Mitchel L. Zoler, PhD

MADRID – In newly updated recommendations for managing rheumatoid arthritis, a EULAR task force retained much from its prior 2010 version but included some significant changes such as elevating the biologic drugs tocilizumab and abatacept to the same status as tumor necrosis factor inhibitors.

The 2013 draft revision may be most notable for what stayed the same from 2010, such as keeping conventional synthetic disease-modifying antirheumatic drugs (DMARDs) as the only first-line interventions for newly diagnosed patients with rheumatoid arthritis (RA). This means the update keeps all biologic DMARDs as secondary treatments reserved for patients who fail to respond adequately to or are intolerant of methotrexate or the other conventional, synthetic DMARDs cited as first-line options: sulfasalazine, hydrochloroquine, and leflunomide.

By maintaining synthetic DMARDs – either methotrexate monotherapy or in combined regimens – as its only first-line options for treating RA, the European League Against Rheumatism (EULAR) Task Force appointed to develop the new revision broke with the 2012 RA management recommendations of the American College of Rheumatology (ACR), which cited treatment with a tumor necrosis factor (TNF) inhibitor as a first-line option, with or without combination with methotrexate, for patients with early RA, high disease activity, and poor prognostic features (Arthritis Care Res. 2012;64:625-39).

The reason to keep all biologic DMARDs as second-line drugs was the evidence that supports the "efficacy of a treat-to-target strategy when adding biologics after insufficient response to methotrexate," said Dr. Josef S. Smolen, professor of rheumatology at the Medical University of Vienna, who presented the draft update during a session at the annual European Congress of Rheumatology. Dr. Smolen stressed that although the EULAR-appointed, 33-member update task force had completed all their votes to approve the draft recommendations, the update was still subject to further review and change before its eventual publication.

The new draft "does not advocate use of biologics as first DMARD strategies because the treat-to-target approach will lead to a similar overall outcome while avoiding the overtreatment of 20%-50% of patients with early RA," Dr. Smolen explained. The revision also does not endorse monotherapy with a TNF inhibitor or any other type of biologic DMARD.

Another major break from the past in the new revision is its leveling of the role for tocilizumab (Actemra) and abatacept (Orencia) alongside the several TNF inhibitor DMARDs now on the worldwide market. Last year’s ACR recommendations specified anti-TNF drugs as an option for initial therapy of patients with high disease activity and poor prognostic features, as well as low disease activity patients who get inadequate benefit from synthetic DMARDs. In the ACR recommendations, abatacept as well as rituximab (Rituxan) fell lower in the management algorithm, while tocilizumab was completely off the page.

Not only do the new EULAR recommendations place tocilizumab and abatacept on the same level as the TNF inhibitors, the EULAR draft further singles out tocilizumab as the "preferred agent" for patients who must receive a biologic DMARD as monotherapy rather than the preferred way, in combination with methotrexate. "Preference is given to combining all biologicals with methotrexate," Dr. Smolen said. The revision also cites rituximab as another biologic DMARD to consider, but it’s not ranked as high as the others.

In another change from 2010, the task force specially noted the potential benefit from using multiple conventional synthetic DMARDs for initial treatment. "The 2013 task force reiterates the evidence-based view that conventional synthetic DMARD monotherpy is effective, but based on some newer trial data on conventional synthetic DMARD combination therapy, the task force more explicitly endorses combination of conventional synthetic DMARDs early on. Preference to combination is not given because of possible limitations in the design of these trials and conflicting trial data."

The 2013 recommendations also specify a role for tofacitinib (Xeljanz), which received U.S. marketing approval late last year. Dr. Smolen highlighted that the task force reached a consensus on how to fit tofacitinib into the treatment algorithm in early April, before the European Medicines Agency denied the drug European marketing approval in late April. Despite the drug being turned down as a treatment option for European patients, "the task force was convinced of the clinical, functional, and structural efficacy of tofacitinib based on available evidence." However, citing a possibly higher risk for flare of herpes zoster, compared with biologic DMARDs, the task force said that tofacitinib should be used only in patients who had failed at least one biologic drug and "preferably two" until more experience and registry data became available.

Dr. Smolen said he has been a consultant to, a speaker for, or has received grant support from 14 pharmaceutical companies. He also said he served as the principal investigator for seven trials that assessed six different biologic agents for the treatment of rheumatoid arthritis.

Summary of EULAR’s 2013 RA management recommendations

The draft 2013 EULAR rheumatoid arthritis management recommendations includes three overarching principles and 14 recommendations. Here is a summary of the draft recommendations:

1. Therapy with DMARDs should start as soon as rheumatoid arthritis is diagnosed.

2. Treatment should aim to achieve remission or low disease activity.

3. Monitoring should be frequent, and if there is no improvement after a maximum of 3 months or if the target has not been reached by a maximum of 6 months, treatment should be adjusted.

4. Methotrexate should be part of the first treatment strategy.

5. When methotrexate is contraindicated or not tolerated, consider sulfasalazine or leflunomide as part of the treatment regimen.

6. Early treatment with a combination of conventional synthetic DMARDs is a reasonable alternative to initial methotrexate monotherapy.

7. Consider adding a low-dose glucocorticoid as part of initial treatment for up to 6 months; taper down as rapidly as clinically feasible.

8. If the treatment target is not reached, consider changing to another synthetic DMARD regimen; if the patient has poor prognostic features, consider adding a biological DMARD.

9. If a patient does not respond adequately to treatment with conventional, synthetic DMARDs – with or without concurrent treatment with a glucocorticoid – a biological DMARD should be started along with methotrexate. The biological DMARD could be a TNF inhibitor, abatacept, or tocilizumab.

10. Patients who fail to adequately respond to a biological DMARD should be switched to another biological DMARD. Patients who fail a first TNF inhibitor may be switched to a different TNF inhibitor.

11. Treatment with tofacitinib can be considered after patients fail treatment with biological DMARDs.

12. For patients in persistent remission, first taper down the corticosteroid dosage. If remission persists consider tapering down treatment with any biological DMARD, especially if the patient is also receiving one or more synthetic DMARDs.

13. In patients with sustained, long-term remission, consider tapering down the dosage of conventional, synthetic DMARDs as a shared decision between the patient and physician.

14. When adjusting therapy, take into account progression of structural damage, comorbidities, and safety issues, as well as disease activity.

Source: Dr. Smolen

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

MADRID – In newly updated recommendations for managing rheumatoid arthritis, a EULAR task force retained much from its prior 2010 version but included some significant changes such as elevating the biologic drugs tocilizumab and abatacept to the same status as tumor necrosis factor inhibitors.

The 2013 draft revision may be most notable for what stayed the same from 2010, such as keeping conventional synthetic disease-modifying antirheumatic drugs (DMARDs) as the only first-line interventions for newly diagnosed patients with rheumatoid arthritis (RA). This means the update keeps all biologic DMARDs as secondary treatments reserved for patients who fail to respond adequately to or are intolerant of methotrexate or the other conventional, synthetic DMARDs cited as first-line options: sulfasalazine, hydrochloroquine, and leflunomide.

By maintaining synthetic DMARDs – either methotrexate monotherapy or in combined regimens – as its only first-line options for treating RA, the European League Against Rheumatism (EULAR) Task Force appointed to develop the new revision broke with the 2012 RA management recommendations of the American College of Rheumatology (ACR), which cited treatment with a tumor necrosis factor (TNF) inhibitor as a first-line option, with or without combination with methotrexate, for patients with early RA, high disease activity, and poor prognostic features (Arthritis Care Res. 2012;64:625-39).

The reason to keep all biologic DMARDs as second-line drugs was the evidence that supports the "efficacy of a treat-to-target strategy when adding biologics after insufficient response to methotrexate," said Dr. Josef S. Smolen, professor of rheumatology at the Medical University of Vienna, who presented the draft update during a session at the annual European Congress of Rheumatology. Dr. Smolen stressed that although the EULAR-appointed, 33-member update task force had completed all their votes to approve the draft recommendations, the update was still subject to further review and change before its eventual publication.

The new draft "does not advocate use of biologics as first DMARD strategies because the treat-to-target approach will lead to a similar overall outcome while avoiding the overtreatment of 20%-50% of patients with early RA," Dr. Smolen explained. The revision also does not endorse monotherapy with a TNF inhibitor or any other type of biologic DMARD.

Another major break from the past in the new revision is its leveling of the role for tocilizumab (Actemra) and abatacept (Orencia) alongside the several TNF inhibitor DMARDs now on the worldwide market. Last year’s ACR recommendations specified anti-TNF drugs as an option for initial therapy of patients with high disease activity and poor prognostic features, as well as low disease activity patients who get inadequate benefit from synthetic DMARDs. In the ACR recommendations, abatacept as well as rituximab (Rituxan) fell lower in the management algorithm, while tocilizumab was completely off the page.

Not only do the new EULAR recommendations place tocilizumab and abatacept on the same level as the TNF inhibitors, the EULAR draft further singles out tocilizumab as the "preferred agent" for patients who must receive a biologic DMARD as monotherapy rather than the preferred way, in combination with methotrexate. "Preference is given to combining all biologicals with methotrexate," Dr. Smolen said. The revision also cites rituximab as another biologic DMARD to consider, but it’s not ranked as high as the others.

In another change from 2010, the task force specially noted the potential benefit from using multiple conventional synthetic DMARDs for initial treatment. "The 2013 task force reiterates the evidence-based view that conventional synthetic DMARD monotherpy is effective, but based on some newer trial data on conventional synthetic DMARD combination therapy, the task force more explicitly endorses combination of conventional synthetic DMARDs early on. Preference to combination is not given because of possible limitations in the design of these trials and conflicting trial data."

The 2013 recommendations also specify a role for tofacitinib (Xeljanz), which received U.S. marketing approval late last year. Dr. Smolen highlighted that the task force reached a consensus on how to fit tofacitinib into the treatment algorithm in early April, before the European Medicines Agency denied the drug European marketing approval in late April. Despite the drug being turned down as a treatment option for European patients, "the task force was convinced of the clinical, functional, and structural efficacy of tofacitinib based on available evidence." However, citing a possibly higher risk for flare of herpes zoster, compared with biologic DMARDs, the task force said that tofacitinib should be used only in patients who had failed at least one biologic drug and "preferably two" until more experience and registry data became available.

Dr. Smolen said he has been a consultant to, a speaker for, or has received grant support from 14 pharmaceutical companies. He also said he served as the principal investigator for seven trials that assessed six different biologic agents for the treatment of rheumatoid arthritis.

Summary of EULAR’s 2013 RA management recommendations

The draft 2013 EULAR rheumatoid arthritis management recommendations includes three overarching principles and 14 recommendations. Here is a summary of the draft recommendations:

1. Therapy with DMARDs should start as soon as rheumatoid arthritis is diagnosed.

2. Treatment should aim to achieve remission or low disease activity.

3. Monitoring should be frequent, and if there is no improvement after a maximum of 3 months or if the target has not been reached by a maximum of 6 months, treatment should be adjusted.

4. Methotrexate should be part of the first treatment strategy.

5. When methotrexate is contraindicated or not tolerated, consider sulfasalazine or leflunomide as part of the treatment regimen.

6. Early treatment with a combination of conventional synthetic DMARDs is a reasonable alternative to initial methotrexate monotherapy.

7. Consider adding a low-dose glucocorticoid as part of initial treatment for up to 6 months; taper down as rapidly as clinically feasible.

8. If the treatment target is not reached, consider changing to another synthetic DMARD regimen; if the patient has poor prognostic features, consider adding a biological DMARD.

9. If a patient does not respond adequately to treatment with conventional, synthetic DMARDs – with or without concurrent treatment with a glucocorticoid – a biological DMARD should be started along with methotrexate. The biological DMARD could be a TNF inhibitor, abatacept, or tocilizumab.

10. Patients who fail to adequately respond to a biological DMARD should be switched to another biological DMARD. Patients who fail a first TNF inhibitor may be switched to a different TNF inhibitor.

11. Treatment with tofacitinib can be considered after patients fail treatment with biological DMARDs.

12. For patients in persistent remission, first taper down the corticosteroid dosage. If remission persists consider tapering down treatment with any biological DMARD, especially if the patient is also receiving one or more synthetic DMARDs.

13. In patients with sustained, long-term remission, consider tapering down the dosage of conventional, synthetic DMARDs as a shared decision between the patient and physician.

14. When adjusting therapy, take into account progression of structural damage, comorbidities, and safety issues, as well as disease activity.

Source: Dr. Smolen

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

MADRID – In newly updated recommendations for managing rheumatoid arthritis, a EULAR task force retained much from its prior 2010 version but included some significant changes such as elevating the biologic drugs tocilizumab and abatacept to the same status as tumor necrosis factor inhibitors.

The 2013 draft revision may be most notable for what stayed the same from 2010, such as keeping conventional synthetic disease-modifying antirheumatic drugs (DMARDs) as the only first-line interventions for newly diagnosed patients with rheumatoid arthritis (RA). This means the update keeps all biologic DMARDs as secondary treatments reserved for patients who fail to respond adequately to or are intolerant of methotrexate or the other conventional, synthetic DMARDs cited as first-line options: sulfasalazine, hydrochloroquine, and leflunomide.

By maintaining synthetic DMARDs – either methotrexate monotherapy or in combined regimens – as its only first-line options for treating RA, the European League Against Rheumatism (EULAR) Task Force appointed to develop the new revision broke with the 2012 RA management recommendations of the American College of Rheumatology (ACR), which cited treatment with a tumor necrosis factor (TNF) inhibitor as a first-line option, with or without combination with methotrexate, for patients with early RA, high disease activity, and poor prognostic features (Arthritis Care Res. 2012;64:625-39).

