Naseem S. Miller

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.

Illinois’ burgeoning Medicaid costs, and the program’s expansion in 2014 when more of the Affordable Care Act provisions take effect, could impact voters in the state’s March 20 GOP primary, some analysts predict.

But health care in general won’t play a huge role in terms of the difference among candidates, since all of the GOP hopefuls are trying to distance themselves from the federal health law, said Robert Kaestner, Ph.D., professor at the Institute of Government and Public Affairs at University of Illinois at Chicago.

"They view their conservative base as very opposed to this, so they want to be on the record that they want to repeal all of it or parts of it," he said.

Roughly 16% of Illinois’ non-elderly population (more than 1.8 million people) is uninsured, according to the Kaiser Family Foundation. The state is expected to see a nearly 26% increase in Medicaid enrollment between 2014 and 2019, which is slightly lower than the projected national average of 27.4%, according to the foundation.

"Health care reform is going to expand Medicaid and although the federal government is going to pay a bigger share of it than it has in the past, the state will also bear some of that cost, and it’s a non-trivial cost that will worsen state finances," said Dr. Kaestner.

But some physician groups have a different take on the health law, because it not only increases workforce and payments, but also it expands insurance coverage for the patients.

"Implementing all the elements of ACA would impact the state budget," said Dr. Ellen Brull, the government relations committee chair for Illinois Academy of Family Physicians, which supports the health law. "However, the goal of universal coverage remains our national policy and in Illinois we would see an increase of 600,000 more individuals receiving health care coverage."

Meanwhile, the candidates haven’t put forth any alternatives or specific plans of their own. Although they’ve said they would get rid of certain aspects of the health law, such as the insurance exchanges or the individual mandates, "they haven’t specifically talked about rolling back Medicaid expansions," said Dr. Kaestner.

"Nobody’s really talking about how to reform Medicaid, not just in Illinois, but in all the states," he added.

With Democrats in control of the state House and Senate as well as a Democratic governor, Illinois is working to implement health reform and is in the process of establishing its health insurance exchange. The state has received more than $5 million in establishment grants so far from the federal government, according to the Kaiser Family Foundation.

But the process has been politically controversial. The General Assembly is working on a compromise language in the House to address the next steps in establishing an exchange, Dr. Brull said. "Enabling legislation should have already passed so that actual work in building the infrastructure could have started."

While elected state leaders support the ACA, the Illinois Chamber of Commerce joined 14 other state chambers and business organizations in February to file an amicus brief in the U.S. Supreme Court challenging the health reform law. The brief requests that that the constitutionality of the law "be decided without delay in order to relieve uncertainties now facing employers and their employees."

There are 69 delegates at stake in the Illinois GOP primary, and with no clear front-runner so far, the state’s primary could play a more important role than it has in previous elections.

A recent poll by Chicago Tribune/WGN-TV showed former Pennsylvania Sen. Rick Santorum (31%) is trailing only slightly behind former Massachusetts Gov. Mitt Romney (35%) in the March 20 primary. Former House Speaker New Gingrich came in third place at 12% and Rep. Ron Paul (R-Tex.) was at 7%.

In a February Gallup poll, health law was ranked the 4th most important issue in the upcoming presidential election among U.S. registered voters; two-thirds said that the issue was extremely or very important to them. The economy, unemployment, and the federal budget deficit took the top three spots. Health law outranked terrorism and taxes.

Illinois’ burgeoning Medicaid costs, and the program’s expansion in 2014 when more of the Affordable Care Act provisions take effect, could impact voters in the state’s March 20 GOP primary, some analysts predict.

But health care in general won’t play a huge role in terms of the difference among candidates, since all of the GOP hopefuls are trying to distance themselves from the federal health law, said Robert Kaestner, Ph.D., professor at the Institute of Government and Public Affairs at University of Illinois at Chicago.

"They view their conservative base as very opposed to this, so they want to be on the record that they want to repeal all of it or parts of it," he said.

Roughly 16% of Illinois’ non-elderly population (more than 1.8 million people) is uninsured, according to the Kaiser Family Foundation. The state is expected to see a nearly 26% increase in Medicaid enrollment between 2014 and 2019, which is slightly lower than the projected national average of 27.4%, according to the foundation.

"Health care reform is going to expand Medicaid and although the federal government is going to pay a bigger share of it than it has in the past, the state will also bear some of that cost, and it’s a non-trivial cost that will worsen state finances," said Dr. Kaestner.

But some physician groups have a different take on the health law, because it not only increases workforce and payments, but also it expands insurance coverage for the patients.

"Implementing all the elements of ACA would impact the state budget," said Dr. Ellen Brull, the government relations committee chair for Illinois Academy of Family Physicians, which supports the health law. "However, the goal of universal coverage remains our national policy and in Illinois we would see an increase of 600,000 more individuals receiving health care coverage."

Meanwhile, the candidates haven’t put forth any alternatives or specific plans of their own. Although they’ve said they would get rid of certain aspects of the health law, such as the insurance exchanges or the individual mandates, "they haven’t specifically talked about rolling back Medicaid expansions," said Dr. Kaestner.

"Nobody’s really talking about how to reform Medicaid, not just in Illinois, but in all the states," he added.

With Democrats in control of the state House and Senate as well as a Democratic governor, Illinois is working to implement health reform and is in the process of establishing its health insurance exchange. The state has received more than $5 million in establishment grants so far from the federal government, according to the Kaiser Family Foundation.

But the process has been politically controversial. The General Assembly is working on a compromise language in the House to address the next steps in establishing an exchange, Dr. Brull said. "Enabling legislation should have already passed so that actual work in building the infrastructure could have started."

While elected state leaders support the ACA, the Illinois Chamber of Commerce joined 14 other state chambers and business organizations in February to file an amicus brief in the U.S. Supreme Court challenging the health reform law. The brief requests that that the constitutionality of the law "be decided without delay in order to relieve uncertainties now facing employers and their employees."

There are 69 delegates at stake in the Illinois GOP primary, and with no clear front-runner so far, the state’s primary could play a more important role than it has in previous elections.

A recent poll by Chicago Tribune/WGN-TV showed former Pennsylvania Sen. Rick Santorum (31%) is trailing only slightly behind former Massachusetts Gov. Mitt Romney (35%) in the March 20 primary. Former House Speaker New Gingrich came in third place at 12% and Rep. Ron Paul (R-Tex.) was at 7%.

In a February Gallup poll, health law was ranked the 4th most important issue in the upcoming presidential election among U.S. registered voters; two-thirds said that the issue was extremely or very important to them. The economy, unemployment, and the federal budget deficit took the top three spots. Health law outranked terrorism and taxes.

Illinois’ burgeoning Medicaid costs, and the program’s expansion in 2014 when more of the Affordable Care Act provisions take effect, could impact voters in the state’s March 20 GOP primary, some analysts predict.

But health care in general won’t play a huge role in terms of the difference among candidates, since all of the GOP hopefuls are trying to distance themselves from the federal health law, said Robert Kaestner, Ph.D., professor at the Institute of Government and Public Affairs at University of Illinois at Chicago.

