Annual Cardiovascular Conference at Snowmass

SNOWMASS, COLO. – The presence of preoperative dysfunction in more than any one of four key organ systems profoundly reduces survival in patients undergoing surgical aortic valve replacement, a study showed.

"If you have two or more dysfunctional organ systems, you really need to think about what you’re doing for this patient. At 5 years, only about 40% of these patients are alive. It makes a lot of sense to me to say that if you have a patient with severe COPD [chronic obstructive pulmonary disease] and renal dysfunction, that patient should probably never get a surgical valve," Dr. Vinod H. Thourani said at the Annual Cardiovascular Conference at Snowmass.

In a retrospective analysis of a registry with prospectively entered data, 29% of 1,759 patients who underwent surgical aortic valve replacement (SAVR) with or without coronary artery bypass grafting at Emory University during 2002-2010 had preoperative dysfunction of one or more of four organ systems under scrutiny. Eighty-five patients had severe COPD, as defined by a forced expiratory volume in 1 second (FEV₁) that was less than 50% of predicted, 140 had chronic renal failure, 149 had a prior stroke, and 241 had heart failure with a left ventricular ejection less than 35%.

Patients with chronic renal failure had far and away the worst 30-day and long-term outcomes. Half were dead within 3 years. The 7-year survival rate was just 11.7%.

The second-worst outcomes were seen in patients with severe COPD preoperatively. Their 7-year survival rate was 30.8%.

"Anyone with an FEV₁ below about 40% becomes a higher-risk surgical candidate; think instead of TAVR [transcatheter aortic valve replacement],"advised Dr. Thourani of the division of cardiothoracic surgery at Emory University, Atlanta.

In contrast, outcomes in patients with either heart failure or prior stroke "were not that bad," he said, pointing to 7-year survival rates of 55.9% and 48.6%, respectively.

Ninety-five patients (5.4%) in this recently published study (Ann. Thorac. Surg. 2013;95:838-45) had more than one dysfunctional organ system prior to SAVR. Median survival in patients without dysfunction in any of the four organ systems was 8.2 years and counting. With one dysfunctional organ, it was still good at 7.2 years. However, with two dysfunctional organ systems, the median survival dropped precipitously to 4.1 years. With three dysfunctional organ systems, it was 5.9 years.

Dr. Thourini serves as a consultant to Edwards Lifesciences, Sorin, and St. Jude Medical.

bjancin@frontlinemedcom.com

SNOWMASS, COLO. – The presence of preoperative dysfunction in more than any one of four key organ systems profoundly reduces survival in patients undergoing surgical aortic valve replacement, a study showed.

"If you have two or more dysfunctional organ systems, you really need to think about what you’re doing for this patient. At 5 years, only about 40% of these patients are alive. It makes a lot of sense to me to say that if you have a patient with severe COPD [chronic obstructive pulmonary disease] and renal dysfunction, that patient should probably never get a surgical valve," Dr. Vinod H. Thourani said at the Annual Cardiovascular Conference at Snowmass.

In a retrospective analysis of a registry with prospectively entered data, 29% of 1,759 patients who underwent surgical aortic valve replacement (SAVR) with or without coronary artery bypass grafting at Emory University during 2002-2010 had preoperative dysfunction of one or more of four organ systems under scrutiny. Eighty-five patients had severe COPD, as defined by a forced expiratory volume in 1 second (FEV₁) that was less than 50% of predicted, 140 had chronic renal failure, 149 had a prior stroke, and 241 had heart failure with a left ventricular ejection less than 35%.

Patients with chronic renal failure had far and away the worst 30-day and long-term outcomes. Half were dead within 3 years. The 7-year survival rate was just 11.7%.

The second-worst outcomes were seen in patients with severe COPD preoperatively. Their 7-year survival rate was 30.8%.

"Anyone with an FEV₁ below about 40% becomes a higher-risk surgical candidate; think instead of TAVR [transcatheter aortic valve replacement],"advised Dr. Thourani of the division of cardiothoracic surgery at Emory University, Atlanta.

In contrast, outcomes in patients with either heart failure or prior stroke "were not that bad," he said, pointing to 7-year survival rates of 55.9% and 48.6%, respectively.

Ninety-five patients (5.4%) in this recently published study (Ann. Thorac. Surg. 2013;95:838-45) had more than one dysfunctional organ system prior to SAVR. Median survival in patients without dysfunction in any of the four organ systems was 8.2 years and counting. With one dysfunctional organ, it was still good at 7.2 years. However, with two dysfunctional organ systems, the median survival dropped precipitously to 4.1 years. With three dysfunctional organ systems, it was 5.9 years.

Dr. Thourini serves as a consultant to Edwards Lifesciences, Sorin, and St. Jude Medical.

bjancin@frontlinemedcom.com

SNOWMASS, COLO. – The presence of preoperative dysfunction in more than any one of four key organ systems profoundly reduces survival in patients undergoing surgical aortic valve replacement, a study showed.

"If you have two or more dysfunctional organ systems, you really need to think about what you’re doing for this patient. At 5 years, only about 40% of these patients are alive. It makes a lot of sense to me to say that if you have a patient with severe COPD [chronic obstructive pulmonary disease] and renal dysfunction, that patient should probably never get a surgical valve," Dr. Vinod H. Thourani said at the Annual Cardiovascular Conference at Snowmass.

In a retrospective analysis of a registry with prospectively entered data, 29% of 1,759 patients who underwent surgical aortic valve replacement (SAVR) with or without coronary artery bypass grafting at Emory University during 2002-2010 had preoperative dysfunction of one or more of four organ systems under scrutiny. Eighty-five patients had severe COPD, as defined by a forced expiratory volume in 1 second (FEV₁) that was less than 50% of predicted, 140 had chronic renal failure, 149 had a prior stroke, and 241 had heart failure with a left ventricular ejection less than 35%.

Patients with chronic renal failure had far and away the worst 30-day and long-term outcomes. Half were dead within 3 years. The 7-year survival rate was just 11.7%.

The second-worst outcomes were seen in patients with severe COPD preoperatively. Their 7-year survival rate was 30.8%.

"Anyone with an FEV₁ below about 40% becomes a higher-risk surgical candidate; think instead of TAVR [transcatheter aortic valve replacement],"advised Dr. Thourani of the division of cardiothoracic surgery at Emory University, Atlanta.

In contrast, outcomes in patients with either heart failure or prior stroke "were not that bad," he said, pointing to 7-year survival rates of 55.9% and 48.6%, respectively.

Ninety-five patients (5.4%) in this recently published study (Ann. Thorac. Surg. 2013;95:838-45) had more than one dysfunctional organ system prior to SAVR. Median survival in patients without dysfunction in any of the four organ systems was 8.2 years and counting. With one dysfunctional organ, it was still good at 7.2 years. However, with two dysfunctional organ systems, the median survival dropped precipitously to 4.1 years. With three dysfunctional organ systems, it was 5.9 years.

Dr. Thourini serves as a consultant to Edwards Lifesciences, Sorin, and St. Jude Medical.

bjancin@frontlinemedcom.com

SNOWMASS, COLO. – A recent randomized trial provides physicians with important new guidance on how to manage antithrombotic therapy in patients requiring oral anticoagulation who develop an acute coronary syndrome and undergo percutaneous coronary revascularization with stent implantation.

"I think this is one of the most important trials in cardiology published last year. I think it has to rank in the top five," Dr. Patrick T. O’Gara commented at the Annual Cardiovascular Conference at Snowmass.

The trial is WOEST, a Dutch/Belgian multicenter, randomized, open-label study in which 573 such patients were assigned to triple antithrombotic therapy with clopidogrel and aspirin on top of their background warfarin, or to dual therapy with warfarin and clopidogrel.

The primary outcome was the rate of bleeding during the first year following stent implantation. The rate was 19.4% in patients on double therapy and 44.4% in those on triple therapy, for a highly significant 64% reduction in relative risk favoring the less aggressive antithrombotic strategy. At least one blood transfusion was required during the follow-up period by 3.9% of patients receiving dual therapy, compared with 9.5% of patients on triple therapy (Lancet 2013;381:1107-15).

"The more than twofold excess risk of bleeding in patients treated with triple versus double antithrombotic therapy is not a surprise. What was a surprise in this particular study was that a secondary endpoint of death/MI/stroke/target vessel revascularization/stent thrombosis was also higher in the triple-therapy group," said Dr. O’Gara, professor of medicine at Harvard Medical School and director of clinical cardiology at Brigham and Women’s Hospital, Boston.

Indeed, the rate of this composite endpoint was 17.6% with triple therapy, compared with 11.1% with double therapy, for a 40% relative risk reduction.

"This study implies that the use of clopidogrel and a vitamin K antagonist is not only safer but actually might be more efficacious than a strategy of triple antithrombotic therapy following stent deployment," observed Dr. O’Gara, the American College of Cardiology (ACC) president-elect.

"Obviously this will need to be validated in other groups, and the sample size here is relatively small at under 600 patients, but this study has set the standard against which we need to design future trials and begin to make some clinical decisions. I think this gives us a great deal of cover with the use of clopidogrel plus warfarin after PCI [percutaneous coronary intervention] in patients, particularly in those in whom you think the risk of recurrent stroke is relatively low," according to the cardiologist.

Dr. O’Gara, who chairs the ACC/American Heart Association STEMI Guideline Writing Committee, predicted the committee will take a close look at WOEST when it meets this spring to adjudicate revisions in the 2013 guidelines.

WOEST was funded by Dutch and Belgian research foundations. Dr. O’Gara reported having no financial conflicts.

bjancin@frontlinemedcom.com

SNOWMASS, COLO. – A recent randomized trial provides physicians with important new guidance on how to manage antithrombotic therapy in patients requiring oral anticoagulation who develop an acute coronary syndrome and undergo percutaneous coronary revascularization with stent implantation.

"I think this is one of the most important trials in cardiology published last year. I think it has to rank in the top five," Dr. Patrick T. O’Gara commented at the Annual Cardiovascular Conference at Snowmass.

The trial is WOEST, a Dutch/Belgian multicenter, randomized, open-label study in which 573 such patients were assigned to triple antithrombotic therapy with clopidogrel and aspirin on top of their background warfarin, or to dual therapy with warfarin and clopidogrel.

The primary outcome was the rate of bleeding during the first year following stent implantation. The rate was 19.4% in patients on double therapy and 44.4% in those on triple therapy, for a highly significant 64% reduction in relative risk favoring the less aggressive antithrombotic strategy. At least one blood transfusion was required during the follow-up period by 3.9% of patients receiving dual therapy, compared with 9.5% of patients on triple therapy (Lancet 2013;381:1107-15).

"The more than twofold excess risk of bleeding in patients treated with triple versus double antithrombotic therapy is not a surprise. What was a surprise in this particular study was that a secondary endpoint of death/MI/stroke/target vessel revascularization/stent thrombosis was also higher in the triple-therapy group," said Dr. O’Gara, professor of medicine at Harvard Medical School and director of clinical cardiology at Brigham and Women’s Hospital, Boston.

Indeed, the rate of this composite endpoint was 17.6% with triple therapy, compared with 11.1% with double therapy, for a 40% relative risk reduction.

"This study implies that the use of clopidogrel and a vitamin K antagonist is not only safer but actually might be more efficacious than a strategy of triple antithrombotic therapy following stent deployment," observed Dr. O’Gara, the American College of Cardiology (ACC) president-elect.

"Obviously this will need to be validated in other groups, and the sample size here is relatively small at under 600 patients, but this study has set the standard against which we need to design future trials and begin to make some clinical decisions. I think this gives us a great deal of cover with the use of clopidogrel plus warfarin after PCI [percutaneous coronary intervention] in patients, particularly in those in whom you think the risk of recurrent stroke is relatively low," according to the cardiologist.

Dr. O’Gara, who chairs the ACC/American Heart Association STEMI Guideline Writing Committee, predicted the committee will take a close look at WOEST when it meets this spring to adjudicate revisions in the 2013 guidelines.

WOEST was funded by Dutch and Belgian research foundations. Dr. O’Gara reported having no financial conflicts.

bjancin@frontlinemedcom.com

SNOWMASS, COLO. – A recent randomized trial provides physicians with important new guidance on how to manage antithrombotic therapy in patients requiring oral anticoagulation who develop an acute coronary syndrome and undergo percutaneous coronary revascularization with stent implantation.

"I think this is one of the most important trials in cardiology published last year. I think it has to rank in the top five," Dr. Patrick T. O’Gara commented at the Annual Cardiovascular Conference at Snowmass.

The trial is WOEST, a Dutch/Belgian multicenter, randomized, open-label study in which 573 such patients were assigned to triple antithrombotic therapy with clopidogrel and aspirin on top of their background warfarin, or to dual therapy with warfarin and clopidogrel.

The primary outcome was the rate of bleeding during the first year following stent implantation. The rate was 19.4% in patients on double therapy and 44.4% in those on triple therapy, for a highly significant 64% reduction in relative risk favoring the less aggressive antithrombotic strategy. At least one blood transfusion was required during the follow-up period by 3.9% of patients receiving dual therapy, compared with 9.5% of patients on triple therapy (Lancet 2013;381:1107-15).

"The more than twofold excess risk of bleeding in patients treated with triple versus double antithrombotic therapy is not a surprise. What was a surprise in this particular study was that a secondary endpoint of death/MI/stroke/target vessel revascularization/stent thrombosis was also higher in the triple-therapy group," said Dr. O’Gara, professor of medicine at Harvard Medical School and director of clinical cardiology at Brigham and Women’s Hospital, Boston.

Indeed, the rate of this composite endpoint was 17.6% with triple therapy, compared with 11.1% with double therapy, for a 40% relative risk reduction.

"This study implies that the use of clopidogrel and a vitamin K antagonist is not only safer but actually might be more efficacious than a strategy of triple antithrombotic therapy following stent deployment," observed Dr. O’Gara, the American College of Cardiology (ACC) president-elect.

"Obviously this will need to be validated in other groups, and the sample size here is relatively small at under 600 patients, but this study has set the standard against which we need to design future trials and begin to make some clinical decisions. I think this gives us a great deal of cover with the use of clopidogrel plus warfarin after PCI [percutaneous coronary intervention] in patients, particularly in those in whom you think the risk of recurrent stroke is relatively low," according to the cardiologist.

Dr. O’Gara, who chairs the ACC/American Heart Association STEMI Guideline Writing Committee, predicted the committee will take a close look at WOEST when it meets this spring to adjudicate revisions in the 2013 guidelines.

