFs less than 50%, the survival advantage with surgery was 30% at 4 years.

However, there appears to be a survival advantage with PCI in these groups at up to 1 year of follow-up. "We should keep in mind that in many of these subgroups, the survival with percutaneous intervention is better than surgery in that first 6-10 months after the procedure. The reason for that, of course, is the procedural mortality," Dr. Edwards said.

They also defined a low-risk population (about 20% of the total population). They looked at survival advantages at years 1-4. "I think this is important because it illustrates that surgery really does start to declare its advantage in year 1 to year 2. Then it looks like it begins to plateau off a little bit," he said. "Still, at 4 years for both high-risk and low-risk patients, you’ve got more than a 25% survival advantage for surgery."

He noted that "this is a Medicare population, so we would be on shaky ground if we tried to extrapolate these results to a global population."

He concluded by saying that "the results should improve the quality of care for patients with coronary disease, and it should clarify the indications for intervention in the subgroups that we’ve presented here."

Prediction Models Gleaned From Data

During the same presentation, Dr. David M. Shahian reported on long-term prediction models of death and nonfatal events for both CABG and PCI. "Longer term outcomes are clearly going to be necessary if we’re really going to determine the true comparative effectiveness of these various strategies." he said.

The researchers looked at all isolated CABG patients at STS-participating hospitals who were discharged between the beginning of 2002 and the end of 2007. STS procedural records were linked to CMS claims and denominator files.

The final cohort included 348,341 CABG patients at 917 sites. Follow-up was through 2008 (median follow-up, 4 years). Long-term variables were based on those from short-term CABG models and clinical experience. Separate hazard ratios were estimated for each of these variables for four time intervals: 0-30 days, 31-80 days, 181-730 days, and more than 2 years.

Kaplan-Meier estimated mortality rates for CABG were 3% at 30 days, 6% at 180 days, 8% at 1 year, 11% at 2 years, and 23% at 3 years. Predicted mortality rates were superimposable with observed mortality rates, said Dr. Shahian, who is a cardiothoracic surgeon at Harvard Medical School in Boston. Dr. Shahian is also the chair of the STS Adult Cardiac Surgery Database and the STS Quality Measurement Task Force.

"We did observe the obesity paradox here. It’s the frail, almost cachectic individuals, who do the worst, while the more obese individuals tend to do better over time," he said.

The impact of some predictors changed over time. For example, patients with an acute MI have an increased initial mortality risk, which becomes generally insignificant over 1-2 years. In addition, early reoperation, shock, and emergency status have high up-front risks that decrease over time. However, preoperative atrial fibrillation progressively increases risk over time, he said.

"Among hospital survivors, higher ejection fraction and higher [body mass index] are protective at all time periods. A past history of stroke ... [and] chronic lung-disease immunosuppression have a persistent and negative impact on survival. Smoking, diabetes, dialysis-dependent renal failure – their negative impact increases over time. ... Some early important risk factors, like shock, emergency status, and reoperation are not predictors of late outcomes."

Dr. Edwards and. Dr. Shahian reported no relevant financial relationships.

FT. LAUDERDALE, FLA. – Coronary artery bypass graft surgery shows a clear long-term survival advantage in certain high-risk groups over percutaneous coronary intervention, based on results of the largest study of real-world data so far.

The survival advantage for a composite high-risk group – including patients aged 75 years and older, patients with diabetes, those with ejection fractions (EF) less than 50%, and those with a glomerular filtration rate (GFR) less than 60 mL/min per 1.73 m² – was 28% at 4 years, Dr. Fred H. Edwards reported at the annual meeting of the Society of Thoracic Surgeons.

The findings come from the ASCERT (The American College of Cardiology Foundation – The Society of Thoracic Surgeons Collaboration on the Comparative Effectiveness of Revascularization Strategies) study, in which researchers compared catheter- and surgery-based procedures using the existing ACC and STS databases, as well as the Centers for Medicare and Medicaid Services 100% denominator file data. The study was designed to identify specific patient characteristics that favor one mode of treatment over the other.

The ACC and the STS both have large registries containing detailed clinical information on millions of procedures. However, the information in these databases extends to only 1 month after the procedure. The researchers linked this short-term clinical information with the administrative data registry from the CMS to provide long-term mortality, rehospitalization, and resource utilization outcomes. The 3- to 5-year outcomes after coronary artery bypass graft (CABG) surgery are being compared with those after percutaneous coronary intervention (PCI) – primarily using drug-eluting coronary stents, from the STS and ACC databases, respectively. In addition to survival, researchers are assessing the need for additional procedures and hospitalizations, new cardiac disease conditions, and the medications being taken at various points in time after the coronary artery procedure.

Patients in this CMS population were at least 65 years of age with two- to three-vessel disease. Patients with either single-vessel disease or left-main disease were excluded.

"[This study has] a population that is actually 10 times greater than the sum total of all patients ever having been enrolled in randomized [revascularization] trials," said Dr. Edwards, who is medical director of cardiothoracic surgery at the University of Florida/Shands Jacksonville,and chairman of the STS National Database.

Data from both the STS and ACC databases were linked to data from the CMS. A propensity score – the probability of having CABG – was calculated for each patient, and clinically important subgroups were identified before the files were linked. The propensity scores and inverse weighting were used to calculate adjusted survival curves. "Then we compared the survival for coronary bypass and percutaneous intervention for groups having very similar characteristics," said Dr. Edwards.

High- and Low-Risk Groups Identified

This analysis included a total of 189,793 patients, of which 103,549 received PCI. Dr. Edwards presented the survival results for high-risk subgroups; the overall results will be presented at the ACC’s Annual Scientific Session in March, he said.

High-risk subgroups include patients who were aged 75 years and older, had diabetes, had EFs less than 50%, and had a GFR less than 60 mL/min per 1.73 m².

For those aged 75 years and older, the mortality risk ratio at 4 years was 0.78 favoring surgery. Correspondingly, the survival advantage in this group for surgery was 22%. For patients with three-vessel disease, the survival advantage at 4 years was 25%. Patients with insulin-dependent diabetes had a 28% survival advantage at 4 years with CABG, compared with PCI. For patients with EFs less than 50%, the survival advantage with surgery was 30% at 4 years.

However, there appears to be a survival advantage with PCI in these groups at up to 1 year of follow-up. "We should keep in mind that in many of these subgroups, the survival with percutaneous intervention is better than surgery in that first 6-10 months after the procedure. The reason for that, of course, is the procedural mortality," Dr. Edwards said.

They also defined a low-risk population (about 20% of the total population). They looked at survival advantages at years 1-4. "I think this is important because it illustrates that surgery really does start to declare its advantage in year 1 to year 2. Then it looks like it begins to plateau off a little bit," he said. "Still, at 4 years for both high-risk and low-risk patients, you’ve got more than a 25% survival advantage for surgery."

He noted that "this is a Medicare population, so we would be on shaky ground if we tried to extrapolate these results to a global population."

He concluded by saying that "the results should improve the quality of care for patients with coronary disease, and it should clarify the indications for intervention in the subgroups that we’ve presented here."

Prediction Models Gleaned From Data

During the same presentation, Dr. David M. Shahian reported on long-term prediction models of death and nonfatal events for both CABG and PCI. "Longer term outcomes are clearly going to be necessary if we’re really going to determine the true comparative effectiveness of these various strategies." he said.

The researchers looked at all isolated CABG patients at STS-participating hospitals who were discharged between the beginning of 2002 and the end of 2007. STS procedural records were linked to CMS claims and denominator files.

The final cohort included 348,341 CABG patients at 917 sites. Follow-up was through 2008 (median follow-up, 4 years). Long-term variables were based on those from short-term CABG models and clinical experience. Separate hazard ratios were estimated for each of these variables for four time intervals: 0-30 days, 31-80 days, 181-730 days, and more than 2 years.

