Acquired Cardiovascular Disease

LOS ANGELES – There are perfectly good reasons for hospitals to offer elective percutaneous coronary intervention without on-site cardiac surgery backup, but saving institutional dollars isn’t among them.

That’s the bottom line from CPORT-E (Cardiovascular Patient Outcomes Research Team/Non-Primary Percutaneous Coronary Intervention Economic Study), the prespecified economic analysis conducted as part of the landmark CPORT trial.

The estimated medical costs per CPORT participant, including the index revascularization and hospitalization as well as costs incurred during 9 months of follow-up, averaged $29,136 in hospitals without on-site coronary artery bypass surgery backup and $25,412 in centers with backup. This 15% difference did not reach statistical significance, Eric L. Eisenstein, DBA, reported at the annual scientific sessions of the American Heart Association.

Bruce Jancin/IMNG Medical Media

Patients assigned to PCI at hospitals without on-site cardiac surgery actually had a shorter average length of stay; however, their total hospitalization costs ran higher because the study protocol dictated that their post-PCI care take place in the intensive care unit. Patients in centers with no on-site CABG backup also had a significantly higher rate of repeat target vessel revascularization during 9 months of follow-up: 6.5% compared with 5.4% when PCI was performed in hospitals with surgical backup, explained Dr. Eisenstein of Duke Clinical Research Institute, Durham, N.C.

CPORT was a randomized, prospective trial in which elective PCI performed at hospitals with or without on-site cardiac surgery backup was compared for nearly 19,000 participants. As previously reported (N. Engl. J. Med. 2012;366:1792-802), there were no significant differences between the two patient populations in terms of the coprimary end points of 6-week mortality (0.9% at hospitals without on-site surgery and 1.0% at those with backup) and 9-month major adverse cardiac events (12.1% without versus 11.2% with on-site surgical backup).

Discussant Dr. Mark A. Hlatky noted that 9-month total costs in CPORT-E were 22% higher at low-PCI-volume sites without surgery but only 7% higher at high-volume sites without surgery than at hospitals having on-site CABG backup.

"That’s a very interesting issue: The crucial factor driving costs may not be whether surgery is present on site or not, but the PCI volume at the site. If we have a low-volume site there may be higher costs and more adverse events. Whenever you do something in higher volumes you’re more efficient economically and you may actually do a little bit better job," said Dr. Hlatky of Stanford (Calif.) University.

As a matter of health policy, introducing elective PCI at hospitals without on-site cardiac surgery is attractive because it improves access, particularly for patients in rural areas. Another consideration is that these centers without on-site surgery may be available for emergency PCI, thereby avoiding the delays inherent in patient transfer to a distant center, he observed.

Discussant Dr. David O. Williams called CPORT "an extremely well-organized and well-conducted trial. It was a large study and the findings, I believe, are quite valid. To be applicable, however, hospitals will need to replicate all the necessary operational and training activities inherent in the trial, which were really quite extensive." That means no money-saving shortcuts, such as eliminating a post-PCI stay in the ICU.

"I believe this trial is significant and will likely impact the manner in which PCI is performed in the U.S. The performance of PCI in hospitals without on-site CABG surgery, I believe, will be adopted and become the standard of care," predicted Dr. Williams, an interventional cardiologist at Brigham and Women’s Hospital, Boston.

Dr. Eisenstein had research grants from Medtronic and Eli Lilly. Dr. Williams reported grants from medical device companies. Dr. Hlatky had no conflicts.

[email protected]

LOS ANGELES – There are perfectly good reasons for hospitals to offer elective percutaneous coronary intervention without on-site cardiac surgery backup, but saving institutional dollars isn’t among them.

That’s the bottom line from CPORT-E (Cardiovascular Patient Outcomes Research Team/Non-Primary Percutaneous Coronary Intervention Economic Study), the prespecified economic analysis conducted as part of the landmark CPORT trial.

The estimated medical costs per CPORT participant, including the index revascularization and hospitalization as well as costs incurred during 9 months of follow-up, averaged $29,136 in hospitals without on-site coronary artery bypass surgery backup and $25,412 in centers with backup. This 15% difference did not reach statistical significance, Eric L. Eisenstein, DBA, reported at the annual scientific sessions of the American Heart Association.

Bruce Jancin/IMNG Medical Media

Patients assigned to PCI at hospitals without on-site cardiac surgery actually had a shorter average length of stay; however, their total hospitalization costs ran higher because the study protocol dictated that their post-PCI care take place in the intensive care unit. Patients in centers with no on-site CABG backup also had a significantly higher rate of repeat target vessel revascularization during 9 months of follow-up: 6.5% compared with 5.4% when PCI was performed in hospitals with surgical backup, explained Dr. Eisenstein of Duke Clinical Research Institute, Durham, N.C.

CPORT was a randomized, prospective trial in which elective PCI performed at hospitals with or without on-site cardiac surgery backup was compared for nearly 19,000 participants. As previously reported (N. Engl. J. Med. 2012;366:1792-802), there were no significant differences between the two patient populations in terms of the coprimary end points of 6-week mortality (0.9% at hospitals without on-site surgery and 1.0% at those with backup) and 9-month major adverse cardiac events (12.1% without versus 11.2% with on-site surgical backup).

Discussant Dr. Mark A. Hlatky noted that 9-month total costs in CPORT-E were 22% higher at low-PCI-volume sites without surgery but only 7% higher at high-volume sites without surgery than at hospitals having on-site CABG backup.

"That’s a very interesting issue: The crucial factor driving costs may not be whether surgery is present on site or not, but the PCI volume at the site. If we have a low-volume site there may be higher costs and more adverse events. Whenever you do something in higher volumes you’re more efficient economically and you may actually do a little bit better job," said Dr. Hlatky of Stanford (Calif.) University.

As a matter of health policy, introducing elective PCI at hospitals without on-site cardiac surgery is attractive because it improves access, particularly for patients in rural areas. Another consideration is that these centers without on-site surgery may be available for emergency PCI, thereby avoiding the delays inherent in patient transfer to a distant center, he observed.

Discussant Dr. David O. Williams called CPORT "an extremely well-organized and well-conducted trial. It was a large study and the findings, I believe, are quite valid. To be applicable, however, hospitals will need to replicate all the necessary operational and training activities inherent in the trial, which were really quite extensive." That means no money-saving shortcuts, such as eliminating a post-PCI stay in the ICU.

"I believe this trial is significant and will likely impact the manner in which PCI is performed in the U.S. The performance of PCI in hospitals without on-site CABG surgery, I believe, will be adopted and become the standard of care," predicted Dr. Williams, an interventional cardiologist at Brigham and Women’s Hospital, Boston.

Dr. Eisenstein had research grants from Medtronic and Eli Lilly. Dr. Williams reported grants from medical device companies. Dr. Hlatky had no conflicts.

[email protected]

LOS ANGELES – There are perfectly good reasons for hospitals to offer elective percutaneous coronary intervention without on-site cardiac surgery backup, but saving institutional dollars isn’t among them.

That’s the bottom line from CPORT-E (Cardiovascular Patient Outcomes Research Team/Non-Primary Percutaneous Coronary Intervention Economic Study), the prespecified economic analysis conducted as part of the landmark CPORT trial.

The estimated medical costs per CPORT participant, including the index revascularization and hospitalization as well as costs incurred during 9 months of follow-up, averaged $29,136 in hospitals without on-site coronary artery bypass surgery backup and $25,412 in centers with backup. This 15% difference did not reach statistical significance, Eric L. Eisenstein, DBA, reported at the annual scientific sessions of the American Heart Association.

Bruce Jancin/IMNG Medical Media

Patients assigned to PCI at hospitals without on-site cardiac surgery actually had a shorter average length of stay; however, their total hospitalization costs ran higher because the study protocol dictated that their post-PCI care take place in the intensive care unit. Patients in centers with no on-site CABG backup also had a significantly higher rate of repeat target vessel revascularization during 9 months of follow-up: 6.5% compared with 5.4% when PCI was performed in hospitals with surgical backup, explained Dr. Eisenstein of Duke Clinical Research Institute, Durham, N.C.

CPORT was a randomized, prospective trial in which elective PCI performed at hospitals with or without on-site cardiac surgery backup was compared for nearly 19,000 participants. As previously reported (N. Engl. J. Med. 2012;366:1792-802), there were no significant differences between the two patient populations in terms of the coprimary end points of 6-week mortality (0.9% at hospitals without on-site surgery and 1.0% at those with backup) and 9-month major adverse cardiac events (12.1% without versus 11.2% with on-site surgical backup).

Discussant Dr. Mark A. Hlatky noted that 9-month total costs in CPORT-E were 22% higher at low-PCI-volume sites without surgery but only 7% higher at high-volume sites without surgery than at hospitals having on-site CABG backup.

"That’s a very interesting issue: The crucial factor driving costs may not be whether surgery is present on site or not, but the PCI volume at the site. If we have a low-volume site there may be higher costs and more adverse events. Whenever you do something in higher volumes you’re more efficient economically and you may actually do a little bit better job," said Dr. Hlatky of Stanford (Calif.) University.

As a matter of health policy, introducing elective PCI at hospitals without on-site cardiac surgery is attractive because it improves access, particularly for patients in rural areas. Another consideration is that these centers without on-site surgery may be available for emergency PCI, thereby avoiding the delays inherent in patient transfer to a distant center, he observed.

Discussant Dr. David O. Williams called CPORT "an extremely well-organized and well-conducted trial. It was a large study and the findings, I believe, are quite valid. To be applicable, however, hospitals will need to replicate all the necessary operational and training activities inherent in the trial, which were really quite extensive." That means no money-saving shortcuts, such as eliminating a post-PCI stay in the ICU.

"I believe this trial is significant and will likely impact the manner in which PCI is performed in the U.S. The performance of PCI in hospitals without on-site CABG surgery, I believe, will be adopted and become the standard of care," predicted Dr. Williams, an interventional cardiologist at Brigham and Women’s Hospital, Boston.

Dr. Eisenstein had research grants from Medtronic and Eli Lilly. Dr. Williams reported grants from medical device companies. Dr. Hlatky had no conflicts.

[email protected]

At 1 year, overall survival after implantation with the transcatheter aortic CoreValve in the postmarket ADVANCE study was 82.1% and cardiovascular survival 88.2%. This compares with survival rates of 87.4% and 91.7% at 6 months and 95.5% and 96.6% at 30 days, principal investigator Dr. Axel Linke said at Transcatheter Cardiovascular Therapeutics 2012.

"If you put it into the perspective of the PARTNER A and B cohorts [in the pivotal trial in the Sapien transcatheter valve system], our mortality rate is, in absolute values, 8% to 13% lower," he said in an interview.

One explanation is that the 1,015-patient, postmarket ADVANCE study sought out centers experienced with transcatheter aortic valve implantation (TAVI). The 44 centers in Western Europe, Asia, and South America had to have performed at least 40 TAVI procedures, with some German centers having done as many as 500, to be certified by a TAVI proctor and to have a heart team in place. In comparison, some centers in the PARTNER trial of the Edwards Lifesciences Sapien valve contributed just six or seven patients and were selected based on their experience with general cardiologic intervention, he observed.

The 1-year survival rates in ADVANCE also surpass those from early registries, notably the French Aortic National CoreValve and Edwards Registry, where the initial experience with TAVI was associated with interventional mistakes, which were linked to early mortality, Dr. Linke said. The CoreValve System has been implanted in more than 30,000 patients since approval in the European Union in 2007, but is limited to investigational use in the United States.

No details were presented regarding mortality in various subgroups or complications such as stroke, paravalvular leaks or left bundle branch block (LBBB). A recent analysis raised concerns about LBBB, showing that one-third of 202 consecutive patients with no prior conduction disturbances developed new-onset LBBB after TAVI with a balloon-expandable valve (Sapien or Sapien XT). Although it resolved in 37.7% by hospital discharge and 57.3% at 6- to 12-month follow-up, patients with persistent LBBB had a significantly higher incidence of syncope and complete atrioventricular block requiring a permanent pacemaker (J. Am. Coll. Cardiol. 2012;60:1743-52 [doi:10.1016/j.jacc.2012.035].

The researchers will look at LBBB in detailed analyses expected from ADVANCE, but there’s been no evidence of a problem with LBBB in earlier follow-up in ADVANCE or from other CoreValve users.

Quality of life data from ADVANCE, reported in a separate poster session at the meeting, showed significant benefits with CoreValve, even in higher-risk patients. The access route used during TAVI had no impact on quality of life improvement at 6 months.