"They view their conservative base as very opposed to this, so they want to be on the record that they want to repeal all of it or parts of it," he said.

Roughly 16% of Illinois’ non-elderly population (more than 1.8 million people) is uninsured, according to the Kaiser Family Foundation. The state is expected to see a nearly 26% increase in Medicaid enrollment between 2014 and 2019, which is slightly lower than the projected national average of 27.4%, according to the foundation.

"Health care reform is going to expand Medicaid and although the federal government is going to pay a bigger share of it than it has in the past, the state will also bear some of that cost, and it’s a non-trivial cost that will worsen state finances," said Dr. Kaestner.

But some physician groups have a different take on the health law, because it not only increases workforce and payments, but also it expands insurance coverage for the patients.

"Implementing all the elements of ACA would impact the state budget," said Dr. Ellen Brull, the government relations committee chair for Illinois Academy of Family Physicians, which supports the health law. "However, the goal of universal coverage remains our national policy and in Illinois we would see an increase of 600,000 more individuals receiving health care coverage."

Meanwhile, the candidates haven’t put forth any alternatives or specific plans of their own. Although they’ve said they would get rid of certain aspects of the health law, such as the insurance exchanges or the individual mandates, "they haven’t specifically talked about rolling back Medicaid expansions," said Dr. Kaestner.

"Nobody’s really talking about how to reform Medicaid, not just in Illinois, but in all the states," he added.

With Democrats in control of the state House and Senate as well as a Democratic governor, Illinois is working to implement health reform and is in the process of establishing its health insurance exchange. The state has received more than $5 million in establishment grants so far from the federal government, according to the Kaiser Family Foundation.

But the process has been politically controversial. The General Assembly is working on a compromise language in the House to address the next steps in establishing an exchange, Dr. Brull said. "Enabling legislation should have already passed so that actual work in building the infrastructure could have started."

While elected state leaders support the ACA, the Illinois Chamber of Commerce joined 14 other state chambers and business organizations in February to file an amicus brief in the U.S. Supreme Court challenging the health reform law. The brief requests that that the constitutionality of the law "be decided without delay in order to relieve uncertainties now facing employers and their employees."

There are 69 delegates at stake in the Illinois GOP primary, and with no clear front-runner so far, the state’s primary could play a more important role than it has in previous elections.

A recent poll by Chicago Tribune/WGN-TV showed former Pennsylvania Sen. Rick Santorum (31%) is trailing only slightly behind former Massachusetts Gov. Mitt Romney (35%) in the March 20 primary. Former House Speaker New Gingrich came in third place at 12% and Rep. Ron Paul (R-Tex.) was at 7%.

In a February Gallup poll, health law was ranked the 4th most important issue in the upcoming presidential election among U.S. registered voters; two-thirds said that the issue was extremely or very important to them. The economy, unemployment, and the federal budget deficit took the top three spots. Health law outranked terrorism and taxes.

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 recently addressed in a consensus document.

"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 recently addressed in a consensus document.

"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 recently addressed in a consensus document.

"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.

Heart teams remain the cornerstone of any transcatheter aortic valve replacement procedure, new credentialing recommendations for TAVR programs emphasized.

The document, released by four leading cardiovascular organizations, serves as a starting point for programs and institutions that want to assess their potential for implementing and/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 document writing committee, said in a statement. "TAVR is a complex procedure that has the potential to serve many patients, and it is up to us to deliver the highest standards of care available," added Dr. Tommaso, medical director of the cardiac catheterization lab at Skokie Hospital, NorthShore HealthSystem, Chicago.

The 48-page document, prepared jointly by the American College of Cardiology Foundation, the Society for Cardiovascular Angiography and Interventions, the American Association for Thoracic Surgery, and the Society of Thoracic Surgeons, defines operator and institutional requirements for performing the procedure, and emphasizes the presence of multidisciplinary teams, which go beyond the collaboration between interventional cardiologists and cardiac surgeons.

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

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," according to the document.

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.

TAVR, which was approved in the United States in November 2011, is still in its infancy, so due to lack of data, many of the recommendations are based on expert consensus, according to the document.

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 and chief of cardiac surgery at Harvard University, said in a statement.

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

Heart teams remain the cornerstone of any transcatheter aortic valve replacement procedure, new credentialing recommendations for TAVR programs emphasized.

The document, released by four leading cardiovascular organizations, serves as a starting point for programs and institutions that want to assess their potential for implementing and/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 document writing committee, said in a statement. "TAVR is a complex procedure that has the potential to serve many patients, and it is up to us to deliver the highest standards of care available," added Dr. Tommaso, medical director of the cardiac catheterization lab at Skokie Hospital, NorthShore HealthSystem, Chicago.

The 48-page document, prepared jointly by the American College of Cardiology Foundation, the Society for Cardiovascular Angiography and Interventions, the American Association for Thoracic Surgery, and the Society of Thoracic Surgeons, defines operator and institutional requirements for performing the procedure, and emphasizes the presence of multidisciplinary teams, which go beyond the collaboration between interventional cardiologists and cardiac surgeons.

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

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," according to the document.

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.

TAVR, which was approved in the United States in November 2011, is still in its infancy, so due to lack of data, many of the recommendations are based on expert consensus, according to the document.

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 and chief of cardiac surgery at Harvard University, said in a statement.

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

Heart teams remain the cornerstone of any transcatheter aortic valve replacement procedure, new credentialing recommendations for TAVR programs emphasized.

The document, released by four leading cardiovascular organizations, serves as a starting point for programs and institutions that want to assess their potential for implementing and/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 document writing committee, said in a statement. "TAVR is a complex procedure that has the potential to serve many patients, and it is up to us to deliver the highest standards of care available," added Dr. Tommaso, medical director of the cardiac catheterization lab at Skokie Hospital, NorthShore HealthSystem, Chicago.

The 48-page document, prepared jointly by the American College of Cardiology Foundation, the Society for Cardiovascular Angiography and Interventions, the American Association for Thoracic Surgery, and the Society of Thoracic Surgeons, defines operator and institutional requirements for performing the procedure, and emphasizes the presence of multidisciplinary teams, which go beyond the collaboration between interventional cardiologists and cardiac surgeons.

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

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," according to the document.

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.

TAVR, which was approved in the United States in November 2011, is still in its infancy, so due to lack of data, many of the recommendations are based on expert consensus, according to the document.

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 and chief of cardiac surgery at Harvard University, said in a statement.

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

FDA Sends Warning to Merck

The U.S. Food and Drug Administration sent a warning letter to drug maker Merck, because the company failed to meet the deadline for completing a postmarketing study of sitagliptin (Januvia) and sitagliptin/metformin (Janumet). As a result, the agency wrote Merck, “your product is considered misbranded.” Merck had committed to conducting a 3-month pancreatic safety study in rodents to assess the risk of acute pancreatitis associated with sitagliptin. “Failure to promptly correct this violation may result in regulatory action by the FDA without further notice,” the agency wrote in its warning letter. Such actions could include civil financial penalties, and additional penalties if the violation is not corrected, the agency warned. In a statement, Merck officials said they would submit the final protocol for the rodent study within 30 days of the warning letter, and will start the study within 6 months.