WOEST was funded by Dutch and Belgian research foundations. Dr. O’Gara reported having no financial conflicts.

bjancin@frontlinemedcom.com

SNOWMASS, COLO. – Competition among hospitals and between cardiology groups constitutes the greatest barrier to well-functioning regional networks for ST-elevation myocardial infarction therapy, according to Dr. Bernard J. Gersh.

"We’ve got the resources in this country, but we are competitive. That’s the name of the game. So this is a real challenge. It’s an area where the state chapters of the American College of Cardiology could really help," said Dr. Gersh, professor of medicine at the Mayo Clinic, Rochester, Minn.

The 2013 ACC/American Heart Association STEMI (ST-elevation myocardial infarction) guidelines list as a class I recommendation that "each community should develop a STEMI system of care." But a one-size-fits-all approach won’t work. Creating an efficient network to deliver reperfusion therapy to as many STEMI patients as quickly as possible in Los Angeles, where there is seemingly a percutaneous coronary intervention (PCI) center every few blocks, poses a very different set of challenges than in, say, Wyoming, with two cardiac catheterization laboratories to serve nearly a 100,000–square mile area, the cardiologist said.

He recalled a recent conversation with a colleague from a midsize Eastern city with four PCI hospitals. All four run three call schedules per 24 hours so an interventional cardiologist is always available. But collectively the hospitals handle an average of only five or six STEMIs per week.

"Can you really justify that? It’s just not a good allocation of resources. Furthermore, if you look at all the epidemiology coming out of the U.S. and the Western World, STEMI is in decline. Only about 30% of MIs now are STEMIs, and it’s going to be less and less," Dr. Gersh continued.

He said he admires the approach taken in Vienna. Three hospital systems serve this capital city of 1.7 million. Each system keeps its PCI center open from 8 a.m. to 5 p.m. After 5, however, the three PCI hospitals alternate call. The ambulance is diverted to go directly to the hospital whose catheterization lab is kept open that night.

"They can do that in Vienna. Can we do that here? I don’t know," he said at the annual cardiovascular conference at Snowmass.

Dr. Gersh noted that the American Heart Association Mission: Lifeline program, which was created to increase timely access to PCI for STEMI patients, recently published the first-ever national survey of regional STEMI systems. The purpose was to identify best practices, financing strategies, and barriers to system implementation. Responses were obtained from 381 STEMI networks with 899 PCI hospitals.

The single most commonly cited barrier to network implementation and optimal functioning was hospital competition, identified as a significant problem in 37% of the systems. Next came emergency medical services (EMS) transport and finances, cited by 26% of respondents. The third most common barrier was competition between cardiology groups, which was an issue in 21% of networks.

The predominant funding sources for STEMI systems were PCI hospitals and cardiology practices.

Based on his favorable personal experience with the Mayo Clinic STEMI network, which uses three helicopters, an airplane, and ground ambulances to serve 28 hospitals as far as 150 miles away, Dr. Gersh said it’s clear from the national survey results that most STEMI systems around the country are doing a lot of the important things right.

For example, 92% of systems activate the cath lab with a single phone call, 97% of PCI hospitals accept a STEMI patient 24/7 regardless of bed availability, and 84% of programs operate a data registry with continuous audit. Two-thirds of STEMI systems have the capability to transmit ECGs from at least some of their ambulances (Circ. Cardiovasc. Qual. Outcomes 2012;5:423-8).

In 87% of the networks nationwide, an emergency department physician can activate the cath lab without cardiology consultation. However, the Mayo Clinic network takes a different approach: Transferred patients bypass the emergency department and are taken straight to the coronary care unit or cath lab, according to Dr. Gersh.

In an editorial accompanying the Mission: Lifeline survey report, Dr. Timothy D. Henry, who in 2002 helped organize the nation’s first regional STEMI system at the Minneapolis Heart Institute, said, "The growth of regional STEMI systems in the United States over the past decade has clearly exceeded our expectations."

"Seven years ago," he added, "we published an article raising the question whether it was time for a national policy concerning the treatment of STEMI patients. Today, we are no closer to that policy, but I am no longer certain it is either necessary or if it would be helpful. Certainly, state and national legislation to support our financially strapped EMS would be welcome, including a 12-lead ECG in each ambulance, [an] automated external defibrillator in all public places, and support for both EMS training and data collection, as well. Public policy changes to provide financial incentives for more rational use of resources to support regional STEMI systems rather than building more catheterization laboratories would also be helpful" (Circulation 2012;126:166-8).

Dr. Gersh reported that he serves as a consultant to Abbott, Boston Scientific, GE Healthcare, Medispec, Merck, Ortho-McNeil-Janssen, and St. Jude Medical.

SNOWMASS, COLO. – Competition among hospitals and between cardiology groups constitutes the greatest barrier to well-functioning regional networks for ST-elevation myocardial infarction therapy, according to Dr. Bernard J. Gersh.

"We’ve got the resources in this country, but we are competitive. That’s the name of the game. So this is a real challenge. It’s an area where the state chapters of the American College of Cardiology could really help," said Dr. Gersh, professor of medicine at the Mayo Clinic, Rochester, Minn.

The 2013 ACC/American Heart Association STEMI (ST-elevation myocardial infarction) guidelines list as a class I recommendation that "each community should develop a STEMI system of care." But a one-size-fits-all approach won’t work. Creating an efficient network to deliver reperfusion therapy to as many STEMI patients as quickly as possible in Los Angeles, where there is seemingly a percutaneous coronary intervention (PCI) center every few blocks, poses a very different set of challenges than in, say, Wyoming, with two cardiac catheterization laboratories to serve nearly a 100,000–square mile area, the cardiologist said.

He recalled a recent conversation with a colleague from a midsize Eastern city with four PCI hospitals. All four run three call schedules per 24 hours so an interventional cardiologist is always available. But collectively the hospitals handle an average of only five or six STEMIs per week.

"Can you really justify that? It’s just not a good allocation of resources. Furthermore, if you look at all the epidemiology coming out of the U.S. and the Western World, STEMI is in decline. Only about 30% of MIs now are STEMIs, and it’s going to be less and less," Dr. Gersh continued.

He said he admires the approach taken in Vienna. Three hospital systems serve this capital city of 1.7 million. Each system keeps its PCI center open from 8 a.m. to 5 p.m. After 5, however, the three PCI hospitals alternate call. The ambulance is diverted to go directly to the hospital whose catheterization lab is kept open that night.

"They can do that in Vienna. Can we do that here? I don’t know," he said at the annual cardiovascular conference at Snowmass.

Dr. Gersh noted that the American Heart Association Mission: Lifeline program, which was created to increase timely access to PCI for STEMI patients, recently published the first-ever national survey of regional STEMI systems. The purpose was to identify best practices, financing strategies, and barriers to system implementation. Responses were obtained from 381 STEMI networks with 899 PCI hospitals.

The single most commonly cited barrier to network implementation and optimal functioning was hospital competition, identified as a significant problem in 37% of the systems. Next came emergency medical services (EMS) transport and finances, cited by 26% of respondents. The third most common barrier was competition between cardiology groups, which was an issue in 21% of networks.

The predominant funding sources for STEMI systems were PCI hospitals and cardiology practices.

Based on his favorable personal experience with the Mayo Clinic STEMI network, which uses three helicopters, an airplane, and ground ambulances to serve 28 hospitals as far as 150 miles away, Dr. Gersh said it’s clear from the national survey results that most STEMI systems around the country are doing a lot of the important things right.

For example, 92% of systems activate the cath lab with a single phone call, 97% of PCI hospitals accept a STEMI patient 24/7 regardless of bed availability, and 84% of programs operate a data registry with continuous audit. Two-thirds of STEMI systems have the capability to transmit ECGs from at least some of their ambulances (Circ. Cardiovasc. Qual. Outcomes 2012;5:423-8).

In 87% of the networks nationwide, an emergency department physician can activate the cath lab without cardiology consultation. However, the Mayo Clinic network takes a different approach: Transferred patients bypass the emergency department and are taken straight to the coronary care unit or cath lab, according to Dr. Gersh.

In an editorial accompanying the Mission: Lifeline survey report, Dr. Timothy D. Henry, who in 2002 helped organize the nation’s first regional STEMI system at the Minneapolis Heart Institute, said, "The growth of regional STEMI systems in the United States over the past decade has clearly exceeded our expectations."

"Seven years ago," he added, "we published an article raising the question whether it was time for a national policy concerning the treatment of STEMI patients. Today, we are no closer to that policy, but I am no longer certain it is either necessary or if it would be helpful. Certainly, state and national legislation to support our financially strapped EMS would be welcome, including a 12-lead ECG in each ambulance, [an] automated external defibrillator in all public places, and support for both EMS training and data collection, as well. Public policy changes to provide financial incentives for more rational use of resources to support regional STEMI systems rather than building more catheterization laboratories would also be helpful" (Circulation 2012;126:166-8).

Dr. Gersh reported that he serves as a consultant to Abbott, Boston Scientific, GE Healthcare, Medispec, Merck, Ortho-McNeil-Janssen, and St. Jude Medical.

SNOWMASS, COLO. – Competition among hospitals and between cardiology groups constitutes the greatest barrier to well-functioning regional networks for ST-elevation myocardial infarction therapy, according to Dr. Bernard J. Gersh.

"We’ve got the resources in this country, but we are competitive. That’s the name of the game. So this is a real challenge. It’s an area where the state chapters of the American College of Cardiology could really help," said Dr. Gersh, professor of medicine at the Mayo Clinic, Rochester, Minn.

The 2013 ACC/American Heart Association STEMI (ST-elevation myocardial infarction) guidelines list as a class I recommendation that "each community should develop a STEMI system of care." But a one-size-fits-all approach won’t work. Creating an efficient network to deliver reperfusion therapy to as many STEMI patients as quickly as possible in Los Angeles, where there is seemingly a percutaneous coronary intervention (PCI) center every few blocks, poses a very different set of challenges than in, say, Wyoming, with two cardiac catheterization laboratories to serve nearly a 100,000–square mile area, the cardiologist said.

He recalled a recent conversation with a colleague from a midsize Eastern city with four PCI hospitals. All four run three call schedules per 24 hours so an interventional cardiologist is always available. But collectively the hospitals handle an average of only five or six STEMIs per week.

"Can you really justify that? It’s just not a good allocation of resources. Furthermore, if you look at all the epidemiology coming out of the U.S. and the Western World, STEMI is in decline. Only about 30% of MIs now are STEMIs, and it’s going to be less and less," Dr. Gersh continued.

He said he admires the approach taken in Vienna. Three hospital systems serve this capital city of 1.7 million. Each system keeps its PCI center open from 8 a.m. to 5 p.m. After 5, however, the three PCI hospitals alternate call. The ambulance is diverted to go directly to the hospital whose catheterization lab is kept open that night.

"They can do that in Vienna. Can we do that here? I don’t know," he said at the annual cardiovascular conference at Snowmass.

Dr. Gersh noted that the American Heart Association Mission: Lifeline program, which was created to increase timely access to PCI for STEMI patients, recently published the first-ever national survey of regional STEMI systems. The purpose was to identify best practices, financing strategies, and barriers to system implementation. Responses were obtained from 381 STEMI networks with 899 PCI hospitals.

The single most commonly cited barrier to network implementation and optimal functioning was hospital competition, identified as a significant problem in 37% of the systems. Next came emergency medical services (EMS) transport and finances, cited by 26% of respondents. The third most common barrier was competition between cardiology groups, which was an issue in 21% of networks.

The predominant funding sources for STEMI systems were PCI hospitals and cardiology practices.

Based on his favorable personal experience with the Mayo Clinic STEMI network, which uses three helicopters, an airplane, and ground ambulances to serve 28 hospitals as far as 150 miles away, Dr. Gersh said it’s clear from the national survey results that most STEMI systems around the country are doing a lot of the important things right.

For example, 92% of systems activate the cath lab with a single phone call, 97% of PCI hospitals accept a STEMI patient 24/7 regardless of bed availability, and 84% of programs operate a data registry with continuous audit. Two-thirds of STEMI systems have the capability to transmit ECGs from at least some of their ambulances (Circ. Cardiovasc. Qual. Outcomes 2012;5:423-8).

In 87% of the networks nationwide, an emergency department physician can activate the cath lab without cardiology consultation. However, the Mayo Clinic network takes a different approach: Transferred patients bypass the emergency department and are taken straight to the coronary care unit or cath lab, according to Dr. Gersh.

In an editorial accompanying the Mission: Lifeline survey report, Dr. Timothy D. Henry, who in 2002 helped organize the nation’s first regional STEMI system at the Minneapolis Heart Institute, said, "The growth of regional STEMI systems in the United States over the past decade has clearly exceeded our expectations."

"Seven years ago," he added, "we published an article raising the question whether it was time for a national policy concerning the treatment of STEMI patients. Today, we are no closer to that policy, but I am no longer certain it is either necessary or if it would be helpful. Certainly, state and national legislation to support our financially strapped EMS would be welcome, including a 12-lead ECG in each ambulance, [an] automated external defibrillator in all public places, and support for both EMS training and data collection, as well. Public policy changes to provide financial incentives for more rational use of resources to support regional STEMI systems rather than building more catheterization laboratories would also be helpful" (Circulation 2012;126:166-8).

Dr. Gersh reported that he serves as a consultant to Abbott, Boston Scientific, GE Healthcare, Medispec, Merck, Ortho-McNeil-Janssen, and St. Jude Medical.

SNOWMASS, COLO. – Surgical aortic valve replacement is a mature operation with durable outcomes, but surgeons aren’t standing still in the face of competition posed by cardiologists’ transcatheter alternative.

Well along in clinical development is a minimally invasive surgical aortic valve replacement (SAVR), which utilizes a novel hybrid valve deployed via a 10-second balloon inflation, thereby avoiding the time-consuming suturing and knot-tying required when traditional surgical valves are sewn into place. This minimally invasive procedure involves a partial sternotomy so as to better maintain the skeletal integrity of the sternum, Dr. Michael J. Mack explained at the annual cardiovascular conference at Snowmass sponsored by the American College of Cardiology.

"I think this has the potential to cut surgical times in half. Indeed, the operations are now taking a total time of about 1 hour 45 minutes. This makes SAVR a better option for elderly patients who may not be TAVR candidates," said Dr. Mack, medical director of cardiovascular surgery for the Baylor Health Care System and director of cardiovascular research at the Heart Hospital in Plano, Tex.

A major clinical trial of the innovative hybrid no-suture valve, called the Edwards Lifesciences Intuity Valve System, has been completed in Europe, and another is underway in the United States. Other major medical device companies are also developing no-stitch surgical aortic valves.

"Now we can make SAVR better because there’s a less-invasive option. This never would have happened in surgery unless TAVR happened," Dr. Mack observed.