Dr. Linke has served as a consultant for Medtronic, the study sponsor.

[email protected]

At 1 year, overall survival after implantation with the transcatheter aortic CoreValve in the postmarket ADVANCE study was 82.1% and cardiovascular survival 88.2%. This compares with survival rates of 87.4% and 91.7% at 6 months and 95.5% and 96.6% at 30 days, principal investigator Dr. Axel Linke said at Transcatheter Cardiovascular Therapeutics 2012.

"If you put it into the perspective of the PARTNER A and B cohorts [in the pivotal trial in the Sapien transcatheter valve system], our mortality rate is, in absolute values, 8% to 13% lower," he said in an interview.

One explanation is that the 1,015-patient, postmarket ADVANCE study sought out centers experienced with transcatheter aortic valve implantation (TAVI). The 44 centers in Western Europe, Asia, and South America had to have performed at least 40 TAVI procedures, with some German centers having done as many as 500, to be certified by a TAVI proctor and to have a heart team in place. In comparison, some centers in the PARTNER trial of the Edwards Lifesciences Sapien valve contributed just six or seven patients and were selected based on their experience with general cardiologic intervention, he observed.

The 1-year survival rates in ADVANCE also surpass those from early registries, notably the French Aortic National CoreValve and Edwards Registry, where the initial experience with TAVI was associated with interventional mistakes, which were linked to early mortality, Dr. Linke said. The CoreValve System has been implanted in more than 30,000 patients since approval in the European Union in 2007, but is limited to investigational use in the United States.

No details were presented regarding mortality in various subgroups or complications such as stroke, paravalvular leaks or left bundle branch block (LBBB). A recent analysis raised concerns about LBBB, showing that one-third of 202 consecutive patients with no prior conduction disturbances developed new-onset LBBB after TAVI with a balloon-expandable valve (Sapien or Sapien XT). Although it resolved in 37.7% by hospital discharge and 57.3% at 6- to 12-month follow-up, patients with persistent LBBB had a significantly higher incidence of syncope and complete atrioventricular block requiring a permanent pacemaker (J. Am. Coll. Cardiol. 2012;60:1743-52 [doi:10.1016/j.jacc.2012.035].

The researchers will look at LBBB in detailed analyses expected from ADVANCE, but there’s been no evidence of a problem with LBBB in earlier follow-up in ADVANCE or from other CoreValve users.

Quality of life data from ADVANCE, reported in a separate poster session at the meeting, showed significant benefits with CoreValve, even in higher-risk patients. The access route used during TAVI had no impact on quality of life improvement at 6 months.

Dr. Linke has served as a consultant for Medtronic, the study sponsor.

[email protected]

At 1 year, overall survival after implantation with the transcatheter aortic CoreValve in the postmarket ADVANCE study was 82.1% and cardiovascular survival 88.2%. This compares with survival rates of 87.4% and 91.7% at 6 months and 95.5% and 96.6% at 30 days, principal investigator Dr. Axel Linke said at Transcatheter Cardiovascular Therapeutics 2012.

"If you put it into the perspective of the PARTNER A and B cohorts [in the pivotal trial in the Sapien transcatheter valve system], our mortality rate is, in absolute values, 8% to 13% lower," he said in an interview.

One explanation is that the 1,015-patient, postmarket ADVANCE study sought out centers experienced with transcatheter aortic valve implantation (TAVI). The 44 centers in Western Europe, Asia, and South America had to have performed at least 40 TAVI procedures, with some German centers having done as many as 500, to be certified by a TAVI proctor and to have a heart team in place. In comparison, some centers in the PARTNER trial of the Edwards Lifesciences Sapien valve contributed just six or seven patients and were selected based on their experience with general cardiologic intervention, he observed.

The 1-year survival rates in ADVANCE also surpass those from early registries, notably the French Aortic National CoreValve and Edwards Registry, where the initial experience with TAVI was associated with interventional mistakes, which were linked to early mortality, Dr. Linke said. The CoreValve System has been implanted in more than 30,000 patients since approval in the European Union in 2007, but is limited to investigational use in the United States.

No details were presented regarding mortality in various subgroups or complications such as stroke, paravalvular leaks or left bundle branch block (LBBB). A recent analysis raised concerns about LBBB, showing that one-third of 202 consecutive patients with no prior conduction disturbances developed new-onset LBBB after TAVI with a balloon-expandable valve (Sapien or Sapien XT). Although it resolved in 37.7% by hospital discharge and 57.3% at 6- to 12-month follow-up, patients with persistent LBBB had a significantly higher incidence of syncope and complete atrioventricular block requiring a permanent pacemaker (J. Am. Coll. Cardiol. 2012;60:1743-52 [doi:10.1016/j.jacc.2012.035].

The researchers will look at LBBB in detailed analyses expected from ADVANCE, but there’s been no evidence of a problem with LBBB in earlier follow-up in ADVANCE or from other CoreValve users.

Quality of life data from ADVANCE, reported in a separate poster session at the meeting, showed significant benefits with CoreValve, even in higher-risk patients. The access route used during TAVI had no impact on quality of life improvement at 6 months.

Dr. Linke has served as a consultant for Medtronic, the study sponsor.

[email protected]

LOS ANGELES  – Patients with diabetes who had revascularization for multivessel coronary artery disease fared significantly better with coronary artery bypass grafting than with percutaneous coronary intervention using drug-eluting stents in the landmark FREEDOM trial.

FREEDOM (Future Revascularization Evaluation in Patients With Diabetes Mellitus: Optimal Management of Multivessel Disease) was an international randomized trial involving 1,900 subjects who were considered candidates for both CABG and PCI. The primary outcome – a composite of 5-year all-cause mortality and nonfatal MI or stroke – occurred in 26.6% of the PCI group, compared with 18.7% of the CABG group. That’s a 7.9% absolute reduction and 30% lower relative risk. The CABG advantage held up regardless of SYNTAX score, a measure of disease extent.

"The results are clear. I think this is going to change practice," FREEDOM chair Dr. Valentin Fuster predicted in presenting the study’s main findings at the annual scientific sessions of the American Heart Association.

Bruce Jancin/IMNG Medical Media

Participants in the CABG group had a 5-year mortality of 10.9%, compared with 16.3% in the PCI group. Their nonfatal MI rate was less than half of that in the PCI group: 6.0% vs. 13.9%.

The CABG group’s 5.2% nonfatal stroke rate was significantly higher than the 2.4% rate in the PCI group. However, the excess of strokes in the CABG group was confined to the first 30 days post procedure; after that, stroke rates in the two groups didn’t differ significantly. Only 13% of strokes were hemorrhagic. The majority of strokes occurred more than 1 year post procedure, according to Dr. Fuster, professor of medicine and director of the cardiovascular institute at Mount Sinai Medical Center, New York.

The repeat revascularization rate after 1 year of follow-up was 13% in the PCI group and 5% in CABG-treated patients. At 5 years, repeat revascularization had occurred in 30% of the PCI group, compared with 13% in the CABG group.

Thirteen percent of FREEDOM participants had two-vessel disease, and the rest had triple-vessel disease. Outcomes in both groups were superior with CABG.

The CABG and PCI groups didn’t differ significantly in 30-day rates of major bleeding or acute renal failure.

Seventeen years ago, the National Heart, Lung, and Blood Institute issued a clinical alert recommending CABG over PCI for patients with diabetes on the strength of the results of BARI, the Bypass Angioplasty Revascularization Investigation (N. Engl. J. Med. 1996;335:217-25) Yet, PCI has since become increasingly popular in diabetes patients.

Many interventional cardiologists have dismissed the results of BARI and other smaller studies favoring CABG as irrelevant in the contemporary era of much-improved PCI techniques and drug-eluting stents, even though the current joint AHA/American College of Cardiology/Society for Coronary Angiography and Interventions guidelines state as a class IIa recommendation that "it is reasonable" to choose CABG with left internal mammary artery grafting over PCI in diabetic patients with multivessel disease.

FREEDOM discussant and interventional cardiologist Dr. David O. Williams said that this new study should put an end to the controversy. He predicted the guidelines will be revised to raise CABG from a class IIa recommendation to class I.

"The study is very convincing, and I think the guidelines will eventually come down very strongly on this. And so will payers, by the way – and that’s another group that can exert influence," observed Dr. Williams of Brigham and Women’s Hospital, Boston.

Another discussant, Dr. Alice K. Jacobs, also an interventional cardiologist, said she was impressed by the FREEDOM finding that CABG was superior in all patient subgroups, even in patients with normal left ventricular function.

"Certainly it has been the case that if you had reduced left ventricular function, the needle would swing toward CABG, but now even with normal left ventricular function, patients fare better. That needs to be recognized," said Dr. Jacobs, professor of medicine at Boston University.

"With a diabetic patient who is a candidate for either procedure, one would have to think long and hard about performing PCI at this point," she added.

Interventional cardiologist Dr. Gilles Montalescot of Pitie-Salpétrière University Hospital, Paris, found the demonstrated mortality benefit for CABG in FREEDOM compelling.

"This signal cannot be ignored. There has been some reluctance on the part of interventional cardiologists to send patients who have diabetes to the [operating room] for CABG. We should use these FREEDOM data to convince our colleagues that the way to go is to send our patients for surgery, whatever their SYNTAX score. But I think often the patients, too, have been reluctant to go to the OR," he said.

Dr. Fuster agreed, adding that a key implication of FREEDOM is that when a diabetic patient is scheduled for coronary angiography, a conversation about the study findings needs to occur before the trip to the catheterization laboratory. That way the patient understands in advance that if multivessel disease is found, strong consideration needs to be given to CABG.

"To me the crux of the trial is to tell the patient early," Dr. Fuster said.

Persons with diabetes comprise roughly 25% of the nearly 1 million patients who undergo multivessel coronary revascularization each year in the United States.

Simultaneous with Dr. Fuster’s presentation at the AHA meeting, the FREEDOM results were published online in the New England Journal of Medicine (doi:10.1056/NEJMoa1211585).

The FREEDOM trial was funded by the National Heart, Lung, and Blood Institute. Dr. Fuster said he had no relevant financial conflicts. The discussants have received research grants from medical device manufacturers.

LOS ANGELES  – Patients with diabetes who had revascularization for multivessel coronary artery disease fared significantly better with coronary artery bypass grafting than with percutaneous coronary intervention using drug-eluting stents in the landmark FREEDOM trial.

FREEDOM (Future Revascularization Evaluation in Patients With Diabetes Mellitus: Optimal Management of Multivessel Disease) was an international randomized trial involving 1,900 subjects who were considered candidates for both CABG and PCI. The primary outcome – a composite of 5-year all-cause mortality and nonfatal MI or stroke – occurred in 26.6% of the PCI group, compared with 18.7% of the CABG group. That’s a 7.9% absolute reduction and 30% lower relative risk. The CABG advantage held up regardless of SYNTAX score, a measure of disease extent.

"The results are clear. I think this is going to change practice," FREEDOM chair Dr. Valentin Fuster predicted in presenting the study’s main findings at the annual scientific sessions of the American Heart Association.

Bruce Jancin/IMNG Medical Media

Participants in the CABG group had a 5-year mortality of 10.9%, compared with 16.3% in the PCI group. Their nonfatal MI rate was less than half of that in the PCI group: 6.0% vs. 13.9%.

The CABG group’s 5.2% nonfatal stroke rate was significantly higher than the 2.4% rate in the PCI group. However, the excess of strokes in the CABG group was confined to the first 30 days post procedure; after that, stroke rates in the two groups didn’t differ significantly. Only 13% of strokes were hemorrhagic. The majority of strokes occurred more than 1 year post procedure, according to Dr. Fuster, professor of medicine and director of the cardiovascular institute at Mount Sinai Medical Center, New York.

The repeat revascularization rate after 1 year of follow-up was 13% in the PCI group and 5% in CABG-treated patients. At 5 years, repeat revascularization had occurred in 30% of the PCI group, compared with 13% in the CABG group.

Thirteen percent of FREEDOM participants had two-vessel disease, and the rest had triple-vessel disease. Outcomes in both groups were superior with CABG.

The CABG and PCI groups didn’t differ significantly in 30-day rates of major bleeding or acute renal failure.

Seventeen years ago, the National Heart, Lung, and Blood Institute issued a clinical alert recommending CABG over PCI for patients with diabetes on the strength of the results of BARI, the Bypass Angioplasty Revascularization Investigation (N. Engl. J. Med. 1996;335:217-25) Yet, PCI has since become increasingly popular in diabetes patients.

