Thoracic Surgery News (Archived)

FT. LAUDERDALE, FLA. – At this year’s Society of Thoracic Surgeons Meeting, the 48th Annual, many topics were discussed that are of particular relevance to thoracic surgery trainees. These topics ranged from the future scope of our practice, to our ongoing collaborations with our medical colleagues, and included issues relating to acquiring a job.

In terms of the evolving cardiothoracic surgery practice, there were separate sessions devoted to the transcatheter aortic valve techniques. Data presented demonstrated the expanding role and the increasing safety of these approaches in select patient populations.

Hybrid and multidisciplinary approaches to coronary surgery, thoracic aortic aneurysm, valvular and pleural based diseases are ever increasing. Being well versed and open to these approaches will become an increasing part of cardiothoracic surgery care in the upcoming decade.

A common theme of the morning sessions was the ever increasing collaborative nature of our specialty. This sentiment was expressed by Dr. Michael Mack’s Presidential Address and Dr. Friedrich Mohr’s C.Walton Lillehei Lecture. In both of these excellent talks, the need for, and multitude of benefits of collaboration were espoused. These are collaborations with our fellow surgeons, our anesthesiologists, cardiologists and pulmonologists, and ancillary support staff. The benefits go beyond those of improving patient care and expanding procedures to deep rich friendships and enjoyable relationships. As Dr. Mack aptly put it "a rising tide floats all boats."

On Sunday there was a special session devoted to resident issues. This session included Dr. Ara Vaporciyan, Dr. Edward Verrier, Dr. John Ikonomidis, Dr. Kevin Accola, Dr. Peter Smith, and Dr. William Baumgartner. The emphasis of this session was to aid in the trainee job search and to facilitate the transition into that first position. Lectures focused on how to market oneself, negotiating contracts, billing, and the ubiquitous role of teaching.

Residents were encouraged to speak to as many people as possible and to develop a set of skills that they can articulate being able to bring to a practice. In both academic and private practices, one needs to be flexible but also protective of one’s time.

We need to be conscious of our choices, in terms of time, procedures, call, commitments, and family. The new practice environment is an intermingled one where we need to be vigilant of the results of our decisions.

Negotiating with potential partners and employees should be done in good faith. The three take homes were that one wants to ensure that there is a good fit in the practice, you are joining a family that you have to live with, and the cardiothoracic surgery community is a small one.

Residents were encouraged to have a lawyer review their contract, not so much as to bargain or get an edge up, but so as to completely understand what one is agreeing to. In addition, most contracts are standard among large institutions but having counsel review a contract can identify gross omissions or concerns.

Early on in the practice, new employees should seek out courses and knowledge on billing and coding. While bills will likely be submitted by a "biller," they are ultimately responsible. Knowing what can and cannot be billed for is key.

We were encouraged to stay abreast of the billing and coding process to ensure an accurate submission and to improve our knowledge of practice management as well.

Trainees are cautioned that while some may not choose to pursue academic practices, teaching is an ever present component of our work-life. Cardiothoracic surgeons have the opportunity and obligation to teach to our colleagues, our ancillary support staff, and our patients.

The benefits of this teaching are that ultimately patients bet better care. Those who support us are empowered to take active roles in patient care and the patients themselves become invested in their health care.

Finally, Dr. George Hicks, chief of Cardiac Surgery at the University of Rochester Medical Center, was honored for his mentoring of young surgeons. He was awarded the Socrates Award for his devotion to thoracic resident education. The Socrates Award is given by the Thoracic Surgery Residents Association to a faculty member who demonstrates excellence in resident training.

In addition, the American Board of Thoracic Surgery emphasized the need for thorough board preparation, the recent changes in the certifying exam, and the need to have a depth and breadth of both thoracic and cardiac knowledge.

FT. LAUDERDALE, FLA. – At this year’s Society of Thoracic Surgeons Meeting, the 48th Annual, many topics were discussed that are of particular relevance to thoracic surgery trainees. These topics ranged from the future scope of our practice, to our ongoing collaborations with our medical colleagues, and included issues relating to acquiring a job.

In terms of the evolving cardiothoracic surgery practice, there were separate sessions devoted to the transcatheter aortic valve techniques. Data presented demonstrated the expanding role and the increasing safety of these approaches in select patient populations.

Hybrid and multidisciplinary approaches to coronary surgery, thoracic aortic aneurysm, valvular and pleural based diseases are ever increasing. Being well versed and open to these approaches will become an increasing part of cardiothoracic surgery care in the upcoming decade.

A common theme of the morning sessions was the ever increasing collaborative nature of our specialty. This sentiment was expressed by Dr. Michael Mack’s Presidential Address and Dr. Friedrich Mohr’s C.Walton Lillehei Lecture. In both of these excellent talks, the need for, and multitude of benefits of collaboration were espoused. These are collaborations with our fellow surgeons, our anesthesiologists, cardiologists and pulmonologists, and ancillary support staff. The benefits go beyond those of improving patient care and expanding procedures to deep rich friendships and enjoyable relationships. As Dr. Mack aptly put it "a rising tide floats all boats."

On Sunday there was a special session devoted to resident issues. This session included Dr. Ara Vaporciyan, Dr. Edward Verrier, Dr. John Ikonomidis, Dr. Kevin Accola, Dr. Peter Smith, and Dr. William Baumgartner. The emphasis of this session was to aid in the trainee job search and to facilitate the transition into that first position. Lectures focused on how to market oneself, negotiating contracts, billing, and the ubiquitous role of teaching.

Residents were encouraged to speak to as many people as possible and to develop a set of skills that they can articulate being able to bring to a practice. In both academic and private practices, one needs to be flexible but also protective of one’s time.

We need to be conscious of our choices, in terms of time, procedures, call, commitments, and family. The new practice environment is an intermingled one where we need to be vigilant of the results of our decisions.

Negotiating with potential partners and employees should be done in good faith. The three take homes were that one wants to ensure that there is a good fit in the practice, you are joining a family that you have to live with, and the cardiothoracic surgery community is a small one.

Residents were encouraged to have a lawyer review their contract, not so much as to bargain or get an edge up, but so as to completely understand what one is agreeing to. In addition, most contracts are standard among large institutions but having counsel review a contract can identify gross omissions or concerns.

Early on in the practice, new employees should seek out courses and knowledge on billing and coding. While bills will likely be submitted by a "biller," they are ultimately responsible. Knowing what can and cannot be billed for is key.

We were encouraged to stay abreast of the billing and coding process to ensure an accurate submission and to improve our knowledge of practice management as well.

Trainees are cautioned that while some may not choose to pursue academic practices, teaching is an ever present component of our work-life. Cardiothoracic surgeons have the opportunity and obligation to teach to our colleagues, our ancillary support staff, and our patients.

The benefits of this teaching are that ultimately patients bet better care. Those who support us are empowered to take active roles in patient care and the patients themselves become invested in their health care.

Finally, Dr. George Hicks, chief of Cardiac Surgery at the University of Rochester Medical Center, was honored for his mentoring of young surgeons. He was awarded the Socrates Award for his devotion to thoracic resident education. The Socrates Award is given by the Thoracic Surgery Residents Association to a faculty member who demonstrates excellence in resident training.

In addition, the American Board of Thoracic Surgery emphasized the need for thorough board preparation, the recent changes in the certifying exam, and the need to have a depth and breadth of both thoracic and cardiac knowledge.

FT. LAUDERDALE, FLA. – At this year’s Society of Thoracic Surgeons Meeting, the 48th Annual, many topics were discussed that are of particular relevance to thoracic surgery trainees. These topics ranged from the future scope of our practice, to our ongoing collaborations with our medical colleagues, and included issues relating to acquiring a job.

In terms of the evolving cardiothoracic surgery practice, there were separate sessions devoted to the transcatheter aortic valve techniques. Data presented demonstrated the expanding role and the increasing safety of these approaches in select patient populations.

Hybrid and multidisciplinary approaches to coronary surgery, thoracic aortic aneurysm, valvular and pleural based diseases are ever increasing. Being well versed and open to these approaches will become an increasing part of cardiothoracic surgery care in the upcoming decade.

A common theme of the morning sessions was the ever increasing collaborative nature of our specialty. This sentiment was expressed by Dr. Michael Mack’s Presidential Address and Dr. Friedrich Mohr’s C.Walton Lillehei Lecture. In both of these excellent talks, the need for, and multitude of benefits of collaboration were espoused. These are collaborations with our fellow surgeons, our anesthesiologists, cardiologists and pulmonologists, and ancillary support staff. The benefits go beyond those of improving patient care and expanding procedures to deep rich friendships and enjoyable relationships. As Dr. Mack aptly put it "a rising tide floats all boats."