Kaplan-Meier estimated mortality rates for CABG were 3% at 30 days, 6% at 180 days, 8% at 1 year, 11% at 2 years, and 23% at 3 years. Predicted mortality rates were superimposable with observed mortality rates, said Dr. Shahian, who is a cardiothoracic surgeon at Harvard Medical School in Boston. Dr. Shahian is also the chair of the STS Adult Cardiac Surgery Database and the STS Quality Measurement Task Force.

"We did observe the obesity paradox here. It’s the frail, almost cachectic individuals, who do the worst, while the more obese individuals tend to do better over time," he said.

The impact of some predictors changed over time. For example, patients with an acute MI have an increased initial mortality risk, which becomes generally insignificant over 1-2 years. In addition, early reoperation, shock, and emergency status have high up-front risks that decrease over time. However, preoperative atrial fibrillation progressively increases risk over time, he said.

"Among hospital survivors, higher ejection fraction and higher [body mass index] are protective at all time periods. A past history of stroke ... [and] chronic lung-disease immunosuppression have a persistent and negative impact on survival. Smoking, diabetes, dialysis-dependent renal failure – their negative impact increases over time. ... Some early important risk factors, like shock, emergency status, and reoperation are not predictors of late outcomes."

Dr. Edwards and. Dr. Shahian reported no relevant financial relationships.

FT. LAUDERDALE, FLA. – Coronary artery bypass graft surgery shows a clear long-term survival advantage in certain high-risk groups over percutaneous coronary intervention, based on results of the largest study of real-world data so far.

The survival advantage for a composite high-risk group – including patients aged 75 years and older, patients with diabetes, those with ejection fractions (EF) less than 50%, and those with a glomerular filtration rate (GFR) less than 60 mL/min per 1.73 m² – was 28% at 4 years, Dr. Fred H. Edwards reported at the annual meeting of the Society of Thoracic Surgeons.

The findings come from the ASCERT (The American College of Cardiology Foundation – The Society of Thoracic Surgeons Collaboration on the Comparative Effectiveness of Revascularization Strategies) study, in which researchers compared catheter- and surgery-based procedures using the existing ACC and STS databases, as well as the Centers for Medicare and Medicaid Services 100% denominator file data. The study was designed to identify specific patient characteristics that favor one mode of treatment over the other.

The ACC and the STS both have large registries containing detailed clinical information on millions of procedures. However, the information in these databases extends to only 1 month after the procedure. The researchers linked this short-term clinical information with the administrative data registry from the CMS to provide long-term mortality, rehospitalization, and resource utilization outcomes. The 3- to 5-year outcomes after coronary artery bypass graft (CABG) surgery are being compared with those after percutaneous coronary intervention (PCI) – primarily using drug-eluting coronary stents, from the STS and ACC databases, respectively. In addition to survival, researchers are assessing the need for additional procedures and hospitalizations, new cardiac disease conditions, and the medications being taken at various points in time after the coronary artery procedure.

Patients in this CMS population were at least 65 years of age with two- to three-vessel disease. Patients with either single-vessel disease or left-main disease were excluded.

"[This study has] a population that is actually 10 times greater than the sum total of all patients ever having been enrolled in randomized [revascularization] trials," said Dr. Edwards, who is medical director of cardiothoracic surgery at the University of Florida/Shands Jacksonville,and chairman of the STS National Database.

Data from both the STS and ACC databases were linked to data from the CMS. A propensity score – the probability of having CABG – was calculated for each patient, and clinically important subgroups were identified before the files were linked. The propensity scores and inverse weighting were used to calculate adjusted survival curves. "Then we compared the survival for coronary bypass and percutaneous intervention for groups having very similar characteristics," said Dr. Edwards.

High- and Low-Risk Groups Identified

This analysis included a total of 189,793 patients, of which 103,549 received PCI. Dr. Edwards presented the survival results for high-risk subgroups; the overall results will be presented at the ACC’s Annual Scientific Session in March, he said.

High-risk subgroups include patients who were aged 75 years and older, had diabetes, had EFs less than 50%, and had a GFR less than 60 mL/min per 1.73 m².

For those aged 75 years and older, the mortality risk ratio at 4 years was 0.78 favoring surgery. Correspondingly, the survival advantage in this group for surgery was 22%. For patients with three-vessel disease, the survival advantage at 4 years was 25%. Patients with insulin-dependent diabetes had a 28% survival advantage at 4 years with CABG, compared with PCI. For patients with EFs less than 50%, the survival advantage with surgery was 30% at 4 years.

However, there appears to be a survival advantage with PCI in these groups at up to 1 year of follow-up. "We should keep in mind that in many of these subgroups, the survival with percutaneous intervention is better than surgery in that first 6-10 months after the procedure. The reason for that, of course, is the procedural mortality," Dr. Edwards said.

They also defined a low-risk population (about 20% of the total population). They looked at survival advantages at years 1-4. "I think this is important because it illustrates that surgery really does start to declare its advantage in year 1 to year 2. Then it looks like it begins to plateau off a little bit," he said. "Still, at 4 years for both high-risk and low-risk patients, you’ve got more than a 25% survival advantage for surgery."

He noted that "this is a Medicare population, so we would be on shaky ground if we tried to extrapolate these results to a global population."

He concluded by saying that "the results should improve the quality of care for patients with coronary disease, and it should clarify the indications for intervention in the subgroups that we’ve presented here."

Prediction Models Gleaned From Data

During the same presentation, Dr. David M. Shahian reported on long-term prediction models of death and nonfatal events for both CABG and PCI. "Longer term outcomes are clearly going to be necessary if we’re really going to determine the true comparative effectiveness of these various strategies." he said.

The researchers looked at all isolated CABG patients at STS-participating hospitals who were discharged between the beginning of 2002 and the end of 2007. STS procedural records were linked to CMS claims and denominator files.

The final cohort included 348,341 CABG patients at 917 sites. Follow-up was through 2008 (median follow-up, 4 years). Long-term variables were based on those from short-term CABG models and clinical experience. Separate hazard ratios were estimated for each of these variables for four time intervals: 0-30 days, 31-80 days, 181-730 days, and more than 2 years.

Kaplan-Meier estimated mortality rates for CABG were 3% at 30 days, 6% at 180 days, 8% at 1 year, 11% at 2 years, and 23% at 3 years. Predicted mortality rates were superimposable with observed mortality rates, said Dr. Shahian, who is a cardiothoracic surgeon at Harvard Medical School in Boston. Dr. Shahian is also the chair of the STS Adult Cardiac Surgery Database and the STS Quality Measurement Task Force.

"We did observe the obesity paradox here. It’s the frail, almost cachectic individuals, who do the worst, while the more obese individuals tend to do better over time," he said.

The impact of some predictors changed over time. For example, patients with an acute MI have an increased initial mortality risk, which becomes generally insignificant over 1-2 years. In addition, early reoperation, shock, and emergency status have high up-front risks that decrease over time. However, preoperative atrial fibrillation progressively increases risk over time, he said.

"Among hospital survivors, higher ejection fraction and higher [body mass index] are protective at all time periods. A past history of stroke ... [and] chronic lung-disease immunosuppression have a persistent and negative impact on survival. Smoking, diabetes, dialysis-dependent renal failure – their negative impact increases over time. ... Some early important risk factors, like shock, emergency status, and reoperation are not predictors of late outcomes."

Dr. Edwards and. Dr. Shahian reported no relevant financial relationships.

FT. LAUDERDALE, FLA. – Coronary artery bypass graft surgery shows a clear long-term survival advantage in certain high-risk groups over percutaneous coronary intervention, based on results of the largest study of real-world data so far.

The survival advantage for a composite high-risk group – including patients aged 75 years and older, patients with diabetes, those with ejection fractions (EF) less than 50%, and those with a glomerular filtration rate (GFR) less than 60 mL/min per 1.73 m² – was 28% at 4 years, Dr. Fred H. Edwards reported at the annual meeting of the Society of Thoracic Surgeons.