Many interventional cardiologists have dismissed the results of BARI and other smaller studies favoring CABG as irrelevant in the contemporary era of much-improved PCI techniques and drug-eluting stents, even though the current joint AHA/American College of Cardiology/Society for Coronary Angiography and Interventions guidelines state as a class IIa recommendation that "it is reasonable" to choose CABG with left internal mammary artery grafting over PCI in diabetic patients with multivessel disease.

FREEDOM discussant and interventional cardiologist Dr. David O. Williams said that this new study should put an end to the controversy. He predicted the guidelines will be revised to raise CABG from a class IIa recommendation to class I.

"The study is very convincing, and I think the guidelines will eventually come down very strongly on this. And so will payers, by the way – and that’s another group that can exert influence," observed Dr. Williams of Brigham and Women’s Hospital, Boston.

Another discussant, Dr. Alice K. Jacobs, also an interventional cardiologist, said she was impressed by the FREEDOM finding that CABG was superior in all patient subgroups, even in patients with normal left ventricular function.

"Certainly it has been the case that if you had reduced left ventricular function, the needle would swing toward CABG, but now even with normal left ventricular function, patients fare better. That needs to be recognized," said Dr. Jacobs, professor of medicine at Boston University.

"With a diabetic patient who is a candidate for either procedure, one would have to think long and hard about performing PCI at this point," she added.

Interventional cardiologist Dr. Gilles Montalescot of Pitie-Salpétrière University Hospital, Paris, found the demonstrated mortality benefit for CABG in FREEDOM compelling.

"This signal cannot be ignored. There has been some reluctance on the part of interventional cardiologists to send patients who have diabetes to the [operating room] for CABG. We should use these FREEDOM data to convince our colleagues that the way to go is to send our patients for surgery, whatever their SYNTAX score. But I think often the patients, too, have been reluctant to go to the OR," he said.

Dr. Fuster agreed, adding that a key implication of FREEDOM is that when a diabetic patient is scheduled for coronary angiography, a conversation about the study findings needs to occur before the trip to the catheterization laboratory. That way the patient understands in advance that if multivessel disease is found, strong consideration needs to be given to CABG.

"To me the crux of the trial is to tell the patient early," Dr. Fuster said.

Persons with diabetes comprise roughly 25% of the nearly 1 million patients who undergo multivessel coronary revascularization each year in the United States.

Simultaneous with Dr. Fuster’s presentation at the AHA meeting, the FREEDOM results were published online in the New England Journal of Medicine (doi:10.1056/NEJMoa1211585).

The FREEDOM trial was funded by the National Heart, Lung, and Blood Institute. Dr. Fuster said he had no relevant financial conflicts. The discussants have received research grants from medical device manufacturers.

LOS ANGELES  – Patients with diabetes who had revascularization for multivessel coronary artery disease fared significantly better with coronary artery bypass grafting than with percutaneous coronary intervention using drug-eluting stents in the landmark FREEDOM trial.

FREEDOM (Future Revascularization Evaluation in Patients With Diabetes Mellitus: Optimal Management of Multivessel Disease) was an international randomized trial involving 1,900 subjects who were considered candidates for both CABG and PCI. The primary outcome – a composite of 5-year all-cause mortality and nonfatal MI or stroke – occurred in 26.6% of the PCI group, compared with 18.7% of the CABG group. That’s a 7.9% absolute reduction and 30% lower relative risk. The CABG advantage held up regardless of SYNTAX score, a measure of disease extent.

"The results are clear. I think this is going to change practice," FREEDOM chair Dr. Valentin Fuster predicted in presenting the study’s main findings at the annual scientific sessions of the American Heart Association.

Bruce Jancin/IMNG Medical Media

Participants in the CABG group had a 5-year mortality of 10.9%, compared with 16.3% in the PCI group. Their nonfatal MI rate was less than half of that in the PCI group: 6.0% vs. 13.9%.

The CABG group’s 5.2% nonfatal stroke rate was significantly higher than the 2.4% rate in the PCI group. However, the excess of strokes in the CABG group was confined to the first 30 days post procedure; after that, stroke rates in the two groups didn’t differ significantly. Only 13% of strokes were hemorrhagic. The majority of strokes occurred more than 1 year post procedure, according to Dr. Fuster, professor of medicine and director of the cardiovascular institute at Mount Sinai Medical Center, New York.

The repeat revascularization rate after 1 year of follow-up was 13% in the PCI group and 5% in CABG-treated patients. At 5 years, repeat revascularization had occurred in 30% of the PCI group, compared with 13% in the CABG group.

Thirteen percent of FREEDOM participants had two-vessel disease, and the rest had triple-vessel disease. Outcomes in both groups were superior with CABG.

The CABG and PCI groups didn’t differ significantly in 30-day rates of major bleeding or acute renal failure.

Seventeen years ago, the National Heart, Lung, and Blood Institute issued a clinical alert recommending CABG over PCI for patients with diabetes on the strength of the results of BARI, the Bypass Angioplasty Revascularization Investigation (N. Engl. J. Med. 1996;335:217-25) Yet, PCI has since become increasingly popular in diabetes patients.

Many interventional cardiologists have dismissed the results of BARI and other smaller studies favoring CABG as irrelevant in the contemporary era of much-improved PCI techniques and drug-eluting stents, even though the current joint AHA/American College of Cardiology/Society for Coronary Angiography and Interventions guidelines state as a class IIa recommendation that "it is reasonable" to choose CABG with left internal mammary artery grafting over PCI in diabetic patients with multivessel disease.

FREEDOM discussant and interventional cardiologist Dr. David O. Williams said that this new study should put an end to the controversy. He predicted the guidelines will be revised to raise CABG from a class IIa recommendation to class I.

"The study is very convincing, and I think the guidelines will eventually come down very strongly on this. And so will payers, by the way – and that’s another group that can exert influence," observed Dr. Williams of Brigham and Women’s Hospital, Boston.

Another discussant, Dr. Alice K. Jacobs, also an interventional cardiologist, said she was impressed by the FREEDOM finding that CABG was superior in all patient subgroups, even in patients with normal left ventricular function.

"Certainly it has been the case that if you had reduced left ventricular function, the needle would swing toward CABG, but now even with normal left ventricular function, patients fare better. That needs to be recognized," said Dr. Jacobs, professor of medicine at Boston University.

"With a diabetic patient who is a candidate for either procedure, one would have to think long and hard about performing PCI at this point," she added.

Interventional cardiologist Dr. Gilles Montalescot of Pitie-Salpétrière University Hospital, Paris, found the demonstrated mortality benefit for CABG in FREEDOM compelling.

"This signal cannot be ignored. There has been some reluctance on the part of interventional cardiologists to send patients who have diabetes to the [operating room] for CABG. We should use these FREEDOM data to convince our colleagues that the way to go is to send our patients for surgery, whatever their SYNTAX score. But I think often the patients, too, have been reluctant to go to the OR," he said.

Dr. Fuster agreed, adding that a key implication of FREEDOM is that when a diabetic patient is scheduled for coronary angiography, a conversation about the study findings needs to occur before the trip to the catheterization laboratory. That way the patient understands in advance that if multivessel disease is found, strong consideration needs to be given to CABG.

"To me the crux of the trial is to tell the patient early," Dr. Fuster said.

Persons with diabetes comprise roughly 25% of the nearly 1 million patients who undergo multivessel coronary revascularization each year in the United States.

Simultaneous with Dr. Fuster’s presentation at the AHA meeting, the FREEDOM results were published online in the New England Journal of Medicine (doi:10.1056/NEJMoa1211585).

The FREEDOM trial was funded by the National Heart, Lung, and Blood Institute. Dr. Fuster said he had no relevant financial conflicts. The discussants have received research grants from medical device manufacturers.

LOS ANGELES  – Patients with diabetes who had revascularization for multivessel coronary artery disease fared significantly better with coronary artery bypass grafting than with percutaneous coronary intervention using drug-eluting stents in the landmark FREEDOM trial.

FREEDOM (Future Revascularization Evaluation in Patients With Diabetes Mellitus: Optimal Management of Multivessel Disease) was an international randomized trial involving 1,900 subjects who were considered candidates for both CABG and PCI. The primary outcome – a composite of 5-year all-cause mortality and nonfatal MI or stroke – occurred in 26.6% of the PCI group, compared with 18.7% of the CABG group. That’s a 7.9% absolute reduction and 30% lower relative risk. The CABG advantage held up regardless of SYNTAX score, a measure of disease extent.

"The results are clear. I think this is going to change practice," FREEDOM chair Dr. Valentin Fuster predicted in presenting the study’s main findings at the annual scientific sessions of the American Heart Association.

Bruce Jancin/IMNG Medical Media

Participants in the CABG group had a 5-year mortality of 10.9%, compared with 16.3% in the PCI group. Their nonfatal MI rate was less than half of that in the PCI group: 6.0% vs. 13.9%.

The CABG group’s 5.2% nonfatal stroke rate was significantly higher than the 2.4% rate in the PCI group. However, the excess of strokes in the CABG group was confined to the first 30 days post procedure; after that, stroke rates in the two groups didn’t differ significantly. Only 13% of strokes were hemorrhagic. The majority of strokes occurred more than 1 year post procedure, according to Dr. Fuster, professor of medicine and director of the cardiovascular institute at Mount Sinai Medical Center, New York.

The repeat revascularization rate after 1 year of follow-up was 13% in the PCI group and 5% in CABG-treated patients. At 5 years, repeat revascularization had occurred in 30% of the PCI group, compared with 13% in the CABG group.

Thirteen percent of FREEDOM participants had two-vessel disease, and the rest had triple-vessel disease. Outcomes in both groups were superior with CABG.

The CABG and PCI groups didn’t differ significantly in 30-day rates of major bleeding or acute renal failure.

Seventeen years ago, the National Heart, Lung, and Blood Institute issued a clinical alert recommending CABG over PCI for patients with diabetes on the strength of the results of BARI, the Bypass Angioplasty Revascularization Investigation (N. Engl. J. Med. 1996;335:217-25) Yet, PCI has since become increasingly popular in diabetes patients.

Many interventional cardiologists have dismissed the results of BARI and other smaller studies favoring CABG as irrelevant in the contemporary era of much-improved PCI techniques and drug-eluting stents, even though the current joint AHA/American College of Cardiology/Society for Coronary Angiography and Interventions guidelines state as a class IIa recommendation that "it is reasonable" to choose CABG with left internal mammary artery grafting over PCI in diabetic patients with multivessel disease.

FREEDOM discussant and interventional cardiologist Dr. David O. Williams said that this new study should put an end to the controversy. He predicted the guidelines will be revised to raise CABG from a class IIa recommendation to class I.

"The study is very convincing, and I think the guidelines will eventually come down very strongly on this. And so will payers, by the way – and that’s another group that can exert influence," observed Dr. Williams of Brigham and Women’s Hospital, Boston.

Another discussant, Dr. Alice K. Jacobs, also an interventional cardiologist, said she was impressed by the FREEDOM finding that CABG was superior in all patient subgroups, even in patients with normal left ventricular function.

"Certainly it has been the case that if you had reduced left ventricular function, the needle would swing toward CABG, but now even with normal left ventricular function, patients fare better. That needs to be recognized," said Dr. Jacobs, professor of medicine at Boston University.

"With a diabetic patient who is a candidate for either procedure, one would have to think long and hard about performing PCI at this point," she added.

Interventional cardiologist Dr. Gilles Montalescot of Pitie-Salpétrière University Hospital, Paris, found the demonstrated mortality benefit for CABG in FREEDOM compelling.

"This signal cannot be ignored. There has been some reluctance on the part of interventional cardiologists to send patients who have diabetes to the [operating room] for CABG. We should use these FREEDOM data to convince our colleagues that the way to go is to send our patients for surgery, whatever their SYNTAX score. But I think often the patients, too, have been reluctant to go to the OR," he said.

Dr. Fuster agreed, adding that a key implication of FREEDOM is that when a diabetic patient is scheduled for coronary angiography, a conversation about the study findings needs to occur before the trip to the catheterization laboratory. That way the patient understands in advance that if multivessel disease is found, strong consideration needs to be given to CABG.

"To me the crux of the trial is to tell the patient early," Dr. Fuster said.

Persons with diabetes comprise roughly 25% of the nearly 1 million patients who undergo multivessel coronary revascularization each year in the United States.

Simultaneous with Dr. Fuster’s presentation at the AHA meeting, the FREEDOM results were published online in the New England Journal of Medicine (doi:10.1056/NEJMoa1211585).

