Cheryl Clark

LAS VEGAS – Federal officials have spent months listening to doctors’ complaints about their frustrating EHRs and are responding with a core group of changes to simplify and standardize health IT.

“We’ve made a great start, but we’re still at a stage where technology often hurts rather than helps physicians to provide better care,” Andy Slavitt, acting administrator of the Centers for Medicare & Medicaid Services, said March 1 at the annual meeting of the Health Information and Management Systems Society.

©thinkstockphotos.com

He provided some examples of complaints he hears from doctors: “Ordering aspirin takes eight clicks on the computer; to order full-strength aspirin, 16,” he said as the audience laughed.

And, “the systems don’t talk to each other. It’s actually the opposite. I can’t even access the hospital because of a firewall, and I can’t even get into the EMR at the hospital to look at patient records.”

And, “I can’t track my patients’ referrals,” or “I sent them to the hospital and I don’t know what happened.”

Mr. Slavitt said that he has 700 complaints from doctors just like those. “But the good news is that they’re not describing problems that we don’t know how to solve.”

And, he said, solving them is exactly what the CMS and a host of other agencies within the Health and Human Services department are trying to do with a raft of new proposed rules and announcements designed to more easily connect patients and providers with health care information necessary to provide better care.

Mr. Slavitt’s view of the EHR situation was echoed by Dr. Karen DeSalvo, national coordinator for Health Information Technology, who said that her husband is a practicing physician with real time frustrations.

“That’s my dinner conversation,” she said. “He’s a very clinically busy emergency medicine doc, and he wants the system to enable his workflow, and just like many physicians, it’s the same common refrain.”

Part of the solution is a proposed rule announced March 1 that would allow the Office of the National Coordinator for Heath Information Technology (ONC) to directly review certified health IT systems “and take action necessary including requiring the correction of nonconformities found in health IT … and suspending and terminating certifications.”

The proposed rule would:

• Enable ONC to directly review certified health IT products, including certified EHRs, and address circumstances such as potential risks to public health and safety. This would complement the existing responsibilities of ONC-Authorized Certification Bodies.

• Give ONC direct oversight of health IT testing bodies.

• Publish information on the performance of certified EHRs and other certified health IT products so that users can easily understand both the positive and negative aspects of each product.

Also on March 1, ONC announced $625,000 worth of challenge awards to encourage the development of mobile apps that patients and physicians can use to manage health information. The challenge will encourage the use of open, standardized application programming interfaces and one federal programming language standard (the Health Level 7 – Fast Healthcare Interoperability Resources or FHIR).

More expected rule making will come in several months to roll out expectations under MACRA, the Medicare Access & CHIP Reauthorization Act of 2015, including the Merit-Based Incentive Payment System (MIPS) and more alternative payment models such as accountable care organizations and bundled payment plans.

Under MIPS, Mr. Slavitt said, Congress is asking to measure quality, resource use, use of technology and practice improvement.

In addition, Mr. Slavitt said the CMS intends to roll out EHR requirements for long-term care facilities and behavioral health care providers. And, he said, “significant, significant effort and rules are underway” to improve quality and access for patients under the Medicaid program.

“I need physicians who are committed and who feel that part of their role is to take care of people who need care the most, who have lower socioeconomic status and who are more difficult to treat.”

LAS VEGAS – Federal officials have spent months listening to doctors’ complaints about their frustrating EHRs and are responding with a core group of changes to simplify and standardize health IT.

“We’ve made a great start, but we’re still at a stage where technology often hurts rather than helps physicians to provide better care,” Andy Slavitt, acting administrator of the Centers for Medicare & Medicaid Services, said March 1 at the annual meeting of the Health Information and Management Systems Society.

©thinkstockphotos.com

He provided some examples of complaints he hears from doctors: “Ordering aspirin takes eight clicks on the computer; to order full-strength aspirin, 16,” he said as the audience laughed.

And, “the systems don’t talk to each other. It’s actually the opposite. I can’t even access the hospital because of a firewall, and I can’t even get into the EMR at the hospital to look at patient records.”

And, “I can’t track my patients’ referrals,” or “I sent them to the hospital and I don’t know what happened.”

Mr. Slavitt said that he has 700 complaints from doctors just like those. “But the good news is that they’re not describing problems that we don’t know how to solve.”