The findings come from the ASCERT (The American College of Cardiology Foundation – The Society of Thoracic Surgeons Collaboration on the Comparative Effectiveness of Revascularization Strategies) study, in which researchers compared catheter- and surgery-based procedures using the existing ACC and STS databases, as well as the Centers for Medicare and Medicaid Services 100% denominator file data. The study was designed to identify specific patient characteristics that favor one mode of treatment over the other.

The ACC and the STS both have large registries containing detailed clinical information on millions of procedures. However, the information in these databases extends to only 1 month after the procedure. The researchers linked this short-term clinical information with the administrative data registry from the CMS to provide long-term mortality, rehospitalization, and resource utilization outcomes. The 3- to 5-year outcomes after coronary artery bypass graft (CABG) surgery are being compared with those after percutaneous coronary intervention (PCI) – primarily using drug-eluting coronary stents, from the STS and ACC databases, respectively. In addition to survival, researchers are assessing the need for additional procedures and hospitalizations, new cardiac disease conditions, and the medications being taken at various points in time after the coronary artery procedure.

Patients in this CMS population were at least 65 years of age with two- to three-vessel disease. Patients with either single-vessel disease or left-main disease were excluded.

"[This study has] a population that is actually 10 times greater than the sum total of all patients ever having been enrolled in randomized [revascularization] trials," said Dr. Edwards, who is medical director of cardiothoracic surgery at the University of Florida/Shands Jacksonville,and chairman of the STS National Database.

Data from both the STS and ACC databases were linked to data from the CMS. A propensity score – the probability of having CABG – was calculated for each patient, and clinically important subgroups were identified before the files were linked. The propensity scores and inverse weighting were used to calculate adjusted survival curves. "Then we compared the survival for coronary bypass and percutaneous intervention for groups having very similar characteristics," said Dr. Edwards.

High- and Low-Risk Groups Identified

This analysis included a total of 189,793 patients, of which 103,549 received PCI. Dr. Edwards presented the survival results for high-risk subgroups; the overall results will be presented at the ACC’s Annual Scientific Session in March, he said.

High-risk subgroups include patients who were aged 75 years and older, had diabetes, had EFs less than 50%, and had a GFR less than 60 mL/min per 1.73 m².

For those aged 75 years and older, the mortality risk ratio at 4 years was 0.78 favoring surgery. Correspondingly, the survival advantage in this group for surgery was 22%. For patients with three-vessel disease, the survival advantage at 4 years was 25%. Patients with insulin-dependent diabetes had a 28% survival advantage at 4 years with CABG, compared with PCI. For patients with EFs less than 50%, the survival advantage with surgery was 30% at 4 years.

However, there appears to be a survival advantage with PCI in these groups at up to 1 year of follow-up. "We should keep in mind that in many of these subgroups, the survival with percutaneous intervention is better than surgery in that first 6-10 months after the procedure. The reason for that, of course, is the procedural mortality," Dr. Edwards said.

They also defined a low-risk population (about 20% of the total population). They looked at survival advantages at years 1-4. "I think this is important because it illustrates that surgery really does start to declare its advantage in year 1 to year 2. Then it looks like it begins to plateau off a little bit," he said. "Still, at 4 years for both high-risk and low-risk patients, you’ve got more than a 25% survival advantage for surgery."

He noted that "this is a Medicare population, so we would be on shaky ground if we tried to extrapolate these results to a global population."

He concluded by saying that "the results should improve the quality of care for patients with coronary disease, and it should clarify the indications for intervention in the subgroups that we’ve presented here."

Prediction Models Gleaned From Data

During the same presentation, Dr. David M. Shahian reported on long-term prediction models of death and nonfatal events for both CABG and PCI. "Longer term outcomes are clearly going to be necessary if we’re really going to determine the true comparative effectiveness of these various strategies." he said.

The researchers looked at all isolated CABG patients at STS-participating hospitals who were discharged between the beginning of 2002 and the end of 2007. STS procedural records were linked to CMS claims and denominator files.

The final cohort included 348,341 CABG patients at 917 sites. Follow-up was through 2008 (median follow-up, 4 years). Long-term variables were based on those from short-term CABG models and clinical experience. Separate hazard ratios were estimated for each of these variables for four time intervals: 0-30 days, 31-80 days, 181-730 days, and more than 2 years.

Kaplan-Meier estimated mortality rates for CABG were 3% at 30 days, 6% at 180 days, 8% at 1 year, 11% at 2 years, and 23% at 3 years. Predicted mortality rates were superimposable with observed mortality rates, said Dr. Shahian, who is a cardiothoracic surgeon at Harvard Medical School in Boston. Dr. Shahian is also the chair of the STS Adult Cardiac Surgery Database and the STS Quality Measurement Task Force.

"We did observe the obesity paradox here. It’s the frail, almost cachectic individuals, who do the worst, while the more obese individuals tend to do better over time," he said.

The impact of some predictors changed over time. For example, patients with an acute MI have an increased initial mortality risk, which becomes generally insignificant over 1-2 years. In addition, early reoperation, shock, and emergency status have high up-front risks that decrease over time. However, preoperative atrial fibrillation progressively increases risk over time, he said.

"Among hospital survivors, higher ejection fraction and higher [body mass index] are protective at all time periods. A past history of stroke ... [and] chronic lung-disease immunosuppression have a persistent and negative impact on survival. Smoking, diabetes, dialysis-dependent renal failure – their negative impact increases over time. ... Some early important risk factors, like shock, emergency status, and reoperation are not predictors of late outcomes."

Dr. Edwards and. Dr. Shahian reported no relevant financial relationships.

FT. LAUDERDALE, FLA. – Coronary artery bypass graft surgery shows a clear long-term survival advantage in certain high-risk groups over percutaneous coronary intervention, based on results of the largest study of real-world data so far.

The survival advantage for a composite high-risk group – including patients aged 75 years and older, patients with diabetes, those with ejection fractions (EF) less than 50%, and those with a glomerular filtration rate (GFR) less than 60 mL/min per 1.73 m² – was 28% at 4 years, Dr. Fred H. Edwards reported at the annual meeting of the Society of Thoracic Surgeons.

The findings come from the ASCERT (The American College of Cardiology Foundation – The Society of Thoracic Surgeons Collaboration on the Comparative Effectiveness of Revascularization Strategies) study, in which researchers compared catheter- and surgery-based procedures using the existing ACC and STS databases, as well as the Centers for Medicare and Medicaid Services 100% denominator file data. The study was designed to identify specific patient characteristics that favor one mode of treatment over the other.

The ACC and the STS both have large registries containing detailed clinical information on millions of procedures. However, the information in these databases extends to only 1 month after the procedure. The researchers linked this short-term clinical information with the administrative data registry from the CMS to provide long-term mortality, rehospitalization, and resource utilization outcomes. The 3- to 5-year outcomes after coronary artery bypass graft (CABG) surgery are being compared with those after percutaneous coronary intervention (PCI) – primarily using drug-eluting coronary stents, from the STS and ACC databases, respectively. In addition to survival, researchers are assessing the need for additional procedures and hospitalizations, new cardiac disease conditions, and the medications being taken at various points in time after the coronary artery procedure.

Patients in this CMS population were at least 65 years of age with two- to three-vessel disease. Patients with either single-vessel disease or left-main disease were excluded.

"[This study has] a population that is actually 10 times greater than the sum total of all patients ever having been enrolled in randomized [revascularization] trials," said Dr. Edwards, who is medical director of cardiothoracic surgery at the University of Florida/Shands Jacksonville,and chairman of the STS National Database.

Data from both the STS and ACC databases were linked to data from the CMS. A propensity score – the probability of having CABG – was calculated for each patient, and clinically important subgroups were identified before the files were linked. The propensity scores and inverse weighting were used to calculate adjusted survival curves. "Then we compared the survival for coronary bypass and percutaneous intervention for groups having very similar characteristics," said Dr. Edwards.