He reported receiving research grants from Edwards Lifesciences.

b.jancin@elsevier.com

SNOWMASS, COLO. – Surgical aortic valve replacement is a mature operation with durable outcomes, but surgeons aren’t standing still in the face of competition posed by cardiologists’ transcatheter alternative.

Well along in clinical development is a minimally invasive surgical aortic valve replacement (SAVR), which utilizes a novel hybrid valve deployed via a 10-second balloon inflation, thereby avoiding the time-consuming suturing and knot-tying required when traditional surgical valves are sewn into place. This minimally invasive procedure involves a partial sternotomy so as to better maintain the skeletal integrity of the sternum, Dr. Michael J. Mack explained at the annual cardiovascular conference at Snowmass sponsored by the American College of Cardiology.

"I think this has the potential to cut surgical times in half. Indeed, the operations are now taking a total time of about 1 hour 45 minutes. This makes SAVR a better option for elderly patients who may not be TAVR candidates," said Dr. Mack, medical director of cardiovascular surgery for the Baylor Health Care System and director of cardiovascular research at the Heart Hospital in Plano, Tex.

A major clinical trial of the innovative hybrid no-suture valve, called the Edwards Lifesciences Intuity Valve System, has been completed in Europe, and another is underway in the United States. Other major medical device companies are also developing no-stitch surgical aortic valves.

"Now we can make SAVR better because there’s a less-invasive option. This never would have happened in surgery unless TAVR happened," Dr. Mack observed.

He reported receiving research grants from Edwards Lifesciences.

b.jancin@elsevier.com

SNOWMASS, COLO. – Surgical aortic valve replacement is a mature operation with durable outcomes, but surgeons aren’t standing still in the face of competition posed by cardiologists’ transcatheter alternative.

Well along in clinical development is a minimally invasive surgical aortic valve replacement (SAVR), which utilizes a novel hybrid valve deployed via a 10-second balloon inflation, thereby avoiding the time-consuming suturing and knot-tying required when traditional surgical valves are sewn into place. This minimally invasive procedure involves a partial sternotomy so as to better maintain the skeletal integrity of the sternum, Dr. Michael J. Mack explained at the annual cardiovascular conference at Snowmass sponsored by the American College of Cardiology.

"I think this has the potential to cut surgical times in half. Indeed, the operations are now taking a total time of about 1 hour 45 minutes. This makes SAVR a better option for elderly patients who may not be TAVR candidates," said Dr. Mack, medical director of cardiovascular surgery for the Baylor Health Care System and director of cardiovascular research at the Heart Hospital in Plano, Tex.

A major clinical trial of the innovative hybrid no-suture valve, called the Edwards Lifesciences Intuity Valve System, has been completed in Europe, and another is underway in the United States. Other major medical device companies are also developing no-stitch surgical aortic valves.

"Now we can make SAVR better because there’s a less-invasive option. This never would have happened in surgery unless TAVR happened," Dr. Mack observed.

He reported receiving research grants from Edwards Lifesciences.

b.jancin@elsevier.com

SNOWMASS, COLO. – Fractional flow reserve measurement has rapidly emerged as the tool of choice for deciding in the catheterization laboratory whether to revascularize an intermediate 50%-70% stenosis in a patient with stable ischemic heart disease, according to Dr. E. Murat *Tuzcu.

The evidence is now compelling that fractional flow reserve (FFR) calculated invasively from coronary pressure measurement is superior to angiographic assessment, intravascular ultrasound, or optical coherence tomography for this purpose.

"When the question is, ‘What should we do with the borderline lesion?’ the answer is fractional flow reserve, even in the left main coronary artery," Dr. Tuzcu, professor of medicine at the Cleveland Clinic, asserted at the Annual Cardiovascular Conference at Snowmass.

FFR is the method par excellence for determining if an intermediate stenosis is hemodynamically significant; that is, whether the lesion is responsible for reversible ischemia. If it is, then coronary stenting will improve the patient’s functional status and reduce the likelihood of acute MI and all-cause mortality down the road. If FFR indicates that the stenosis is not responsible for reversible ischemia, however, then PCI won’t improve the patient’s prognosis. FFR has the additional virtues of being fast and simple, and it enables immediate decision-making in the cath lab, he explained.

For Dr. Tuzcu, the game changer for FFR was the DEFER study, which he considers to be one of the most important clinical trials in the field of interventional cardiology in the past decade. It showed that, by using FFR, cardiologists could be more selective in their use of PCI in the setting of stable ischemic heart disease.

DEFER was a multicenter Dutch/Belgian study in which 325 patients underwent FFR measurement just prior to planned PCI for an intermediate stenosis. If the FFR value was less than 0.75 – indicative of reversible ischemia – then PCI was performed as planned. If it was 0.75 or greater, patients were randomized to PCI or to deferred PCI.

At 5 years of follow-up, the rate of cardiac death or acute MI was 3.3% in the 91 patients with an FFR of 0.75 or more in the deferred PCI group – less than 1% per year. That wasn’t significantly different from the 7.9% rate among the 90 patients with an FFR of at least 0.75 who underwent prompt PCI. In contrast, the combined endpoint occurred in 15.7% of the 144 PCI-treated patients with FFR evidence of reversible ischemia due to the target lesion (J. Am. Coll. Cardiol. 2007;49:2105-11.)

DEFER was conducted in the bare metal–stent era. The next major clinical trial advancing FFR was the FAME (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) study, in which 1,005 patients with multivessel CAD were randomized to PCI with drug-eluting stents guided by FFR or by angiography alone. The FFR definition of reversible ischemia used in FAME and subsequent trials was a value of 0.80 or less.

The 2-year rate of death or MI was 8.4% in the FFR-guided group, significantly less than the 12.9% rate in the angiography-guided patients. For patients with stenotic lesions deferred from PCI on the basis of an FFR greater than 0.80, the 2-year rate of MI was just 0.2%, with a revascularization rate of 3.2% (J. Am. Coll. Cardiol. 2010;56:177-84).

Nearly half of all stenoses were categorized angiographically as intermediate, 50%-70% lesions. FFR classified 35% of such lesions as functionally significant, while 65% were not associated with reversible ischemia (J. Am. Coll. Cardiol. 2010;55:2816-21).

In the FAME-2 trial, 888 patients with stable CAD and at least one functionally significant stenosis with an FFR of 0.80 or less were randomized to PCI plus optimal medical therapy or to optimal medical therapy alone. Recruitment was halted prematurely by the data safety monitoring board because the combined endpoint of death, MI, or urgent revascularization had occurred in 4.3% of the PCI group versus 12.7% of those assigned to optimal medical management alone (N. Engl. J. Med. 2012;367:991-1001).

Dr. Tuzcu noted that optical coherence tomography (OCT) has drawn much interest as a tool for identifying hemodynamically severe coronary stenoses. "It provides great pictures with tremendous resolution. For looking at stent strut coverage, OCT is a star tool. It’s almost like histology," he said.

It can’t, however, hold a candle to FFR for hemodynamic assessment of stenoses, he added, pointing to a recent Spanish study comparing FFR, OCT, and intravascular ultrasound (IVUS) for this purpose. OCT and IVUS displayed moderate diagnostic efficiency, with no clinically meaningful difference between them, but Dr. Tuzcu concurred with the investigators that the low specificity of OCT and IVUS precludes their use in lieu of FFR for functional assessment (J. Am. Coll. Cardiol. 2012;59:1080-9).

The most recent significant development on the FFR front was Dr. Gregg W. Stone’s presentation of the pooled results of the VERDICT and FIRST trials at the Transcatheter Cardiovascular Therapeutics conference in Miami last October. VERDICT and FIRST included 516 patients with 544 intermediate coronary stenoses evaluated by both FFR and IVUS at 24 centers in nine countries. The bottom line was that IVUS-determined minimum luminal cross-sectional area was only modestly correlated with FFR, according to Dr. Stone, professor of medicine and director of cardiovascular research and education at Columbia University Medical Center/New York Presbyterian Hospital.

"I think this clearly showed – and probably conclusively showed – that, while IVUS is useful in many, many settings, it’s probably not the best tool when FFR is available for deciding which lesion is significant and which is not," Dr. Tuzcu said.

"IVUS is a pretty good tool, sometimes, for morphologic assessment. I like it when there’s an issue with the left main coronary artery. I can size the artery, I can understand an ostial lesion, and I can certainly understand better a bifurcation or trifurcation of the left main coronary artery," he added.

The current American College of Cardiology/American Heart Association guidelines give IVUS a class IIa rating as "reasonable" to assess angiographically intermediate stenoses of the left main coronary artery. FFR gets the same relatively tepid IIa rating for assessment of intermediate stenoses in any coronary arteries. In contrast, the latest European Society of Cardiology guidelines on coronary revascularization have bumped up FFR to a class Ia rating, making it the standard for this assessment.

Dr. Tuzcu reported having no financial conflicts.

b.jancin@elsevier.com

*CORRECTION, 3/1/2013: In an earlier version of this story, the name of Dr. E. Murat Tuzcu was spelled incorrectly. This version has been updated.

SNOWMASS, COLO. – Fractional flow reserve measurement has rapidly emerged as the tool of choice for deciding in the catheterization laboratory whether to revascularize an intermediate 50%-70% stenosis in a patient with stable ischemic heart disease, according to Dr. E. Murat *Tuzcu.

The evidence is now compelling that fractional flow reserve (FFR) calculated invasively from coronary pressure measurement is superior to angiographic assessment, intravascular ultrasound, or optical coherence tomography for this purpose.

"When the question is, ‘What should we do with the borderline lesion?’ the answer is fractional flow reserve, even in the left main coronary artery," Dr. Tuzcu, professor of medicine at the Cleveland Clinic, asserted at the Annual Cardiovascular Conference at Snowmass.

FFR is the method par excellence for determining if an intermediate stenosis is hemodynamically significant; that is, whether the lesion is responsible for reversible ischemia. If it is, then coronary stenting will improve the patient’s functional status and reduce the likelihood of acute MI and all-cause mortality down the road. If FFR indicates that the stenosis is not responsible for reversible ischemia, however, then PCI won’t improve the patient’s prognosis. FFR has the additional virtues of being fast and simple, and it enables immediate decision-making in the cath lab, he explained.

For Dr. Tuzcu, the game changer for FFR was the DEFER study, which he considers to be one of the most important clinical trials in the field of interventional cardiology in the past decade. It showed that, by using FFR, cardiologists could be more selective in their use of PCI in the setting of stable ischemic heart disease.

DEFER was a multicenter Dutch/Belgian study in which 325 patients underwent FFR measurement just prior to planned PCI for an intermediate stenosis. If the FFR value was less than 0.75 – indicative of reversible ischemia – then PCI was performed as planned. If it was 0.75 or greater, patients were randomized to PCI or to deferred PCI.

At 5 years of follow-up, the rate of cardiac death or acute MI was 3.3% in the 91 patients with an FFR of 0.75 or more in the deferred PCI group – less than 1% per year. That wasn’t significantly different from the 7.9% rate among the 90 patients with an FFR of at least 0.75 who underwent prompt PCI. In contrast, the combined endpoint occurred in 15.7% of the 144 PCI-treated patients with FFR evidence of reversible ischemia due to the target lesion (J. Am. Coll. Cardiol. 2007;49:2105-11.)

DEFER was conducted in the bare metal–stent era. The next major clinical trial advancing FFR was the FAME (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) study, in which 1,005 patients with multivessel CAD were randomized to PCI with drug-eluting stents guided by FFR or by angiography alone. The FFR definition of reversible ischemia used in FAME and subsequent trials was a value of 0.80 or less.

The 2-year rate of death or MI was 8.4% in the FFR-guided group, significantly less than the 12.9% rate in the angiography-guided patients. For patients with stenotic lesions deferred from PCI on the basis of an FFR greater than 0.80, the 2-year rate of MI was just 0.2%, with a revascularization rate of 3.2% (J. Am. Coll. Cardiol. 2010;56:177-84).

Nearly half of all stenoses were categorized angiographically as intermediate, 50%-70% lesions. FFR classified 35% of such lesions as functionally significant, while 65% were not associated with reversible ischemia (J. Am. Coll. Cardiol. 2010;55:2816-21).

In the FAME-2 trial, 888 patients with stable CAD and at least one functionally significant stenosis with an FFR of 0.80 or less were randomized to PCI plus optimal medical therapy or to optimal medical therapy alone. Recruitment was halted prematurely by the data safety monitoring board because the combined endpoint of death, MI, or urgent revascularization had occurred in 4.3% of the PCI group versus 12.7% of those assigned to optimal medical management alone (N. Engl. J. Med. 2012;367:991-1001).

Dr. Tuzcu noted that optical coherence tomography (OCT) has drawn much interest as a tool for identifying hemodynamically severe coronary stenoses. "It provides great pictures with tremendous resolution. For looking at stent strut coverage, OCT is a star tool. It’s almost like histology," he said.

It can’t, however, hold a candle to FFR for hemodynamic assessment of stenoses, he added, pointing to a recent Spanish study comparing FFR, OCT, and intravascular ultrasound (IVUS) for this purpose. OCT and IVUS displayed moderate diagnostic efficiency, with no clinically meaningful difference between them, but Dr. Tuzcu concurred with the investigators that the low specificity of OCT and IVUS precludes their use in lieu of FFR for functional assessment (J. Am. Coll. Cardiol. 2012;59:1080-9).

The most recent significant development on the FFR front was Dr. Gregg W. Stone’s presentation of the pooled results of the VERDICT and FIRST trials at the Transcatheter Cardiovascular Therapeutics conference in Miami last October. VERDICT and FIRST included 516 patients with 544 intermediate coronary stenoses evaluated by both FFR and IVUS at 24 centers in nine countries. The bottom line was that IVUS-determined minimum luminal cross-sectional area was only modestly correlated with FFR, according to Dr. Stone, professor of medicine and director of cardiovascular research and education at Columbia University Medical Center/New York Presbyterian Hospital.

"I think this clearly showed – and probably conclusively showed – that, while IVUS is useful in many, many settings, it’s probably not the best tool when FFR is available for deciding which lesion is significant and which is not," Dr. Tuzcu said.

"IVUS is a pretty good tool, sometimes, for morphologic assessment. I like it when there’s an issue with the left main coronary artery. I can size the artery, I can understand an ostial lesion, and I can certainly understand better a bifurcation or trifurcation of the left main coronary artery," he added.

The current American College of Cardiology/American Heart Association guidelines give IVUS a class IIa rating as "reasonable" to assess angiographically intermediate stenoses of the left main coronary artery. FFR gets the same relatively tepid IIa rating for assessment of intermediate stenoses in any coronary arteries. In contrast, the latest European Society of Cardiology guidelines on coronary revascularization have bumped up FFR to a class Ia rating, making it the standard for this assessment.