And, he said, solving them is exactly what the CMS and a host of other agencies within the Health and Human Services department are trying to do with a raft of new proposed rules and announcements designed to more easily connect patients and providers with health care information necessary to provide better care.

Mr. Slavitt’s view of the EHR situation was echoed by Dr. Karen DeSalvo, national coordinator for Health Information Technology, who said that her husband is a practicing physician with real time frustrations.

“That’s my dinner conversation,” she said. “He’s a very clinically busy emergency medicine doc, and he wants the system to enable his workflow, and just like many physicians, it’s the same common refrain.”

Part of the solution is a proposed rule announced March 1 that would allow the Office of the National Coordinator for Heath Information Technology (ONC) to directly review certified health IT systems “and take action necessary including requiring the correction of nonconformities found in health IT … and suspending and terminating certifications.”

The proposed rule would:

• Enable ONC to directly review certified health IT products, including certified EHRs, and address circumstances such as potential risks to public health and safety. This would complement the existing responsibilities of ONC-Authorized Certification Bodies.

• Give ONC direct oversight of health IT testing bodies.

• Publish information on the performance of certified EHRs and other certified health IT products so that users can easily understand both the positive and negative aspects of each product.

Also on March 1, ONC announced $625,000 worth of challenge awards to encourage the development of mobile apps that patients and physicians can use to manage health information. The challenge will encourage the use of open, standardized application programming interfaces and one federal programming language standard (the Health Level 7 – Fast Healthcare Interoperability Resources or FHIR).

More expected rule making will come in several months to roll out expectations under MACRA, the Medicare Access & CHIP Reauthorization Act of 2015, including the Merit-Based Incentive Payment System (MIPS) and more alternative payment models such as accountable care organizations and bundled payment plans.

Under MIPS, Mr. Slavitt said, Congress is asking to measure quality, resource use, use of technology and practice improvement.

In addition, Mr. Slavitt said the CMS intends to roll out EHR requirements for long-term care facilities and behavioral health care providers. And, he said, “significant, significant effort and rules are underway” to improve quality and access for patients under the Medicaid program.

“I need physicians who are committed and who feel that part of their role is to take care of people who need care the most, who have lower socioeconomic status and who are more difficult to treat.”

LAS VEGAS – Federal officials have spent months listening to doctors’ complaints about their frustrating EHRs and are responding with a core group of changes to simplify and standardize health IT.

“We’ve made a great start, but we’re still at a stage where technology often hurts rather than helps physicians to provide better care,” Andy Slavitt, acting administrator of the Centers for Medicare & Medicaid Services, said March 1 at the annual meeting of the Health Information and Management Systems Society.

©thinkstockphotos.com

He provided some examples of complaints he hears from doctors: “Ordering aspirin takes eight clicks on the computer; to order full-strength aspirin, 16,” he said as the audience laughed.

And, “the systems don’t talk to each other. It’s actually the opposite. I can’t even access the hospital because of a firewall, and I can’t even get into the EMR at the hospital to look at patient records.”

And, “I can’t track my patients’ referrals,” or “I sent them to the hospital and I don’t know what happened.”

Mr. Slavitt said that he has 700 complaints from doctors just like those. “But the good news is that they’re not describing problems that we don’t know how to solve.”

And, he said, solving them is exactly what the CMS and a host of other agencies within the Health and Human Services department are trying to do with a raft of new proposed rules and announcements designed to more easily connect patients and providers with health care information necessary to provide better care.

Mr. Slavitt’s view of the EHR situation was echoed by Dr. Karen DeSalvo, national coordinator for Health Information Technology, who said that her husband is a practicing physician with real time frustrations.

“That’s my dinner conversation,” she said. “He’s a very clinically busy emergency medicine doc, and he wants the system to enable his workflow, and just like many physicians, it’s the same common refrain.”

Part of the solution is a proposed rule announced March 1 that would allow the Office of the National Coordinator for Heath Information Technology (ONC) to directly review certified health IT systems “and take action necessary including requiring the correction of nonconformities found in health IT … and suspending and terminating certifications.”

The proposed rule would:

• Enable ONC to directly review certified health IT products, including certified EHRs, and address circumstances such as potential risks to public health and safety. This would complement the existing responsibilities of ONC-Authorized Certification Bodies.

• Give ONC direct oversight of health IT testing bodies.

• Publish information on the performance of certified EHRs and other certified health IT products so that users can easily understand both the positive and negative aspects of each product.