ADA Applauds Funding

The Centers for Disease Control and Prevention received $10 million in funding from the U.S. Department of Health and Human Services for Fiscal Year 2012 to administer the National Diabetes Prevention Program, a national network of lifestyle intervention programs based on Diabetes Prevention Program clinical trial. In a statement, the American Diabetes Association applauded the funding. “Expansion of the National Diabetes Prevention Program will allow more Americans with prediabetes to participate in a proven program to lower their risk for type 2 diabetes and its dangerous complications,” said L. Hunter Limbaugh, Chair of the Board of the ADA, in a statement. But they expressed concern about President Obama's Fiscal Year 2013 budget. “The Association is concerned that the Administration's Budget does not provide adequate resources to continue the nation's investment in diabetes prevention and research at National Institutes of Health and the [CDC], both of which are critically important to addressing the diabetes epidemic.

Entity Promotes Collaborative Care

Six national health profession organizations have created the Interprofessional Education Collaborative, or IPEC, in an effort to create a more collaborative and patient-centered care environment. The stand-alone collaborative aims to advance interprofessional education around the nation, and is planning to share information on best practices and collaborative practice innovation. “Better patient care depends on all members of the health care team understanding each other's roles and knowing how to work together effectively,” said Dr. Darrell G. Kirch, president and CEO of Association of American Medical Colleges, one of the founding members of IPEC, in a statement.

Health IT Progress Report

At least 2,000 hospitals and 41,000 physicians have received $3.1 billion in incentive payments from the Health and Human Services department for certifying meaningful use of health information technology, the department said in a report. The American Hospital Association surveyed its members and found that 35% of hospitals were using electronic health records in 2011, up from 16% in 2009. Seven states had a significantly higher level of adoption, compared with the national average, of at least a basic electronic health record: Florida, Illinois, Massachusetts, Minnesota, Missouri, Virginia, and Wisconsin. The Centers for Medicare and Medicaid Services had compiled data showing that enrollment in incentive programs is increasing. In January, the agency provided $519 million to eligible providers.

FDA Sends Warning to Merck

The U.S. Food and Drug Administration sent a warning letter to drug maker Merck, because the company failed to meet the deadline for completing a postmarketing study of sitagliptin (Januvia) and sitagliptin/metformin (Janumet). As a result, the agency wrote Merck, “your product is considered misbranded.” Merck had committed to conducting a 3-month pancreatic safety study in rodents to assess the risk of acute pancreatitis associated with sitagliptin. “Failure to promptly correct this violation may result in regulatory action by the FDA without further notice,” the agency wrote in its warning letter. Such actions could include civil financial penalties, and additional penalties if the violation is not corrected, the agency warned. In a statement, Merck officials said they would submit the final protocol for the rodent study within 30 days of the warning letter, and will start the study within 6 months.

ADA Applauds Funding

The Centers for Disease Control and Prevention received $10 million in funding from the U.S. Department of Health and Human Services for Fiscal Year 2012 to administer the National Diabetes Prevention Program, a national network of lifestyle intervention programs based on Diabetes Prevention Program clinical trial. In a statement, the American Diabetes Association applauded the funding. “Expansion of the National Diabetes Prevention Program will allow more Americans with prediabetes to participate in a proven program to lower their risk for type 2 diabetes and its dangerous complications,” said L. Hunter Limbaugh, Chair of the Board of the ADA, in a statement. But they expressed concern about President Obama's Fiscal Year 2013 budget. “The Association is concerned that the Administration's Budget does not provide adequate resources to continue the nation's investment in diabetes prevention and research at National Institutes of Health and the [CDC], both of which are critically important to addressing the diabetes epidemic.

Entity Promotes Collaborative Care

Six national health profession organizations have created the Interprofessional Education Collaborative, or IPEC, in an effort to create a more collaborative and patient-centered care environment. The stand-alone collaborative aims to advance interprofessional education around the nation, and is planning to share information on best practices and collaborative practice innovation. “Better patient care depends on all members of the health care team understanding each other's roles and knowing how to work together effectively,” said Dr. Darrell G. Kirch, president and CEO of Association of American Medical Colleges, one of the founding members of IPEC, in a statement.

Health IT Progress Report

At least 2,000 hospitals and 41,000 physicians have received $3.1 billion in incentive payments from the Health and Human Services department for certifying meaningful use of health information technology, the department said in a report. The American Hospital Association surveyed its members and found that 35% of hospitals were using electronic health records in 2011, up from 16% in 2009. Seven states had a significantly higher level of adoption, compared with the national average, of at least a basic electronic health record: Florida, Illinois, Massachusetts, Minnesota, Missouri, Virginia, and Wisconsin. The Centers for Medicare and Medicaid Services had compiled data showing that enrollment in incentive programs is increasing. In January, the agency provided $519 million to eligible providers.

FDA Sends Warning to Merck

The U.S. Food and Drug Administration sent a warning letter to drug maker Merck, because the company failed to meet the deadline for completing a postmarketing study of sitagliptin (Januvia) and sitagliptin/metformin (Janumet). As a result, the agency wrote Merck, “your product is considered misbranded.” Merck had committed to conducting a 3-month pancreatic safety study in rodents to assess the risk of acute pancreatitis associated with sitagliptin. “Failure to promptly correct this violation may result in regulatory action by the FDA without further notice,” the agency wrote in its warning letter. Such actions could include civil financial penalties, and additional penalties if the violation is not corrected, the agency warned. In a statement, Merck officials said they would submit the final protocol for the rodent study within 30 days of the warning letter, and will start the study within 6 months.

ADA Applauds Funding

The Centers for Disease Control and Prevention received $10 million in funding from the U.S. Department of Health and Human Services for Fiscal Year 2012 to administer the National Diabetes Prevention Program, a national network of lifestyle intervention programs based on Diabetes Prevention Program clinical trial. In a statement, the American Diabetes Association applauded the funding. “Expansion of the National Diabetes Prevention Program will allow more Americans with prediabetes to participate in a proven program to lower their risk for type 2 diabetes and its dangerous complications,” said L. Hunter Limbaugh, Chair of the Board of the ADA, in a statement. But they expressed concern about President Obama's Fiscal Year 2013 budget. “The Association is concerned that the Administration's Budget does not provide adequate resources to continue the nation's investment in diabetes prevention and research at National Institutes of Health and the [CDC], both of which are critically important to addressing the diabetes epidemic.

Entity Promotes Collaborative Care

Six national health profession organizations have created the Interprofessional Education Collaborative, or IPEC, in an effort to create a more collaborative and patient-centered care environment. The stand-alone collaborative aims to advance interprofessional education around the nation, and is planning to share information on best practices and collaborative practice innovation. “Better patient care depends on all members of the health care team understanding each other's roles and knowing how to work together effectively,” said Dr. Darrell G. Kirch, president and CEO of Association of American Medical Colleges, one of the founding members of IPEC, in a statement.