Dr. Tuzcu reported having no financial conflicts.

b.jancin@elsevier.com

*CORRECTION, 3/1/2013: In an earlier version of this story, the name of Dr. E. Murat Tuzcu was spelled incorrectly. This version has been updated.

SNOWMASS, COLO. – Fractional flow reserve measurement has rapidly emerged as the tool of choice for deciding in the catheterization laboratory whether to revascularize an intermediate 50%-70% stenosis in a patient with stable ischemic heart disease, according to Dr. E. Murat *Tuzcu.

The evidence is now compelling that fractional flow reserve (FFR) calculated invasively from coronary pressure measurement is superior to angiographic assessment, intravascular ultrasound, or optical coherence tomography for this purpose.

"When the question is, ‘What should we do with the borderline lesion?’ the answer is fractional flow reserve, even in the left main coronary artery," Dr. Tuzcu, professor of medicine at the Cleveland Clinic, asserted at the Annual Cardiovascular Conference at Snowmass.

FFR is the method par excellence for determining if an intermediate stenosis is hemodynamically significant; that is, whether the lesion is responsible for reversible ischemia. If it is, then coronary stenting will improve the patient’s functional status and reduce the likelihood of acute MI and all-cause mortality down the road. If FFR indicates that the stenosis is not responsible for reversible ischemia, however, then PCI won’t improve the patient’s prognosis. FFR has the additional virtues of being fast and simple, and it enables immediate decision-making in the cath lab, he explained.

For Dr. Tuzcu, the game changer for FFR was the DEFER study, which he considers to be one of the most important clinical trials in the field of interventional cardiology in the past decade. It showed that, by using FFR, cardiologists could be more selective in their use of PCI in the setting of stable ischemic heart disease.

DEFER was a multicenter Dutch/Belgian study in which 325 patients underwent FFR measurement just prior to planned PCI for an intermediate stenosis. If the FFR value was less than 0.75 – indicative of reversible ischemia – then PCI was performed as planned. If it was 0.75 or greater, patients were randomized to PCI or to deferred PCI.

At 5 years of follow-up, the rate of cardiac death or acute MI was 3.3% in the 91 patients with an FFR of 0.75 or more in the deferred PCI group – less than 1% per year. That wasn’t significantly different from the 7.9% rate among the 90 patients with an FFR of at least 0.75 who underwent prompt PCI. In contrast, the combined endpoint occurred in 15.7% of the 144 PCI-treated patients with FFR evidence of reversible ischemia due to the target lesion (J. Am. Coll. Cardiol. 2007;49:2105-11.)

DEFER was conducted in the bare metal–stent era. The next major clinical trial advancing FFR was the FAME (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) study, in which 1,005 patients with multivessel CAD were randomized to PCI with drug-eluting stents guided by FFR or by angiography alone. The FFR definition of reversible ischemia used in FAME and subsequent trials was a value of 0.80 or less.

The 2-year rate of death or MI was 8.4% in the FFR-guided group, significantly less than the 12.9% rate in the angiography-guided patients. For patients with stenotic lesions deferred from PCI on the basis of an FFR greater than 0.80, the 2-year rate of MI was just 0.2%, with a revascularization rate of 3.2% (J. Am. Coll. Cardiol. 2010;56:177-84).

Nearly half of all stenoses were categorized angiographically as intermediate, 50%-70% lesions. FFR classified 35% of such lesions as functionally significant, while 65% were not associated with reversible ischemia (J. Am. Coll. Cardiol. 2010;55:2816-21).

In the FAME-2 trial, 888 patients with stable CAD and at least one functionally significant stenosis with an FFR of 0.80 or less were randomized to PCI plus optimal medical therapy or to optimal medical therapy alone. Recruitment was halted prematurely by the data safety monitoring board because the combined endpoint of death, MI, or urgent revascularization had occurred in 4.3% of the PCI group versus 12.7% of those assigned to optimal medical management alone (N. Engl. J. Med. 2012;367:991-1001).

Dr. Tuzcu noted that optical coherence tomography (OCT) has drawn much interest as a tool for identifying hemodynamically severe coronary stenoses. "It provides great pictures with tremendous resolution. For looking at stent strut coverage, OCT is a star tool. It’s almost like histology," he said.

It can’t, however, hold a candle to FFR for hemodynamic assessment of stenoses, he added, pointing to a recent Spanish study comparing FFR, OCT, and intravascular ultrasound (IVUS) for this purpose. OCT and IVUS displayed moderate diagnostic efficiency, with no clinically meaningful difference between them, but Dr. Tuzcu concurred with the investigators that the low specificity of OCT and IVUS precludes their use in lieu of FFR for functional assessment (J. Am. Coll. Cardiol. 2012;59:1080-9).

The most recent significant development on the FFR front was Dr. Gregg W. Stone’s presentation of the pooled results of the VERDICT and FIRST trials at the Transcatheter Cardiovascular Therapeutics conference in Miami last October. VERDICT and FIRST included 516 patients with 544 intermediate coronary stenoses evaluated by both FFR and IVUS at 24 centers in nine countries. The bottom line was that IVUS-determined minimum luminal cross-sectional area was only modestly correlated with FFR, according to Dr. Stone, professor of medicine and director of cardiovascular research and education at Columbia University Medical Center/New York Presbyterian Hospital.

"I think this clearly showed – and probably conclusively showed – that, while IVUS is useful in many, many settings, it’s probably not the best tool when FFR is available for deciding which lesion is significant and which is not," Dr. Tuzcu said.

"IVUS is a pretty good tool, sometimes, for morphologic assessment. I like it when there’s an issue with the left main coronary artery. I can size the artery, I can understand an ostial lesion, and I can certainly understand better a bifurcation or trifurcation of the left main coronary artery," he added.

The current American College of Cardiology/American Heart Association guidelines give IVUS a class IIa rating as "reasonable" to assess angiographically intermediate stenoses of the left main coronary artery. FFR gets the same relatively tepid IIa rating for assessment of intermediate stenoses in any coronary arteries. In contrast, the latest European Society of Cardiology guidelines on coronary revascularization have bumped up FFR to a class Ia rating, making it the standard for this assessment.

Dr. Tuzcu reported having no financial conflicts.

b.jancin@elsevier.com

*CORRECTION, 3/1/2013: In an earlier version of this story, the name of Dr. E. Murat Tuzcu was spelled incorrectly. This version has been updated.

SNOWMASS, COLO. – It has been a full decade since publication of the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC-7), and the beleaguered authors of the still unreleased JNC-8 are taking heat over the delay.

"They’re calling JNC-8 ‘JNC-Late’ now. We hope it’ll be out in the next several months," Dr. Sidney C. Smith, a member of the JNC-8 expert panel, said at the Annual Cardiovascular Conference at Snowmass, sponsored by the American College of Cardiology.

The preliminary version of the guidelines is done. The delay has been due in large part to an unprecedented degree of prerelease review by numerous government agencies at a multitude of levels. This extensive and time-consuming advance scrutiny was instituted mainly because many health officials felt blindsided by the publication of the U.S. Preventive Health Services Task Force controversial mammography guidelines, which kicked up a hornet’s nest of criticism in the breast cancer and public health communities. Government officials don’t ever want to be caught by surprise like that again, explained Dr. Smith, professor of medicine at the University of North Carolina, Chapel Hill.

Although the prominent cardiologist wasn’t about to spill the beans regarding the recommendations contained in JNC-8, he did share the key issues the expert panel wrestled with and the general concepts that emerged. It seems clear that JNC-8 will differ in important ways from the first seven reports.

The overarching principle followed in developing JNC-8 was reliance almost exclusively upon randomized clinical trial data in fashioning solidly evidence-based guidelines. The large body of observational and epidemiologic studies suggesting lower is better when it comes to blood pressure was relegated to the backseat.

The JNC-8 panelists took as their charge the 2001 Institute of Medicine report that scathingly described a "quality chasm" in health care due to overreliance upon individual training and experience rather than scientific evidence in medical decision-making.

"They fired a shot across our bow," recalled Dr. Smith. He took the message to heart, later serving as senior author of an influential analysis of all ACC/American Heart Association guidelines published during 1984-2008. Of the 7,196 recommendations involving 22 cardiology topics, the investigators categorized only 11% as level of evidence A, while 48% were level C, meaning "based upon expert opinion" (JAMA 2009;301:831-41).

"Physicians are evaluated based on their adherence to guidelines, so it’s important to know the basis for recommendations," Dr. Smith observed at the Snowmass conference.

The JNC-8 panel, in examining the evidence for various blood pressure treatment goals in patients with hypertension, found solid, consistent clinical trial evidence for benefit with a target systolic blood pressure below 150 mm Hg. But as was highlighted in an influential review by a European Society of Hypertension task force, there are no compelling data from randomized trials to show that all patients with high blood pressure should be treated to a target of less than 140/90 mm Hg (J. Hypertens. 2009;27:2121-58).

Specifically, the European task force noted there has never been a randomized outcome trial showing clinical benefit for treating elderly patients to a target systolic BP of less than 140 mm Hg. Moreover, no clinical trials have ever enrolled elderly patients with grade 1 hypertension – that is, a systolic BP of 140-159 mm Hg; all trials in the elderly required an entry-level SBP of at least 160 mm Hg.

Similarly, the European analysis showed there is no compelling clinical trial evidence to support recommendations to lower blood pressure to less than 130/80 mm Hg in diabetic patients or those with a history of cardiovascular disease.

More recently, and consistent with that conclusion, the very large ACCORD trial showed no reduction in major adverse cardiovascular events when patients with type 2 diabetes at high risk for cardiovascular disease were treated to a systolic BP target of less than 120 mm Hg as compared to less than 140 mm Hg (N. Engl. J. Med. 2010;362:1575-85). And a subgroup analysis involving 6,400 diabetic patients with coronary artery disease in the INVEST trial showed no additional reduction in cardiovascular events with maintenance of systolic BP below 130 mm Hg as compared to below 140 mm Hg (JAMA 2010;304:61-8), Dr. Smith noted.

He outlined multiple reasons why it’s important not to intensify antihypertensive drug therapy to reduce blood pressure below the level proved beneficial in clinical trials. For one thing, growing evidence of late suggests the long-debated J-curve phenomenon does exist, and that drug regimens that reduce blood pressure to 120-125/70-75 mm Hg or below may be accompanied by an increase in coronary events. And even if intensifying antihypertensive drug therapy to below the level proved in trials isn’t harmful, then it’s not beneficial, and it’s a waste of money, a source of unnecessary exposure to the risk of side effects, and a possible contributor to reduced adherence to other medications.

One emerging concept in hypertension that is likely to find expression in JNC-8 is that combining drugs from different classes is a more effective means of lowering blood pressure than is maximizing the dose of a single drug. Another is that visit-to-visit variability in systolic BP is an important predictor of stroke risk independent of mean systolic BP, and calcium channel blockers produce less visit-to-visit variation than do other drug classes (Lancet 2010;375:895-915).

So, will JNC-8 back away from the time-honored recommendation to treat all patients with high blood pressure, including those who are elderly, to less than 140/90 mm Hg? Dr. Smith wouldn’t say.

"We have a dilemma here," he observed. "Do we do what makes sense intuitively in extrapolating from very strong, solid, observational data, or do we need to mount large randomized controlled trials, like the Institute of Medicine would say?"

He did note that an SBP goal of less than 140 mm Hg has been an important public health goal for several decades. "We’ve seen good things happen – we’ve seen a decline in stroke – during that time, even though we don’t have the supporting randomized controlled trials," Dr. Smith said.

JNC-8 is one of five major sets of National Heart, Lung, and Blood Institute–sponsored cardiovascular guidelines in the works. Dr. Smith predicted the obesity report, like JNC-8, will probably be released in the spring. Meanwhile, the Adult Treatment Panel 4 (ATP 4) cholesterol report, the risk assessment guidelines, and the lifestyle report are nearing completion.

"I would expect them to be out by summer," he said.

Dr. Smith reported having no financial conflicts.

b.jancin@elsevier.com

SNOWMASS, COLO. – It has been a full decade since publication of the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC-7), and the beleaguered authors of the still unreleased JNC-8 are taking heat over the delay.

"They’re calling JNC-8 ‘JNC-Late’ now. We hope it’ll be out in the next several months," Dr. Sidney C. Smith, a member of the JNC-8 expert panel, said at the Annual Cardiovascular Conference at Snowmass, sponsored by the American College of Cardiology.

The preliminary version of the guidelines is done. The delay has been due in large part to an unprecedented degree of prerelease review by numerous government agencies at a multitude of levels. This extensive and time-consuming advance scrutiny was instituted mainly because many health officials felt blindsided by the publication of the U.S. Preventive Health Services Task Force controversial mammography guidelines, which kicked up a hornet’s nest of criticism in the breast cancer and public health communities. Government officials don’t ever want to be caught by surprise like that again, explained Dr. Smith, professor of medicine at the University of North Carolina, Chapel Hill.

Although the prominent cardiologist wasn’t about to spill the beans regarding the recommendations contained in JNC-8, he did share the key issues the expert panel wrestled with and the general concepts that emerged. It seems clear that JNC-8 will differ in important ways from the first seven reports.

The overarching principle followed in developing JNC-8 was reliance almost exclusively upon randomized clinical trial data in fashioning solidly evidence-based guidelines. The large body of observational and epidemiologic studies suggesting lower is better when it comes to blood pressure was relegated to the backseat.

The JNC-8 panelists took as their charge the 2001 Institute of Medicine report that scathingly described a "quality chasm" in health care due to overreliance upon individual training and experience rather than scientific evidence in medical decision-making.

"They fired a shot across our bow," recalled Dr. Smith. He took the message to heart, later serving as senior author of an influential analysis of all ACC/American Heart Association guidelines published during 1984-2008. Of the 7,196 recommendations involving 22 cardiology topics, the investigators categorized only 11% as level of evidence A, while 48% were level C, meaning "based upon expert opinion" (JAMA 2009;301:831-41).

"Physicians are evaluated based on their adherence to guidelines, so it’s important to know the basis for recommendations," Dr. Smith observed at the Snowmass conference.

The JNC-8 panel, in examining the evidence for various blood pressure treatment goals in patients with hypertension, found solid, consistent clinical trial evidence for benefit with a target systolic blood pressure below 150 mm Hg. But as was highlighted in an influential review by a European Society of Hypertension task force, there are no compelling data from randomized trials to show that all patients with high blood pressure should be treated to a target of less than 140/90 mm Hg (J. Hypertens. 2009;27:2121-58).