Also on March 1, ONC announced $625,000 worth of challenge awards to encourage the development of mobile apps that patients and physicians can use to manage health information. The challenge will encourage the use of open, standardized application programming interfaces and one federal programming language standard (the Health Level 7 – Fast Healthcare Interoperability Resources or FHIR).

More expected rule making will come in several months to roll out expectations under MACRA, the Medicare Access & CHIP Reauthorization Act of 2015, including the Merit-Based Incentive Payment System (MIPS) and more alternative payment models such as accountable care organizations and bundled payment plans.

Under MIPS, Mr. Slavitt said, Congress is asking to measure quality, resource use, use of technology and practice improvement.

In addition, Mr. Slavitt said the CMS intends to roll out EHR requirements for long-term care facilities and behavioral health care providers. And, he said, “significant, significant effort and rules are underway” to improve quality and access for patients under the Medicaid program.

“I need physicians who are committed and who feel that part of their role is to take care of people who need care the most, who have lower socioeconomic status and who are more difficult to treat.”

LAS VEGAS – Health care data interoperability should get a huge boost under a public-private effort announced Feb. 29 by U.S. Department of Health and Human Services Secretary Sylvia Burwell.

The nation’s top five health care systems and companies, which provide the electronic health record systems that cover more than 90% of U.S. hospital patients, have agreed to principles designed to improve patient access to health data and eliminate the practice of data blocking.

They also have agreed to adopt federally recognized, national interoperability standards, Ms. Burwell announced at the annual meeting of the Healthcare Information and Management Systems Society.

“Technology is not just one leg of our strategy to build a better health care system for our nation – it supports the entire effort,” Ms. Burwell said. “We are working to unlock health care data and information so that providers are better informed and patients and families can access their health care information, making them empowered, active participants in their own care.”

Courtesy HHS

In a show of support, medical specialty societies including the American Academy of Family Physicians, the American College of Physicians, the American Society of Clinical Oncology, and the American Medical Association also signed on to the commitment.

“We have made tremendous progress to bring health care into the 21st century,” Ms. Burwell said. “In 6 short years, we have tripled the adoption of electronic health records. Today, three-quarters of physicians are using them. And nearly every hospital uses EHRs, meaning that there is now a digital care footprint for almost everyone in this country.”

To unlock all those data and make them useful to health care providers and patients, the health IT companies and health care systems have agreed to the following steps:

• Implement application programming interface (API) technology so that smartphone and tablet apps can be created, facilitating patient use and transfer of their health care data.

• Work so providers can share patient health care data with patients and other providers whenever permitted by law, while not blocking such sharing either intentionally or unintentionally.

• Use the federally recognized Fast Healthcare Interoperability Resources (FHIR) data standard.

This commitment is a “major step forward” to help patients “not just in one episode, but over the long term,” explained Dr. Karen DeSalvo, National Coordinator for Health Information Technology. The agreement means the health care system is “on the threshold of a truly historic opportunity to transform quality of care,” she added.

Federal officials have a timeline for progress toward these goals by 2018, Dr. DeSalvo noted. But “the private sector wants to pull that forward and be leaders with us,” she said. “So, our expectation is that the calls and the commitments and the associated actions that these developers have declared will be seeing some changes by the fall.”

To highlight health information technology’s promise, Ms. Burwell shared a story about electronic health records’ use to find children affected by lead pollution in the water supplies of Flint, Mich.

Alerted to the problem by a friend, pediatrician Mona Hanna-Attisha of Hurley Medical Center in Flint tried to determine whether pipe corrosion might leach dangerous levels of lead into the water supply, Ms. Burwell said.

“She knew the danger lead posed and began what she called a ‘crusade’ to find out if it was affecting children,” Ms. Burwell explained. Dr. Hanna-Attisha mined Hurley’s medical records to “compare blood test results from more than 700 children in the area and map home addresses for geographic variations.

“She quickly discovered that the percentage of children in Flint with lead poisoning had doubled, and even tripled, in some neighborhoods,” Burwell said.

If those results had still been on paper, “it would have taken forever to get these results,” she said.

“Dr. Hanna-Attisha’s story shows us the power of putting health care data to work,” Ms. Burwell noted. “It allows us to see the connections in our communities and helps us put patients in the center of their care.”