The FREEDOM trial was funded by the National Heart, Lung, and Blood Institute. Dr. Fuster said he had no relevant financial conflicts. The discussants have received research grants from medical device manufacturers.

LOS ANGELES  – Patients with diabetes who had revascularization for multivessel coronary artery disease fared significantly better with coronary artery bypass grafting than with percutaneous coronary intervention using drug-eluting stents in the landmark FREEDOM trial.

FREEDOM (Future Revascularization Evaluation in Patients With Diabetes Mellitus: Optimal Management of Multivessel Disease) was an international randomized trial involving 1,900 subjects who were considered candidates for both CABG and PCI. The primary outcome – a composite of 5-year all-cause mortality and nonfatal MI or stroke – occurred in 26.6% of the PCI group, compared with 18.7% of the CABG group. That’s a 7.9% absolute reduction and 30% lower relative risk. The CABG advantage held up regardless of SYNTAX score, a measure of disease extent.

"The results are clear. I think this is going to change practice," FREEDOM chair Dr. Valentin Fuster predicted in presenting the study’s main findings at the annual scientific sessions of the American Heart Association.

Bruce Jancin/IMNG Medical Media

Participants in the CABG group had a 5-year mortality of 10.9%, compared with 16.3% in the PCI group. Their nonfatal MI rate was less than half of that in the PCI group: 6.0% vs. 13.9%.

The CABG group’s 5.2% nonfatal stroke rate was significantly higher than the 2.4% rate in the PCI group. However, the excess of strokes in the CABG group was confined to the first 30 days post procedure; after that, stroke rates in the two groups didn’t differ significantly. Only 13% of strokes were hemorrhagic. The majority of strokes occurred more than 1 year post procedure, according to Dr. Fuster, professor of medicine and director of the cardiovascular institute at Mount Sinai Medical Center, New York.

The repeat revascularization rate after 1 year of follow-up was 13% in the PCI group and 5% in CABG-treated patients. At 5 years, repeat revascularization had occurred in 30% of the PCI group, compared with 13% in the CABG group.

Thirteen percent of FREEDOM participants had two-vessel disease, and the rest had triple-vessel disease. Outcomes in both groups were superior with CABG.

The CABG and PCI groups didn’t differ significantly in 30-day rates of major bleeding or acute renal failure.

Seventeen years ago, the National Heart, Lung, and Blood Institute issued a clinical alert recommending CABG over PCI for patients with diabetes on the strength of the results of BARI, the Bypass Angioplasty Revascularization Investigation (N. Engl. J. Med. 1996;335:217-25) Yet, PCI has since become increasingly popular in diabetes patients.

Many interventional cardiologists have dismissed the results of BARI and other smaller studies favoring CABG as irrelevant in the contemporary era of much-improved PCI techniques and drug-eluting stents, even though the current joint AHA/American College of Cardiology/Society for Coronary Angiography and Interventions guidelines state as a class IIa recommendation that "it is reasonable" to choose CABG with left internal mammary artery grafting over PCI in diabetic patients with multivessel disease.

FREEDOM discussant and interventional cardiologist Dr. David O. Williams said that this new study should put an end to the controversy. He predicted the guidelines will be revised to raise CABG from a class IIa recommendation to class I.

"The study is very convincing, and I think the guidelines will eventually come down very strongly on this. And so will payers, by the way – and that’s another group that can exert influence," observed Dr. Williams of Brigham and Women’s Hospital, Boston.

Another discussant, Dr. Alice K. Jacobs, also an interventional cardiologist, said she was impressed by the FREEDOM finding that CABG was superior in all patient subgroups, even in patients with normal left ventricular function.

"Certainly it has been the case that if you had reduced left ventricular function, the needle would swing toward CABG, but now even with normal left ventricular function, patients fare better. That needs to be recognized," said Dr. Jacobs, professor of medicine at Boston University.

"With a diabetic patient who is a candidate for either procedure, one would have to think long and hard about performing PCI at this point," she added.

Interventional cardiologist Dr. Gilles Montalescot of Pitie-Salpétrière University Hospital, Paris, found the demonstrated mortality benefit for CABG in FREEDOM compelling.

"This signal cannot be ignored. There has been some reluctance on the part of interventional cardiologists to send patients who have diabetes to the [operating room] for CABG. We should use these FREEDOM data to convince our colleagues that the way to go is to send our patients for surgery, whatever their SYNTAX score. But I think often the patients, too, have been reluctant to go to the OR," he said.

Dr. Fuster agreed, adding that a key implication of FREEDOM is that when a diabetic patient is scheduled for coronary angiography, a conversation about the study findings needs to occur before the trip to the catheterization laboratory. That way the patient understands in advance that if multivessel disease is found, strong consideration needs to be given to CABG.

"To me the crux of the trial is to tell the patient early," Dr. Fuster said.

Persons with diabetes comprise roughly 25% of the nearly 1 million patients who undergo multivessel coronary revascularization each year in the United States.

Simultaneous with Dr. Fuster’s presentation at the AHA meeting, the FREEDOM results were published online in the New England Journal of Medicine (doi:10.1056/NEJMoa1211585).

The FREEDOM trial was funded by the National Heart, Lung, and Blood Institute. Dr. Fuster said he had no relevant financial conflicts. The discussants have received research grants from medical device manufacturers.

LOS ANGELES  – Patients with diabetes who had revascularization for multivessel coronary artery disease fared significantly better with coronary artery bypass grafting than with percutaneous coronary intervention using drug-eluting stents in the landmark FREEDOM trial.

FREEDOM (Future Revascularization Evaluation in Patients With Diabetes Mellitus: Optimal Management of Multivessel Disease) was an international randomized trial involving 1,900 subjects who were considered candidates for both CABG and PCI. The primary outcome – a composite of 5-year all-cause mortality and nonfatal MI or stroke – occurred in 26.6% of the PCI group, compared with 18.7% of the CABG group. That’s a 7.9% absolute reduction and 30% lower relative risk. The CABG advantage held up regardless of SYNTAX score, a measure of disease extent.

"The results are clear. I think this is going to change practice," FREEDOM chair Dr. Valentin Fuster predicted in presenting the study’s main findings at the annual scientific sessions of the American Heart Association.

Bruce Jancin/IMNG Medical Media

Participants in the CABG group had a 5-year mortality of 10.9%, compared with 16.3% in the PCI group. Their nonfatal MI rate was less than half of that in the PCI group: 6.0% vs. 13.9%.

The CABG group’s 5.2% nonfatal stroke rate was significantly higher than the 2.4% rate in the PCI group. However, the excess of strokes in the CABG group was confined to the first 30 days post procedure; after that, stroke rates in the two groups didn’t differ significantly. Only 13% of strokes were hemorrhagic. The majority of strokes occurred more than 1 year post procedure, according to Dr. Fuster, professor of medicine and director of the cardiovascular institute at Mount Sinai Medical Center, New York.

The repeat revascularization rate after 1 year of follow-up was 13% in the PCI group and 5% in CABG-treated patients. At 5 years, repeat revascularization had occurred in 30% of the PCI group, compared with 13% in the CABG group.

Thirteen percent of FREEDOM participants had two-vessel disease, and the rest had triple-vessel disease. Outcomes in both groups were superior with CABG.

The CABG and PCI groups didn’t differ significantly in 30-day rates of major bleeding or acute renal failure.

Seventeen years ago, the National Heart, Lung, and Blood Institute issued a clinical alert recommending CABG over PCI for patients with diabetes on the strength of the results of BARI, the Bypass Angioplasty Revascularization Investigation (N. Engl. J. Med. 1996;335:217-25) Yet, PCI has since become increasingly popular in diabetes patients.

Many interventional cardiologists have dismissed the results of BARI and other smaller studies favoring CABG as irrelevant in the contemporary era of much-improved PCI techniques and drug-eluting stents, even though the current joint AHA/American College of Cardiology/Society for Coronary Angiography and Interventions guidelines state as a class IIa recommendation that "it is reasonable" to choose CABG with left internal mammary artery grafting over PCI in diabetic patients with multivessel disease.

FREEDOM discussant and interventional cardiologist Dr. David O. Williams said that this new study should put an end to the controversy. He predicted the guidelines will be revised to raise CABG from a class IIa recommendation to class I.

"The study is very convincing, and I think the guidelines will eventually come down very strongly on this. And so will payers, by the way – and that’s another group that can exert influence," observed Dr. Williams of Brigham and Women’s Hospital, Boston.

Another discussant, Dr. Alice K. Jacobs, also an interventional cardiologist, said she was impressed by the FREEDOM finding that CABG was superior in all patient subgroups, even in patients with normal left ventricular function.

"Certainly it has been the case that if you had reduced left ventricular function, the needle would swing toward CABG, but now even with normal left ventricular function, patients fare better. That needs to be recognized," said Dr. Jacobs, professor of medicine at Boston University.

"With a diabetic patient who is a candidate for either procedure, one would have to think long and hard about performing PCI at this point," she added.

Interventional cardiologist Dr. Gilles Montalescot of Pitie-Salpétrière University Hospital, Paris, found the demonstrated mortality benefit for CABG in FREEDOM compelling.

"This signal cannot be ignored. There has been some reluctance on the part of interventional cardiologists to send patients who have diabetes to the [operating room] for CABG. We should use these FREEDOM data to convince our colleagues that the way to go is to send our patients for surgery, whatever their SYNTAX score. But I think often the patients, too, have been reluctant to go to the OR," he said.

Dr. Fuster agreed, adding that a key implication of FREEDOM is that when a diabetic patient is scheduled for coronary angiography, a conversation about the study findings needs to occur before the trip to the catheterization laboratory. That way the patient understands in advance that if multivessel disease is found, strong consideration needs to be given to CABG.

"To me the crux of the trial is to tell the patient early," Dr. Fuster said.

Persons with diabetes comprise roughly 25% of the nearly 1 million patients who undergo multivessel coronary revascularization each year in the United States.

Simultaneous with Dr. Fuster’s presentation at the AHA meeting, the FREEDOM results were published online in the New England Journal of Medicine (doi:10.1056/NEJMoa1211585).

The FREEDOM trial was funded by the National Heart, Lung, and Blood Institute. Dr. Fuster said he had no relevant financial conflicts. The discussants have received research grants from medical device manufacturers.

The use of percutaneous coronary intervention for acute myocardial infarction was found to be lower in three states that implemented public reporting of PCI outcomes than in seven nearby states without public reporting, according to a study of nearly 98,000 cases.

In addition, the use of PCI for acute MI declined in one state after public reporting of PCI outcomes was implemented there, said Dr. Karen E. Joynt of the departments of health policy and management at Harvard School of Public Health, Boston, and her associates.

Nevertheless, public reporting was not associated with any change in mortality for patients with acute MI in this study, they noted.

Collecting and publicly reporting patient outcomes is a tool intended to improve health care by motivating clinicians to improve their performance and allowing patients to choose the highest-quality hospitals. Critics of this strategy, however, say that it creates disincentives for physicians and hospitals to care for the sickest patients and may lead them to avoid offering lifesaving procedures such as PCI to the sickest or highest-risk patients.

To date, no national studies have examined whether public reporting of PCI outcomes has affected either the rates of PCI or the outcomes in patients with acute MI. Dr. Joynt and her colleagues did so using data from Medicare files.

They first performed a cross-sectional analysis of PCI rates in 30,745 patients who had a discharge diagnosis of acute MI in a single year, 2010. They compared the rates in three states that mandated public reporting -- Massachusetts, Pennsylvania, and New York -- against rates in seven nearby states that did not (Maine, Vermont, New Hampshire, Connecticut, Rhode Island, Maryland, and Delaware).

Patients in the public-reporting states were significantly less likely to receive PCI (37.7%) than were those in nonreporting states (42.7%). This trend was most pronounced in MI patients who had ST-elevation MI, cardiogenic shock, or cardiac arrest and was not seen in patients with non- ST-elevation MI, the investigators said (JAMA 2012;308:1460-8).

When the patients were categorized by age -- 65-74 years vs. 75 years and older -- the results were the same: Regardless of their age, patients in publicly reporting states were less likely to receive PCI than were those in nonreporting states.

The researchers then performed a longitudinal analysis of trends in PCI rates for 49,660 acute MI patients in reporting states and 48,142 in nonreporting states who were treated in 2002-2010. They focused on the experience in Massachusetts, tracking the rates before public reporting of PCI was implemented there (2002-2004) with the rates after it was implemented (2006-2010).