Specifically, the European task force noted there has never been a randomized outcome trial showing clinical benefit for treating elderly patients to a target systolic BP of less than 140 mm Hg. Moreover, no clinical trials have ever enrolled elderly patients with grade 1 hypertension – that is, a systolic BP of 140-159 mm Hg; all trials in the elderly required an entry-level SBP of at least 160 mm Hg.

Similarly, the European analysis showed there is no compelling clinical trial evidence to support recommendations to lower blood pressure to less than 130/80 mm Hg in diabetic patients or those with a history of cardiovascular disease.

More recently, and consistent with that conclusion, the very large ACCORD trial showed no reduction in major adverse cardiovascular events when patients with type 2 diabetes at high risk for cardiovascular disease were treated to a systolic BP target of less than 120 mm Hg as compared to less than 140 mm Hg (N. Engl. J. Med. 2010;362:1575-85). And a subgroup analysis involving 6,400 diabetic patients with coronary artery disease in the INVEST trial showed no additional reduction in cardiovascular events with maintenance of systolic BP below 130 mm Hg as compared to below 140 mm Hg (JAMA 2010;304:61-8), Dr. Smith noted.

He outlined multiple reasons why it’s important not to intensify antihypertensive drug therapy to reduce blood pressure below the level proved beneficial in clinical trials. For one thing, growing evidence of late suggests the long-debated J-curve phenomenon does exist, and that drug regimens that reduce blood pressure to 120-125/70-75 mm Hg or below may be accompanied by an increase in coronary events. And even if intensifying antihypertensive drug therapy to below the level proved in trials isn’t harmful, then it’s not beneficial, and it’s a waste of money, a source of unnecessary exposure to the risk of side effects, and a possible contributor to reduced adherence to other medications.

One emerging concept in hypertension that is likely to find expression in JNC-8 is that combining drugs from different classes is a more effective means of lowering blood pressure than is maximizing the dose of a single drug. Another is that visit-to-visit variability in systolic BP is an important predictor of stroke risk independent of mean systolic BP, and calcium channel blockers produce less visit-to-visit variation than do other drug classes (Lancet 2010;375:895-915).

So, will JNC-8 back away from the time-honored recommendation to treat all patients with high blood pressure, including those who are elderly, to less than 140/90 mm Hg? Dr. Smith wouldn’t say.

"We have a dilemma here," he observed. "Do we do what makes sense intuitively in extrapolating from very strong, solid, observational data, or do we need to mount large randomized controlled trials, like the Institute of Medicine would say?"

He did note that an SBP goal of less than 140 mm Hg has been an important public health goal for several decades. "We’ve seen good things happen – we’ve seen a decline in stroke – during that time, even though we don’t have the supporting randomized controlled trials," Dr. Smith said.

JNC-8 is one of five major sets of National Heart, Lung, and Blood Institute–sponsored cardiovascular guidelines in the works. Dr. Smith predicted the obesity report, like JNC-8, will probably be released in the spring. Meanwhile, the Adult Treatment Panel 4 (ATP 4) cholesterol report, the risk assessment guidelines, and the lifestyle report are nearing completion.

"I would expect them to be out by summer," he said.

Dr. Smith reported having no financial conflicts.

b.jancin@elsevier.com

SNOWMASS, COLO. – It has been a full decade since publication of the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC-7), and the beleaguered authors of the still unreleased JNC-8 are taking heat over the delay.

"They’re calling JNC-8 ‘JNC-Late’ now. We hope it’ll be out in the next several months," Dr. Sidney C. Smith, a member of the JNC-8 expert panel, said at the Annual Cardiovascular Conference at Snowmass, sponsored by the American College of Cardiology.

The preliminary version of the guidelines is done. The delay has been due in large part to an unprecedented degree of prerelease review by numerous government agencies at a multitude of levels. This extensive and time-consuming advance scrutiny was instituted mainly because many health officials felt blindsided by the publication of the U.S. Preventive Health Services Task Force controversial mammography guidelines, which kicked up a hornet’s nest of criticism in the breast cancer and public health communities. Government officials don’t ever want to be caught by surprise like that again, explained Dr. Smith, professor of medicine at the University of North Carolina, Chapel Hill.

Although the prominent cardiologist wasn’t about to spill the beans regarding the recommendations contained in JNC-8, he did share the key issues the expert panel wrestled with and the general concepts that emerged. It seems clear that JNC-8 will differ in important ways from the first seven reports.

The overarching principle followed in developing JNC-8 was reliance almost exclusively upon randomized clinical trial data in fashioning solidly evidence-based guidelines. The large body of observational and epidemiologic studies suggesting lower is better when it comes to blood pressure was relegated to the backseat.

The JNC-8 panelists took as their charge the 2001 Institute of Medicine report that scathingly described a "quality chasm" in health care due to overreliance upon individual training and experience rather than scientific evidence in medical decision-making.

"They fired a shot across our bow," recalled Dr. Smith. He took the message to heart, later serving as senior author of an influential analysis of all ACC/American Heart Association guidelines published during 1984-2008. Of the 7,196 recommendations involving 22 cardiology topics, the investigators categorized only 11% as level of evidence A, while 48% were level C, meaning "based upon expert opinion" (JAMA 2009;301:831-41).

"Physicians are evaluated based on their adherence to guidelines, so it’s important to know the basis for recommendations," Dr. Smith observed at the Snowmass conference.

The JNC-8 panel, in examining the evidence for various blood pressure treatment goals in patients with hypertension, found solid, consistent clinical trial evidence for benefit with a target systolic blood pressure below 150 mm Hg. But as was highlighted in an influential review by a European Society of Hypertension task force, there are no compelling data from randomized trials to show that all patients with high blood pressure should be treated to a target of less than 140/90 mm Hg (J. Hypertens. 2009;27:2121-58).

Specifically, the European task force noted there has never been a randomized outcome trial showing clinical benefit for treating elderly patients to a target systolic BP of less than 140 mm Hg. Moreover, no clinical trials have ever enrolled elderly patients with grade 1 hypertension – that is, a systolic BP of 140-159 mm Hg; all trials in the elderly required an entry-level SBP of at least 160 mm Hg.

Similarly, the European analysis showed there is no compelling clinical trial evidence to support recommendations to lower blood pressure to less than 130/80 mm Hg in diabetic patients or those with a history of cardiovascular disease.

More recently, and consistent with that conclusion, the very large ACCORD trial showed no reduction in major adverse cardiovascular events when patients with type 2 diabetes at high risk for cardiovascular disease were treated to a systolic BP target of less than 120 mm Hg as compared to less than 140 mm Hg (N. Engl. J. Med. 2010;362:1575-85). And a subgroup analysis involving 6,400 diabetic patients with coronary artery disease in the INVEST trial showed no additional reduction in cardiovascular events with maintenance of systolic BP below 130 mm Hg as compared to below 140 mm Hg (JAMA 2010;304:61-8), Dr. Smith noted.

He outlined multiple reasons why it’s important not to intensify antihypertensive drug therapy to reduce blood pressure below the level proved beneficial in clinical trials. For one thing, growing evidence of late suggests the long-debated J-curve phenomenon does exist, and that drug regimens that reduce blood pressure to 120-125/70-75 mm Hg or below may be accompanied by an increase in coronary events. And even if intensifying antihypertensive drug therapy to below the level proved in trials isn’t harmful, then it’s not beneficial, and it’s a waste of money, a source of unnecessary exposure to the risk of side effects, and a possible contributor to reduced adherence to other medications.

One emerging concept in hypertension that is likely to find expression in JNC-8 is that combining drugs from different classes is a more effective means of lowering blood pressure than is maximizing the dose of a single drug. Another is that visit-to-visit variability in systolic BP is an important predictor of stroke risk independent of mean systolic BP, and calcium channel blockers produce less visit-to-visit variation than do other drug classes (Lancet 2010;375:895-915).

So, will JNC-8 back away from the time-honored recommendation to treat all patients with high blood pressure, including those who are elderly, to less than 140/90 mm Hg? Dr. Smith wouldn’t say.

"We have a dilemma here," he observed. "Do we do what makes sense intuitively in extrapolating from very strong, solid, observational data, or do we need to mount large randomized controlled trials, like the Institute of Medicine would say?"

He did note that an SBP goal of less than 140 mm Hg has been an important public health goal for several decades. "We’ve seen good things happen – we’ve seen a decline in stroke – during that time, even though we don’t have the supporting randomized controlled trials," Dr. Smith said.

JNC-8 is one of five major sets of National Heart, Lung, and Blood Institute–sponsored cardiovascular guidelines in the works. Dr. Smith predicted the obesity report, like JNC-8, will probably be released in the spring. Meanwhile, the Adult Treatment Panel 4 (ATP 4) cholesterol report, the risk assessment guidelines, and the lifestyle report are nearing completion.

"I would expect them to be out by summer," he said.

Dr. Smith reported having no financial conflicts.

b.jancin@elsevier.com

SNOWMASS, COLO. – Valve-sparing root replacement has emerged as the procedure of choice in patients with isolated aortic root disease and a normally functioning aortic valve, according to Dr. Thoralf M. Sundt III.

"The valve-sparing root operations, in contrast to some of the other things we surgeons have come up with over the last decade or so, are increasing in popularity. They’re more and more commonly done, and that’s a good sign. I think the marketplace has spoken and this is clearly a good operation. It’s an operation that can be learned, and surgeons can do it with good results," he said at the Annual Cardiovascular Conference at Snowmass.

Valve-sparing root replacement (VSRR) spares a patient from the complications associated with lifelong anticoagulation for a mechanical valve, and the durability of VSRR appears to be superior to that of third-generation bioprostheses, the surgeon added.

"They’re holding up pretty well. The outcomes approach those with mechanical valves," said Dr. Sundt, chief of cardiac surgery at Massachusetts General Hospital and professor of surgery at Harvard Medical School, Boston.

Moreover, he continued, VSRR has another big advantage over bioprosthetic valves: "If you have to re-operate, it’s a whole lot more fun to do so on someone who’s had a VSRR and put a new biologic valve inside a native annulus than it is to try to take out that old bioprosthesis and put a new bioprosthesis in."

A meta-analysis of 11 studies comparing VSRR with total root replacement in patients with Marfan syndrome concluded that composite valve-related event rates for the two surgical strategies were not significantly different. The thromboembolic event rate was 0.3% per year in VSRR-treated patients, significantly lower than the still-quite-reasonable 0.7% per year rate after total root replacement (Heart 2011;97:955-8).

A recent study by surgeons at Stanford (Calif.) University gave VSRR a thumbs up regarding mid-term durability of outcomes through 6 years of follow-up, with a mean 2.9-year and maximum 6-year follow-up. The series included 75 patients with bicuspid aortic valve disease treated by VSRR.

Six-year actuarial survival was 99%, with 90% freedom from reoperation and no strokes. Thirty-one percent of patients had 2+ aortic regurgitation preoperatively; at echocardiographic follow-up a mean of 2.9 years post surgery, only a couple of patients had 2+ aortic regurgitation and no one was more severely affected. The Stanford investigators plan to update their results when follow-up reaches 10 years or more (J. Thorac. Cardiovasc. Surg. Dec. 20, 2012 [doi:10.1016/j.jtcvs.2012.11.043]).

The VSRR was developed by Dr. Tirone David of the University of Toronto. The procedure involves skeletonizing the root while preserving the leaflets and their attachments to the aortic wall. The aortic valve is then reimplanted inside a tubular Dacron graft, and then the coronary arteries are reimplanted.

"It’s probably the neatest development in terms of surgical options for the aortic valve in a long time," Dr. Sundt said.

He reported having no financial conflicts.

b.jancin@elsevier.com

SNOWMASS, COLO. – Valve-sparing root replacement has emerged as the procedure of choice in patients with isolated aortic root disease and a normally functioning aortic valve, according to Dr. Thoralf M. Sundt III.

"The valve-sparing root operations, in contrast to some of the other things we surgeons have come up with over the last decade or so, are increasing in popularity. They’re more and more commonly done, and that’s a good sign. I think the marketplace has spoken and this is clearly a good operation. It’s an operation that can be learned, and surgeons can do it with good results," he said at the Annual Cardiovascular Conference at Snowmass.

Valve-sparing root replacement (VSRR) spares a patient from the complications associated with lifelong anticoagulation for a mechanical valve, and the durability of VSRR appears to be superior to that of third-generation bioprostheses, the surgeon added.

"They’re holding up pretty well. The outcomes approach those with mechanical valves," said Dr. Sundt, chief of cardiac surgery at Massachusetts General Hospital and professor of surgery at Harvard Medical School, Boston.

Moreover, he continued, VSRR has another big advantage over bioprosthetic valves: "If you have to re-operate, it’s a whole lot more fun to do so on someone who’s had a VSRR and put a new biologic valve inside a native annulus than it is to try to take out that old bioprosthesis and put a new bioprosthesis in."

A meta-analysis of 11 studies comparing VSRR with total root replacement in patients with Marfan syndrome concluded that composite valve-related event rates for the two surgical strategies were not significantly different. The thromboembolic event rate was 0.3% per year in VSRR-treated patients, significantly lower than the still-quite-reasonable 0.7% per year rate after total root replacement (Heart 2011;97:955-8).

A recent study by surgeons at Stanford (Calif.) University gave VSRR a thumbs up regarding mid-term durability of outcomes through 6 years of follow-up, with a mean 2.9-year and maximum 6-year follow-up. The series included 75 patients with bicuspid aortic valve disease treated by VSRR.

Six-year actuarial survival was 99%, with 90% freedom from reoperation and no strokes. Thirty-one percent of patients had 2+ aortic regurgitation preoperatively; at echocardiographic follow-up a mean of 2.9 years post surgery, only a couple of patients had 2+ aortic regurgitation and no one was more severely affected. The Stanford investigators plan to update their results when follow-up reaches 10 years or more (J. Thorac. Cardiovasc. Surg. Dec. 20, 2012 [doi:10.1016/j.jtcvs.2012.11.043]).

The VSRR was developed by Dr. Tirone David of the University of Toronto. The procedure involves skeletonizing the root while preserving the leaflets and their attachments to the aortic wall. The aortic valve is then reimplanted inside a tubular Dacron graft, and then the coronary arteries are reimplanted.

"It’s probably the neatest development in terms of surgical options for the aortic valve in a long time," Dr. Sundt said.

He reported having no financial conflicts.

b.jancin@elsevier.com

SNOWMASS, COLO. – Valve-sparing root replacement has emerged as the procedure of choice in patients with isolated aortic root disease and a normally functioning aortic valve, according to Dr. Thoralf M. Sundt III.

"The valve-sparing root operations, in contrast to some of the other things we surgeons have come up with over the last decade or so, are increasing in popularity. They’re more and more commonly done, and that’s a good sign. I think the marketplace has spoken and this is clearly a good operation. It’s an operation that can be learned, and surgeons can do it with good results," he said at the Annual Cardiovascular Conference at Snowmass.