The reason to keep all biologic DMARDs as second-line drugs was the evidence that supports the "efficacy of a treat-to-target strategy when adding biologics after insufficient response to methotrexate," said Dr. Josef S. Smolen, professor of rheumatology at the Medical University of Vienna, who presented the draft update during a session at the annual European Congress of Rheumatology. Dr. Smolen stressed that although the EULAR-appointed, 33-member update task force had completed all their votes to approve the draft recommendations, the update was still subject to further review and change before its eventual publication.

The new draft "does not advocate use of biologics as first DMARD strategies because the treat-to-target approach will lead to a similar overall outcome while avoiding the overtreatment of 20%-50% of patients with early RA," Dr. Smolen explained. The revision also does not endorse monotherapy with a TNF inhibitor or any other type of biologic DMARD.

Another major break from the past in the new revision is its leveling of the role for tocilizumab (Actemra) and abatacept (Orencia) alongside the several TNF inhibitor DMARDs now on the worldwide market. Last year’s ACR recommendations specified anti-TNF drugs as an option for initial therapy of patients with high disease activity and poor prognostic features, as well as low disease activity patients who get inadequate benefit from synthetic DMARDs. In the ACR recommendations, abatacept as well as rituximab (Rituxan) fell lower in the management algorithm, while tocilizumab was completely off the page.

Not only do the new EULAR recommendations place tocilizumab and abatacept on the same level as the TNF inhibitors, the EULAR draft further singles out tocilizumab as the "preferred agent" for patients who must receive a biologic DMARD as monotherapy rather than the preferred way, in combination with methotrexate. "Preference is given to combining all biologicals with methotrexate," Dr. Smolen said. The revision also cites rituximab as another biologic DMARD to consider, but it’s not ranked as high as the others.

In another change from 2010, the task force specially noted the potential benefit from using multiple conventional synthetic DMARDs for initial treatment. "The 2013 task force reiterates the evidence-based view that conventional synthetic DMARD monotherpy is effective, but based on some newer trial data on conventional synthetic DMARD combination therapy, the task force more explicitly endorses combination of conventional synthetic DMARDs early on. Preference to combination is not given because of possible limitations in the design of these trials and conflicting trial data."

The 2013 recommendations also specify a role for tofacitinib (Xeljanz), which received U.S. marketing approval late last year. Dr. Smolen highlighted that the task force reached a consensus on how to fit tofacitinib into the treatment algorithm in early April, before the European Medicines Agency denied the drug European marketing approval in late April. Despite the drug being turned down as a treatment option for European patients, "the task force was convinced of the clinical, functional, and structural efficacy of tofacitinib based on available evidence." However, citing a possibly higher risk for flare of herpes zoster, compared with biologic DMARDs, the task force said that tofacitinib should be used only in patients who had failed at least one biologic drug and "preferably two" until more experience and registry data became available.

Dr. Smolen said he has been a consultant to, a speaker for, or has received grant support from 14 pharmaceutical companies. He also said he served as the principal investigator for seven trials that assessed six different biologic agents for the treatment of rheumatoid arthritis.

Summary of EULAR’s 2013 RA management recommendations

The draft 2013 EULAR rheumatoid arthritis management recommendations includes three overarching principles and 14 recommendations. Here is a summary of the draft recommendations:

1. Therapy with DMARDs should start as soon as rheumatoid arthritis is diagnosed.

2. Treatment should aim to achieve remission or low disease activity.

3. Monitoring should be frequent, and if there is no improvement after a maximum of 3 months or if the target has not been reached by a maximum of 6 months, treatment should be adjusted.

4. Methotrexate should be part of the first treatment strategy.

5. When methotrexate is contraindicated or not tolerated, consider sulfasalazine or leflunomide as part of the treatment regimen.

6. Early treatment with a combination of conventional synthetic DMARDs is a reasonable alternative to initial methotrexate monotherapy.

7. Consider adding a low-dose glucocorticoid as part of initial treatment for up to 6 months; taper down as rapidly as clinically feasible.

8. If the treatment target is not reached, consider changing to another synthetic DMARD regimen; if the patient has poor prognostic features, consider adding a biological DMARD.

9. If a patient does not respond adequately to treatment with conventional, synthetic DMARDs – with or without concurrent treatment with a glucocorticoid – a biological DMARD should be started along with methotrexate. The biological DMARD could be a TNF inhibitor, abatacept, or tocilizumab.

10. Patients who fail to adequately respond to a biological DMARD should be switched to another biological DMARD. Patients who fail a first TNF inhibitor may be switched to a different TNF inhibitor.

11. Treatment with tofacitinib can be considered after patients fail treatment with biological DMARDs.

12. For patients in persistent remission, first taper down the corticosteroid dosage. If remission persists consider tapering down treatment with any biological DMARD, especially if the patient is also receiving one or more synthetic DMARDs.

13. In patients with sustained, long-term remission, consider tapering down the dosage of conventional, synthetic DMARDs as a shared decision between the patient and physician.

14. When adjusting therapy, take into account progression of structural damage, comorbidities, and safety issues, as well as disease activity.

Source: Dr. Smolen

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

Is mild aortic regurgitation following transcatheter aortic valve replacement okay, or do patients face an unacceptably high risk for death when their procedure has that outcome?

That’s a question dogging transcatheter aortic valve replacement (TAVR) right now that will only get answered as more patients undergo TAVR and follow-up times increase. But it is also a question that probably comes up almost every day in cath labs performing TAVR.

Last month during EuroPCR, I heard the wrap-up for a just-completed TAVR case. After the replacement valve was placed, the patient had mild aortic regurgitation, and a key decision of the case was whether or not to try to fiddle with the valve to improve on that. Given the valvular calcification and the frailty of the patient, the physicians in the lab as well as those on the panel in the hall uniformly agreed that stopping at mild regurgitation was the best option for this case.

But hearing that, I also recalled the comment in March from Dr. Friederich-Wilhelm Mohr when he was reporting the most recent results from the German national TAVR registry. Dr. Mohr looked at the outcomes of patients with mild regurgitation and concluded that "regurgitation matters, whether is it mild or severe." In the German 1-year outcome results from nearly 2,700 patients who underwent transvascular TAVR, those who emerged with mild aortic regurgitation had a 25% 1-year mortality rate, compared with a 21% rate among patients who had no regurgitation flowing TAVR, and compared with a 50% rate in the small number of patients who emerged from TAVR with severe regurgitation. Dr. Mohr did not say whether he applied statistical analysis to those 21% and 25% results to determine if it was a significant difference.

Back to the case, is that possible 4% absolute difference in 1-year mortality worth the risk of possible clinical complications that fiddling with the valve might cause and with no guarantee of getting an improved result? The interventionalists thought that in this patient, the answer was to leave well enough alone.

But in the bigger picture, the answer lies in better TAVR devices that produce higher rates of patients with no regurgitation. In the German registry using 2011 TAVR technology, 56% of the transvascular TAVR patients had mild aortic regurgitation after their procedure finished. Dr. Mohr said that rate was too high.

Also at EuroPCR was a report from Dr. Ian Meredith from Melbourne on 60 patients treated with a new TAVR system designed to allow easy repositioning of the valve. Also, surrounding the valve as it gets placed in the patient’s heart is a layer of something Dr. Meredith likened to cling wrap, to fill and seal the small crevices around the new valve. In 53 patients with 30-day follow-up, one patient (2%) had moderate regurgitation, 10 patients (19%) had mild regurgitation, 13 (25%) had trace regurgitation, and 29 (55%) had no regurgitation. If those rates hold up with wider and longer use, it would be an advance, though still room for further improvement. By comparison, typical reported rates using the approved Sapien TAVR device show 15% moderate or severe regurgitation at 30 days following TAVR, 45% mild, and less than 20% with none.

Is mild aortic regurgitation following transcatheter aortic valve replacement okay, or do patients face an unacceptably high risk for death when their procedure has that outcome?

That’s a question dogging transcatheter aortic valve replacement (TAVR) right now that will only get answered as more patients undergo TAVR and follow-up times increase. But it is also a question that probably comes up almost every day in cath labs performing TAVR.

Last month during EuroPCR, I heard the wrap-up for a just-completed TAVR case. After the replacement valve was placed, the patient had mild aortic regurgitation, and a key decision of the case was whether or not to try to fiddle with the valve to improve on that. Given the valvular calcification and the frailty of the patient, the physicians in the lab as well as those on the panel in the hall uniformly agreed that stopping at mild regurgitation was the best option for this case.

But hearing that, I also recalled the comment in March from Dr. Friederich-Wilhelm Mohr when he was reporting the most recent results from the German national TAVR registry. Dr. Mohr looked at the outcomes of patients with mild regurgitation and concluded that "regurgitation matters, whether is it mild or severe." In the German 1-year outcome results from nearly 2,700 patients who underwent transvascular TAVR, those who emerged with mild aortic regurgitation had a 25% 1-year mortality rate, compared with a 21% rate among patients who had no regurgitation flowing TAVR, and compared with a 50% rate in the small number of patients who emerged from TAVR with severe regurgitation. Dr. Mohr did not say whether he applied statistical analysis to those 21% and 25% results to determine if it was a significant difference.

Back to the case, is that possible 4% absolute difference in 1-year mortality worth the risk of possible clinical complications that fiddling with the valve might cause and with no guarantee of getting an improved result? The interventionalists thought that in this patient, the answer was to leave well enough alone.

But in the bigger picture, the answer lies in better TAVR devices that produce higher rates of patients with no regurgitation. In the German registry using 2011 TAVR technology, 56% of the transvascular TAVR patients had mild aortic regurgitation after their procedure finished. Dr. Mohr said that rate was too high.

Also at EuroPCR was a report from Dr. Ian Meredith from Melbourne on 60 patients treated with a new TAVR system designed to allow easy repositioning of the valve. Also, surrounding the valve as it gets placed in the patient’s heart is a layer of something Dr. Meredith likened to cling wrap, to fill and seal the small crevices around the new valve. In 53 patients with 30-day follow-up, one patient (2%) had moderate regurgitation, 10 patients (19%) had mild regurgitation, 13 (25%) had trace regurgitation, and 29 (55%) had no regurgitation. If those rates hold up with wider and longer use, it would be an advance, though still room for further improvement. By comparison, typical reported rates using the approved Sapien TAVR device show 15% moderate or severe regurgitation at 30 days following TAVR, 45% mild, and less than 20% with none.

Is mild aortic regurgitation following transcatheter aortic valve replacement okay, or do patients face an unacceptably high risk for death when their procedure has that outcome?

That’s a question dogging transcatheter aortic valve replacement (TAVR) right now that will only get answered as more patients undergo TAVR and follow-up times increase. But it is also a question that probably comes up almost every day in cath labs performing TAVR.

Last month during EuroPCR, I heard the wrap-up for a just-completed TAVR case. After the replacement valve was placed, the patient had mild aortic regurgitation, and a key decision of the case was whether or not to try to fiddle with the valve to improve on that. Given the valvular calcification and the frailty of the patient, the physicians in the lab as well as those on the panel in the hall uniformly agreed that stopping at mild regurgitation was the best option for this case.

But hearing that, I also recalled the comment in March from Dr. Friederich-Wilhelm Mohr when he was reporting the most recent results from the German national TAVR registry. Dr. Mohr looked at the outcomes of patients with mild regurgitation and concluded that "regurgitation matters, whether is it mild or severe." In the German 1-year outcome results from nearly 2,700 patients who underwent transvascular TAVR, those who emerged with mild aortic regurgitation had a 25% 1-year mortality rate, compared with a 21% rate among patients who had no regurgitation flowing TAVR, and compared with a 50% rate in the small number of patients who emerged from TAVR with severe regurgitation. Dr. Mohr did not say whether he applied statistical analysis to those 21% and 25% results to determine if it was a significant difference.

Back to the case, is that possible 4% absolute difference in 1-year mortality worth the risk of possible clinical complications that fiddling with the valve might cause and with no guarantee of getting an improved result? The interventionalists thought that in this patient, the answer was to leave well enough alone.

But in the bigger picture, the answer lies in better TAVR devices that produce higher rates of patients with no regurgitation. In the German registry using 2011 TAVR technology, 56% of the transvascular TAVR patients had mild aortic regurgitation after their procedure finished. Dr. Mohr said that rate was too high.

Also at EuroPCR was a report from Dr. Ian Meredith from Melbourne on 60 patients treated with a new TAVR system designed to allow easy repositioning of the valve. Also, surrounding the valve as it gets placed in the patient’s heart is a layer of something Dr. Meredith likened to cling wrap, to fill and seal the small crevices around the new valve. In 53 patients with 30-day follow-up, one patient (2%) had moderate regurgitation, 10 patients (19%) had mild regurgitation, 13 (25%) had trace regurgitation, and 29 (55%) had no regurgitation. If those rates hold up with wider and longer use, it would be an advance, though still room for further improvement. By comparison, typical reported rates using the approved Sapien TAVR device show 15% moderate or severe regurgitation at 30 days following TAVR, 45% mild, and less than 20% with none.

The panel of cardiologists who revised U.S. competency standards for coronary interventionalists acknowledged prevailing case-volume realities and cut the minimum number of cases recommended for active operators to 50 per year, down from a long-standing recommendation of 75 coronary interventions annually.

The Clinical Competence and Training Task Force, assembled by the American College of Cardiology, the American Heart Association, and the Society for Cardiovascular Angiography and Interventions (SCAI), also made the linked change of halving prior recommended coronary case volumes for catheterization-laboratory centers, with a new recommended minimum target of 200 cases per year per site, down from the 400 annual cases called for in the 2007 version of the clinical competence statement for cardiac interventions.

The 2013 revision, with a focus specifically on coronary-artery interventions, appeared online on the websites of all three organizations (J. Am. Coll. Cardiol. 2013 [doi:10.1016/j.jacc.2013.05.002]).