Dr. David Classen, chief information officer of the patient safety organization Pascal Metrics and an author of a 2011 Institute of Medicine report on health IT and patient safety, applauded the announcement and the commitment from major EHR vendors and hospital systems have signed on.

“That was one of the things [the IOM expert panel] envisioned – a public-private partnership that would really help this. That’s close to optimal in my view.”

But “the devil’s in the details,” said Dr. Classen, associate professor of medicine at the University of Utah. “When it comes to sharing safety information, it’s not just removal of the gag clauses, it’s also the confidentiality clauses, and the intellectual property protections. Those things too can inhibit sharing of safety information. The challenge here is that [EHR vendors] worry that if they’re so interoperable, they convert their proprietary technology into something that could virtually be open source...and everyone can look at it. Those are legitimate concerns.”

Another concern is agreeing on a common alphabet. “Without that, this is not going to work,” he said. “All these vendor products grew up in silos, without standards imposed on them. So naturally, they’re going to have a Tower of Babel, which means most of them aren’t going to be speaking the same language.”

LAS VEGAS – Health care data interoperability should get a huge boost under a public-private effort announced Feb. 29 by U.S. Department of Health and Human Services Secretary Sylvia Burwell.

The nation’s top five health care systems and companies, which provide the electronic health record systems that cover more than 90% of U.S. hospital patients, have agreed to principles designed to improve patient access to health data and eliminate the practice of data blocking.

They also have agreed to adopt federally recognized, national interoperability standards, Ms. Burwell announced at the annual meeting of the Healthcare Information and Management Systems Society.

“Technology is not just one leg of our strategy to build a better health care system for our nation – it supports the entire effort,” Ms. Burwell said. “We are working to unlock health care data and information so that providers are better informed and patients and families can access their health care information, making them empowered, active participants in their own care.”

Courtesy HHS

In a show of support, medical specialty societies including the American Academy of Family Physicians, the American College of Physicians, the American Society of Clinical Oncology, and the American Medical Association also signed on to the commitment.

“We have made tremendous progress to bring health care into the 21st century,” Ms. Burwell said. “In 6 short years, we have tripled the adoption of electronic health records. Today, three-quarters of physicians are using them. And nearly every hospital uses EHRs, meaning that there is now a digital care footprint for almost everyone in this country.”

To unlock all those data and make them useful to health care providers and patients, the health IT companies and health care systems have agreed to the following steps:

• Implement application programming interface (API) technology so that smartphone and tablet apps can be created, facilitating patient use and transfer of their health care data.

• Work so providers can share patient health care data with patients and other providers whenever permitted by law, while not blocking such sharing either intentionally or unintentionally.

• Use the federally recognized Fast Healthcare Interoperability Resources (FHIR) data standard.

This commitment is a “major step forward” to help patients “not just in one episode, but over the long term,” explained Dr. Karen DeSalvo, National Coordinator for Health Information Technology. The agreement means the health care system is “on the threshold of a truly historic opportunity to transform quality of care,” she added.

Federal officials have a timeline for progress toward these goals by 2018, Dr. DeSalvo noted. But “the private sector wants to pull that forward and be leaders with us,” she said. “So, our expectation is that the calls and the commitments and the associated actions that these developers have declared will be seeing some changes by the fall.”

To highlight health information technology’s promise, Ms. Burwell shared a story about electronic health records’ use to find children affected by lead pollution in the water supplies of Flint, Mich.

Alerted to the problem by a friend, pediatrician Mona Hanna-Attisha of Hurley Medical Center in Flint tried to determine whether pipe corrosion might leach dangerous levels of lead into the water supply, Ms. Burwell said.

“She knew the danger lead posed and began what she called a ‘crusade’ to find out if it was affecting children,” Ms. Burwell explained. Dr. Hanna-Attisha mined Hurley’s medical records to “compare blood test results from more than 700 children in the area and map home addresses for geographic variations.

“She quickly discovered that the percentage of children in Flint with lead poisoning had doubled, and even tripled, in some neighborhoods,” Burwell said.

If those results had still been on paper, “it would have taken forever to get these results,” she said.

“Dr. Hanna-Attisha’s story shows us the power of putting health care data to work,” Ms. Burwell noted. “It allows us to see the connections in our communities and helps us put patients in the center of their care.”

Dr. David Classen, chief information officer of the patient safety organization Pascal Metrics and an author of a 2011 Institute of Medicine report on health IT and patient safety, applauded the announcement and the commitment from major EHR vendors and hospital systems have signed on.

