ACC 2012

CHICAGO – Women with mechanical heart valves who unintentionally become pregnant while on warfarin often expect their obstetricians to recommend pregnancy termination, but that’s not what contemporary practice guidelines advocate.

Neither the latest American College of Chest Physicians guidelines (CHEST 2012;141[2 suppl]: e691S-e736S doi 10.1378/chest.11-2300) nor the European Society of Cardiology guidelines (Eur. Heart J. 2011;32:3147-97) recommend pregnancy termination under those circumstances, Dr. Anthony R. Gregg noted at the annual meeting of the American College of Cardiology.

"Studies show the risk to the fetus is fairly low overall, so there’s no recommendation for pregnancy termination," said Dr. Gregg, professor of obstetrics and gynecology, chief of maternal-fetal medicine, and director of obstetrics at the University of Florida Shands Hospital, Gainesville.

This assertion may come as a surprise to many cardiologists and primary care physicians. After all, every medical student has heard of the fetal warfarin syndrome. But while it affects about 30% of pregnancies with first-trimester warfarin exposure, the degree of severity is highly variable, he explained.

Often a woman doesn’t realize she is pregnant until weeks 6-8 of gestation or even later. The fetus has already been exposed to warfarin. Under those circumstances, the guidelines uniformly recommend that the patient with a mechanical heart valve be switched to low-molecular-weight heparin or unfractionated heparin, then returned to warfarin after 13 weeks’ gestation. She is then maintained on that well-studied oral anticoagulant until week 34, when she should once again be switched to low-molecular-weight heparin or unfractionated heparin as the time of delivery draws closer.

In the case of a planned pregnancy, the recommendation is for a patient with a mechanical valve to be on low-molecular-weight heparin or unfractionated heparin from the time of conception through 13 weeks’ gestation before switching back to warfarin. But that guidance doesn’t apply to women with the older mechanical heart valves posing maximum thromboembolic risk; those patients are best managed on warfarin continuously throughout pregnancy until the week-34 switch to low-molecular-weight heparin or unfractionated heparin.

"We try to point out to patients that they’re not out of the woods despite the fact that we’re following professional organizations’ guidelines. Sometimes they assume that since we’re following guidelines there’s no risk at all. The bottom line is warfarin can cross the placenta in pregnancy. There are lots of documented cases of fetal intracranial bleeding. We follow our patients across pregnancy looking for any evidence of warfarin-induced fetal intracranial hemorrhage," he said.

Dr. Gregg reported having no financial conflicts.

CHICAGO – Women with mechanical heart valves who unintentionally become pregnant while on warfarin often expect their obstetricians to recommend pregnancy termination, but that’s not what contemporary practice guidelines advocate.

Neither the latest American College of Chest Physicians guidelines (CHEST 2012;141[2 suppl]: e691S-e736S doi 10.1378/chest.11-2300) nor the European Society of Cardiology guidelines (Eur. Heart J. 2011;32:3147-97) recommend pregnancy termination under those circumstances, Dr. Anthony R. Gregg noted at the annual meeting of the American College of Cardiology.

"Studies show the risk to the fetus is fairly low overall, so there’s no recommendation for pregnancy termination," said Dr. Gregg, professor of obstetrics and gynecology, chief of maternal-fetal medicine, and director of obstetrics at the University of Florida Shands Hospital, Gainesville.

This assertion may come as a surprise to many cardiologists and primary care physicians. After all, every medical student has heard of the fetal warfarin syndrome. But while it affects about 30% of pregnancies with first-trimester warfarin exposure, the degree of severity is highly variable, he explained.

Often a woman doesn’t realize she is pregnant until weeks 6-8 of gestation or even later. The fetus has already been exposed to warfarin. Under those circumstances, the guidelines uniformly recommend that the patient with a mechanical heart valve be switched to low-molecular-weight heparin or unfractionated heparin, then returned to warfarin after 13 weeks’ gestation. She is then maintained on that well-studied oral anticoagulant until week 34, when she should once again be switched to low-molecular-weight heparin or unfractionated heparin as the time of delivery draws closer.

In the case of a planned pregnancy, the recommendation is for a patient with a mechanical valve to be on low-molecular-weight heparin or unfractionated heparin from the time of conception through 13 weeks’ gestation before switching back to warfarin. But that guidance doesn’t apply to women with the older mechanical heart valves posing maximum thromboembolic risk; those patients are best managed on warfarin continuously throughout pregnancy until the week-34 switch to low-molecular-weight heparin or unfractionated heparin.

"We try to point out to patients that they’re not out of the woods despite the fact that we’re following professional organizations’ guidelines. Sometimes they assume that since we’re following guidelines there’s no risk at all. The bottom line is warfarin can cross the placenta in pregnancy. There are lots of documented cases of fetal intracranial bleeding. We follow our patients across pregnancy looking for any evidence of warfarin-induced fetal intracranial hemorrhage," he said.

Dr. Gregg reported having no financial conflicts.

CHICAGO – Women with mechanical heart valves who unintentionally become pregnant while on warfarin often expect their obstetricians to recommend pregnancy termination, but that’s not what contemporary practice guidelines advocate.

Neither the latest American College of Chest Physicians guidelines (CHEST 2012;141[2 suppl]: e691S-e736S doi 10.1378/chest.11-2300) nor the European Society of Cardiology guidelines (Eur. Heart J. 2011;32:3147-97) recommend pregnancy termination under those circumstances, Dr. Anthony R. Gregg noted at the annual meeting of the American College of Cardiology.

"Studies show the risk to the fetus is fairly low overall, so there’s no recommendation for pregnancy termination," said Dr. Gregg, professor of obstetrics and gynecology, chief of maternal-fetal medicine, and director of obstetrics at the University of Florida Shands Hospital, Gainesville.

This assertion may come as a surprise to many cardiologists and primary care physicians. After all, every medical student has heard of the fetal warfarin syndrome. But while it affects about 30% of pregnancies with first-trimester warfarin exposure, the degree of severity is highly variable, he explained.

Often a woman doesn’t realize she is pregnant until weeks 6-8 of gestation or even later. The fetus has already been exposed to warfarin. Under those circumstances, the guidelines uniformly recommend that the patient with a mechanical heart valve be switched to low-molecular-weight heparin or unfractionated heparin, then returned to warfarin after 13 weeks’ gestation. She is then maintained on that well-studied oral anticoagulant until week 34, when she should once again be switched to low-molecular-weight heparin or unfractionated heparin as the time of delivery draws closer.

In the case of a planned pregnancy, the recommendation is for a patient with a mechanical valve to be on low-molecular-weight heparin or unfractionated heparin from the time of conception through 13 weeks’ gestation before switching back to warfarin. But that guidance doesn’t apply to women with the older mechanical heart valves posing maximum thromboembolic risk; those patients are best managed on warfarin continuously throughout pregnancy until the week-34 switch to low-molecular-weight heparin or unfractionated heparin.

"We try to point out to patients that they’re not out of the woods despite the fact that we’re following professional organizations’ guidelines. Sometimes they assume that since we’re following guidelines there’s no risk at all. The bottom line is warfarin can cross the placenta in pregnancy. There are lots of documented cases of fetal intracranial bleeding. We follow our patients across pregnancy looking for any evidence of warfarin-induced fetal intracranial hemorrhage," he said.

Dr. Gregg reported having no financial conflicts.

CHICAGO – Treatment of calcified femoropopliteal lesions with orbital atherectomy led to 12-month patency similar to that of balloon angioplasty but with a substantially reduced need for stenting, in a randomized, controlled study of 50 patients.

Orbital atherectomy changed vessel compliance, which allowed lower pressure balloon dilatation and hence less vessel disruption, which appeared to produce a low rate of restenosis with minimal stent use. "Lower dissection rates and reduced use of bailout stents preserves treatment options in the future," Dr. Raymond Dattilo noted in a poster at the annual meeting of the American College of Cardiology. Minimizing stent use in distal, superficial femoral and popliteal arteries also reduces the risk of stent fracture, said Dr. Dattilo, a cardiologist and director of endovascular medicine at St. Francis Health Center in Topeka, Kan.

He ran the COMPLIANCE 360° study to determine whether orbital atherectomy of calcified femoropopliteal lesions using the Diamondback Orbital Atherectomy System reduced the need for stenting without diminishing 12-month vessel patency when compared with percutaneous balloon angioplasty and selected stent use. The study enrolled 50 patients with 65 femoropopliteal lesions. Randomization resulted in two treatment arms with similar patients and types of lesions (based on degree of calcification and plaque morphology). The only statistically significant difference between the two treatment arms was in the percentage of patients with diabetes, which affected 18 (72%) patients randomized to orbital atherectomy and 10 (40%) patients treated with balloon angioplasty and bail-out stenting.

Maximum balloon pressure used during angioplasty was 4 atmospheres in the 25 patients treated with orbital atherectomy, and 9 atmospheres in the 25 patients who did not undergo atherectomy. Among the patients treated with atherectomy, two (8%) required a bailout stent, compared with 21 (84%) in the angioplasty-only group, a statistically significant difference.

At 6 months after treatment, 16 of 22 patients (73%) in the atherectomy group with 6-month follow-up had avoided stent placement, were free from target lesion revascularization, and had no restenosis as assessed by duplex ultrasound. Among 24 patients in the balloon angioplasty group assessed after 6 months, two patients (8%) met these same efficacy criteria.

After 12 months, 5 patients in the atherectomy group out of 20 with 12-month follow-up had restenosis or required repeat target lesion revascularization, compared with 5 of 21 patients in the angioplasty group. The 12-month results showed that the two strategies resulted in similar rates of long-term vessel patency, but the atherectomy patients avoided stent placement, Dr. Dattilo reported.

The COMPLIANCE 360° study was sponsored by Cardiovascular Systems. Dr. Dattilo said that he has been a consultant to, a speaker for, and has received research grants from Cardiovascular Systems.

CHICAGO – Treatment of calcified femoropopliteal lesions with orbital atherectomy led to 12-month patency similar to that of balloon angioplasty but with a substantially reduced need for stenting, in a randomized, controlled study of 50 patients.

Orbital atherectomy changed vessel compliance, which allowed lower pressure balloon dilatation and hence less vessel disruption, which appeared to produce a low rate of restenosis with minimal stent use. "Lower dissection rates and reduced use of bailout stents preserves treatment options in the future," Dr. Raymond Dattilo noted in a poster at the annual meeting of the American College of Cardiology. Minimizing stent use in distal, superficial femoral and popliteal arteries also reduces the risk of stent fracture, said Dr. Dattilo, a cardiologist and director of endovascular medicine at St. Francis Health Center in Topeka, Kan.

He ran the COMPLIANCE 360° study to determine whether orbital atherectomy of calcified femoropopliteal lesions using the Diamondback Orbital Atherectomy System reduced the need for stenting without diminishing 12-month vessel patency when compared with percutaneous balloon angioplasty and selected stent use. The study enrolled 50 patients with 65 femoropopliteal lesions. Randomization resulted in two treatment arms with similar patients and types of lesions (based on degree of calcification and plaque morphology). The only statistically significant difference between the two treatment arms was in the percentage of patients with diabetes, which affected 18 (72%) patients randomized to orbital atherectomy and 10 (40%) patients treated with balloon angioplasty and bail-out stenting.

Maximum balloon pressure used during angioplasty was 4 atmospheres in the 25 patients treated with orbital atherectomy, and 9 atmospheres in the 25 patients who did not undergo atherectomy. Among the patients treated with atherectomy, two (8%) required a bailout stent, compared with 21 (84%) in the angioplasty-only group, a statistically significant difference.

At 6 months after treatment, 16 of 22 patients (73%) in the atherectomy group with 6-month follow-up had avoided stent placement, were free from target lesion revascularization, and had no restenosis as assessed by duplex ultrasound. Among 24 patients in the balloon angioplasty group assessed after 6 months, two patients (8%) met these same efficacy criteria.

After 12 months, 5 patients in the atherectomy group out of 20 with 12-month follow-up had restenosis or required repeat target lesion revascularization, compared with 5 of 21 patients in the angioplasty group. The 12-month results showed that the two strategies resulted in similar rates of long-term vessel patency, but the atherectomy patients avoided stent placement, Dr. Dattilo reported.

The COMPLIANCE 360° study was sponsored by Cardiovascular Systems. Dr. Dattilo said that he has been a consultant to, a speaker for, and has received research grants from Cardiovascular Systems.

CHICAGO – Treatment of calcified femoropopliteal lesions with orbital atherectomy led to 12-month patency similar to that of balloon angioplasty but with a substantially reduced need for stenting, in a randomized, controlled study of 50 patients.

Orbital atherectomy changed vessel compliance, which allowed lower pressure balloon dilatation and hence less vessel disruption, which appeared to produce a low rate of restenosis with minimal stent use. "Lower dissection rates and reduced use of bailout stents preserves treatment options in the future," Dr. Raymond Dattilo noted in a poster at the annual meeting of the American College of Cardiology. Minimizing stent use in distal, superficial femoral and popliteal arteries also reduces the risk of stent fracture, said Dr. Dattilo, a cardiologist and director of endovascular medicine at St. Francis Health Center in Topeka, Kan.

He ran the COMPLIANCE 360° study to determine whether orbital atherectomy of calcified femoropopliteal lesions using the Diamondback Orbital Atherectomy System reduced the need for stenting without diminishing 12-month vessel patency when compared with percutaneous balloon angioplasty and selected stent use. The study enrolled 50 patients with 65 femoropopliteal lesions. Randomization resulted in two treatment arms with similar patients and types of lesions (based on degree of calcification and plaque morphology). The only statistically significant difference between the two treatment arms was in the percentage of patients with diabetes, which affected 18 (72%) patients randomized to orbital atherectomy and 10 (40%) patients treated with balloon angioplasty and bail-out stenting.

Maximum balloon pressure used during angioplasty was 4 atmospheres in the 25 patients treated with orbital atherectomy, and 9 atmospheres in the 25 patients who did not undergo atherectomy. Among the patients treated with atherectomy, two (8%) required a bailout stent, compared with 21 (84%) in the angioplasty-only group, a statistically significant difference.

At 6 months after treatment, 16 of 22 patients (73%) in the atherectomy group with 6-month follow-up had avoided stent placement, were free from target lesion revascularization, and had no restenosis as assessed by duplex ultrasound. Among 24 patients in the balloon angioplasty group assessed after 6 months, two patients (8%) met these same efficacy criteria.

After 12 months, 5 patients in the atherectomy group out of 20 with 12-month follow-up had restenosis or required repeat target lesion revascularization, compared with 5 of 21 patients in the angioplasty group. The 12-month results showed that the two strategies resulted in similar rates of long-term vessel patency, but the atherectomy patients avoided stent placement, Dr. Dattilo reported.

The COMPLIANCE 360° study was sponsored by Cardiovascular Systems. Dr. Dattilo said that he has been a consultant to, a speaker for, and has received research grants from Cardiovascular Systems.

CHICAGO – Coronary dissection, a rare and sometimes fatal condition, surpassed atherosclerosis as the most common cause of pregnancy-associated acute myocardial infarction in a retrospective analysis of 150 women.

Pregnant women also appear to be at increased risk of coronary dissection during coronary angiography and percutaneous coronary intervention, leading to death in one patient, coronary artery bypass grafting in four, and multiple stenting in two.

Patrice Wendling/IMNG Medical Media

Moreover, standard treatment with thrombolytic agents may actually increase the risk of hemorrhage and further progression of the dissection in pregnant patients, Dr. Uri Elkayam explained at the annual meeting of the American College of Cardiology.

"Because of this, we are ready now to come up with some strong recommendations that we hope will be reflected in the guidelines that the approach to heart attack in pregnancy should be different than that recommended in the general population," said Dr. Elkayam, professor of medicine in the cardiovascular medicine division at the University of Southern California in Los Angeles and director of the Heart Failure Program at USC Medical Center and University Hospital.

Although the European Society of Cardiology recently published guidelines for the management of cardiovascular diseases during pregnancy (Eur. Heart J. 2011;32:3147-97), neither the American College of Cardiology nor the American Heart Association has specific guidelines.

The analysis included 150 cases of myocardial infarction during pregnancy or the 12 weeks after delivery that were identified in the literature, consulted on, or cared for by the research team since 2005. The women’s average age was 34 years, and 75% were at least 30 years old.

The cause of acute MI was coronary dissection in 56 of the 129 women who had angiography, with 10 dissections occurring in the third trimester and 41 postpartum. Atherosclerotic coronary artery disease, the most common cause of acute MI in the general population, was identified in only 35 women, followed by intracoronary thrombus without evidence of atherosclerosis in 22, normal coronary anatomy with possible spasm in 16, documented spasm in 3, and takotsubo cardiomyopathy in 1. Four of the 22 patients with intracoronary thrombus did not undergo an angiogram.

Coronary dissection, which is thought to occur during pregnancy because of hormonally mediated weakening of the walls of coronary arteries, was managed with bypass surgery in 41.5% of patients, stenting in 38%, medication without coronary intervention in 22%, and a Bentall procedure in 1%.

Percutaneous coronary intervention (PCI) was performed in 40% of all patients and coronary angiography in 79%.

The use of thrombolytic therapy is relatively contraindicated in pregnancy due to the risk of bleeding. In addition, thrombolytic therapy may not be effective in women with normal coronaries, spasm, or coronary dissection, and in the last group it can even be detrimental, Dr. Elkayam observed.

"Thrombolytic therapy should therefore be considered second choice to primary PCI in patients with ST-segment elevation MI during pregnancy, especially during the third trimester, [in] the peripartum and early postpartum periods when the incidence of dissection is high," he suggested.

The use of angiography to determine the cause of the MI and guide therapy is recommended in pregnant women with ST-segment elevation MI and in other high-risk MI patients, but because of the increased risk of iatrogenic coronary dissection, stable and low-risk non-STEMI patients should be treated noninvasively during pregnancy and postpartum, Dr. Elkayam recommended.

Most women in the current analysis did not present with traditional cardiovascular risk factors. Only 9% had diabetes, 15% had hypertension, and 20% had hyperlipidemia, although one-fourth were smokers.

Maternal mortality was 7%, down from 20% during 1922-1995 and 11% during 1996-2005, as previously reported by the researchers (Ann. Intern. Med. 1996;125:751-62; J. Am. Coll. Cardiol. 2008;52:171-80). In spite of the decreased rate of maternal death, women who experience a pregnancy-related MI are three to five times more likely to die than nonpregnant women of comparable age, he said.

Fetal deaths, driven largely by maternal mortality, were also lower at 5%, compared with 12% and 9% in the previous analyses.

Still, Dr. Elkayam stressed that women should not avoid becoming pregnant because of fears of an MI, as the incidence is extremely low, at one in 16,000 deliveries. Although maternal and fetal mortality have been decreasing, the number of women with cardiac problems in pregnancy is rising due to older maternal age at first pregnancy; a spike in age-related cardiovascular risk factors such as diabetes, obesity, and hypertension; and mostly, improved treatment of congenital heart disease, allowing more women to reach childbearing age.

"In general, most patients with mild and even moderate cardiac problems can become pregnant and have children safely," he said in an interview. "Patients are often getting information that is not realistic, usually exaggerating the risk. The reality is such that most physicians are not interested in really managing this problem, and so oftentimes women with heart disease will get advice not to become pregnant."

Dr. Elkayam said women with heart disease should be treated by a cardiologist and obstetrician experienced in managing cardiac problems in pregnancy, and that high-risk patients should managed by an expert multidisciplinary team in a specialist center. He also called for a national registry, similar to the registry established in Europe, to better track outcomes of pregnancy-related heart disease in general, including MI.

Dr. Elkayam reported no conflicts of interest.

CHICAGO – Coronary dissection, a rare and sometimes fatal condition, surpassed atherosclerosis as the most common cause of pregnancy-associated acute myocardial infarction in a retrospective analysis of 150 women.

Pregnant women also appear to be at increased risk of coronary dissection during coronary angiography and percutaneous coronary intervention, leading to death in one patient, coronary artery bypass grafting in four, and multiple stenting in two.

Patrice Wendling/IMNG Medical Media

Moreover, standard treatment with thrombolytic agents may actually increase the risk of hemorrhage and further progression of the dissection in pregnant patients, Dr. Uri Elkayam explained at the annual meeting of the American College of Cardiology.

"Because of this, we are ready now to come up with some strong recommendations that we hope will be reflected in the guidelines that the approach to heart attack in pregnancy should be different than that recommended in the general population," said Dr. Elkayam, professor of medicine in the cardiovascular medicine division at the University of Southern California in Los Angeles and director of the Heart Failure Program at USC Medical Center and University Hospital.

Although the European Society of Cardiology recently published guidelines for the management of cardiovascular diseases during pregnancy (Eur. Heart J. 2011;32:3147-97), neither the American College of Cardiology nor the American Heart Association has specific guidelines.

The analysis included 150 cases of myocardial infarction during pregnancy or the 12 weeks after delivery that were identified in the literature, consulted on, or cared for by the research team since 2005. The women’s average age was 34 years, and 75% were at least 30 years old.

The cause of acute MI was coronary dissection in 56 of the 129 women who had angiography, with 10 dissections occurring in the third trimester and 41 postpartum. Atherosclerotic coronary artery disease, the most common cause of acute MI in the general population, was identified in only 35 women, followed by intracoronary thrombus without evidence of atherosclerosis in 22, normal coronary anatomy with possible spasm in 16, documented spasm in 3, and takotsubo cardiomyopathy in 1. Four of the 22 patients with intracoronary thrombus did not undergo an angiogram.

Coronary dissection, which is thought to occur during pregnancy because of hormonally mediated weakening of the walls of coronary arteries, was managed with bypass surgery in 41.5% of patients, stenting in 38%, medication without coronary intervention in 22%, and a Bentall procedure in 1%.

Percutaneous coronary intervention (PCI) was performed in 40% of all patients and coronary angiography in 79%.

The use of thrombolytic therapy is relatively contraindicated in pregnancy due to the risk of bleeding. In addition, thrombolytic therapy may not be effective in women with normal coronaries, spasm, or coronary dissection, and in the last group it can even be detrimental, Dr. Elkayam observed.

"Thrombolytic therapy should therefore be considered second choice to primary PCI in patients with ST-segment elevation MI during pregnancy, especially during the third trimester, [in] the peripartum and early postpartum periods when the incidence of dissection is high," he suggested.

The use of angiography to determine the cause of the MI and guide therapy is recommended in pregnant women with ST-segment elevation MI and in other high-risk MI patients, but because of the increased risk of iatrogenic coronary dissection, stable and low-risk non-STEMI patients should be treated noninvasively during pregnancy and postpartum, Dr. Elkayam recommended.

Most women in the current analysis did not present with traditional cardiovascular risk factors. Only 9% had diabetes, 15% had hypertension, and 20% had hyperlipidemia, although one-fourth were smokers.

Maternal mortality was 7%, down from 20% during 1922-1995 and 11% during 1996-2005, as previously reported by the researchers (Ann. Intern. Med. 1996;125:751-62; J. Am. Coll. Cardiol. 2008;52:171-80). In spite of the decreased rate of maternal death, women who experience a pregnancy-related MI are three to five times more likely to die than nonpregnant women of comparable age, he said.

Fetal deaths, driven largely by maternal mortality, were also lower at 5%, compared with 12% and 9% in the previous analyses.

Still, Dr. Elkayam stressed that women should not avoid becoming pregnant because of fears of an MI, as the incidence is extremely low, at one in 16,000 deliveries. Although maternal and fetal mortality have been decreasing, the number of women with cardiac problems in pregnancy is rising due to older maternal age at first pregnancy; a spike in age-related cardiovascular risk factors such as diabetes, obesity, and hypertension; and mostly, improved treatment of congenital heart disease, allowing more women to reach childbearing age.

"In general, most patients with mild and even moderate cardiac problems can become pregnant and have children safely," he said in an interview. "Patients are often getting information that is not realistic, usually exaggerating the risk. The reality is such that most physicians are not interested in really managing this problem, and so oftentimes women with heart disease will get advice not to become pregnant."

Dr. Elkayam said women with heart disease should be treated by a cardiologist and obstetrician experienced in managing cardiac problems in pregnancy, and that high-risk patients should managed by an expert multidisciplinary team in a specialist center. He also called for a national registry, similar to the registry established in Europe, to better track outcomes of pregnancy-related heart disease in general, including MI.

Dr. Elkayam reported no conflicts of interest.

CHICAGO – Coronary dissection, a rare and sometimes fatal condition, surpassed atherosclerosis as the most common cause of pregnancy-associated acute myocardial infarction in a retrospective analysis of 150 women.

Pregnant women also appear to be at increased risk of coronary dissection during coronary angiography and percutaneous coronary intervention, leading to death in one patient, coronary artery bypass grafting in four, and multiple stenting in two.

Patrice Wendling/IMNG Medical Media

Moreover, standard treatment with thrombolytic agents may actually increase the risk of hemorrhage and further progression of the dissection in pregnant patients, Dr. Uri Elkayam explained at the annual meeting of the American College of Cardiology.

"Because of this, we are ready now to come up with some strong recommendations that we hope will be reflected in the guidelines that the approach to heart attack in pregnancy should be different than that recommended in the general population," said Dr. Elkayam, professor of medicine in the cardiovascular medicine division at the University of Southern California in Los Angeles and director of the Heart Failure Program at USC Medical Center and University Hospital.

Although the European Society of Cardiology recently published guidelines for the management of cardiovascular diseases during pregnancy (Eur. Heart J. 2011;32:3147-97), neither the American College of Cardiology nor the American Heart Association has specific guidelines.

The analysis included 150 cases of myocardial infarction during pregnancy or the 12 weeks after delivery that were identified in the literature, consulted on, or cared for by the research team since 2005. The women’s average age was 34 years, and 75% were at least 30 years old.

The cause of acute MI was coronary dissection in 56 of the 129 women who had angiography, with 10 dissections occurring in the third trimester and 41 postpartum. Atherosclerotic coronary artery disease, the most common cause of acute MI in the general population, was identified in only 35 women, followed by intracoronary thrombus without evidence of atherosclerosis in 22, normal coronary anatomy with possible spasm in 16, documented spasm in 3, and takotsubo cardiomyopathy in 1. Four of the 22 patients with intracoronary thrombus did not undergo an angiogram.

Coronary dissection, which is thought to occur during pregnancy because of hormonally mediated weakening of the walls of coronary arteries, was managed with bypass surgery in 41.5% of patients, stenting in 38%, medication without coronary intervention in 22%, and a Bentall procedure in 1%.

Percutaneous coronary intervention (PCI) was performed in 40% of all patients and coronary angiography in 79%.

The use of thrombolytic therapy is relatively contraindicated in pregnancy due to the risk of bleeding. In addition, thrombolytic therapy may not be effective in women with normal coronaries, spasm, or coronary dissection, and in the last group it can even be detrimental, Dr. Elkayam observed.

"Thrombolytic therapy should therefore be considered second choice to primary PCI in patients with ST-segment elevation MI during pregnancy, especially during the third trimester, [in] the peripartum and early postpartum periods when the incidence of dissection is high," he suggested.

The use of angiography to determine the cause of the MI and guide therapy is recommended in pregnant women with ST-segment elevation MI and in other high-risk MI patients, but because of the increased risk of iatrogenic coronary dissection, stable and low-risk non-STEMI patients should be treated noninvasively during pregnancy and postpartum, Dr. Elkayam recommended.

Most women in the current analysis did not present with traditional cardiovascular risk factors. Only 9% had diabetes, 15% had hypertension, and 20% had hyperlipidemia, although one-fourth were smokers.

Maternal mortality was 7%, down from 20% during 1922-1995 and 11% during 1996-2005, as previously reported by the researchers (Ann. Intern. Med. 1996;125:751-62; J. Am. Coll. Cardiol. 2008;52:171-80). In spite of the decreased rate of maternal death, women who experience a pregnancy-related MI are three to five times more likely to die than nonpregnant women of comparable age, he said.

Fetal deaths, driven largely by maternal mortality, were also lower at 5%, compared with 12% and 9% in the previous analyses.

Still, Dr. Elkayam stressed that women should not avoid becoming pregnant because of fears of an MI, as the incidence is extremely low, at one in 16,000 deliveries. Although maternal and fetal mortality have been decreasing, the number of women with cardiac problems in pregnancy is rising due to older maternal age at first pregnancy; a spike in age-related cardiovascular risk factors such as diabetes, obesity, and hypertension; and mostly, improved treatment of congenital heart disease, allowing more women to reach childbearing age.

"In general, most patients with mild and even moderate cardiac problems can become pregnant and have children safely," he said in an interview. "Patients are often getting information that is not realistic, usually exaggerating the risk. The reality is such that most physicians are not interested in really managing this problem, and so oftentimes women with heart disease will get advice not to become pregnant."

Dr. Elkayam said women with heart disease should be treated by a cardiologist and obstetrician experienced in managing cardiac problems in pregnancy, and that high-risk patients should managed by an expert multidisciplinary team in a specialist center. He also called for a national registry, similar to the registry established in Europe, to better track outcomes of pregnancy-related heart disease in general, including MI.

Dr. Elkayam reported no conflicts of interest.

CHICAGO – The new oral anticoagulants for stroke prevention in atrial fibrillation may be garnering all the buzz, but don’t count out warfarin.

"It’s not just a knee-jerk reaction that all patients should be switched to the new agents. It’s dependent upon how well you as a physician are managing your patients on warfarin," Dr. Jack E. Ansell asserted at the annual meeting of the American College of Cardiology.

"Warfarin therapy is all about management. If it’s not managed well, you can compare it to anything, and anything is going to be better. And if it’s managed very well, then it’s very difficult to beat warfarin therapy," said Dr. Ansell, chairman of the department of medicine at Lenox Hill Hospital in New York.

A growing body of evidence indicates that the new standard in high-quality management of warfarin therapy involves patient self-testing of International Normalized Ratios at home using a fingerstick blood sample and portable point-of-care device.

Case in point: Dr. Ansell presented highlights of the new STABLE study, in which he and his coinvestigators conducted a retrospective analysis of the real-world experience of more than 29,000 warfarin-treated patients enrolled in a national commercial comprehensive self-test support service (JACC 2012 March 27 [doi: 10.1016/S0735-1097(12)61865-8]).

Patients who performed frequent self-testing – meaning more than 80% of their self-testing was done on a weekly basis had a mean time spent in the therapeutic INR range (TTR) of 74%. That’s unprecedented, he said.

By comparison, in the pivotal RE-LY randomized trial for dabigatran (Pradaxa), the control group on warfarin had a TTR of 64% (N. Engl. J. Med. 2009;361:1139-51). In the ROCKET-AF trial of rivaroxaban (Xarelto), warfarin controls had a TTR of 55% (N. Engl. J. Med. 2011;365:883-91). And in the ARISTOTLE study of apixaban (Eliquis), an agent expected to soon receive Food and Drug Administration marketing approval, the warfarin control group had a TTR of 62% (N. Engl. J. Med. 2011;365:981-92). In all these major randomized trials involving the novel oral anticoagulants, patients assigned to warfarin were closely managed, but in traditional fashion – home self-testing wasn’t involved.

In contrast, in the STABLE study, the overall TTR, including those patients who self-tested variably and inconsistently, was still 69.7%.

"This is important because the cost-effectiveness analyses done with dabigatran and the other new anticoagulants suggest that when you get up to a TTR above 70% with warfarin, the cost-effectiveness of the new agents diminishes and warfarin actually becomes more cost-effective," according to Dr. Ansell.

A particularly impressive finding in STABLE was that patients who did weekly self-testing had a 2.3% incidence of critical value INR results, defined as an INR below 1.5 or greater than 5.0. "This is really a phenomenally low result," he commented. It represented a 48% reduction from the 4.4% incidence in patients with variable self-testing frequency.

Participants in the STABLE study tested themselves at home, but their warfarin dosing was managed by their referring physicians or anticoagulation clinics. Thus, an individual’s TTR reflected the warfarin management expertise of the referral source.

There are several reasons why home monitoring achieves better TTRs and – as shown in other studies – lower major bleeding and thrombotic event rates than with usual care or anticoagulation clinics not utilizing patient self-monitoring, Dr. Ansell said. Home testing is more frequent, timely, and consistent, and the immediate feedback regarding INR results is likely to promote adherence.

A variant of patient self-testing starting to catch on in the United States is patient self-management. This entails teaching patients how to manage their own warfarin dose on the basis of their home INR measurements.

The most recent American College of Chest Physicians clinical practice guidelines on antithrombotic therapy for atrial fibrillation give patient self-management of warfarin therapy a class 2B recommendation, stating, "For patients treated with vitamin K antagonists who are motivated and can demonstrate competency in self-management strategies, including the self-testing equipment, we suggest patient self-management rather than the usual outpatient INR monitoring" (CHEST 2012;141: 2 suppl. e531S-e575S [doi: 10.1378/chest.11-2304]).

Session cochair Dr. Samuel Z. Goldhaber agreed with Dr. Ansell that warfarin still has a place in anticoagulation therapy. The fact that it costs as little as $4 per month while dabigatran, for example, retails for 60 times that amount, is not to be shrugged off in an era of runaway health care spending. Plus, warfarin, for all its drawbacks, is a known quantity backed by more than a half century of clinical experience.

"Even though warfarin can cause horrible complications, there are no more surprises left about what warfarin can do," observed Dr. Goldhaber, professor of medicine at Harvard Medical School and director of the venous thromboembolism research group at Brigham and Women’s Hospital, Boston.

A potential game changer for warfarin is the possibility that rapid pharmacogenetic testing will enable physicians to improve upon the current method of warfarin dosing.

One advantage warfarin has is that bleeding episodes can be reversed by administration of vitamin K. In contrast, there is as yet no reliable means of reversing major bleeding in patients on the novel anticoagulants. But Dr. Lars Wallentin said this limitation of the new agents is outweighed by the consistent finding that they have lower rates of intracranial hemorrhage than those of warfarin.

"There is no antidote to warfarin that has proven to have any effect in patients with ICH. And there is no evidence as far as I can see that however you control INR you can reach as low a level of ICH as with these new agents. I think this is a specific downside of warfarin that we can’t get away from," said Dr. Wallentin, professor of cardiology at Uppsala (Sweden) University.

The STABLE study was funded by Alere Home Monitoring, Inc. Dr. Ansell is a consultant to the company.

Dr. Goldhaber has served as a consultant to numerous pharmaceutical companies developing cardiovascular medications.

Dr. Wallentin was principal investigator in the ARISTOTLE study of apixaban, funded by Pfizer and Bristol Myers Squibb, and has served as a consultant to those and other pharmaceutical companies.

CHICAGO – The new oral anticoagulants for stroke prevention in atrial fibrillation may be garnering all the buzz, but don’t count out warfarin.

"It’s not just a knee-jerk reaction that all patients should be switched to the new agents. It’s dependent upon how well you as a physician are managing your patients on warfarin," Dr. Jack E. Ansell asserted at the annual meeting of the American College of Cardiology.

"Warfarin therapy is all about management. If it’s not managed well, you can compare it to anything, and anything is going to be better. And if it’s managed very well, then it’s very difficult to beat warfarin therapy," said Dr. Ansell, chairman of the department of medicine at Lenox Hill Hospital in New York.

A growing body of evidence indicates that the new standard in high-quality management of warfarin therapy involves patient self-testing of International Normalized Ratios at home using a fingerstick blood sample and portable point-of-care device.

Case in point: Dr. Ansell presented highlights of the new STABLE study, in which he and his coinvestigators conducted a retrospective analysis of the real-world experience of more than 29,000 warfarin-treated patients enrolled in a national commercial comprehensive self-test support service (JACC 2012 March 27 [doi: 10.1016/S0735-1097(12)61865-8]).

Patients who performed frequent self-testing – meaning more than 80% of their self-testing was done on a weekly basis had a mean time spent in the therapeutic INR range (TTR) of 74%. That’s unprecedented, he said.

By comparison, in the pivotal RE-LY randomized trial for dabigatran (Pradaxa), the control group on warfarin had a TTR of 64% (N. Engl. J. Med. 2009;361:1139-51). In the ROCKET-AF trial of rivaroxaban (Xarelto), warfarin controls had a TTR of 55% (N. Engl. J. Med. 2011;365:883-91). And in the ARISTOTLE study of apixaban (Eliquis), an agent expected to soon receive Food and Drug Administration marketing approval, the warfarin control group had a TTR of 62% (N. Engl. J. Med. 2011;365:981-92). In all these major randomized trials involving the novel oral anticoagulants, patients assigned to warfarin were closely managed, but in traditional fashion – home self-testing wasn’t involved.

In contrast, in the STABLE study, the overall TTR, including those patients who self-tested variably and inconsistently, was still 69.7%.

"This is important because the cost-effectiveness analyses done with dabigatran and the other new anticoagulants suggest that when you get up to a TTR above 70% with warfarin, the cost-effectiveness of the new agents diminishes and warfarin actually becomes more cost-effective," according to Dr. Ansell.

A particularly impressive finding in STABLE was that patients who did weekly self-testing had a 2.3% incidence of critical value INR results, defined as an INR below 1.5 or greater than 5.0. "This is really a phenomenally low result," he commented. It represented a 48% reduction from the 4.4% incidence in patients with variable self-testing frequency.

Participants in the STABLE study tested themselves at home, but their warfarin dosing was managed by their referring physicians or anticoagulation clinics. Thus, an individual’s TTR reflected the warfarin management expertise of the referral source.

There are several reasons why home monitoring achieves better TTRs and – as shown in other studies – lower major bleeding and thrombotic event rates than with usual care or anticoagulation clinics not utilizing patient self-monitoring, Dr. Ansell said. Home testing is more frequent, timely, and consistent, and the immediate feedback regarding INR results is likely to promote adherence.

A variant of patient self-testing starting to catch on in the United States is patient self-management. This entails teaching patients how to manage their own warfarin dose on the basis of their home INR measurements.

The most recent American College of Chest Physicians clinical practice guidelines on antithrombotic therapy for atrial fibrillation give patient self-management of warfarin therapy a class 2B recommendation, stating, "For patients treated with vitamin K antagonists who are motivated and can demonstrate competency in self-management strategies, including the self-testing equipment, we suggest patient self-management rather than the usual outpatient INR monitoring" (CHEST 2012;141: 2 suppl. e531S-e575S [doi: 10.1378/chest.11-2304]).

Session cochair Dr. Samuel Z. Goldhaber agreed with Dr. Ansell that warfarin still has a place in anticoagulation therapy. The fact that it costs as little as $4 per month while dabigatran, for example, retails for 60 times that amount, is not to be shrugged off in an era of runaway health care spending. Plus, warfarin, for all its drawbacks, is a known quantity backed by more than a half century of clinical experience.

"Even though warfarin can cause horrible complications, there are no more surprises left about what warfarin can do," observed Dr. Goldhaber, professor of medicine at Harvard Medical School and director of the venous thromboembolism research group at Brigham and Women’s Hospital, Boston.

A potential game changer for warfarin is the possibility that rapid pharmacogenetic testing will enable physicians to improve upon the current method of warfarin dosing.

One advantage warfarin has is that bleeding episodes can be reversed by administration of vitamin K. In contrast, there is as yet no reliable means of reversing major bleeding in patients on the novel anticoagulants. But Dr. Lars Wallentin said this limitation of the new agents is outweighed by the consistent finding that they have lower rates of intracranial hemorrhage than those of warfarin.

"There is no antidote to warfarin that has proven to have any effect in patients with ICH. And there is no evidence as far as I can see that however you control INR you can reach as low a level of ICH as with these new agents. I think this is a specific downside of warfarin that we can’t get away from," said Dr. Wallentin, professor of cardiology at Uppsala (Sweden) University.

The STABLE study was funded by Alere Home Monitoring, Inc. Dr. Ansell is a consultant to the company.

Dr. Goldhaber has served as a consultant to numerous pharmaceutical companies developing cardiovascular medications.

Dr. Wallentin was principal investigator in the ARISTOTLE study of apixaban, funded by Pfizer and Bristol Myers Squibb, and has served as a consultant to those and other pharmaceutical companies.

CHICAGO – The new oral anticoagulants for stroke prevention in atrial fibrillation may be garnering all the buzz, but don’t count out warfarin.

"It’s not just a knee-jerk reaction that all patients should be switched to the new agents. It’s dependent upon how well you as a physician are managing your patients on warfarin," Dr. Jack E. Ansell asserted at the annual meeting of the American College of Cardiology.

"Warfarin therapy is all about management. If it’s not managed well, you can compare it to anything, and anything is going to be better. And if it’s managed very well, then it’s very difficult to beat warfarin therapy," said Dr. Ansell, chairman of the department of medicine at Lenox Hill Hospital in New York.

A growing body of evidence indicates that the new standard in high-quality management of warfarin therapy involves patient self-testing of International Normalized Ratios at home using a fingerstick blood sample and portable point-of-care device.

Case in point: Dr. Ansell presented highlights of the new STABLE study, in which he and his coinvestigators conducted a retrospective analysis of the real-world experience of more than 29,000 warfarin-treated patients enrolled in a national commercial comprehensive self-test support service (JACC 2012 March 27 [doi: 10.1016/S0735-1097(12)61865-8]).

Patients who performed frequent self-testing – meaning more than 80% of their self-testing was done on a weekly basis had a mean time spent in the therapeutic INR range (TTR) of 74%. That’s unprecedented, he said.

By comparison, in the pivotal RE-LY randomized trial for dabigatran (Pradaxa), the control group on warfarin had a TTR of 64% (N. Engl. J. Med. 2009;361:1139-51). In the ROCKET-AF trial of rivaroxaban (Xarelto), warfarin controls had a TTR of 55% (N. Engl. J. Med. 2011;365:883-91). And in the ARISTOTLE study of apixaban (Eliquis), an agent expected to soon receive Food and Drug Administration marketing approval, the warfarin control group had a TTR of 62% (N. Engl. J. Med. 2011;365:981-92). In all these major randomized trials involving the novel oral anticoagulants, patients assigned to warfarin were closely managed, but in traditional fashion – home self-testing wasn’t involved.

In contrast, in the STABLE study, the overall TTR, including those patients who self-tested variably and inconsistently, was still 69.7%.

"This is important because the cost-effectiveness analyses done with dabigatran and the other new anticoagulants suggest that when you get up to a TTR above 70% with warfarin, the cost-effectiveness of the new agents diminishes and warfarin actually becomes more cost-effective," according to Dr. Ansell.

A particularly impressive finding in STABLE was that patients who did weekly self-testing had a 2.3% incidence of critical value INR results, defined as an INR below 1.5 or greater than 5.0. "This is really a phenomenally low result," he commented. It represented a 48% reduction from the 4.4% incidence in patients with variable self-testing frequency.

Participants in the STABLE study tested themselves at home, but their warfarin dosing was managed by their referring physicians or anticoagulation clinics. Thus, an individual’s TTR reflected the warfarin management expertise of the referral source.

There are several reasons why home monitoring achieves better TTRs and – as shown in other studies – lower major bleeding and thrombotic event rates than with usual care or anticoagulation clinics not utilizing patient self-monitoring, Dr. Ansell said. Home testing is more frequent, timely, and consistent, and the immediate feedback regarding INR results is likely to promote adherence.

A variant of patient self-testing starting to catch on in the United States is patient self-management. This entails teaching patients how to manage their own warfarin dose on the basis of their home INR measurements.

The most recent American College of Chest Physicians clinical practice guidelines on antithrombotic therapy for atrial fibrillation give patient self-management of warfarin therapy a class 2B recommendation, stating, "For patients treated with vitamin K antagonists who are motivated and can demonstrate competency in self-management strategies, including the self-testing equipment, we suggest patient self-management rather than the usual outpatient INR monitoring" (CHEST 2012;141: 2 suppl. e531S-e575S [doi: 10.1378/chest.11-2304]).

Session cochair Dr. Samuel Z. Goldhaber agreed with Dr. Ansell that warfarin still has a place in anticoagulation therapy. The fact that it costs as little as $4 per month while dabigatran, for example, retails for 60 times that amount, is not to be shrugged off in an era of runaway health care spending. Plus, warfarin, for all its drawbacks, is a known quantity backed by more than a half century of clinical experience.

"Even though warfarin can cause horrible complications, there are no more surprises left about what warfarin can do," observed Dr. Goldhaber, professor of medicine at Harvard Medical School and director of the venous thromboembolism research group at Brigham and Women’s Hospital, Boston.

A potential game changer for warfarin is the possibility that rapid pharmacogenetic testing will enable physicians to improve upon the current method of warfarin dosing.

One advantage warfarin has is that bleeding episodes can be reversed by administration of vitamin K. In contrast, there is as yet no reliable means of reversing major bleeding in patients on the novel anticoagulants. But Dr. Lars Wallentin said this limitation of the new agents is outweighed by the consistent finding that they have lower rates of intracranial hemorrhage than those of warfarin.

"There is no antidote to warfarin that has proven to have any effect in patients with ICH. And there is no evidence as far as I can see that however you control INR you can reach as low a level of ICH as with these new agents. I think this is a specific downside of warfarin that we can’t get away from," said Dr. Wallentin, professor of cardiology at Uppsala (Sweden) University.

The STABLE study was funded by Alere Home Monitoring, Inc. Dr. Ansell is a consultant to the company.

Dr. Goldhaber has served as a consultant to numerous pharmaceutical companies developing cardiovascular medications.

Dr. Wallentin was principal investigator in the ARISTOTLE study of apixaban, funded by Pfizer and Bristol Myers Squibb, and has served as a consultant to those and other pharmaceutical companies.

CHICAGO – Leg and foot amputations for elderly U.S. patients with peripheral artery disease dropped by more than half during the period 2000-2008 for unknown reasons, based on a review of Medicare data.

During the 9-year period studied, the rate of lower-extremity amputations among U.S. Medicare beneficiaries fell from 9,650/100,000 beneficiaries with peripheral artery disease (PAD) to 4,274/100,000, Dr. W. Schuyler Jones and his associates reported in a poster at the meeting.

Their analysis of the 2000-2008 Medicare data also showed significant regional variations in lower-extremity amputation rates in PAD patients, with the highest rate in New England and the lowest rate in the East North Central region (Illinois, Indiana, Michigan, Ohio, and Wisconsin). Again, no clear explanation exists for this pattern, said Dr. Jones, an interventional cardiologist at Duke University in Durham, N.C., and his associates.

Their analysis of data from the Centers for Medicare & Medicaid Services included 3,354,264 diagnosed with PAD during 2000-2008, of whom 249,310 (7%) underwent amputation of a foot or leg, either below or above the knee. The average age of all PAD patients was 77 years old among both those who underwent amputations and those who did not have this surgery. The analysis identified four factors that were significant, independent predictors of having an amputation: male sex, African American race, and the presence of renal disease or diabetes.

During the 9-year period, the annual incidence of patients newly diagnosed with PAD remained relatively steady, with 398,000 diagnosed in 2000 and 397,000 diagnosed in 2008. The rates showed some year-to-year fluctuation, ranging from a low of 304,000 in 2003 to a high of 517,000 in 2006.

In contrast, the annual incidence of lower-extremity amputations showed a clear downward trajectory, with a sharp drop starting in 2005. During 2000-2004, the annual amputation rate hovered at about 10,000 cases/100,000 patients with PAD, but then fell to 7,455/100,000 in 2005, and fell further to 4,261/100,000 in 2006. During the subsequent 2 years the rate remained at about the same low level first reached in 2006. Roughly similar patterns existed for the subgroups of patients who underwent above-the-knee amputations, below-the-knee amputations, or foot amputations.

The authors of the report performed an analysis of amputation rates by U.S. Census geographic regions for the entire period of 2000-2008 that they adjusted by regional differences in patients’ age, sex, race, comorbidities, and year of amputation. They set the amputation rate in the South Atlantic region as their reference level, and found four regions with significantly higher rates of amputations: New England ran 16% higher, the West South Central region (Arkansas, Louisiana, Oklahoma, and Texas) ran 12% higher, Mid Atlantic (Connecticut, New Jersey, New York, and Pennsylvania) was 8% higher, and the Pacific region (Alaska, California, Hawaii, Oregon, and Washington) was 3% above the reference level. Three other U.S. regions had amputations rates below the reference level, headed by the East North Central which ran 11% below the South Atlantic region, followed by the Mountain region at 10% lower, and the West North Central region (Iowa, Kansas, Minnesota, Missouri, Nebraska, North Dakota, and South Dakota) which was 5% below the reference level.

Dr. Jones said that he had no disclosures.

CHICAGO – Leg and foot amputations for elderly U.S. patients with peripheral artery disease dropped by more than half during the period 2000-2008 for unknown reasons, based on a review of Medicare data.

During the 9-year period studied, the rate of lower-extremity amputations among U.S. Medicare beneficiaries fell from 9,650/100,000 beneficiaries with peripheral artery disease (PAD) to 4,274/100,000, Dr. W. Schuyler Jones and his associates reported in a poster at the meeting.

Their analysis of the 2000-2008 Medicare data also showed significant regional variations in lower-extremity amputation rates in PAD patients, with the highest rate in New England and the lowest rate in the East North Central region (Illinois, Indiana, Michigan, Ohio, and Wisconsin). Again, no clear explanation exists for this pattern, said Dr. Jones, an interventional cardiologist at Duke University in Durham, N.C., and his associates.

Their analysis of data from the Centers for Medicare & Medicaid Services included 3,354,264 diagnosed with PAD during 2000-2008, of whom 249,310 (7%) underwent amputation of a foot or leg, either below or above the knee. The average age of all PAD patients was 77 years old among both those who underwent amputations and those who did not have this surgery. The analysis identified four factors that were significant, independent predictors of having an amputation: male sex, African American race, and the presence of renal disease or diabetes.

During the 9-year period, the annual incidence of patients newly diagnosed with PAD remained relatively steady, with 398,000 diagnosed in 2000 and 397,000 diagnosed in 2008. The rates showed some year-to-year fluctuation, ranging from a low of 304,000 in 2003 to a high of 517,000 in 2006.

In contrast, the annual incidence of lower-extremity amputations showed a clear downward trajectory, with a sharp drop starting in 2005. During 2000-2004, the annual amputation rate hovered at about 10,000 cases/100,000 patients with PAD, but then fell to 7,455/100,000 in 2005, and fell further to 4,261/100,000 in 2006. During the subsequent 2 years the rate remained at about the same low level first reached in 2006. Roughly similar patterns existed for the subgroups of patients who underwent above-the-knee amputations, below-the-knee amputations, or foot amputations.

The authors of the report performed an analysis of amputation rates by U.S. Census geographic regions for the entire period of 2000-2008 that they adjusted by regional differences in patients’ age, sex, race, comorbidities, and year of amputation. They set the amputation rate in the South Atlantic region as their reference level, and found four regions with significantly higher rates of amputations: New England ran 16% higher, the West South Central region (Arkansas, Louisiana, Oklahoma, and Texas) ran 12% higher, Mid Atlantic (Connecticut, New Jersey, New York, and Pennsylvania) was 8% higher, and the Pacific region (Alaska, California, Hawaii, Oregon, and Washington) was 3% above the reference level. Three other U.S. regions had amputations rates below the reference level, headed by the East North Central which ran 11% below the South Atlantic region, followed by the Mountain region at 10% lower, and the West North Central region (Iowa, Kansas, Minnesota, Missouri, Nebraska, North Dakota, and South Dakota) which was 5% below the reference level.

Dr. Jones said that he had no disclosures.

CHICAGO – Leg and foot amputations for elderly U.S. patients with peripheral artery disease dropped by more than half during the period 2000-2008 for unknown reasons, based on a review of Medicare data.

During the 9-year period studied, the rate of lower-extremity amputations among U.S. Medicare beneficiaries fell from 9,650/100,000 beneficiaries with peripheral artery disease (PAD) to 4,274/100,000, Dr. W. Schuyler Jones and his associates reported in a poster at the meeting.

Their analysis of the 2000-2008 Medicare data also showed significant regional variations in lower-extremity amputation rates in PAD patients, with the highest rate in New England and the lowest rate in the East North Central region (Illinois, Indiana, Michigan, Ohio, and Wisconsin). Again, no clear explanation exists for this pattern, said Dr. Jones, an interventional cardiologist at Duke University in Durham, N.C., and his associates.

Their analysis of data from the Centers for Medicare & Medicaid Services included 3,354,264 diagnosed with PAD during 2000-2008, of whom 249,310 (7%) underwent amputation of a foot or leg, either below or above the knee. The average age of all PAD patients was 77 years old among both those who underwent amputations and those who did not have this surgery. The analysis identified four factors that were significant, independent predictors of having an amputation: male sex, African American race, and the presence of renal disease or diabetes.

During the 9-year period, the annual incidence of patients newly diagnosed with PAD remained relatively steady, with 398,000 diagnosed in 2000 and 397,000 diagnosed in 2008. The rates showed some year-to-year fluctuation, ranging from a low of 304,000 in 2003 to a high of 517,000 in 2006.

In contrast, the annual incidence of lower-extremity amputations showed a clear downward trajectory, with a sharp drop starting in 2005. During 2000-2004, the annual amputation rate hovered at about 10,000 cases/100,000 patients with PAD, but then fell to 7,455/100,000 in 2005, and fell further to 4,261/100,000 in 2006. During the subsequent 2 years the rate remained at about the same low level first reached in 2006. Roughly similar patterns existed for the subgroups of patients who underwent above-the-knee amputations, below-the-knee amputations, or foot amputations.

The authors of the report performed an analysis of amputation rates by U.S. Census geographic regions for the entire period of 2000-2008 that they adjusted by regional differences in patients’ age, sex, race, comorbidities, and year of amputation. They set the amputation rate in the South Atlantic region as their reference level, and found four regions with significantly higher rates of amputations: New England ran 16% higher, the West South Central region (Arkansas, Louisiana, Oklahoma, and Texas) ran 12% higher, Mid Atlantic (Connecticut, New Jersey, New York, and Pennsylvania) was 8% higher, and the Pacific region (Alaska, California, Hawaii, Oregon, and Washington) was 3% above the reference level. Three other U.S. regions had amputations rates below the reference level, headed by the East North Central which ran 11% below the South Atlantic region, followed by the Mountain region at 10% lower, and the West North Central region (Iowa, Kansas, Minnesota, Missouri, Nebraska, North Dakota, and South Dakota) which was 5% below the reference level.

Dr. Jones said that he had no disclosures.

CHICAGO – The conventional teaching that pregnant women with congenital heart disease should undergo a passive second stage of labor assisted by forceps or vacuum delivery has been called into question.

Avoidance of active pushing during labor by such patients has long been recommended because of theoretical concerns that the reduction in preload and increased myocardial oxygen requirement that occur with the Valsalva maneuver place women with congenital heart disease at increased risk for cardiac events. But the issue has never actually been studied – until recently, noted Dr. Katherine E. Economy, a maternal-fetal medicine specialist at Brigham and Women’s Hospital, Boston.

"We’ve looked at this in our institution, and what we found is that avoiding Valsalva is associated with worse maternal outcomes: more third- and fourth-degree lacerations and more postpartum hemorrhages. So although the patient numbers were small, this has really encouraged us to move away from doing assisted second stage," she said at the annual meeting of the American College of Cardiology.

Other dogmata widely accepted by cardiologists, obstetricians, and anesthesiologists are that pregnant women with congenital heart disease should routinely be delivered a few weeks early, and by cesarean section. Dr. Economy challenged both notions.

For the Valsalva study, she and her coinvestigators carried out a retrospective cohort study including 112 pregnancies in 65 women with congenital heart disease who were delivered at the hospital during 1998-2005. The focus was on evaluating obstetric outcomes, as the great majority of previous studies of pregnancy outcomes in patients with congenital heart disease addressed maternal cardiac events.

Roughly three-quarters of the women were instructed not to push during the second stage of labor; they underwent a planned assisted delivery in accord with conventional teaching. However, during the study period a shift in practice philosophy occurred in the Boston congenital heart obstetric service, such that women were allowed a trial of pushing on an individualized basis.

Among the 62 pregnancies that reached the second stage of labor, nine (20%) postpartum hemorrhages and seven (16%) third- or fourth-degree lacerations occurred among 45 no-Valsalva patients, compared with none in 17 (0%) women who pushed during labor. The only maternal adverse cardiac event (2%) occurred in a woman who did not do the Valsalva maneuver.

Adverse obstetric events occurred in one-third of women. However, a multivariate analysis didn’t identify any reliable independent predictors for sustaining an adverse obstetric event. Thus, women with congenital heart disease who move forward with pregnancy are at an overall increased risk for adverse obstetric outcomes, but baseline maternal cardiac factors aren’t helpful in picking out a higher-risk subgroup.

The most common adverse obstetric outcome was preterm delivery; the 21% incidence was nearly twice that seen in the general population. Also noteworthy were the 14% incidence of postpartum hemorrhage and the 10% rate of preterm premature rupture of membranes (Int. J. Cardiol. 2010;144:195-9).

Dr. Economy observed that with growing numbers of women with congenital heart disease who survive well into their childbearing years, congenital heart disease now accounts for more than 50% of heart disease in pregnancy. And although maternal deaths due to hemorrhage or venous thromboembolism have fallen sharply over the last 20 years, maternal deaths from cardiovascular disease have risen. Indeed, cardiac disease in pregnancy is now the leading cause of indirect maternal mortality.

"So we think of this in maternal-fetal medicine as a major public health issue," the ob.gyn. said.

She noted that in discussing the possibility of termination in the event of unplanned pregnancy in a patient with congenital heart disease, it’s important to understand that by the second trimester, many of the cardiovascular changes in pregnancy – including a 30%-50% increase in cardiac output, a drop in systemic vascular resistance, and an increase in heart rate – will already have occurred. At that point, the maternal risk may not be altered all that much by terminating.

Managing maternal cardiac risk in patients with congenital aortic root dilatation in accord with joint multispecialty society-backed guidelines (J. Am. Coll. Cardiol. 2010;55:1509-44) entails strict blood pressure control with a beta-blocker, the discontinuation of angiotensin receptor blocker therapy, a monthly or bimonthly echocardiography, an MRI without gadolinium, and delivery in a center with cardiac surgery backup.

In the management of obstetric risk in patients with aortic disease, Dr. Economy recommends a first trimester ultrasound for dating, sequential cervical length measurements beginning at 16 weeks, serious consideration of cerclage placement if the cervix shortens, and ultrasound for fetal growth surveillance.

Interestingly, patients with Marfan syndrome or other connective tissue disorders associated with aortic disease have a high rate of cervical incompetence (Placenta 2009;30:207-15). That’s probably because the cervix is 90% collagen; thus, the cervix may be affected by the same genetic defects that lead to other, more familiar manifestations of disordered connective tissue synthesis and metabolism, she explained.

Timing of delivery is individualized based upon cardiac status, gestational age, Bishop score, and other factors.

"Many of you probably start to lose your nerve a bit at the end and say, ‘Pregnancy is bad for heart disease; we should just deliver.’ But generally speaking, if your patients are doing well in the third trimester, there’s really no reason to induce prematurity," Dr. Economy asserted.

She cited a large multicenter study that has turned heads in the world of maternal-fetal medicine. The study showed significantly increased rates of NICU admission, newborn sepsis, and respiratory complications requiring prolonged intubation with delivery at 37-38 weeks’ gestation, compared with 39 weeks’, in a broad population of pregnant women (N. Engl. J. Med. 2009;360:111-20).

"If your patients are doing well, let them stay pregnant," the ob.gyn. urged.

Cesarean section is really popular in patients with congenital heart disease. The joint guidelines state, "Fetal delivery via cesarean section is reasonable for patients with significant aortic enlargement, dissection, or severe aortic valve regurgitation" (Circulation 2010;121:1544-79). But Dr. Economy pointed out that this recommendation is rated class II, level of evidence C, meaning that it is based solely on expert opinion. And these joint guidelines were drawn up and approved by numerous cardiovascular and imaging societies without the endorsement of any obstetric organizations.

"I would put to you that every time you think about a cesarean section, you stop and remember that cesarean section is worse for women. For all women. C-section is worse for them, okay? It increases the risk of significant blood loss, increases infection risk, and increases the risk of venous thromboembolism," she said.

"My personal opinion is cesarean section should be reserved for obstetric indications – things like failure to progress, breech presentation, or nonreassuring fetal status in labor. The vast majority of patients will be better served by vaginal delivery. Plan on an interdisciplinary effort between obstetrics, cardiology, anesthesiology, and nursing," Dr. Economy advised.

Dr. Economy and her associates reported that they had no relevant financial disclosures.

CHICAGO – The conventional teaching that pregnant women with congenital heart disease should undergo a passive second stage of labor assisted by forceps or vacuum delivery has been called into question.

Avoidance of active pushing during labor by such patients has long been recommended because of theoretical concerns that the reduction in preload and increased myocardial oxygen requirement that occur with the Valsalva maneuver place women with congenital heart disease at increased risk for cardiac events. But the issue has never actually been studied – until recently, noted Dr. Katherine E. Economy, a maternal-fetal medicine specialist at Brigham and Women’s Hospital, Boston.

"We’ve looked at this in our institution, and what we found is that avoiding Valsalva is associated with worse maternal outcomes: more third- and fourth-degree lacerations and more postpartum hemorrhages. So although the patient numbers were small, this has really encouraged us to move away from doing assisted second stage," she said at the annual meeting of the American College of Cardiology.

Other dogmata widely accepted by cardiologists, obstetricians, and anesthesiologists are that pregnant women with congenital heart disease should routinely be delivered a few weeks early, and by cesarean section. Dr. Economy challenged both notions.

For the Valsalva study, she and her coinvestigators carried out a retrospective cohort study including 112 pregnancies in 65 women with congenital heart disease who were delivered at the hospital during 1998-2005. The focus was on evaluating obstetric outcomes, as the great majority of previous studies of pregnancy outcomes in patients with congenital heart disease addressed maternal cardiac events.

Roughly three-quarters of the women were instructed not to push during the second stage of labor; they underwent a planned assisted delivery in accord with conventional teaching. However, during the study period a shift in practice philosophy occurred in the Boston congenital heart obstetric service, such that women were allowed a trial of pushing on an individualized basis.

Among the 62 pregnancies that reached the second stage of labor, nine (20%) postpartum hemorrhages and seven (16%) third- or fourth-degree lacerations occurred among 45 no-Valsalva patients, compared with none in 17 (0%) women who pushed during labor. The only maternal adverse cardiac event (2%) occurred in a woman who did not do the Valsalva maneuver.

Adverse obstetric events occurred in one-third of women. However, a multivariate analysis didn’t identify any reliable independent predictors for sustaining an adverse obstetric event. Thus, women with congenital heart disease who move forward with pregnancy are at an overall increased risk for adverse obstetric outcomes, but baseline maternal cardiac factors aren’t helpful in picking out a higher-risk subgroup.

The most common adverse obstetric outcome was preterm delivery; the 21% incidence was nearly twice that seen in the general population. Also noteworthy were the 14% incidence of postpartum hemorrhage and the 10% rate of preterm premature rupture of membranes (Int. J. Cardiol. 2010;144:195-9).

Dr. Economy observed that with growing numbers of women with congenital heart disease who survive well into their childbearing years, congenital heart disease now accounts for more than 50% of heart disease in pregnancy. And although maternal deaths due to hemorrhage or venous thromboembolism have fallen sharply over the last 20 years, maternal deaths from cardiovascular disease have risen. Indeed, cardiac disease in pregnancy is now the leading cause of indirect maternal mortality.

"So we think of this in maternal-fetal medicine as a major public health issue," the ob.gyn. said.

She noted that in discussing the possibility of termination in the event of unplanned pregnancy in a patient with congenital heart disease, it’s important to understand that by the second trimester, many of the cardiovascular changes in pregnancy – including a 30%-50% increase in cardiac output, a drop in systemic vascular resistance, and an increase in heart rate – will already have occurred. At that point, the maternal risk may not be altered all that much by terminating.

Managing maternal cardiac risk in patients with congenital aortic root dilatation in accord with joint multispecialty society-backed guidelines (J. Am. Coll. Cardiol. 2010;55:1509-44) entails strict blood pressure control with a beta-blocker, the discontinuation of angiotensin receptor blocker therapy, a monthly or bimonthly echocardiography, an MRI without gadolinium, and delivery in a center with cardiac surgery backup.

In the management of obstetric risk in patients with aortic disease, Dr. Economy recommends a first trimester ultrasound for dating, sequential cervical length measurements beginning at 16 weeks, serious consideration of cerclage placement if the cervix shortens, and ultrasound for fetal growth surveillance.

Interestingly, patients with Marfan syndrome or other connective tissue disorders associated with aortic disease have a high rate of cervical incompetence (Placenta 2009;30:207-15). That’s probably because the cervix is 90% collagen; thus, the cervix may be affected by the same genetic defects that lead to other, more familiar manifestations of disordered connective tissue synthesis and metabolism, she explained.

Timing of delivery is individualized based upon cardiac status, gestational age, Bishop score, and other factors.

"Many of you probably start to lose your nerve a bit at the end and say, ‘Pregnancy is bad for heart disease; we should just deliver.’ But generally speaking, if your patients are doing well in the third trimester, there’s really no reason to induce prematurity," Dr. Economy asserted.

She cited a large multicenter study that has turned heads in the world of maternal-fetal medicine. The study showed significantly increased rates of NICU admission, newborn sepsis, and respiratory complications requiring prolonged intubation with delivery at 37-38 weeks’ gestation, compared with 39 weeks’, in a broad population of pregnant women (N. Engl. J. Med. 2009;360:111-20).

"If your patients are doing well, let them stay pregnant," the ob.gyn. urged.

Cesarean section is really popular in patients with congenital heart disease. The joint guidelines state, "Fetal delivery via cesarean section is reasonable for patients with significant aortic enlargement, dissection, or severe aortic valve regurgitation" (Circulation 2010;121:1544-79). But Dr. Economy pointed out that this recommendation is rated class II, level of evidence C, meaning that it is based solely on expert opinion. And these joint guidelines were drawn up and approved by numerous cardiovascular and imaging societies without the endorsement of any obstetric organizations.

"I would put to you that every time you think about a cesarean section, you stop and remember that cesarean section is worse for women. For all women. C-section is worse for them, okay? It increases the risk of significant blood loss, increases infection risk, and increases the risk of venous thromboembolism," she said.

"My personal opinion is cesarean section should be reserved for obstetric indications – things like failure to progress, breech presentation, or nonreassuring fetal status in labor. The vast majority of patients will be better served by vaginal delivery. Plan on an interdisciplinary effort between obstetrics, cardiology, anesthesiology, and nursing," Dr. Economy advised.

Dr. Economy and her associates reported that they had no relevant financial disclosures.

CHICAGO – The conventional teaching that pregnant women with congenital heart disease should undergo a passive second stage of labor assisted by forceps or vacuum delivery has been called into question.

Avoidance of active pushing during labor by such patients has long been recommended because of theoretical concerns that the reduction in preload and increased myocardial oxygen requirement that occur with the Valsalva maneuver place women with congenital heart disease at increased risk for cardiac events. But the issue has never actually been studied – until recently, noted Dr. Katherine E. Economy, a maternal-fetal medicine specialist at Brigham and Women’s Hospital, Boston.

"We’ve looked at this in our institution, and what we found is that avoiding Valsalva is associated with worse maternal outcomes: more third- and fourth-degree lacerations and more postpartum hemorrhages. So although the patient numbers were small, this has really encouraged us to move away from doing assisted second stage," she said at the annual meeting of the American College of Cardiology.

Other dogmata widely accepted by cardiologists, obstetricians, and anesthesiologists are that pregnant women with congenital heart disease should routinely be delivered a few weeks early, and by cesarean section. Dr. Economy challenged both notions.

For the Valsalva study, she and her coinvestigators carried out a retrospective cohort study including 112 pregnancies in 65 women with congenital heart disease who were delivered at the hospital during 1998-2005. The focus was on evaluating obstetric outcomes, as the great majority of previous studies of pregnancy outcomes in patients with congenital heart disease addressed maternal cardiac events.

Roughly three-quarters of the women were instructed not to push during the second stage of labor; they underwent a planned assisted delivery in accord with conventional teaching. However, during the study period a shift in practice philosophy occurred in the Boston congenital heart obstetric service, such that women were allowed a trial of pushing on an individualized basis.

Among the 62 pregnancies that reached the second stage of labor, nine (20%) postpartum hemorrhages and seven (16%) third- or fourth-degree lacerations occurred among 45 no-Valsalva patients, compared with none in 17 (0%) women who pushed during labor. The only maternal adverse cardiac event (2%) occurred in a woman who did not do the Valsalva maneuver.

Adverse obstetric events occurred in one-third of women. However, a multivariate analysis didn’t identify any reliable independent predictors for sustaining an adverse obstetric event. Thus, women with congenital heart disease who move forward with pregnancy are at an overall increased risk for adverse obstetric outcomes, but baseline maternal cardiac factors aren’t helpful in picking out a higher-risk subgroup.

The most common adverse obstetric outcome was preterm delivery; the 21% incidence was nearly twice that seen in the general population. Also noteworthy were the 14% incidence of postpartum hemorrhage and the 10% rate of preterm premature rupture of membranes (Int. J. Cardiol. 2010;144:195-9).

Dr. Economy observed that with growing numbers of women with congenital heart disease who survive well into their childbearing years, congenital heart disease now accounts for more than 50% of heart disease in pregnancy. And although maternal deaths due to hemorrhage or venous thromboembolism have fallen sharply over the last 20 years, maternal deaths from cardiovascular disease have risen. Indeed, cardiac disease in pregnancy is now the leading cause of indirect maternal mortality.

"So we think of this in maternal-fetal medicine as a major public health issue," the ob.gyn. said.

She noted that in discussing the possibility of termination in the event of unplanned pregnancy in a patient with congenital heart disease, it’s important to understand that by the second trimester, many of the cardiovascular changes in pregnancy – including a 30%-50% increase in cardiac output, a drop in systemic vascular resistance, and an increase in heart rate – will already have occurred. At that point, the maternal risk may not be altered all that much by terminating.

Managing maternal cardiac risk in patients with congenital aortic root dilatation in accord with joint multispecialty society-backed guidelines (J. Am. Coll. Cardiol. 2010;55:1509-44) entails strict blood pressure control with a beta-blocker, the discontinuation of angiotensin receptor blocker therapy, a monthly or bimonthly echocardiography, an MRI without gadolinium, and delivery in a center with cardiac surgery backup.

In the management of obstetric risk in patients with aortic disease, Dr. Economy recommends a first trimester ultrasound for dating, sequential cervical length measurements beginning at 16 weeks, serious consideration of cerclage placement if the cervix shortens, and ultrasound for fetal growth surveillance.

Interestingly, patients with Marfan syndrome or other connective tissue disorders associated with aortic disease have a high rate of cervical incompetence (Placenta 2009;30:207-15). That’s probably because the cervix is 90% collagen; thus, the cervix may be affected by the same genetic defects that lead to other, more familiar manifestations of disordered connective tissue synthesis and metabolism, she explained.

Timing of delivery is individualized based upon cardiac status, gestational age, Bishop score, and other factors.

"Many of you probably start to lose your nerve a bit at the end and say, ‘Pregnancy is bad for heart disease; we should just deliver.’ But generally speaking, if your patients are doing well in the third trimester, there’s really no reason to induce prematurity," Dr. Economy asserted.

She cited a large multicenter study that has turned heads in the world of maternal-fetal medicine. The study showed significantly increased rates of NICU admission, newborn sepsis, and respiratory complications requiring prolonged intubation with delivery at 37-38 weeks’ gestation, compared with 39 weeks’, in a broad population of pregnant women (N. Engl. J. Med. 2009;360:111-20).

"If your patients are doing well, let them stay pregnant," the ob.gyn. urged.

Cesarean section is really popular in patients with congenital heart disease. The joint guidelines state, "Fetal delivery via cesarean section is reasonable for patients with significant aortic enlargement, dissection, or severe aortic valve regurgitation" (Circulation 2010;121:1544-79). But Dr. Economy pointed out that this recommendation is rated class II, level of evidence C, meaning that it is based solely on expert opinion. And these joint guidelines were drawn up and approved by numerous cardiovascular and imaging societies without the endorsement of any obstetric organizations.

"I would put to you that every time you think about a cesarean section, you stop and remember that cesarean section is worse for women. For all women. C-section is worse for them, okay? It increases the risk of significant blood loss, increases infection risk, and increases the risk of venous thromboembolism," she said.

"My personal opinion is cesarean section should be reserved for obstetric indications – things like failure to progress, breech presentation, or nonreassuring fetal status in labor. The vast majority of patients will be better served by vaginal delivery. Plan on an interdisciplinary effort between obstetrics, cardiology, anesthesiology, and nursing," Dr. Economy advised.

Dr. Economy and her associates reported that they had no relevant financial disclosures.

CHICAGO – The obesity paradox has emerged among coronary artery bypass graft surgery patients in New Jersey. That is, a fat patient undergoing CABG in the state is significantly more likely to be alive several years later than is a normal-weight person.

Analysis of 60,635 patients in the state’s vaunted, ground-breaking Myocardial Infarction Data Acquisition System (MIDAS) database who underwent an isolated CABG procedure during 1998-2007 showed a significantly greater mortality in normal-weight patients as compared with those who were overweight or obese, through 2 years of postsurgical follow-up, according to Dr. Yingzi Deng of Robert Wood Johnson Medical School, New Brunswick, N.J.

For example, from 90 days through 2 years post CABG, all-cause mortality in 13,306 normal-weight patients was 6.3%, compared with 4.1% in 25,648 overweight patients and 3.8% in 21,681 obese patients, she reported at the conference.

This translated to a 29% reduction in the relative risk of death in overweight and a 30% decrease in mortality risk in obese patients in a multivariate analysis adjusted for numerous potential confounders including age, gender, year of surgery, smoking status, diabetes, hypertension, chronic renal or pulmonary disease, left main disease, and ejection fraction.

Earlier studies had shown that better short-term outcomes in CABG patients who were overweight or obese patients (J. Am. Coll. Cardiol. 2003;42:668-76). The MIDAS registry study reflecting the statewide New Jersey experience provided a unique opportunity to see how body mass index affects long-term survival following CABG.

The obesity paradox has also been shown to pertain to patients undergoing percutaneous coronary intervention, as well as to patients hospitalized for acute deterioration of heart failure. The explanation for this intriguingly counterintuitive phenomenon remains unclear.

Dr. Deng reported having no financial conflicts.

CHICAGO – The obesity paradox has emerged among coronary artery bypass graft surgery patients in New Jersey. That is, a fat patient undergoing CABG in the state is significantly more likely to be alive several years later than is a normal-weight person.

Analysis of 60,635 patients in the state’s vaunted, ground-breaking Myocardial Infarction Data Acquisition System (MIDAS) database who underwent an isolated CABG procedure during 1998-2007 showed a significantly greater mortality in normal-weight patients as compared with those who were overweight or obese, through 2 years of postsurgical follow-up, according to Dr. Yingzi Deng of Robert Wood Johnson Medical School, New Brunswick, N.J.

For example, from 90 days through 2 years post CABG, all-cause mortality in 13,306 normal-weight patients was 6.3%, compared with 4.1% in 25,648 overweight patients and 3.8% in 21,681 obese patients, she reported at the conference.

This translated to a 29% reduction in the relative risk of death in overweight and a 30% decrease in mortality risk in obese patients in a multivariate analysis adjusted for numerous potential confounders including age, gender, year of surgery, smoking status, diabetes, hypertension, chronic renal or pulmonary disease, left main disease, and ejection fraction.

Earlier studies had shown that better short-term outcomes in CABG patients who were overweight or obese patients (J. Am. Coll. Cardiol. 2003;42:668-76). The MIDAS registry study reflecting the statewide New Jersey experience provided a unique opportunity to see how body mass index affects long-term survival following CABG.

The obesity paradox has also been shown to pertain to patients undergoing percutaneous coronary intervention, as well as to patients hospitalized for acute deterioration of heart failure. The explanation for this intriguingly counterintuitive phenomenon remains unclear.

Dr. Deng reported having no financial conflicts.

CHICAGO – The obesity paradox has emerged among coronary artery bypass graft surgery patients in New Jersey. That is, a fat patient undergoing CABG in the state is significantly more likely to be alive several years later than is a normal-weight person.

Analysis of 60,635 patients in the state’s vaunted, ground-breaking Myocardial Infarction Data Acquisition System (MIDAS) database who underwent an isolated CABG procedure during 1998-2007 showed a significantly greater mortality in normal-weight patients as compared with those who were overweight or obese, through 2 years of postsurgical follow-up, according to Dr. Yingzi Deng of Robert Wood Johnson Medical School, New Brunswick, N.J.

For example, from 90 days through 2 years post CABG, all-cause mortality in 13,306 normal-weight patients was 6.3%, compared with 4.1% in 25,648 overweight patients and 3.8% in 21,681 obese patients, she reported at the conference.

This translated to a 29% reduction in the relative risk of death in overweight and a 30% decrease in mortality risk in obese patients in a multivariate analysis adjusted for numerous potential confounders including age, gender, year of surgery, smoking status, diabetes, hypertension, chronic renal or pulmonary disease, left main disease, and ejection fraction.

Earlier studies had shown that better short-term outcomes in CABG patients who were overweight or obese patients (J. Am. Coll. Cardiol. 2003;42:668-76). The MIDAS registry study reflecting the statewide New Jersey experience provided a unique opportunity to see how body mass index affects long-term survival following CABG.

The obesity paradox has also been shown to pertain to patients undergoing percutaneous coronary intervention, as well as to patients hospitalized for acute deterioration of heart failure. The explanation for this intriguingly counterintuitive phenomenon remains unclear.

Dr. Deng reported having no financial conflicts.

CHICAGO – Recent cuts in the door-to-balloon time for treating patients hospitalized with an acute myocardial infarction came with the cost of increased "false alarm" activations of the hospital’s emergency coronary-catheterization laboratory team.

At the University of Michigan, the rate of coronary-catheterization lab activations that proved unnecessary because patients did not have ST-elevation myocardial infarctions (STEMI) jumped from 23% of all activations in 2007 to 48% in 2011, Dr. Geoffrey D. Barnes and his associates reported in a poster at the annual meeting of the American College of Cardiology.

This spike in false-alarm activations coincided with a reduction in the average time to route patients with suspected STEMI from their entry to the hospital’s emergency department to the catheterization lab to start their percutaneous intervention (the "door-to-balloon" time) from 73 minutes in 2007 to 64 minutes in 2011. The concurrence of these two trends was more than coincidence, Dr. Barnes said.

"In 2006, the American Heart Association launched its door-to-balloon initiative [Circulation 2006;113:2152-63], so we looked, starting in 2007," to see how efforts to cut door-to-balloon time affected false activations. "In 2007, our door-to-balloon time was in the 70s [minutes] and we cut the time by an average of about 10 minutes per patient, but at the expense of a rise in false activations," Dr. Barnes said in an interview.

"We’re the only group I know of that has examined this trend over time, but while presenting this poster a lot of interventionalists who came by said that they’ve seen it too," said Dr. Barnes, a cardiologist at the University of Michigan, Ann Arbor.

Now that they have identified the problem, Dr. Barnes and his associates believe there is a way to address the false-activation issue without compromising rapid responses. The key, they believe, is giving more consideration to each case and gauging the likelihood of a real STEMI rather than knee-jerk activations.

"The system became ‘page no matter what,’ which initially made sense, but maybe now we can finesse it a bit" and continue to have rapid responses without taxing resources as much, he said.

"In our new algorithm, we say that when patients are highly suspicious, with clear symptoms and ECG findings, by all means activate. But when it’s questionable, call and ask for a cardiology consult first; you don’t have to activate the entire team. That’s the first step," Dr. Barnes said.

"Also, we have two [emergency medical] systems that feed into our hospital, and we find more false activations from one system than the other. They use different ECG machines that use different algorithms, so we have been in touch with the ECG manufacturers to try to change that. That should have a major impact, because the paramedics use it as their major barometer" for acute MI, he noted.

Dr. Barnes acknowledged that the plan to swap activations for cardiology consults will be tricky and require commitment.

"The problem is that, when [a paramedic or emergency physician] asks for a consult it takes time, but when you activate the cath lab everything else stops. Activating the cath lab has been the best way to get a cardiologist. What we are now doing is improving our access outside of acute MIs, for patients with chest pain who are not clear-cut STEMIs.

"If we can keep the average door-to-balloon time at 65 minutes or less I think we’ll be doing well, especially if we keep the number of patients with a time greater than 90 minutes very small," he said. On the false-positive side, "we have set a target of 20%," Dr. Barnes said. "We want to get all the STEMIs, and so we’re willing to have some false positives, but a 50% rate is not the right number."

Dr. Barnes said that he had no disclosures.

CHICAGO – Recent cuts in the door-to-balloon time for treating patients hospitalized with an acute myocardial infarction came with the cost of increased "false alarm" activations of the hospital’s emergency coronary-catheterization laboratory team.

At the University of Michigan, the rate of coronary-catheterization lab activations that proved unnecessary because patients did not have ST-elevation myocardial infarctions (STEMI) jumped from 23% of all activations in 2007 to 48% in 2011, Dr. Geoffrey D. Barnes and his associates reported in a poster at the annual meeting of the American College of Cardiology.

This spike in false-alarm activations coincided with a reduction in the average time to route patients with suspected STEMI from their entry to the hospital’s emergency department to the catheterization lab to start their percutaneous intervention (the "door-to-balloon" time) from 73 minutes in 2007 to 64 minutes in 2011. The concurrence of these two trends was more than coincidence, Dr. Barnes said.

"In 2006, the American Heart Association launched its door-to-balloon initiative [Circulation 2006;113:2152-63], so we looked, starting in 2007," to see how efforts to cut door-to-balloon time affected false activations. "In 2007, our door-to-balloon time was in the 70s [minutes] and we cut the time by an average of about 10 minutes per patient, but at the expense of a rise in false activations," Dr. Barnes said in an interview.

"We’re the only group I know of that has examined this trend over time, but while presenting this poster a lot of interventionalists who came by said that they’ve seen it too," said Dr. Barnes, a cardiologist at the University of Michigan, Ann Arbor.

Now that they have identified the problem, Dr. Barnes and his associates believe there is a way to address the false-activation issue without compromising rapid responses. The key, they believe, is giving more consideration to each case and gauging the likelihood of a real STEMI rather than knee-jerk activations.

"The system became ‘page no matter what,’ which initially made sense, but maybe now we can finesse it a bit" and continue to have rapid responses without taxing resources as much, he said.

"In our new algorithm, we say that when patients are highly suspicious, with clear symptoms and ECG findings, by all means activate. But when it’s questionable, call and ask for a cardiology consult first; you don’t have to activate the entire team. That’s the first step," Dr. Barnes said.

"Also, we have two [emergency medical] systems that feed into our hospital, and we find more false activations from one system than the other. They use different ECG machines that use different algorithms, so we have been in touch with the ECG manufacturers to try to change that. That should have a major impact, because the paramedics use it as their major barometer" for acute MI, he noted.

Dr. Barnes acknowledged that the plan to swap activations for cardiology consults will be tricky and require commitment.

"The problem is that, when [a paramedic or emergency physician] asks for a consult it takes time, but when you activate the cath lab everything else stops. Activating the cath lab has been the best way to get a cardiologist. What we are now doing is improving our access outside of acute MIs, for patients with chest pain who are not clear-cut STEMIs.

"If we can keep the average door-to-balloon time at 65 minutes or less I think we’ll be doing well, especially if we keep the number of patients with a time greater than 90 minutes very small," he said. On the false-positive side, "we have set a target of 20%," Dr. Barnes said. "We want to get all the STEMIs, and so we’re willing to have some false positives, but a 50% rate is not the right number."

Dr. Barnes said that he had no disclosures.

CHICAGO – Recent cuts in the door-to-balloon time for treating patients hospitalized with an acute myocardial infarction came with the cost of increased "false alarm" activations of the hospital’s emergency coronary-catheterization laboratory team.

At the University of Michigan, the rate of coronary-catheterization lab activations that proved unnecessary because patients did not have ST-elevation myocardial infarctions (STEMI) jumped from 23% of all activations in 2007 to 48% in 2011, Dr. Geoffrey D. Barnes and his associates reported in a poster at the annual meeting of the American College of Cardiology.

This spike in false-alarm activations coincided with a reduction in the average time to route patients with suspected STEMI from their entry to the hospital’s emergency department to the catheterization lab to start their percutaneous intervention (the "door-to-balloon" time) from 73 minutes in 2007 to 64 minutes in 2011. The concurrence of these two trends was more than coincidence, Dr. Barnes said.

"In 2006, the American Heart Association launched its door-to-balloon initiative [Circulation 2006;113:2152-63], so we looked, starting in 2007," to see how efforts to cut door-to-balloon time affected false activations. "In 2007, our door-to-balloon time was in the 70s [minutes] and we cut the time by an average of about 10 minutes per patient, but at the expense of a rise in false activations," Dr. Barnes said in an interview.

"We’re the only group I know of that has examined this trend over time, but while presenting this poster a lot of interventionalists who came by said that they’ve seen it too," said Dr. Barnes, a cardiologist at the University of Michigan, Ann Arbor.

Now that they have identified the problem, Dr. Barnes and his associates believe there is a way to address the false-activation issue without compromising rapid responses. The key, they believe, is giving more consideration to each case and gauging the likelihood of a real STEMI rather than knee-jerk activations.

"The system became ‘page no matter what,’ which initially made sense, but maybe now we can finesse it a bit" and continue to have rapid responses without taxing resources as much, he said.

"In our new algorithm, we say that when patients are highly suspicious, with clear symptoms and ECG findings, by all means activate. But when it’s questionable, call and ask for a cardiology consult first; you don’t have to activate the entire team. That’s the first step," Dr. Barnes said.

"Also, we have two [emergency medical] systems that feed into our hospital, and we find more false activations from one system than the other. They use different ECG machines that use different algorithms, so we have been in touch with the ECG manufacturers to try to change that. That should have a major impact, because the paramedics use it as their major barometer" for acute MI, he noted.

Dr. Barnes acknowledged that the plan to swap activations for cardiology consults will be tricky and require commitment.

"The problem is that, when [a paramedic or emergency physician] asks for a consult it takes time, but when you activate the cath lab everything else stops. Activating the cath lab has been the best way to get a cardiologist. What we are now doing is improving our access outside of acute MIs, for patients with chest pain who are not clear-cut STEMIs.

"If we can keep the average door-to-balloon time at 65 minutes or less I think we’ll be doing well, especially if we keep the number of patients with a time greater than 90 minutes very small," he said. On the false-positive side, "we have set a target of 20%," Dr. Barnes said. "We want to get all the STEMIs, and so we’re willing to have some false positives, but a 50% rate is not the right number."

Dr. Barnes said that he had no disclosures.

CHICAGO – Lowering LDL cholesterol early in life would prevent three times more cardiovascular events per unit of LDL-reduction compared to the current practice of initiating LDL-lowering statin therapy decades later, based on the findings of a novel genomic analysis known as a mendelian randomized controlled trial.

"People who’ve already been exposed to a lifetime of (elevated levels of) LDL have developed a certain underlying atherosclerotic burden. Lowering LDL at that point – even intensively – can merely stabilize the plaque or cause it to regress only slightly. One is still left with an underlying atherosclerotic plaque that can disrupt and cause symptoms or acute events. The alternative would be to start much earlier in life, before the plaque develops. And that’s what we tested," Dr. Brian A. Ference explained at the annual meeting of the American College of Cardiology.

Dr. Ference emphasized that he wasn’t arguing in favor of routinely starting statin therapy in children with high LDL levels. "A reasonable policy may be to promote a greater awareness of LDL cholesterol levels and a new emphasis on diet and lifestyle to keep LDL low, and in those persons in their 20s who can’t maintain ideal levels of cholesterol – somewhere between 50 and 70 mg/dL – it may be reasonable at that time to begin contemplating adding medication to prevent the development of atherosclerotic plaque."

His mendelian randomized controlled trial was not a conventional prospective clinical trial. That would be utterly impractical because it would take half a century or more. Rather, the mendelian randomized controlled trial was essentially a series of nine natural randomized trials conducted using a database comprised of more than 326,000 people whose genetic status was known with regard to nine single nucleotide polymorphisms (SNPs) associated with low LDL levels throughout life.

"We based this study on the concept of in vivo randomization, which suggests that at the time of conception polymorphisms are allocated randomly and that inheriting an allele that is associated with a lower LDL is analogous to being randomized at the time of birth to a medicine that lowers LDL for the whole of one’s lifetime. In contrast, inheriting the other allele is analogous to being allocated to usual care. So if one compares the risk of coronary [heart] disease (CHD) between the two groups, it should be analogous to a long-term trial," according to Dr. Ference, director of the cardiovascular genomic research center at Wayne State University, Detroit.

He and his fellow researchers compared CHD rates in individuals with the low-LDL SNPs to those in the huge database without the SNPs. Next they compared CHD rates in subjects with each of the nine SNPs to rates in statin-treated patients included in a large meta-analysis of statin randomized controlled trials that was carried out by the Cholesterol Treatment Trialists’ Collaboration.

Each of the nine SNPs was consistently associated with a 55% reduction in CHD risk for each 39 mg/dL lower lifetime exposure to LDL. In contrast, to achieve the same 55% reduction in CHD risk by starting statin therapy at age 63 – the average age at enrollment in the statin trials – a 116 mg/dL decrease in LDL would be required.

Dr. Ference noted that the nine SNPs lowered LDL via different mechanisms, suggesting that the associated beneficial decrease in CHD was mediated through LDL lowering per se and that the manner in which the reductions are achieved wasn’t important. Thus, lowering LDL via diet and exercise beginning early in life should be as effective in terms of reducing CHD risk as any other means of doing so, including drug therapy.

Dr. Ference reported having no financial conflicts.

CHICAGO – Lowering LDL cholesterol early in life would prevent three times more cardiovascular events per unit of LDL-reduction compared to the current practice of initiating LDL-lowering statin therapy decades later, based on the findings of a novel genomic analysis known as a mendelian randomized controlled trial.

"People who’ve already been exposed to a lifetime of (elevated levels of) LDL have developed a certain underlying atherosclerotic burden. Lowering LDL at that point – even intensively – can merely stabilize the plaque or cause it to regress only slightly. One is still left with an underlying atherosclerotic plaque that can disrupt and cause symptoms or acute events. The alternative would be to start much earlier in life, before the plaque develops. And that’s what we tested," Dr. Brian A. Ference explained at the annual meeting of the American College of Cardiology.