Although the revised case numbers will likely be what first captures the attention, these changes were not the most central to the new revision, said Dr. Theodore A. Bass, professor and chief of cardiology at the University of Florida, Jacksonville, and vice chair of the task force. He focused on the diverse, 35-item list of core competency components that is the backbone of the new revision.

"It’s a much broader view of what competency involves," he said in an interview. "In the past, competency was taking an exam, or having a certain knowledge base. But now we realize that other skills are also extremely important," such as appropriate patient selection, using technologies in a safe and appropriate manner, and delivering patient-centered care, said Dr. Bass, president-elect of SCAI.

The new statement "is the first cardiovascular competency statement to fully utilize the six-domains structure promulgated by the Accreditation Council of Graduate Medical Education and adopted and endorsed by the American Board of Internal Medicine," Dr. John Gordon Harold, chair of the writing committee, said in a written statement.

"It goes beyond medical knowledge and procedure performance to include the important issues of leading an interdisciplinary team, working in a complex system, communicating effectively, engaging in continuous quality improvement at individual and system levels, adhering to evidence-based medicine, and demonstrating the highest levels of professionalism," said Dr. Harold, who is also ACC president and a cardiologist at Cedars-Sinai Heart Institute in Los Angeles.

Although the new statement is wide ranging, the case-number issue stands out as something the task force worked on at length, with a quarter of the statement devoted to various aspects of the issue for both individual operators and for cath labs.

"Volume has been used as a surrogate for quality because it measurable, but there has never been clear data that there is a strong correlation," said Dr. Bass. Plus, the original individual volume number, the venerable figure of 75 cases per year that has been around since at least 1990, when it appeared in the first clinical competency statement, "was not data based; it was judgment based," he noted. "Volume is not the be all and end all. We thought that 100 cases over 2 years seemed in the sweet spot for all considerations."

"Low-volume operators can self- restrict what they do and get very good outcomes with less volume," said Dr. Christopher J. White, professor and chair for cardiovascular diseases at the Ochsner Clinic, New Orleans, and a member of the task force. "Rather than use an arbitrary volume as a surrogate for quality, it is more useful to actually measure quality, with a tool like the NCDR [National Cardiovascular Data Registry] for CathPCI."

Another issue is the feasibility of calling for annual rates of 75 cases individually and 400 per center, given recent trends with substantially fewer U.S. percutaneous coronary interventions (PCI), compared with the mid-2000s, and the growing number of interventionalists. The statement notes that "a majority of interventional cardiologists in the United States are not achieving the previously recommended threshold of 75 PCIs annually."

Also, these days most interventional cardiologists perform other types of procedures that may not count as PCIs but still keep their skills sharp – things like peripheral vascular procedures, carotid stenting, and trans- catheter aortic valve replacements, Dr. Bass said. And there is the issue of society’s need to have important acute care services like primary PCI for myocardial infarctions available in even remote areas, where higher case volumes are hard to maintain.

"Cath labs with fewer than 200 cases per year should examine what they do and have stringent quality assurance measures in place," he said.

Two other notable changes in the 2013 competency revision are the inclusion for the first time of radial-artery access as an identified competency. Radial access "is still just under 20% of all U.S. PCI, but that’s up exponentially from a few years ago," Dr. Bass said. "There is a huge amount of patient preference for it, and the next generation is now trained in it. Radial access is the future."

The new revision focused exclusively on coronary artery interventions, with other common cardiac percutaneous procedures like valvuloplasty on hold for a different competency task force that will deal with structural and noncoronary interventions, Dr. Bass said.

Dr. Bass, Dr. Harold, and Dr. White had no relevant disclosures.

mzoler@frontlinemedcom.com

The panel of cardiologists who revised U.S. competency standards for coronary interventionalists acknowledged prevailing case-volume realities and cut the minimum number of cases recommended for active operators to 50 per year, down from a long-standing recommendation of 75 coronary interventions annually.

The Clinical Competence and Training Task Force, assembled by the American College of Cardiology, the American Heart Association, and the Society for Cardiovascular Angiography and Interventions (SCAI), also made the linked change of halving prior recommended coronary case volumes for catheterization-laboratory centers, with a new recommended minimum target of 200 cases per year per site, down from the 400 annual cases called for in the 2007 version of the clinical competence statement for cardiac interventions.

The 2013 revision, with a focus specifically on coronary-artery interventions, appeared online on the websites of all three organizations (J. Am. Coll. Cardiol. 2013 [doi:10.1016/j.jacc.2013.05.002]).

Although the revised case numbers will likely be what first captures the attention, these changes were not the most central to the new revision, said Dr. Theodore A. Bass, professor and chief of cardiology at the University of Florida, Jacksonville, and vice chair of the task force. He focused on the diverse, 35-item list of core competency components that is the backbone of the new revision.

"It’s a much broader view of what competency involves," he said in an interview. "In the past, competency was taking an exam, or having a certain knowledge base. But now we realize that other skills are also extremely important," such as appropriate patient selection, using technologies in a safe and appropriate manner, and delivering patient-centered care, said Dr. Bass, president-elect of SCAI.

The new statement "is the first cardiovascular competency statement to fully utilize the six-domains structure promulgated by the Accreditation Council of Graduate Medical Education and adopted and endorsed by the American Board of Internal Medicine," Dr. John Gordon Harold, chair of the writing committee, said in a written statement.

"It goes beyond medical knowledge and procedure performance to include the important issues of leading an interdisciplinary team, working in a complex system, communicating effectively, engaging in continuous quality improvement at individual and system levels, adhering to evidence-based medicine, and demonstrating the highest levels of professionalism," said Dr. Harold, who is also ACC president and a cardiologist at Cedars-Sinai Heart Institute in Los Angeles.

Although the new statement is wide ranging, the case-number issue stands out as something the task force worked on at length, with a quarter of the statement devoted to various aspects of the issue for both individual operators and for cath labs.

"Volume has been used as a surrogate for quality because it measurable, but there has never been clear data that there is a strong correlation," said Dr. Bass. Plus, the original individual volume number, the venerable figure of 75 cases per year that has been around since at least 1990, when it appeared in the first clinical competency statement, "was not data based; it was judgment based," he noted. "Volume is not the be all and end all. We thought that 100 cases over 2 years seemed in the sweet spot for all considerations."

"Low-volume operators can self- restrict what they do and get very good outcomes with less volume," said Dr. Christopher J. White, professor and chair for cardiovascular diseases at the Ochsner Clinic, New Orleans, and a member of the task force. "Rather than use an arbitrary volume as a surrogate for quality, it is more useful to actually measure quality, with a tool like the NCDR [National Cardiovascular Data Registry] for CathPCI."

Another issue is the feasibility of calling for annual rates of 75 cases individually and 400 per center, given recent trends with substantially fewer U.S. percutaneous coronary interventions (PCI), compared with the mid-2000s, and the growing number of interventionalists. The statement notes that "a majority of interventional cardiologists in the United States are not achieving the previously recommended threshold of 75 PCIs annually."

Also, these days most interventional cardiologists perform other types of procedures that may not count as PCIs but still keep their skills sharp – things like peripheral vascular procedures, carotid stenting, and trans- catheter aortic valve replacements, Dr. Bass said. And there is the issue of society’s need to have important acute care services like primary PCI for myocardial infarctions available in even remote areas, where higher case volumes are hard to maintain.

"Cath labs with fewer than 200 cases per year should examine what they do and have stringent quality assurance measures in place," he said.

Two other notable changes in the 2013 competency revision are the inclusion for the first time of radial-artery access as an identified competency. Radial access "is still just under 20% of all U.S. PCI, but that’s up exponentially from a few years ago," Dr. Bass said. "There is a huge amount of patient preference for it, and the next generation is now trained in it. Radial access is the future."

The new revision focused exclusively on coronary artery interventions, with other common cardiac percutaneous procedures like valvuloplasty on hold for a different competency task force that will deal with structural and noncoronary interventions, Dr. Bass said.

Dr. Bass, Dr. Harold, and Dr. White had no relevant disclosures.

mzoler@frontlinemedcom.com

The panel of cardiologists who revised U.S. competency standards for coronary interventionalists acknowledged prevailing case-volume realities and cut the minimum number of cases recommended for active operators to 50 per year, down from a long-standing recommendation of 75 coronary interventions annually.

The Clinical Competence and Training Task Force, assembled by the American College of Cardiology, the American Heart Association, and the Society for Cardiovascular Angiography and Interventions (SCAI), also made the linked change of halving prior recommended coronary case volumes for catheterization-laboratory centers, with a new recommended minimum target of 200 cases per year per site, down from the 400 annual cases called for in the 2007 version of the clinical competence statement for cardiac interventions.

The 2013 revision, with a focus specifically on coronary-artery interventions, appeared online on the websites of all three organizations (J. Am. Coll. Cardiol. 2013 [doi:10.1016/j.jacc.2013.05.002]).

Although the revised case numbers will likely be what first captures the attention, these changes were not the most central to the new revision, said Dr. Theodore A. Bass, professor and chief of cardiology at the University of Florida, Jacksonville, and vice chair of the task force. He focused on the diverse, 35-item list of core competency components that is the backbone of the new revision.

"It’s a much broader view of what competency involves," he said in an interview. "In the past, competency was taking an exam, or having a certain knowledge base. But now we realize that other skills are also extremely important," such as appropriate patient selection, using technologies in a safe and appropriate manner, and delivering patient-centered care, said Dr. Bass, president-elect of SCAI.

The new statement "is the first cardiovascular competency statement to fully utilize the six-domains structure promulgated by the Accreditation Council of Graduate Medical Education and adopted and endorsed by the American Board of Internal Medicine," Dr. John Gordon Harold, chair of the writing committee, said in a written statement.

"It goes beyond medical knowledge and procedure performance to include the important issues of leading an interdisciplinary team, working in a complex system, communicating effectively, engaging in continuous quality improvement at individual and system levels, adhering to evidence-based medicine, and demonstrating the highest levels of professionalism," said Dr. Harold, who is also ACC president and a cardiologist at Cedars-Sinai Heart Institute in Los Angeles.

Although the new statement is wide ranging, the case-number issue stands out as something the task force worked on at length, with a quarter of the statement devoted to various aspects of the issue for both individual operators and for cath labs.

"Volume has been used as a surrogate for quality because it measurable, but there has never been clear data that there is a strong correlation," said Dr. Bass. Plus, the original individual volume number, the venerable figure of 75 cases per year that has been around since at least 1990, when it appeared in the first clinical competency statement, "was not data based; it was judgment based," he noted. "Volume is not the be all and end all. We thought that 100 cases over 2 years seemed in the sweet spot for all considerations."

"Low-volume operators can self- restrict what they do and get very good outcomes with less volume," said Dr. Christopher J. White, professor and chair for cardiovascular diseases at the Ochsner Clinic, New Orleans, and a member of the task force. "Rather than use an arbitrary volume as a surrogate for quality, it is more useful to actually measure quality, with a tool like the NCDR [National Cardiovascular Data Registry] for CathPCI."

Another issue is the feasibility of calling for annual rates of 75 cases individually and 400 per center, given recent trends with substantially fewer U.S. percutaneous coronary interventions (PCI), compared with the mid-2000s, and the growing number of interventionalists. The statement notes that "a majority of interventional cardiologists in the United States are not achieving the previously recommended threshold of 75 PCIs annually."

Also, these days most interventional cardiologists perform other types of procedures that may not count as PCIs but still keep their skills sharp – things like peripheral vascular procedures, carotid stenting, and trans- catheter aortic valve replacements, Dr. Bass said. And there is the issue of society’s need to have important acute care services like primary PCI for myocardial infarctions available in even remote areas, where higher case volumes are hard to maintain.

"Cath labs with fewer than 200 cases per year should examine what they do and have stringent quality assurance measures in place," he said.

Two other notable changes in the 2013 competency revision are the inclusion for the first time of radial-artery access as an identified competency. Radial access "is still just under 20% of all U.S. PCI, but that’s up exponentially from a few years ago," Dr. Bass said. "There is a huge amount of patient preference for it, and the next generation is now trained in it. Radial access is the future."

The new revision focused exclusively on coronary artery interventions, with other common cardiac percutaneous procedures like valvuloplasty on hold for a different competency task force that will deal with structural and noncoronary interventions, Dr. Bass said.

Dr. Bass, Dr. Harold, and Dr. White had no relevant disclosures.

mzoler@frontlinemedcom.com

PARIS – Pressure wire assessment of ischemia in patients with stable angina changed the management strategy for these patients 27% of the time compared with decisions based solely on coronary anatomy information from angiography, in a prospective, multicenter British study with 200 patients.

Basing management of patients with stable angina on an angiogram alone is a "flawed" strategy, Dr. Nick Curzen said at the annual congress of the European Association of Percutaneous Cardiovascular Intervention. "Management of patients would be improved by routine use of fractional flow reserve [FFR] assessment at the diagnostic stage," he said.

Mitchel L. Zoler/IMNG Medical Media

Dr. Curzen stressed that this was a pilot study, and said that he is now trying to gather the funding needed to start a large-scale randomized trial to compare management decisions made with angiography alone with those made by routine ischemia assessment using a pressure wire to measure FFR throughout the main coronary branches of patients with stable angina suspected to be of coronary origin. Another limitation of the current results is "we have no idea whether this approach will be cost effective," he said.

Although results from three prior studies – DEFER (J. Am Coll. Cardiol. 2007;49:2105-11), FAME (N. Engl. J. Med. 2009;360:213-24), and FAME 2 (N. Engl. J. Med. 2012;367:991-1001) – together established definitively that measuring FFR with a pressure wire benefited patients by allowing interventionalists to identify clinically important coronary stenoses during percutaneous coronary intervention (PCI), the new study moved the time of pressure wire use earlier in the course of patient management.