High- and Low-Risk Groups Identified

This analysis included a total of 189,793 patients, of which 103,549 received PCI. Dr. Edwards presented the survival results for high-risk subgroups; the overall results will be presented at the ACC’s Annual Scientific Session in March, he said.

High-risk subgroups include patients who were aged 75 years and older, had diabetes, had EFs less than 50%, and had a GFR less than 60 mL/min per 1.73 m².

For those aged 75 years and older, the mortality risk ratio at 4 years was 0.78 favoring surgery. Correspondingly, the survival advantage in this group for surgery was 22%. For patients with three-vessel disease, the survival advantage at 4 years was 25%. Patients with insulin-dependent diabetes had a 28% survival advantage at 4 years with CABG, compared with PCI. For patients with EFs less than 50%, the survival advantage with surgery was 30% at 4 years.

However, there appears to be a survival advantage with PCI in these groups at up to 1 year of follow-up. "We should keep in mind that in many of these subgroups, the survival with percutaneous intervention is better than surgery in that first 6-10 months after the procedure. The reason for that, of course, is the procedural mortality," Dr. Edwards said.

They also defined a low-risk population (about 20% of the total population). They looked at survival advantages at years 1-4. "I think this is important because it illustrates that surgery really does start to declare its advantage in year 1 to year 2. Then it looks like it begins to plateau off a little bit," he said. "Still, at 4 years for both high-risk and low-risk patients, you’ve got more than a 25% survival advantage for surgery."

He noted that "this is a Medicare population, so we would be on shaky ground if we tried to extrapolate these results to a global population."

He concluded by saying that "the results should improve the quality of care for patients with coronary disease, and it should clarify the indications for intervention in the subgroups that we’ve presented here."

Prediction Models Gleaned From Data

During the same presentation, Dr. David M. Shahian reported on long-term prediction models of death and nonfatal events for both CABG and PCI. "Longer term outcomes are clearly going to be necessary if we’re really going to determine the true comparative effectiveness of these various strategies." he said.

The researchers looked at all isolated CABG patients at STS-participating hospitals who were discharged between the beginning of 2002 and the end of 2007. STS procedural records were linked to CMS claims and denominator files.

The final cohort included 348,341 CABG patients at 917 sites. Follow-up was through 2008 (median follow-up, 4 years). Long-term variables were based on those from short-term CABG models and clinical experience. Separate hazard ratios were estimated for each of these variables for four time intervals: 0-30 days, 31-80 days, 181-730 days, and more than 2 years.

Kaplan-Meier estimated mortality rates for CABG were 3% at 30 days, 6% at 180 days, 8% at 1 year, 11% at 2 years, and 23% at 3 years. Predicted mortality rates were superimposable with observed mortality rates, said Dr. Shahian, who is a cardiothoracic surgeon at Harvard Medical School in Boston. Dr. Shahian is also the chair of the STS Adult Cardiac Surgery Database and the STS Quality Measurement Task Force.

"We did observe the obesity paradox here. It’s the frail, almost cachectic individuals, who do the worst, while the more obese individuals tend to do better over time," he said.

The impact of some predictors changed over time. For example, patients with an acute MI have an increased initial mortality risk, which becomes generally insignificant over 1-2 years. In addition, early reoperation, shock, and emergency status have high up-front risks that decrease over time. However, preoperative atrial fibrillation progressively increases risk over time, he said.

"Among hospital survivors, higher ejection fraction and higher [body mass index] are protective at all time periods. A past history of stroke ... [and] chronic lung-disease immunosuppression have a persistent and negative impact on survival. Smoking, diabetes, dialysis-dependent renal failure – their negative impact increases over time. ... Some early important risk factors, like shock, emergency status, and reoperation are not predictors of late outcomes."

Dr. Edwards and. Dr. Shahian reported no relevant financial relationships.

FT. LAUDERDALE, FLA. – Coronary artery bypass graft surgery shows a clear long-term survival advantage in certain high-risk groups over percutaneous coronary intervention, based on results of the largest study of real-world data so far.

The survival advantage for a composite high-risk group – including patients aged 75 years and older, patients with diabetes, those with ejection fractions (EF) less than 50%, and those with a glomerular filtration rate (GFR) less than 60 mL/min per 1.73 m² – was 28% at 4 years, Dr. Fred H. Edwards reported at the annual meeting of the Society of Thoracic Surgeons.

The findings come from the ASCERT (The American College of Cardiology Foundation – The Society of Thoracic Surgeons Collaboration on the Comparative Effectiveness of Revascularization Strategies) study, in which researchers compared catheter- and surgery-based procedures using the existing ACC and STS databases, as well as the Centers for Medicare and Medicaid Services 100% denominator file data. The study was designed to identify specific patient characteristics that favor one mode of treatment over the other.

The ACC and the STS both have large registries containing detailed clinical information on millions of procedures. However, the information in these databases extends to only 1 month after the procedure. The researchers linked this short-term clinical information with the administrative data registry from the CMS to provide long-term mortality, rehospitalization, and resource utilization outcomes. The 3- to 5-year outcomes after coronary artery bypass graft (CABG) surgery are being compared with those after percutaneous coronary intervention (PCI) – primarily using drug-eluting coronary stents, from the STS and ACC databases, respectively. In addition to survival, researchers are assessing the need for additional procedures and hospitalizations, new cardiac disease conditions, and the medications being taken at various points in time after the coronary artery procedure.

Patients in this CMS population were at least 65 years of age with two- to three-vessel disease. Patients with either single-vessel disease or left-main disease were excluded.

"[This study has] a population that is actually 10 times greater than the sum total of all patients ever having been enrolled in randomized [revascularization] trials," said Dr. Edwards, who is medical director of cardiothoracic surgery at the University of Florida/Shands Jacksonville,and chairman of the STS National Database.

Data from both the STS and ACC databases were linked to data from the CMS. A propensity score – the probability of having CABG – was calculated for each patient, and clinically important subgroups were identified before the files were linked. The propensity scores and inverse weighting were used to calculate adjusted survival curves. "Then we compared the survival for coronary bypass and percutaneous intervention for groups having very similar characteristics," said Dr. Edwards.

High- and Low-Risk Groups Identified

This analysis included a total of 189,793 patients, of which 103,549 received PCI. Dr. Edwards presented the survival results for high-risk subgroups; the overall results will be presented at the ACC’s Annual Scientific Session in March, he said.

High-risk subgroups include patients who were aged 75 years and older, had diabetes, had EFs less than 50%, and had a GFR less than 60 mL/min per 1.73 m².

For those aged 75 years and older, the mortality risk ratio at 4 years was 0.78 favoring surgery. Correspondingly, the survival advantage in this group for surgery was 22%. For patients with three-vessel disease, the survival advantage at 4 years was 25%. Patients with insulin-dependent diabetes had a 28% survival advantage at 4 years with CABG, compared with PCI. For patients with EFs less than 50%, the survival advantage with surgery was 30% at 4 years.

However, there appears to be a survival advantage with PCI in these groups at up to 1 year of follow-up. "We should keep in mind that in many of these subgroups, the survival with percutaneous intervention is better than surgery in that first 6-10 months after the procedure. The reason for that, of course, is the procedural mortality," Dr. Edwards said.

They also defined a low-risk population (about 20% of the total population). They looked at survival advantages at years 1-4. "I think this is important because it illustrates that surgery really does start to declare its advantage in year 1 to year 2. Then it looks like it begins to plateau off a little bit," he said. "Still, at 4 years for both high-risk and low-risk patients, you’ve got more than a 25% survival advantage for surgery."

He noted that "this is a Medicare population, so we would be on shaky ground if we tried to extrapolate these results to a global population."

He concluded by saying that "the results should improve the quality of care for patients with coronary disease, and it should clarify the indications for intervention in the subgroups that we’ve presented here."

Prediction Models Gleaned From Data

During the same presentation, Dr. David M. Shahian reported on long-term prediction models of death and nonfatal events for both CABG and PCI. "Longer term outcomes are clearly going to be necessary if we’re really going to determine the true comparative effectiveness of these various strategies." he said.