Health IT Progress Report

At least 2,000 hospitals and 41,000 physicians have received $3.1 billion in incentive payments from the Health and Human Services department for certifying meaningful use of health information technology, the department said in a report. The American Hospital Association surveyed its members and found that 35% of hospitals were using electronic health records in 2011, up from 16% in 2009. Seven states had a significantly higher level of adoption, compared with the national average, of at least a basic electronic health record: Florida, Illinois, Massachusetts, Minnesota, Missouri, Virginia, and Wisconsin. The Centers for Medicare and Medicaid Services had compiled data showing that enrollment in incentive programs is increasing. In January, the agency provided $519 million to eligible providers.

WASHINGTON – The nation is at the front-end of a potential epidemic, as synthetic marijuana and synthetic hallucinogens known as "bath salts" gain popularity, especially among youth, officials warned Feb. 16.

"There has been a shocking increase in the number of people having adverse events to these synthetic drugs," said R. Gil Kerlikowske, director of the Office of National Drug Control Policy. "We simply cannot afford to wait when it comes to safety of young people."

Synthetic drugs first gained the attention of U.S. officials and health care providers in 2010. When ingested or smoked, they can cause a variety of severe and sometimes long-last effects, including hallucinations, paranoia, and seizures.

So far there have been at least 30 deaths nationwide – including suicides – related to these drugs, estimated Mark Ryan, director of the Louisiana Poison Center. Users reportedly also have attacked paramedics and emergency department staff.

"The calls we get have been among the worst. People are desperate for help," said Deborah Anne Carr, executive director of the American Association of Poison Control Centers.

Mr. Ryan said that at his center, 90% of calls regarding synthetic drugs are placed by health care providers. In contrast, only about 20% of calls regarding other poisoning situations are placed by health care providers.

Unlike other drugs, synthetic drugs usually have an immediate and severe effect, Mr. Ryan pointed out. "So the physicians call and ask ‘What is "bath salt" and what do I do?’ "

Another complication: Synthetic drugs come in a wide range of formulations. "There are literally hundreds of these compounds," said Mr. Ryan. "[Manufacturers] may use same name and get a different compound. There’s no consistency."

According to the Monitoring the Future survey – an annual, nationally representative sample of 8th, 10th, and 12th graders conducted by the University of Michigan, Ann Arbor, and supported by the National Institute on Drug Abuse – approximately one in nine 12th graders reported that they had used "spice" or "K2" (street names for synthetic marijuana) in 2011, making synthetic marijuana the second most frequently used illicit drug after marijuana.

Poison control centers have reported sharp increases in the number of calls related to synthetic drugs. Last year, there were 6,959 calls related to synthetic marijuana and 6,138 calls related to "bath salts," compared with 2,906 and 304 calls respectively in 2010, according to the American Association of Poison Control Centers.

Synthetic marijuana and bath salts often are sold legally in retail outlets such as smoke shops, gas stations, and convenience stores, and are often labeled as herbal incense or plant food. They are frequently labeled "not for human consumption" in order mask their intended purpose and avoid regulation, according to ONDCP.

Meanwhile, lawmakers are beginning to address this new phenomenon on the federal and state level.

The Synthetic Drug Control Act (H.R. 1254), a bill to add a wide variety of synthetic cannabinoid and hallucinogenic drugs to the Controlled Substances Act, was passed by the U.S. House of Representatives at the end of last year and sent to the Senate. Mr. Kerlikowske said that he hoped that the Senate would act on the measure soon.

According to U.S. Customs and Border Protection, many of these products appear to originate overseas.

Synthetic marijuana and bath salts were first detected in the United States in 2008 by the Drug Enforcement Administration, which obtained a temporary Schedule I designation for some of the chemicals used to make bath salts last October. At least 38 states have taken action to control one or more of the chemicals.

Abuse of the substances is an issue in Europe as well, Mr. Ryan said.

"This is a serious ‘wake-up call’ for everyone about the extent of synthetic drug use among kids, and that’s why it’s so important for parents to educate themselves about changing drug trends so they’ll know what to look for," Steve Pasierb, president and CEO of the Partnership at Drugfree.org, a drug abuse information clearinghouse, said in a statement.

The Partnership at Drugfree.org introduced a kit, which includes a slide show about synthetic drugs, a corresponding podcast and video, and a printable guide that details what to look for and what the street names are.

WASHINGTON – The nation is at the front-end of a potential epidemic, as synthetic marijuana and synthetic hallucinogens known as "bath salts" gain popularity, especially among youth, officials warned Feb. 16.

"There has been a shocking increase in the number of people having adverse events to these synthetic drugs," said R. Gil Kerlikowske, director of the Office of National Drug Control Policy. "We simply cannot afford to wait when it comes to safety of young people."

Synthetic drugs first gained the attention of U.S. officials and health care providers in 2010. When ingested or smoked, they can cause a variety of severe and sometimes long-last effects, including hallucinations, paranoia, and seizures.

So far there have been at least 30 deaths nationwide – including suicides – related to these drugs, estimated Mark Ryan, director of the Louisiana Poison Center. Users reportedly also have attacked paramedics and emergency department staff.

"The calls we get have been among the worst. People are desperate for help," said Deborah Anne Carr, executive director of the American Association of Poison Control Centers.

Mr. Ryan said that at his center, 90% of calls regarding synthetic drugs are placed by health care providers. In contrast, only about 20% of calls regarding other poisoning situations are placed by health care providers.

Unlike other drugs, synthetic drugs usually have an immediate and severe effect, Mr. Ryan pointed out. "So the physicians call and ask ‘What is "bath salt" and what do I do?’ "

Another complication: Synthetic drugs come in a wide range of formulations. "There are literally hundreds of these compounds," said Mr. Ryan. "[Manufacturers] may use same name and get a different compound. There’s no consistency."

According to the Monitoring the Future survey – an annual, nationally representative sample of 8th, 10th, and 12th graders conducted by the University of Michigan, Ann Arbor, and supported by the National Institute on Drug Abuse – approximately one in nine 12th graders reported that they had used "spice" or "K2" (street names for synthetic marijuana) in 2011, making synthetic marijuana the second most frequently used illicit drug after marijuana.

Poison control centers have reported sharp increases in the number of calls related to synthetic drugs. Last year, there were 6,959 calls related to synthetic marijuana and 6,138 calls related to "bath salts," compared with 2,906 and 304 calls respectively in 2010, according to the American Association of Poison Control Centers.

Synthetic marijuana and bath salts often are sold legally in retail outlets such as smoke shops, gas stations, and convenience stores, and are often labeled as herbal incense or plant food. They are frequently labeled "not for human consumption" in order mask their intended purpose and avoid regulation, according to ONDCP.

Meanwhile, lawmakers are beginning to address this new phenomenon on the federal and state level.

The Synthetic Drug Control Act (H.R. 1254), a bill to add a wide variety of synthetic cannabinoid and hallucinogenic drugs to the Controlled Substances Act, was passed by the U.S. House of Representatives at the end of last year and sent to the Senate. Mr. Kerlikowske said that he hoped that the Senate would act on the measure soon.