Valve-sparing root replacement (VSRR) spares a patient from the complications associated with lifelong anticoagulation for a mechanical valve, and the durability of VSRR appears to be superior to that of third-generation bioprostheses, the surgeon added.

"They’re holding up pretty well. The outcomes approach those with mechanical valves," said Dr. Sundt, chief of cardiac surgery at Massachusetts General Hospital and professor of surgery at Harvard Medical School, Boston.

Moreover, he continued, VSRR has another big advantage over bioprosthetic valves: "If you have to re-operate, it’s a whole lot more fun to do so on someone who’s had a VSRR and put a new biologic valve inside a native annulus than it is to try to take out that old bioprosthesis and put a new bioprosthesis in."

A meta-analysis of 11 studies comparing VSRR with total root replacement in patients with Marfan syndrome concluded that composite valve-related event rates for the two surgical strategies were not significantly different. The thromboembolic event rate was 0.3% per year in VSRR-treated patients, significantly lower than the still-quite-reasonable 0.7% per year rate after total root replacement (Heart 2011;97:955-8).

A recent study by surgeons at Stanford (Calif.) University gave VSRR a thumbs up regarding mid-term durability of outcomes through 6 years of follow-up, with a mean 2.9-year and maximum 6-year follow-up. The series included 75 patients with bicuspid aortic valve disease treated by VSRR.

Six-year actuarial survival was 99%, with 90% freedom from reoperation and no strokes. Thirty-one percent of patients had 2+ aortic regurgitation preoperatively; at echocardiographic follow-up a mean of 2.9 years post surgery, only a couple of patients had 2+ aortic regurgitation and no one was more severely affected. The Stanford investigators plan to update their results when follow-up reaches 10 years or more (J. Thorac. Cardiovasc. Surg. Dec. 20, 2012 [doi:10.1016/j.jtcvs.2012.11.043]).

The VSRR was developed by Dr. Tirone David of the University of Toronto. The procedure involves skeletonizing the root while preserving the leaflets and their attachments to the aortic wall. The aortic valve is then reimplanted inside a tubular Dacron graft, and then the coronary arteries are reimplanted.

"It’s probably the neatest development in terms of surgical options for the aortic valve in a long time," Dr. Sundt said.

He reported having no financial conflicts.

b.jancin@elsevier.com

Coronary computed tomographic angiography for rule-out of acute coronary syndrome in the emergency department may have moved ahead of SPECT myocardial perfusion imaging – its main noninvasive imaging rival – on the strength of recent evidence of advantages in time-to-discharge and radiation exposure, according to Dr. Christopher M. Kramer.

Myocardial perfusion imaging (MPI) has for roughly a decade been seen as the standard of care for imaging assistance in ED triage of patients presenting with chest pain and a nondiagnostic ECG.

It attained this status based upon the favorable results of the very large randomized ERASE (ER Assessment of Sestamibi for Evaluation of Chest Pain) trial (JAMA 2002;288:2693-700) and other studies in which MPI was compared to usual ED care.

©Elsevier Inc.

But in more recent randomized trials comparing computed tomographic angiography (CTA) to standard ED evaluation protocols, which now often include MPI, CTA has carried the day, Dr. Kramer said at the annual cardiovascular conference at Snowmass sponsored by the American College of Cardiology.

For example, the multicenter ACRIN-PA trial randomized 1,370 low- to intermediate-risk patients presenting with possible ACS to EDs to either early CTA or standard care, which in most cases included MPI. The CTA group had a higher rate of discharge from the ED: 50%, compared with 23%. They also had a median 18.0-hour length of stay, significantly shorter than the 24.8 hours in the control group (N. Engl. J. Med. 2012;366:1393-403).

Moreover, the CTA group had a higher rate of detection of CAD – 9.0% compared to 3.5% because CTA can detect nonobstructive as well as obstructive plaque, added Dr. Kramer, professor of cardiology and of radiology and director of the cardiovascular imaging center at the University of Virginia, Charlottesville.

The ROMICAT II (Rule Out Myocardial Ischemia/Infarction by Computer-Assisted Tomography) trial was a similar story. ROMICAT II was a multicenter trial in which 1,000 patients who presented to an ED with symptoms suggestive of ACS but a nondiagnostic ECG were randomized to CTA or a standard ED evaluation, most often including MPI. A total of 47% of patients in the CTA group were discharged directly from the ED, compared with just 12% in the control arm. Most notably, the median length of stay in the ED was 8.6 hours with CTA vs. 26.7 hours with a standard evaluation, and the mean length of stay in the hospital was reduced from 30.8 hours with standard evaluation to 23.2 hours, a 7.6-hour reduction (N. Engl. J. Med. 2012;367:299-308).

Follow-up demonstrated no cases of undetected ACS occurred in either group.

The average radiation dose to patients in the CTA arm was 14.3 mSv, compared with about 10 mSv for those patients in the standard evaluation group who got MPI. However, ROMICAT II didn’t use the latest CTA equipment.

"With the modern CTA units, the radiation doses have come down quite a lot. With our flash 256 detector in the ED, we can do a study in a patient with a controlled heart rate and a reasonable BMI [body mass index] with about 1 mSv of radiation now," Dr. Kramer recalled.

Costs in the ED were significantly lower in the CTA group than in controls in ROMICAT II because of the faster patient throughput. However, this savings was neutralized by higher in-hospital costs because the CTA group had more cardiac catheterizations and revascularization procedures because more cases of CAD were detected, as in ACRIN-PA.

"The real advantage to CTA is the rapid discharge from the ED. That’s what patients appreciate. They get their CT angiogram and they can go home within an hour or 2. It really improves their experience in the ED, rather than spending all night waiting for their SPECT MPI results. I don’t think you’re saving costs by doing CTA, though, because of this catch-up phenomenon," Dr. Kramer said.

Aside from the fact that MPI takes 3-5 hours, its other main limitations are that it has difficulty in differentiating acute ischemia from acute infarction or an old infarct, according to Dr. Kramer.

The ability of CTA to detect more cases of CAD by identifying nonobstructive plaque may prove to be of clinical import. That’s the underlying hypothesis of the ongoing National Heart, Lung, and Blood Institute–funded PROMISE (Prospective Multicenter Imaging Study for Evaluation of Chest Pain) study, in which 10,000 patients with symptoms suggestive of CAD are being randomized to an initial CTA or to usual care with a functional test, either MPI, stress echocardiography, or exercise ECG.

This study is being conducted in the offices of primary care physicians and cardiologists rather than in EDs. PROMISE has clinical endpoints as its primary outcomes. The study hypothesis is that intervening in patients identified as having nonobstructive CAD will yield improved outcomes. Results remain several years off, Dr. Kramer said.

ED physicians are eager for high-tech help in quickly and reliably ruling out ACS. Acute chest pain accounts for more than 8 million ED visits annually, but in only 1.19 million admissions for ACS.

Besides MPI and CTA, the other two noninvasive imaging technologies available for use in the ED are cardiac magnetic resonance (CMR) and contrast echocardiography. Neither utilizes radiation – a big plus. Yet neither is as widely used as MPI or CTA. That’s because magnetic resonance takes longer than CTA does, and the scanner may not be available at a moment’s notice, as it really needs to be, when a patient presents with chest pain to the ED. Also, expertise in CMR is not widely available. This is also an issue for contrast echo in the ED.

"The problem with contrast echo is that there are really very few centers around the world that can do it well. It really hasn’t caught on in terms of utilization in the ED," according to the cardiologist.

He reported that he serves as a consultant to Synarc and receives research support from Siemens Medical Solutions.

b.jancin@elsevier.com

Coronary computed tomographic angiography for rule-out of acute coronary syndrome in the emergency department may have moved ahead of SPECT myocardial perfusion imaging – its main noninvasive imaging rival – on the strength of recent evidence of advantages in time-to-discharge and radiation exposure, according to Dr. Christopher M. Kramer.

Myocardial perfusion imaging (MPI) has for roughly a decade been seen as the standard of care for imaging assistance in ED triage of patients presenting with chest pain and a nondiagnostic ECG.

It attained this status based upon the favorable results of the very large randomized ERASE (ER Assessment of Sestamibi for Evaluation of Chest Pain) trial (JAMA 2002;288:2693-700) and other studies in which MPI was compared to usual ED care.

©Elsevier Inc.

But in more recent randomized trials comparing computed tomographic angiography (CTA) to standard ED evaluation protocols, which now often include MPI, CTA has carried the day, Dr. Kramer said at the annual cardiovascular conference at Snowmass sponsored by the American College of Cardiology.

For example, the multicenter ACRIN-PA trial randomized 1,370 low- to intermediate-risk patients presenting with possible ACS to EDs to either early CTA or standard care, which in most cases included MPI. The CTA group had a higher rate of discharge from the ED: 50%, compared with 23%. They also had a median 18.0-hour length of stay, significantly shorter than the 24.8 hours in the control group (N. Engl. J. Med. 2012;366:1393-403).

Moreover, the CTA group had a higher rate of detection of CAD – 9.0% compared to 3.5% because CTA can detect nonobstructive as well as obstructive plaque, added Dr. Kramer, professor of cardiology and of radiology and director of the cardiovascular imaging center at the University of Virginia, Charlottesville.

The ROMICAT II (Rule Out Myocardial Ischemia/Infarction by Computer-Assisted Tomography) trial was a similar story. ROMICAT II was a multicenter trial in which 1,000 patients who presented to an ED with symptoms suggestive of ACS but a nondiagnostic ECG were randomized to CTA or a standard ED evaluation, most often including MPI. A total of 47% of patients in the CTA group were discharged directly from the ED, compared with just 12% in the control arm. Most notably, the median length of stay in the ED was 8.6 hours with CTA vs. 26.7 hours with a standard evaluation, and the mean length of stay in the hospital was reduced from 30.8 hours with standard evaluation to 23.2 hours, a 7.6-hour reduction (N. Engl. J. Med. 2012;367:299-308).

Follow-up demonstrated no cases of undetected ACS occurred in either group.

The average radiation dose to patients in the CTA arm was 14.3 mSv, compared with about 10 mSv for those patients in the standard evaluation group who got MPI. However, ROMICAT II didn’t use the latest CTA equipment.

"With the modern CTA units, the radiation doses have come down quite a lot. With our flash 256 detector in the ED, we can do a study in a patient with a controlled heart rate and a reasonable BMI [body mass index] with about 1 mSv of radiation now," Dr. Kramer recalled.

Costs in the ED were significantly lower in the CTA group than in controls in ROMICAT II because of the faster patient throughput. However, this savings was neutralized by higher in-hospital costs because the CTA group had more cardiac catheterizations and revascularization procedures because more cases of CAD were detected, as in ACRIN-PA.

"The real advantage to CTA is the rapid discharge from the ED. That’s what patients appreciate. They get their CT angiogram and they can go home within an hour or 2. It really improves their experience in the ED, rather than spending all night waiting for their SPECT MPI results. I don’t think you’re saving costs by doing CTA, though, because of this catch-up phenomenon," Dr. Kramer said.

Aside from the fact that MPI takes 3-5 hours, its other main limitations are that it has difficulty in differentiating acute ischemia from acute infarction or an old infarct, according to Dr. Kramer.

The ability of CTA to detect more cases of CAD by identifying nonobstructive plaque may prove to be of clinical import. That’s the underlying hypothesis of the ongoing National Heart, Lung, and Blood Institute–funded PROMISE (Prospective Multicenter Imaging Study for Evaluation of Chest Pain) study, in which 10,000 patients with symptoms suggestive of CAD are being randomized to an initial CTA or to usual care with a functional test, either MPI, stress echocardiography, or exercise ECG.

This study is being conducted in the offices of primary care physicians and cardiologists rather than in EDs. PROMISE has clinical endpoints as its primary outcomes. The study hypothesis is that intervening in patients identified as having nonobstructive CAD will yield improved outcomes. Results remain several years off, Dr. Kramer said.

ED physicians are eager for high-tech help in quickly and reliably ruling out ACS. Acute chest pain accounts for more than 8 million ED visits annually, but in only 1.19 million admissions for ACS.

Besides MPI and CTA, the other two noninvasive imaging technologies available for use in the ED are cardiac magnetic resonance (CMR) and contrast echocardiography. Neither utilizes radiation – a big plus. Yet neither is as widely used as MPI or CTA. That’s because magnetic resonance takes longer than CTA does, and the scanner may not be available at a moment’s notice, as it really needs to be, when a patient presents with chest pain to the ED. Also, expertise in CMR is not widely available. This is also an issue for contrast echo in the ED.

"The problem with contrast echo is that there are really very few centers around the world that can do it well. It really hasn’t caught on in terms of utilization in the ED," according to the cardiologist.

He reported that he serves as a consultant to Synarc and receives research support from Siemens Medical Solutions.

b.jancin@elsevier.com

Coronary computed tomographic angiography for rule-out of acute coronary syndrome in the emergency department may have moved ahead of SPECT myocardial perfusion imaging – its main noninvasive imaging rival – on the strength of recent evidence of advantages in time-to-discharge and radiation exposure, according to Dr. Christopher M. Kramer.

Myocardial perfusion imaging (MPI) has for roughly a decade been seen as the standard of care for imaging assistance in ED triage of patients presenting with chest pain and a nondiagnostic ECG.

It attained this status based upon the favorable results of the very large randomized ERASE (ER Assessment of Sestamibi for Evaluation of Chest Pain) trial (JAMA 2002;288:2693-700) and other studies in which MPI was compared to usual ED care.

©Elsevier Inc.

But in more recent randomized trials comparing computed tomographic angiography (CTA) to standard ED evaluation protocols, which now often include MPI, CTA has carried the day, Dr. Kramer said at the annual cardiovascular conference at Snowmass sponsored by the American College of Cardiology.

For example, the multicenter ACRIN-PA trial randomized 1,370 low- to intermediate-risk patients presenting with possible ACS to EDs to either early CTA or standard care, which in most cases included MPI. The CTA group had a higher rate of discharge from the ED: 50%, compared with 23%. They also had a median 18.0-hour length of stay, significantly shorter than the 24.8 hours in the control group (N. Engl. J. Med. 2012;366:1393-403).

Moreover, the CTA group had a higher rate of detection of CAD – 9.0% compared to 3.5% because CTA can detect nonobstructive as well as obstructive plaque, added Dr. Kramer, professor of cardiology and of radiology and director of the cardiovascular imaging center at the University of Virginia, Charlottesville.