"We pushed the time for FFR back to the diagnostic stage, not during PCI itself," said Dr. Curzen, professor of interventional cardiology at the University Hospital in Southampton (England)."The limitation of prior studies is that they did not take into account the options of medical management or coronary artery bypass grafting."

"This is a very, very important study. So far, measurement of fractional flow reserve has only been in patients already committed to undergoing PCI. But these data suggest that adding a pressure wire assessment at the diagnostic stage is potentially disruptive for current practice, it could potentially be very important for allocating resources, it may reduce the need for noninvasive testing, and it may also improve outcomes. I’m a big believer in the importance of ischemia," commented Dr. William Wijns, codirector of the cardiovascular center at OLV Hospital in Aalst, Belgium.

"We now need results from a prospective study to establish a link between this approach and improved outcomes," Dr. Wijns added.

The RIPCORD (Does Routine Pressure Wire Assessment Influence Management Strategy at Coronary Angiography for Diagnosis of Chest Pain?) study enrolled 200 stable angina patients at 10 British centers. All patients underwent diagnostic angiography, and then the cardiologists recorded their treatment recommendation based on the anatomic information only, choosing among medical treatment, PCI, coronary bypass surgery, or need for additional, noninvasive testing, usually an exercise stress test. While the patients remained in the catheterization laboratory, they underwent pressure wire assessment for ischemia. Those findings were presented to the cardiologist, who could then change the initially recommended treatment if necessary based on this additional information.

Taking the FFR information into account changed recommended management for 53 of the 200 patients (27%). The changes led to more aggressive management in some patients and less aggressive treatments for others. For example, among the 90 patients initially flagged for PCI on the basis of their coronary anatomy, the attending cardiologists changed their recommendations to medical management for 24 patients after they found that none of the coronary lesions in these 24 patients caused clinically significant ischemia. On the other hand, among the 72 patients initially slotted for medical management based on their angiogram, the cardiologists found 9 patients whom they realized needed revascularization with PCI (6 patients) or coronary surgery (3 patients), Dr. Curzen reported.

Another result from the FFR assessment was a sharp drop in the number of patients with ambiguous results who required further testing. The number of cases that the cardiologists felt needed further testing dropped from 15 after angiography alone to a single patient once the FFR results were also available.

The study’s secondary endpoint was the change in the number of coronaries identified within each patient with significant stenoses that required treatment. Adding in the FFR information changed this designation for 64 of the 200 patients (32%). For example, angiography identified 84 patients with single-vessel disease, but with the pressure wire results, 24 of these patients were downgraded to having no affected coronary arteries, 6 patients got upgraded to having two-vessel disease, and an additional patient was identified with significant left-main disease that had been missed by angiography.

The study received an unrestricted research grant from St. Jude, which markets a pressure wire (PressureWire). Dr. Curzen said he has been a speaker on behalf of, and a consultant to, St. Jude, but was not reimbursed for the current study. Dr. Wijns said he has received honoraria and research grants from several drug and device companies, but had no disclosures related to St. Jude.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

PARIS – Pressure wire assessment of ischemia in patients with stable angina changed the management strategy for these patients 27% of the time compared with decisions based solely on coronary anatomy information from angiography, in a prospective, multicenter British study with 200 patients.

Basing management of patients with stable angina on an angiogram alone is a "flawed" strategy, Dr. Nick Curzen said at the annual congress of the European Association of Percutaneous Cardiovascular Intervention. "Management of patients would be improved by routine use of fractional flow reserve [FFR] assessment at the diagnostic stage," he said.

Mitchel L. Zoler/IMNG Medical Media

Dr. Curzen stressed that this was a pilot study, and said that he is now trying to gather the funding needed to start a large-scale randomized trial to compare management decisions made with angiography alone with those made by routine ischemia assessment using a pressure wire to measure FFR throughout the main coronary branches of patients with stable angina suspected to be of coronary origin. Another limitation of the current results is "we have no idea whether this approach will be cost effective," he said.

Although results from three prior studies – DEFER (J. Am Coll. Cardiol. 2007;49:2105-11), FAME (N. Engl. J. Med. 2009;360:213-24), and FAME 2 (N. Engl. J. Med. 2012;367:991-1001) – together established definitively that measuring FFR with a pressure wire benefited patients by allowing interventionalists to identify clinically important coronary stenoses during percutaneous coronary intervention (PCI), the new study moved the time of pressure wire use earlier in the course of patient management.

"We pushed the time for FFR back to the diagnostic stage, not during PCI itself," said Dr. Curzen, professor of interventional cardiology at the University Hospital in Southampton (England)."The limitation of prior studies is that they did not take into account the options of medical management or coronary artery bypass grafting."

"This is a very, very important study. So far, measurement of fractional flow reserve has only been in patients already committed to undergoing PCI. But these data suggest that adding a pressure wire assessment at the diagnostic stage is potentially disruptive for current practice, it could potentially be very important for allocating resources, it may reduce the need for noninvasive testing, and it may also improve outcomes. I’m a big believer in the importance of ischemia," commented Dr. William Wijns, codirector of the cardiovascular center at OLV Hospital in Aalst, Belgium.

"We now need results from a prospective study to establish a link between this approach and improved outcomes," Dr. Wijns added.

The RIPCORD (Does Routine Pressure Wire Assessment Influence Management Strategy at Coronary Angiography for Diagnosis of Chest Pain?) study enrolled 200 stable angina patients at 10 British centers. All patients underwent diagnostic angiography, and then the cardiologists recorded their treatment recommendation based on the anatomic information only, choosing among medical treatment, PCI, coronary bypass surgery, or need for additional, noninvasive testing, usually an exercise stress test. While the patients remained in the catheterization laboratory, they underwent pressure wire assessment for ischemia. Those findings were presented to the cardiologist, who could then change the initially recommended treatment if necessary based on this additional information.

Taking the FFR information into account changed recommended management for 53 of the 200 patients (27%). The changes led to more aggressive management in some patients and less aggressive treatments for others. For example, among the 90 patients initially flagged for PCI on the basis of their coronary anatomy, the attending cardiologists changed their recommendations to medical management for 24 patients after they found that none of the coronary lesions in these 24 patients caused clinically significant ischemia. On the other hand, among the 72 patients initially slotted for medical management based on their angiogram, the cardiologists found 9 patients whom they realized needed revascularization with PCI (6 patients) or coronary surgery (3 patients), Dr. Curzen reported.

Another result from the FFR assessment was a sharp drop in the number of patients with ambiguous results who required further testing. The number of cases that the cardiologists felt needed further testing dropped from 15 after angiography alone to a single patient once the FFR results were also available.

The study’s secondary endpoint was the change in the number of coronaries identified within each patient with significant stenoses that required treatment. Adding in the FFR information changed this designation for 64 of the 200 patients (32%). For example, angiography identified 84 patients with single-vessel disease, but with the pressure wire results, 24 of these patients were downgraded to having no affected coronary arteries, 6 patients got upgraded to having two-vessel disease, and an additional patient was identified with significant left-main disease that had been missed by angiography.

The study received an unrestricted research grant from St. Jude, which markets a pressure wire (PressureWire). Dr. Curzen said he has been a speaker on behalf of, and a consultant to, St. Jude, but was not reimbursed for the current study. Dr. Wijns said he has received honoraria and research grants from several drug and device companies, but had no disclosures related to St. Jude.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

PARIS – Pressure wire assessment of ischemia in patients with stable angina changed the management strategy for these patients 27% of the time compared with decisions based solely on coronary anatomy information from angiography, in a prospective, multicenter British study with 200 patients.

Basing management of patients with stable angina on an angiogram alone is a "flawed" strategy, Dr. Nick Curzen said at the annual congress of the European Association of Percutaneous Cardiovascular Intervention. "Management of patients would be improved by routine use of fractional flow reserve [FFR] assessment at the diagnostic stage," he said.

Mitchel L. Zoler/IMNG Medical Media

Dr. Curzen stressed that this was a pilot study, and said that he is now trying to gather the funding needed to start a large-scale randomized trial to compare management decisions made with angiography alone with those made by routine ischemia assessment using a pressure wire to measure FFR throughout the main coronary branches of patients with stable angina suspected to be of coronary origin. Another limitation of the current results is "we have no idea whether this approach will be cost effective," he said.

Although results from three prior studies – DEFER (J. Am Coll. Cardiol. 2007;49:2105-11), FAME (N. Engl. J. Med. 2009;360:213-24), and FAME 2 (N. Engl. J. Med. 2012;367:991-1001) – together established definitively that measuring FFR with a pressure wire benefited patients by allowing interventionalists to identify clinically important coronary stenoses during percutaneous coronary intervention (PCI), the new study moved the time of pressure wire use earlier in the course of patient management.

"We pushed the time for FFR back to the diagnostic stage, not during PCI itself," said Dr. Curzen, professor of interventional cardiology at the University Hospital in Southampton (England)."The limitation of prior studies is that they did not take into account the options of medical management or coronary artery bypass grafting."

"This is a very, very important study. So far, measurement of fractional flow reserve has only been in patients already committed to undergoing PCI. But these data suggest that adding a pressure wire assessment at the diagnostic stage is potentially disruptive for current practice, it could potentially be very important for allocating resources, it may reduce the need for noninvasive testing, and it may also improve outcomes. I’m a big believer in the importance of ischemia," commented Dr. William Wijns, codirector of the cardiovascular center at OLV Hospital in Aalst, Belgium.

"We now need results from a prospective study to establish a link between this approach and improved outcomes," Dr. Wijns added.

The RIPCORD (Does Routine Pressure Wire Assessment Influence Management Strategy at Coronary Angiography for Diagnosis of Chest Pain?) study enrolled 200 stable angina patients at 10 British centers. All patients underwent diagnostic angiography, and then the cardiologists recorded their treatment recommendation based on the anatomic information only, choosing among medical treatment, PCI, coronary bypass surgery, or need for additional, noninvasive testing, usually an exercise stress test. While the patients remained in the catheterization laboratory, they underwent pressure wire assessment for ischemia. Those findings were presented to the cardiologist, who could then change the initially recommended treatment if necessary based on this additional information.

Taking the FFR information into account changed recommended management for 53 of the 200 patients (27%). The changes led to more aggressive management in some patients and less aggressive treatments for others. For example, among the 90 patients initially flagged for PCI on the basis of their coronary anatomy, the attending cardiologists changed their recommendations to medical management for 24 patients after they found that none of the coronary lesions in these 24 patients caused clinically significant ischemia. On the other hand, among the 72 patients initially slotted for medical management based on their angiogram, the cardiologists found 9 patients whom they realized needed revascularization with PCI (6 patients) or coronary surgery (3 patients), Dr. Curzen reported.

Another result from the FFR assessment was a sharp drop in the number of patients with ambiguous results who required further testing. The number of cases that the cardiologists felt needed further testing dropped from 15 after angiography alone to a single patient once the FFR results were also available.

The study’s secondary endpoint was the change in the number of coronaries identified within each patient with significant stenoses that required treatment. Adding in the FFR information changed this designation for 64 of the 200 patients (32%). For example, angiography identified 84 patients with single-vessel disease, but with the pressure wire results, 24 of these patients were downgraded to having no affected coronary arteries, 6 patients got upgraded to having two-vessel disease, and an additional patient was identified with significant left-main disease that had been missed by angiography.

The study received an unrestricted research grant from St. Jude, which markets a pressure wire (PressureWire). Dr. Curzen said he has been a speaker on behalf of, and a consultant to, St. Jude, but was not reimbursed for the current study. Dr. Wijns said he has received honoraria and research grants from several drug and device companies, but had no disclosures related to St. Jude.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

PARIS – Heparin treatment may produce survival rates that rival those seen in treatment with bivalirudin in patients with non–ST-elevation acute coronary syndrome undergoing percutaneous coronary intervention, based on analysis of data from more than 40,000 patients collected in a nationwide Swedish registry.

The new finding “questions the superiority of bivalirudin over heparin in the absence of glycoprotein IIb/IIIa blockade” in these patients and produced some doubt about the need for the extra expense of using bivalirudin (Angiomax) to treat these patients, Dr. Oskar Angerås said at the annual meeting of the European Association of Percutaneous Coronary Interventions. The finding prompted him recently to shift his practice and treat non–ST-elevation acute coronary syndrome (NSTE-ACS) with heparin rather than bivalirudin when performing percutaneous coronary intervention (PCI), he said in an interview. It also led him and his associates to plan to soon start a randomized, controlled trial to compare the two treatment options in about 6,000 Swedish patients, a study he hopes will definitely address this issue.

Mitchel L. Zoler/IMNG Medical Media

Bivalirudin was the highest-rated anticoagulant for use during PCI in the most recent, 2011 guidelines of American College of Cardiology and American Heart Association (J. Am. Coll. Cardiol. 2011;58:e44-e122), while the European Society of Cardiology’s most recent guidelines on managing patients with NTSE-ACS rated fondaparinux (Arixtra) as the top anticoagulant and put bivalirudin, unfractionated heparin, and low-molecular-weight heparin on equal footing a step below fondaparinux (Eur. Heart J. 2011;32:2999-305zz4).

The role of bivalirudin in this setting largely stems from results of the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial (N. Engl. J. Med. 2006;355:2203-16), but the trial has reduced relevance today because of several changes in practice since then, said Dr. Angerås , an interventional cardiologist at Sahlgrenska University Hospital in Gothenburg, Sweden. In ACUITY, all patients received a glycoprotein IIb/IIIa inhibitor, a drug class now infrequently used in these patients. Fewer than 60% of ACUITY patients underwent PCI, fewer than 60% were biomarker positive, and among those who did receive a coronary stent only 6% had their intervention done via radial-artery access, “quite different from our daily practice” today, he said.