The researchers looked at all isolated CABG patients at STS-participating hospitals who were discharged between the beginning of 2002 and the end of 2007. STS procedural records were linked to CMS claims and denominator files.

The final cohort included 348,341 CABG patients at 917 sites. Follow-up was through 2008 (median follow-up, 4 years). Long-term variables were based on those from short-term CABG models and clinical experience. Separate hazard ratios were estimated for each of these variables for four time intervals: 0-30 days, 31-80 days, 181-730 days, and more than 2 years.

Kaplan-Meier estimated mortality rates for CABG were 3% at 30 days, 6% at 180 days, 8% at 1 year, 11% at 2 years, and 23% at 3 years. Predicted mortality rates were superimposable with observed mortality rates, said Dr. Shahian, who is a cardiothoracic surgeon at Harvard Medical School in Boston. Dr. Shahian is also the chair of the STS Adult Cardiac Surgery Database and the STS Quality Measurement Task Force.

"We did observe the obesity paradox here. It’s the frail, almost cachectic individuals, who do the worst, while the more obese individuals tend to do better over time," he said.

The impact of some predictors changed over time. For example, patients with an acute MI have an increased initial mortality risk, which becomes generally insignificant over 1-2 years. In addition, early reoperation, shock, and emergency status have high up-front risks that decrease over time. However, preoperative atrial fibrillation progressively increases risk over time, he said.

"Among hospital survivors, higher ejection fraction and higher [body mass index] are protective at all time periods. A past history of stroke ... [and] chronic lung-disease immunosuppression have a persistent and negative impact on survival. Smoking, diabetes, dialysis-dependent renal failure – their negative impact increases over time. ... Some early important risk factors, like shock, emergency status, and reoperation are not predictors of late outcomes."

Dr. Edwards and. Dr. Shahian reported no relevant financial relationships.

New credentialing recommendations for TAVR programs released by four leading cardiovascular organizations, serve as a starting point for programs and institutions that want to assess their potential for implementing or maintaining a TAVR program.

"As new technologies begin to be incorporated into cardiovascular practice, it is the responsibility of the medical societies to work together to develop standards for optimal patient care," Dr. Carl L. Tommaso, chair of the writing committee, said in a statement.

The 48-page document, prepared jointly by the American College of Cardiology Foundation, the Society for Cardiovascular Angiography and Interventions, the AATS, and the Society of Thoracic Surgeons, defines operator and institutional requirements for the procedure, and emphasizes the use of multidisciplinary teams, which go beyond the collaboration between interventional cardiologists and cardiac surgeons (www.jtcvs.com/webfiles/images/journals/ymtc/ExpertConsensus.pdf).

"A TAVR program that uses only one specialty is fundamentally deficient, and valve therapy programs should not be established without this multidisciplinary partnership," they wrote.

The document also recommends that irrespective of their specialty, physicians in TAVR programs should all have extensive knowledge of valvular heart disease, and they should be able to interpret images. Meanwhile, facilities should contain a full range of diagnostic imaging, in addition to an active valvular heart disease surgical program and "at least two institutionally based cardiac surgeons experienced in valvular surgery."

The role of an invested hospital administration is also emphasized. "There must be dedication on the part of the hospital to provide these services and support, both financially and with no time constraints on the personnel involved," the authors write.

While they lay out minimum case number requirements for surgeons and interventionalists, the authors predict that simulators are "likely to play a significant role in technical training and proficiency maintenance for these evolving procedures," and the training strategy will evolve as the procedure becomes mainstream. Therefore, there "is the need for this to be a dynamic document that we will revisit in the future as the technology evolves, experience grows, and data accumulate," Dr. R. Morton Bolman, cochair of the document writing committee said in a statement.

Dr. Tommaso and Dr. Bolman had no relevant disclosures.

New credentialing recommendations for TAVR programs released by four leading cardiovascular organizations, serve as a starting point for programs and institutions that want to assess their potential for implementing or maintaining a TAVR program.

"As new technologies begin to be incorporated into cardiovascular practice, it is the responsibility of the medical societies to work together to develop standards for optimal patient care," Dr. Carl L. Tommaso, chair of the writing committee, said in a statement.

The 48-page document, prepared jointly by the American College of Cardiology Foundation, the Society for Cardiovascular Angiography and Interventions, the AATS, and the Society of Thoracic Surgeons, defines operator and institutional requirements for the procedure, and emphasizes the use of multidisciplinary teams, which go beyond the collaboration between interventional cardiologists and cardiac surgeons (www.jtcvs.com/webfiles/images/journals/ymtc/ExpertConsensus.pdf).

"A TAVR program that uses only one specialty is fundamentally deficient, and valve therapy programs should not be established without this multidisciplinary partnership," they wrote.

The document also recommends that irrespective of their specialty, physicians in TAVR programs should all have extensive knowledge of valvular heart disease, and they should be able to interpret images. Meanwhile, facilities should contain a full range of diagnostic imaging, in addition to an active valvular heart disease surgical program and "at least two institutionally based cardiac surgeons experienced in valvular surgery."

The role of an invested hospital administration is also emphasized. "There must be dedication on the part of the hospital to provide these services and support, both financially and with no time constraints on the personnel involved," the authors write.

While they lay out minimum case number requirements for surgeons and interventionalists, the authors predict that simulators are "likely to play a significant role in technical training and proficiency maintenance for these evolving procedures," and the training strategy will evolve as the procedure becomes mainstream. Therefore, there "is the need for this to be a dynamic document that we will revisit in the future as the technology evolves, experience grows, and data accumulate," Dr. R. Morton Bolman, cochair of the document writing committee said in a statement.

Dr. Tommaso and Dr. Bolman had no relevant disclosures.

New credentialing recommendations for TAVR programs released by four leading cardiovascular organizations, serve as a starting point for programs and institutions that want to assess their potential for implementing or maintaining a TAVR program.

"As new technologies begin to be incorporated into cardiovascular practice, it is the responsibility of the medical societies to work together to develop standards for optimal patient care," Dr. Carl L. Tommaso, chair of the writing committee, said in a statement.

The 48-page document, prepared jointly by the American College of Cardiology Foundation, the Society for Cardiovascular Angiography and Interventions, the AATS, and the Society of Thoracic Surgeons, defines operator and institutional requirements for the procedure, and emphasizes the use of multidisciplinary teams, which go beyond the collaboration between interventional cardiologists and cardiac surgeons (www.jtcvs.com/webfiles/images/journals/ymtc/ExpertConsensus.pdf).

"A TAVR program that uses only one specialty is fundamentally deficient, and valve therapy programs should not be established without this multidisciplinary partnership," they wrote.

The document also recommends that irrespective of their specialty, physicians in TAVR programs should all have extensive knowledge of valvular heart disease, and they should be able to interpret images. Meanwhile, facilities should contain a full range of diagnostic imaging, in addition to an active valvular heart disease surgical program and "at least two institutionally based cardiac surgeons experienced in valvular surgery."

The role of an invested hospital administration is also emphasized. "There must be dedication on the part of the hospital to provide these services and support, both financially and with no time constraints on the personnel involved," the authors write.

While they lay out minimum case number requirements for surgeons and interventionalists, the authors predict that simulators are "likely to play a significant role in technical training and proficiency maintenance for these evolving procedures," and the training strategy will evolve as the procedure becomes mainstream. Therefore, there "is the need for this to be a dynamic document that we will revisit in the future as the technology evolves, experience grows, and data accumulate," Dr. R. Morton Bolman, cochair of the document writing committee said in a statement.

Dr. Tommaso and Dr. Bolman had no relevant disclosures.

While commending the Centers for Medicare and Medicaid Services on its proposed coverage of the transcatheter aortic valve replacement procedure, makers of the SAPIEN artificial valve asked for more flexibility in the clinical trial limitations set by the agency, in an official comment they released on March 5.