The ROMICAT II (Rule Out Myocardial Ischemia/Infarction by Computer-Assisted Tomography) trial was a similar story. ROMICAT II was a multicenter trial in which 1,000 patients who presented to an ED with symptoms suggestive of ACS but a nondiagnostic ECG were randomized to CTA or a standard ED evaluation, most often including MPI. A total of 47% of patients in the CTA group were discharged directly from the ED, compared with just 12% in the control arm. Most notably, the median length of stay in the ED was 8.6 hours with CTA vs. 26.7 hours with a standard evaluation, and the mean length of stay in the hospital was reduced from 30.8 hours with standard evaluation to 23.2 hours, a 7.6-hour reduction (N. Engl. J. Med. 2012;367:299-308).

Follow-up demonstrated no cases of undetected ACS occurred in either group.

The average radiation dose to patients in the CTA arm was 14.3 mSv, compared with about 10 mSv for those patients in the standard evaluation group who got MPI. However, ROMICAT II didn’t use the latest CTA equipment.

"With the modern CTA units, the radiation doses have come down quite a lot. With our flash 256 detector in the ED, we can do a study in a patient with a controlled heart rate and a reasonable BMI [body mass index] with about 1 mSv of radiation now," Dr. Kramer recalled.

Costs in the ED were significantly lower in the CTA group than in controls in ROMICAT II because of the faster patient throughput. However, this savings was neutralized by higher in-hospital costs because the CTA group had more cardiac catheterizations and revascularization procedures because more cases of CAD were detected, as in ACRIN-PA.

"The real advantage to CTA is the rapid discharge from the ED. That’s what patients appreciate. They get their CT angiogram and they can go home within an hour or 2. It really improves their experience in the ED, rather than spending all night waiting for their SPECT MPI results. I don’t think you’re saving costs by doing CTA, though, because of this catch-up phenomenon," Dr. Kramer said.

Aside from the fact that MPI takes 3-5 hours, its other main limitations are that it has difficulty in differentiating acute ischemia from acute infarction or an old infarct, according to Dr. Kramer.

The ability of CTA to detect more cases of CAD by identifying nonobstructive plaque may prove to be of clinical import. That’s the underlying hypothesis of the ongoing National Heart, Lung, and Blood Institute–funded PROMISE (Prospective Multicenter Imaging Study for Evaluation of Chest Pain) study, in which 10,000 patients with symptoms suggestive of CAD are being randomized to an initial CTA or to usual care with a functional test, either MPI, stress echocardiography, or exercise ECG.

This study is being conducted in the offices of primary care physicians and cardiologists rather than in EDs. PROMISE has clinical endpoints as its primary outcomes. The study hypothesis is that intervening in patients identified as having nonobstructive CAD will yield improved outcomes. Results remain several years off, Dr. Kramer said.

ED physicians are eager for high-tech help in quickly and reliably ruling out ACS. Acute chest pain accounts for more than 8 million ED visits annually, but in only 1.19 million admissions for ACS.

Besides MPI and CTA, the other two noninvasive imaging technologies available for use in the ED are cardiac magnetic resonance (CMR) and contrast echocardiography. Neither utilizes radiation – a big plus. Yet neither is as widely used as MPI or CTA. That’s because magnetic resonance takes longer than CTA does, and the scanner may not be available at a moment’s notice, as it really needs to be, when a patient presents with chest pain to the ED. Also, expertise in CMR is not widely available. This is also an issue for contrast echo in the ED.

"The problem with contrast echo is that there are really very few centers around the world that can do it well. It really hasn’t caught on in terms of utilization in the ED," according to the cardiologist.

He reported that he serves as a consultant to Synarc and receives research support from Siemens Medical Solutions.

b.jancin@elsevier.com

SNOWMASS, COLO. – A patient on chronic warfarin for atrial fibrillation experiences an acute coronary syndrome and gets a coronary stent. What antiplatelet regimen will you prescribe to protect against potentially catastrophic stent thrombosis?

The first-ever randomized trial-based guidance regarding this common and vexing clinical scenario has been provided by the European WOEST (What Is the Optimal Antiplatelet and Anticoagulant Therapy in Patients With Oral Anticoagulation and Coronary Stenting?) trial. The study demonstrated that warfarin plus clopidogrel was superior to warfarin and dual antiplatelet therapy (DAPT) with clopidogrel plus low-dose aspirin, both in terms of bleeding events and 1-year all-cause mortality, Dr. Spencer B. King III observed at the annual cardiovascular conference at Snowmass sponsored by the American College of Cardiology.

"This trial was very impressive. It will be interesting to see how this is handled here in this country. We’ll see how this evolves as guidelines continue to reflect new evidence," said Dr. King, president of the Saint Joseph’s Heart and Vascular Institute and professor of medicine emeritus at Emory University, Atlanta. The trial results were presented at last year’s European Society of Cardiology meeting.

Current ACC/American Heart Association guidelines covering this scenario recommend warfarin at a target INR of 2.0-2.5, 1 year of a potent antiplatelet agent such as clopidogrel, and low-dose aspirin indefinitely. But that’s based upon expert opinion established in the pre-WOEST days, noted Dr. King, who was not involved in WOEST.

In the multicenter WOEST trial, 573 Dutch or Belgian coronary stent recipients on chronic warfarin remained on the anticoagulant and were randomized to DAPT with 75 mg/day of clopidogrel and 80 mg/day of aspirin or to clopidogrel only.

The primary study endpoint, consisting of the cumulative 1-year incidence of all TIMI bleeding events, occurred in 44.9% of patients on triple therapy (warfarin plus DAPT), compared with 19.5% on double therapy with warfarin and clopidogrel. This translated to a highly significant 64% relative risk reduction (P less than .001).

All-cause mortality, one of two secondary endpoints, occurred in 6.4% of patients on triple therapy, significantly more than the 2.6% rate in patients on double therapy. The composite secondary endpoint, comprising death, MI, stroke, stent thrombosis, or target vessel revascularization, occurred in 24% of patients on triple therapy compared to 15.8% on double therapy without aspirin. Of note, the stent thrombosis rate was 1.5% on double therapy versus 3.2% with triple therapy, Dr. King continued.

He added that the current standard recommendation for 12 months of DAPT following stent implantation, a consistent feature in the European Society of Cardiology, American College of Chest Physicians, and ACC/AHA guidelines, is open to question. That’s because the risk of stent thrombosis is greatest in the month or so following stent placement, then drops off sharply. Yet the bleeding risk associated with DAPT remains elevated so long as the patient remains on the regimen.

Incoming ACC President Dr. Patrick T. O’Gara, lead author of the 2013 ACC/AHA Guidelines for the Management of ST-Elevation Myocardial Infarction, confirmed that the recommendation for 12 months of DAPT in stent recipients is based upon expert consensus rather than data from prospective randomized trials, which were nonexistent at the time. This consensus opinion went well beyond the recommended 6 months of clopidogrel advised by the drug’s manufacturer at the time the potent antiplatelet agent won Food and Drug Administration marketing approval.

"I think it’s interesting that we have adopted this recommendation for 12 months of dual antiplatelet therapy, but now we’re reexamining the efficacy beyond 6 months in multiple trials," said Dr. O’Gara, executive medical director of the cardiovascular center at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, Boston.

Neither Dr. O’Gara nor Dr. King reported having any relevant financial interests.

b.jancin@elsevier.com

SNOWMASS, COLO. – A patient on chronic warfarin for atrial fibrillation experiences an acute coronary syndrome and gets a coronary stent. What antiplatelet regimen will you prescribe to protect against potentially catastrophic stent thrombosis?

The first-ever randomized trial-based guidance regarding this common and vexing clinical scenario has been provided by the European WOEST (What Is the Optimal Antiplatelet and Anticoagulant Therapy in Patients With Oral Anticoagulation and Coronary Stenting?) trial. The study demonstrated that warfarin plus clopidogrel was superior to warfarin and dual antiplatelet therapy (DAPT) with clopidogrel plus low-dose aspirin, both in terms of bleeding events and 1-year all-cause mortality, Dr. Spencer B. King III observed at the annual cardiovascular conference at Snowmass sponsored by the American College of Cardiology.

"This trial was very impressive. It will be interesting to see how this is handled here in this country. We’ll see how this evolves as guidelines continue to reflect new evidence," said Dr. King, president of the Saint Joseph’s Heart and Vascular Institute and professor of medicine emeritus at Emory University, Atlanta. The trial results were presented at last year’s European Society of Cardiology meeting.

Current ACC/American Heart Association guidelines covering this scenario recommend warfarin at a target INR of 2.0-2.5, 1 year of a potent antiplatelet agent such as clopidogrel, and low-dose aspirin indefinitely. But that’s based upon expert opinion established in the pre-WOEST days, noted Dr. King, who was not involved in WOEST.

In the multicenter WOEST trial, 573 Dutch or Belgian coronary stent recipients on chronic warfarin remained on the anticoagulant and were randomized to DAPT with 75 mg/day of clopidogrel and 80 mg/day of aspirin or to clopidogrel only.

The primary study endpoint, consisting of the cumulative 1-year incidence of all TIMI bleeding events, occurred in 44.9% of patients on triple therapy (warfarin plus DAPT), compared with 19.5% on double therapy with warfarin and clopidogrel. This translated to a highly significant 64% relative risk reduction (P less than .001).

All-cause mortality, one of two secondary endpoints, occurred in 6.4% of patients on triple therapy, significantly more than the 2.6% rate in patients on double therapy. The composite secondary endpoint, comprising death, MI, stroke, stent thrombosis, or target vessel revascularization, occurred in 24% of patients on triple therapy compared to 15.8% on double therapy without aspirin. Of note, the stent thrombosis rate was 1.5% on double therapy versus 3.2% with triple therapy, Dr. King continued.

He added that the current standard recommendation for 12 months of DAPT following stent implantation, a consistent feature in the European Society of Cardiology, American College of Chest Physicians, and ACC/AHA guidelines, is open to question. That’s because the risk of stent thrombosis is greatest in the month or so following stent placement, then drops off sharply. Yet the bleeding risk associated with DAPT remains elevated so long as the patient remains on the regimen.

Incoming ACC President Dr. Patrick T. O’Gara, lead author of the 2013 ACC/AHA Guidelines for the Management of ST-Elevation Myocardial Infarction, confirmed that the recommendation for 12 months of DAPT in stent recipients is based upon expert consensus rather than data from prospective randomized trials, which were nonexistent at the time. This consensus opinion went well beyond the recommended 6 months of clopidogrel advised by the drug’s manufacturer at the time the potent antiplatelet agent won Food and Drug Administration marketing approval.

"I think it’s interesting that we have adopted this recommendation for 12 months of dual antiplatelet therapy, but now we’re reexamining the efficacy beyond 6 months in multiple trials," said Dr. O’Gara, executive medical director of the cardiovascular center at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, Boston.

Neither Dr. O’Gara nor Dr. King reported having any relevant financial interests.

b.jancin@elsevier.com

SNOWMASS, COLO. – A patient on chronic warfarin for atrial fibrillation experiences an acute coronary syndrome and gets a coronary stent. What antiplatelet regimen will you prescribe to protect against potentially catastrophic stent thrombosis?

The first-ever randomized trial-based guidance regarding this common and vexing clinical scenario has been provided by the European WOEST (What Is the Optimal Antiplatelet and Anticoagulant Therapy in Patients With Oral Anticoagulation and Coronary Stenting?) trial. The study demonstrated that warfarin plus clopidogrel was superior to warfarin and dual antiplatelet therapy (DAPT) with clopidogrel plus low-dose aspirin, both in terms of bleeding events and 1-year all-cause mortality, Dr. Spencer B. King III observed at the annual cardiovascular conference at Snowmass sponsored by the American College of Cardiology.

"This trial was very impressive. It will be interesting to see how this is handled here in this country. We’ll see how this evolves as guidelines continue to reflect new evidence," said Dr. King, president of the Saint Joseph’s Heart and Vascular Institute and professor of medicine emeritus at Emory University, Atlanta. The trial results were presented at last year’s European Society of Cardiology meeting.

Current ACC/American Heart Association guidelines covering this scenario recommend warfarin at a target INR of 2.0-2.5, 1 year of a potent antiplatelet agent such as clopidogrel, and low-dose aspirin indefinitely. But that’s based upon expert opinion established in the pre-WOEST days, noted Dr. King, who was not involved in WOEST.

In the multicenter WOEST trial, 573 Dutch or Belgian coronary stent recipients on chronic warfarin remained on the anticoagulant and were randomized to DAPT with 75 mg/day of clopidogrel and 80 mg/day of aspirin or to clopidogrel only.

The primary study endpoint, consisting of the cumulative 1-year incidence of all TIMI bleeding events, occurred in 44.9% of patients on triple therapy (warfarin plus DAPT), compared with 19.5% on double therapy with warfarin and clopidogrel. This translated to a highly significant 64% relative risk reduction (P less than .001).

All-cause mortality, one of two secondary endpoints, occurred in 6.4% of patients on triple therapy, significantly more than the 2.6% rate in patients on double therapy. The composite secondary endpoint, comprising death, MI, stroke, stent thrombosis, or target vessel revascularization, occurred in 24% of patients on triple therapy compared to 15.8% on double therapy without aspirin. Of note, the stent thrombosis rate was 1.5% on double therapy versus 3.2% with triple therapy, Dr. King continued.

He added that the current standard recommendation for 12 months of DAPT following stent implantation, a consistent feature in the European Society of Cardiology, American College of Chest Physicians, and ACC/AHA guidelines, is open to question. That’s because the risk of stent thrombosis is greatest in the month or so following stent placement, then drops off sharply. Yet the bleeding risk associated with DAPT remains elevated so long as the patient remains on the regimen.

Incoming ACC President Dr. Patrick T. O’Gara, lead author of the 2013 ACC/AHA Guidelines for the Management of ST-Elevation Myocardial Infarction, confirmed that the recommendation for 12 months of DAPT in stent recipients is based upon expert consensus rather than data from prospective randomized trials, which were nonexistent at the time. This consensus opinion went well beyond the recommended 6 months of clopidogrel advised by the drug’s manufacturer at the time the potent antiplatelet agent won Food and Drug Administration marketing approval.

"I think it’s interesting that we have adopted this recommendation for 12 months of dual antiplatelet therapy, but now we’re reexamining the efficacy beyond 6 months in multiple trials," said Dr. O’Gara, executive medical director of the cardiovascular center at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, Boston.

Neither Dr. O’Gara nor Dr. King reported having any relevant financial interests.

b.jancin@elsevier.com

SNOWMASS, COLO–Pregnancy increases the long-term risk of aortic complications in women with Marfan syndrome, according to a recent prospective study causing a stir among adult congenital heart disease specialists.