According to U.S. Customs and Border Protection, many of these products appear to originate overseas.

Synthetic marijuana and bath salts were first detected in the United States in 2008 by the Drug Enforcement Administration, which obtained a temporary Schedule I designation for some of the chemicals used to make bath salts last October. At least 38 states have taken action to control one or more of the chemicals.

Abuse of the substances is an issue in Europe as well, Mr. Ryan said.

"This is a serious ‘wake-up call’ for everyone about the extent of synthetic drug use among kids, and that’s why it’s so important for parents to educate themselves about changing drug trends so they’ll know what to look for," Steve Pasierb, president and CEO of the Partnership at Drugfree.org, a drug abuse information clearinghouse, said in a statement.

The Partnership at Drugfree.org introduced a kit, which includes a slide show about synthetic drugs, a corresponding podcast and video, and a printable guide that details what to look for and what the street names are.

WASHINGTON – The nation is at the front-end of a potential epidemic, as synthetic marijuana and synthetic hallucinogens known as "bath salts" gain popularity, especially among youth, officials warned Feb. 16.

"There has been a shocking increase in the number of people having adverse events to these synthetic drugs," said R. Gil Kerlikowske, director of the Office of National Drug Control Policy. "We simply cannot afford to wait when it comes to safety of young people."

Synthetic drugs first gained the attention of U.S. officials and health care providers in 2010. When ingested or smoked, they can cause a variety of severe and sometimes long-last effects, including hallucinations, paranoia, and seizures.

So far there have been at least 30 deaths nationwide – including suicides – related to these drugs, estimated Mark Ryan, director of the Louisiana Poison Center. Users reportedly also have attacked paramedics and emergency department staff.

"The calls we get have been among the worst. People are desperate for help," said Deborah Anne Carr, executive director of the American Association of Poison Control Centers.

Mr. Ryan said that at his center, 90% of calls regarding synthetic drugs are placed by health care providers. In contrast, only about 20% of calls regarding other poisoning situations are placed by health care providers.

Unlike other drugs, synthetic drugs usually have an immediate and severe effect, Mr. Ryan pointed out. "So the physicians call and ask ‘What is "bath salt" and what do I do?’ "

Another complication: Synthetic drugs come in a wide range of formulations. "There are literally hundreds of these compounds," said Mr. Ryan. "[Manufacturers] may use same name and get a different compound. There’s no consistency."

According to the Monitoring the Future survey – an annual, nationally representative sample of 8th, 10th, and 12th graders conducted by the University of Michigan, Ann Arbor, and supported by the National Institute on Drug Abuse – approximately one in nine 12th graders reported that they had used "spice" or "K2" (street names for synthetic marijuana) in 2011, making synthetic marijuana the second most frequently used illicit drug after marijuana.

Poison control centers have reported sharp increases in the number of calls related to synthetic drugs. Last year, there were 6,959 calls related to synthetic marijuana and 6,138 calls related to "bath salts," compared with 2,906 and 304 calls respectively in 2010, according to the American Association of Poison Control Centers.

Synthetic marijuana and bath salts often are sold legally in retail outlets such as smoke shops, gas stations, and convenience stores, and are often labeled as herbal incense or plant food. They are frequently labeled "not for human consumption" in order mask their intended purpose and avoid regulation, according to ONDCP.

Meanwhile, lawmakers are beginning to address this new phenomenon on the federal and state level.

The Synthetic Drug Control Act (H.R. 1254), a bill to add a wide variety of synthetic cannabinoid and hallucinogenic drugs to the Controlled Substances Act, was passed by the U.S. House of Representatives at the end of last year and sent to the Senate. Mr. Kerlikowske said that he hoped that the Senate would act on the measure soon.

According to U.S. Customs and Border Protection, many of these products appear to originate overseas.

Synthetic marijuana and bath salts were first detected in the United States in 2008 by the Drug Enforcement Administration, which obtained a temporary Schedule I designation for some of the chemicals used to make bath salts last October. At least 38 states have taken action to control one or more of the chemicals.

Abuse of the substances is an issue in Europe as well, Mr. Ryan said.

"This is a serious ‘wake-up call’ for everyone about the extent of synthetic drug use among kids, and that’s why it’s so important for parents to educate themselves about changing drug trends so they’ll know what to look for," Steve Pasierb, president and CEO of the Partnership at Drugfree.org, a drug abuse information clearinghouse, said in a statement.

The Partnership at Drugfree.org introduced a kit, which includes a slide show about synthetic drugs, a corresponding podcast and video, and a printable guide that details what to look for and what the street names are.

WASHINGTON – The antithrombotic agent bivalirudin has a safety profile similar to that of unfractionated heparin for prevention of thrombotic events during percutaneous coronary intervention for an acute coronary syndrome, according to a small, prospective, multicenter trial.

SWITCH III (Switching From Fondaparinux to Bivalirudin or Unfractionated Heparin in ACS Patients Undergoing PCI) is the third in a series of trials looking at anticoagulation combinations in PCI patients.

Treatment of ACS patients with fondaparinux followed by early angiography, then appropriate medical, PCI, or coronary artery bypass graft management is safe and effective, according to lead investigator Dr. Ron Waksman. He cited the OASIS 5 study, which showed the superiority of fondaparinux, a factor Xa inhibitor, over the low-molecular-weight heparin enoxaparin for patients presenting with acute coronary syndrome (N. Engl. J. Med. 2006;354:1464-76).

However, the increase in thrombus within the catheter among patients undergoing PCI suggested that additional anticoagulation during PCI was needed for patients on fondaparinux, he added.

The main objective of the trial was to evaluate the safety of switching from fondaparinux (Arixtra) to either unfractionated heparin or bivalirudin (Angiomax) for patients with acute coronary syndrome undergoing percutaneous coronary angioplasty, said Dr. Waksman, director of experimental angioplasty and emerging technologies for the Cardiovascular Research Institute at MedStar Washington (D.C.) Hospital Center.*

A total of 100 adult patients from six centers in the United States and Canada were enrolled in the study. They presented with ACS, unstable angina, or non–ST-elevated myocardial infarction, and had been treated with fondaparinux within the previous 24 hours. All were eligible for PCI, and required PCI of at least one artery. Their target lesion stenosis was less than 100%.

The primary end point of the study was clinically overt, in-hospital major bleeds. These included fatal bleeds, intracranial hemorrhage, retroperitoneal hemorrhage, and bleeds requiring transfusion of two or more units of RBCs or equivalent whole blood.

The secondary end point was in-hospital death (nonhemorrhagic), vascular access site complications, MI, need for repeat revascularization, procedural complication, and catheter thrombosis.

All patients received fondaparinux (2.5 mg) prior to coronary angiography. They were then randomized to receive bivalirudin (51 patients) or unfractionated heparin (49 patients) during coronary angiography, and were followed through during their hospital stay.

For intraprocedural anticoagulation, three of the patients in bivalirudin group received unfractionated heparin, while one patient in the heparin group received bivalirudin. None of the patients were given low-molecular-weight heparin or lytic therapy.