Edwards Lifesciences, the manufacturer of the only valve approved for the TAVR procedure in the United States, posted its comment during the 60-day period, which began after CMS released its coverage proposal for TAVR in February.

In its proposal, CMS restricts TAVR coverage to five criteria, including the use of an approved valve, presence of multidisciplinary teams, and enrollment in a registry.

Edwards officials wrote they were pleased that CMS had proposed "clear and flexible national coverage for TAVR," and added that "for appropriately selected Medicare beneficiaries, the evidence is more than adequate for CMS to conclude that TAVR improves health outcomes and should be considered reasonable and necessary under the Medicare statute," if provided under the CMS criteria.

The Edwards SAPIEN valve is currently approved for use in inoperable patients with severe aortic stenosis. Other use of the SAPIEN valve is limited to clinical trials. In their comments, Edwards officials asked CMS for flexibility in the trials they consider for coverage determination.

"CMS’s proposed requirement limiting coverage for unlabeled uses to ‘superiority trials’ undermines the agency’s efforts to promote continued US-based clinical investigations in Medicare beneficiaries aimed at better understanding key determinants of health and quality of life outcomes," according to the Edwards’ comments.

"Noninferiority and other clinical trial designs play an important role in the advancement of medical technology," the company added, saying that if the proposed conditions aren’t revised, important, yet relatively small, patient populations may not be able to receive treatment.

Edwards, which said its transcatheter aortic valves have been implanted in more than 25,000 patients around the world, came in strong support of multidisciplinary heart teams, one of the requirements set by CMS for TAVR coverage, and strongly encouraged by leading cardiovascular organizations.

"It is imperative that at least two engaged cardiothoracic surgeons and two interventional cardiologists at each site coordinate all clinicians to form a high-functioning multi-disciplinary heart team, a key concept integral to assuring TAVR success," Edwards officials wrote in their comment.

The company also addressed credentialing, an issue which four leading cardiovascular organizations also addressed in a consensus document (see story at right).

"We support appropriate facility and heart team criteria – rather than traditional individual physician-based credentialing," to achieve TAVR success.

Following the CMS proposal, the Society of Thoracic Surgeons and the American College of Cardiology issued a statement, saying that they were pleased with CMS’s comprehensive approach to the coverage of TAVR.

CMS is expected to issue a final decision on TAVR coverage by May.

While commending the Centers for Medicare and Medicaid Services on its proposed coverage of the transcatheter aortic valve replacement procedure, makers of the SAPIEN artificial valve asked for more flexibility in the clinical trial limitations set by the agency, in an official comment they released on March 5.

Edwards Lifesciences, the manufacturer of the only valve approved for the TAVR procedure in the United States, posted its comment during the 60-day period, which began after CMS released its coverage proposal for TAVR in February.

In its proposal, CMS restricts TAVR coverage to five criteria, including the use of an approved valve, presence of multidisciplinary teams, and enrollment in a registry.

Edwards officials wrote they were pleased that CMS had proposed "clear and flexible national coverage for TAVR," and added that "for appropriately selected Medicare beneficiaries, the evidence is more than adequate for CMS to conclude that TAVR improves health outcomes and should be considered reasonable and necessary under the Medicare statute," if provided under the CMS criteria.

The Edwards SAPIEN valve is currently approved for use in inoperable patients with severe aortic stenosis. Other use of the SAPIEN valve is limited to clinical trials. In their comments, Edwards officials asked CMS for flexibility in the trials they consider for coverage determination.

"CMS’s proposed requirement limiting coverage for unlabeled uses to ‘superiority trials’ undermines the agency’s efforts to promote continued US-based clinical investigations in Medicare beneficiaries aimed at better understanding key determinants of health and quality of life outcomes," according to the Edwards’ comments.

"Noninferiority and other clinical trial designs play an important role in the advancement of medical technology," the company added, saying that if the proposed conditions aren’t revised, important, yet relatively small, patient populations may not be able to receive treatment.

Edwards, which said its transcatheter aortic valves have been implanted in more than 25,000 patients around the world, came in strong support of multidisciplinary heart teams, one of the requirements set by CMS for TAVR coverage, and strongly encouraged by leading cardiovascular organizations.

"It is imperative that at least two engaged cardiothoracic surgeons and two interventional cardiologists at each site coordinate all clinicians to form a high-functioning multi-disciplinary heart team, a key concept integral to assuring TAVR success," Edwards officials wrote in their comment.

The company also addressed credentialing, an issue which four leading cardiovascular organizations also addressed in a consensus document (see story at right).

"We support appropriate facility and heart team criteria – rather than traditional individual physician-based credentialing," to achieve TAVR success.

Following the CMS proposal, the Society of Thoracic Surgeons and the American College of Cardiology issued a statement, saying that they were pleased with CMS’s comprehensive approach to the coverage of TAVR.

CMS is expected to issue a final decision on TAVR coverage by May.

While commending the Centers for Medicare and Medicaid Services on its proposed coverage of the transcatheter aortic valve replacement procedure, makers of the SAPIEN artificial valve asked for more flexibility in the clinical trial limitations set by the agency, in an official comment they released on March 5.

Edwards Lifesciences, the manufacturer of the only valve approved for the TAVR procedure in the United States, posted its comment during the 60-day period, which began after CMS released its coverage proposal for TAVR in February.

In its proposal, CMS restricts TAVR coverage to five criteria, including the use of an approved valve, presence of multidisciplinary teams, and enrollment in a registry.

Edwards officials wrote they were pleased that CMS had proposed "clear and flexible national coverage for TAVR," and added that "for appropriately selected Medicare beneficiaries, the evidence is more than adequate for CMS to conclude that TAVR improves health outcomes and should be considered reasonable and necessary under the Medicare statute," if provided under the CMS criteria.

The Edwards SAPIEN valve is currently approved for use in inoperable patients with severe aortic stenosis. Other use of the SAPIEN valve is limited to clinical trials. In their comments, Edwards officials asked CMS for flexibility in the trials they consider for coverage determination.

"CMS’s proposed requirement limiting coverage for unlabeled uses to ‘superiority trials’ undermines the agency’s efforts to promote continued US-based clinical investigations in Medicare beneficiaries aimed at better understanding key determinants of health and quality of life outcomes," according to the Edwards’ comments.

"Noninferiority and other clinical trial designs play an important role in the advancement of medical technology," the company added, saying that if the proposed conditions aren’t revised, important, yet relatively small, patient populations may not be able to receive treatment.

Edwards, which said its transcatheter aortic valves have been implanted in more than 25,000 patients around the world, came in strong support of multidisciplinary heart teams, one of the requirements set by CMS for TAVR coverage, and strongly encouraged by leading cardiovascular organizations.

"It is imperative that at least two engaged cardiothoracic surgeons and two interventional cardiologists at each site coordinate all clinicians to form a high-functioning multi-disciplinary heart team, a key concept integral to assuring TAVR success," Edwards officials wrote in their comment.

The company also addressed credentialing, an issue which four leading cardiovascular organizations also addressed in a consensus document (see story at right).

"We support appropriate facility and heart team criteria – rather than traditional individual physician-based credentialing," to achieve TAVR success.

Following the CMS proposal, the Society of Thoracic Surgeons and the American College of Cardiology issued a statement, saying that they were pleased with CMS’s comprehensive approach to the coverage of TAVR.

CMS is expected to issue a final decision on TAVR coverage by May.

Intravenous cangrelor may prove to be a useful "bridge" in patients awaiting nonemergency CABG who must first discontinue their regular antiplatelet therapy, according to the results of the Maintenance of Platelet Inhibition With Cangrelor (BRIDGE) trial.