On Sunday there was a special session devoted to resident issues. This session included Dr. Ara Vaporciyan, Dr. Edward Verrier, Dr. John Ikonomidis, Dr. Kevin Accola, Dr. Peter Smith, and Dr. William Baumgartner. The emphasis of this session was to aid in the trainee job search and to facilitate the transition into that first position. Lectures focused on how to market oneself, negotiating contracts, billing, and the ubiquitous role of teaching.

Residents were encouraged to speak to as many people as possible and to develop a set of skills that they can articulate being able to bring to a practice. In both academic and private practices, one needs to be flexible but also protective of one’s time.

We need to be conscious of our choices, in terms of time, procedures, call, commitments, and family. The new practice environment is an intermingled one where we need to be vigilant of the results of our decisions.

Negotiating with potential partners and employees should be done in good faith. The three take homes were that one wants to ensure that there is a good fit in the practice, you are joining a family that you have to live with, and the cardiothoracic surgery community is a small one.

Residents were encouraged to have a lawyer review their contract, not so much as to bargain or get an edge up, but so as to completely understand what one is agreeing to. In addition, most contracts are standard among large institutions but having counsel review a contract can identify gross omissions or concerns.

Early on in the practice, new employees should seek out courses and knowledge on billing and coding. While bills will likely be submitted by a "biller," they are ultimately responsible. Knowing what can and cannot be billed for is key.

We were encouraged to stay abreast of the billing and coding process to ensure an accurate submission and to improve our knowledge of practice management as well.

Trainees are cautioned that while some may not choose to pursue academic practices, teaching is an ever present component of our work-life. Cardiothoracic surgeons have the opportunity and obligation to teach to our colleagues, our ancillary support staff, and our patients.

The benefits of this teaching are that ultimately patients bet better care. Those who support us are empowered to take active roles in patient care and the patients themselves become invested in their health care.

Finally, Dr. George Hicks, chief of Cardiac Surgery at the University of Rochester Medical Center, was honored for his mentoring of young surgeons. He was awarded the Socrates Award for his devotion to thoracic resident education. The Socrates Award is given by the Thoracic Surgery Residents Association to a faculty member who demonstrates excellence in resident training.

In addition, the American Board of Thoracic Surgery emphasized the need for thorough board preparation, the recent changes in the certifying exam, and the need to have a depth and breadth of both thoracic and cardiac knowledge.

Physicians are once again waiting for Congress to avert a 27% Medicare physician fee cut scheduled to take effect on March 1.

The pay cut was originally scheduled to begin Jan. 1, but after much back-and-forth in Congress, the House and Senate passed the Temporary Payroll Tax Cut Continuation Act of 2011 on Dec. 23, which included an extension of 2011 Medicare physician-payment rates through the end of February. President Obama quickly signed the bill into law.

Lawmakers also agreed to appoint a 20-member House-Senate committee to work on a longer-term plan to address the Medicare physician pay issue, along with a full-year extension of the Social Security payroll tax holiday and federally funded unemployment insurance benefits.

The agreement followed several days of brinksmanship by leaders in the House and Senate. It started on Dec. 13, when the House passed a bill that would have replaced the 27% Medicare fee cut with a 1% pay raise for physicians for 2 years. Despite bipartisan support for the so-called doc fix, other controversial provisions in the bill kept it from gaining traction in the Senate. A few days later, the Senate approved their own version of the bill, which extended the payroll tax holiday and unemployment benefits for 2 months and postponed any Medicare cuts until the end of February.

The House initially rejected a short-term fix, and even passed a resolution to formally disagree with the legislation passed by the Senate. But intense public criticism led House leaders to agree to the short-term plan and use the first 2 months of this year to negotiate a compromise.

Physicians remain furious with Congress for its inability to find a long-term solution in 2011. "There’s a tremendous degree of frustration out there," said Robert Doherty, senior vice president for government affairs and public policy at the American College of Physicians. "If Congress is expecting physicians to applaud them for agreeing to a 2-month extension, they’re going to find a lot of silence from the physician community."

Frustration is especially high because members of Congress had signaled early in 2011 that they were interested in crafting a long-term solution to replace the Sustainable Growth Rate formula, the statutory formula that ties spending on physicians’ services to the gross domestic product. In March 2011, leaders in the House Energy and Commerce Committee wrote to several physicians’ groups asking for proposals on how to reform the physician payment system and move to a new system that "reduces spending, pays providers fairly, and pays for services according to their value to the beneficiary."

The letter emphasized the need to act quickly in developing a long-term solution, or risk the "unwanted choice of extending a fundamentally broken payment system or jeopardizing access to care" for Medicare beneficiaries. "We cannot let either happen," the lawmakers wrote.

It’s too soon to tell what Congress will do next, but Mr. Doherty agreed that a long-term solution that would replace the SGR is unlikely right now.

In a worse-case scenario, physicians could be facing a situation similar to 2010, when Congress passed a series of temporary patches during the first half of the year, Mr. Doherty said. That situation could become a reality if lawmakers once again are deadlocked on the larger legislative package. "To a great extent, we’re once again going to be held hostage to negotiations over a broader package on issues that really have nothing to do with the SGR."☐

Physicians are once again waiting for Congress to avert a 27% Medicare physician fee cut scheduled to take effect on March 1.

The pay cut was originally scheduled to begin Jan. 1, but after much back-and-forth in Congress, the House and Senate passed the Temporary Payroll Tax Cut Continuation Act of 2011 on Dec. 23, which included an extension of 2011 Medicare physician-payment rates through the end of February. President Obama quickly signed the bill into law.

Lawmakers also agreed to appoint a 20-member House-Senate committee to work on a longer-term plan to address the Medicare physician pay issue, along with a full-year extension of the Social Security payroll tax holiday and federally funded unemployment insurance benefits.

The agreement followed several days of brinksmanship by leaders in the House and Senate. It started on Dec. 13, when the House passed a bill that would have replaced the 27% Medicare fee cut with a 1% pay raise for physicians for 2 years. Despite bipartisan support for the so-called doc fix, other controversial provisions in the bill kept it from gaining traction in the Senate. A few days later, the Senate approved their own version of the bill, which extended the payroll tax holiday and unemployment benefits for 2 months and postponed any Medicare cuts until the end of February.

The House initially rejected a short-term fix, and even passed a resolution to formally disagree with the legislation passed by the Senate. But intense public criticism led House leaders to agree to the short-term plan and use the first 2 months of this year to negotiate a compromise.

Physicians remain furious with Congress for its inability to find a long-term solution in 2011. "There’s a tremendous degree of frustration out there," said Robert Doherty, senior vice president for government affairs and public policy at the American College of Physicians. "If Congress is expecting physicians to applaud them for agreeing to a 2-month extension, they’re going to find a lot of silence from the physician community."

Frustration is especially high because members of Congress had signaled early in 2011 that they were interested in crafting a long-term solution to replace the Sustainable Growth Rate formula, the statutory formula that ties spending on physicians’ services to the gross domestic product. In March 2011, leaders in the House Energy and Commerce Committee wrote to several physicians’ groups asking for proposals on how to reform the physician payment system and move to a new system that "reduces spending, pays providers fairly, and pays for services according to their value to the beneficiary."

The letter emphasized the need to act quickly in developing a long-term solution, or risk the "unwanted choice of extending a fundamentally broken payment system or jeopardizing access to care" for Medicare beneficiaries. "We cannot let either happen," the lawmakers wrote.

It’s too soon to tell what Congress will do next, but Mr. Doherty agreed that a long-term solution that would replace the SGR is unlikely right now.

In a worse-case scenario, physicians could be facing a situation similar to 2010, when Congress passed a series of temporary patches during the first half of the year, Mr. Doherty said. That situation could become a reality if lawmakers once again are deadlocked on the larger legislative package. "To a great extent, we’re once again going to be held hostage to negotiations over a broader package on issues that really have nothing to do with the SGR."☐

Physicians are once again waiting for Congress to avert a 27% Medicare physician fee cut scheduled to take effect on March 1.

The pay cut was originally scheduled to begin Jan. 1, but after much back-and-forth in Congress, the House and Senate passed the Temporary Payroll Tax Cut Continuation Act of 2011 on Dec. 23, which included an extension of 2011 Medicare physician-payment rates through the end of February. President Obama quickly signed the bill into law.