"This is the first study that says, ‘Even if the aortic root size is okay before pregnancy, the aorta is going to get bigger during pregnancy and it’s not going to go back to baseline. And if your aorta is bigger at the outset, there is a risk for long-term adverse outcomes,’ " Dr. Carole A. Warnes explained at the annual cardiovascular conference at Snowmass sponsored by the American College of Cardiology (ACC).

This study on pregnancy’s impact on aortic growth rate and complications in patients with Marfan syndrome sheds much needed light on an area where there has been a paucity of data. The deficiency of data is reflected in discordant recommendations in the current U.S., European, and Canadian guidelines, said Dr. Warnes, professor of medicine at the Mayo Clinic, Rochester, Minn.

The U.S. guidelines put forth jointly by the ACC, American Heart Association, American Association for Thoracic Surgery, and other groups advocate that Marfan syndrome patients avoid pregnancy if their aortic root diameter exceeds 40 mm and recommend prophylactic aortic replacement in those interested in pregnancy (J. Am. Coll. Cardiol. 2010;55:e27-129).

In contrast, the European guidelines (Eur. Heart J. 2010;31:2915-57) consider an aortic root diameter of 45 mm or less to be generally safe, while strongly discouraging pregnancy in Marfan syndrome patients with a measurement above that threshold because of the associated increased dissection risk. The Canadian guidelines take a similar stance, albeit with a safety threshold of 44 mm rather than 45 mm (Can. J. Cardiol. 2010;26:e80-e97).

The Europeans qualify their position by noting that patients with a prepregnancy aortic root diameter of 40-45 mm who have a rapid aortic root growth rate or a family history of dissection ought to be considered high risk for pregnancy. The European and Canadian guidelines characterize dissection as a rare problem in patients with an aortic root diameter of less than 40 mm.

The recent Utah study included 98 women with Marfan syndrome, 69 of whom collectively had 199 pregnancies, with 170 live births, 26 spontaneous abortions, and 2 ectopic pregnancies.

Serial echocardiograms demonstrated that the aortic growth rate was significantly greater during pregnancy than beforehand, and after pregnancy it didn’t return to baseline. Obstetric complications occurred in 10% of pregnancies. Adverse fetal outcomes occurred in 13%.

Reassuringly, there were no catastrophic peripartum complications. No one required cardiac surgery or experienced aortic dissection during pregnancy. However, women with a prior pregnancy had a greater prevalence of both aortic dissection and elective aortic surgery during long-term follow-up, compared with matched childless women with Marfan syndrome. Thus, it’s important during prepregnancy counseling of women with Marfan syndrome to let them know they’ll need to have elective aortic root surgery at a younger age than if they remain childless, Dr. Warnes noted.

A larger initial root diameter and a faster increase in diameter were independent predictors of long-term adverse cardiovascular events in the Utah study.

Besides the recent Utah study, only two other prospective studies of pregnancy’s impact on aortic growth and complications have been done. Both were much smaller. In an editorial accompanying the Utah study, Dutch physicians combined the three studies to get a fuller picture. No type A dissections occurred during 145 pregnancies in 78 nonoperated women with Marfan syndrome. Of 25 women with an aortic root diameter of 40-51 mm during 29 pregnancies, one experienced a type B dissection, two had carotid artery dissections, and one developed accelerated aortic regurgitation, which went from mild to severe during pregnancy.

Five women underwent aortic root replacement (three electively), prior to six pregnancies. Two of them developed a type B dissection during pregnancy. Both women who underwent a valve-sparing elective aortic root replacement prior to pregnancy had pregnancies complicated by a worsening of aortic regurgitation, which went from trivial to moderate. These findings raise a red flag for Dr. Warnes.

"Even if they’ve had a successful root replacement, it doesn’t mean they’re out of the woods in terms of pregnancy. I think we have to question the role of prophylactic root replacement [as recommended in the U.S. guidelines] because these women will still have type B dissections, and trying to look for a type B dissection during pregnancy is a real difficult issue," the cardiologist observed.

The authors of the editorial concluded that Marfan syndrome patients without previous cardiac complications and who have a baseline aortic root diameter not in excess of 45 mm seem to tolerate pregnancy well as long as they receive good clinical care before, during, and after pregnancy. In contrast, pregnancy should be discouraged in patients with a history of aortic dissection because they are at elevated risk for aortic complications (J. Am. Coll. Cardiol. 2012;60:230-1).

Marfan syndrome is a genetic connective tissue disorder with an incidence of roughly 1 in 5,000 and autosomal dominant inheritance, so the fetus of an affected mom has a 50% chance of having the disorder. Dr. Warnes said that because the diagnostic criteria were overhauled in 2010, patients believed to have Marfan syndrome really ought to be referred to a specialized center in order to confirm or refute the diagnosis according to the contemporary Ghent criteria.

Dr. Warnes reported having no relevant financial interests.

b.jancin@elsevier.com

SNOWMASS, COLO–Pregnancy increases the long-term risk of aortic complications in women with Marfan syndrome, according to a recent prospective study causing a stir among adult congenital heart disease specialists.

"This is the first study that says, ‘Even if the aortic root size is okay before pregnancy, the aorta is going to get bigger during pregnancy and it’s not going to go back to baseline. And if your aorta is bigger at the outset, there is a risk for long-term adverse outcomes,’ " Dr. Carole A. Warnes explained at the annual cardiovascular conference at Snowmass sponsored by the American College of Cardiology (ACC).

This study on pregnancy’s impact on aortic growth rate and complications in patients with Marfan syndrome sheds much needed light on an area where there has been a paucity of data. The deficiency of data is reflected in discordant recommendations in the current U.S., European, and Canadian guidelines, said Dr. Warnes, professor of medicine at the Mayo Clinic, Rochester, Minn.

The U.S. guidelines put forth jointly by the ACC, American Heart Association, American Association for Thoracic Surgery, and other groups advocate that Marfan syndrome patients avoid pregnancy if their aortic root diameter exceeds 40 mm and recommend prophylactic aortic replacement in those interested in pregnancy (J. Am. Coll. Cardiol. 2010;55:e27-129).

In contrast, the European guidelines (Eur. Heart J. 2010;31:2915-57) consider an aortic root diameter of 45 mm or less to be generally safe, while strongly discouraging pregnancy in Marfan syndrome patients with a measurement above that threshold because of the associated increased dissection risk. The Canadian guidelines take a similar stance, albeit with a safety threshold of 44 mm rather than 45 mm (Can. J. Cardiol. 2010;26:e80-e97).

The Europeans qualify their position by noting that patients with a prepregnancy aortic root diameter of 40-45 mm who have a rapid aortic root growth rate or a family history of dissection ought to be considered high risk for pregnancy. The European and Canadian guidelines characterize dissection as a rare problem in patients with an aortic root diameter of less than 40 mm.

The recent Utah study included 98 women with Marfan syndrome, 69 of whom collectively had 199 pregnancies, with 170 live births, 26 spontaneous abortions, and 2 ectopic pregnancies.

Serial echocardiograms demonstrated that the aortic growth rate was significantly greater during pregnancy than beforehand, and after pregnancy it didn’t return to baseline. Obstetric complications occurred in 10% of pregnancies. Adverse fetal outcomes occurred in 13%.

Reassuringly, there were no catastrophic peripartum complications. No one required cardiac surgery or experienced aortic dissection during pregnancy. However, women with a prior pregnancy had a greater prevalence of both aortic dissection and elective aortic surgery during long-term follow-up, compared with matched childless women with Marfan syndrome. Thus, it’s important during prepregnancy counseling of women with Marfan syndrome to let them know they’ll need to have elective aortic root surgery at a younger age than if they remain childless, Dr. Warnes noted.

A larger initial root diameter and a faster increase in diameter were independent predictors of long-term adverse cardiovascular events in the Utah study.

Besides the recent Utah study, only two other prospective studies of pregnancy’s impact on aortic growth and complications have been done. Both were much smaller. In an editorial accompanying the Utah study, Dutch physicians combined the three studies to get a fuller picture. No type A dissections occurred during 145 pregnancies in 78 nonoperated women with Marfan syndrome. Of 25 women with an aortic root diameter of 40-51 mm during 29 pregnancies, one experienced a type B dissection, two had carotid artery dissections, and one developed accelerated aortic regurgitation, which went from mild to severe during pregnancy.

Five women underwent aortic root replacement (three electively), prior to six pregnancies. Two of them developed a type B dissection during pregnancy. Both women who underwent a valve-sparing elective aortic root replacement prior to pregnancy had pregnancies complicated by a worsening of aortic regurgitation, which went from trivial to moderate. These findings raise a red flag for Dr. Warnes.

"Even if they’ve had a successful root replacement, it doesn’t mean they’re out of the woods in terms of pregnancy. I think we have to question the role of prophylactic root replacement [as recommended in the U.S. guidelines] because these women will still have type B dissections, and trying to look for a type B dissection during pregnancy is a real difficult issue," the cardiologist observed.

The authors of the editorial concluded that Marfan syndrome patients without previous cardiac complications and who have a baseline aortic root diameter not in excess of 45 mm seem to tolerate pregnancy well as long as they receive good clinical care before, during, and after pregnancy. In contrast, pregnancy should be discouraged in patients with a history of aortic dissection because they are at elevated risk for aortic complications (J. Am. Coll. Cardiol. 2012;60:230-1).

Marfan syndrome is a genetic connective tissue disorder with an incidence of roughly 1 in 5,000 and autosomal dominant inheritance, so the fetus of an affected mom has a 50% chance of having the disorder. Dr. Warnes said that because the diagnostic criteria were overhauled in 2010, patients believed to have Marfan syndrome really ought to be referred to a specialized center in order to confirm or refute the diagnosis according to the contemporary Ghent criteria.

Dr. Warnes reported having no relevant financial interests.

b.jancin@elsevier.com

SNOWMASS, COLO–Pregnancy increases the long-term risk of aortic complications in women with Marfan syndrome, according to a recent prospective study causing a stir among adult congenital heart disease specialists.

"This is the first study that says, ‘Even if the aortic root size is okay before pregnancy, the aorta is going to get bigger during pregnancy and it’s not going to go back to baseline. And if your aorta is bigger at the outset, there is a risk for long-term adverse outcomes,’ " Dr. Carole A. Warnes explained at the annual cardiovascular conference at Snowmass sponsored by the American College of Cardiology (ACC).

This study on pregnancy’s impact on aortic growth rate and complications in patients with Marfan syndrome sheds much needed light on an area where there has been a paucity of data. The deficiency of data is reflected in discordant recommendations in the current U.S., European, and Canadian guidelines, said Dr. Warnes, professor of medicine at the Mayo Clinic, Rochester, Minn.

The U.S. guidelines put forth jointly by the ACC, American Heart Association, American Association for Thoracic Surgery, and other groups advocate that Marfan syndrome patients avoid pregnancy if their aortic root diameter exceeds 40 mm and recommend prophylactic aortic replacement in those interested in pregnancy (J. Am. Coll. Cardiol. 2010;55:e27-129).

In contrast, the European guidelines (Eur. Heart J. 2010;31:2915-57) consider an aortic root diameter of 45 mm or less to be generally safe, while strongly discouraging pregnancy in Marfan syndrome patients with a measurement above that threshold because of the associated increased dissection risk. The Canadian guidelines take a similar stance, albeit with a safety threshold of 44 mm rather than 45 mm (Can. J. Cardiol. 2010;26:e80-e97).

The Europeans qualify their position by noting that patients with a prepregnancy aortic root diameter of 40-45 mm who have a rapid aortic root growth rate or a family history of dissection ought to be considered high risk for pregnancy. The European and Canadian guidelines characterize dissection as a rare problem in patients with an aortic root diameter of less than 40 mm.

The recent Utah study included 98 women with Marfan syndrome, 69 of whom collectively had 199 pregnancies, with 170 live births, 26 spontaneous abortions, and 2 ectopic pregnancies.

Serial echocardiograms demonstrated that the aortic growth rate was significantly greater during pregnancy than beforehand, and after pregnancy it didn’t return to baseline. Obstetric complications occurred in 10% of pregnancies. Adverse fetal outcomes occurred in 13%.

Reassuringly, there were no catastrophic peripartum complications. No one required cardiac surgery or experienced aortic dissection during pregnancy. However, women with a prior pregnancy had a greater prevalence of both aortic dissection and elective aortic surgery during long-term follow-up, compared with matched childless women with Marfan syndrome. Thus, it’s important during prepregnancy counseling of women with Marfan syndrome to let them know they’ll need to have elective aortic root surgery at a younger age than if they remain childless, Dr. Warnes noted.

A larger initial root diameter and a faster increase in diameter were independent predictors of long-term adverse cardiovascular events in the Utah study.

Besides the recent Utah study, only two other prospective studies of pregnancy’s impact on aortic growth and complications have been done. Both were much smaller. In an editorial accompanying the Utah study, Dutch physicians combined the three studies to get a fuller picture. No type A dissections occurred during 145 pregnancies in 78 nonoperated women with Marfan syndrome. Of 25 women with an aortic root diameter of 40-51 mm during 29 pregnancies, one experienced a type B dissection, two had carotid artery dissections, and one developed accelerated aortic regurgitation, which went from mild to severe during pregnancy.

Five women underwent aortic root replacement (three electively), prior to six pregnancies. Two of them developed a type B dissection during pregnancy. Both women who underwent a valve-sparing elective aortic root replacement prior to pregnancy had pregnancies complicated by a worsening of aortic regurgitation, which went from trivial to moderate. These findings raise a red flag for Dr. Warnes.

"Even if they’ve had a successful root replacement, it doesn’t mean they’re out of the woods in terms of pregnancy. I think we have to question the role of prophylactic root replacement [as recommended in the U.S. guidelines] because these women will still have type B dissections, and trying to look for a type B dissection during pregnancy is a real difficult issue," the cardiologist observed.

The authors of the editorial concluded that Marfan syndrome patients without previous cardiac complications and who have a baseline aortic root diameter not in excess of 45 mm seem to tolerate pregnancy well as long as they receive good clinical care before, during, and after pregnancy. In contrast, pregnancy should be discouraged in patients with a history of aortic dissection because they are at elevated risk for aortic complications (J. Am. Coll. Cardiol. 2012;60:230-1).

Marfan syndrome is a genetic connective tissue disorder with an incidence of roughly 1 in 5,000 and autosomal dominant inheritance, so the fetus of an affected mom has a 50% chance of having the disorder. Dr. Warnes said that because the diagnostic criteria were overhauled in 2010, patients believed to have Marfan syndrome really ought to be referred to a specialized center in order to confirm or refute the diagnosis according to the contemporary Ghent criteria.

Dr. Warnes reported having no relevant financial interests.

b.jancin@elsevier.com