Before public reporting of PCI was implemented, the PCI rate in Massachusetts (40.6%) was comparable with that in nonreporting states (41.8%), but PCI rates in Massachusetts began to decline when reporting was implemented and by 2010 patients in Massachusetts were significantly less likely to receive PCI than were those in nonreporting states.

As in the cross-sectional study, PCI rates in Massachusetts declined the most among MI patients who had cardiogenic shock or cardiac arrest, and these findings did not change when patients were categorized by younger vs. older age.

Despite these declines in PCI rates, there was no significant difference in 30-day mortality between acute MI patients in reporting states (12.8%) and those in nonreporting states (12.1%). Some may find it reassuring that mandating public reporting did not increase patient mortality, but, conversely, it also did not reduce mortality, the researchers said.

The authors proposed two explanations why mortality was not affected by reductions in PCI rates. First, it may be that public reporting had its intended effect of focusing clinicians on performing PCI in only the most appropriate patients. Alternatively, it's possible that public reporting had an effect of pressuring physicians to avoid PCI in eligible but high-risk patients.

This study was funded by the NHLBI. No financial conflicts were reported.

The use of percutaneous coronary intervention for acute myocardial infarction was found to be lower in three states that implemented public reporting of PCI outcomes than in seven nearby states without public reporting, according to a study of nearly 98,000 cases.

In addition, the use of PCI for acute MI declined in one state after public reporting of PCI outcomes was implemented there, said Dr. Karen E. Joynt of the departments of health policy and management at Harvard School of Public Health, Boston, and her associates.

Nevertheless, public reporting was not associated with any change in mortality for patients with acute MI in this study, they noted.

Collecting and publicly reporting patient outcomes is a tool intended to improve health care by motivating clinicians to improve their performance and allowing patients to choose the highest-quality hospitals. Critics of this strategy, however, say that it creates disincentives for physicians and hospitals to care for the sickest patients and may lead them to avoid offering lifesaving procedures such as PCI to the sickest or highest-risk patients.

To date, no national studies have examined whether public reporting of PCI outcomes has affected either the rates of PCI or the outcomes in patients with acute MI. Dr. Joynt and her colleagues did so using data from Medicare files.

They first performed a cross-sectional analysis of PCI rates in 30,745 patients who had a discharge diagnosis of acute MI in a single year, 2010. They compared the rates in three states that mandated public reporting -- Massachusetts, Pennsylvania, and New York -- against rates in seven nearby states that did not (Maine, Vermont, New Hampshire, Connecticut, Rhode Island, Maryland, and Delaware).

Patients in the public-reporting states were significantly less likely to receive PCI (37.7%) than were those in nonreporting states (42.7%). This trend was most pronounced in MI patients who had ST-elevation MI, cardiogenic shock, or cardiac arrest and was not seen in patients with non- ST-elevation MI, the investigators said (JAMA 2012;308:1460-8).

When the patients were categorized by age -- 65-74 years vs. 75 years and older -- the results were the same: Regardless of their age, patients in publicly reporting states were less likely to receive PCI than were those in nonreporting states.

The researchers then performed a longitudinal analysis of trends in PCI rates for 49,660 acute MI patients in reporting states and 48,142 in nonreporting states who were treated in 2002-2010. They focused on the experience in Massachusetts, tracking the rates before public reporting of PCI was implemented there (2002-2004) with the rates after it was implemented (2006-2010).

Before public reporting of PCI was implemented, the PCI rate in Massachusetts (40.6%) was comparable with that in nonreporting states (41.8%), but PCI rates in Massachusetts began to decline when reporting was implemented and by 2010 patients in Massachusetts were significantly less likely to receive PCI than were those in nonreporting states.

As in the cross-sectional study, PCI rates in Massachusetts declined the most among MI patients who had cardiogenic shock or cardiac arrest, and these findings did not change when patients were categorized by younger vs. older age.

Despite these declines in PCI rates, there was no significant difference in 30-day mortality between acute MI patients in reporting states (12.8%) and those in nonreporting states (12.1%). Some may find it reassuring that mandating public reporting did not increase patient mortality, but, conversely, it also did not reduce mortality, the researchers said.

The authors proposed two explanations why mortality was not affected by reductions in PCI rates. First, it may be that public reporting had its intended effect of focusing clinicians on performing PCI in only the most appropriate patients. Alternatively, it's possible that public reporting had an effect of pressuring physicians to avoid PCI in eligible but high-risk patients.

This study was funded by the NHLBI. No financial conflicts were reported.

The use of percutaneous coronary intervention for acute myocardial infarction was found to be lower in three states that implemented public reporting of PCI outcomes than in seven nearby states without public reporting, according to a study of nearly 98,000 cases.

In addition, the use of PCI for acute MI declined in one state after public reporting of PCI outcomes was implemented there, said Dr. Karen E. Joynt of the departments of health policy and management at Harvard School of Public Health, Boston, and her associates.

Nevertheless, public reporting was not associated with any change in mortality for patients with acute MI in this study, they noted.

Collecting and publicly reporting patient outcomes is a tool intended to improve health care by motivating clinicians to improve their performance and allowing patients to choose the highest-quality hospitals. Critics of this strategy, however, say that it creates disincentives for physicians and hospitals to care for the sickest patients and may lead them to avoid offering lifesaving procedures such as PCI to the sickest or highest-risk patients.

To date, no national studies have examined whether public reporting of PCI outcomes has affected either the rates of PCI or the outcomes in patients with acute MI. Dr. Joynt and her colleagues did so using data from Medicare files.

They first performed a cross-sectional analysis of PCI rates in 30,745 patients who had a discharge diagnosis of acute MI in a single year, 2010. They compared the rates in three states that mandated public reporting -- Massachusetts, Pennsylvania, and New York -- against rates in seven nearby states that did not (Maine, Vermont, New Hampshire, Connecticut, Rhode Island, Maryland, and Delaware).

Patients in the public-reporting states were significantly less likely to receive PCI (37.7%) than were those in nonreporting states (42.7%). This trend was most pronounced in MI patients who had ST-elevation MI, cardiogenic shock, or cardiac arrest and was not seen in patients with non- ST-elevation MI, the investigators said (JAMA 2012;308:1460-8).

When the patients were categorized by age -- 65-74 years vs. 75 years and older -- the results were the same: Regardless of their age, patients in publicly reporting states were less likely to receive PCI than were those in nonreporting states.

The researchers then performed a longitudinal analysis of trends in PCI rates for 49,660 acute MI patients in reporting states and 48,142 in nonreporting states who were treated in 2002-2010. They focused on the experience in Massachusetts, tracking the rates before public reporting of PCI was implemented there (2002-2004) with the rates after it was implemented (2006-2010).

Before public reporting of PCI was implemented, the PCI rate in Massachusetts (40.6%) was comparable with that in nonreporting states (41.8%), but PCI rates in Massachusetts began to decline when reporting was implemented and by 2010 patients in Massachusetts were significantly less likely to receive PCI than were those in nonreporting states.

As in the cross-sectional study, PCI rates in Massachusetts declined the most among MI patients who had cardiogenic shock or cardiac arrest, and these findings did not change when patients were categorized by younger vs. older age.

Despite these declines in PCI rates, there was no significant difference in 30-day mortality between acute MI patients in reporting states (12.8%) and those in nonreporting states (12.1%). Some may find it reassuring that mandating public reporting did not increase patient mortality, but, conversely, it also did not reduce mortality, the researchers said.

The authors proposed two explanations why mortality was not affected by reductions in PCI rates. First, it may be that public reporting had its intended effect of focusing clinicians on performing PCI in only the most appropriate patients. Alternatively, it's possible that public reporting had an effect of pressuring physicians to avoid PCI in eligible but high-risk patients.

This study was funded by the NHLBI. No financial conflicts were reported.

The use of percutaneous coronary intervention for acute myocardial infarction was found to be lower in three states that implemented public reporting of PCI outcomes than in seven nearby states without public reporting, according to a study of nearly 98,000 cases.

In addition, the use of PCI for acute MI declined in one state after public reporting of PCI outcomes was implemented there, said Dr. Karen E. Joynt of the departments of health policy and management at Harvard School of Public Health, Boston, and her associates.

Nevertheless, public reporting was not associated with any change in mortality for patients with acute MI in this study, they noted.

Collecting and publicly reporting patient outcomes is a tool intended to improve health care by motivating clinicians to improve their performance and allowing patients to choose the highest-quality hospitals. Critics of this strategy, however, say that it creates disincentives for physicians and hospitals to care for the sickest patients and may lead them to avoid offering lifesaving procedures such as PCI to the sickest or highest-risk patients.

To date, no national studies have examined whether public reporting of PCI outcomes has affected either the rates of PCI or the outcomes in patients with acute MI. Dr. Joynt and her colleagues did so using data from Medicare files.

They first performed a cross-sectional analysis of PCI rates in 30,745 patients who had a discharge diagnosis of acute MI in a single year, 2010. They compared the rates in three states that mandated public reporting -- Massachusetts, Pennsylvania, and New York -- against rates in seven nearby states that did not (Maine, Vermont, New Hampshire, Connecticut, Rhode Island, Maryland, and Delaware).

Patients in the public-reporting states were significantly less likely to receive PCI (37.7%) than were those in nonreporting states (42.7%). This trend was most pronounced in MI patients who had ST-elevation MI, cardiogenic shock, or cardiac arrest and was not seen in patients with non- ST-elevation MI, the investigators said (JAMA 2012;308:1460-8).

When the patients were categorized by age -- 65-74 years vs. 75 years and older -- the results were the same: Regardless of their age, patients in publicly reporting states were less likely to receive PCI than were those in nonreporting states.

The researchers then performed a longitudinal analysis of trends in PCI rates for 49,660 acute MI patients in reporting states and 48,142 in nonreporting states who were treated in 2002-2010. They focused on the experience in Massachusetts, tracking the rates before public reporting of PCI was implemented there (2002-2004) with the rates after it was implemented (2006-2010).

Before public reporting of PCI was implemented, the PCI rate in Massachusetts (40.6%) was comparable with that in nonreporting states (41.8%), but PCI rates in Massachusetts began to decline when reporting was implemented and by 2010 patients in Massachusetts were significantly less likely to receive PCI than were those in nonreporting states.

As in the cross-sectional study, PCI rates in Massachusetts declined the most among MI patients who had cardiogenic shock or cardiac arrest, and these findings did not change when patients were categorized by younger vs. older age.

Despite these declines in PCI rates, there was no significant difference in 30-day mortality between acute MI patients in reporting states (12.8%) and those in nonreporting states (12.1%). Some may find it reassuring that mandating public reporting did not increase patient mortality, but, conversely, it also did not reduce mortality, the researchers said.

The authors proposed two explanations why mortality was not affected by reductions in PCI rates. First, it may be that public reporting had its intended effect of focusing clinicians on performing PCI in only the most appropriate patients. Alternatively, it's possible that public reporting had an effect of pressuring physicians to avoid PCI in eligible but high-risk patients.

This study was funded by the NHLBI. No financial conflicts were reported.

The use of percutaneous coronary intervention for acute myocardial infarction was found to be lower in three states that implemented public reporting of PCI outcomes than in seven nearby states without public reporting, according to a study of nearly 98,000 cases.

In addition, the use of PCI for acute MI declined in one state after public reporting of PCI outcomes was implemented there, said Dr. Karen E. Joynt of the departments of health policy and management at Harvard School of Public Health, Boston, and her associates.

Nevertheless, public reporting was not associated with any change in mortality for patients with acute MI in this study, they noted.

Collecting and publicly reporting patient outcomes is a tool intended to improve health care by motivating clinicians to improve their performance and allowing patients to choose the highest-quality hospitals. Critics of this strategy, however, say that it creates disincentives for physicians and hospitals to care for the sickest patients and may lead them to avoid offering lifesaving procedures such as PCI to the sickest or highest-risk patients.

To date, no national studies have examined whether public reporting of PCI outcomes has affected either the rates of PCI or the outcomes in patients with acute MI. Dr. Joynt and her colleagues did so using data from Medicare files.

They first performed a cross-sectional analysis of PCI rates in 30,745 patients who had a discharge diagnosis of acute MI in a single year, 2010. They compared the rates in three states that mandated public reporting -- Massachusetts, Pennsylvania, and New York -- against rates in seven nearby states that did not (Maine, Vermont, New Hampshire, Connecticut, Rhode Island, Maryland, and Delaware).

Patients in the public-reporting states were significantly less likely to receive PCI (37.7%) than were those in nonreporting states (42.7%). This trend was most pronounced in MI patients who had ST-elevation MI, cardiogenic shock, or cardiac arrest and was not seen in patients with non- ST-elevation MI, the investigators said (JAMA 2012;308:1460-8).