Lawmakers also agreed to appoint a 20-member House-Senate committee to work on a longer-term plan to address the Medicare physician pay issue, along with a full-year extension of the Social Security payroll tax holiday and federally funded unemployment insurance benefits.

The agreement followed several days of brinksmanship by leaders in the House and Senate. It started on Dec. 13, when the House passed a bill that would have replaced the 27% Medicare fee cut with a 1% pay raise for physicians for 2 years. Despite bipartisan support for the so-called doc fix, other controversial provisions in the bill kept it from gaining traction in the Senate. A few days later, the Senate approved their own version of the bill, which extended the payroll tax holiday and unemployment benefits for 2 months and postponed any Medicare cuts until the end of February.

The House initially rejected a short-term fix, and even passed a resolution to formally disagree with the legislation passed by the Senate. But intense public criticism led House leaders to agree to the short-term plan and use the first 2 months of this year to negotiate a compromise.

Physicians remain furious with Congress for its inability to find a long-term solution in 2011. "There’s a tremendous degree of frustration out there," said Robert Doherty, senior vice president for government affairs and public policy at the American College of Physicians. "If Congress is expecting physicians to applaud them for agreeing to a 2-month extension, they’re going to find a lot of silence from the physician community."

Frustration is especially high because members of Congress had signaled early in 2011 that they were interested in crafting a long-term solution to replace the Sustainable Growth Rate formula, the statutory formula that ties spending on physicians’ services to the gross domestic product. In March 2011, leaders in the House Energy and Commerce Committee wrote to several physicians’ groups asking for proposals on how to reform the physician payment system and move to a new system that "reduces spending, pays providers fairly, and pays for services according to their value to the beneficiary."

The letter emphasized the need to act quickly in developing a long-term solution, or risk the "unwanted choice of extending a fundamentally broken payment system or jeopardizing access to care" for Medicare beneficiaries. "We cannot let either happen," the lawmakers wrote.

It’s too soon to tell what Congress will do next, but Mr. Doherty agreed that a long-term solution that would replace the SGR is unlikely right now.

In a worse-case scenario, physicians could be facing a situation similar to 2010, when Congress passed a series of temporary patches during the first half of the year, Mr. Doherty said. That situation could become a reality if lawmakers once again are deadlocked on the larger legislative package. "To a great extent, we’re once again going to be held hostage to negotiations over a broader package on issues that really have nothing to do with the SGR."☐

By PATRICE WENDLING

Elsevier Global Medical News

Would you allow patients to self-refer for a CT lung cancer screening? Would you screen a never-smoker? What size nodule would trigger a follow-up exam? What is your lower age limit and lower pack-year limit for screening? These are just a few of the questions that were tackled during an interactive lung cancer screening session at the recent Radiological Society of North America meeting, and that highlight the uncharted waters physicians face in the wake of the pivotal National Lung Screening Trial.

The NLST demonstrated a 20% reduction in lung cancer mortality when low-dose CT screening was used, compared with chest x-ray, among 53,000 asymptomatic current or former heavy smokers. However, CT produced more than three times the number of positive results and a higher false-positive rate than radiography.

Without a clear plan to manage abnormal findings or a firm handle on cost, policy makers and payers are hesitant to back reimbursement for widespread lung cancer screening. Results of the ongoing NLST cost-effectiveness analysis are expected early next year. Based on already published data, however, a crude back-of-the-envelope estimate puts the incremental cost-effectiveness ratio at $38,000 per life-year gained, NLST investigator Dr. William Black told attendees.

"That actually is a pretty good deal compared to a lot of things we do in medicine, and in fact most people would put the threshold for acceptability somewhere between $50,000 to $100,000 per life-year gained," he said. "So it certainly is feasible"

Dr. Black pointed out that low-dose CT saved 1 lung cancer death per 346 persons screened in NLST, which again is very favorable, compared with the rate of 1 per 2,000 patients for mammography.

Although the session provided just a small snapshot in time, audience responses suggested there is much work ahead. A full 77% of attendees were not using low-dose CT to screen for lung cancer, and 72% reported not being familiar with the recently published National Comprehensive Cancer Network guidelines for lung cancer screening. One-quarter of the audience had no lower age limit for screening, and 34% said they neither provide decision support nor obtained informed consent.

Radiologist and NLST collaborator Dr. Caroline Chiles said that informed consent in NLST helped prepare patients for the potential risks of a screen, for the likelihood of a positive result, and for the fact that a positive result didn’t mean they had lung cancer. "It made a huge difference once they got that letter saying they had a positive screen, because at that point you don’t want everyone rushing out to a surgeon to get that nodule resected," she added.

What attendees and panelists could agree on was the need for smoking cessation to be included in any future lung cancer CT screening program, with 60% of attendees saying they already do so.

Dr. Chiles pointed out that 16.6% of participants in the NELSON lung screening trial quit smoking, compared with 3%-7% in the general public, but that participants were less likely to stay nonsmokers. She also cited a recent MMWR article that said 70% of adult smokers want to quit smoking, but only about half had been advised by a health professional to quit.

"We really have to think of lung cancer screening as being a teachable moment," she said. She suggested that physicians visit www.smokefree.gov for help in guiding their patients. Dr. Black also noted the NLST team is working on a screening fact sheet for physicians and patients that will be made available on the Internet.☐

By PATRICE WENDLING

Elsevier Global Medical News

Would you allow patients to self-refer for a CT lung cancer screening? Would you screen a never-smoker? What size nodule would trigger a follow-up exam? What is your lower age limit and lower pack-year limit for screening? These are just a few of the questions that were tackled during an interactive lung cancer screening session at the recent Radiological Society of North America meeting, and that highlight the uncharted waters physicians face in the wake of the pivotal National Lung Screening Trial.

The NLST demonstrated a 20% reduction in lung cancer mortality when low-dose CT screening was used, compared with chest x-ray, among 53,000 asymptomatic current or former heavy smokers. However, CT produced more than three times the number of positive results and a higher false-positive rate than radiography.

Without a clear plan to manage abnormal findings or a firm handle on cost, policy makers and payers are hesitant to back reimbursement for widespread lung cancer screening. Results of the ongoing NLST cost-effectiveness analysis are expected early next year. Based on already published data, however, a crude back-of-the-envelope estimate puts the incremental cost-effectiveness ratio at $38,000 per life-year gained, NLST investigator Dr. William Black told attendees.

"That actually is a pretty good deal compared to a lot of things we do in medicine, and in fact most people would put the threshold for acceptability somewhere between $50,000 to $100,000 per life-year gained," he said. "So it certainly is feasible"

Dr. Black pointed out that low-dose CT saved 1 lung cancer death per 346 persons screened in NLST, which again is very favorable, compared with the rate of 1 per 2,000 patients for mammography.

Although the session provided just a small snapshot in time, audience responses suggested there is much work ahead. A full 77% of attendees were not using low-dose CT to screen for lung cancer, and 72% reported not being familiar with the recently published National Comprehensive Cancer Network guidelines for lung cancer screening. One-quarter of the audience had no lower age limit for screening, and 34% said they neither provide decision support nor obtained informed consent.

Radiologist and NLST collaborator Dr. Caroline Chiles said that informed consent in NLST helped prepare patients for the potential risks of a screen, for the likelihood of a positive result, and for the fact that a positive result didn’t mean they had lung cancer. "It made a huge difference once they got that letter saying they had a positive screen, because at that point you don’t want everyone rushing out to a surgeon to get that nodule resected," she added.

What attendees and panelists could agree on was the need for smoking cessation to be included in any future lung cancer CT screening program, with 60% of attendees saying they already do so.

Dr. Chiles pointed out that 16.6% of participants in the NELSON lung screening trial quit smoking, compared with 3%-7% in the general public, but that participants were less likely to stay nonsmokers. She also cited a recent MMWR article that said 70% of adult smokers want to quit smoking, but only about half had been advised by a health professional to quit.

"We really have to think of lung cancer screening as being a teachable moment," she said. She suggested that physicians visit www.smokefree.gov for help in guiding their patients. Dr. Black also noted the NLST team is working on a screening fact sheet for physicians and patients that will be made available on the Internet.☐

By PATRICE WENDLING

Elsevier Global Medical News

Would you allow patients to self-refer for a CT lung cancer screening? Would you screen a never-smoker? What size nodule would trigger a follow-up exam? What is your lower age limit and lower pack-year limit for screening? These are just a few of the questions that were tackled during an interactive lung cancer screening session at the recent Radiological Society of North America meeting, and that highlight the uncharted waters physicians face in the wake of the pivotal National Lung Screening Trial.