The practice of discontinuation of antiplatelet therapy is associated with significant morbidity and mortality; in patients who have coronary stents, it raises the risk of stent thrombosis that often leads to myocardial infarction and death. "Cessation of thienopyridine treatment for nearly a week before surgery, with patients not hospitalized or monitored but carrying an excess risk of major ischemic events, has been a troubling and not infrequent problem for clinicians, because it is estimated that approximately 5% of patients will require some type of surgery within the first 12 months after stent implant or [acute coronary syndrome] diagnosis," said Dr. Dominick J. Angiolillo of the department of cardiology, University of Florida, Jacksonville, and his associates.

In this multicenter clinical trial sponsored by the drug’s maker, cangrelor "achieved and maintained target levels of platelet inhibition known to be associated with a low risk of thrombotic events compared with placebo, without a significant excess in bleeding complications," the investigators noted.

Cangrelor is an investigational nonthienopyridine adenosine triphosphate analogue that acts as an antagonist of the P2Y12 receptor. It is characterized by "rapid, potent, predictable, and reversible platelet inhibition," and its extremely short half-life (3-6 minutes) allows "rapid offset of effect."

The investigators hypothesized that cangrelor would allow patients who must discontinue antiplatelet therapy prior to cardiac surgery, especially if they’re taking a P2Y12 inhibitor such as ticlopidine, clopidogrel, or prasugrel, to go off their usual drug without raising their risk for thrombotic events. They tested this hypothesis in a two-part trial.

The first part was an open-label dose-finding study involving 11 adults and concluded that the optimal intravenous dose needed to maintain antiplatelet activity without raising bleeding risks was 0.75 mcg/kg per minute. In the second part of the trial, 210 patients awaiting CABG at 34 medical centers around the world were randomly assigned to receive either cangrelor (106 subjects) or placebo (104 subjects) after thienopyridines were discontinued and throughout the preoperative period – that is, until 1-6 hours before surgical incision.

The mean interval between discontinuation of thienopyridines and infusion of the study drug was 29 hours, and the mean duration of the infusion was approximately 3 days. The primary end point was the percentage of patients who showed platelet reactivity of less than 240 P2Y12 Reaction Units (PRUs) throughout the infusion of the study drug.

"This level approximated the levels of platelet reactivity expected to be maintained if a thienopyridine had not been discontinued," the investigators explained.

This end point was met by 99% of the cangrelor group but only 19% of the placebo group (JAMA 2012;307:265-74).

Moreover, cangrelor did not raise the rate of excessive bleeding related to CABG surgery. This safety end point occurred in 22 patients: 11.8% of the cangrelor group and 10.4% of the placebo group, a nonsignificant difference.

The number of minor bleeding events was numerically higher with cangrelor but did not reach statistical significance. This favorable safety profile, even with prolonged infusion of up to 7 days, was "reassuring," the researchers noted.

Ischemic end points prior to surgery were low, occurring in 2.8% (3 of 106) and 4.0% (4 of 101) of patients in the cangrelor and placebo groups.

"These observations support the hypothesis that intravenous cangrelor is a feasible management strategy, providing prolonged platelet P2Y12 inhibition in patients who must wait for cardiac surgery after thienopyridine discontinuation," they said.

The study was sponsored by the Medicines Company. Dr. Angiolillo reported ties to various pharmaceutical companies.

Intravenous cangrelor may prove to be a useful "bridge" in patients awaiting nonemergency CABG who must first discontinue their regular antiplatelet therapy, according to the results of the Maintenance of Platelet Inhibition With Cangrelor (BRIDGE) trial.

The practice of discontinuation of antiplatelet therapy is associated with significant morbidity and mortality; in patients who have coronary stents, it raises the risk of stent thrombosis that often leads to myocardial infarction and death. "Cessation of thienopyridine treatment for nearly a week before surgery, with patients not hospitalized or monitored but carrying an excess risk of major ischemic events, has been a troubling and not infrequent problem for clinicians, because it is estimated that approximately 5% of patients will require some type of surgery within the first 12 months after stent implant or [acute coronary syndrome] diagnosis," said Dr. Dominick J. Angiolillo of the department of cardiology, University of Florida, Jacksonville, and his associates.

In this multicenter clinical trial sponsored by the drug’s maker, cangrelor "achieved and maintained target levels of platelet inhibition known to be associated with a low risk of thrombotic events compared with placebo, without a significant excess in bleeding complications," the investigators noted.

Cangrelor is an investigational nonthienopyridine adenosine triphosphate analogue that acts as an antagonist of the P2Y12 receptor. It is characterized by "rapid, potent, predictable, and reversible platelet inhibition," and its extremely short half-life (3-6 minutes) allows "rapid offset of effect."

The investigators hypothesized that cangrelor would allow patients who must discontinue antiplatelet therapy prior to cardiac surgery, especially if they’re taking a P2Y12 inhibitor such as ticlopidine, clopidogrel, or prasugrel, to go off their usual drug without raising their risk for thrombotic events. They tested this hypothesis in a two-part trial.

The first part was an open-label dose-finding study involving 11 adults and concluded that the optimal intravenous dose needed to maintain antiplatelet activity without raising bleeding risks was 0.75 mcg/kg per minute. In the second part of the trial, 210 patients awaiting CABG at 34 medical centers around the world were randomly assigned to receive either cangrelor (106 subjects) or placebo (104 subjects) after thienopyridines were discontinued and throughout the preoperative period – that is, until 1-6 hours before surgical incision.

The mean interval between discontinuation of thienopyridines and infusion of the study drug was 29 hours, and the mean duration of the infusion was approximately 3 days. The primary end point was the percentage of patients who showed platelet reactivity of less than 240 P2Y12 Reaction Units (PRUs) throughout the infusion of the study drug.

"This level approximated the levels of platelet reactivity expected to be maintained if a thienopyridine had not been discontinued," the investigators explained.

This end point was met by 99% of the cangrelor group but only 19% of the placebo group (JAMA 2012;307:265-74).

Moreover, cangrelor did not raise the rate of excessive bleeding related to CABG surgery. This safety end point occurred in 22 patients: 11.8% of the cangrelor group and 10.4% of the placebo group, a nonsignificant difference.

The number of minor bleeding events was numerically higher with cangrelor but did not reach statistical significance. This favorable safety profile, even with prolonged infusion of up to 7 days, was "reassuring," the researchers noted.

Ischemic end points prior to surgery were low, occurring in 2.8% (3 of 106) and 4.0% (4 of 101) of patients in the cangrelor and placebo groups.

"These observations support the hypothesis that intravenous cangrelor is a feasible management strategy, providing prolonged platelet P2Y12 inhibition in patients who must wait for cardiac surgery after thienopyridine discontinuation," they said.

The study was sponsored by the Medicines Company. Dr. Angiolillo reported ties to various pharmaceutical companies.

Intravenous cangrelor may prove to be a useful "bridge" in patients awaiting nonemergency CABG who must first discontinue their regular antiplatelet therapy, according to the results of the Maintenance of Platelet Inhibition With Cangrelor (BRIDGE) trial.

The practice of discontinuation of antiplatelet therapy is associated with significant morbidity and mortality; in patients who have coronary stents, it raises the risk of stent thrombosis that often leads to myocardial infarction and death. "Cessation of thienopyridine treatment for nearly a week before surgery, with patients not hospitalized or monitored but carrying an excess risk of major ischemic events, has been a troubling and not infrequent problem for clinicians, because it is estimated that approximately 5% of patients will require some type of surgery within the first 12 months after stent implant or [acute coronary syndrome] diagnosis," said Dr. Dominick J. Angiolillo of the department of cardiology, University of Florida, Jacksonville, and his associates.

In this multicenter clinical trial sponsored by the drug’s maker, cangrelor "achieved and maintained target levels of platelet inhibition known to be associated with a low risk of thrombotic events compared with placebo, without a significant excess in bleeding complications," the investigators noted.

Cangrelor is an investigational nonthienopyridine adenosine triphosphate analogue that acts as an antagonist of the P2Y12 receptor. It is characterized by "rapid, potent, predictable, and reversible platelet inhibition," and its extremely short half-life (3-6 minutes) allows "rapid offset of effect."