Two other published studies also compared bivalirudin and heparin, the Hirulog Angioplasty Study (N. Engl. J. Med. 1995;333:764-9), and the Intracoronary Stenting and Antithrombosis Regimen: Rapid Early Action for Coronary Treatment (ISAR-REACT) 3 trial (N. Engl. J. Med. 2008;359:688-96), but both of those studies only found a difference in bleeding complications in favor of bivalirudin, but no mortality difference between the drugs, he noted.

To assess the impact of the two alternatives on patient survival in more contemporary practice, Dr. Angerås and his associates 41,537 consecutive NSTE-ACS patients who underwent PCI without use of a glycoprotein IIb/IIIa inhibitor at any of the 28 Swedish centers that participate in the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) during 2006-2011. The patients averaged about 68 years of age, about 75% were biomarker positive, and about 47% underwent PCI using a radial-artery approach. Nearly 27,000 of these patients received heparin, either in the unfractionated or low-molecular weight form, and about 8,700 received bivalirudin. Data on anticoagulant use were not available for about 6,000 patients.

Among the roughly 35,000 patients with known anticoagulant treatment, those who received bivalirudin had a statistically significant 50% increased 30-day mortality rate, compared with those who receive heparin. After the researchers did a series of statistical adjustments to control for both known and unknown confounders, the mortality rates in the heparin and bivalirudin subgroups became roughly similar, without a statistically significant difference, Dr. Angerås reported. The researchers saw similar mortality rates, regardless of the anticoagulant used; the patient’s age, sex, PCI access site; or the presence or absence of diabetes. The registry data also showed no statistically significant difference in bleeding episodes between the heparin- and bivalirudin-treated patients, but Dr. Angerås said that information on bleeding was not available for all of the years included in the analysis.

Patients who receive heparin and bivalirudin “are two different groups,” commented Dr. Andreas Baumbach, an interventional cardiologist at the Bristol (England) Heart Institute and designated discussant for the study. “It’s no surprise to me that in the group that I would consider to have higher risk,” the patients who received bivalirudin “had more endpoints. When you do all the statistical analysis and make the two groups equal by risk, then you see no difference.”

Dr. Angerås agreed. “We are very cautious about our conclusion,” and he stressed that the issue will not be clearly settled until results from the randomized, controlled study are available.

He also said that he found the result surprising, especially because until recently bivalirudin had been his anticoagulant of choice. Now that he has switched to more routinely using heparin, he has channeled the money he saves on each case into more liberal use of drug-eluting coronary stents in these patients. “Our drug-eluting stent use has risen from about 30% of patients to about 80%,” Dr. Angerås said in an interview. He also acknowledged that bleeding is not a benign complication, but added that bleeding is a surrogate endpoint with less clinical importance if it doesn’t produce increased mortality, and that in the data he reported bleeding rates were roughly equal between the bivalirudin and heparin subgroups.

Dr. Angerås said that he had no disclosures. Dr. Baumbach said that he has received research support from the Medicines Company, which markets bivalirudin (Angiomax).

mzoler@frontlinemedcom.com

PARIS – Heparin treatment may produce survival rates that rival those seen in treatment with bivalirudin in patients with non–ST-elevation acute coronary syndrome undergoing percutaneous coronary intervention, based on analysis of data from more than 40,000 patients collected in a nationwide Swedish registry.

The new finding “questions the superiority of bivalirudin over heparin in the absence of glycoprotein IIb/IIIa blockade” in these patients and produced some doubt about the need for the extra expense of using bivalirudin (Angiomax) to treat these patients, Dr. Oskar Angerås said at the annual meeting of the European Association of Percutaneous Coronary Interventions. The finding prompted him recently to shift his practice and treat non–ST-elevation acute coronary syndrome (NSTE-ACS) with heparin rather than bivalirudin when performing percutaneous coronary intervention (PCI), he said in an interview. It also led him and his associates to plan to soon start a randomized, controlled trial to compare the two treatment options in about 6,000 Swedish patients, a study he hopes will definitely address this issue.

Mitchel L. Zoler/IMNG Medical Media

Bivalirudin was the highest-rated anticoagulant for use during PCI in the most recent, 2011 guidelines of American College of Cardiology and American Heart Association (J. Am. Coll. Cardiol. 2011;58:e44-e122), while the European Society of Cardiology’s most recent guidelines on managing patients with NTSE-ACS rated fondaparinux (Arixtra) as the top anticoagulant and put bivalirudin, unfractionated heparin, and low-molecular-weight heparin on equal footing a step below fondaparinux (Eur. Heart J. 2011;32:2999-305zz4).

The role of bivalirudin in this setting largely stems from results of the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial (N. Engl. J. Med. 2006;355:2203-16), but the trial has reduced relevance today because of several changes in practice since then, said Dr. Angerås , an interventional cardiologist at Sahlgrenska University Hospital in Gothenburg, Sweden. In ACUITY, all patients received a glycoprotein IIb/IIIa inhibitor, a drug class now infrequently used in these patients. Fewer than 60% of ACUITY patients underwent PCI, fewer than 60% were biomarker positive, and among those who did receive a coronary stent only 6% had their intervention done via radial-artery access, “quite different from our daily practice” today, he said.

Two other published studies also compared bivalirudin and heparin, the Hirulog Angioplasty Study (N. Engl. J. Med. 1995;333:764-9), and the Intracoronary Stenting and Antithrombosis Regimen: Rapid Early Action for Coronary Treatment (ISAR-REACT) 3 trial (N. Engl. J. Med. 2008;359:688-96), but both of those studies only found a difference in bleeding complications in favor of bivalirudin, but no mortality difference between the drugs, he noted.

To assess the impact of the two alternatives on patient survival in more contemporary practice, Dr. Angerås and his associates 41,537 consecutive NSTE-ACS patients who underwent PCI without use of a glycoprotein IIb/IIIa inhibitor at any of the 28 Swedish centers that participate in the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) during 2006-2011. The patients averaged about 68 years of age, about 75% were biomarker positive, and about 47% underwent PCI using a radial-artery approach. Nearly 27,000 of these patients received heparin, either in the unfractionated or low-molecular weight form, and about 8,700 received bivalirudin. Data on anticoagulant use were not available for about 6,000 patients.

Among the roughly 35,000 patients with known anticoagulant treatment, those who received bivalirudin had a statistically significant 50% increased 30-day mortality rate, compared with those who receive heparin. After the researchers did a series of statistical adjustments to control for both known and unknown confounders, the mortality rates in the heparin and bivalirudin subgroups became roughly similar, without a statistically significant difference, Dr. Angerås reported. The researchers saw similar mortality rates, regardless of the anticoagulant used; the patient’s age, sex, PCI access site; or the presence or absence of diabetes. The registry data also showed no statistically significant difference in bleeding episodes between the heparin- and bivalirudin-treated patients, but Dr. Angerås said that information on bleeding was not available for all of the years included in the analysis.

Patients who receive heparin and bivalirudin “are two different groups,” commented Dr. Andreas Baumbach, an interventional cardiologist at the Bristol (England) Heart Institute and designated discussant for the study. “It’s no surprise to me that in the group that I would consider to have higher risk,” the patients who received bivalirudin “had more endpoints. When you do all the statistical analysis and make the two groups equal by risk, then you see no difference.”

Dr. Angerås agreed. “We are very cautious about our conclusion,” and he stressed that the issue will not be clearly settled until results from the randomized, controlled study are available.

He also said that he found the result surprising, especially because until recently bivalirudin had been his anticoagulant of choice. Now that he has switched to more routinely using heparin, he has channeled the money he saves on each case into more liberal use of drug-eluting coronary stents in these patients. “Our drug-eluting stent use has risen from about 30% of patients to about 80%,” Dr. Angerås said in an interview. He also acknowledged that bleeding is not a benign complication, but added that bleeding is a surrogate endpoint with less clinical importance if it doesn’t produce increased mortality, and that in the data he reported bleeding rates were roughly equal between the bivalirudin and heparin subgroups.

Dr. Angerås said that he had no disclosures. Dr. Baumbach said that he has received research support from the Medicines Company, which markets bivalirudin (Angiomax).

mzoler@frontlinemedcom.com

PARIS – Heparin treatment may produce survival rates that rival those seen in treatment with bivalirudin in patients with non–ST-elevation acute coronary syndrome undergoing percutaneous coronary intervention, based on analysis of data from more than 40,000 patients collected in a nationwide Swedish registry.

The new finding “questions the superiority of bivalirudin over heparin in the absence of glycoprotein IIb/IIIa blockade” in these patients and produced some doubt about the need for the extra expense of using bivalirudin (Angiomax) to treat these patients, Dr. Oskar Angerås said at the annual meeting of the European Association of Percutaneous Coronary Interventions. The finding prompted him recently to shift his practice and treat non–ST-elevation acute coronary syndrome (NSTE-ACS) with heparin rather than bivalirudin when performing percutaneous coronary intervention (PCI), he said in an interview. It also led him and his associates to plan to soon start a randomized, controlled trial to compare the two treatment options in about 6,000 Swedish patients, a study he hopes will definitely address this issue.

Mitchel L. Zoler/IMNG Medical Media

Bivalirudin was the highest-rated anticoagulant for use during PCI in the most recent, 2011 guidelines of American College of Cardiology and American Heart Association (J. Am. Coll. Cardiol. 2011;58:e44-e122), while the European Society of Cardiology’s most recent guidelines on managing patients with NTSE-ACS rated fondaparinux (Arixtra) as the top anticoagulant and put bivalirudin, unfractionated heparin, and low-molecular-weight heparin on equal footing a step below fondaparinux (Eur. Heart J. 2011;32:2999-305zz4).

The role of bivalirudin in this setting largely stems from results of the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial (N. Engl. J. Med. 2006;355:2203-16), but the trial has reduced relevance today because of several changes in practice since then, said Dr. Angerås , an interventional cardiologist at Sahlgrenska University Hospital in Gothenburg, Sweden. In ACUITY, all patients received a glycoprotein IIb/IIIa inhibitor, a drug class now infrequently used in these patients. Fewer than 60% of ACUITY patients underwent PCI, fewer than 60% were biomarker positive, and among those who did receive a coronary stent only 6% had their intervention done via radial-artery access, “quite different from our daily practice” today, he said.

Two other published studies also compared bivalirudin and heparin, the Hirulog Angioplasty Study (N. Engl. J. Med. 1995;333:764-9), and the Intracoronary Stenting and Antithrombosis Regimen: Rapid Early Action for Coronary Treatment (ISAR-REACT) 3 trial (N. Engl. J. Med. 2008;359:688-96), but both of those studies only found a difference in bleeding complications in favor of bivalirudin, but no mortality difference between the drugs, he noted.

To assess the impact of the two alternatives on patient survival in more contemporary practice, Dr. Angerås and his associates 41,537 consecutive NSTE-ACS patients who underwent PCI without use of a glycoprotein IIb/IIIa inhibitor at any of the 28 Swedish centers that participate in the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) during 2006-2011. The patients averaged about 68 years of age, about 75% were biomarker positive, and about 47% underwent PCI using a radial-artery approach. Nearly 27,000 of these patients received heparin, either in the unfractionated or low-molecular weight form, and about 8,700 received bivalirudin. Data on anticoagulant use were not available for about 6,000 patients.

Among the roughly 35,000 patients with known anticoagulant treatment, those who received bivalirudin had a statistically significant 50% increased 30-day mortality rate, compared with those who receive heparin. After the researchers did a series of statistical adjustments to control for both known and unknown confounders, the mortality rates in the heparin and bivalirudin subgroups became roughly similar, without a statistically significant difference, Dr. Angerås reported. The researchers saw similar mortality rates, regardless of the anticoagulant used; the patient’s age, sex, PCI access site; or the presence or absence of diabetes. The registry data also showed no statistically significant difference in bleeding episodes between the heparin- and bivalirudin-treated patients, but Dr. Angerås said that information on bleeding was not available for all of the years included in the analysis.

Patients who receive heparin and bivalirudin “are two different groups,” commented Dr. Andreas Baumbach, an interventional cardiologist at the Bristol (England) Heart Institute and designated discussant for the study. “It’s no surprise to me that in the group that I would consider to have higher risk,” the patients who received bivalirudin “had more endpoints. When you do all the statistical analysis and make the two groups equal by risk, then you see no difference.”

Dr. Angerås agreed. “We are very cautious about our conclusion,” and he stressed that the issue will not be clearly settled until results from the randomized, controlled study are available.

He also said that he found the result surprising, especially because until recently bivalirudin had been his anticoagulant of choice. Now that he has switched to more routinely using heparin, he has channeled the money he saves on each case into more liberal use of drug-eluting coronary stents in these patients. “Our drug-eluting stent use has risen from about 30% of patients to about 80%,” Dr. Angerås said in an interview. He also acknowledged that bleeding is not a benign complication, but added that bleeding is a surrogate endpoint with less clinical importance if it doesn’t produce increased mortality, and that in the data he reported bleeding rates were roughly equal between the bivalirudin and heparin subgroups.

Dr. Angerås said that he had no disclosures. Dr. Baumbach said that he has received research support from the Medicines Company, which markets bivalirudin (Angiomax).

mzoler@frontlinemedcom.com

ROME – Young adults with congenital heart disease lose roughly 1% of their predicted exercise capacity each year, based on follow-up of more than 500 patients at one German center.

The "slow but persistent decline" in patients with congenital heart disease "exceeds the decline of reference values for age" compiled in 2009 from the general German population, Jan Müller, Ph.D., said at the annual meeting of the European Association for Cardiovascular Prevention and Rehabilitation*.

Results from prior, smaller studies also showed greater-than-expected progressive loss of exercise capacity in adults with congenital heart disease, but those had been smaller studies, and had not involved as diversified a range of congenital heart diseases as the new study. The 522 patients reviewed by Dr. Müller and his associates included 29% with pulmonary valve dysfunction and 26% with a left-ventricular outflow obstruction, congenital defects not previously covered in longitudinal reports on exercise capacity, said Dr. Müller, a researcher in sports science at the German Heart Center in Munich.