The NLST demonstrated a 20% reduction in lung cancer mortality when low-dose CT screening was used, compared with chest x-ray, among 53,000 asymptomatic current or former heavy smokers. However, CT produced more than three times the number of positive results and a higher false-positive rate than radiography.

Without a clear plan to manage abnormal findings or a firm handle on cost, policy makers and payers are hesitant to back reimbursement for widespread lung cancer screening. Results of the ongoing NLST cost-effectiveness analysis are expected early next year. Based on already published data, however, a crude back-of-the-envelope estimate puts the incremental cost-effectiveness ratio at $38,000 per life-year gained, NLST investigator Dr. William Black told attendees.

"That actually is a pretty good deal compared to a lot of things we do in medicine, and in fact most people would put the threshold for acceptability somewhere between $50,000 to $100,000 per life-year gained," he said. "So it certainly is feasible"

Dr. Black pointed out that low-dose CT saved 1 lung cancer death per 346 persons screened in NLST, which again is very favorable, compared with the rate of 1 per 2,000 patients for mammography.

Although the session provided just a small snapshot in time, audience responses suggested there is much work ahead. A full 77% of attendees were not using low-dose CT to screen for lung cancer, and 72% reported not being familiar with the recently published National Comprehensive Cancer Network guidelines for lung cancer screening. One-quarter of the audience had no lower age limit for screening, and 34% said they neither provide decision support nor obtained informed consent.

Radiologist and NLST collaborator Dr. Caroline Chiles said that informed consent in NLST helped prepare patients for the potential risks of a screen, for the likelihood of a positive result, and for the fact that a positive result didn’t mean they had lung cancer. "It made a huge difference once they got that letter saying they had a positive screen, because at that point you don’t want everyone rushing out to a surgeon to get that nodule resected," she added.

What attendees and panelists could agree on was the need for smoking cessation to be included in any future lung cancer CT screening program, with 60% of attendees saying they already do so.

Dr. Chiles pointed out that 16.6% of participants in the NELSON lung screening trial quit smoking, compared with 3%-7% in the general public, but that participants were less likely to stay nonsmokers. She also cited a recent MMWR article that said 70% of adult smokers want to quit smoking, but only about half had been advised by a health professional to quit.

"We really have to think of lung cancer screening as being a teachable moment," she said. She suggested that physicians visit www.smokefree.gov for help in guiding their patients. Dr. Black also noted the NLST team is working on a screening fact sheet for physicians and patients that will be made available on the Internet.☐

By PATRICE WENDLING

Elsevier Global Medical News

Would you allow patients to self-refer for a CT lung cancer screening? Would you screen a never-smoker? What size nodule would trigger a follow-up exam? What is your lower age limit and lower pack-year limit for screening? These are just a few of the questions that were tackled during an interactive lung cancer screening session at the recent Radiological Society of North America meeting, and that highlight the uncharted waters physicians face in the wake of the pivotal National Lung Screening Trial.

The NLST demonstrated a 20% reduction in lung cancer mortality when low-dose CT screening was used, compared with chest x-ray, among 53,000 asymptomatic current or former heavy smokers. However, CT produced more than three times the number of positive results and a higher false-positive rate than radiography.

Without a clear plan to manage abnormal findings or a firm handle on cost, policy makers and payers are hesitant to back reimbursement for widespread lung cancer screening. Results of the ongoing NLST cost-effectiveness analysis are expected early next year. Based on already published data, however, a crude back-of-the-envelope estimate puts the incremental cost-effectiveness ratio at $38,000 per life-year gained, NLST investigator Dr. William Black told attendees.

"That actually is a pretty good deal compared to a lot of things we do in medicine, and in fact most people would put the threshold for acceptability somewhere between $50,000 to $100,000 per life-year gained," he said. "So it certainly is feasible"

Dr. Black pointed out that low-dose CT saved 1 lung cancer death per 346 persons screened in NLST, which again is very favorable, compared with the rate of 1 per 2,000 patients for mammography.

Although the session provided just a small snapshot in time, audience responses suggested there is much work ahead. A full 77% of attendees were not using low-dose CT to screen for lung cancer, and 72% reported not being familiar with the recently published National Comprehensive Cancer Network guidelines for lung cancer screening. One-quarter of the audience had no lower age limit for screening, and 34% said they neither provide decision support nor obtained informed consent.

Radiologist and NLST collaborator Dr. Caroline Chiles said that informed consent in NLST helped prepare patients for the potential risks of a screen, for the likelihood of a positive result, and for the fact that a positive result didn’t mean they had lung cancer. "It made a huge difference once they got that letter saying they had a positive screen, because at that point you don’t want everyone rushing out to a surgeon to get that nodule resected," she added.

What attendees and panelists could agree on was the need for smoking cessation to be included in any future lung cancer CT screening program, with 60% of attendees saying they already do so.

Dr. Chiles pointed out that 16.6% of participants in the NELSON lung screening trial quit smoking, compared with 3%-7% in the general public, but that participants were less likely to stay nonsmokers. She also cited a recent MMWR article that said 70% of adult smokers want to quit smoking, but only about half had been advised by a health professional to quit.

"We really have to think of lung cancer screening as being a teachable moment," she said. She suggested that physicians visit www.smokefree.gov for help in guiding their patients. Dr. Black also noted the NLST team is working on a screening fact sheet for physicians and patients that will be made available on the Internet.☐

By PATRICE WENDLING

Elsevier Global Medical News

Would you allow patients to self-refer for a CT lung cancer screening? Would you screen a never-smoker? What size nodule would trigger a follow-up exam? What is your lower age limit and lower pack-year limit for screening? These are just a few of the questions that were tackled during an interactive lung cancer screening session at the recent Radiological Society of North America meeting, and that highlight the uncharted waters physicians face in the wake of the pivotal National Lung Screening Trial.

The NLST demonstrated a 20% reduction in lung cancer mortality when low-dose CT screening was used, compared with chest x-ray, among 53,000 asymptomatic current or former heavy smokers. However, CT produced more than three times the number of positive results and a higher false-positive rate than radiography.

Without a clear plan to manage abnormal findings or a firm handle on cost, policy makers and payers are hesitant to back reimbursement for widespread lung cancer screening. Results of the ongoing NLST cost-effectiveness analysis are expected early next year. Based on already published data, however, a crude back-of-the-envelope estimate puts the incremental cost-effectiveness ratio at $38,000 per life-year gained, NLST investigator Dr. William Black told attendees.

"That actually is a pretty good deal compared to a lot of things we do in medicine, and in fact most people would put the threshold for acceptability somewhere between $50,000 to $100,000 per life-year gained," he said. "So it certainly is feasible"

Dr. Black pointed out that low-dose CT saved 1 lung cancer death per 346 persons screened in NLST, which again is very favorable, compared with the rate of 1 per 2,000 patients for mammography.

Although the session provided just a small snapshot in time, audience responses suggested there is much work ahead. A full 77% of attendees were not using low-dose CT to screen for lung cancer, and 72% reported not being familiar with the recently published National Comprehensive Cancer Network guidelines for lung cancer screening. One-quarter of the audience had no lower age limit for screening, and 34% said they neither provide decision support nor obtained informed consent.

Radiologist and NLST collaborator Dr. Caroline Chiles said that informed consent in NLST helped prepare patients for the potential risks of a screen, for the likelihood of a positive result, and for the fact that a positive result didn’t mean they had lung cancer. "It made a huge difference once they got that letter saying they had a positive screen, because at that point you don’t want everyone rushing out to a surgeon to get that nodule resected," she added.

What attendees and panelists could agree on was the need for smoking cessation to be included in any future lung cancer CT screening program, with 60% of attendees saying they already do so.

Dr. Chiles pointed out that 16.6% of participants in the NELSON lung screening trial quit smoking, compared with 3%-7% in the general public, but that participants were less likely to stay nonsmokers. She also cited a recent MMWR article that said 70% of adult smokers want to quit smoking, but only about half had been advised by a health professional to quit.

"We really have to think of lung cancer screening as being a teachable moment," she said. She suggested that physicians visit www.smokefree.gov for help in guiding their patients. Dr. Black also noted the NLST team is working on a screening fact sheet for physicians and patients that will be made available on the Internet.☐

By PATRICE WENDLING

Elsevier Global Medical News

Would you allow patients to self-refer for a CT lung cancer screening? Would you screen a never-smoker? What size nodule would trigger a follow-up exam? What is your lower age limit and lower pack-year limit for screening? These are just a few of the questions that were tackled during an interactive lung cancer screening session at the recent Radiological Society of North America meeting, and that highlight the uncharted waters physicians face in the wake of the pivotal National Lung Screening Trial.