“That was one of the things [the IOM expert panel] envisioned – a public-private partnership that would really help this. That’s close to optimal in my view.”

But “the devil’s in the details,” said Dr. Classen, associate professor of medicine at the University of Utah. “When it comes to sharing safety information, it’s not just removal of the gag clauses, it’s also the confidentiality clauses, and the intellectual property protections. Those things too can inhibit sharing of safety information. The challenge here is that [EHR vendors] worry that if they’re so interoperable, they convert their proprietary technology into something that could virtually be open source...and everyone can look at it. Those are legitimate concerns.”

Another concern is agreeing on a common alphabet. “Without that, this is not going to work,” he said. “All these vendor products grew up in silos, without standards imposed on them. So naturally, they’re going to have a Tower of Babel, which means most of them aren’t going to be speaking the same language.”

LAS VEGAS – Health care data interoperability should get a huge boost under a public-private effort announced Feb. 29 by U.S. Department of Health and Human Services Secretary Sylvia Burwell.

The nation’s top five health care systems and companies, which provide the electronic health record systems that cover more than 90% of U.S. hospital patients, have agreed to principles designed to improve patient access to health data and eliminate the practice of data blocking.

They also have agreed to adopt federally recognized, national interoperability standards, Ms. Burwell announced at the annual meeting of the Healthcare Information and Management Systems Society.

“Technology is not just one leg of our strategy to build a better health care system for our nation – it supports the entire effort,” Ms. Burwell said. “We are working to unlock health care data and information so that providers are better informed and patients and families can access their health care information, making them empowered, active participants in their own care.”

Courtesy HHS

In a show of support, medical specialty societies including the American Academy of Family Physicians, the American College of Physicians, the American Society of Clinical Oncology, and the American Medical Association also signed on to the commitment.

“We have made tremendous progress to bring health care into the 21st century,” Ms. Burwell said. “In 6 short years, we have tripled the adoption of electronic health records. Today, three-quarters of physicians are using them. And nearly every hospital uses EHRs, meaning that there is now a digital care footprint for almost everyone in this country.”

To unlock all those data and make them useful to health care providers and patients, the health IT companies and health care systems have agreed to the following steps:

• Implement application programming interface (API) technology so that smartphone and tablet apps can be created, facilitating patient use and transfer of their health care data.

• Work so providers can share patient health care data with patients and other providers whenever permitted by law, while not blocking such sharing either intentionally or unintentionally.

• Use the federally recognized Fast Healthcare Interoperability Resources (FHIR) data standard.

This commitment is a “major step forward” to help patients “not just in one episode, but over the long term,” explained Dr. Karen DeSalvo, National Coordinator for Health Information Technology. The agreement means the health care system is “on the threshold of a truly historic opportunity to transform quality of care,” she added.

Federal officials have a timeline for progress toward these goals by 2018, Dr. DeSalvo noted. But “the private sector wants to pull that forward and be leaders with us,” she said. “So, our expectation is that the calls and the commitments and the associated actions that these developers have declared will be seeing some changes by the fall.”

To highlight health information technology’s promise, Ms. Burwell shared a story about electronic health records’ use to find children affected by lead pollution in the water supplies of Flint, Mich.

Alerted to the problem by a friend, pediatrician Mona Hanna-Attisha of Hurley Medical Center in Flint tried to determine whether pipe corrosion might leach dangerous levels of lead into the water supply, Ms. Burwell said.

“She knew the danger lead posed and began what she called a ‘crusade’ to find out if it was affecting children,” Ms. Burwell explained. Dr. Hanna-Attisha mined Hurley’s medical records to “compare blood test results from more than 700 children in the area and map home addresses for geographic variations.

“She quickly discovered that the percentage of children in Flint with lead poisoning had doubled, and even tripled, in some neighborhoods,” Burwell said.

If those results had still been on paper, “it would have taken forever to get these results,” she said.

“Dr. Hanna-Attisha’s story shows us the power of putting health care data to work,” Ms. Burwell noted. “It allows us to see the connections in our communities and helps us put patients in the center of their care.”

Dr. David Classen, chief information officer of the patient safety organization Pascal Metrics and an author of a 2011 Institute of Medicine report on health IT and patient safety, applauded the announcement and the commitment from major EHR vendors and hospital systems have signed on.