"We don’t know whether the rate of decline is prognostic, but we know that patients with lower exercise capacity have worse outcomes," he said in an interview. He also believes that these patients would benefit from a training-program intervention, but that has not yet been proven in a study.

Dr. Müller and his associates reviewed records from more than 5,000 cardiopulmonary exercise tests done on patients with congenital heart disease at the Heart Center between July 2001 and August 2012. The series included 522 patients who had serial, validated tests run at least 6 months apart and who did not undergo any medical or surgical intervention during the inter-test period. The average interval between the initial and subsequent test was about 2.5 years. The patients averaged about 25 years of age at baseline and about 27 years old at the time of their second test, and 59% were men.

The next most common congenital disorder following pulmonary valve dysfunction and left-ventricular outflow obstruction was need for arterial switch or congenitally corrected transposition of the great arteries, in 18%, followed by Fontan circulation in 11%, Epstein’s anomaly in 8%, and less common defects in the remaining patients.

Although the group overall lost an average of about 1% of their predicted peak oxygen uptake per year during follow-up, the rate of loss varied substantially by type of congenital defect. Patients with Epstein’s anomaly lost an average of 1.54% of predicted annually, those with a left-ventricular outflow obstruction averaged a 1.28% decline from predicted per year, and patients with pulmonary valve dysfunction averaged a 1.12% loss per year. Patients with lower than average annual loses included those with an arterial switch or transposition, with an average 0.67% loss per year, and patients with Fontan circulation, with an annual loss that averaged only 0.02%. Because exercise capacities were calculated as a percent of predicted values, they included adjustment for age, sex, weight, and height.

The analysis also showed other statistically significant functional declines in the entire group during follow-up, including an average annual fall of 0.76% in peak oxygen delivery per heartbeat, and a 1.49-beat/min decline in peak heart rate.

The rate of decline in exercise capacity was about the same regardless of patient age. And in a multivariate analysis, patients with a pacemaker were significantly more likely to have a larger average annual decline in exercise capacity, he said.

Dr. Müller said that he had no disclosures.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

*Correction, 5/29/2013: An earlier version of this story misstated the meeting name.

ROME – Young adults with congenital heart disease lose roughly 1% of their predicted exercise capacity each year, based on follow-up of more than 500 patients at one German center.

The "slow but persistent decline" in patients with congenital heart disease "exceeds the decline of reference values for age" compiled in 2009 from the general German population, Jan Müller, Ph.D., said at the annual meeting of the European Association for Cardiovascular Prevention and Rehabilitation*.

Results from prior, smaller studies also showed greater-than-expected progressive loss of exercise capacity in adults with congenital heart disease, but those had been smaller studies, and had not involved as diversified a range of congenital heart diseases as the new study. The 522 patients reviewed by Dr. Müller and his associates included 29% with pulmonary valve dysfunction and 26% with a left-ventricular outflow obstruction, congenital defects not previously covered in longitudinal reports on exercise capacity, said Dr. Müller, a researcher in sports science at the German Heart Center in Munich.

"We don’t know whether the rate of decline is prognostic, but we know that patients with lower exercise capacity have worse outcomes," he said in an interview. He also believes that these patients would benefit from a training-program intervention, but that has not yet been proven in a study.

Dr. Müller and his associates reviewed records from more than 5,000 cardiopulmonary exercise tests done on patients with congenital heart disease at the Heart Center between July 2001 and August 2012. The series included 522 patients who had serial, validated tests run at least 6 months apart and who did not undergo any medical or surgical intervention during the inter-test period. The average interval between the initial and subsequent test was about 2.5 years. The patients averaged about 25 years of age at baseline and about 27 years old at the time of their second test, and 59% were men.

The next most common congenital disorder following pulmonary valve dysfunction and left-ventricular outflow obstruction was need for arterial switch or congenitally corrected transposition of the great arteries, in 18%, followed by Fontan circulation in 11%, Epstein’s anomaly in 8%, and less common defects in the remaining patients.

Although the group overall lost an average of about 1% of their predicted peak oxygen uptake per year during follow-up, the rate of loss varied substantially by type of congenital defect. Patients with Epstein’s anomaly lost an average of 1.54% of predicted annually, those with a left-ventricular outflow obstruction averaged a 1.28% decline from predicted per year, and patients with pulmonary valve dysfunction averaged a 1.12% loss per year. Patients with lower than average annual loses included those with an arterial switch or transposition, with an average 0.67% loss per year, and patients with Fontan circulation, with an annual loss that averaged only 0.02%. Because exercise capacities were calculated as a percent of predicted values, they included adjustment for age, sex, weight, and height.

The analysis also showed other statistically significant functional declines in the entire group during follow-up, including an average annual fall of 0.76% in peak oxygen delivery per heartbeat, and a 1.49-beat/min decline in peak heart rate.

The rate of decline in exercise capacity was about the same regardless of patient age. And in a multivariate analysis, patients with a pacemaker were significantly more likely to have a larger average annual decline in exercise capacity, he said.

Dr. Müller said that he had no disclosures.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

*Correction, 5/29/2013: An earlier version of this story misstated the meeting name.

ROME – Young adults with congenital heart disease lose roughly 1% of their predicted exercise capacity each year, based on follow-up of more than 500 patients at one German center.

The "slow but persistent decline" in patients with congenital heart disease "exceeds the decline of reference values for age" compiled in 2009 from the general German population, Jan Müller, Ph.D., said at the annual meeting of the European Association for Cardiovascular Prevention and Rehabilitation*.

Results from prior, smaller studies also showed greater-than-expected progressive loss of exercise capacity in adults with congenital heart disease, but those had been smaller studies, and had not involved as diversified a range of congenital heart diseases as the new study. The 522 patients reviewed by Dr. Müller and his associates included 29% with pulmonary valve dysfunction and 26% with a left-ventricular outflow obstruction, congenital defects not previously covered in longitudinal reports on exercise capacity, said Dr. Müller, a researcher in sports science at the German Heart Center in Munich.

"We don’t know whether the rate of decline is prognostic, but we know that patients with lower exercise capacity have worse outcomes," he said in an interview. He also believes that these patients would benefit from a training-program intervention, but that has not yet been proven in a study.

Dr. Müller and his associates reviewed records from more than 5,000 cardiopulmonary exercise tests done on patients with congenital heart disease at the Heart Center between July 2001 and August 2012. The series included 522 patients who had serial, validated tests run at least 6 months apart and who did not undergo any medical or surgical intervention during the inter-test period. The average interval between the initial and subsequent test was about 2.5 years. The patients averaged about 25 years of age at baseline and about 27 years old at the time of their second test, and 59% were men.

The next most common congenital disorder following pulmonary valve dysfunction and left-ventricular outflow obstruction was need for arterial switch or congenitally corrected transposition of the great arteries, in 18%, followed by Fontan circulation in 11%, Epstein’s anomaly in 8%, and less common defects in the remaining patients.

Although the group overall lost an average of about 1% of their predicted peak oxygen uptake per year during follow-up, the rate of loss varied substantially by type of congenital defect. Patients with Epstein’s anomaly lost an average of 1.54% of predicted annually, those with a left-ventricular outflow obstruction averaged a 1.28% decline from predicted per year, and patients with pulmonary valve dysfunction averaged a 1.12% loss per year. Patients with lower than average annual loses included those with an arterial switch or transposition, with an average 0.67% loss per year, and patients with Fontan circulation, with an annual loss that averaged only 0.02%. Because exercise capacities were calculated as a percent of predicted values, they included adjustment for age, sex, weight, and height.

The analysis also showed other statistically significant functional declines in the entire group during follow-up, including an average annual fall of 0.76% in peak oxygen delivery per heartbeat, and a 1.49-beat/min decline in peak heart rate.

The rate of decline in exercise capacity was about the same regardless of patient age. And in a multivariate analysis, patients with a pacemaker were significantly more likely to have a larger average annual decline in exercise capacity, he said.

Dr. Müller said that he had no disclosures.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

*Correction, 5/29/2013: An earlier version of this story misstated the meeting name.

ROME – A moderate walk on a treadmill for 1 km proved useful for calculating a patient’s peak oxygen uptake and cardiopulmonary exercise capacity, and provided significant prognostic information for patients with cardiac disease, in a study with more than 1,200 Italian men.

The treadmill walk test "is a low-cost and simple tool for the indirect evaluation of cardiorespiratory fitness in cardiac outpatients," Dr. Giorgio Chiaranda said in a poster at the annual meeting of the European Association for Cardiovascular Prevention and Rehabilitation.

Cardiac patients in the highest quartile for cardiorespiratory fitness measured by the walk test had a two-thirds reduction in their mortality, compared with patients in the lowest fitness quartile during a median follow-up of 8 years.

The researchers had previously reported the development of a new submaximal protocol to predict peak oxygen uptake using a moderate, perceptually regulated 1-km treadmill walk test (J. Cardiopulm. Rehabil. Prev. 2012;32:262-9). They developed the walk test as an alternative to the standard maximal cardiopulmonary exercise test, which is relatively expensive and can be impractical in some settings. The investigators initially developed the walk test in 178 men with cardiac disease; the new study was performed to validate the walk test using prospectively collected follow-up data.

After a cardiac event, 1,255 outpatient men were referred to a cardiac rehabilitation program. They averaged 61 years of age, with a range from 25 to 85 years. Their average body mass index was 27.6 kg/m², and their average left ventricular ejection fraction was 56%(range, 21%-80%. Their index cardiac disease event was coronary artery bypass surgery in 49%, myocardial infarction in 28%, percutaneous coronary intervention in 9%, valve replacement in 9%, and other procedures in 5%.

All patients underwent a 1-km treadmill walk test, during which they were reminded to maintain a moderate pace. Testing produced no complications. Patients in the lowest quartile for their predicted peak oxygen uptake had a level of 19.6 mL/kg per minute or less. Patients in the highest quartile had a rate of at least 25.1 mL/kg per minute.

During a median follow-up of 8 years, 141 (11%) of the patients died. A multivariate analysis adjusted for several demographic and clinical factors including age, body mass index, ejection fraction, smoking status, hypertension, family history, cholesterol levels, glucose level, and renal function. Patients in the fittest quartile had a follow-up mortality rate that was 67% lower than that of patients in the least-fit quartile. Patients in the next most-fit quartile had a mortality rate that was 50% lower than that of the least-fit group. Both between-group differences were statistically significant, Dr. Chiaranda of the University of Ferrara (Italy) Center for Sports Medicine and his associates found. Cardiorespiratory fitness could account for 71% of the variability in mortality during follow-up.

The researchers found the lowest mortality rate among patients from the fittest quartile who further improved their peak oxygen uptake during follow-up, based on a second 1-km walk test performed 1 year following their baseline test in 964 patients. Patients with increased fitness on follow-up had an 89% reduced mortality rate compared with patients from the least-fit quartile who did not show improvement in their fitness after the first follow-up year.

Dr. Chiaranda and his associates said they had no relevant financial disclosures.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

ROME – A moderate walk on a treadmill for 1 km proved useful for calculating a patient’s peak oxygen uptake and cardiopulmonary exercise capacity, and provided significant prognostic information for patients with cardiac disease, in a study with more than 1,200 Italian men.

The treadmill walk test "is a low-cost and simple tool for the indirect evaluation of cardiorespiratory fitness in cardiac outpatients," Dr. Giorgio Chiaranda said in a poster at the annual meeting of the European Association for Cardiovascular Prevention and Rehabilitation.

Cardiac patients in the highest quartile for cardiorespiratory fitness measured by the walk test had a two-thirds reduction in their mortality, compared with patients in the lowest fitness quartile during a median follow-up of 8 years.

The researchers had previously reported the development of a new submaximal protocol to predict peak oxygen uptake using a moderate, perceptually regulated 1-km treadmill walk test (J. Cardiopulm. Rehabil. Prev. 2012;32:262-9). They developed the walk test as an alternative to the standard maximal cardiopulmonary exercise test, which is relatively expensive and can be impractical in some settings. The investigators initially developed the walk test in 178 men with cardiac disease; the new study was performed to validate the walk test using prospectively collected follow-up data.

After a cardiac event, 1,255 outpatient men were referred to a cardiac rehabilitation program. They averaged 61 years of age, with a range from 25 to 85 years. Their average body mass index was 27.6 kg/m², and their average left ventricular ejection fraction was 56%(range, 21%-80%. Their index cardiac disease event was coronary artery bypass surgery in 49%, myocardial infarction in 28%, percutaneous coronary intervention in 9%, valve replacement in 9%, and other procedures in 5%.

All patients underwent a 1-km treadmill walk test, during which they were reminded to maintain a moderate pace. Testing produced no complications. Patients in the lowest quartile for their predicted peak oxygen uptake had a level of 19.6 mL/kg per minute or less. Patients in the highest quartile had a rate of at least 25.1 mL/kg per minute.

During a median follow-up of 8 years, 141 (11%) of the patients died. A multivariate analysis adjusted for several demographic and clinical factors including age, body mass index, ejection fraction, smoking status, hypertension, family history, cholesterol levels, glucose level, and renal function. Patients in the fittest quartile had a follow-up mortality rate that was 67% lower than that of patients in the least-fit quartile. Patients in the next most-fit quartile had a mortality rate that was 50% lower than that of the least-fit group. Both between-group differences were statistically significant, Dr. Chiaranda of the University of Ferrara (Italy) Center for Sports Medicine and his associates found. Cardiorespiratory fitness could account for 71% of the variability in mortality during follow-up.