Radial access was the more common angiographic route, used in 35 of the bivalirudin group and 33 of the heparin group, an indication of the growing use of that approach, Dr. Waksman said.

The average percentage of diameter stenosis was 80.5 in bivalirudin group and 78.6 in the heparin group. The procedure length was similar in both groups.

Regarding the primary outcome, no deaths or fatal bleeding occurred in either group. However, one of the patients in the bivalirudin group experienced major bleeding.

The secondary, efficacy end points were similar between groups for the most part. There was no catheter thrombosis, myocardial infarction, or stent thrombosis in either arm. However, there was 2% repeat revascularization in the heparin group, compared with none in the bivalirudin group. Access site complications, on the other hand, were more common in the bivalirudin group, at 5.9%, compared with 2% with fractionated heparin.

"Lack of intracatheter thrombus in the bivalirudin group suggests that it can be used safely in ACS patients initially treated with upstream fondaparinux," said Dr. Waksman.

Dr. Gregg W. Stone, who commented on the study at the meeting, called the findings "interesting and thought provoking." However, "I don’t think it will have much of an impact in the United States, because going through something like fondaparinux or low-molecular-weight heparin for days before going to the cath lab could just lead to an increase in adverse outcomes during the waiting period," said Dr. Stone, director of cardiovascular research and education at New York–Presbyterian Hospital and professor of medicine at Columbia University, New York.

The study had two major limitations. It included only a small number of patients and "it is not powered to detect intergroup differences," said Dr. Waksman. In addition, nearly two-thirds of the patients were treated via the radial artery, which may have minimized bleeding at the access site, he added.

Dr. Waksman added that larger randomized trials are needed to establish the safety and efficacy of bivalirudin in clinical settings.

SWITCH III was sponsored by MedStar Washington Hospital Center* and GlaxoSmithKline, which makes fondaparinux. Dr. Waksman has received honoraria from Abbott Laboratories, Boston Scientific, and Merck, and consulting fees from Medtronic. Dr. Stone has received consulting fees and honoraria from Abbott Vascular, Boston Scientific, Medtronic, Volcano, The Medicines Company (maker of bivalirudin), Daiichi Sankyo, and Eli Lilly.

CORRECTION: The name of the institution has been corrected.

WASHINGTON – The antithrombotic agent bivalirudin has a safety profile similar to that of unfractionated heparin for prevention of thrombotic events during percutaneous coronary intervention for an acute coronary syndrome, according to a small, prospective, multicenter trial.

SWITCH III (Switching From Fondaparinux to Bivalirudin or Unfractionated Heparin in ACS Patients Undergoing PCI) is the third in a series of trials looking at anticoagulation combinations in PCI patients.

Treatment of ACS patients with fondaparinux followed by early angiography, then appropriate medical, PCI, or coronary artery bypass graft management is safe and effective, according to lead investigator Dr. Ron Waksman. He cited the OASIS 5 study, which showed the superiority of fondaparinux, a factor Xa inhibitor, over the low-molecular-weight heparin enoxaparin for patients presenting with acute coronary syndrome (N. Engl. J. Med. 2006;354:1464-76).

However, the increase in thrombus within the catheter among patients undergoing PCI suggested that additional anticoagulation during PCI was needed for patients on fondaparinux, he added.

The main objective of the trial was to evaluate the safety of switching from fondaparinux (Arixtra) to either unfractionated heparin or bivalirudin (Angiomax) for patients with acute coronary syndrome undergoing percutaneous coronary angioplasty, said Dr. Waksman, director of experimental angioplasty and emerging technologies for the Cardiovascular Research Institute at MedStar Washington (D.C.) Hospital Center.*

A total of 100 adult patients from six centers in the United States and Canada were enrolled in the study. They presented with ACS, unstable angina, or non–ST-elevated myocardial infarction, and had been treated with fondaparinux within the previous 24 hours. All were eligible for PCI, and required PCI of at least one artery. Their target lesion stenosis was less than 100%.

The primary end point of the study was clinically overt, in-hospital major bleeds. These included fatal bleeds, intracranial hemorrhage, retroperitoneal hemorrhage, and bleeds requiring transfusion of two or more units of RBCs or equivalent whole blood.

The secondary end point was in-hospital death (nonhemorrhagic), vascular access site complications, MI, need for repeat revascularization, procedural complication, and catheter thrombosis.

All patients received fondaparinux (2.5 mg) prior to coronary angiography. They were then randomized to receive bivalirudin (51 patients) or unfractionated heparin (49 patients) during coronary angiography, and were followed through during their hospital stay.

For intraprocedural anticoagulation, three of the patients in bivalirudin group received unfractionated heparin, while one patient in the heparin group received bivalirudin. None of the patients were given low-molecular-weight heparin or lytic therapy.

Radial access was the more common angiographic route, used in 35 of the bivalirudin group and 33 of the heparin group, an indication of the growing use of that approach, Dr. Waksman said.

The average percentage of diameter stenosis was 80.5 in bivalirudin group and 78.6 in the heparin group. The procedure length was similar in both groups.

Regarding the primary outcome, no deaths or fatal bleeding occurred in either group. However, one of the patients in the bivalirudin group experienced major bleeding.

The secondary, efficacy end points were similar between groups for the most part. There was no catheter thrombosis, myocardial infarction, or stent thrombosis in either arm. However, there was 2% repeat revascularization in the heparin group, compared with none in the bivalirudin group. Access site complications, on the other hand, were more common in the bivalirudin group, at 5.9%, compared with 2% with fractionated heparin.

"Lack of intracatheter thrombus in the bivalirudin group suggests that it can be used safely in ACS patients initially treated with upstream fondaparinux," said Dr. Waksman.

Dr. Gregg W. Stone, who commented on the study at the meeting, called the findings "interesting and thought provoking." However, "I don’t think it will have much of an impact in the United States, because going through something like fondaparinux or low-molecular-weight heparin for days before going to the cath lab could just lead to an increase in adverse outcomes during the waiting period," said Dr. Stone, director of cardiovascular research and education at New York–Presbyterian Hospital and professor of medicine at Columbia University, New York.

The study had two major limitations. It included only a small number of patients and "it is not powered to detect intergroup differences," said Dr. Waksman. In addition, nearly two-thirds of the patients were treated via the radial artery, which may have minimized bleeding at the access site, he added.

Dr. Waksman added that larger randomized trials are needed to establish the safety and efficacy of bivalirudin in clinical settings.

SWITCH III was sponsored by MedStar Washington Hospital Center* and GlaxoSmithKline, which makes fondaparinux. Dr. Waksman has received honoraria from Abbott Laboratories, Boston Scientific, and Merck, and consulting fees from Medtronic. Dr. Stone has received consulting fees and honoraria from Abbott Vascular, Boston Scientific, Medtronic, Volcano, The Medicines Company (maker of bivalirudin), Daiichi Sankyo, and Eli Lilly.

CORRECTION: The name of the institution has been corrected.