When the patients were categorized by age -- 65-74 years vs. 75 years and older -- the results were the same: Regardless of their age, patients in publicly reporting states were less likely to receive PCI than were those in nonreporting states.

The researchers then performed a longitudinal analysis of trends in PCI rates for 49,660 acute MI patients in reporting states and 48,142 in nonreporting states who were treated in 2002-2010. They focused on the experience in Massachusetts, tracking the rates before public reporting of PCI was implemented there (2002-2004) with the rates after it was implemented (2006-2010).

Before public reporting of PCI was implemented, the PCI rate in Massachusetts (40.6%) was comparable with that in nonreporting states (41.8%), but PCI rates in Massachusetts began to decline when reporting was implemented and by 2010 patients in Massachusetts were significantly less likely to receive PCI than were those in nonreporting states.

As in the cross-sectional study, PCI rates in Massachusetts declined the most among MI patients who had cardiogenic shock or cardiac arrest, and these findings did not change when patients were categorized by younger vs. older age.

Despite these declines in PCI rates, there was no significant difference in 30-day mortality between acute MI patients in reporting states (12.8%) and those in nonreporting states (12.1%). Some may find it reassuring that mandating public reporting did not increase patient mortality, but, conversely, it also did not reduce mortality, the researchers said.

The authors proposed two explanations why mortality was not affected by reductions in PCI rates. First, it may be that public reporting had its intended effect of focusing clinicians on performing PCI in only the most appropriate patients. Alternatively, it's possible that public reporting had an effect of pressuring physicians to avoid PCI in eligible but high-risk patients.

This study was funded by the NHLBI. No financial conflicts were reported.

The use of percutaneous coronary intervention for acute myocardial infarction was found to be lower in three states that implemented public reporting of PCI outcomes than in seven nearby states without public reporting, according to a study of nearly 98,000 cases.

In addition, the use of PCI for acute MI declined in one state after public reporting of PCI outcomes was implemented there, said Dr. Karen E. Joynt of the departments of health policy and management at Harvard School of Public Health, Boston, and her associates.

Nevertheless, public reporting was not associated with any change in mortality for patients with acute MI in this study, they noted.

Collecting and publicly reporting patient outcomes is a tool intended to improve health care by motivating clinicians to improve their performance and allowing patients to choose the highest-quality hospitals. Critics of this strategy, however, say that it creates disincentives for physicians and hospitals to care for the sickest patients and may lead them to avoid offering lifesaving procedures such as PCI to the sickest or highest-risk patients.

To date, no national studies have examined whether public reporting of PCI outcomes has affected either the rates of PCI or the outcomes in patients with acute MI. Dr. Joynt and her colleagues did so using data from Medicare files.

They first performed a cross-sectional analysis of PCI rates in 30,745 patients who had a discharge diagnosis of acute MI in a single year, 2010. They compared the rates in three states that mandated public reporting -- Massachusetts, Pennsylvania, and New York -- against rates in seven nearby states that did not (Maine, Vermont, New Hampshire, Connecticut, Rhode Island, Maryland, and Delaware).

Patients in the public-reporting states were significantly less likely to receive PCI (37.7%) than were those in nonreporting states (42.7%). This trend was most pronounced in MI patients who had ST-elevation MI, cardiogenic shock, or cardiac arrest and was not seen in patients with non- ST-elevation MI, the investigators said (JAMA 2012;308:1460-8).

When the patients were categorized by age -- 65-74 years vs. 75 years and older -- the results were the same: Regardless of their age, patients in publicly reporting states were less likely to receive PCI than were those in nonreporting states.

The researchers then performed a longitudinal analysis of trends in PCI rates for 49,660 acute MI patients in reporting states and 48,142 in nonreporting states who were treated in 2002-2010. They focused on the experience in Massachusetts, tracking the rates before public reporting of PCI was implemented there (2002-2004) with the rates after it was implemented (2006-2010).

Before public reporting of PCI was implemented, the PCI rate in Massachusetts (40.6%) was comparable with that in nonreporting states (41.8%), but PCI rates in Massachusetts began to decline when reporting was implemented and by 2010 patients in Massachusetts were significantly less likely to receive PCI than were those in nonreporting states.

As in the cross-sectional study, PCI rates in Massachusetts declined the most among MI patients who had cardiogenic shock or cardiac arrest, and these findings did not change when patients were categorized by younger vs. older age.

Despite these declines in PCI rates, there was no significant difference in 30-day mortality between acute MI patients in reporting states (12.8%) and those in nonreporting states (12.1%). Some may find it reassuring that mandating public reporting did not increase patient mortality, but, conversely, it also did not reduce mortality, the researchers said.

The authors proposed two explanations why mortality was not affected by reductions in PCI rates. First, it may be that public reporting had its intended effect of focusing clinicians on performing PCI in only the most appropriate patients. Alternatively, it's possible that public reporting had an effect of pressuring physicians to avoid PCI in eligible but high-risk patients.

This study was funded by the NHLBI. No financial conflicts were reported.

MUNICH -- In-hospital mortality and complications following transcatheter aortic valve implantation in the real-world setting are comparable with those achieved in randomized controlled studies, according to data from the first large-scale national registry capturing surgical and catheter-based procedures.

"In high-risk patients, the in-hospital mortality with TAVI is at least as good, if not better, as with the surgical approach," said Dr. Christian Hamm, who presented data from 13,860 patients in the German Aortic Valve Registry (GARY) at the annual congress of the European Society of Cardiology.

Patrice Wendling/IMNG Medical Media

In-hospital mortality was 2.2% for conventional aortic valve replacement surgery alone, 4.6% for conventional surgery with coronary artery bypass grafting (CABG), 5.5% for TAVI using a transvascular approach, and 7.8% for TAVI with a transapical approach.

After adjusting for the expected higher risk profile of TAVI patients, the risk of in-hospital death was not increased with transvascular TAVI, compared with surgery alone, although there was a trend toward increased risk with transapical TAVI in both younger patients and those aged 75 years and older, said Dr. Hamm, medical director of the Kerckhoff Heart and Thorax Centre, Bad Nauheim, Germany.

When asked by the media whether the higher mortality may be diminishing use of the transapical approach, GARY coauthor Dr. Friedrich-Wilhelm Mohr said that similar rates have been seen in the source registry and that these patients tend to have slightly more comorbidities and vascular disease.

"The current data in 2012 do not show a pull back," said Dr. Mohr, medical director of the Leipzig (Germany) Heart Center. "It’s almost the same situation as here: two-thirds transfemoral and one-third transapical."

Consistent with earlier observations, the rate of cerebrovascular events was lowest in patients undergoing surgery without CABG at 2.2% and was "in the range of 3.5%" for all other groups, Dr. Hamm reported.

Discussant Dr. Olaf Wendler said it’s convincing that cerebrovascular complications are lower than in the landmark PARTNER (Placement of Aortic Transcatheter Valves) trial, which reported a 5% major stroke rate among TAVI patients at 30 days.

"This may be less of a problem than we thought about transcatheter-valve treatment in the past," he said. "However, again we don’t have all the details, definitions of the adverse events, and we don’t have a clear idea of how adverse events were adjudicated in this registry."

Rates of vascular complications and new onset atrioventricular (AV) blockage were highest after transvascular TAVI, while renal failure was most common after the transapical approach, said Dr. Wendler, professor at King’s College Hospital in London.

Specifically, vascular complications were reported in 12% of the transvascular patients, compared with 2.5% for the transapical approach, 2% for surgery plus CABG, and 1% for those patients who received surgery alone.

Residual postimplant aortic regurgitation, which has been linked to long-term TAVI outcome, "seemed to be excellent because more than 90% of patients had no or grade I regurgitation," Dr. Hamm said.

Only 7% of transvascular and 3% of transapical patients had grade II regurgitation, and only 1% of transapical and no transvascular patients had grade III or IV regurgitation.

Although between-valve comparisons were limited since the CoreValve was not implanted transapically, grade I or II aortic regurgitation was more common with the CoreValve (70%) than with the Edwards prosthesis (45.7%).

Despite the increasing shift of TAVI in lower-risk patients, data from GARY show that TAVI is being performed predominantly in high-risk patients, as recommended in various guidelines, Dr. Hamm said.

Participation in GARY is voluntary, with 92 of 99 German centers currently taking part. As of July 2012, more than 26,000 patients were included, of whom 23% were TAVI patients.

The current analysis included 13,860 patients from 53 cardiac surgery units and 69 cardiology units. Of these patients, 6,523 underwent surgery alone, 3,462 surgery plus CABG, 2,694 transvascular TAVI, and 1,181 transapical TAVI.

At baseline, TAVI patients were significantly older than surgical patients (average of 81 years transvascular and 80.3 years transapical vs. 68 years surgical); had significantly more comorbidities including atrial fibrillation, hypertension, and diabetes; and were significantly more likely to have a left ventricular ejection fraction below 30%.

Roughly half of elderly patients more than 75 years of age now receive TAVI in Germany, which is quite impressive and by far a higher number than any other country worldwide, said Dr. Wendler.

German investigators also have developed a novel risk scoring system called the AKL score, which, unlike the logistic EuroSCORE or Society of Thoracic Surgeons (STS) risk score, is based only on patients with aortic valve disease.

"The EuroSCORE, as many of us know, is not very suitable in this scenario," Dr. Hamm said.

When the GARY authors compared observed vs. expected in-hospital mortality based on patients’ EuroSCORE, the observed risk for mortality was much lower than predicted by the EuroSCORE.

When the same analysis was performed using the AKL score, however, the observed and expected mortality outcomes were very similar, suggesting the "AKL score much better reflects the real outcome of the patients," he said.

Dr. Wendler remarked that in low-risk patients, however, the observed in-hospital mortality was higher than what was predicted, "questioning if this is the right treatment for this group of patients."

GARY is supported by the German Heart Foundation and unrestricted grants from heart valve manufacturers. Dr. Hamm disclosed honoraria from Medtronic and Edwards Lifesciences and participation in clinical trials with Medtronic, Edwards, Symetis, and JenaValve.

Dr. Mohr reported no conflicts of interest. Dr. Wendler reported research ties with Edwards and consulting for Edwards and St. Jude Medical.

MUNICH -- In-hospital mortality and complications following transcatheter aortic valve implantation in the real-world setting are comparable with those achieved in randomized controlled studies, according to data from the first large-scale national registry capturing surgical and catheter-based procedures.

"In high-risk patients, the in-hospital mortality with TAVI is at least as good, if not better, as with the surgical approach," said Dr. Christian Hamm, who presented data from 13,860 patients in the German Aortic Valve Registry (GARY) at the annual congress of the European Society of Cardiology.

Patrice Wendling/IMNG Medical Media

In-hospital mortality was 2.2% for conventional aortic valve replacement surgery alone, 4.6% for conventional surgery with coronary artery bypass grafting (CABG), 5.5% for TAVI using a transvascular approach, and 7.8% for TAVI with a transapical approach.

After adjusting for the expected higher risk profile of TAVI patients, the risk of in-hospital death was not increased with transvascular TAVI, compared with surgery alone, although there was a trend toward increased risk with transapical TAVI in both younger patients and those aged 75 years and older, said Dr. Hamm, medical director of the Kerckhoff Heart and Thorax Centre, Bad Nauheim, Germany.

When asked by the media whether the higher mortality may be diminishing use of the transapical approach, GARY coauthor Dr. Friedrich-Wilhelm Mohr said that similar rates have been seen in the source registry and that these patients tend to have slightly more comorbidities and vascular disease.

"The current data in 2012 do not show a pull back," said Dr. Mohr, medical director of the Leipzig (Germany) Heart Center. "It’s almost the same situation as here: two-thirds transfemoral and one-third transapical."

Consistent with earlier observations, the rate of cerebrovascular events was lowest in patients undergoing surgery without CABG at 2.2% and was "in the range of 3.5%" for all other groups, Dr. Hamm reported.

Discussant Dr. Olaf Wendler said it’s convincing that cerebrovascular complications are lower than in the landmark PARTNER (Placement of Aortic Transcatheter Valves) trial, which reported a 5% major stroke rate among TAVI patients at 30 days.

"This may be less of a problem than we thought about transcatheter-valve treatment in the past," he said. "However, again we don’t have all the details, definitions of the adverse events, and we don’t have a clear idea of how adverse events were adjudicated in this registry."