The researchers found the lowest mortality rate among patients from the fittest quartile who further improved their peak oxygen uptake during follow-up, based on a second 1-km walk test performed 1 year following their baseline test in 964 patients. Patients with increased fitness on follow-up had an 89% reduced mortality rate compared with patients from the least-fit quartile who did not show improvement in their fitness after the first follow-up year.

Dr. Chiaranda and his associates said they had no relevant financial disclosures.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

ROME – A moderate walk on a treadmill for 1 km proved useful for calculating a patient’s peak oxygen uptake and cardiopulmonary exercise capacity, and provided significant prognostic information for patients with cardiac disease, in a study with more than 1,200 Italian men.

The treadmill walk test "is a low-cost and simple tool for the indirect evaluation of cardiorespiratory fitness in cardiac outpatients," Dr. Giorgio Chiaranda said in a poster at the annual meeting of the European Association for Cardiovascular Prevention and Rehabilitation.

Cardiac patients in the highest quartile for cardiorespiratory fitness measured by the walk test had a two-thirds reduction in their mortality, compared with patients in the lowest fitness quartile during a median follow-up of 8 years.

The researchers had previously reported the development of a new submaximal protocol to predict peak oxygen uptake using a moderate, perceptually regulated 1-km treadmill walk test (J. Cardiopulm. Rehabil. Prev. 2012;32:262-9). They developed the walk test as an alternative to the standard maximal cardiopulmonary exercise test, which is relatively expensive and can be impractical in some settings. The investigators initially developed the walk test in 178 men with cardiac disease; the new study was performed to validate the walk test using prospectively collected follow-up data.

After a cardiac event, 1,255 outpatient men were referred to a cardiac rehabilitation program. They averaged 61 years of age, with a range from 25 to 85 years. Their average body mass index was 27.6 kg/m², and their average left ventricular ejection fraction was 56%(range, 21%-80%. Their index cardiac disease event was coronary artery bypass surgery in 49%, myocardial infarction in 28%, percutaneous coronary intervention in 9%, valve replacement in 9%, and other procedures in 5%.

All patients underwent a 1-km treadmill walk test, during which they were reminded to maintain a moderate pace. Testing produced no complications. Patients in the lowest quartile for their predicted peak oxygen uptake had a level of 19.6 mL/kg per minute or less. Patients in the highest quartile had a rate of at least 25.1 mL/kg per minute.

During a median follow-up of 8 years, 141 (11%) of the patients died. A multivariate analysis adjusted for several demographic and clinical factors including age, body mass index, ejection fraction, smoking status, hypertension, family history, cholesterol levels, glucose level, and renal function. Patients in the fittest quartile had a follow-up mortality rate that was 67% lower than that of patients in the least-fit quartile. Patients in the next most-fit quartile had a mortality rate that was 50% lower than that of the least-fit group. Both between-group differences were statistically significant, Dr. Chiaranda of the University of Ferrara (Italy) Center for Sports Medicine and his associates found. Cardiorespiratory fitness could account for 71% of the variability in mortality during follow-up.

The researchers found the lowest mortality rate among patients from the fittest quartile who further improved their peak oxygen uptake during follow-up, based on a second 1-km walk test performed 1 year following their baseline test in 964 patients. Patients with increased fitness on follow-up had an 89% reduced mortality rate compared with patients from the least-fit quartile who did not show improvement in their fitness after the first follow-up year.

Dr. Chiaranda and his associates said they had no relevant financial disclosures.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

Earn 0.25 hours AMA PRA Category 1 credit: Read this article, and click the link at the end to take the post-test.

ROME  – Unrecognized heart failure is common among older patients with type 2 diabetes, on the basis of a study of 581 Dutch diabetes patients.

A comprehensive screening examination and assessment of Dutch patients with type 2 diabetes who were at least 60 years old and had no prior history of heart failure identified 161 patients (28%) with heart failure, Dr. Leandra J.M. Boonman-de Winter and her associates reported in a poster at the annual meeting of the European Association for Cardiovascular Prevention and Rehabilitation*.

The newly identified heart failure patients included 28 (5% of the total group screened) with reduced left ventricular function and 133 (23%) with preserved left ventricular function, said Dr. Boonman-de Winter, a researcher at University Medical Center in Utrecht, the Netherlands, and her associates.

To identify these heart failure cases, the researchers performed an extensive work-up on each patient with type 2 diabetes, including a medical history, physical examination, ECG, and echocardiography. A panel of expert cardiologists made the diagnosis of heart failure using criteria of the European Society for Cardiology (Eur. Heart J. 2012;33:1787-847).

The researchers also performed a multivariate analysis to identify demographic and clinical factors that significantly linked with the presence of heart failure in the patients with diabetes. Dyspnea or fatigue linked with a sixfold increased prevalence of heart failure; ankle edema or nocturia, a history of ischemic heart disease, and age greater than 75 years old each linked with a doubled heart-failure prevalence; and hypertension linked with a 70% increased prevalence of heart failure.

These five factors together could account for 80% of the heart failure cases found among the patients with type 2 diabetes, the researchers reported. They recommended using these five factors to identify older patients with diabetes to more thoroughly screen for heart failure.

Dr. Boonman-de Winter and her associates said that they had no disclosures.

To earn 0.25 hours AMA PRA Category 1 credit after reading this article, take the post-test here.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

*Correction, 5/29/2013: An earlier version of this story misstated the meeting name.

Earn 0.25 hours AMA PRA Category 1 credit: Read this article, and click the link at the end to take the post-test.

ROME  – Unrecognized heart failure is common among older patients with type 2 diabetes, on the basis of a study of 581 Dutch diabetes patients.

A comprehensive screening examination and assessment of Dutch patients with type 2 diabetes who were at least 60 years old and had no prior history of heart failure identified 161 patients (28%) with heart failure, Dr. Leandra J.M. Boonman-de Winter and her associates reported in a poster at the annual meeting of the European Association for Cardiovascular Prevention and Rehabilitation*.

The newly identified heart failure patients included 28 (5% of the total group screened) with reduced left ventricular function and 133 (23%) with preserved left ventricular function, said Dr. Boonman-de Winter, a researcher at University Medical Center in Utrecht, the Netherlands, and her associates.

To identify these heart failure cases, the researchers performed an extensive work-up on each patient with type 2 diabetes, including a medical history, physical examination, ECG, and echocardiography. A panel of expert cardiologists made the diagnosis of heart failure using criteria of the European Society for Cardiology (Eur. Heart J. 2012;33:1787-847).

The researchers also performed a multivariate analysis to identify demographic and clinical factors that significantly linked with the presence of heart failure in the patients with diabetes. Dyspnea or fatigue linked with a sixfold increased prevalence of heart failure; ankle edema or nocturia, a history of ischemic heart disease, and age greater than 75 years old each linked with a doubled heart-failure prevalence; and hypertension linked with a 70% increased prevalence of heart failure.

These five factors together could account for 80% of the heart failure cases found among the patients with type 2 diabetes, the researchers reported. They recommended using these five factors to identify older patients with diabetes to more thoroughly screen for heart failure.

Dr. Boonman-de Winter and her associates said that they had no disclosures.

To earn 0.25 hours AMA PRA Category 1 credit after reading this article, take the post-test here.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

*Correction, 5/29/2013: An earlier version of this story misstated the meeting name.

Earn 0.25 hours AMA PRA Category 1 credit: Read this article, and click the link at the end to take the post-test.

ROME  – Unrecognized heart failure is common among older patients with type 2 diabetes, on the basis of a study of 581 Dutch diabetes patients.

A comprehensive screening examination and assessment of Dutch patients with type 2 diabetes who were at least 60 years old and had no prior history of heart failure identified 161 patients (28%) with heart failure, Dr. Leandra J.M. Boonman-de Winter and her associates reported in a poster at the annual meeting of the European Association for Cardiovascular Prevention and Rehabilitation*.

The newly identified heart failure patients included 28 (5% of the total group screened) with reduced left ventricular function and 133 (23%) with preserved left ventricular function, said Dr. Boonman-de Winter, a researcher at University Medical Center in Utrecht, the Netherlands, and her associates.

To identify these heart failure cases, the researchers performed an extensive work-up on each patient with type 2 diabetes, including a medical history, physical examination, ECG, and echocardiography. A panel of expert cardiologists made the diagnosis of heart failure using criteria of the European Society for Cardiology (Eur. Heart J. 2012;33:1787-847).

The researchers also performed a multivariate analysis to identify demographic and clinical factors that significantly linked with the presence of heart failure in the patients with diabetes. Dyspnea or fatigue linked with a sixfold increased prevalence of heart failure; ankle edema or nocturia, a history of ischemic heart disease, and age greater than 75 years old each linked with a doubled heart-failure prevalence; and hypertension linked with a 70% increased prevalence of heart failure.

These five factors together could account for 80% of the heart failure cases found among the patients with type 2 diabetes, the researchers reported. They recommended using these five factors to identify older patients with diabetes to more thoroughly screen for heart failure.

Dr. Boonman-de Winter and her associates said that they had no disclosures.

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mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

*Correction, 5/29/2013: An earlier version of this story misstated the meeting name.

ROME  – Unrecognized heart failure is common among older patients with type 2 diabetes, on the basis of a study of 581 Dutch diabetes patients.

A comprehensive screening examination and assessment of Dutch patients with type 2 diabetes who were at least 60 years old and had no prior history of heart failure identified 161 patients (28%) with heart failure, Dr. Leandra J.M. Boonman-de Winter and her associates reported in a poster at the annual meeting of the European Association for Cardiovascular Prevention and Rehabilitation*.

The newly identified heart failure patients included 28 (5% of the total group screened) with reduced left ventricular function and 133 (23%) with preserved left ventricular function, said Dr. Boonman-de Winter, a researcher at University Medical Center in Utrecht, the Netherlands, and her associates.

To identify these heart failure cases, the researchers performed an extensive work-up on each patient with type 2 diabetes, including a medical history, physical examination, ECG, and echocardiography. A panel of expert cardiologists made the diagnosis of heart failure using criteria of the European Society for Cardiology (Eur. Heart J. 2012;33:1787-847).

The researchers also performed a multivariate analysis to identify demographic and clinical factors that significantly linked with the presence of heart failure in the patients with diabetes. Dyspnea or fatigue linked with a sixfold increased prevalence of heart failure; ankle edema or nocturia, a history of ischemic heart disease, and age greater than 75 years old each linked with a doubled heart-failure prevalence; and hypertension linked with a 70% increased prevalence of heart failure.

These five factors together could account for 80% of the heart failure cases found among the patients with type 2 diabetes, the researchers reported. They recommended using these five factors to identify older patients with diabetes to more thoroughly screen for heart failure.

Dr. Boonman-de Winter and her associates said that they had no disclosures.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

*Correction, 5/29/2013: An earlier version of this story misstated the meeting name.

ROME  – Unrecognized heart failure is common among older patients with type 2 diabetes, on the basis of a study of 581 Dutch diabetes patients.

A comprehensive screening examination and assessment of Dutch patients with type 2 diabetes who were at least 60 years old and had no prior history of heart failure identified 161 patients (28%) with heart failure, Dr. Leandra J.M. Boonman-de Winter and her associates reported in a poster at the annual meeting of the European Association for Cardiovascular Prevention and Rehabilitation*.

The newly identified heart failure patients included 28 (5% of the total group screened) with reduced left ventricular function and 133 (23%) with preserved left ventricular function, said Dr. Boonman-de Winter, a researcher at University Medical Center in Utrecht, the Netherlands, and her associates.

To identify these heart failure cases, the researchers performed an extensive work-up on each patient with type 2 diabetes, including a medical history, physical examination, ECG, and echocardiography. A panel of expert cardiologists made the diagnosis of heart failure using criteria of the European Society for Cardiology (Eur. Heart J. 2012;33:1787-847).

The researchers also performed a multivariate analysis to identify demographic and clinical factors that significantly linked with the presence of heart failure in the patients with diabetes. Dyspnea or fatigue linked with a sixfold increased prevalence of heart failure; ankle edema or nocturia, a history of ischemic heart disease, and age greater than 75 years old each linked with a doubled heart-failure prevalence; and hypertension linked with a 70% increased prevalence of heart failure.

These five factors together could account for 80% of the heart failure cases found among the patients with type 2 diabetes, the researchers reported. They recommended using these five factors to identify older patients with diabetes to more thoroughly screen for heart failure.

Dr. Boonman-de Winter and her associates said that they had no disclosures.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

*Correction, 5/29/2013: An earlier version of this story misstated the meeting name.

ROME  – Unrecognized heart failure is common among older patients with type 2 diabetes, on the basis of a study of 581 Dutch diabetes patients.

A comprehensive screening examination and assessment of Dutch patients with type 2 diabetes who were at least 60 years old and had no prior history of heart failure identified 161 patients (28%) with heart failure, Dr. Leandra J.M. Boonman-de Winter and her associates reported in a poster at the annual meeting of the European Association for Cardiovascular Prevention and Rehabilitation*.

The newly identified heart failure patients included 28 (5% of the total group screened) with reduced left ventricular function and 133 (23%) with preserved left ventricular function, said Dr. Boonman-de Winter, a researcher at University Medical Center in Utrecht, the Netherlands, and her associates.

To identify these heart failure cases, the researchers performed an extensive work-up on each patient with type 2 diabetes, including a medical history, physical examination, ECG, and echocardiography. A panel of expert cardiologists made the diagnosis of heart failure using criteria of the European Society for Cardiology (Eur. Heart J. 2012;33:1787-847).

The researchers also performed a multivariate analysis to identify demographic and clinical factors that significantly linked with the presence of heart failure in the patients with diabetes. Dyspnea or fatigue linked with a sixfold increased prevalence of heart failure; ankle edema or nocturia, a history of ischemic heart disease, and age greater than 75 years old each linked with a doubled heart-failure prevalence; and hypertension linked with a 70% increased prevalence of heart failure.