The investigators hypothesized that cangrelor would allow patients who must discontinue antiplatelet therapy prior to cardiac surgery, especially if they’re taking a P2Y12 inhibitor such as ticlopidine, clopidogrel, or prasugrel, to go off their usual drug without raising their risk for thrombotic events. They tested this hypothesis in a two-part trial.

The first part was an open-label dose-finding study involving 11 adults and concluded that the optimal intravenous dose needed to maintain antiplatelet activity without raising bleeding risks was 0.75 mcg/kg per minute. In the second part of the trial, 210 patients awaiting CABG at 34 medical centers around the world were randomly assigned to receive either cangrelor (106 subjects) or placebo (104 subjects) after thienopyridines were discontinued and throughout the preoperative period – that is, until 1-6 hours before surgical incision.

The mean interval between discontinuation of thienopyridines and infusion of the study drug was 29 hours, and the mean duration of the infusion was approximately 3 days. The primary end point was the percentage of patients who showed platelet reactivity of less than 240 P2Y12 Reaction Units (PRUs) throughout the infusion of the study drug.

"This level approximated the levels of platelet reactivity expected to be maintained if a thienopyridine had not been discontinued," the investigators explained.

This end point was met by 99% of the cangrelor group but only 19% of the placebo group (JAMA 2012;307:265-74).

Moreover, cangrelor did not raise the rate of excessive bleeding related to CABG surgery. This safety end point occurred in 22 patients: 11.8% of the cangrelor group and 10.4% of the placebo group, a nonsignificant difference.

The number of minor bleeding events was numerically higher with cangrelor but did not reach statistical significance. This favorable safety profile, even with prolonged infusion of up to 7 days, was "reassuring," the researchers noted.

Ischemic end points prior to surgery were low, occurring in 2.8% (3 of 106) and 4.0% (4 of 101) of patients in the cangrelor and placebo groups.

"These observations support the hypothesis that intravenous cangrelor is a feasible management strategy, providing prolonged platelet P2Y12 inhibition in patients who must wait for cardiac surgery after thienopyridine discontinuation," they said.

The study was sponsored by the Medicines Company. Dr. Angiolillo reported ties to various pharmaceutical companies.

New credentialing recommendations for TAVR programs released by four leading cardiovascular organizations, serve as a starting point for programs and institutions that want to assess their potential for implementing or maintaining a TAVR program.

"As new technologies begin to be incorporated into cardiovascular practice, it is the responsibility of the medical societies to work together to develop standards for optimal patient care," Dr. Carl L. Tommaso, chair of the writing committee, said in a statement.

The 48-page document, prepared jointly by the American College of Cardiology Foundation, the Society for Cardiovascular Angiography and Interventions, the AATS, and the Society of Thoracic Surgeons, defines operator and institutional requirements for the procedure, and emphasizes the use of multidisciplinary teams, which go beyond the collaboration between interventional cardiologists and cardiac surgeons (www.jtcvs.com/webfiles/images/journals/ymtc/ExpertConsensus.pdf).

"A TAVR program that uses only one specialty is fundamentally deficient, and valve therapy programs should not be established without this multidisciplinary partnership," they wrote.

The document also recommends that irrespective of their specialty, physicians in TAVR programs should all have extensive knowledge of valvular heart disease, and they should be able to interpret images. Meanwhile, facilities should contain a full range of diagnostic imaging, in addition to an active valvular heart disease surgical program and "at least two institutionally based cardiac surgeons experienced in valvular surgery."

The role of an invested hospital administration is also emphasized. "There must be dedication on the part of the hospital to provide these services and support, both financially and with no time constraints on the personnel involved," the authors write.

While they lay out minimum case number requirements for surgeons and interventionalists, the authors predict that simulators are "likely to play a significant role in technical training and proficiency maintenance for these evolving procedures," and the training strategy will evolve as the procedure becomes mainstream. Therefore, there "is the need for this to be a dynamic document that we will revisit in the future as the technology evolves, experience grows, and data accumulate," Dr. R. Morton Bolman, cochair of the document writing committee said in a statement.

Dr. Tommaso and Dr. Bolman had no relevant disclosures.

New credentialing recommendations for TAVR programs released by four leading cardiovascular organizations, serve as a starting point for programs and institutions that want to assess their potential for implementing or maintaining a TAVR program.

"As new technologies begin to be incorporated into cardiovascular practice, it is the responsibility of the medical societies to work together to develop standards for optimal patient care," Dr. Carl L. Tommaso, chair of the writing committee, said in a statement.

The 48-page document, prepared jointly by the American College of Cardiology Foundation, the Society for Cardiovascular Angiography and Interventions, the AATS, and the Society of Thoracic Surgeons, defines operator and institutional requirements for the procedure, and emphasizes the use of multidisciplinary teams, which go beyond the collaboration between interventional cardiologists and cardiac surgeons (www.jtcvs.com/webfiles/images/journals/ymtc/ExpertConsensus.pdf).

"A TAVR program that uses only one specialty is fundamentally deficient, and valve therapy programs should not be established without this multidisciplinary partnership," they wrote.

The document also recommends that irrespective of their specialty, physicians in TAVR programs should all have extensive knowledge of valvular heart disease, and they should be able to interpret images. Meanwhile, facilities should contain a full range of diagnostic imaging, in addition to an active valvular heart disease surgical program and "at least two institutionally based cardiac surgeons experienced in valvular surgery."

The role of an invested hospital administration is also emphasized. "There must be dedication on the part of the hospital to provide these services and support, both financially and with no time constraints on the personnel involved," the authors write.

While they lay out minimum case number requirements for surgeons and interventionalists, the authors predict that simulators are "likely to play a significant role in technical training and proficiency maintenance for these evolving procedures," and the training strategy will evolve as the procedure becomes mainstream. Therefore, there "is the need for this to be a dynamic document that we will revisit in the future as the technology evolves, experience grows, and data accumulate," Dr. R. Morton Bolman, cochair of the document writing committee said in a statement.

Dr. Tommaso and Dr. Bolman had no relevant disclosures.

New credentialing recommendations for TAVR programs released by four leading cardiovascular organizations, serve as a starting point for programs and institutions that want to assess their potential for implementing or maintaining a TAVR program.

"As new technologies begin to be incorporated into cardiovascular practice, it is the responsibility of the medical societies to work together to develop standards for optimal patient care," Dr. Carl L. Tommaso, chair of the writing committee, said in a statement.

The 48-page document, prepared jointly by the American College of Cardiology Foundation, the Society for Cardiovascular Angiography and Interventions, the AATS, and the Society of Thoracic Surgeons, defines operator and institutional requirements for the procedure, and emphasizes the use of multidisciplinary teams, which go beyond the collaboration between interventional cardiologists and cardiac surgeons (www.jtcvs.com/webfiles/images/journals/ymtc/ExpertConsensus.pdf).

"A TAVR program that uses only one specialty is fundamentally deficient, and valve therapy programs should not be established without this multidisciplinary partnership," they wrote.

The document also recommends that irrespective of their specialty, physicians in TAVR programs should all have extensive knowledge of valvular heart disease, and they should be able to interpret images. Meanwhile, facilities should contain a full range of diagnostic imaging, in addition to an active valvular heart disease surgical program and "at least two institutionally based cardiac surgeons experienced in valvular surgery."

The role of an invested hospital administration is also emphasized. "There must be dedication on the part of the hospital to provide these services and support, both financially and with no time constraints on the personnel involved," the authors write.

While they lay out minimum case number requirements for surgeons and interventionalists, the authors predict that simulators are "likely to play a significant role in technical training and proficiency maintenance for these evolving procedures," and the training strategy will evolve as the procedure becomes mainstream. Therefore, there "is the need for this to be a dynamic document that we will revisit in the future as the technology evolves, experience grows, and data accumulate," Dr. R. Morton Bolman, cochair of the document writing committee said in a statement.

Dr. Tommaso and Dr. Bolman had no relevant disclosures.