WASHINGTON – The antithrombotic agent bivalirudin has a safety profile similar to that of unfractionated heparin for prevention of thrombotic events during percutaneous coronary intervention for an acute coronary syndrome, according to a small, prospective, multicenter trial.

SWITCH III (Switching From Fondaparinux to Bivalirudin or Unfractionated Heparin in ACS Patients Undergoing PCI) is the third in a series of trials looking at anticoagulation combinations in PCI patients.

Treatment of ACS patients with fondaparinux followed by early angiography, then appropriate medical, PCI, or coronary artery bypass graft management is safe and effective, according to lead investigator Dr. Ron Waksman. He cited the OASIS 5 study, which showed the superiority of fondaparinux, a factor Xa inhibitor, over the low-molecular-weight heparin enoxaparin for patients presenting with acute coronary syndrome (N. Engl. J. Med. 2006;354:1464-76).

However, the increase in thrombus within the catheter among patients undergoing PCI suggested that additional anticoagulation during PCI was needed for patients on fondaparinux, he added.

The main objective of the trial was to evaluate the safety of switching from fondaparinux (Arixtra) to either unfractionated heparin or bivalirudin (Angiomax) for patients with acute coronary syndrome undergoing percutaneous coronary angioplasty, said Dr. Waksman, director of experimental angioplasty and emerging technologies for the Cardiovascular Research Institute at MedStar Washington (D.C.) Hospital Center.*

A total of 100 adult patients from six centers in the United States and Canada were enrolled in the study. They presented with ACS, unstable angina, or non–ST-elevated myocardial infarction, and had been treated with fondaparinux within the previous 24 hours. All were eligible for PCI, and required PCI of at least one artery. Their target lesion stenosis was less than 100%.

The primary end point of the study was clinically overt, in-hospital major bleeds. These included fatal bleeds, intracranial hemorrhage, retroperitoneal hemorrhage, and bleeds requiring transfusion of two or more units of RBCs or equivalent whole blood.

The secondary end point was in-hospital death (nonhemorrhagic), vascular access site complications, MI, need for repeat revascularization, procedural complication, and catheter thrombosis.

All patients received fondaparinux (2.5 mg) prior to coronary angiography. They were then randomized to receive bivalirudin (51 patients) or unfractionated heparin (49 patients) during coronary angiography, and were followed through during their hospital stay.

For intraprocedural anticoagulation, three of the patients in bivalirudin group received unfractionated heparin, while one patient in the heparin group received bivalirudin. None of the patients were given low-molecular-weight heparin or lytic therapy.

Radial access was the more common angiographic route, used in 35 of the bivalirudin group and 33 of the heparin group, an indication of the growing use of that approach, Dr. Waksman said.

The average percentage of diameter stenosis was 80.5 in bivalirudin group and 78.6 in the heparin group. The procedure length was similar in both groups.

Regarding the primary outcome, no deaths or fatal bleeding occurred in either group. However, one of the patients in the bivalirudin group experienced major bleeding.

The secondary, efficacy end points were similar between groups for the most part. There was no catheter thrombosis, myocardial infarction, or stent thrombosis in either arm. However, there was 2% repeat revascularization in the heparin group, compared with none in the bivalirudin group. Access site complications, on the other hand, were more common in the bivalirudin group, at 5.9%, compared with 2% with fractionated heparin.

"Lack of intracatheter thrombus in the bivalirudin group suggests that it can be used safely in ACS patients initially treated with upstream fondaparinux," said Dr. Waksman.

Dr. Gregg W. Stone, who commented on the study at the meeting, called the findings "interesting and thought provoking." However, "I don’t think it will have much of an impact in the United States, because going through something like fondaparinux or low-molecular-weight heparin for days before going to the cath lab could just lead to an increase in adverse outcomes during the waiting period," said Dr. Stone, director of cardiovascular research and education at New York–Presbyterian Hospital and professor of medicine at Columbia University, New York.

The study had two major limitations. It included only a small number of patients and "it is not powered to detect intergroup differences," said Dr. Waksman. In addition, nearly two-thirds of the patients were treated via the radial artery, which may have minimized bleeding at the access site, he added.

Dr. Waksman added that larger randomized trials are needed to establish the safety and efficacy of bivalirudin in clinical settings.

SWITCH III was sponsored by MedStar Washington Hospital Center* and GlaxoSmithKline, which makes fondaparinux. Dr. Waksman has received honoraria from Abbott Laboratories, Boston Scientific, and Merck, and consulting fees from Medtronic. Dr. Stone has received consulting fees and honoraria from Abbott Vascular, Boston Scientific, Medtronic, Volcano, The Medicines Company (maker of bivalirudin), Daiichi Sankyo, and Eli Lilly.

CORRECTION: The name of the institution has been corrected.

WASHINGTON – Now that transcatheter aortic valve replacement is approved in the United States and there’s a proposal for its Medicare reimbursement, more centers and cardiologists are turning their attention to the procedure.

"Valves are perhaps not in their infancy, but at least in their adolescence," said Dr. Spencer B. King, a cardiologist at Saint Joseph’s Heart and Vascular Institute, Atlanta, during his presentation at a symposium where valve replacement procedures, including transcatheter aortic valve replacement (TAVR), took center stage. The symposium was sponsored by the Cardiovascular Research Institute at MedStar Washington (D.C.) Hospital Center.*

TAVR "is adding another dimension to what interventional cardiologists can do," said Dr. Ron Waksman, chair of this year’s program and director of experimental angioplasty and emerging technologies for the Cardiovascular Research Institute.

One of the main features of the procedure that was established early on as a necessity is the implementation of a "Heart Team," and its importance was stressed during the presentations about TAVR.

"It takes a multidisciplinary approach to get this on the right track," said Dr. Eberhard Grube, chief of cardiology and angiology at Helios Heart Centre in Siegburg, Germany, during his presentation. He noted the importance of a team approach to patient management before and after the procedure.

In addition to discussions about the TAVR technique and imaging, leaders discussed issues surrounding patient selection and criteria.

The procedure is currently approved only for inoperable patients with severe aortic stenosis, on the basis of the PARTNER trial’s cohort B population. This cohort is flanked by cohort C, or inoperable patients with several comorbidities, and cohort A, or high-risk patients. It is expected that TAVR will eventually be approved for high-risk patients, but experts expressed concern about the procedure creeping up toward the very sick cohort C–type patients, and called for better disability and comorbidity indices.

"We can always make the aortic valve better," said Dr. Michael J. Reardon, chief of cardiac surgery at the Methodist Hospital, Houston. "But where do you draw the red line?" he asked.

"I think one of the real signs of a mature TAVR program is the number of people it turns down," said Dr. Reardon. "Early on, we want to help everybody; but as the Heart Team realizes that we’re going to give [patients] a new valve – not a new body – we’re going to start turning more patients down. I think that will actually improve the perception of TAVR as a whole."

The valve’s durability also remains in question, especially if it is eventually used in younger patients with more years ahead of them.

Dr. Paul Corso, director of cardiac surgery at, and associate director of, the cardiology division at MedStar Washington Hospital Center, erred on the side of caution, citing premature excitement surrounding previous valves.

"Let’s not jump on the bandwagon," he said. "I love the idea that [TAVR] is being done and I think it has great promise ... but we don’t have the data."

Financing TAVR is another issue. The procedure’s Medicare reimbursement is still unclear. The Centers for Medicare and Medicaid Services has issued a coverage proposal, and it’s expected to issue a final decision in May.

"We’re still studying the document and understanding it," said Dr. Waksman, who is also associate director of the division of cardiology at MedStar Washington Hospital Center. "I think the societies and physicians like to work with CMS and like to work the FDA to find out what is logical, because hospitals won’t be able to carry the toll of financing without reimbursement, so we have to know exactly what the boundaries are."

CORRECTION: The name and location of the institution have been corrected.

WASHINGTON – Now that transcatheter aortic valve replacement is approved in the United States and there’s a proposal for its Medicare reimbursement, more centers and cardiologists are turning their attention to the procedure.

"Valves are perhaps not in their infancy, but at least in their adolescence," said Dr. Spencer B. King, a cardiologist at Saint Joseph’s Heart and Vascular Institute, Atlanta, during his presentation at a symposium where valve replacement procedures, including transcatheter aortic valve replacement (TAVR), took center stage. The symposium was sponsored by the Cardiovascular Research Institute at MedStar Washington (D.C.) Hospital Center.*

TAVR "is adding another dimension to what interventional cardiologists can do," said Dr. Ron Waksman, chair of this year’s program and director of experimental angioplasty and emerging technologies for the Cardiovascular Research Institute.

One of the main features of the procedure that was established early on as a necessity is the implementation of a "Heart Team," and its importance was stressed during the presentations about TAVR.

"It takes a multidisciplinary approach to get this on the right track," said Dr. Eberhard Grube, chief of cardiology and angiology at Helios Heart Centre in Siegburg, Germany, during his presentation. He noted the importance of a team approach to patient management before and after the procedure.

In addition to discussions about the TAVR technique and imaging, leaders discussed issues surrounding patient selection and criteria.

The procedure is currently approved only for inoperable patients with severe aortic stenosis, on the basis of the PARTNER trial’s cohort B population. This cohort is flanked by cohort C, or inoperable patients with several comorbidities, and cohort A, or high-risk patients. It is expected that TAVR will eventually be approved for high-risk patients, but experts expressed concern about the procedure creeping up toward the very sick cohort C–type patients, and called for better disability and comorbidity indices.

"We can always make the aortic valve better," said Dr. Michael J. Reardon, chief of cardiac surgery at the Methodist Hospital, Houston. "But where do you draw the red line?" he asked.

"I think one of the real signs of a mature TAVR program is the number of people it turns down," said Dr. Reardon. "Early on, we want to help everybody; but as the Heart Team realizes that we’re going to give [patients] a new valve – not a new body – we’re going to start turning more patients down. I think that will actually improve the perception of TAVR as a whole."

The valve’s durability also remains in question, especially if it is eventually used in younger patients with more years ahead of them.

Dr. Paul Corso, director of cardiac surgery at, and associate director of, the cardiology division at MedStar Washington Hospital Center, erred on the side of caution, citing premature excitement surrounding previous valves.

"Let’s not jump on the bandwagon," he said. "I love the idea that [TAVR] is being done and I think it has great promise ... but we don’t have the data."

Financing TAVR is another issue. The procedure’s Medicare reimbursement is still unclear. The Centers for Medicare and Medicaid Services has issued a coverage proposal, and it’s expected to issue a final decision in May.

"We’re still studying the document and understanding it," said Dr. Waksman, who is also associate director of the division of cardiology at MedStar Washington Hospital Center. "I think the societies and physicians like to work with CMS and like to work the FDA to find out what is logical, because hospitals won’t be able to carry the toll of financing without reimbursement, so we have to know exactly what the boundaries are."

CORRECTION: The name and location of the institution have been corrected.

WASHINGTON – Now that transcatheter aortic valve replacement is approved in the United States and there’s a proposal for its Medicare reimbursement, more centers and cardiologists are turning their attention to the procedure.

"Valves are perhaps not in their infancy, but at least in their adolescence," said Dr. Spencer B. King, a cardiologist at Saint Joseph’s Heart and Vascular Institute, Atlanta, during his presentation at a symposium where valve replacement procedures, including transcatheter aortic valve replacement (TAVR), took center stage. The symposium was sponsored by the Cardiovascular Research Institute at MedStar Washington (D.C.) Hospital Center.*

TAVR "is adding another dimension to what interventional cardiologists can do," said Dr. Ron Waksman, chair of this year’s program and director of experimental angioplasty and emerging technologies for the Cardiovascular Research Institute.

One of the main features of the procedure that was established early on as a necessity is the implementation of a "Heart Team," and its importance was stressed during the presentations about TAVR.

"It takes a multidisciplinary approach to get this on the right track," said Dr. Eberhard Grube, chief of cardiology and angiology at Helios Heart Centre in Siegburg, Germany, during his presentation. He noted the importance of a team approach to patient management before and after the procedure.

In addition to discussions about the TAVR technique and imaging, leaders discussed issues surrounding patient selection and criteria.

The procedure is currently approved only for inoperable patients with severe aortic stenosis, on the basis of the PARTNER trial’s cohort B population. This cohort is flanked by cohort C, or inoperable patients with several comorbidities, and cohort A, or high-risk patients. It is expected that TAVR will eventually be approved for high-risk patients, but experts expressed concern about the procedure creeping up toward the very sick cohort C–type patients, and called for better disability and comorbidity indices.

"We can always make the aortic valve better," said Dr. Michael J. Reardon, chief of cardiac surgery at the Methodist Hospital, Houston. "But where do you draw the red line?" he asked.

"I think one of the real signs of a mature TAVR program is the number of people it turns down," said Dr. Reardon. "Early on, we want to help everybody; but as the Heart Team realizes that we’re going to give [patients] a new valve – not a new body – we’re going to start turning more patients down. I think that will actually improve the perception of TAVR as a whole."

The valve’s durability also remains in question, especially if it is eventually used in younger patients with more years ahead of them.

Dr. Paul Corso, director of cardiac surgery at, and associate director of, the cardiology division at MedStar Washington Hospital Center, erred on the side of caution, citing premature excitement surrounding previous valves.

"Let’s not jump on the bandwagon," he said. "I love the idea that [TAVR] is being done and I think it has great promise ... but we don’t have the data."

Financing TAVR is another issue. The procedure’s Medicare reimbursement is still unclear. The Centers for Medicare and Medicaid Services has issued a coverage proposal, and it’s expected to issue a final decision in May.

"We’re still studying the document and understanding it," said Dr. Waksman, who is also associate director of the division of cardiology at MedStar Washington Hospital Center. "I think the societies and physicians like to work with CMS and like to work the FDA to find out what is logical, because hospitals won’t be able to carry the toll of financing without reimbursement, so we have to know exactly what the boundaries are."

CORRECTION: The name and location of the institution have been corrected.