These five factors together could account for 80% of the heart failure cases found among the patients with type 2 diabetes, the researchers reported. They recommended using these five factors to identify older patients with diabetes to more thoroughly screen for heart failure.

Dr. Boonman-de Winter and her associates said that they had no disclosures.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

*Correction, 5/29/2013: An earlier version of this story misstated the meeting name.

BRUSSELS – Researchers developing advanced imaging techniques for breast cancer patients are striving to move beyond merely documenting the size and shape of tumors to also generate information on a tumor’s physiologic characteristics and molecular composition. But these goals remain investigational, leaving the proven role of advanced imaging techniques somewhat limited.

Work is underway trying to combine the structural information obtained from MRI with metabolic imaging using a glucose tracer and positron emission tomography (PET). Investigators are also trying to expand the capabilities of PET and single-photon emission computed tomography (SPECT) with new labeled tracers that can help visualize estrogen receptors, androgen receptors, and HER2 receptors.

Mitchel L. Zoler/IMNG Medical Media

But even the most basic PET and SPECT analyses available today require more supporting data before they can enter routine practice. "We have to prove that it affects clinical decision making and is useful," said Dr. Elisabeth de Vries, during an imaging session at the IMPAKT 2013 Breast Cancer Conference.

Currently, the development of imaging modalities for assessing breast cancer drug targets like HER2 and estrogen receptors is "still in its infancy," said Dr. de Vries, professor and head of the department of medical oncology at the University of Groningen, the Netherlands.

The potential exists to use PET and SPECT to find and assess tumor metastases throughout a patient’s body, and to gain insight into receptor heterogeneity with a new tracer for each important breast cancer marker, but these methods still need refinement and documentation of utility, she said.

Dr. Katja Pinker-Domenig believes that the best imaging information to guide breast cancer management will come from combining information from multiple sources, such as MRI and PET or MRI and SPECT, and her group has begun to assess these couplings. Last December, they reported their experience using 3-Tesla MRI and labeled glucose in PET imaging to assess 60 patients with lesions initially detected by mammography or ultrasound and classified as categories 3-5 on the Breast Imaging Reporting and Data System (BI-RADS).

Combining the two methods resulted in a diagnostic sensitivity of 100%, a specificity of 91%, and a diagnostic accuracy of 97%, significantly better than the 97%/77%/90% rates obtained in the same patients using MRI alone, they reported at the annual meeting of the Radiological Society of North America (RSNA). Adding the metabolic PET assessment to MRI produced two false positives and unnecessary biopsies, compared with five false positives and unneeded biopsies that would have been done based on MRI only, said Dr. Pinker-Domenig, a radiologist at the Medical University of Vienna.

Another MRI enhancement she is working on adds information from MRI diffusion-weighted imaging, which can distinguish benign cells, which freely diffuse and have a high apparent diffusion coefficient, and malignant cells, which have much more restricted diffusion. In another report at the RSNA last December, Dr. Pinker-Domenig and her associates presented results from 233 patients with 279 suspicious breast lesions examined by diffusion-weighted imaging using a 3-Tesla magnetic field. Overall sensitivity was 92% and specificity was 90% compared with subsequent biopsy and histopathology.

"With diffusion-weighted imaging we can often see changes before they are visible with contrast-enhanced MRI. We can even see malignancies disappear during chemotherapy. What is thrilling about DWI is that we can see changes before we can pick them up with conventional imaging with contrast-enhanced MRI," she said.

Mitchel L. Zoler/IMNG Medical Media

Another way of dealing with the limitations of conventional, stand-alone MRI has been to move to higher magnetic field strengths, at 3 or 7 Tesla. Last year, Dr. Pinker-Domenig and her associates reported results using 3-Tesla MRI on 150 breast cancer patients with 99% sensitivity, 81% specificity, and a diagnostic accuracy of 93% (Eur. Radiol. 2012;22:322-30), results she called "pretty good but not sufficient." In February, the group reported at the annual meeting of the European Society of Radiology their initial experience in 25 patients using 7-Tesla MRI to image breast cancers. The boost in field strength produced only a modest uptick in sensitivity and diagnostic accuracy, but Dr. Pinker-Domenig maintained the extra cost was worth it because "the pictures are clearer," and they also likely provide more information on tumor heterogeneity, she said.

In contrast to these advances, using imaging to assess bone metastases in breast cancer patients has made little progress. "We’re not very good at looking at bone metastases with bone scans, x-rays, or PET," said Dr. Gary Cook, a radiologist at King’s College, London. These imaging modalities allow radiologists to see gross changes, but not in the detail needed for reproducible measurements. "There is a lack of sensitive, specific, reproducible, and quantifiable methods to monitor bone metastases," he said.

The conference was sponsored by the European Society for Medical Oncology.

Dr. Pinker-Domenig and Dr. Cook had no disclosures. Dr. de Vries said that she has received grant support from Genentech and Novartis.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

BRUSSELS – Researchers developing advanced imaging techniques for breast cancer patients are striving to move beyond merely documenting the size and shape of tumors to also generate information on a tumor’s physiologic characteristics and molecular composition. But these goals remain investigational, leaving the proven role of advanced imaging techniques somewhat limited.

Work is underway trying to combine the structural information obtained from MRI with metabolic imaging using a glucose tracer and positron emission tomography (PET). Investigators are also trying to expand the capabilities of PET and single-photon emission computed tomography (SPECT) with new labeled tracers that can help visualize estrogen receptors, androgen receptors, and HER2 receptors.

Mitchel L. Zoler/IMNG Medical Media

But even the most basic PET and SPECT analyses available today require more supporting data before they can enter routine practice. "We have to prove that it affects clinical decision making and is useful," said Dr. Elisabeth de Vries, during an imaging session at the IMPAKT 2013 Breast Cancer Conference.

Currently, the development of imaging modalities for assessing breast cancer drug targets like HER2 and estrogen receptors is "still in its infancy," said Dr. de Vries, professor and head of the department of medical oncology at the University of Groningen, the Netherlands.

The potential exists to use PET and SPECT to find and assess tumor metastases throughout a patient’s body, and to gain insight into receptor heterogeneity with a new tracer for each important breast cancer marker, but these methods still need refinement and documentation of utility, she said.

Dr. Katja Pinker-Domenig believes that the best imaging information to guide breast cancer management will come from combining information from multiple sources, such as MRI and PET or MRI and SPECT, and her group has begun to assess these couplings. Last December, they reported their experience using 3-Tesla MRI and labeled glucose in PET imaging to assess 60 patients with lesions initially detected by mammography or ultrasound and classified as categories 3-5 on the Breast Imaging Reporting and Data System (BI-RADS).

Combining the two methods resulted in a diagnostic sensitivity of 100%, a specificity of 91%, and a diagnostic accuracy of 97%, significantly better than the 97%/77%/90% rates obtained in the same patients using MRI alone, they reported at the annual meeting of the Radiological Society of North America (RSNA). Adding the metabolic PET assessment to MRI produced two false positives and unnecessary biopsies, compared with five false positives and unneeded biopsies that would have been done based on MRI only, said Dr. Pinker-Domenig, a radiologist at the Medical University of Vienna.

Another MRI enhancement she is working on adds information from MRI diffusion-weighted imaging, which can distinguish benign cells, which freely diffuse and have a high apparent diffusion coefficient, and malignant cells, which have much more restricted diffusion. In another report at the RSNA last December, Dr. Pinker-Domenig and her associates presented results from 233 patients with 279 suspicious breast lesions examined by diffusion-weighted imaging using a 3-Tesla magnetic field. Overall sensitivity was 92% and specificity was 90% compared with subsequent biopsy and histopathology.

"With diffusion-weighted imaging we can often see changes before they are visible with contrast-enhanced MRI. We can even see malignancies disappear during chemotherapy. What is thrilling about DWI is that we can see changes before we can pick them up with conventional imaging with contrast-enhanced MRI," she said.

Mitchel L. Zoler/IMNG Medical Media

Another way of dealing with the limitations of conventional, stand-alone MRI has been to move to higher magnetic field strengths, at 3 or 7 Tesla. Last year, Dr. Pinker-Domenig and her associates reported results using 3-Tesla MRI on 150 breast cancer patients with 99% sensitivity, 81% specificity, and a diagnostic accuracy of 93% (Eur. Radiol. 2012;22:322-30), results she called "pretty good but not sufficient." In February, the group reported at the annual meeting of the European Society of Radiology their initial experience in 25 patients using 7-Tesla MRI to image breast cancers. The boost in field strength produced only a modest uptick in sensitivity and diagnostic accuracy, but Dr. Pinker-Domenig maintained the extra cost was worth it because "the pictures are clearer," and they also likely provide more information on tumor heterogeneity, she said.

In contrast to these advances, using imaging to assess bone metastases in breast cancer patients has made little progress. "We’re not very good at looking at bone metastases with bone scans, x-rays, or PET," said Dr. Gary Cook, a radiologist at King’s College, London. These imaging modalities allow radiologists to see gross changes, but not in the detail needed for reproducible measurements. "There is a lack of sensitive, specific, reproducible, and quantifiable methods to monitor bone metastases," he said.

The conference was sponsored by the European Society for Medical Oncology.

Dr. Pinker-Domenig and Dr. Cook had no disclosures. Dr. de Vries said that she has received grant support from Genentech and Novartis.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

BRUSSELS – Researchers developing advanced imaging techniques for breast cancer patients are striving to move beyond merely documenting the size and shape of tumors to also generate information on a tumor’s physiologic characteristics and molecular composition. But these goals remain investigational, leaving the proven role of advanced imaging techniques somewhat limited.

Work is underway trying to combine the structural information obtained from MRI with metabolic imaging using a glucose tracer and positron emission tomography (PET). Investigators are also trying to expand the capabilities of PET and single-photon emission computed tomography (SPECT) with new labeled tracers that can help visualize estrogen receptors, androgen receptors, and HER2 receptors.

Mitchel L. Zoler/IMNG Medical Media

But even the most basic PET and SPECT analyses available today require more supporting data before they can enter routine practice. "We have to prove that it affects clinical decision making and is useful," said Dr. Elisabeth de Vries, during an imaging session at the IMPAKT 2013 Breast Cancer Conference.

Currently, the development of imaging modalities for assessing breast cancer drug targets like HER2 and estrogen receptors is "still in its infancy," said Dr. de Vries, professor and head of the department of medical oncology at the University of Groningen, the Netherlands.

The potential exists to use PET and SPECT to find and assess tumor metastases throughout a patient’s body, and to gain insight into receptor heterogeneity with a new tracer for each important breast cancer marker, but these methods still need refinement and documentation of utility, she said.

Dr. Katja Pinker-Domenig believes that the best imaging information to guide breast cancer management will come from combining information from multiple sources, such as MRI and PET or MRI and SPECT, and her group has begun to assess these couplings. Last December, they reported their experience using 3-Tesla MRI and labeled glucose in PET imaging to assess 60 patients with lesions initially detected by mammography or ultrasound and classified as categories 3-5 on the Breast Imaging Reporting and Data System (BI-RADS).

Combining the two methods resulted in a diagnostic sensitivity of 100%, a specificity of 91%, and a diagnostic accuracy of 97%, significantly better than the 97%/77%/90% rates obtained in the same patients using MRI alone, they reported at the annual meeting of the Radiological Society of North America (RSNA). Adding the metabolic PET assessment to MRI produced two false positives and unnecessary biopsies, compared with five false positives and unneeded biopsies that would have been done based on MRI only, said Dr. Pinker-Domenig, a radiologist at the Medical University of Vienna.

Another MRI enhancement she is working on adds information from MRI diffusion-weighted imaging, which can distinguish benign cells, which freely diffuse and have a high apparent diffusion coefficient, and malignant cells, which have much more restricted diffusion. In another report at the RSNA last December, Dr. Pinker-Domenig and her associates presented results from 233 patients with 279 suspicious breast lesions examined by diffusion-weighted imaging using a 3-Tesla magnetic field. Overall sensitivity was 92% and specificity was 90% compared with subsequent biopsy and histopathology.

"With diffusion-weighted imaging we can often see changes before they are visible with contrast-enhanced MRI. We can even see malignancies disappear during chemotherapy. What is thrilling about DWI is that we can see changes before we can pick them up with conventional imaging with contrast-enhanced MRI," she said.

Mitchel L. Zoler/IMNG Medical Media

Another way of dealing with the limitations of conventional, stand-alone MRI has been to move to higher magnetic field strengths, at 3 or 7 Tesla. Last year, Dr. Pinker-Domenig and her associates reported results using 3-Tesla MRI on 150 breast cancer patients with 99% sensitivity, 81% specificity, and a diagnostic accuracy of 93% (Eur. Radiol. 2012;22:322-30), results she called "pretty good but not sufficient." In February, the group reported at the annual meeting of the European Society of Radiology their initial experience in 25 patients using 7-Tesla MRI to image breast cancers. The boost in field strength produced only a modest uptick in sensitivity and diagnostic accuracy, but Dr. Pinker-Domenig maintained the extra cost was worth it because "the pictures are clearer," and they also likely provide more information on tumor heterogeneity, she said.

In contrast to these advances, using imaging to assess bone metastases in breast cancer patients has made little progress. "We’re not very good at looking at bone metastases with bone scans, x-rays, or PET," said Dr. Gary Cook, a radiologist at King’s College, London. These imaging modalities allow radiologists to see gross changes, but not in the detail needed for reproducible measurements. "There is a lack of sensitive, specific, reproducible, and quantifiable methods to monitor bone metastases," he said.

The conference was sponsored by the European Society for Medical Oncology.

Dr. Pinker-Domenig and Dr. Cook had no disclosures. Dr. de Vries said that she has received grant support from Genentech and Novartis.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler