Naseem S. Miller

The HeartWare Ventricular Assist System, a small left ventricular assist device that is implanted in the chest instead of the abdomen, has been approved by the Food and Drug Administration as a bridge to heart transplant for end-stage heart failure patients.

The HeartWare Ventricular Assist System, manufactured by HeartWare, includes an implantable pump with an external driver and power source. The device is another treatment option for advanced heart failure patients, especially those who are smaller in size or can’t have an abdominal implant.

The approval of the continuous-flow pump device comes less than 3 years after the agency approved Thoratec’s HeartMate II left ventricular assist device (LVAD) for destination therapy. That device quickly replaced the previous generation of pulsatile-flow devices.

This is the first time that the FDA has approved a ventricular assist device using comparator data from a registry as a control, according to the agency.

The approval was based on data from the ADVANCE trial, which compared the outcomes of 137 patients implanted with the HeartWare System and of patients registered by the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). The registry has been in place since 2005, collecting information on patients who received an approved mechanical circulatory support device implant.

A total of 140 patients received the investigational pump, and 499 patients received a commercially available pump implanted contemporaneously. At 180 days, 90.7% of the investigational pump patients and 90.1% of the controls had survived, establishing the noninferiority of the investigational pump (P less than .001; 15% noninferiority margin). Infection, right heart failure, device replacement, stroke, kidney dysfunction, hemolysis, and arrhythmia rates for the HVAD were similar to those reported previously for the HeartMate II, according to Dr. Keith D. Aaronson and his colleagues in the study (Circulation. 2012;125:3191-3200).

Results of the ADVANCE trial showed that at 6 months, median 6-minute walk distance improved by 128.5 m, and "functional capacity and quality of life improved markedly, and the adverse event profile was favorable," according to the authors.

In a news release, FDA officials noted that "although rates of most key adverse events were comparable, the risk of stroke associated with the HeartWare LVAD necessitates patients and clinicians to discuss all treatment options before deciding to use the device."

"Well-designed registries in targeted product areas can enhance the public health and provide a cost-effective approach to clinical research for industry innovators," Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in a statement. For HeartWare, registry data directly facilitated the development and availability of this new device. The registry is a joint effort involving the FDA; National Heart, Lung, and Blood Institute; Centers for Medicare and Medicaid Services (CMS); and clinicians, scientists, and industry.

The FDA approval of the bridge-to-transplant pump comes on the heels of a Medicare Advisory (MEDCAC) meeting, where heart societies and prominent heart failure experts discussed the state of VAD research. The panel stressed the importance of multidisciplinary heart teams, and said that there’s not enough data to show that the indications for VADs can be expanded to include lower-risk patients.

Medicare currently does not have an open National Coverage Determination (NCD) for VADs. Medicare currently reimburses VADs, under certain criteria, as a bridge-to-transplant and as destination therapy.

Dr. Sean Pinney, who spoke at the MEDCAC meeting on behalf of the Heart Failure Society of America, said that the society supported the NCD and did "not endorse any change in the current patient selection criteria which derive from prospective randomized trials." He added that there’s a need for more well-controlled clinical trials, including those that would examine "less sick" patients.

"We do not endorse expansion of destination therapy into this population in the absence of randomized clinical trials," said Dr. Pinney, associate professor of medicine at Mount Sinai Medical Center in New York.

The 140 U.S. centers that place LVADs are expected to implant nearly 3,000 devices this year. Nearly 4,600 patients have received an LVAD since 2010.

"This is a rapidly evolving field," said Dr. Mariell Jessup, president-elect of the American Heart Association and professor of medicine at the University of Pennsylvania Heart & Vascular Center in Philadelphia. "It’s only to be expected that CMS would open coverage determination. It’s a costly technology, and outcomes are a lot better than several years ago," she said.

Physicians quoted in this story reported no financial conflicts.

The HeartWare Ventricular Assist System, a small left ventricular assist device that is implanted in the chest instead of the abdomen, has been approved by the Food and Drug Administration as a bridge to heart transplant for end-stage heart failure patients.

The HeartWare Ventricular Assist System, manufactured by HeartWare, includes an implantable pump with an external driver and power source. The device is another treatment option for advanced heart failure patients, especially those who are smaller in size or can’t have an abdominal implant.

The approval of the continuous-flow pump device comes less than 3 years after the agency approved Thoratec’s HeartMate II left ventricular assist device (LVAD) for destination therapy. That device quickly replaced the previous generation of pulsatile-flow devices.

This is the first time that the FDA has approved a ventricular assist device using comparator data from a registry as a control, according to the agency.

The approval was based on data from the ADVANCE trial, which compared the outcomes of 137 patients implanted with the HeartWare System and of patients registered by the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). The registry has been in place since 2005, collecting information on patients who received an approved mechanical circulatory support device implant.

A total of 140 patients received the investigational pump, and 499 patients received a commercially available pump implanted contemporaneously. At 180 days, 90.7% of the investigational pump patients and 90.1% of the controls had survived, establishing the noninferiority of the investigational pump (P less than .001; 15% noninferiority margin). Infection, right heart failure, device replacement, stroke, kidney dysfunction, hemolysis, and arrhythmia rates for the HVAD were similar to those reported previously for the HeartMate II, according to Dr. Keith D. Aaronson and his colleagues in the study (Circulation. 2012;125:3191-3200).

Results of the ADVANCE trial showed that at 6 months, median 6-minute walk distance improved by 128.5 m, and "functional capacity and quality of life improved markedly, and the adverse event profile was favorable," according to the authors.

In a news release, FDA officials noted that "although rates of most key adverse events were comparable, the risk of stroke associated with the HeartWare LVAD necessitates patients and clinicians to discuss all treatment options before deciding to use the device."

"Well-designed registries in targeted product areas can enhance the public health and provide a cost-effective approach to clinical research for industry innovators," Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in a statement. For HeartWare, registry data directly facilitated the development and availability of this new device. The registry is a joint effort involving the FDA; National Heart, Lung, and Blood Institute; Centers for Medicare and Medicaid Services (CMS); and clinicians, scientists, and industry.

The FDA approval of the bridge-to-transplant pump comes on the heels of a Medicare Advisory (MEDCAC) meeting, where heart societies and prominent heart failure experts discussed the state of VAD research. The panel stressed the importance of multidisciplinary heart teams, and said that there’s not enough data to show that the indications for VADs can be expanded to include lower-risk patients.

Medicare currently does not have an open National Coverage Determination (NCD) for VADs. Medicare currently reimburses VADs, under certain criteria, as a bridge-to-transplant and as destination therapy.

Dr. Sean Pinney, who spoke at the MEDCAC meeting on behalf of the Heart Failure Society of America, said that the society supported the NCD and did "not endorse any change in the current patient selection criteria which derive from prospective randomized trials." He added that there’s a need for more well-controlled clinical trials, including those that would examine "less sick" patients.

"We do not endorse expansion of destination therapy into this population in the absence of randomized clinical trials," said Dr. Pinney, associate professor of medicine at Mount Sinai Medical Center in New York.

The 140 U.S. centers that place LVADs are expected to implant nearly 3,000 devices this year. Nearly 4,600 patients have received an LVAD since 2010.

"This is a rapidly evolving field," said Dr. Mariell Jessup, president-elect of the American Heart Association and professor of medicine at the University of Pennsylvania Heart & Vascular Center in Philadelphia. "It’s only to be expected that CMS would open coverage determination. It’s a costly technology, and outcomes are a lot better than several years ago," she said.

Physicians quoted in this story reported no financial conflicts.

The HeartWare Ventricular Assist System, a small left ventricular assist device that is implanted in the chest instead of the abdomen, has been approved by the Food and Drug Administration as a bridge to heart transplant for end-stage heart failure patients.

The HeartWare Ventricular Assist System, manufactured by HeartWare, includes an implantable pump with an external driver and power source. The device is another treatment option for advanced heart failure patients, especially those who are smaller in size or can’t have an abdominal implant.

The approval of the continuous-flow pump device comes less than 3 years after the agency approved Thoratec’s HeartMate II left ventricular assist device (LVAD) for destination therapy. That device quickly replaced the previous generation of pulsatile-flow devices.

This is the first time that the FDA has approved a ventricular assist device using comparator data from a registry as a control, according to the agency.

The approval was based on data from the ADVANCE trial, which compared the outcomes of 137 patients implanted with the HeartWare System and of patients registered by the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). The registry has been in place since 2005, collecting information on patients who received an approved mechanical circulatory support device implant.

A total of 140 patients received the investigational pump, and 499 patients received a commercially available pump implanted contemporaneously. At 180 days, 90.7% of the investigational pump patients and 90.1% of the controls had survived, establishing the noninferiority of the investigational pump (P less than .001; 15% noninferiority margin). Infection, right heart failure, device replacement, stroke, kidney dysfunction, hemolysis, and arrhythmia rates for the HVAD were similar to those reported previously for the HeartMate II, according to Dr. Keith D. Aaronson and his colleagues in the study (Circulation. 2012;125:3191-3200).

Results of the ADVANCE trial showed that at 6 months, median 6-minute walk distance improved by 128.5 m, and "functional capacity and quality of life improved markedly, and the adverse event profile was favorable," according to the authors.

In a news release, FDA officials noted that "although rates of most key adverse events were comparable, the risk of stroke associated with the HeartWare LVAD necessitates patients and clinicians to discuss all treatment options before deciding to use the device."

"Well-designed registries in targeted product areas can enhance the public health and provide a cost-effective approach to clinical research for industry innovators," Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in a statement. For HeartWare, registry data directly facilitated the development and availability of this new device. The registry is a joint effort involving the FDA; National Heart, Lung, and Blood Institute; Centers for Medicare and Medicaid Services (CMS); and clinicians, scientists, and industry.

The FDA approval of the bridge-to-transplant pump comes on the heels of a Medicare Advisory (MEDCAC) meeting, where heart societies and prominent heart failure experts discussed the state of VAD research. The panel stressed the importance of multidisciplinary heart teams, and said that there’s not enough data to show that the indications for VADs can be expanded to include lower-risk patients.

Medicare currently does not have an open National Coverage Determination (NCD) for VADs. Medicare currently reimburses VADs, under certain criteria, as a bridge-to-transplant and as destination therapy.

Dr. Sean Pinney, who spoke at the MEDCAC meeting on behalf of the Heart Failure Society of America, said that the society supported the NCD and did "not endorse any change in the current patient selection criteria which derive from prospective randomized trials." He added that there’s a need for more well-controlled clinical trials, including those that would examine "less sick" patients.

"We do not endorse expansion of destination therapy into this population in the absence of randomized clinical trials," said Dr. Pinney, associate professor of medicine at Mount Sinai Medical Center in New York.

The 140 U.S. centers that place LVADs are expected to implant nearly 3,000 devices this year. Nearly 4,600 patients have received an LVAD since 2010.

"This is a rapidly evolving field," said Dr. Mariell Jessup, president-elect of the American Heart Association and professor of medicine at the University of Pennsylvania Heart & Vascular Center in Philadelphia. "It’s only to be expected that CMS would open coverage determination. It’s a costly technology, and outcomes are a lot better than several years ago," she said.

Physicians quoted in this story reported no financial conflicts.

LOS ANGELES – Chelation therapy resulted in a slight reduction in cardiovascular events in patients with coronary artery disease and a prior myocardial infarction, according to a randomized, government-funded trial, but the findings are far from practice changing.

Experts at the annual scientific sessions of the American Heart Association, including the study’s authors, were quick to point out that the results yielded more questions than answers, and called for additional research to confirm or refute the findings.

"Intriguing as the results are, they are unexpected and should not be interpreted as an indication to adopt chelation therapy into clinical practice," said Dr. Elliott Antman, chair of the AHA Scientific Sessions Program Committee, and a cardiologist at Brigham and Women’s Hospital in Boston.

The therapy did not reduce mortality, and a substudy showed that patients did not have any sustained improvement in their quality of life.

Dr. Gervasio A. Lamas, the study’s lead author and a cardiologist at Mount Sinai Medical Center in Miami Beach, said that the trial "does not constitute evidence to recommend the clinical application of chelation therapy."

Chelation, which is not approved by the Food and Drug Administration (FDA), is an intravenous therapy in which the synthetic amino acid ethylenediaminetetraacetic acid (EDTA) binds to and extracts metals. The controversial treatment has been around since the 1950s, and research findings have been inconsistent.

In the case of heart disease, the idea is that EDTA binds to the calcium in the arterial plaques.

"But there are no data that show that it happens," said Dr. Sidney Goldstein, professor of medicine at Wayne State University in Detroit, who was not involved in the study. "I wouldn’t put much value on the [trial], because the science is thin or nonexistent," he said about the $30 million NIH-funded study.

TACT (Trial to Assess Chelation Therapy) was a randomized, double-blind, placebo-controlled study that was 20 times larger than previous studies conducted on the controversial treatment (Am. Heart J. 2012;163:7-12).

The trial has had its share of turbulence since it enrolled the first patient in 2003. It was once stopped after the FDA raised concerns about its process and conduct. After taking corrective steps, the investigators had to scale down the study population from nearly 2,400 to 1,700 owing to difficulty enrolling patients.

Researchers randomized and followed the 1,708 post-MI patients for an average of 4 years at 134 sites in the United States and Canada from September 2003 to October 2010. Their goal was to test the benefits and risks of 40 infusions of a 500-mL multicomponent disodium EDTA chelation solution compared with placebo, which was a solution of normal saline and 1.2% dextrose.

A total of 55,222 EDTA and placebo infusions were administered during the trial, each patient receiving 30 weekly infusions followed by 10 maintenance infusions 2-8 weeks apart. Each infusion lasted for about 3 hours.

The primary composite end point was death, MI, stroke, coronary revascularization, and hospitalization for angina. The composite secondary end point was irreversible ischemic events, including cardiovascular death, nonfatal MI, and nonfatal stroke.

Patients were at least 50 years old (mean age, 65 years). The average body mass index for both groups was 30 kg/m², and roughly 30% of each group had diabetes.

Sixty-five percent of the patients completed all 40 infusions, and 76% completed at least 30. Meanwhile, 30% discontinued infusions for several reasons, and 17% percent withdrew consent.

The results showed that 39 fewer patients in the chelation therapy group had a cardiovascular event compared with the placebo group, a nonsignificant difference that was driven largely by coronary revascularization, where there was a 3% difference between the two groups (15% vs. 18%), a "soft end point," according to Dr. Goldstein.

There were no significant benefits for angina (1.5% in the EDTA chelation group vs. 2.1% in the placebo group), mortality (10.4% vs. 10.7%, respectively), MI (6.2% vs. 7.7%), or stroke (1.2% vs. 1.5%).

Seventy-nine patients (12%) discontinued infusions due to adverse events or side effects. Of those, 17 reached an end point, 11 had heart failure, and 7 had cardiac issues, among other reasons.

There were four unexpected severe adverse events, including two deaths, one in each group.

A surprising effect was found in the diabetes subgroup, for which researchers did not have a biological explanation. Diabetes patients had 35 fewer events than the placebo group (P = .002). The difference was minimal in the subgroup with no diabetes.

"Although there were some aspects of the trial that suggested chelation may be beneficial, too many questions remain to recommend chelation as standard therapy at this time," said Dr. David. O. Williams, a cardiologist at Brigham and Women’s Hospital, who was not involved in the study. He pointed out that many patients didn’t receive complete study therapy, and a substantial number dropped out of the trial, which meant that their outcomes didn’t contribute to the follow-up data.

He also said that the primary end point was a composite of many different cardiovascular events, and data for individual events were not available. In addition, there remained an absence of clear biological rationale.

Interest in chelation therapy has been increasing, at least until recently, according to national data. In 2007, nearly 111,000 people received chelation, an almost 68% increase from 2002.

But the procedure can be harmful, especially if infusions occur quickly, causing hypocalcemia. Three of those cases that led to patient death were recorded in a 2006 Centers for Disease Control and Prevention report.

"To suggest that [chelation therapy] is steeped in controversy is an understatement," said Dr. Paul W. Armstrong, professor of medicine at the University of Alberta in Edmonton, who commented on the trial at a press briefing. "We owe the investigators a debt of gratitude for undertaking this subject," he said. But, "the results are hypothesis generating and not practice changing."

The National Center for Complementary and Alternative Medicine and the National Heart, Lung, and Blood Institute funded the study. Dr. Armstrong received research grants from several companies including Boehringer Ingelheim and AstraZeneca. Dr. Antman and Dr. Williams had no relevant disclosures. Dr. Goldstein is the medical editor of Cardiology News.

LOS ANGELES – Chelation therapy resulted in a slight reduction in cardiovascular events in patients with coronary artery disease and a prior myocardial infarction, according to a randomized, government-funded trial, but the findings are far from practice changing.

Experts at the annual scientific sessions of the American Heart Association, including the study’s authors, were quick to point out that the results yielded more questions than answers, and called for additional research to confirm or refute the findings.

"Intriguing as the results are, they are unexpected and should not be interpreted as an indication to adopt chelation therapy into clinical practice," said Dr. Elliott Antman, chair of the AHA Scientific Sessions Program Committee, and a cardiologist at Brigham and Women’s Hospital in Boston.

The therapy did not reduce mortality, and a substudy showed that patients did not have any sustained improvement in their quality of life.

Dr. Gervasio A. Lamas, the study’s lead author and a cardiologist at Mount Sinai Medical Center in Miami Beach, said that the trial "does not constitute evidence to recommend the clinical application of chelation therapy."

Chelation, which is not approved by the Food and Drug Administration (FDA), is an intravenous therapy in which the synthetic amino acid ethylenediaminetetraacetic acid (EDTA) binds to and extracts metals. The controversial treatment has been around since the 1950s, and research findings have been inconsistent.

In the case of heart disease, the idea is that EDTA binds to the calcium in the arterial plaques.

"But there are no data that show that it happens," said Dr. Sidney Goldstein, professor of medicine at Wayne State University in Detroit, who was not involved in the study. "I wouldn’t put much value on the [trial], because the science is thin or nonexistent," he said about the $30 million NIH-funded study.

TACT (Trial to Assess Chelation Therapy) was a randomized, double-blind, placebo-controlled study that was 20 times larger than previous studies conducted on the controversial treatment (Am. Heart J. 2012;163:7-12).

The trial has had its share of turbulence since it enrolled the first patient in 2003. It was once stopped after the FDA raised concerns about its process and conduct. After taking corrective steps, the investigators had to scale down the study population from nearly 2,400 to 1,700 owing to difficulty enrolling patients.

Researchers randomized and followed the 1,708 post-MI patients for an average of 4 years at 134 sites in the United States and Canada from September 2003 to October 2010. Their goal was to test the benefits and risks of 40 infusions of a 500-mL multicomponent disodium EDTA chelation solution compared with placebo, which was a solution of normal saline and 1.2% dextrose.

A total of 55,222 EDTA and placebo infusions were administered during the trial, each patient receiving 30 weekly infusions followed by 10 maintenance infusions 2-8 weeks apart. Each infusion lasted for about 3 hours.

The primary composite end point was death, MI, stroke, coronary revascularization, and hospitalization for angina. The composite secondary end point was irreversible ischemic events, including cardiovascular death, nonfatal MI, and nonfatal stroke.

Patients were at least 50 years old (mean age, 65 years). The average body mass index for both groups was 30 kg/m², and roughly 30% of each group had diabetes.

Sixty-five percent of the patients completed all 40 infusions, and 76% completed at least 30. Meanwhile, 30% discontinued infusions for several reasons, and 17% percent withdrew consent.

The results showed that 39 fewer patients in the chelation therapy group had a cardiovascular event compared with the placebo group, a nonsignificant difference that was driven largely by coronary revascularization, where there was a 3% difference between the two groups (15% vs. 18%), a "soft end point," according to Dr. Goldstein.

There were no significant benefits for angina (1.5% in the EDTA chelation group vs. 2.1% in the placebo group), mortality (10.4% vs. 10.7%, respectively), MI (6.2% vs. 7.7%), or stroke (1.2% vs. 1.5%).

Seventy-nine patients (12%) discontinued infusions due to adverse events or side effects. Of those, 17 reached an end point, 11 had heart failure, and 7 had cardiac issues, among other reasons.

There were four unexpected severe adverse events, including two deaths, one in each group.

A surprising effect was found in the diabetes subgroup, for which researchers did not have a biological explanation. Diabetes patients had 35 fewer events than the placebo group (P = .002). The difference was minimal in the subgroup with no diabetes.

"Although there were some aspects of the trial that suggested chelation may be beneficial, too many questions remain to recommend chelation as standard therapy at this time," said Dr. David. O. Williams, a cardiologist at Brigham and Women’s Hospital, who was not involved in the study. He pointed out that many patients didn’t receive complete study therapy, and a substantial number dropped out of the trial, which meant that their outcomes didn’t contribute to the follow-up data.

He also said that the primary end point was a composite of many different cardiovascular events, and data for individual events were not available. In addition, there remained an absence of clear biological rationale.

Interest in chelation therapy has been increasing, at least until recently, according to national data. In 2007, nearly 111,000 people received chelation, an almost 68% increase from 2002.

But the procedure can be harmful, especially if infusions occur quickly, causing hypocalcemia. Three of those cases that led to patient death were recorded in a 2006 Centers for Disease Control and Prevention report.

"To suggest that [chelation therapy] is steeped in controversy is an understatement," said Dr. Paul W. Armstrong, professor of medicine at the University of Alberta in Edmonton, who commented on the trial at a press briefing. "We owe the investigators a debt of gratitude for undertaking this subject," he said. But, "the results are hypothesis generating and not practice changing."

The National Center for Complementary and Alternative Medicine and the National Heart, Lung, and Blood Institute funded the study. Dr. Armstrong received research grants from several companies including Boehringer Ingelheim and AstraZeneca. Dr. Antman and Dr. Williams had no relevant disclosures. Dr. Goldstein is the medical editor of Cardiology News.

LOS ANGELES – Chelation therapy resulted in a slight reduction in cardiovascular events in patients with coronary artery disease and a prior myocardial infarction, according to a randomized, government-funded trial, but the findings are far from practice changing.

Experts at the annual scientific sessions of the American Heart Association, including the study’s authors, were quick to point out that the results yielded more questions than answers, and called for additional research to confirm or refute the findings.

"Intriguing as the results are, they are unexpected and should not be interpreted as an indication to adopt chelation therapy into clinical practice," said Dr. Elliott Antman, chair of the AHA Scientific Sessions Program Committee, and a cardiologist at Brigham and Women’s Hospital in Boston.

The therapy did not reduce mortality, and a substudy showed that patients did not have any sustained improvement in their quality of life.

Dr. Gervasio A. Lamas, the study’s lead author and a cardiologist at Mount Sinai Medical Center in Miami Beach, said that the trial "does not constitute evidence to recommend the clinical application of chelation therapy."

Chelation, which is not approved by the Food and Drug Administration (FDA), is an intravenous therapy in which the synthetic amino acid ethylenediaminetetraacetic acid (EDTA) binds to and extracts metals. The controversial treatment has been around since the 1950s, and research findings have been inconsistent.

In the case of heart disease, the idea is that EDTA binds to the calcium in the arterial plaques.

"But there are no data that show that it happens," said Dr. Sidney Goldstein, professor of medicine at Wayne State University in Detroit, who was not involved in the study. "I wouldn’t put much value on the [trial], because the science is thin or nonexistent," he said about the $30 million NIH-funded study.

TACT (Trial to Assess Chelation Therapy) was a randomized, double-blind, placebo-controlled study that was 20 times larger than previous studies conducted on the controversial treatment (Am. Heart J. 2012;163:7-12).

The trial has had its share of turbulence since it enrolled the first patient in 2003. It was once stopped after the FDA raised concerns about its process and conduct. After taking corrective steps, the investigators had to scale down the study population from nearly 2,400 to 1,700 owing to difficulty enrolling patients.

Researchers randomized and followed the 1,708 post-MI patients for an average of 4 years at 134 sites in the United States and Canada from September 2003 to October 2010. Their goal was to test the benefits and risks of 40 infusions of a 500-mL multicomponent disodium EDTA chelation solution compared with placebo, which was a solution of normal saline and 1.2% dextrose.

A total of 55,222 EDTA and placebo infusions were administered during the trial, each patient receiving 30 weekly infusions followed by 10 maintenance infusions 2-8 weeks apart. Each infusion lasted for about 3 hours.

The primary composite end point was death, MI, stroke, coronary revascularization, and hospitalization for angina. The composite secondary end point was irreversible ischemic events, including cardiovascular death, nonfatal MI, and nonfatal stroke.

Patients were at least 50 years old (mean age, 65 years). The average body mass index for both groups was 30 kg/m², and roughly 30% of each group had diabetes.

Sixty-five percent of the patients completed all 40 infusions, and 76% completed at least 30. Meanwhile, 30% discontinued infusions for several reasons, and 17% percent withdrew consent.

The results showed that 39 fewer patients in the chelation therapy group had a cardiovascular event compared with the placebo group, a nonsignificant difference that was driven largely by coronary revascularization, where there was a 3% difference between the two groups (15% vs. 18%), a "soft end point," according to Dr. Goldstein.

There were no significant benefits for angina (1.5% in the EDTA chelation group vs. 2.1% in the placebo group), mortality (10.4% vs. 10.7%, respectively), MI (6.2% vs. 7.7%), or stroke (1.2% vs. 1.5%).

Seventy-nine patients (12%) discontinued infusions due to adverse events or side effects. Of those, 17 reached an end point, 11 had heart failure, and 7 had cardiac issues, among other reasons.

There were four unexpected severe adverse events, including two deaths, one in each group.

A surprising effect was found in the diabetes subgroup, for which researchers did not have a biological explanation. Diabetes patients had 35 fewer events than the placebo group (P = .002). The difference was minimal in the subgroup with no diabetes.

"Although there were some aspects of the trial that suggested chelation may be beneficial, too many questions remain to recommend chelation as standard therapy at this time," said Dr. David. O. Williams, a cardiologist at Brigham and Women’s Hospital, who was not involved in the study. He pointed out that many patients didn’t receive complete study therapy, and a substantial number dropped out of the trial, which meant that their outcomes didn’t contribute to the follow-up data.

He also said that the primary end point was a composite of many different cardiovascular events, and data for individual events were not available. In addition, there remained an absence of clear biological rationale.

Interest in chelation therapy has been increasing, at least until recently, according to national data. In 2007, nearly 111,000 people received chelation, an almost 68% increase from 2002.

But the procedure can be harmful, especially if infusions occur quickly, causing hypocalcemia. Three of those cases that led to patient death were recorded in a 2006 Centers for Disease Control and Prevention report.

"To suggest that [chelation therapy] is steeped in controversy is an understatement," said Dr. Paul W. Armstrong, professor of medicine at the University of Alberta in Edmonton, who commented on the trial at a press briefing. "We owe the investigators a debt of gratitude for undertaking this subject," he said. But, "the results are hypothesis generating and not practice changing."

The National Center for Complementary and Alternative Medicine and the National Heart, Lung, and Blood Institute funded the study. Dr. Armstrong received research grants from several companies including Boehringer Ingelheim and AstraZeneca. Dr. Antman and Dr. Williams had no relevant disclosures. Dr. Goldstein is the medical editor of Cardiology News.

LOS ANGELES – Taking multivitamins daily did not provide any cardiovascular benefits to a large group of American men who were followed for more than a decade in a randomized trial.

While the results showed that multivitamins posed no health risks, experts said at the annual scientific sessions of the American Heart Association that the findings will help them frame the conversation when advising patients.

©Graça Victoria/iStockphoto.com

"The message needs to remain simple and focused," Dr. Eva M. Lonn, professor of medicine at McMaster University, Ontario, wrote in an editorial (JAMA 2012 Nov. 7;308:1802-3). "CVD is largely preventable, and this can be achieved by eating healthy foods, exercising regularly, avoiding tobacco products, and, for those with high risk factor levels or previous CVD events, taking proven, safe, and effective medications."

This is the second arm of the Physicians’ Health Study II, a randomized, double-blind, placebo-controlled trial, which followed nearly 15,000 male U.S. physicians for 11 years, aiming to evaluate the risk and benefits of a multivitamin, vitamin E, vitamin C, and beta carotene in prevention of cancer, cardiovascular disease, eye disease, and cognitive decline.

The results from the first arm of the large trial, published recently, showed that daily multivitamin supplementation had a modest but significant effect on reducing the risk of cancer. Researchers will present the two remaining studies in the near future.

It’s not clear whether the findings can be applied to the population as a whole, according to the study’s authors and other experts, especially since the study’s participants were relatively homogenous, healthy, and had a good nutritional intake.

Still, "this is a very well-run study," said Dr. John G. Harold, a cardiologist at Cedar Sinai Heart Institute, Los Angeles, who was not involved in the study. "This is one more example of a clinical trial that is changing what was up until now driven by opinion rather than fact."

Multivitamins are the most common supplement consumed by U.S. adults, yet most of the studies about their effect on cardiovascular health have been observational, and their results inconsistent. And while randomized trials like this are needed, conducting them is difficult, said Howard D. Sesso, Sc.D., the study’s lead author and an associate epidemiologist at Brigham and Women’s Hospital, Boston. "Many people who take multivitamins are unwilling to be randomized and receive placebos," he said.

Meanwhile, the physicians who participated in the study were incredibly dedicated to the trial, said Dr. Sesso, showing photos of some who had posed with their multivitamin packets at home, while traveling, or exploring nature.

Researchers followed 14,641 male U.S. physicians, initially 50 years or older, from 1997 to June 2011. There were 7,317 participants in the multivitamin group and 7,324 in the placebo group. They received monthly packs of multivitamins or placebo every 6 months during the first year, and annually thereafter. Morbidity and mortality follow-up were 98.2% and 99.9%, respectively.

Adherence was 67.5% in the multivitamin group and 67.1% in the placebo group at the end of the follow-up period.

The mean age of the study population was 64.3 years, and the population was predominantly white, and relatively healthy. Only 4% said that they were current smokers and close to 60% said that they exercised once or more per week.

In addition, 42% of the participants said that they had a history of hypertension, and 35% had a history of high cholesterol. Almost 6% had a history of diabetes.

At baseline, 5% of the men at a history of cardiovascular disease and 9% had a history of cancer.

The primary end point was major cardiovascular events, including nonfatal myocardial infarction, nonfatal stroke, and cardiovascular mortality. Secondary end points included stroke and MI individually.

Results showed that men who took a daily multivitamin didn’t experience any benefit for the primary end point and secondary end points.

There were 867 major cardiovascular events in the multivitamin group and 856 in the placebo group, or 11.0 and 10.8 events/1,000 person-years, a nonsignificant difference. Likewise, there were no significant differences between groups in total strokes (317 in the multivitamin group and 311 in the placebo group) or cardiovascular deaths (408 and 421, respectively). The results were published simultaneously with the presentation at the meeting (JAMA 2012 Nov. 7;308:1751-60).

The results showed no significant effects on gastrointestinal tract symptoms, fatigue, drowsiness, skin discoloration, and migraine.

The population was relatively well nourished, researchers pointed out, "for which supplementation may offer no additional benefit," they wrote.

Also, behavioral interventions such as exercise and medications such as lipid-lowering therapies can effectively lower the CVD risk and make it difficult for a multivitamin to "meaningfully contribute toward risk reduction," researchers wrote.

They added that there is a need to further understand how essential vitamins and minerals, even at standard levels, may differently interact and influence cardiovascular and cancer mechanisms.

"We’re seeing more and more negative studies," about supplements, said Dr. Harold, highlighting the research’s limited understanding of the agents’ biological impact and pathophysiology.

Coinvestigator J. Michael Gaziano, a cardiologist at Brigham and Women’s Hospital, said that he had no problems with his patients taking multivitamins as long as it was to mainly prevent vitamin deficiencies, and for its modest effect in reducing cancer. "But when it comes to preventing heart disease, we don’t have to invest our energy on multivitamins," he said.

Dr. Sesso, who is younger than the study’s cohort, said he did not take multivitamins but kept a good diet and exercised. Dr. Harold said he took multivitamins. Dr. Gaziano said he was trim, had a healthy diet, didn’t smoke, and exercised, but he wouldn’t say whether he took multivitamins. He said he wouldn’t reveal that information until all the data from the Physicians’ Health Study II were published. "I think it’s not unreasonable to take a multivitamin," he said.

Dr. Gaziano reported having received investigator-initiated research funding from the National Institutes of Health, the Veterans Administration, and BASF Corp. He received assistance with the study agents and packaging from BASF and Pfizer. Study packaging was provided by DSM Nutritional Products. Dr. Harold said he had no relevant disclosures. Dr. Sesso received research support from NIH and investigator-initiated grant from BASF. Dr. Lonn reported serving as a consultant to Merck and Servier; providing expert testimony for Merck; receiving grants or grants pending from AstraZeneca, GlaxoSmithKline, and Hoffman-LaRoche; and receiving payment for lectures from Novartis and Merck.

LOS ANGELES – Taking multivitamins daily did not provide any cardiovascular benefits to a large group of American men who were followed for more than a decade in a randomized trial.

While the results showed that multivitamins posed no health risks, experts said at the annual scientific sessions of the American Heart Association that the findings will help them frame the conversation when advising patients.

©Graça Victoria/iStockphoto.com

"The message needs to remain simple and focused," Dr. Eva M. Lonn, professor of medicine at McMaster University, Ontario, wrote in an editorial (JAMA 2012 Nov. 7;308:1802-3). "CVD is largely preventable, and this can be achieved by eating healthy foods, exercising regularly, avoiding tobacco products, and, for those with high risk factor levels or previous CVD events, taking proven, safe, and effective medications."

This is the second arm of the Physicians’ Health Study II, a randomized, double-blind, placebo-controlled trial, which followed nearly 15,000 male U.S. physicians for 11 years, aiming to evaluate the risk and benefits of a multivitamin, vitamin E, vitamin C, and beta carotene in prevention of cancer, cardiovascular disease, eye disease, and cognitive decline.

The results from the first arm of the large trial, published recently, showed that daily multivitamin supplementation had a modest but significant effect on reducing the risk of cancer. Researchers will present the two remaining studies in the near future.

It’s not clear whether the findings can be applied to the population as a whole, according to the study’s authors and other experts, especially since the study’s participants were relatively homogenous, healthy, and had a good nutritional intake.

Still, "this is a very well-run study," said Dr. John G. Harold, a cardiologist at Cedar Sinai Heart Institute, Los Angeles, who was not involved in the study. "This is one more example of a clinical trial that is changing what was up until now driven by opinion rather than fact."

Multivitamins are the most common supplement consumed by U.S. adults, yet most of the studies about their effect on cardiovascular health have been observational, and their results inconsistent. And while randomized trials like this are needed, conducting them is difficult, said Howard D. Sesso, Sc.D., the study’s lead author and an associate epidemiologist at Brigham and Women’s Hospital, Boston. "Many people who take multivitamins are unwilling to be randomized and receive placebos," he said.

Meanwhile, the physicians who participated in the study were incredibly dedicated to the trial, said Dr. Sesso, showing photos of some who had posed with their multivitamin packets at home, while traveling, or exploring nature.

Researchers followed 14,641 male U.S. physicians, initially 50 years or older, from 1997 to June 2011. There were 7,317 participants in the multivitamin group and 7,324 in the placebo group. They received monthly packs of multivitamins or placebo every 6 months during the first year, and annually thereafter. Morbidity and mortality follow-up were 98.2% and 99.9%, respectively.

Adherence was 67.5% in the multivitamin group and 67.1% in the placebo group at the end of the follow-up period.

The mean age of the study population was 64.3 years, and the population was predominantly white, and relatively healthy. Only 4% said that they were current smokers and close to 60% said that they exercised once or more per week.

In addition, 42% of the participants said that they had a history of hypertension, and 35% had a history of high cholesterol. Almost 6% had a history of diabetes.

At baseline, 5% of the men at a history of cardiovascular disease and 9% had a history of cancer.

The primary end point was major cardiovascular events, including nonfatal myocardial infarction, nonfatal stroke, and cardiovascular mortality. Secondary end points included stroke and MI individually.

Results showed that men who took a daily multivitamin didn’t experience any benefit for the primary end point and secondary end points.

There were 867 major cardiovascular events in the multivitamin group and 856 in the placebo group, or 11.0 and 10.8 events/1,000 person-years, a nonsignificant difference. Likewise, there were no significant differences between groups in total strokes (317 in the multivitamin group and 311 in the placebo group) or cardiovascular deaths (408 and 421, respectively). The results were published simultaneously with the presentation at the meeting (JAMA 2012 Nov. 7;308:1751-60).

The results showed no significant effects on gastrointestinal tract symptoms, fatigue, drowsiness, skin discoloration, and migraine.

The population was relatively well nourished, researchers pointed out, "for which supplementation may offer no additional benefit," they wrote.

Also, behavioral interventions such as exercise and medications such as lipid-lowering therapies can effectively lower the CVD risk and make it difficult for a multivitamin to "meaningfully contribute toward risk reduction," researchers wrote.

They added that there is a need to further understand how essential vitamins and minerals, even at standard levels, may differently interact and influence cardiovascular and cancer mechanisms.

"We’re seeing more and more negative studies," about supplements, said Dr. Harold, highlighting the research’s limited understanding of the agents’ biological impact and pathophysiology.

Coinvestigator J. Michael Gaziano, a cardiologist at Brigham and Women’s Hospital, said that he had no problems with his patients taking multivitamins as long as it was to mainly prevent vitamin deficiencies, and for its modest effect in reducing cancer. "But when it comes to preventing heart disease, we don’t have to invest our energy on multivitamins," he said.

Dr. Sesso, who is younger than the study’s cohort, said he did not take multivitamins but kept a good diet and exercised. Dr. Harold said he took multivitamins. Dr. Gaziano said he was trim, had a healthy diet, didn’t smoke, and exercised, but he wouldn’t say whether he took multivitamins. He said he wouldn’t reveal that information until all the data from the Physicians’ Health Study II were published. "I think it’s not unreasonable to take a multivitamin," he said.

Dr. Gaziano reported having received investigator-initiated research funding from the National Institutes of Health, the Veterans Administration, and BASF Corp. He received assistance with the study agents and packaging from BASF and Pfizer. Study packaging was provided by DSM Nutritional Products. Dr. Harold said he had no relevant disclosures. Dr. Sesso received research support from NIH and investigator-initiated grant from BASF. Dr. Lonn reported serving as a consultant to Merck and Servier; providing expert testimony for Merck; receiving grants or grants pending from AstraZeneca, GlaxoSmithKline, and Hoffman-LaRoche; and receiving payment for lectures from Novartis and Merck.

LOS ANGELES – Taking multivitamins daily did not provide any cardiovascular benefits to a large group of American men who were followed for more than a decade in a randomized trial.

While the results showed that multivitamins posed no health risks, experts said at the annual scientific sessions of the American Heart Association that the findings will help them frame the conversation when advising patients.

©Graça Victoria/iStockphoto.com

"The message needs to remain simple and focused," Dr. Eva M. Lonn, professor of medicine at McMaster University, Ontario, wrote in an editorial (JAMA 2012 Nov. 7;308:1802-3). "CVD is largely preventable, and this can be achieved by eating healthy foods, exercising regularly, avoiding tobacco products, and, for those with high risk factor levels or previous CVD events, taking proven, safe, and effective medications."

This is the second arm of the Physicians’ Health Study II, a randomized, double-blind, placebo-controlled trial, which followed nearly 15,000 male U.S. physicians for 11 years, aiming to evaluate the risk and benefits of a multivitamin, vitamin E, vitamin C, and beta carotene in prevention of cancer, cardiovascular disease, eye disease, and cognitive decline.

The results from the first arm of the large trial, published recently, showed that daily multivitamin supplementation had a modest but significant effect on reducing the risk of cancer. Researchers will present the two remaining studies in the near future.

It’s not clear whether the findings can be applied to the population as a whole, according to the study’s authors and other experts, especially since the study’s participants were relatively homogenous, healthy, and had a good nutritional intake.

Still, "this is a very well-run study," said Dr. John G. Harold, a cardiologist at Cedar Sinai Heart Institute, Los Angeles, who was not involved in the study. "This is one more example of a clinical trial that is changing what was up until now driven by opinion rather than fact."

Multivitamins are the most common supplement consumed by U.S. adults, yet most of the studies about their effect on cardiovascular health have been observational, and their results inconsistent. And while randomized trials like this are needed, conducting them is difficult, said Howard D. Sesso, Sc.D., the study’s lead author and an associate epidemiologist at Brigham and Women’s Hospital, Boston. "Many people who take multivitamins are unwilling to be randomized and receive placebos," he said.

Meanwhile, the physicians who participated in the study were incredibly dedicated to the trial, said Dr. Sesso, showing photos of some who had posed with their multivitamin packets at home, while traveling, or exploring nature.

Researchers followed 14,641 male U.S. physicians, initially 50 years or older, from 1997 to June 2011. There were 7,317 participants in the multivitamin group and 7,324 in the placebo group. They received monthly packs of multivitamins or placebo every 6 months during the first year, and annually thereafter. Morbidity and mortality follow-up were 98.2% and 99.9%, respectively.

Adherence was 67.5% in the multivitamin group and 67.1% in the placebo group at the end of the follow-up period.

The mean age of the study population was 64.3 years, and the population was predominantly white, and relatively healthy. Only 4% said that they were current smokers and close to 60% said that they exercised once or more per week.

In addition, 42% of the participants said that they had a history of hypertension, and 35% had a history of high cholesterol. Almost 6% had a history of diabetes.

At baseline, 5% of the men at a history of cardiovascular disease and 9% had a history of cancer.

The primary end point was major cardiovascular events, including nonfatal myocardial infarction, nonfatal stroke, and cardiovascular mortality. Secondary end points included stroke and MI individually.

Results showed that men who took a daily multivitamin didn’t experience any benefit for the primary end point and secondary end points.

There were 867 major cardiovascular events in the multivitamin group and 856 in the placebo group, or 11.0 and 10.8 events/1,000 person-years, a nonsignificant difference. Likewise, there were no significant differences between groups in total strokes (317 in the multivitamin group and 311 in the placebo group) or cardiovascular deaths (408 and 421, respectively). The results were published simultaneously with the presentation at the meeting (JAMA 2012 Nov. 7;308:1751-60).

The results showed no significant effects on gastrointestinal tract symptoms, fatigue, drowsiness, skin discoloration, and migraine.

The population was relatively well nourished, researchers pointed out, "for which supplementation may offer no additional benefit," they wrote.

Also, behavioral interventions such as exercise and medications such as lipid-lowering therapies can effectively lower the CVD risk and make it difficult for a multivitamin to "meaningfully contribute toward risk reduction," researchers wrote.

They added that there is a need to further understand how essential vitamins and minerals, even at standard levels, may differently interact and influence cardiovascular and cancer mechanisms.

"We’re seeing more and more negative studies," about supplements, said Dr. Harold, highlighting the research’s limited understanding of the agents’ biological impact and pathophysiology.

Coinvestigator J. Michael Gaziano, a cardiologist at Brigham and Women’s Hospital, said that he had no problems with his patients taking multivitamins as long as it was to mainly prevent vitamin deficiencies, and for its modest effect in reducing cancer. "But when it comes to preventing heart disease, we don’t have to invest our energy on multivitamins," he said.

Dr. Sesso, who is younger than the study’s cohort, said he did not take multivitamins but kept a good diet and exercised. Dr. Harold said he took multivitamins. Dr. Gaziano said he was trim, had a healthy diet, didn’t smoke, and exercised, but he wouldn’t say whether he took multivitamins. He said he wouldn’t reveal that information until all the data from the Physicians’ Health Study II were published. "I think it’s not unreasonable to take a multivitamin," he said.

Dr. Gaziano reported having received investigator-initiated research funding from the National Institutes of Health, the Veterans Administration, and BASF Corp. He received assistance with the study agents and packaging from BASF and Pfizer. Study packaging was provided by DSM Nutritional Products. Dr. Harold said he had no relevant disclosures. Dr. Sesso received research support from NIH and investigator-initiated grant from BASF. Dr. Lonn reported serving as a consultant to Merck and Servier; providing expert testimony for Merck; receiving grants or grants pending from AstraZeneca, GlaxoSmithKline, and Hoffman-LaRoche; and receiving payment for lectures from Novartis and Merck.

NEW ORLEANS – More physicians are using text messaging to communicate with each other and their teams in hospitals, a hint toward a shift from pagers, which have been a regular accessory to scrubs and white coats for the past 30 years.

The trend is driven by the surge in cell phone use and advances in technology, not to mention the new crop of tech-savvy interns and residents, according to the few studies that have focused on text messaging among health care professionals.

©Yankin Chauvin/Fotolia.com

The studies are quick to point out one major caveat: Most text messages are not encrypted, and many hospitals and health systems have yet to implement policies and secure programs to protect the exchanged information.

"This is a wake-up call," Dr. Stephanie Kuhlmann said at the annual meeting of the American Academy of Pediatrics. "Hospitals need to be aware of this trend and need to find a way to secure these text messages."

Dr. Kuhlmann, who is a pediatric hospitalist and assistant professor of pediatrics at the University of Kansas, Wichita, doesn’t carry a pager. She receives pages on her cell phone. She uses text messaging with colleagues, residents, and other members of the hospital team, whether it’s for administrative purposes, patient-care issues, or arranging a meetup.

Seeing the trend in her workplace, Dr. Kuhlmann and her colleagues decided to conduct an electronic survey of pediatric hospitalists about their use of text messaging.

The survey revealed that although face-to-face and phone communication were the most common types of contact (92% each) among the 106 surveyed, nearly 60% of the respondents said they received work-related text messages and 12% said they sent more than 10 messages per shift.

The text messages were to or from other pediatric hospitalists 59% of the time, from fellows or residents 34% of the time, and from subspecialists and consulting physicians 25% of the time. Nearly half of the respondents said that they received text messages when they were not on call.

"It’s a quick way to communicate or ask a quick question. You don’t have to stay on hold on the phone," Dr. Kuhlmann said.

Meanwhile, 41% of the respondents said they were worried about violating the Health Insurance Portability and Accountability Act (HIPAA), highlighting a need for text messaging encryption, said Dr. Kuhlmann.

In another survey, conducted by the IT security company Imprivata, more than 60% of hospital IT executives said that they were very concerned about HIPAA compliance.

Roughly 72% of the 114 respondents said that they had policies in place to prevent personal health information from being included in text messages. Yet, some 60% said they didn’t have a secure text messaging solution in place.

Almost two-thirds said that they believed pagers will be replaced by secure text messaging within 3 years.

Imprivata is among a handful of companies to offer HIPAA-compliant or encrypted text messaging programs and software for hospitals and health care systems.

Dr. Kuhlmann said that she wasn’t aware of any head-to-head comparisons for the available encrypted texting programs.

She and her colleagues, who are conducting more studies on the subject, said that there’s a need for more research on the accuracy and effectiveness of text message communication in hospitals and patient privacy issues.

Dr. Kulhmann said she had no relevant financial disclosures.

NEW ORLEANS – More physicians are using text messaging to communicate with each other and their teams in hospitals, a hint toward a shift from pagers, which have been a regular accessory to scrubs and white coats for the past 30 years.

The trend is driven by the surge in cell phone use and advances in technology, not to mention the new crop of tech-savvy interns and residents, according to the few studies that have focused on text messaging among health care professionals.

©Yankin Chauvin/Fotolia.com

The studies are quick to point out one major caveat: Most text messages are not encrypted, and many hospitals and health systems have yet to implement policies and secure programs to protect the exchanged information.

"This is a wake-up call," Dr. Stephanie Kuhlmann said at the annual meeting of the American Academy of Pediatrics. "Hospitals need to be aware of this trend and need to find a way to secure these text messages."

Dr. Kuhlmann, who is a pediatric hospitalist and assistant professor of pediatrics at the University of Kansas, Wichita, doesn’t carry a pager. She receives pages on her cell phone. She uses text messaging with colleagues, residents, and other members of the hospital team, whether it’s for administrative purposes, patient-care issues, or arranging a meetup.

Seeing the trend in her workplace, Dr. Kuhlmann and her colleagues decided to conduct an electronic survey of pediatric hospitalists about their use of text messaging.

The survey revealed that although face-to-face and phone communication were the most common types of contact (92% each) among the 106 surveyed, nearly 60% of the respondents said they received work-related text messages and 12% said they sent more than 10 messages per shift.

The text messages were to or from other pediatric hospitalists 59% of the time, from fellows or residents 34% of the time, and from subspecialists and consulting physicians 25% of the time. Nearly half of the respondents said that they received text messages when they were not on call.

"It’s a quick way to communicate or ask a quick question. You don’t have to stay on hold on the phone," Dr. Kuhlmann said.

Meanwhile, 41% of the respondents said they were worried about violating the Health Insurance Portability and Accountability Act (HIPAA), highlighting a need for text messaging encryption, said Dr. Kuhlmann.

In another survey, conducted by the IT security company Imprivata, more than 60% of hospital IT executives said that they were very concerned about HIPAA compliance.

Roughly 72% of the 114 respondents said that they had policies in place to prevent personal health information from being included in text messages. Yet, some 60% said they didn’t have a secure text messaging solution in place.

Almost two-thirds said that they believed pagers will be replaced by secure text messaging within 3 years.

Imprivata is among a handful of companies to offer HIPAA-compliant or encrypted text messaging programs and software for hospitals and health care systems.

Dr. Kuhlmann said that she wasn’t aware of any head-to-head comparisons for the available encrypted texting programs.

She and her colleagues, who are conducting more studies on the subject, said that there’s a need for more research on the accuracy and effectiveness of text message communication in hospitals and patient privacy issues.

Dr. Kulhmann said she had no relevant financial disclosures.

NEW ORLEANS – More physicians are using text messaging to communicate with each other and their teams in hospitals, a hint toward a shift from pagers, which have been a regular accessory to scrubs and white coats for the past 30 years.

The trend is driven by the surge in cell phone use and advances in technology, not to mention the new crop of tech-savvy interns and residents, according to the few studies that have focused on text messaging among health care professionals.

©Yankin Chauvin/Fotolia.com

The studies are quick to point out one major caveat: Most text messages are not encrypted, and many hospitals and health systems have yet to implement policies and secure programs to protect the exchanged information.

"This is a wake-up call," Dr. Stephanie Kuhlmann said at the annual meeting of the American Academy of Pediatrics. "Hospitals need to be aware of this trend and need to find a way to secure these text messages."

Dr. Kuhlmann, who is a pediatric hospitalist and assistant professor of pediatrics at the University of Kansas, Wichita, doesn’t carry a pager. She receives pages on her cell phone. She uses text messaging with colleagues, residents, and other members of the hospital team, whether it’s for administrative purposes, patient-care issues, or arranging a meetup.

Seeing the trend in her workplace, Dr. Kuhlmann and her colleagues decided to conduct an electronic survey of pediatric hospitalists about their use of text messaging.

The survey revealed that although face-to-face and phone communication were the most common types of contact (92% each) among the 106 surveyed, nearly 60% of the respondents said they received work-related text messages and 12% said they sent more than 10 messages per shift.

The text messages were to or from other pediatric hospitalists 59% of the time, from fellows or residents 34% of the time, and from subspecialists and consulting physicians 25% of the time. Nearly half of the respondents said that they received text messages when they were not on call.

"It’s a quick way to communicate or ask a quick question. You don’t have to stay on hold on the phone," Dr. Kuhlmann said.

Meanwhile, 41% of the respondents said they were worried about violating the Health Insurance Portability and Accountability Act (HIPAA), highlighting a need for text messaging encryption, said Dr. Kuhlmann.

In another survey, conducted by the IT security company Imprivata, more than 60% of hospital IT executives said that they were very concerned about HIPAA compliance.

Roughly 72% of the 114 respondents said that they had policies in place to prevent personal health information from being included in text messages. Yet, some 60% said they didn’t have a secure text messaging solution in place.

Almost two-thirds said that they believed pagers will be replaced by secure text messaging within 3 years.

Imprivata is among a handful of companies to offer HIPAA-compliant or encrypted text messaging programs and software for hospitals and health care systems.

Dr. Kuhlmann said that she wasn’t aware of any head-to-head comparisons for the available encrypted texting programs.

She and her colleagues, who are conducting more studies on the subject, said that there’s a need for more research on the accuracy and effectiveness of text message communication in hospitals and patient privacy issues.

Dr. Kulhmann said she had no relevant financial disclosures.

NEW ORLEANS – In response to the rising rates of overweight and obesity among children, the American Academy of Pediatrics has launched a new institute to provide pediatricians with tools and resources to fight the epidemic.

The Institute for Healthy Childhood Weight is housed within the AAP and is funded by government grants and corporate sponsors.

"Over the past decade we’ve been building the effort, and this institute serves to integrate the obesity efforts across the academy," said Dr. Sandra Hassink, chair of the institute’s steering committee.

In a video interview, Dr. Hassink, who is the director of the Nemours Obesity Initiative at Alfred I. duPont Hospital for Children in Wilmington, Del., further explained the role of the Institute, and talked about how it can benefit pediatricians and their practices:

Dr. Hassink said she had no disclosures.

NEW ORLEANS – In response to the rising rates of overweight and obesity among children, the American Academy of Pediatrics has launched a new institute to provide pediatricians with tools and resources to fight the epidemic.

The Institute for Healthy Childhood Weight is housed within the AAP and is funded by government grants and corporate sponsors.

"Over the past decade we’ve been building the effort, and this institute serves to integrate the obesity efforts across the academy," said Dr. Sandra Hassink, chair of the institute’s steering committee.

In a video interview, Dr. Hassink, who is the director of the Nemours Obesity Initiative at Alfred I. duPont Hospital for Children in Wilmington, Del., further explained the role of the Institute, and talked about how it can benefit pediatricians and their practices:

Dr. Hassink said she had no disclosures.

NEW ORLEANS – In response to the rising rates of overweight and obesity among children, the American Academy of Pediatrics has launched a new institute to provide pediatricians with tools and resources to fight the epidemic.

The Institute for Healthy Childhood Weight is housed within the AAP and is funded by government grants and corporate sponsors.

"Over the past decade we’ve been building the effort, and this institute serves to integrate the obesity efforts across the academy," said Dr. Sandra Hassink, chair of the institute’s steering committee.

In a video interview, Dr. Hassink, who is the director of the Nemours Obesity Initiative at Alfred I. duPont Hospital for Children in Wilmington, Del., further explained the role of the Institute, and talked about how it can benefit pediatricians and their practices:

Dr. Hassink said she had no disclosures.

The National Cardiovascular Data Registry for the first time has published a report on the state of diagnostic catheterization and percutaneous coronary intervention in the United States based on data from nearly 2 million patients and 1,500 laboratories.

The document does not show specific information on individual facilities or patients, but it provides perspective and benchmarks on various aspects of invasive cardiac procedures.

It is more of "a biopsy of where things are in invasive cardiology today," said lead author Dr. Gregory J. Dehmer.

The report is an aggregate of data collected from facilities registered with CathPCI Registry, which captures as many as 85% of the PCI procedures performed in the United States (J. Amer. Coll. Cardiol. 2012 [doi:10.1016/j.jacc.2012.08.966]).

Between January 2010 and June 2011, almost half of the registered facilities performed 400 or fewer PCI procedures annually (considered low volume), while 13% performed more than 1,000.

Only 4% of PCI procedures were performed in laboratories that performed 200 or fewer procedures per year. Nearly 90% of the facilities that were considered low volume did not have on-site cardiac surgery.

The authors pointed out that the 2011 PCI guideline recommends that low-volume operators not perform PCI procedures at low-volume facilities and that facilities performing fewer than 200 PCI procedures, "unless geographically isolated, carefully consider whether to continue to offer this service."

Forty-nine centers reported performing 10 or fewer PCI procedures annually.

Patients were broken down in two groups: nearly 1.1 million who underwent only diagnostic cardiac catheterization, and more than 940,000 patients who underwent PCI.

In both groups, almost 80% of the patients were overweight, and more than 40% were obese, possibly pointing to the fact that "America is getting fatter," said Dr. Dehmer, professor of medicine at Texas A&M Health Science Center, Bryan. Approximately 1% of the patients were considered thin.

Of those undergoing PCI, roughly 70% had a type of acute coronary syndrome, while nearly 45% of patients who underwent diagnostic procedures had an acute coronary syndrome at presentation.

Meanwhile, roughly 87% of the patients who underwent PCI had a single vessel treated. These data show that "interventional cardiologists had not used multivessel PCI excessively," said Dr. Dehmer. Also, 13% of the patients had two vessels treated, and 0.7% had three vessels treated.

The limitation to this information, however, was that the data did not pick up on patients who had a staged procedure, Dr. Dehmer pointed out.

The report also showed that U.S. interventional cardiologists still prefer the femoral route to radial or brachial access in patients undergoing PCI (93% vs. 7% vs. 0.4%, respectively) or diagnostic procedures (91% vs. 8% vs. 0.4%, respectively).

Although the United States is lagging behind Europe in using radial approach, "it’s catching on," said Dr. Dehmer, reflecting on changes in his own practice.

There has also been a lot of concern about the overuse of coronary CT angiography, said Dr. Dehmer. The analysis shows that the test was performed on less than 3% of PCI patients, and on less than 2% of those undergoing diagnostic catheterization.

The report also shed light on trends in medications prescribed. Clopidogrel, for instance, was the most frequently used thienopyridine (76%), while glycoprotein IIb/IIIa inhibitors were used in nearly 30% of PCI cases and 34% of patients who had an acute coronary syndrome.

In comparison, bivalirudin was used in almost 60% of the cases, "maintaining a strong presence," said Dr. Dehmer. Low-molecular-weight heparin was used in nearly 10% of the cases. Dr. Dehmer added that data was not captured for the recently approved ticagrelor.

Nearly all patients without contraindication were receiving aspirin and a thienopyridine at the time of discharge.

Authors noted that the CathPCI Registry is not only used to understand the practice of invasive cardiology but also to drive a higher level of quality into individual practices.

CathPCI Registry, which has been around since the late 1990s, sends quarterly reports to participating facilities.

Dr. Dehmer said that National Cardiovascular Data Registry is planning to update the public report periodically, "so that the next time we can see how things are changing."

Dr. Dehmer had no relevant disclosures.

The National Cardiovascular Data Registry for the first time has published a report on the state of diagnostic catheterization and percutaneous coronary intervention in the United States based on data from nearly 2 million patients and 1,500 laboratories.

The document does not show specific information on individual facilities or patients, but it provides perspective and benchmarks on various aspects of invasive cardiac procedures.

It is more of "a biopsy of where things are in invasive cardiology today," said lead author Dr. Gregory J. Dehmer.

The report is an aggregate of data collected from facilities registered with CathPCI Registry, which captures as many as 85% of the PCI procedures performed in the United States (J. Amer. Coll. Cardiol. 2012 [doi:10.1016/j.jacc.2012.08.966]).

Between January 2010 and June 2011, almost half of the registered facilities performed 400 or fewer PCI procedures annually (considered low volume), while 13% performed more than 1,000.

Only 4% of PCI procedures were performed in laboratories that performed 200 or fewer procedures per year. Nearly 90% of the facilities that were considered low volume did not have on-site cardiac surgery.

The authors pointed out that the 2011 PCI guideline recommends that low-volume operators not perform PCI procedures at low-volume facilities and that facilities performing fewer than 200 PCI procedures, "unless geographically isolated, carefully consider whether to continue to offer this service."

Forty-nine centers reported performing 10 or fewer PCI procedures annually.

Patients were broken down in two groups: nearly 1.1 million who underwent only diagnostic cardiac catheterization, and more than 940,000 patients who underwent PCI.

In both groups, almost 80% of the patients were overweight, and more than 40% were obese, possibly pointing to the fact that "America is getting fatter," said Dr. Dehmer, professor of medicine at Texas A&M Health Science Center, Bryan. Approximately 1% of the patients were considered thin.

Of those undergoing PCI, roughly 70% had a type of acute coronary syndrome, while nearly 45% of patients who underwent diagnostic procedures had an acute coronary syndrome at presentation.

Meanwhile, roughly 87% of the patients who underwent PCI had a single vessel treated. These data show that "interventional cardiologists had not used multivessel PCI excessively," said Dr. Dehmer. Also, 13% of the patients had two vessels treated, and 0.7% had three vessels treated.

The limitation to this information, however, was that the data did not pick up on patients who had a staged procedure, Dr. Dehmer pointed out.

The report also showed that U.S. interventional cardiologists still prefer the femoral route to radial or brachial access in patients undergoing PCI (93% vs. 7% vs. 0.4%, respectively) or diagnostic procedures (91% vs. 8% vs. 0.4%, respectively).

Although the United States is lagging behind Europe in using radial approach, "it’s catching on," said Dr. Dehmer, reflecting on changes in his own practice.

There has also been a lot of concern about the overuse of coronary CT angiography, said Dr. Dehmer. The analysis shows that the test was performed on less than 3% of PCI patients, and on less than 2% of those undergoing diagnostic catheterization.

The report also shed light on trends in medications prescribed. Clopidogrel, for instance, was the most frequently used thienopyridine (76%), while glycoprotein IIb/IIIa inhibitors were used in nearly 30% of PCI cases and 34% of patients who had an acute coronary syndrome.

In comparison, bivalirudin was used in almost 60% of the cases, "maintaining a strong presence," said Dr. Dehmer. Low-molecular-weight heparin was used in nearly 10% of the cases. Dr. Dehmer added that data was not captured for the recently approved ticagrelor.

Nearly all patients without contraindication were receiving aspirin and a thienopyridine at the time of discharge.

Authors noted that the CathPCI Registry is not only used to understand the practice of invasive cardiology but also to drive a higher level of quality into individual practices.

CathPCI Registry, which has been around since the late 1990s, sends quarterly reports to participating facilities.

Dr. Dehmer said that National Cardiovascular Data Registry is planning to update the public report periodically, "so that the next time we can see how things are changing."

Dr. Dehmer had no relevant disclosures.

The National Cardiovascular Data Registry for the first time has published a report on the state of diagnostic catheterization and percutaneous coronary intervention in the United States based on data from nearly 2 million patients and 1,500 laboratories.

The document does not show specific information on individual facilities or patients, but it provides perspective and benchmarks on various aspects of invasive cardiac procedures.

It is more of "a biopsy of where things are in invasive cardiology today," said lead author Dr. Gregory J. Dehmer.

The report is an aggregate of data collected from facilities registered with CathPCI Registry, which captures as many as 85% of the PCI procedures performed in the United States (J. Amer. Coll. Cardiol. 2012 [doi:10.1016/j.jacc.2012.08.966]).

Between January 2010 and June 2011, almost half of the registered facilities performed 400 or fewer PCI procedures annually (considered low volume), while 13% performed more than 1,000.

Only 4% of PCI procedures were performed in laboratories that performed 200 or fewer procedures per year. Nearly 90% of the facilities that were considered low volume did not have on-site cardiac surgery.

The authors pointed out that the 2011 PCI guideline recommends that low-volume operators not perform PCI procedures at low-volume facilities and that facilities performing fewer than 200 PCI procedures, "unless geographically isolated, carefully consider whether to continue to offer this service."

Forty-nine centers reported performing 10 or fewer PCI procedures annually.

Patients were broken down in two groups: nearly 1.1 million who underwent only diagnostic cardiac catheterization, and more than 940,000 patients who underwent PCI.

In both groups, almost 80% of the patients were overweight, and more than 40% were obese, possibly pointing to the fact that "America is getting fatter," said Dr. Dehmer, professor of medicine at Texas A&M Health Science Center, Bryan. Approximately 1% of the patients were considered thin.

Of those undergoing PCI, roughly 70% had a type of acute coronary syndrome, while nearly 45% of patients who underwent diagnostic procedures had an acute coronary syndrome at presentation.

Meanwhile, roughly 87% of the patients who underwent PCI had a single vessel treated. These data show that "interventional cardiologists had not used multivessel PCI excessively," said Dr. Dehmer. Also, 13% of the patients had two vessels treated, and 0.7% had three vessels treated.

The limitation to this information, however, was that the data did not pick up on patients who had a staged procedure, Dr. Dehmer pointed out.

The report also showed that U.S. interventional cardiologists still prefer the femoral route to radial or brachial access in patients undergoing PCI (93% vs. 7% vs. 0.4%, respectively) or diagnostic procedures (91% vs. 8% vs. 0.4%, respectively).

Although the United States is lagging behind Europe in using radial approach, "it’s catching on," said Dr. Dehmer, reflecting on changes in his own practice.

There has also been a lot of concern about the overuse of coronary CT angiography, said Dr. Dehmer. The analysis shows that the test was performed on less than 3% of PCI patients, and on less than 2% of those undergoing diagnostic catheterization.

The report also shed light on trends in medications prescribed. Clopidogrel, for instance, was the most frequently used thienopyridine (76%), while glycoprotein IIb/IIIa inhibitors were used in nearly 30% of PCI cases and 34% of patients who had an acute coronary syndrome.

In comparison, bivalirudin was used in almost 60% of the cases, "maintaining a strong presence," said Dr. Dehmer. Low-molecular-weight heparin was used in nearly 10% of the cases. Dr. Dehmer added that data was not captured for the recently approved ticagrelor.

Nearly all patients without contraindication were receiving aspirin and a thienopyridine at the time of discharge.

Authors noted that the CathPCI Registry is not only used to understand the practice of invasive cardiology but also to drive a higher level of quality into individual practices.

CathPCI Registry, which has been around since the late 1990s, sends quarterly reports to participating facilities.

Dr. Dehmer said that National Cardiovascular Data Registry is planning to update the public report periodically, "so that the next time we can see how things are changing."

Dr. Dehmer had no relevant disclosures.

NEW ORLEANS – Few adolescent girls who visited an emergency department were screened for pregnancy, even if they presented with lower abdominal pain or underwent a radiologic exam, according to analysis of national data.

Several factors could contribute to the lapse, according to lead author Dr. Monika Goyal.

"We, as providers, consider pregnancy to be more an adult issue and often fail to consider it when evaluating teenagers," said Dr. Goyal of the departments of pediatrics and emergency medicine at George Washington University, Washington.

Dr. Cora Collette Breuner, discussant and a member of the AAP Committee on Adolescence, noted that it can be difficult to see an adolescent confidentially in the ED setting. "We’re afraid of offending the patients and their families," she said.

Indeed, interventions that standardize sexual history taking for every adolescent, and pregnancy screening when patients may be exposed to teratogenic tests is among the solutions to increase the screening rates, said Dr. Goyal, who is also an attending ED physician at Children’s National Medical Center in Washington.

In her retrospective analysis, Dr. Goyal and her colleagues used the National Hospital Ambulatory Medical Care Survey from 2000 to 2009, identifying 22,866 records of female patients aged 14-21 years who were evaluated in EDs.

Of the 77 million female adolescents who visited ED during the 9-year-period, about 19% (14.5 million) received a pregnancy test.

Of those who presented with lower abdominal pain, 42% were tested. Meanwhile, 22% of those who underwent radiologic imaging were tested for pregnancy, so did 28% of the patients were exposed to potentially teratogenic radiation, such as chest radiographs or CT scans. Black patients, as well as those with non-private health insurance, who were admitted, and those with a chief complaint of lower abdominal pain or genitourinary symptoms were significantly more likely to be screened for pregnancy.

"This is a well-done study, and the findings are a bit surprising," commented Dr. Breuner, who is also a professor of adolescent medicine at the University of Washington, Seattle. "I really thought the numbers [for pregnancy screening] would be higher for abdominal pain."

Dr. Goyal advised pediatricians to conduct a confidential sexual history with every adolescent patient.

"Furthermore, we should have standardized protocols for pregnancy testing for complaints that may be associated with pregnancy related symptoms or anytime a patient may be exposed to therapies or diagnostics that may be harmful if pregnant."

Dr. Goyal and Dr. Breuner had no disclosures.

NEW ORLEANS – Few adolescent girls who visited an emergency department were screened for pregnancy, even if they presented with lower abdominal pain or underwent a radiologic exam, according to analysis of national data.

Several factors could contribute to the lapse, according to lead author Dr. Monika Goyal.

"We, as providers, consider pregnancy to be more an adult issue and often fail to consider it when evaluating teenagers," said Dr. Goyal of the departments of pediatrics and emergency medicine at George Washington University, Washington.

Dr. Cora Collette Breuner, discussant and a member of the AAP Committee on Adolescence, noted that it can be difficult to see an adolescent confidentially in the ED setting. "We’re afraid of offending the patients and their families," she said.

Indeed, interventions that standardize sexual history taking for every adolescent, and pregnancy screening when patients may be exposed to teratogenic tests is among the solutions to increase the screening rates, said Dr. Goyal, who is also an attending ED physician at Children’s National Medical Center in Washington.

In her retrospective analysis, Dr. Goyal and her colleagues used the National Hospital Ambulatory Medical Care Survey from 2000 to 2009, identifying 22,866 records of female patients aged 14-21 years who were evaluated in EDs.

Of the 77 million female adolescents who visited ED during the 9-year-period, about 19% (14.5 million) received a pregnancy test.

Of those who presented with lower abdominal pain, 42% were tested. Meanwhile, 22% of those who underwent radiologic imaging were tested for pregnancy, so did 28% of the patients were exposed to potentially teratogenic radiation, such as chest radiographs or CT scans. Black patients, as well as those with non-private health insurance, who were admitted, and those with a chief complaint of lower abdominal pain or genitourinary symptoms were significantly more likely to be screened for pregnancy.

"This is a well-done study, and the findings are a bit surprising," commented Dr. Breuner, who is also a professor of adolescent medicine at the University of Washington, Seattle. "I really thought the numbers [for pregnancy screening] would be higher for abdominal pain."

Dr. Goyal advised pediatricians to conduct a confidential sexual history with every adolescent patient.

"Furthermore, we should have standardized protocols for pregnancy testing for complaints that may be associated with pregnancy related symptoms or anytime a patient may be exposed to therapies or diagnostics that may be harmful if pregnant."

Dr. Goyal and Dr. Breuner had no disclosures.

NEW ORLEANS – Few adolescent girls who visited an emergency department were screened for pregnancy, even if they presented with lower abdominal pain or underwent a radiologic exam, according to analysis of national data.

Several factors could contribute to the lapse, according to lead author Dr. Monika Goyal.

"We, as providers, consider pregnancy to be more an adult issue and often fail to consider it when evaluating teenagers," said Dr. Goyal of the departments of pediatrics and emergency medicine at George Washington University, Washington.

Dr. Cora Collette Breuner, discussant and a member of the AAP Committee on Adolescence, noted that it can be difficult to see an adolescent confidentially in the ED setting. "We’re afraid of offending the patients and their families," she said.

Indeed, interventions that standardize sexual history taking for every adolescent, and pregnancy screening when patients may be exposed to teratogenic tests is among the solutions to increase the screening rates, said Dr. Goyal, who is also an attending ED physician at Children’s National Medical Center in Washington.

In her retrospective analysis, Dr. Goyal and her colleagues used the National Hospital Ambulatory Medical Care Survey from 2000 to 2009, identifying 22,866 records of female patients aged 14-21 years who were evaluated in EDs.

Of the 77 million female adolescents who visited ED during the 9-year-period, about 19% (14.5 million) received a pregnancy test.

Of those who presented with lower abdominal pain, 42% were tested. Meanwhile, 22% of those who underwent radiologic imaging were tested for pregnancy, so did 28% of the patients were exposed to potentially teratogenic radiation, such as chest radiographs or CT scans. Black patients, as well as those with non-private health insurance, who were admitted, and those with a chief complaint of lower abdominal pain or genitourinary symptoms were significantly more likely to be screened for pregnancy.

"This is a well-done study, and the findings are a bit surprising," commented Dr. Breuner, who is also a professor of adolescent medicine at the University of Washington, Seattle. "I really thought the numbers [for pregnancy screening] would be higher for abdominal pain."

Dr. Goyal advised pediatricians to conduct a confidential sexual history with every adolescent patient.

"Furthermore, we should have standardized protocols for pregnancy testing for complaints that may be associated with pregnancy related symptoms or anytime a patient may be exposed to therapies or diagnostics that may be harmful if pregnant."

Dr. Goyal and Dr. Breuner had no disclosures.

MUNICH  – Obesity is a strong predictor of atrial fibrillation in otherwise healthy fertile women, according to an analysis of a nationwide Danish registry.

The findings showed that obese women had a twofold increase in the risk of developing atrial fibrillation, compared with healthy-weight women. The risk nearly tripled in very obese women.

"This is just one more study to show that obesity is bad," said Dr. Miguel Quinones, the 2013 American College of Cardiology meeting chair, who was not involved in the study. He added that the study presented very strong data.

Previous studies have shown that obesity increases the risk of new-onset AF in patients with known risk factors, such as genetic predisposition, obstructive sleep apnea, and inflammation, said the authors. The study sheds light on yet another population where obesity increases the risk of AF, and it applies to a broader population, said Dr. Deniz Karasoy, who presented the study.

"Previous studies conducted on individuals with established risk factors for developing atrial fibrillation have demonstrated higher relative risk of new-onset AF in men compared to women," he said, in an interview. "Although we have not examined this specific association, we believe that this association is also valid regarding the obese men."

Obesity and atrial fibrillation are among the largest public health related challenges in the Western world, according to the authors.

Dr. Karasoy predicted an increasing prevalence of atrial fibrillation, and in more resistant forms, due to the increasing prevalence of obesity worldwide.

To slow the trend, pervasive primary prevention efforts, such as strategies that would promote weight loss, are needed, said Dr. Karasoy, a research fellow at Cardiovascular Research Center Gentofte, in Denmark.

The study was based on nationwide registry of about 271,000 healthy Danish women, between the ages of 20 and 50 years, who had given birth during 2004-2009.

The women were followed for an average of 4.6 years. Researchers broke down the cohort to five groups: underweight (body mass index below 18.5 kg/m²); normal weight (BMI of 18.5-25); overweight (BMI: 25-30); obese (BMI: 30-35); and extremely obese (BMI greater than 35).

During this period, researchers identified 110 new cases of AF.

Overall AF incidence rate was 9.3 per 100,000 person-years. For normal weight, overweight, obese and very obese women, AF incidence rates were 7.4, 8.5, 15.8, and 27.3 per 100,000 person-years, respectively.

After adjustment for age, comorbidity, medication and smoking, the results showed that obese women had a twofold increase in the risk of developing AF, compared with healthy weight women (hazard ratio, 2.04). That risk more than tripled in very obese women (HR, 3.50). No significant risk increase was observed in the overweight group.

The study did not address obesity’s mechanism of action on atrial fibrillation.

Dr. Karasoy and Dr. Quinones said that they had no relevant disclosures.

MUNICH  – Obesity is a strong predictor of atrial fibrillation in otherwise healthy fertile women, according to an analysis of a nationwide Danish registry.

The findings showed that obese women had a twofold increase in the risk of developing atrial fibrillation, compared with healthy-weight women. The risk nearly tripled in very obese women.

"This is just one more study to show that obesity is bad," said Dr. Miguel Quinones, the 2013 American College of Cardiology meeting chair, who was not involved in the study. He added that the study presented very strong data.

Previous studies have shown that obesity increases the risk of new-onset AF in patients with known risk factors, such as genetic predisposition, obstructive sleep apnea, and inflammation, said the authors. The study sheds light on yet another population where obesity increases the risk of AF, and it applies to a broader population, said Dr. Deniz Karasoy, who presented the study.

"Previous studies conducted on individuals with established risk factors for developing atrial fibrillation have demonstrated higher relative risk of new-onset AF in men compared to women," he said, in an interview. "Although we have not examined this specific association, we believe that this association is also valid regarding the obese men."

Obesity and atrial fibrillation are among the largest public health related challenges in the Western world, according to the authors.

Dr. Karasoy predicted an increasing prevalence of atrial fibrillation, and in more resistant forms, due to the increasing prevalence of obesity worldwide.

To slow the trend, pervasive primary prevention efforts, such as strategies that would promote weight loss, are needed, said Dr. Karasoy, a research fellow at Cardiovascular Research Center Gentofte, in Denmark.

The study was based on nationwide registry of about 271,000 healthy Danish women, between the ages of 20 and 50 years, who had given birth during 2004-2009.

The women were followed for an average of 4.6 years. Researchers broke down the cohort to five groups: underweight (body mass index below 18.5 kg/m²); normal weight (BMI of 18.5-25); overweight (BMI: 25-30); obese (BMI: 30-35); and extremely obese (BMI greater than 35).

During this period, researchers identified 110 new cases of AF.

Overall AF incidence rate was 9.3 per 100,000 person-years. For normal weight, overweight, obese and very obese women, AF incidence rates were 7.4, 8.5, 15.8, and 27.3 per 100,000 person-years, respectively.

After adjustment for age, comorbidity, medication and smoking, the results showed that obese women had a twofold increase in the risk of developing AF, compared with healthy weight women (hazard ratio, 2.04). That risk more than tripled in very obese women (HR, 3.50). No significant risk increase was observed in the overweight group.

The study did not address obesity’s mechanism of action on atrial fibrillation.

Dr. Karasoy and Dr. Quinones said that they had no relevant disclosures.

MUNICH  – Obesity is a strong predictor of atrial fibrillation in otherwise healthy fertile women, according to an analysis of a nationwide Danish registry.

The findings showed that obese women had a twofold increase in the risk of developing atrial fibrillation, compared with healthy-weight women. The risk nearly tripled in very obese women.

"This is just one more study to show that obesity is bad," said Dr. Miguel Quinones, the 2013 American College of Cardiology meeting chair, who was not involved in the study. He added that the study presented very strong data.

Previous studies have shown that obesity increases the risk of new-onset AF in patients with known risk factors, such as genetic predisposition, obstructive sleep apnea, and inflammation, said the authors. The study sheds light on yet another population where obesity increases the risk of AF, and it applies to a broader population, said Dr. Deniz Karasoy, who presented the study.

"Previous studies conducted on individuals with established risk factors for developing atrial fibrillation have demonstrated higher relative risk of new-onset AF in men compared to women," he said, in an interview. "Although we have not examined this specific association, we believe that this association is also valid regarding the obese men."

Obesity and atrial fibrillation are among the largest public health related challenges in the Western world, according to the authors.

Dr. Karasoy predicted an increasing prevalence of atrial fibrillation, and in more resistant forms, due to the increasing prevalence of obesity worldwide.

To slow the trend, pervasive primary prevention efforts, such as strategies that would promote weight loss, are needed, said Dr. Karasoy, a research fellow at Cardiovascular Research Center Gentofte, in Denmark.

The study was based on nationwide registry of about 271,000 healthy Danish women, between the ages of 20 and 50 years, who had given birth during 2004-2009.

The women were followed for an average of 4.6 years. Researchers broke down the cohort to five groups: underweight (body mass index below 18.5 kg/m²); normal weight (BMI of 18.5-25); overweight (BMI: 25-30); obese (BMI: 30-35); and extremely obese (BMI greater than 35).

During this period, researchers identified 110 new cases of AF.

Overall AF incidence rate was 9.3 per 100,000 person-years. For normal weight, overweight, obese and very obese women, AF incidence rates were 7.4, 8.5, 15.8, and 27.3 per 100,000 person-years, respectively.

After adjustment for age, comorbidity, medication and smoking, the results showed that obese women had a twofold increase in the risk of developing AF, compared with healthy weight women (hazard ratio, 2.04). That risk more than tripled in very obese women (HR, 3.50). No significant risk increase was observed in the overweight group.

The study did not address obesity’s mechanism of action on atrial fibrillation.

Dr. Karasoy and Dr. Quinones said that they had no relevant disclosures.