Dr. Ference emphasized that he wasn’t arguing in favor of routinely starting statin therapy in children with high LDL levels. "A reasonable policy may be to promote a greater awareness of LDL cholesterol levels and a new emphasis on diet and lifestyle to keep LDL low, and in those persons in their 20s who can’t maintain ideal levels of cholesterol – somewhere between 50 and 70 mg/dL – it may be reasonable at that time to begin contemplating adding medication to prevent the development of atherosclerotic plaque."

His mendelian randomized controlled trial was not a conventional prospective clinical trial. That would be utterly impractical because it would take half a century or more. Rather, the mendelian randomized controlled trial was essentially a series of nine natural randomized trials conducted using a database comprised of more than 326,000 people whose genetic status was known with regard to nine single nucleotide polymorphisms (SNPs) associated with low LDL levels throughout life.

"We based this study on the concept of in vivo randomization, which suggests that at the time of conception polymorphisms are allocated randomly and that inheriting an allele that is associated with a lower LDL is analogous to being randomized at the time of birth to a medicine that lowers LDL for the whole of one’s lifetime. In contrast, inheriting the other allele is analogous to being allocated to usual care. So if one compares the risk of coronary [heart] disease (CHD) between the two groups, it should be analogous to a long-term trial," according to Dr. Ference, director of the cardiovascular genomic research center at Wayne State University, Detroit.

He and his fellow researchers compared CHD rates in individuals with the low-LDL SNPs to those in the huge database without the SNPs. Next they compared CHD rates in subjects with each of the nine SNPs to rates in statin-treated patients included in a large meta-analysis of statin randomized controlled trials that was carried out by the Cholesterol Treatment Trialists’ Collaboration.

Each of the nine SNPs was consistently associated with a 55% reduction in CHD risk for each 39 mg/dL lower lifetime exposure to LDL. In contrast, to achieve the same 55% reduction in CHD risk by starting statin therapy at age 63 – the average age at enrollment in the statin trials – a 116 mg/dL decrease in LDL would be required.

Dr. Ference noted that the nine SNPs lowered LDL via different mechanisms, suggesting that the associated beneficial decrease in CHD was mediated through LDL lowering per se and that the manner in which the reductions are achieved wasn’t important. Thus, lowering LDL via diet and exercise beginning early in life should be as effective in terms of reducing CHD risk as any other means of doing so, including drug therapy.

Dr. Ference reported having no financial conflicts.

CHICAGO – Lowering LDL cholesterol early in life would prevent three times more cardiovascular events per unit of LDL-reduction compared to the current practice of initiating LDL-lowering statin therapy decades later, based on the findings of a novel genomic analysis known as a mendelian randomized controlled trial.

"People who’ve already been exposed to a lifetime of (elevated levels of) LDL have developed a certain underlying atherosclerotic burden. Lowering LDL at that point – even intensively – can merely stabilize the plaque or cause it to regress only slightly. One is still left with an underlying atherosclerotic plaque that can disrupt and cause symptoms or acute events. The alternative would be to start much earlier in life, before the plaque develops. And that’s what we tested," Dr. Brian A. Ference explained at the annual meeting of the American College of Cardiology.

Dr. Ference emphasized that he wasn’t arguing in favor of routinely starting statin therapy in children with high LDL levels. "A reasonable policy may be to promote a greater awareness of LDL cholesterol levels and a new emphasis on diet and lifestyle to keep LDL low, and in those persons in their 20s who can’t maintain ideal levels of cholesterol – somewhere between 50 and 70 mg/dL – it may be reasonable at that time to begin contemplating adding medication to prevent the development of atherosclerotic plaque."

His mendelian randomized controlled trial was not a conventional prospective clinical trial. That would be utterly impractical because it would take half a century or more. Rather, the mendelian randomized controlled trial was essentially a series of nine natural randomized trials conducted using a database comprised of more than 326,000 people whose genetic status was known with regard to nine single nucleotide polymorphisms (SNPs) associated with low LDL levels throughout life.

"We based this study on the concept of in vivo randomization, which suggests that at the time of conception polymorphisms are allocated randomly and that inheriting an allele that is associated with a lower LDL is analogous to being randomized at the time of birth to a medicine that lowers LDL for the whole of one’s lifetime. In contrast, inheriting the other allele is analogous to being allocated to usual care. So if one compares the risk of coronary [heart] disease (CHD) between the two groups, it should be analogous to a long-term trial," according to Dr. Ference, director of the cardiovascular genomic research center at Wayne State University, Detroit.

He and his fellow researchers compared CHD rates in individuals with the low-LDL SNPs to those in the huge database without the SNPs. Next they compared CHD rates in subjects with each of the nine SNPs to rates in statin-treated patients included in a large meta-analysis of statin randomized controlled trials that was carried out by the Cholesterol Treatment Trialists’ Collaboration.

Each of the nine SNPs was consistently associated with a 55% reduction in CHD risk for each 39 mg/dL lower lifetime exposure to LDL. In contrast, to achieve the same 55% reduction in CHD risk by starting statin therapy at age 63 – the average age at enrollment in the statin trials – a 116 mg/dL decrease in LDL would be required.

Dr. Ference noted that the nine SNPs lowered LDL via different mechanisms, suggesting that the associated beneficial decrease in CHD was mediated through LDL lowering per se and that the manner in which the reductions are achieved wasn’t important. Thus, lowering LDL via diet and exercise beginning early in life should be as effective in terms of reducing CHD risk as any other means of doing so, including drug therapy.

Dr. Ference reported having no financial conflicts.

CHICAGO – Patients who received treatment with a nonsteroidal anti-inflammatory drug following a first-time myocardial infarction had a significantly increased rate of subsequent atrial fibrillation or stroke, based on data collected since 1997 from more than 88,000 Danish residents.

Compared with patients who did not receive an NSAID, those given at least one prescription of a NSAID following hospitalization for a first-time myocardial infarction (MI) had statistically significant increased rates of subsequent atrial fibrillation, 23%, and of a subsequent stroke, 25%, in an analysis that adjusted for possible confounders, Dr. Anne-Marie Schjerning Olsen and her associates reported in a poster at the meeting.

The findings add to existing evidence that NSAID treatment poses a cardiovascular risk to certain patients. Further, the results highlight the need to assess cardiovascular risk and balance that risk from NSAID treatment against its possible benefit before prescribing these drugs, they said.

Last year, Dr. Olsen and her associates reported results from another analysis using the same database showing that NSAID use by patients following a MI boosted their risk for death or a second MI.

The new study reviewed nationwide hospitalization and pharmacy records for 88,458 Danish residents who were at least 30 years old, were hospitalized for a first-time MI during 1997-2009 and had no history of prior atrial fibrillation. Their mean age was 68 years, and 64% were men. During follow-up, 46% of the patients filled at least one prescription for an NSAID. In addition, during the study period, 9,578 of the post-MI patients were hospitalized for atrial fibrillation, and 7,687 were hospitalized for a stroke.

Among the NSAID users, the incidence of atrial fibrillation in the post-MI patients was 26.9 cases/1,000 person-years, and the stroke incidence was 21.2 cases/1,000 person-years, reported Dr. Olsen, a cardiology researcher at Gentofte Hospital in Copenhagen, and her associates.

In an analysis that adjusted for age, gender, calendar year, concomitant drug use, and comorbidities, use of any type of NSAID boosted the atrial fibrillation risk by 23% and the stroke risk by 25%, compared with the risk in patients who did not take an NSAID.

The greatest adverse effect was linked with rofecoxib (Vioxx) treatment, which was associated with a 35% increased risk for atrial fibrillation and a 2.5-fold increased risk for stroke, both statistically significant differences, compared with non–NSAID users.

Other individual NSAIDs in the analysis included celecoxib (Celebrex), which was linked with a statistically significant, roughly 80% increased rate of stroke compared with non–NSAID users. Celecoxib did not have a significant impact on atrial fibrillation rate. Ibuprofen and diclofenac each boosted the rate of atrial fibrillation and of stroke by about the same amount as did all of the NSAIDs together. Naproxen did not have a statistically significant effect on either end point.

Dr. Olsen said that she had no disclosures.

CHICAGO – Patients who received treatment with a nonsteroidal anti-inflammatory drug following a first-time myocardial infarction had a significantly increased rate of subsequent atrial fibrillation or stroke, based on data collected since 1997 from more than 88,000 Danish residents.

Compared with patients who did not receive an NSAID, those given at least one prescription of a NSAID following hospitalization for a first-time myocardial infarction (MI) had statistically significant increased rates of subsequent atrial fibrillation, 23%, and of a subsequent stroke, 25%, in an analysis that adjusted for possible confounders, Dr. Anne-Marie Schjerning Olsen and her associates reported in a poster at the meeting.

The findings add to existing evidence that NSAID treatment poses a cardiovascular risk to certain patients. Further, the results highlight the need to assess cardiovascular risk and balance that risk from NSAID treatment against its possible benefit before prescribing these drugs, they said.

Last year, Dr. Olsen and her associates reported results from another analysis using the same database showing that NSAID use by patients following a MI boosted their risk for death or a second MI.

The new study reviewed nationwide hospitalization and pharmacy records for 88,458 Danish residents who were at least 30 years old, were hospitalized for a first-time MI during 1997-2009 and had no history of prior atrial fibrillation. Their mean age was 68 years, and 64% were men. During follow-up, 46% of the patients filled at least one prescription for an NSAID. In addition, during the study period, 9,578 of the post-MI patients were hospitalized for atrial fibrillation, and 7,687 were hospitalized for a stroke.

Among the NSAID users, the incidence of atrial fibrillation in the post-MI patients was 26.9 cases/1,000 person-years, and the stroke incidence was 21.2 cases/1,000 person-years, reported Dr. Olsen, a cardiology researcher at Gentofte Hospital in Copenhagen, and her associates.

In an analysis that adjusted for age, gender, calendar year, concomitant drug use, and comorbidities, use of any type of NSAID boosted the atrial fibrillation risk by 23% and the stroke risk by 25%, compared with the risk in patients who did not take an NSAID.

The greatest adverse effect was linked with rofecoxib (Vioxx) treatment, which was associated with a 35% increased risk for atrial fibrillation and a 2.5-fold increased risk for stroke, both statistically significant differences, compared with non–NSAID users.

Other individual NSAIDs in the analysis included celecoxib (Celebrex), which was linked with a statistically significant, roughly 80% increased rate of stroke compared with non–NSAID users. Celecoxib did not have a significant impact on atrial fibrillation rate. Ibuprofen and diclofenac each boosted the rate of atrial fibrillation and of stroke by about the same amount as did all of the NSAIDs together. Naproxen did not have a statistically significant effect on either end point.

Dr. Olsen said that she had no disclosures.

CHICAGO – Patients who received treatment with a nonsteroidal anti-inflammatory drug following a first-time myocardial infarction had a significantly increased rate of subsequent atrial fibrillation or stroke, based on data collected since 1997 from more than 88,000 Danish residents.

Compared with patients who did not receive an NSAID, those given at least one prescription of a NSAID following hospitalization for a first-time myocardial infarction (MI) had statistically significant increased rates of subsequent atrial fibrillation, 23%, and of a subsequent stroke, 25%, in an analysis that adjusted for possible confounders, Dr. Anne-Marie Schjerning Olsen and her associates reported in a poster at the meeting.

The findings add to existing evidence that NSAID treatment poses a cardiovascular risk to certain patients. Further, the results highlight the need to assess cardiovascular risk and balance that risk from NSAID treatment against its possible benefit before prescribing these drugs, they said.

Last year, Dr. Olsen and her associates reported results from another analysis using the same database showing that NSAID use by patients following a MI boosted their risk for death or a second MI.

The new study reviewed nationwide hospitalization and pharmacy records for 88,458 Danish residents who were at least 30 years old, were hospitalized for a first-time MI during 1997-2009 and had no history of prior atrial fibrillation. Their mean age was 68 years, and 64% were men. During follow-up, 46% of the patients filled at least one prescription for an NSAID. In addition, during the study period, 9,578 of the post-MI patients were hospitalized for atrial fibrillation, and 7,687 were hospitalized for a stroke.

Among the NSAID users, the incidence of atrial fibrillation in the post-MI patients was 26.9 cases/1,000 person-years, and the stroke incidence was 21.2 cases/1,000 person-years, reported Dr. Olsen, a cardiology researcher at Gentofte Hospital in Copenhagen, and her associates.

In an analysis that adjusted for age, gender, calendar year, concomitant drug use, and comorbidities, use of any type of NSAID boosted the atrial fibrillation risk by 23% and the stroke risk by 25%, compared with the risk in patients who did not take an NSAID.

The greatest adverse effect was linked with rofecoxib (Vioxx) treatment, which was associated with a 35% increased risk for atrial fibrillation and a 2.5-fold increased risk for stroke, both statistically significant differences, compared with non–NSAID users.

Other individual NSAIDs in the analysis included celecoxib (Celebrex), which was linked with a statistically significant, roughly 80% increased rate of stroke compared with non–NSAID users. Celecoxib did not have a significant impact on atrial fibrillation rate. Ibuprofen and diclofenac each boosted the rate of atrial fibrillation and of stroke by about the same amount as did all of the NSAIDs together. Naproxen did not have a statistically significant effect on either end point.

Dr. Olsen said that she had no disclosures.