“That was one of the things [the IOM expert panel] envisioned – a public-private partnership that would really help this. That’s close to optimal in my view.”

But “the devil’s in the details,” said Dr. Classen, associate professor of medicine at the University of Utah. “When it comes to sharing safety information, it’s not just removal of the gag clauses, it’s also the confidentiality clauses, and the intellectual property protections. Those things too can inhibit sharing of safety information. The challenge here is that [EHR vendors] worry that if they’re so interoperable, they convert their proprietary technology into something that could virtually be open source...and everyone can look at it. Those are legitimate concerns.”

Another concern is agreeing on a common alphabet. “Without that, this is not going to work,” he said. “All these vendor products grew up in silos, without standards imposed on them. So naturally, they’re going to have a Tower of Babel, which means most of them aren’t going to be speaking the same language.”

SAN DIEGO – Contrast agents administered through the coronary vessels for invasive angiography led to significantly more kidney damage than contrast agents administered intravenously for coronary computed tomography angiography, according to a randomized study.

In the Coronary Artery Disease-Management (CAD-Man) study, contrast-induced kidney injury was two to three times more likely after intracoronary than after intravenous contrast administration, explained study investigators Dr. Eva Schönenberger and Dr. Marc Dewey of Charité Medical University, Berlin.

Contrast agents used to detect and treat blockages in coronary arteries are known to damage the kidneys in 2%-20% of patients. In the United States, about 4 million doses of contrast are administered directly into the coronary vessels during invasive catheterization, and 40 million into superficial veins, said Dr. Dewey, Heisenberg Professor of Radiology at the German Research Foundation and vice chair of the department of radiology at Charité.

That makes contrast administration a significant clinical decision for physicians, he added, not just because of potential for harm, but also the potential for added costs.

CAD-Man included 326 patients with suspected coronary disease. Researchers randomized 161 patients to intracoronary contrast agent (ICA) for invasive coronary angiography and 165 patients to IV contrast agent for coronary computed tomography angiography (CTA). All patients received the same contrast agent.

Blood samples were taken at baseline before the procedure, and at two time points after: between 18 and 24 hours, and between 46 and 50 hours. Baseline creatinine levels were similar in the two groups. The researchers defined contrast-associated nephrotoxicity as an increase in creatinine of at least 0.5 mg/dL, or 25%.

At follow-up, 21 of 158 ICA patients (13%) and 9 of 160 CTA patients (6%) had contrast-associated nephropathy, a significant difference (P less than .05). In patients without coronary disease, 13% of ICA patients and 4% of CTA patients developed contrast-associated nephropathy, also a significant difference (P less than .05).

Catheter administration concentrates more contrast in the heart and above the kidneys than intravenous administration, Dr. Schönenberger explained at the meeting sponsored by the American Society of Nephrology. Thus, the increased kidney damage in invasive-angiography patients may be due to higher dosages of contrast in their kidneys.

Physicians “have to keep in mind that putting contrast agents directly into the coronaries might produce more of an increase of creatinine, and more acute kidney injury, than just giving it through an IV,” explained Dr. Schönenberger, a nephrologist in the department of anesthesiology and operative intensive care medicine at Charité.

Physicians should take this information into consideration when deciding how to administer contrast for patients suspected of having coronary artery disease, Dr. Dewey noted. “In addition to being noninvasive, cardiac CT may thus also have the advantage of reducing kidney risk.”

Cost should be a big concern as well. Dr. Dewey referred to published literature indicating that contrast-induced kidney injury can lead to “longer hospital and intensive care unit stays, [increased] dialysis, cost of adverse events, and higher mortality rates. The in-hospital cost was $10,000 per contrast-induced acute kidney injury, and the 1-year cost of treatment was more than $11,000.”

Because CAD-Man’s last patient was enrolled in mid-September, the data are still being analyzed, Dr. Schönenberger noted. Therefore, some confounders may be discovered that influenced the results.

For example, cardiologists may select their sicker patients for invasive procedures in order to be ready to insert stents, so there may not be as much flexibility in which approach to use.

Also unclear is the amount of contrast used for each patient in each arm of this study. Some physicians may have used more contrast for patients suspected of having disease that was harder to detect, although that part of the analysis remains under review, Dr. Dewey and Dr. Schönenberger said.

It remains unclear whether the nephrotoxicity found in the invasive angiography group was all due to the contrast, Dr. Schönenberger noted, or whether some of it might have been caused by small particles of hardened cholesterol spreading to blood vessels in the kidneys – a process known as atheroembolic renal disease. That, too, is under review.

The contrast agent used in the study, low-osmolar nonionic Xenetix 350, is used in 96 countries but is not approved by the U.S. Food and Drug Administration, Dr. Schönenberger said. However, it is very similar to those agents that are in use in the United States, she added.

The study was funded by the German Research Foundation through the Heisenberg Professorship Program. The researchers reported no financial disclosures.

SAN DIEGO – Contrast agents administered through the coronary vessels for invasive angiography led to significantly more kidney damage than contrast agents administered intravenously for coronary computed tomography angiography, according to a randomized study.

In the Coronary Artery Disease-Management (CAD-Man) study, contrast-induced kidney injury was two to three times more likely after intracoronary than after intravenous contrast administration, explained study investigators Dr. Eva Schönenberger and Dr. Marc Dewey of Charité Medical University, Berlin.

Contrast agents used to detect and treat blockages in coronary arteries are known to damage the kidneys in 2%-20% of patients. In the United States, about 4 million doses of contrast are administered directly into the coronary vessels during invasive catheterization, and 40 million into superficial veins, said Dr. Dewey, Heisenberg Professor of Radiology at the German Research Foundation and vice chair of the department of radiology at Charité.

That makes contrast administration a significant clinical decision for physicians, he added, not just because of potential for harm, but also the potential for added costs.

CAD-Man included 326 patients with suspected coronary disease. Researchers randomized 161 patients to intracoronary contrast agent (ICA) for invasive coronary angiography and 165 patients to IV contrast agent for coronary computed tomography angiography (CTA). All patients received the same contrast agent.

Blood samples were taken at baseline before the procedure, and at two time points after: between 18 and 24 hours, and between 46 and 50 hours. Baseline creatinine levels were similar in the two groups. The researchers defined contrast-associated nephrotoxicity as an increase in creatinine of at least 0.5 mg/dL, or 25%.

At follow-up, 21 of 158 ICA patients (13%) and 9 of 160 CTA patients (6%) had contrast-associated nephropathy, a significant difference (P less than .05). In patients without coronary disease, 13% of ICA patients and 4% of CTA patients developed contrast-associated nephropathy, also a significant difference (P less than .05).

Catheter administration concentrates more contrast in the heart and above the kidneys than intravenous administration, Dr. Schönenberger explained at the meeting sponsored by the American Society of Nephrology. Thus, the increased kidney damage in invasive-angiography patients may be due to higher dosages of contrast in their kidneys.

Physicians “have to keep in mind that putting contrast agents directly into the coronaries might produce more of an increase of creatinine, and more acute kidney injury, than just giving it through an IV,” explained Dr. Schönenberger, a nephrologist in the department of anesthesiology and operative intensive care medicine at Charité.

Physicians should take this information into consideration when deciding how to administer contrast for patients suspected of having coronary artery disease, Dr. Dewey noted. “In addition to being noninvasive, cardiac CT may thus also have the advantage of reducing kidney risk.”

Cost should be a big concern as well. Dr. Dewey referred to published literature indicating that contrast-induced kidney injury can lead to “longer hospital and intensive care unit stays, [increased] dialysis, cost of adverse events, and higher mortality rates. The in-hospital cost was $10,000 per contrast-induced acute kidney injury, and the 1-year cost of treatment was more than $11,000.”

Because CAD-Man’s last patient was enrolled in mid-September, the data are still being analyzed, Dr. Schönenberger noted. Therefore, some confounders may be discovered that influenced the results.

For example, cardiologists may select their sicker patients for invasive procedures in order to be ready to insert stents, so there may not be as much flexibility in which approach to use.

Also unclear is the amount of contrast used for each patient in each arm of this study. Some physicians may have used more contrast for patients suspected of having disease that was harder to detect, although that part of the analysis remains under review, Dr. Dewey and Dr. Schönenberger said.

It remains unclear whether the nephrotoxicity found in the invasive angiography group was all due to the contrast, Dr. Schönenberger noted, or whether some of it might have been caused by small particles of hardened cholesterol spreading to blood vessels in the kidneys – a process known as atheroembolic renal disease. That, too, is under review.