Rates of vascular complications and new onset atrioventricular (AV) blockage were highest after transvascular TAVI, while renal failure was most common after the transapical approach, said Dr. Wendler, professor at King’s College Hospital in London.

Specifically, vascular complications were reported in 12% of the transvascular patients, compared with 2.5% for the transapical approach, 2% for surgery plus CABG, and 1% for those patients who received surgery alone.

Residual postimplant aortic regurgitation, which has been linked to long-term TAVI outcome, "seemed to be excellent because more than 90% of patients had no or grade I regurgitation," Dr. Hamm said.

Only 7% of transvascular and 3% of transapical patients had grade II regurgitation, and only 1% of transapical and no transvascular patients had grade III or IV regurgitation.

Although between-valve comparisons were limited since the CoreValve was not implanted transapically, grade I or II aortic regurgitation was more common with the CoreValve (70%) than with the Edwards prosthesis (45.7%).

Despite the increasing shift of TAVI in lower-risk patients, data from GARY show that TAVI is being performed predominantly in high-risk patients, as recommended in various guidelines, Dr. Hamm said.

Participation in GARY is voluntary, with 92 of 99 German centers currently taking part. As of July 2012, more than 26,000 patients were included, of whom 23% were TAVI patients.

The current analysis included 13,860 patients from 53 cardiac surgery units and 69 cardiology units. Of these patients, 6,523 underwent surgery alone, 3,462 surgery plus CABG, 2,694 transvascular TAVI, and 1,181 transapical TAVI.

At baseline, TAVI patients were significantly older than surgical patients (average of 81 years transvascular and 80.3 years transapical vs. 68 years surgical); had significantly more comorbidities including atrial fibrillation, hypertension, and diabetes; and were significantly more likely to have a left ventricular ejection fraction below 30%.

Roughly half of elderly patients more than 75 years of age now receive TAVI in Germany, which is quite impressive and by far a higher number than any other country worldwide, said Dr. Wendler.

German investigators also have developed a novel risk scoring system called the AKL score, which, unlike the logistic EuroSCORE or Society of Thoracic Surgeons (STS) risk score, is based only on patients with aortic valve disease.

"The EuroSCORE, as many of us know, is not very suitable in this scenario," Dr. Hamm said.

When the GARY authors compared observed vs. expected in-hospital mortality based on patients’ EuroSCORE, the observed risk for mortality was much lower than predicted by the EuroSCORE.

When the same analysis was performed using the AKL score, however, the observed and expected mortality outcomes were very similar, suggesting the "AKL score much better reflects the real outcome of the patients," he said.

Dr. Wendler remarked that in low-risk patients, however, the observed in-hospital mortality was higher than what was predicted, "questioning if this is the right treatment for this group of patients."

GARY is supported by the German Heart Foundation and unrestricted grants from heart valve manufacturers. Dr. Hamm disclosed honoraria from Medtronic and Edwards Lifesciences and participation in clinical trials with Medtronic, Edwards, Symetis, and JenaValve.

Dr. Mohr reported no conflicts of interest. Dr. Wendler reported research ties with Edwards and consulting for Edwards and St. Jude Medical.

MUNICH -- In-hospital mortality and complications following transcatheter aortic valve implantation in the real-world setting are comparable with those achieved in randomized controlled studies, according to data from the first large-scale national registry capturing surgical and catheter-based procedures.

"In high-risk patients, the in-hospital mortality with TAVI is at least as good, if not better, as with the surgical approach," said Dr. Christian Hamm, who presented data from 13,860 patients in the German Aortic Valve Registry (GARY) at the annual congress of the European Society of Cardiology.

Patrice Wendling/IMNG Medical Media

In-hospital mortality was 2.2% for conventional aortic valve replacement surgery alone, 4.6% for conventional surgery with coronary artery bypass grafting (CABG), 5.5% for TAVI using a transvascular approach, and 7.8% for TAVI with a transapical approach.

After adjusting for the expected higher risk profile of TAVI patients, the risk of in-hospital death was not increased with transvascular TAVI, compared with surgery alone, although there was a trend toward increased risk with transapical TAVI in both younger patients and those aged 75 years and older, said Dr. Hamm, medical director of the Kerckhoff Heart and Thorax Centre, Bad Nauheim, Germany.

When asked by the media whether the higher mortality may be diminishing use of the transapical approach, GARY coauthor Dr. Friedrich-Wilhelm Mohr said that similar rates have been seen in the source registry and that these patients tend to have slightly more comorbidities and vascular disease.

"The current data in 2012 do not show a pull back," said Dr. Mohr, medical director of the Leipzig (Germany) Heart Center. "It’s almost the same situation as here: two-thirds transfemoral and one-third transapical."

Consistent with earlier observations, the rate of cerebrovascular events was lowest in patients undergoing surgery without CABG at 2.2% and was "in the range of 3.5%" for all other groups, Dr. Hamm reported.

Discussant Dr. Olaf Wendler said it’s convincing that cerebrovascular complications are lower than in the landmark PARTNER (Placement of Aortic Transcatheter Valves) trial, which reported a 5% major stroke rate among TAVI patients at 30 days.

"This may be less of a problem than we thought about transcatheter-valve treatment in the past," he said. "However, again we don’t have all the details, definitions of the adverse events, and we don’t have a clear idea of how adverse events were adjudicated in this registry."

Rates of vascular complications and new onset atrioventricular (AV) blockage were highest after transvascular TAVI, while renal failure was most common after the transapical approach, said Dr. Wendler, professor at King’s College Hospital in London.

Specifically, vascular complications were reported in 12% of the transvascular patients, compared with 2.5% for the transapical approach, 2% for surgery plus CABG, and 1% for those patients who received surgery alone.

Residual postimplant aortic regurgitation, which has been linked to long-term TAVI outcome, "seemed to be excellent because more than 90% of patients had no or grade I regurgitation," Dr. Hamm said.

Only 7% of transvascular and 3% of transapical patients had grade II regurgitation, and only 1% of transapical and no transvascular patients had grade III or IV regurgitation.

Although between-valve comparisons were limited since the CoreValve was not implanted transapically, grade I or II aortic regurgitation was more common with the CoreValve (70%) than with the Edwards prosthesis (45.7%).

Despite the increasing shift of TAVI in lower-risk patients, data from GARY show that TAVI is being performed predominantly in high-risk patients, as recommended in various guidelines, Dr. Hamm said.

Participation in GARY is voluntary, with 92 of 99 German centers currently taking part. As of July 2012, more than 26,000 patients were included, of whom 23% were TAVI patients.

The current analysis included 13,860 patients from 53 cardiac surgery units and 69 cardiology units. Of these patients, 6,523 underwent surgery alone, 3,462 surgery plus CABG, 2,694 transvascular TAVI, and 1,181 transapical TAVI.

At baseline, TAVI patients were significantly older than surgical patients (average of 81 years transvascular and 80.3 years transapical vs. 68 years surgical); had significantly more comorbidities including atrial fibrillation, hypertension, and diabetes; and were significantly more likely to have a left ventricular ejection fraction below 30%.

Roughly half of elderly patients more than 75 years of age now receive TAVI in Germany, which is quite impressive and by far a higher number than any other country worldwide, said Dr. Wendler.

German investigators also have developed a novel risk scoring system called the AKL score, which, unlike the logistic EuroSCORE or Society of Thoracic Surgeons (STS) risk score, is based only on patients with aortic valve disease.

"The EuroSCORE, as many of us know, is not very suitable in this scenario," Dr. Hamm said.

When the GARY authors compared observed vs. expected in-hospital mortality based on patients’ EuroSCORE, the observed risk for mortality was much lower than predicted by the EuroSCORE.

When the same analysis was performed using the AKL score, however, the observed and expected mortality outcomes were very similar, suggesting the "AKL score much better reflects the real outcome of the patients," he said.

Dr. Wendler remarked that in low-risk patients, however, the observed in-hospital mortality was higher than what was predicted, "questioning if this is the right treatment for this group of patients."

GARY is supported by the German Heart Foundation and unrestricted grants from heart valve manufacturers. Dr. Hamm disclosed honoraria from Medtronic and Edwards Lifesciences and participation in clinical trials with Medtronic, Edwards, Symetis, and JenaValve.

Dr. Mohr reported no conflicts of interest. Dr. Wendler reported research ties with Edwards and consulting for Edwards and St. Jude Medical.

MUNICH -- In-hospital mortality and complications following transcatheter aortic valve implantation in the real-world setting are comparable with those achieved in randomized controlled studies, according to data from the first large-scale national registry capturing surgical and catheter-based procedures.

"In high-risk patients, the in-hospital mortality with TAVI is at least as good, if not better, as with the surgical approach," said Dr. Christian Hamm, who presented data from 13,860 patients in the German Aortic Valve Registry (GARY) at the annual congress of the European Society of Cardiology.

Patrice Wendling/IMNG Medical Media

In-hospital mortality was 2.2% for conventional aortic valve replacement surgery alone, 4.6% for conventional surgery with coronary artery bypass grafting (CABG), 5.5% for TAVI using a transvascular approach, and 7.8% for TAVI with a transapical approach.

After adjusting for the expected higher risk profile of TAVI patients, the risk of in-hospital death was not increased with transvascular TAVI, compared with surgery alone, although there was a trend toward increased risk with transapical TAVI in both younger patients and those aged 75 years and older, said Dr. Hamm, medical director of the Kerckhoff Heart and Thorax Centre, Bad Nauheim, Germany.

When asked by the media whether the higher mortality may be diminishing use of the transapical approach, GARY coauthor Dr. Friedrich-Wilhelm Mohr said that similar rates have been seen in the source registry and that these patients tend to have slightly more comorbidities and vascular disease.

"The current data in 2012 do not show a pull back," said Dr. Mohr, medical director of the Leipzig (Germany) Heart Center. "It’s almost the same situation as here: two-thirds transfemoral and one-third transapical."

Consistent with earlier observations, the rate of cerebrovascular events was lowest in patients undergoing surgery without CABG at 2.2% and was "in the range of 3.5%" for all other groups, Dr. Hamm reported.

Discussant Dr. Olaf Wendler said it’s convincing that cerebrovascular complications are lower than in the landmark PARTNER (Placement of Aortic Transcatheter Valves) trial, which reported a 5% major stroke rate among TAVI patients at 30 days.

"This may be less of a problem than we thought about transcatheter-valve treatment in the past," he said. "However, again we don’t have all the details, definitions of the adverse events, and we don’t have a clear idea of how adverse events were adjudicated in this registry."

Rates of vascular complications and new onset atrioventricular (AV) blockage were highest after transvascular TAVI, while renal failure was most common after the transapical approach, said Dr. Wendler, professor at King’s College Hospital in London.

Specifically, vascular complications were reported in 12% of the transvascular patients, compared with 2.5% for the transapical approach, 2% for surgery plus CABG, and 1% for those patients who received surgery alone.

Residual postimplant aortic regurgitation, which has been linked to long-term TAVI outcome, "seemed to be excellent because more than 90% of patients had no or grade I regurgitation," Dr. Hamm said.

Only 7% of transvascular and 3% of transapical patients had grade II regurgitation, and only 1% of transapical and no transvascular patients had grade III or IV regurgitation.

Although between-valve comparisons were limited since the CoreValve was not implanted transapically, grade I or II aortic regurgitation was more common with the CoreValve (70%) than with the Edwards prosthesis (45.7%).

Despite the increasing shift of TAVI in lower-risk patients, data from GARY show that TAVI is being performed predominantly in high-risk patients, as recommended in various guidelines, Dr. Hamm said.

Participation in GARY is voluntary, with 92 of 99 German centers currently taking part. As of July 2012, more than 26,000 patients were included, of whom 23% were TAVI patients.

The current analysis included 13,860 patients from 53 cardiac surgery units and 69 cardiology units. Of these patients, 6,523 underwent surgery alone, 3,462 surgery plus CABG, 2,694 transvascular TAVI, and 1,181 transapical TAVI.

At baseline, TAVI patients were significantly older than surgical patients (average of 81 years transvascular and 80.3 years transapical vs. 68 years surgical); had significantly more comorbidities including atrial fibrillation, hypertension, and diabetes; and were significantly more likely to have a left ventricular ejection fraction below 30%.

Roughly half of elderly patients more than 75 years of age now receive TAVI in Germany, which is quite impressive and by far a higher number than any other country worldwide, said Dr. Wendler.

German investigators also have developed a novel risk scoring system called the AKL score, which, unlike the logistic EuroSCORE or Society of Thoracic Surgeons (STS) risk score, is based only on patients with aortic valve disease.

"The EuroSCORE, as many of us know, is not very suitable in this scenario," Dr. Hamm said.

When the GARY authors compared observed vs. expected in-hospital mortality based on patients’ EuroSCORE, the observed risk for mortality was much lower than predicted by the EuroSCORE.

When the same analysis was performed using the AKL score, however, the observed and expected mortality outcomes were very similar, suggesting the "AKL score much better reflects the real outcome of the patients," he said.

Dr. Wendler remarked that in low-risk patients, however, the observed in-hospital mortality was higher than what was predicted, "questioning if this is the right treatment for this group of patients."

GARY is supported by the German Heart Foundation and unrestricted grants from heart valve manufacturers. Dr. Hamm disclosed honoraria from Medtronic and Edwards Lifesciences and participation in clinical trials with Medtronic, Edwards, Symetis, and JenaValve.

Dr. Mohr reported no conflicts of interest. Dr. Wendler reported research ties with Edwards and consulting for Edwards and St. Jude Medical.

MUNICH -- In-hospital mortality and complications following transcatheter aortic valve implantation in the real-world setting are comparable with those achieved in randomized controlled studies, according to data from the first large-scale national registry capturing surgical and catheter-based procedures.

"In high-risk patients, the in-hospital mortality with TAVI is at least as good, if not better, as with the surgical approach," said Dr. Christian Hamm, who presented data from 13,860 patients in the German Aortic Valve Registry (GARY) at the annual congress of the European Society of Cardiology.

Patrice Wendling/IMNG Medical Media

In-hospital mortality was 2.2% for conventional aortic valve replacement surgery alone, 4.6% for conventional surgery with coronary artery bypass grafting (CABG), 5.5% for TAVI using a transvascular approach, and 7.8% for TAVI with a transapical approach.

After adjusting for the expected higher risk profile of TAVI patients, the risk of in-hospital death was not increased with transvascular TAVI, compared with surgery alone, although there was a trend toward increased risk with transapical TAVI in both younger patients and those aged 75 years and older, said Dr. Hamm, medical director of the Kerckhoff Heart and Thorax Centre, Bad Nauheim, Germany.

When asked by the media whether the higher mortality may be diminishing use of the transapical approach, GARY coauthor Dr. Friedrich-Wilhelm Mohr said that similar rates have been seen in the source registry and that these patients tend to have slightly more comorbidities and vascular disease.

"The current data in 2012 do not show a pull back," said Dr. Mohr, medical director of the Leipzig (Germany) Heart Center. "It’s almost the same situation as here: two-thirds transfemoral and one-third transapical."

Consistent with earlier observations, the rate of cerebrovascular events was lowest in patients undergoing surgery without CABG at 2.2% and was "in the range of 3.5%" for all other groups, Dr. Hamm reported.

Discussant Dr. Olaf Wendler said it’s convincing that cerebrovascular complications are lower than in the landmark PARTNER (Placement of Aortic Transcatheter Valves) trial, which reported a 5% major stroke rate among TAVI patients at 30 days.

"This may be less of a problem than we thought about transcatheter-valve treatment in the past," he said. "However, again we don’t have all the details, definitions of the adverse events, and we don’t have a clear idea of how adverse events were adjudicated in this registry."

Rates of vascular complications and new onset atrioventricular (AV) blockage were highest after transvascular TAVI, while renal failure was most common after the transapical approach, said Dr. Wendler, professor at King’s College Hospital in London.

Specifically, vascular complications were reported in 12% of the transvascular patients, compared with 2.5% for the transapical approach, 2% for surgery plus CABG, and 1% for those patients who received surgery alone.

Residual postimplant aortic regurgitation, which has been linked to long-term TAVI outcome, "seemed to be excellent because more than 90% of patients had no or grade I regurgitation," Dr. Hamm said.

Only 7% of transvascular and 3% of transapical patients had grade II regurgitation, and only 1% of transapical and no transvascular patients had grade III or IV regurgitation.

Although between-valve comparisons were limited since the CoreValve was not implanted transapically, grade I or II aortic regurgitation was more common with the CoreValve (70%) than with the Edwards prosthesis (45.7%).

Despite the increasing shift of TAVI in lower-risk patients, data from GARY show that TAVI is being performed predominantly in high-risk patients, as recommended in various guidelines, Dr. Hamm said.

Participation in GARY is voluntary, with 92 of 99 German centers currently taking part. As of July 2012, more than 26,000 patients were included, of whom 23% were TAVI patients.

The current analysis included 13,860 patients from 53 cardiac surgery units and 69 cardiology units. Of these patients, 6,523 underwent surgery alone, 3,462 surgery plus CABG, 2,694 transvascular TAVI, and 1,181 transapical TAVI.

At baseline, TAVI patients were significantly older than surgical patients (average of 81 years transvascular and 80.3 years transapical vs. 68 years surgical); had significantly more comorbidities including atrial fibrillation, hypertension, and diabetes; and were significantly more likely to have a left ventricular ejection fraction below 30%.

Roughly half of elderly patients more than 75 years of age now receive TAVI in Germany, which is quite impressive and by far a higher number than any other country worldwide, said Dr. Wendler.

German investigators also have developed a novel risk scoring system called the AKL score, which, unlike the logistic EuroSCORE or Society of Thoracic Surgeons (STS) risk score, is based only on patients with aortic valve disease.

"The EuroSCORE, as many of us know, is not very suitable in this scenario," Dr. Hamm said.

When the GARY authors compared observed vs. expected in-hospital mortality based on patients’ EuroSCORE, the observed risk for mortality was much lower than predicted by the EuroSCORE.

When the same analysis was performed using the AKL score, however, the observed and expected mortality outcomes were very similar, suggesting the "AKL score much better reflects the real outcome of the patients," he said.

Dr. Wendler remarked that in low-risk patients, however, the observed in-hospital mortality was higher than what was predicted, "questioning if this is the right treatment for this group of patients."

GARY is supported by the German Heart Foundation and unrestricted grants from heart valve manufacturers. Dr. Hamm disclosed honoraria from Medtronic and Edwards Lifesciences and participation in clinical trials with Medtronic, Edwards, Symetis, and JenaValve.

Dr. Mohr reported no conflicts of interest. Dr. Wendler reported research ties with Edwards and consulting for Edwards and St. Jude Medical.

MUNICH -- In-hospital mortality and complications following transcatheter aortic valve implantation in the real-world setting are comparable with those achieved in randomized controlled studies, according to data from the first large-scale national registry capturing surgical and catheter-based procedures.

"In high-risk patients, the in-hospital mortality with TAVI is at least as good, if not better, as with the surgical approach," said Dr. Christian Hamm, who presented data from 13,860 patients in the German Aortic Valve Registry (GARY) at the annual congress of the European Society of Cardiology.

Patrice Wendling/IMNG Medical Media

In-hospital mortality was 2.2% for conventional aortic valve replacement surgery alone, 4.6% for conventional surgery with coronary artery bypass grafting (CABG), 5.5% for TAVI using a transvascular approach, and 7.8% for TAVI with a transapical approach.

After adjusting for the expected higher risk profile of TAVI patients, the risk of in-hospital death was not increased with transvascular TAVI, compared with surgery alone, although there was a trend toward increased risk with transapical TAVI in both younger patients and those aged 75 years and older, said Dr. Hamm, medical director of the Kerckhoff Heart and Thorax Centre, Bad Nauheim, Germany.

When asked by the media whether the higher mortality may be diminishing use of the transapical approach, GARY coauthor Dr. Friedrich-Wilhelm Mohr said that similar rates have been seen in the source registry and that these patients tend to have slightly more comorbidities and vascular disease.

"The current data in 2012 do not show a pull back," said Dr. Mohr, medical director of the Leipzig (Germany) Heart Center. "It’s almost the same situation as here: two-thirds transfemoral and one-third transapical."

Consistent with earlier observations, the rate of cerebrovascular events was lowest in patients undergoing surgery without CABG at 2.2% and was "in the range of 3.5%" for all other groups, Dr. Hamm reported.

Discussant Dr. Olaf Wendler said it’s convincing that cerebrovascular complications are lower than in the landmark PARTNER (Placement of Aortic Transcatheter Valves) trial, which reported a 5% major stroke rate among TAVI patients at 30 days.

"This may be less of a problem than we thought about transcatheter-valve treatment in the past," he said. "However, again we don’t have all the details, definitions of the adverse events, and we don’t have a clear idea of how adverse events were adjudicated in this registry."

Rates of vascular complications and new onset atrioventricular (AV) blockage were highest after transvascular TAVI, while renal failure was most common after the transapical approach, said Dr. Wendler, professor at King’s College Hospital in London.

Specifically, vascular complications were reported in 12% of the transvascular patients, compared with 2.5% for the transapical approach, 2% for surgery plus CABG, and 1% for those patients who received surgery alone.

Residual postimplant aortic regurgitation, which has been linked to long-term TAVI outcome, "seemed to be excellent because more than 90% of patients had no or grade I regurgitation," Dr. Hamm said.

Only 7% of transvascular and 3% of transapical patients had grade II regurgitation, and only 1% of transapical and no transvascular patients had grade III or IV regurgitation.

Although between-valve comparisons were limited since the CoreValve was not implanted transapically, grade I or II aortic regurgitation was more common with the CoreValve (70%) than with the Edwards prosthesis (45.7%).

Despite the increasing shift of TAVI in lower-risk patients, data from GARY show that TAVI is being performed predominantly in high-risk patients, as recommended in various guidelines, Dr. Hamm said.

Participation in GARY is voluntary, with 92 of 99 German centers currently taking part. As of July 2012, more than 26,000 patients were included, of whom 23% were TAVI patients.

The current analysis included 13,860 patients from 53 cardiac surgery units and 69 cardiology units. Of these patients, 6,523 underwent surgery alone, 3,462 surgery plus CABG, 2,694 transvascular TAVI, and 1,181 transapical TAVI.

At baseline, TAVI patients were significantly older than surgical patients (average of 81 years transvascular and 80.3 years transapical vs. 68 years surgical); had significantly more comorbidities including atrial fibrillation, hypertension, and diabetes; and were significantly more likely to have a left ventricular ejection fraction below 30%.

Roughly half of elderly patients more than 75 years of age now receive TAVI in Germany, which is quite impressive and by far a higher number than any other country worldwide, said Dr. Wendler.

German investigators also have developed a novel risk scoring system called the AKL score, which, unlike the logistic EuroSCORE or Society of Thoracic Surgeons (STS) risk score, is based only on patients with aortic valve disease.

"The EuroSCORE, as many of us know, is not very suitable in this scenario," Dr. Hamm said.

When the GARY authors compared observed vs. expected in-hospital mortality based on patients’ EuroSCORE, the observed risk for mortality was much lower than predicted by the EuroSCORE.

When the same analysis was performed using the AKL score, however, the observed and expected mortality outcomes were very similar, suggesting the "AKL score much better reflects the real outcome of the patients," he said.

Dr. Wendler remarked that in low-risk patients, however, the observed in-hospital mortality was higher than what was predicted, "questioning if this is the right treatment for this group of patients."

GARY is supported by the German Heart Foundation and unrestricted grants from heart valve manufacturers. Dr. Hamm disclosed honoraria from Medtronic and Edwards Lifesciences and participation in clinical trials with Medtronic, Edwards, Symetis, and JenaValve.

Dr. Mohr reported no conflicts of interest. Dr. Wendler reported research ties with Edwards and consulting for Edwards and St. Jude Medical.

One day after President Obama's reelection, we caught up with Dr. Elliott Antman, American Heart Association's 2012 Program Chair, for comments on how the results of the election could impact physicians' practices and patient care.

One day after President Obama's reelection, we caught up with Dr. Elliott Antman, American Heart Association's 2012 Program Chair, for comments on how the results of the election could impact physicians' practices and patient care.

One day after President Obama's reelection, we caught up with Dr. Elliott Antman, American Heart Association's 2012 Program Chair, for comments on how the results of the election could impact physicians' practices and patient care.

One day after President Obama's reelection, we caught up with Dr. Elliott Antman, American Heart Association's 2012 Program Chair, for comments on how the results of the election could impact physicians' practices and patient care.

One day after President Obama's reelection, we caught up with Dr. Elliott Antman, American Heart Association's 2012 Program Chair, for comments on how the results of the election could impact physicians' practices and patient care.

One day after President Obama's reelection, we caught up with Dr. Elliott Antman, American Heart Association's 2012 Program Chair, for comments on how the results of the election could impact physicians' practices and patient care.