The contrast agent used in the study, low-osmolar nonionic Xenetix 350, is used in 96 countries but is not approved by the U.S. Food and Drug Administration, Dr. Schönenberger said. However, it is very similar to those agents that are in use in the United States, she added.

The study was funded by the German Research Foundation through the Heisenberg Professorship Program. The researchers reported no financial disclosures.

SAN DIEGO – Contrast agents administered through the coronary vessels for invasive angiography led to significantly more kidney damage than contrast agents administered intravenously for coronary computed tomography angiography, according to a randomized study.

In the Coronary Artery Disease-Management (CAD-Man) study, contrast-induced kidney injury was two to three times more likely after intracoronary than after intravenous contrast administration, explained study investigators Dr. Eva Schönenberger and Dr. Marc Dewey of Charité Medical University, Berlin.

Contrast agents used to detect and treat blockages in coronary arteries are known to damage the kidneys in 2%-20% of patients. In the United States, about 4 million doses of contrast are administered directly into the coronary vessels during invasive catheterization, and 40 million into superficial veins, said Dr. Dewey, Heisenberg Professor of Radiology at the German Research Foundation and vice chair of the department of radiology at Charité.

That makes contrast administration a significant clinical decision for physicians, he added, not just because of potential for harm, but also the potential for added costs.

CAD-Man included 326 patients with suspected coronary disease. Researchers randomized 161 patients to intracoronary contrast agent (ICA) for invasive coronary angiography and 165 patients to IV contrast agent for coronary computed tomography angiography (CTA). All patients received the same contrast agent.

Blood samples were taken at baseline before the procedure, and at two time points after: between 18 and 24 hours, and between 46 and 50 hours. Baseline creatinine levels were similar in the two groups. The researchers defined contrast-associated nephrotoxicity as an increase in creatinine of at least 0.5 mg/dL, or 25%.

At follow-up, 21 of 158 ICA patients (13%) and 9 of 160 CTA patients (6%) had contrast-associated nephropathy, a significant difference (P less than .05). In patients without coronary disease, 13% of ICA patients and 4% of CTA patients developed contrast-associated nephropathy, also a significant difference (P less than .05).

Catheter administration concentrates more contrast in the heart and above the kidneys than intravenous administration, Dr. Schönenberger explained at the meeting sponsored by the American Society of Nephrology. Thus, the increased kidney damage in invasive-angiography patients may be due to higher dosages of contrast in their kidneys.

Physicians “have to keep in mind that putting contrast agents directly into the coronaries might produce more of an increase of creatinine, and more acute kidney injury, than just giving it through an IV,” explained Dr. Schönenberger, a nephrologist in the department of anesthesiology and operative intensive care medicine at Charité.

Physicians should take this information into consideration when deciding how to administer contrast for patients suspected of having coronary artery disease, Dr. Dewey noted. “In addition to being noninvasive, cardiac CT may thus also have the advantage of reducing kidney risk.”

Cost should be a big concern as well. Dr. Dewey referred to published literature indicating that contrast-induced kidney injury can lead to “longer hospital and intensive care unit stays, [increased] dialysis, cost of adverse events, and higher mortality rates. The in-hospital cost was $10,000 per contrast-induced acute kidney injury, and the 1-year cost of treatment was more than $11,000.”

Because CAD-Man’s last patient was enrolled in mid-September, the data are still being analyzed, Dr. Schönenberger noted. Therefore, some confounders may be discovered that influenced the results.

For example, cardiologists may select their sicker patients for invasive procedures in order to be ready to insert stents, so there may not be as much flexibility in which approach to use.

Also unclear is the amount of contrast used for each patient in each arm of this study. Some physicians may have used more contrast for patients suspected of having disease that was harder to detect, although that part of the analysis remains under review, Dr. Dewey and Dr. Schönenberger said.

It remains unclear whether the nephrotoxicity found in the invasive angiography group was all due to the contrast, Dr. Schönenberger noted, or whether some of it might have been caused by small particles of hardened cholesterol spreading to blood vessels in the kidneys – a process known as atheroembolic renal disease. That, too, is under review.

The contrast agent used in the study, low-osmolar nonionic Xenetix 350, is used in 96 countries but is not approved by the U.S. Food and Drug Administration, Dr. Schönenberger said. However, it is very similar to those agents that are in use in the United States, she added.

The study was funded by the German Research Foundation through the Heisenberg Professorship Program. The researchers reported no financial disclosures.