The NLST demonstrated a 20% reduction in lung cancer mortality when low-dose CT screening was used, compared with chest x-ray, among 53,000 asymptomatic current or former heavy smokers. However, CT produced more than three times the number of positive results and a higher false-positive rate than radiography.

Without a clear plan to manage abnormal findings or a firm handle on cost, policy makers and payers are hesitant to back reimbursement for widespread lung cancer screening. Results of the ongoing NLST cost-effectiveness analysis are expected early next year. Based on already published data, however, a crude back-of-the-envelope estimate puts the incremental cost-effectiveness ratio at $38,000 per life-year gained, NLST investigator Dr. William Black told attendees.

"That actually is a pretty good deal compared to a lot of things we do in medicine, and in fact most people would put the threshold for acceptability somewhere between $50,000 to $100,000 per life-year gained," he said. "So it certainly is feasible"

Dr. Black pointed out that low-dose CT saved 1 lung cancer death per 346 persons screened in NLST, which again is very favorable, compared with the rate of 1 per 2,000 patients for mammography.

Although the session provided just a small snapshot in time, audience responses suggested there is much work ahead. A full 77% of attendees were not using low-dose CT to screen for lung cancer, and 72% reported not being familiar with the recently published National Comprehensive Cancer Network guidelines for lung cancer screening. One-quarter of the audience had no lower age limit for screening, and 34% said they neither provide decision support nor obtained informed consent.

Radiologist and NLST collaborator Dr. Caroline Chiles said that informed consent in NLST helped prepare patients for the potential risks of a screen, for the likelihood of a positive result, and for the fact that a positive result didn’t mean they had lung cancer. "It made a huge difference once they got that letter saying they had a positive screen, because at that point you don’t want everyone rushing out to a surgeon to get that nodule resected," she added.

What attendees and panelists could agree on was the need for smoking cessation to be included in any future lung cancer CT screening program, with 60% of attendees saying they already do so.

Dr. Chiles pointed out that 16.6% of participants in the NELSON lung screening trial quit smoking, compared with 3%-7% in the general public, but that participants were less likely to stay nonsmokers. She also cited a recent MMWR article that said 70% of adult smokers want to quit smoking, but only about half had been advised by a health professional to quit.

"We really have to think of lung cancer screening as being a teachable moment," she said. She suggested that physicians visit www.smokefree.gov for help in guiding their patients. Dr. Black also noted the NLST team is working on a screening fact sheet for physicians and patients that will be made available on the Internet.☐

HOT SPRINGS, VA. – Since tort reform in Texas, the number of lawsuits and associated costs have decreased, but patient complaints to the state medical board and board investigations of physicians have risen, according to an analysis presented at the annual meeting of the Southern Surgical Association.

Dr. Ronald M. Stewart and his colleagues from the University of Texas Health Science Center at San Antonio obtained publicly available data from the Texas Medical Board and compared the 7-year period before tort reform (1996-2002) and the 6 years after the law was enacted (2004-2010).

The data were adjusted for the increase in the physician population; before reform there were about 170 physicians per 100,000 residents. After the law went into effect, the number rose to 195 physicians per 100,000, said Dr. Stewart. Before reform, about 125 complaints per 1,000 physicians were made to the medical board. That number increased by 13% after reform, to around 140 complaints per 1,000 physicians, said Dr. Stewart.

The rate of investigations increased from 38 per 1,000 to 52 per 1,000, with 5% of physicians the subject of a medical board inquiry. Postreform, there were more disciplinary actions when compared with open investigations, at about 8 per 1,000 in the latter period. Before reform, 0.5 per 1,000 physicians were ordered to revoke or to voluntarily surrender their licenses; after reform, that value rose to 0.8 per 1,000, a significant increase, noted Dr. Stewart.

The most striking change before and after reform was the decline in financial penalties. The state collected a total of $4.7 million in the postreform period. To put that figure into context, the San Antonio department of surgery alone spent $4.8 million on liability settlements in the prereform period, said Dr. Stewart.

It’s not clear why complaints and disciplinary actions went up, Dr. Stewart said. Having access to electronic information and greater awareness of the ability to complain to the medical board probably spurred more patient reporting.

The increases in investigations and disciplinary actions were mainly driven by the legislature, according to Dr. Stewart. The lawmakers mandated greater oversight by the medical board, so that undoubtedly led an enforcement increase.

Dr. Stewart said that putting malpractice in the hands of the medical board had decreased costs and been generally positive. For instance, he said, the medical board process is transparent and allows more input from stakeholders like physicians.

"There’s no question that the benefits of tort reform in my opinion outweigh the potential negative consequences to physicians," he said.

Dr. Stewart and Dr. Postier reported no financial conflicts. ☐

HOT SPRINGS, VA. – Since tort reform in Texas, the number of lawsuits and associated costs have decreased, but patient complaints to the state medical board and board investigations of physicians have risen, according to an analysis presented at the annual meeting of the Southern Surgical Association.

Dr. Ronald M. Stewart and his colleagues from the University of Texas Health Science Center at San Antonio obtained publicly available data from the Texas Medical Board and compared the 7-year period before tort reform (1996-2002) and the 6 years after the law was enacted (2004-2010).

The data were adjusted for the increase in the physician population; before reform there were about 170 physicians per 100,000 residents. After the law went into effect, the number rose to 195 physicians per 100,000, said Dr. Stewart. Before reform, about 125 complaints per 1,000 physicians were made to the medical board. That number increased by 13% after reform, to around 140 complaints per 1,000 physicians, said Dr. Stewart.

The rate of investigations increased from 38 per 1,000 to 52 per 1,000, with 5% of physicians the subject of a medical board inquiry. Postreform, there were more disciplinary actions when compared with open investigations, at about 8 per 1,000 in the latter period. Before reform, 0.5 per 1,000 physicians were ordered to revoke or to voluntarily surrender their licenses; after reform, that value rose to 0.8 per 1,000, a significant increase, noted Dr. Stewart.

The most striking change before and after reform was the decline in financial penalties. The state collected a total of $4.7 million in the postreform period. To put that figure into context, the San Antonio department of surgery alone spent $4.8 million on liability settlements in the prereform period, said Dr. Stewart.

It’s not clear why complaints and disciplinary actions went up, Dr. Stewart said. Having access to electronic information and greater awareness of the ability to complain to the medical board probably spurred more patient reporting.

The increases in investigations and disciplinary actions were mainly driven by the legislature, according to Dr. Stewart. The lawmakers mandated greater oversight by the medical board, so that undoubtedly led an enforcement increase.

Dr. Stewart said that putting malpractice in the hands of the medical board had decreased costs and been generally positive. For instance, he said, the medical board process is transparent and allows more input from stakeholders like physicians.

"There’s no question that the benefits of tort reform in my opinion outweigh the potential negative consequences to physicians," he said.

Dr. Stewart and Dr. Postier reported no financial conflicts. ☐

HOT SPRINGS, VA. – Since tort reform in Texas, the number of lawsuits and associated costs have decreased, but patient complaints to the state medical board and board investigations of physicians have risen, according to an analysis presented at the annual meeting of the Southern Surgical Association.

Dr. Ronald M. Stewart and his colleagues from the University of Texas Health Science Center at San Antonio obtained publicly available data from the Texas Medical Board and compared the 7-year period before tort reform (1996-2002) and the 6 years after the law was enacted (2004-2010).

The data were adjusted for the increase in the physician population; before reform there were about 170 physicians per 100,000 residents. After the law went into effect, the number rose to 195 physicians per 100,000, said Dr. Stewart. Before reform, about 125 complaints per 1,000 physicians were made to the medical board. That number increased by 13% after reform, to around 140 complaints per 1,000 physicians, said Dr. Stewart.

The rate of investigations increased from 38 per 1,000 to 52 per 1,000, with 5% of physicians the subject of a medical board inquiry. Postreform, there were more disciplinary actions when compared with open investigations, at about 8 per 1,000 in the latter period. Before reform, 0.5 per 1,000 physicians were ordered to revoke or to voluntarily surrender their licenses; after reform, that value rose to 0.8 per 1,000, a significant increase, noted Dr. Stewart.

The most striking change before and after reform was the decline in financial penalties. The state collected a total of $4.7 million in the postreform period. To put that figure into context, the San Antonio department of surgery alone spent $4.8 million on liability settlements in the prereform period, said Dr. Stewart.

It’s not clear why complaints and disciplinary actions went up, Dr. Stewart said. Having access to electronic information and greater awareness of the ability to complain to the medical board probably spurred more patient reporting.

The increases in investigations and disciplinary actions were mainly driven by the legislature, according to Dr. Stewart. The lawmakers mandated greater oversight by the medical board, so that undoubtedly led an enforcement increase.

Dr. Stewart said that putting malpractice in the hands of the medical board had decreased costs and been generally positive. For instance, he said, the medical board process is transparent and allows more input from stakeholders like physicians.

"There’s no question that the benefits of tort reform in my opinion outweigh the potential negative consequences to physicians," he said.

Dr. Stewart and Dr. Postier reported no financial conflicts. ☐

ORLANDO -- Minimally invasive surgical ablation for atrial fibrillation that is refractory to antiarrhythmic agents was significantly more effective than catheter ablation in the first-ever randomized trial comparing the two therapies.

The higher rate of freedom from left atrial arrhythmia that was achieved surgically came at a cost of more procedural complications, most of which were managed conservatively and without prolongation of hospitalization.

The clinical trial was conducted at two European medical centers. It involved 124 patients with drug-refractory paroxysmal or persistent atrial fibrillation (AF) who were deemed to be at high risk of having an unsuccessful catheter ablation procedure.

Two-thirds of participants were judged high risk because they had experienced a return of their AF after a prior catheter ablation, whereas the remaining patients were considered at high risk for an unsuccessful catheter ablation because of left atrial enlargement and hypertension, Dr. Lucas V.A. Boersma explained when presenting the results of the FAST (Ablation or Surgery for Atrial Fibrillation Treatment) trial at the annual scientific sessions of the American Heart Association.

Patients were randomized to pulmonary vein isolation by catheter ablation or to a video-assisted thoracoscopic surgical ablation procedure pioneered at the University of Cincinnati (J. Thorac. Cardiovasc. Surg. 2005;130:797-802). Surgical ablation was performed under general anesthesia, but unlike catheter ablation it did not include fluoroscopy, noted Dr. Boersma, a cardiologist at St. Antonius Hospital, Nieuwegein, the Netherlands.

The primary efficacy end point was freedom from left atrial arrhythmia lasting longer than 30 seconds without antiarrhythmic drugs at 12 months post procedure; this was achieved in 66% of the surgical ablation group, compared with 37% of the catheter ablation group.

Adverse events occurred during the 12 months of follow-up in 34% of the surgical group, compared with 16% of the catheter ablation group. Most of the adverse events in the surgical group were procedural complications, mainly consisting of pneumothorax and bleeding.

Discussant Dr. A. Marc Gillinov, a cardiac surgeon at the Cleveland Clinic, praised FAST as a well-designed, clearly focused study with important clinical implications, given that roughly one-fourth of Americans will eventually develop AF.

"The clear inference from this trial is that if catheter ablation fails and a patient comes to me, I will say to that patient, ‘We have many options, but we now have data to suggest we should discuss surgical ablation as one of those options because if you’ve had a catheter ablation and it failed, surgical ablation has a good chance of restoring you to sinus rhythm," he said.

"Most of the excess morbidity was related to chest drainage: retained fluid or air. I think it’s reasonable to state that those complications are not major and are probably preventable," he added.

The FAST trial was funded by St. Antonius Hospital and the University of Barcelona. Dr. Boersma disclosed that he has served as a consultant to Medtronic, and Dr. Gillinov serves as a consultant for Edwards Lifesciences and AtriCure. ☐

ORLANDO -- Minimally invasive surgical ablation for atrial fibrillation that is refractory to antiarrhythmic agents was significantly more effective than catheter ablation in the first-ever randomized trial comparing the two therapies.

The higher rate of freedom from left atrial arrhythmia that was achieved surgically came at a cost of more procedural complications, most of which were managed conservatively and without prolongation of hospitalization.

The clinical trial was conducted at two European medical centers. It involved 124 patients with drug-refractory paroxysmal or persistent atrial fibrillation (AF) who were deemed to be at high risk of having an unsuccessful catheter ablation procedure.

Two-thirds of participants were judged high risk because they had experienced a return of their AF after a prior catheter ablation, whereas the remaining patients were considered at high risk for an unsuccessful catheter ablation because of left atrial enlargement and hypertension, Dr. Lucas V.A. Boersma explained when presenting the results of the FAST (Ablation or Surgery for Atrial Fibrillation Treatment) trial at the annual scientific sessions of the American Heart Association.

Patients were randomized to pulmonary vein isolation by catheter ablation or to a video-assisted thoracoscopic surgical ablation procedure pioneered at the University of Cincinnati (J. Thorac. Cardiovasc. Surg. 2005;130:797-802). Surgical ablation was performed under general anesthesia, but unlike catheter ablation it did not include fluoroscopy, noted Dr. Boersma, a cardiologist at St. Antonius Hospital, Nieuwegein, the Netherlands.

The primary efficacy end point was freedom from left atrial arrhythmia lasting longer than 30 seconds without antiarrhythmic drugs at 12 months post procedure; this was achieved in 66% of the surgical ablation group, compared with 37% of the catheter ablation group.

Adverse events occurred during the 12 months of follow-up in 34% of the surgical group, compared with 16% of the catheter ablation group. Most of the adverse events in the surgical group were procedural complications, mainly consisting of pneumothorax and bleeding.

Discussant Dr. A. Marc Gillinov, a cardiac surgeon at the Cleveland Clinic, praised FAST as a well-designed, clearly focused study with important clinical implications, given that roughly one-fourth of Americans will eventually develop AF.

"The clear inference from this trial is that if catheter ablation fails and a patient comes to me, I will say to that patient, ‘We have many options, but we now have data to suggest we should discuss surgical ablation as one of those options because if you’ve had a catheter ablation and it failed, surgical ablation has a good chance of restoring you to sinus rhythm," he said.

"Most of the excess morbidity was related to chest drainage: retained fluid or air. I think it’s reasonable to state that those complications are not major and are probably preventable," he added.

The FAST trial was funded by St. Antonius Hospital and the University of Barcelona. Dr. Boersma disclosed that he has served as a consultant to Medtronic, and Dr. Gillinov serves as a consultant for Edwards Lifesciences and AtriCure. ☐

ORLANDO -- Minimally invasive surgical ablation for atrial fibrillation that is refractory to antiarrhythmic agents was significantly more effective than catheter ablation in the first-ever randomized trial comparing the two therapies.

The higher rate of freedom from left atrial arrhythmia that was achieved surgically came at a cost of more procedural complications, most of which were managed conservatively and without prolongation of hospitalization.

The clinical trial was conducted at two European medical centers. It involved 124 patients with drug-refractory paroxysmal or persistent atrial fibrillation (AF) who were deemed to be at high risk of having an unsuccessful catheter ablation procedure.

Two-thirds of participants were judged high risk because they had experienced a return of their AF after a prior catheter ablation, whereas the remaining patients were considered at high risk for an unsuccessful catheter ablation because of left atrial enlargement and hypertension, Dr. Lucas V.A. Boersma explained when presenting the results of the FAST (Ablation or Surgery for Atrial Fibrillation Treatment) trial at the annual scientific sessions of the American Heart Association.

Patients were randomized to pulmonary vein isolation by catheter ablation or to a video-assisted thoracoscopic surgical ablation procedure pioneered at the University of Cincinnati (J. Thorac. Cardiovasc. Surg. 2005;130:797-802). Surgical ablation was performed under general anesthesia, but unlike catheter ablation it did not include fluoroscopy, noted Dr. Boersma, a cardiologist at St. Antonius Hospital, Nieuwegein, the Netherlands.

The primary efficacy end point was freedom from left atrial arrhythmia lasting longer than 30 seconds without antiarrhythmic drugs at 12 months post procedure; this was achieved in 66% of the surgical ablation group, compared with 37% of the catheter ablation group.

Adverse events occurred during the 12 months of follow-up in 34% of the surgical group, compared with 16% of the catheter ablation group. Most of the adverse events in the surgical group were procedural complications, mainly consisting of pneumothorax and bleeding.

Discussant Dr. A. Marc Gillinov, a cardiac surgeon at the Cleveland Clinic, praised FAST as a well-designed, clearly focused study with important clinical implications, given that roughly one-fourth of Americans will eventually develop AF.

"The clear inference from this trial is that if catheter ablation fails and a patient comes to me, I will say to that patient, ‘We have many options, but we now have data to suggest we should discuss surgical ablation as one of those options because if you’ve had a catheter ablation and it failed, surgical ablation has a good chance of restoring you to sinus rhythm," he said.

"Most of the excess morbidity was related to chest drainage: retained fluid or air. I think it’s reasonable to state that those complications are not major and are probably preventable," he added.

The FAST trial was funded by St. Antonius Hospital and the University of Barcelona. Dr. Boersma disclosed that he has served as a consultant to Medtronic, and Dr. Gillinov serves as a consultant for Edwards Lifesciences and AtriCure. ☐

ORLANDO -- Minimally invasive surgical ablation for atrial fibrillation that is refractory to antiarrhythmic agents was significantly more effective than catheter ablation in the first-ever randomized trial comparing the two therapies.

The higher rate of freedom from left atrial arrhythmia that was achieved surgically came at a cost of more procedural complications, most of which were managed conservatively and without prolongation of hospitalization.

The clinical trial was conducted at two European medical centers. It involved 124 patients with drug-refractory paroxysmal or persistent atrial fibrillation (AF) who were deemed to be at high risk of having an unsuccessful catheter ablation procedure.

Two-thirds of participants were judged high risk because they had experienced a return of their AF after a prior catheter ablation, whereas the remaining patients were considered at high risk for an unsuccessful catheter ablation because of left atrial enlargement and hypertension, Dr. Lucas V.A. Boersma explained when presenting the results of the FAST (Ablation or Surgery for Atrial Fibrillation Treatment) trial at the annual scientific sessions of the American Heart Association.

Patients were randomized to pulmonary vein isolation by catheter ablation or to a video-assisted thoracoscopic surgical ablation procedure pioneered at the University of Cincinnati (J. Thorac. Cardiovasc. Surg. 2005;130:797-802). Surgical ablation was performed under general anesthesia, but unlike catheter ablation it did not include fluoroscopy, noted Dr. Boersma, a cardiologist at St. Antonius Hospital, Nieuwegein, the Netherlands.

The primary efficacy end point was freedom from left atrial arrhythmia lasting longer than 30 seconds without antiarrhythmic drugs at 12 months post procedure; this was achieved in 66% of the surgical ablation group, compared with 37% of the catheter ablation group.

Adverse events occurred during the 12 months of follow-up in 34% of the surgical group, compared with 16% of the catheter ablation group. Most of the adverse events in the surgical group were procedural complications, mainly consisting of pneumothorax and bleeding.

Discussant Dr. A. Marc Gillinov, a cardiac surgeon at the Cleveland Clinic, praised FAST as a well-designed, clearly focused study with important clinical implications, given that roughly one-fourth of Americans will eventually develop AF.

"The clear inference from this trial is that if catheter ablation fails and a patient comes to me, I will say to that patient, ‘We have many options, but we now have data to suggest we should discuss surgical ablation as one of those options because if you’ve had a catheter ablation and it failed, surgical ablation has a good chance of restoring you to sinus rhythm," he said.

"Most of the excess morbidity was related to chest drainage: retained fluid or air. I think it’s reasonable to state that those complications are not major and are probably preventable," he added.

The FAST trial was funded by St. Antonius Hospital and the University of Barcelona. Dr. Boersma disclosed that he has served as a consultant to Medtronic, and Dr. Gillinov serves as a consultant for Edwards Lifesciences and AtriCure. ☐

ORLANDO -- Minimally invasive surgical ablation for atrial fibrillation that is refractory to antiarrhythmic agents was significantly more effective than catheter ablation in the first-ever randomized trial comparing the two therapies.

The higher rate of freedom from left atrial arrhythmia that was achieved surgically came at a cost of more procedural complications, most of which were managed conservatively and without prolongation of hospitalization.

The clinical trial was conducted at two European medical centers. It involved 124 patients with drug-refractory paroxysmal or persistent atrial fibrillation (AF) who were deemed to be at high risk of having an unsuccessful catheter ablation procedure.

Two-thirds of participants were judged high risk because they had experienced a return of their AF after a prior catheter ablation, whereas the remaining patients were considered at high risk for an unsuccessful catheter ablation because of left atrial enlargement and hypertension, Dr. Lucas V.A. Boersma explained when presenting the results of the FAST (Ablation or Surgery for Atrial Fibrillation Treatment) trial at the annual scientific sessions of the American Heart Association.

Patients were randomized to pulmonary vein isolation by catheter ablation or to a video-assisted thoracoscopic surgical ablation procedure pioneered at the University of Cincinnati (J. Thorac. Cardiovasc. Surg. 2005;130:797-802). Surgical ablation was performed under general anesthesia, but unlike catheter ablation it did not include fluoroscopy, noted Dr. Boersma, a cardiologist at St. Antonius Hospital, Nieuwegein, the Netherlands.

The primary efficacy end point was freedom from left atrial arrhythmia lasting longer than 30 seconds without antiarrhythmic drugs at 12 months post procedure; this was achieved in 66% of the surgical ablation group, compared with 37% of the catheter ablation group.

Adverse events occurred during the 12 months of follow-up in 34% of the surgical group, compared with 16% of the catheter ablation group. Most of the adverse events in the surgical group were procedural complications, mainly consisting of pneumothorax and bleeding.

Discussant Dr. A. Marc Gillinov, a cardiac surgeon at the Cleveland Clinic, praised FAST as a well-designed, clearly focused study with important clinical implications, given that roughly one-fourth of Americans will eventually develop AF.

"The clear inference from this trial is that if catheter ablation fails and a patient comes to me, I will say to that patient, ‘We have many options, but we now have data to suggest we should discuss surgical ablation as one of those options because if you’ve had a catheter ablation and it failed, surgical ablation has a good chance of restoring you to sinus rhythm," he said.

"Most of the excess morbidity was related to chest drainage: retained fluid or air. I think it’s reasonable to state that those complications are not major and are probably preventable," he added.

The FAST trial was funded by St. Antonius Hospital and the University of Barcelona. Dr. Boersma disclosed that he has served as a consultant to Medtronic, and Dr. Gillinov serves as a consultant for Edwards Lifesciences and AtriCure. ☐

ORLANDO -- Minimally invasive surgical ablation for atrial fibrillation that is refractory to antiarrhythmic agents was significantly more effective than catheter ablation in the first-ever randomized trial comparing the two therapies.

The higher rate of freedom from left atrial arrhythmia that was achieved surgically came at a cost of more procedural complications, most of which were managed conservatively and without prolongation of hospitalization.

The clinical trial was conducted at two European medical centers. It involved 124 patients with drug-refractory paroxysmal or persistent atrial fibrillation (AF) who were deemed to be at high risk of having an unsuccessful catheter ablation procedure.

Two-thirds of participants were judged high risk because they had experienced a return of their AF after a prior catheter ablation, whereas the remaining patients were considered at high risk for an unsuccessful catheter ablation because of left atrial enlargement and hypertension, Dr. Lucas V.A. Boersma explained when presenting the results of the FAST (Ablation or Surgery for Atrial Fibrillation Treatment) trial at the annual scientific sessions of the American Heart Association.

Patients were randomized to pulmonary vein isolation by catheter ablation or to a video-assisted thoracoscopic surgical ablation procedure pioneered at the University of Cincinnati (J. Thorac. Cardiovasc. Surg. 2005;130:797-802). Surgical ablation was performed under general anesthesia, but unlike catheter ablation it did not include fluoroscopy, noted Dr. Boersma, a cardiologist at St. Antonius Hospital, Nieuwegein, the Netherlands.

The primary efficacy end point was freedom from left atrial arrhythmia lasting longer than 30 seconds without antiarrhythmic drugs at 12 months post procedure; this was achieved in 66% of the surgical ablation group, compared with 37% of the catheter ablation group.

Adverse events occurred during the 12 months of follow-up in 34% of the surgical group, compared with 16% of the catheter ablation group. Most of the adverse events in the surgical group were procedural complications, mainly consisting of pneumothorax and bleeding.

Discussant Dr. A. Marc Gillinov, a cardiac surgeon at the Cleveland Clinic, praised FAST as a well-designed, clearly focused study with important clinical implications, given that roughly one-fourth of Americans will eventually develop AF.

"The clear inference from this trial is that if catheter ablation fails and a patient comes to me, I will say to that patient, ‘We have many options, but we now have data to suggest we should discuss surgical ablation as one of those options because if you’ve had a catheter ablation and it failed, surgical ablation has a good chance of restoring you to sinus rhythm," he said.

"Most of the excess morbidity was related to chest drainage: retained fluid or air. I think it’s reasonable to state that those complications are not major and are probably preventable," he added.

The FAST trial was funded by St. Antonius Hospital and the University of Barcelona. Dr. Boersma disclosed that he has served as a consultant to Medtronic, and Dr. Gillinov serves as a consultant for Edwards Lifesciences and AtriCure. ☐

NATIONAL HARBOR, MD. – Patients with short-segment Barrett’s esophagus who had additional ablative therapies after endoscopic mucosal resection had no significant improvement in recurrence or mortality rates, compared with patients who did not have additional therapies.

The study of 213 patients was presented at the annual meeting of the American College of Gastroenterology. "Endoscopic mucosal resection and ablative therapies are now widely used to remove and ablate the Barrett’s mucosa," said Dr. Jianmin Tian of the Mayo Clinic in Rochester, Minn.

However, it is unclear whether additional ablative therapies after endoscopic mucosal resection (EMR) can improve outcomes for patients with short-segment Barrett’s esophagus (SSBE), defined as less than 3 cm.

To assess the value of additional ablation, Dr. Tian and colleagues conducted a retrospective cohort study of 213 adults with SSBE who were treated in a tertiary referral center. The study population included 93 patients who underwent EMR and 120 patients who underwent EMR plus additional ablative therapies.

The additional ablative therapies included radiofrequency ablation, photodynamic therapy, multipolar/bipolar electrocautery, cryotherapy, and argon plasma coagulation.

The recurrence rate was not significantly different in the EMR-only group, compared with the EMR-plus-ablation group (10% vs. 12%), after control for age, sex, Charlson comorbidity index, and specific condition (either intestinal metaplasia or dysplasia), Dr. Tian said. Similarly, the mortality rate was not significantly different between the two groups (15% vs. 18%, respectively).

The study included patients with SSBE and high-grade dysplasia or early esophageal cancer who had achieved complete remission of their dysplasia or intestinal metaplasia. Patients with a history of esophagectomy were excluded. Recurrence was defined as finding dysplasia or early esophageal cancer after two consecutive negative esophagogastroduodenoscopy exams with complete response.

The findings suggest that ablation of the gastroesophageal junction may not reduce recurrence, said Dr. Tian. The study was limited by its retrospective design and small size. But the study’s strengths include a relatively long follow-up period, the inclusion of two consecutive negative esophagogastroduodenoscopy exams, and systematic surveillance biopsies from the esophagus and the gastroesophageal junction, he noted.

Areas for further research include validating the findings in a randomized, controlled trial; data collection from patients with long-segment Barrett’s esophagus; and investigating the clinical significance of recurrence at the gastroesophageal junction, he said.

Dr. Tian reported no conflicts. ☐

NATIONAL HARBOR, MD. – Patients with short-segment Barrett’s esophagus who had additional ablative therapies after endoscopic mucosal resection had no significant improvement in recurrence or mortality rates, compared with patients who did not have additional therapies.

The study of 213 patients was presented at the annual meeting of the American College of Gastroenterology. "Endoscopic mucosal resection and ablative therapies are now widely used to remove and ablate the Barrett’s mucosa," said Dr. Jianmin Tian of the Mayo Clinic in Rochester, Minn.

However, it is unclear whether additional ablative therapies after endoscopic mucosal resection (EMR) can improve outcomes for patients with short-segment Barrett’s esophagus (SSBE), defined as less than 3 cm.

To assess the value of additional ablation, Dr. Tian and colleagues conducted a retrospective cohort study of 213 adults with SSBE who were treated in a tertiary referral center. The study population included 93 patients who underwent EMR and 120 patients who underwent EMR plus additional ablative therapies.

The additional ablative therapies included radiofrequency ablation, photodynamic therapy, multipolar/bipolar electrocautery, cryotherapy, and argon plasma coagulation.

The recurrence rate was not significantly different in the EMR-only group, compared with the EMR-plus-ablation group (10% vs. 12%), after control for age, sex, Charlson comorbidity index, and specific condition (either intestinal metaplasia or dysplasia), Dr. Tian said. Similarly, the mortality rate was not significantly different between the two groups (15% vs. 18%, respectively).

The study included patients with SSBE and high-grade dysplasia or early esophageal cancer who had achieved complete remission of their dysplasia or intestinal metaplasia. Patients with a history of esophagectomy were excluded. Recurrence was defined as finding dysplasia or early esophageal cancer after two consecutive negative esophagogastroduodenoscopy exams with complete response.

The findings suggest that ablation of the gastroesophageal junction may not reduce recurrence, said Dr. Tian. The study was limited by its retrospective design and small size. But the study’s strengths include a relatively long follow-up period, the inclusion of two consecutive negative esophagogastroduodenoscopy exams, and systematic surveillance biopsies from the esophagus and the gastroesophageal junction, he noted.

Areas for further research include validating the findings in a randomized, controlled trial; data collection from patients with long-segment Barrett’s esophagus; and investigating the clinical significance of recurrence at the gastroesophageal junction, he said.

Dr. Tian reported no conflicts. ☐

NATIONAL HARBOR, MD. – Patients with short-segment Barrett’s esophagus who had additional ablative therapies after endoscopic mucosal resection had no significant improvement in recurrence or mortality rates, compared with patients who did not have additional therapies.

The study of 213 patients was presented at the annual meeting of the American College of Gastroenterology. "Endoscopic mucosal resection and ablative therapies are now widely used to remove and ablate the Barrett’s mucosa," said Dr. Jianmin Tian of the Mayo Clinic in Rochester, Minn.

However, it is unclear whether additional ablative therapies after endoscopic mucosal resection (EMR) can improve outcomes for patients with short-segment Barrett’s esophagus (SSBE), defined as less than 3 cm.

To assess the value of additional ablation, Dr. Tian and colleagues conducted a retrospective cohort study of 213 adults with SSBE who were treated in a tertiary referral center. The study population included 93 patients who underwent EMR and 120 patients who underwent EMR plus additional ablative therapies.

The additional ablative therapies included radiofrequency ablation, photodynamic therapy, multipolar/bipolar electrocautery, cryotherapy, and argon plasma coagulation.

The recurrence rate was not significantly different in the EMR-only group, compared with the EMR-plus-ablation group (10% vs. 12%), after control for age, sex, Charlson comorbidity index, and specific condition (either intestinal metaplasia or dysplasia), Dr. Tian said. Similarly, the mortality rate was not significantly different between the two groups (15% vs. 18%, respectively).

The study included patients with SSBE and high-grade dysplasia or early esophageal cancer who had achieved complete remission of their dysplasia or intestinal metaplasia. Patients with a history of esophagectomy were excluded. Recurrence was defined as finding dysplasia or early esophageal cancer after two consecutive negative esophagogastroduodenoscopy exams with complete response.

The findings suggest that ablation of the gastroesophageal junction may not reduce recurrence, said Dr. Tian. The study was limited by its retrospective design and small size. But the study’s strengths include a relatively long follow-up period, the inclusion of two consecutive negative esophagogastroduodenoscopy exams, and systematic surveillance biopsies from the esophagus and the gastroesophageal junction, he noted.

Areas for further research include validating the findings in a randomized, controlled trial; data collection from patients with long-segment Barrett’s esophagus; and investigating the clinical significance of recurrence at the gastroesophageal junction, he said.

Dr. Tian reported no conflicts. ☐

NATIONAL HARBOR, MD. – Patients with short-segment Barrett’s esophagus who had additional ablative therapies after endoscopic mucosal resection had no significant improvement in recurrence or mortality rates, compared with patients who did not have additional therapies.

The study of 213 patients was presented at the annual meeting of the American College of Gastroenterology. "Endoscopic mucosal resection and ablative therapies are now widely used to remove and ablate the Barrett’s mucosa," said Dr. Jianmin Tian of the Mayo Clinic in Rochester, Minn.

However, it is unclear whether additional ablative therapies after endoscopic mucosal resection (EMR) can improve outcomes for patients with short-segment Barrett’s esophagus (SSBE), defined as less than 3 cm.

To assess the value of additional ablation, Dr. Tian and colleagues conducted a retrospective cohort study of 213 adults with SSBE who were treated in a tertiary referral center. The study population included 93 patients who underwent EMR and 120 patients who underwent EMR plus additional ablative therapies.

The additional ablative therapies included radiofrequency ablation, photodynamic therapy, multipolar/bipolar electrocautery, cryotherapy, and argon plasma coagulation.

The recurrence rate was not significantly different in the EMR-only group, compared with the EMR-plus-ablation group (10% vs. 12%), after control for age, sex, Charlson comorbidity index, and specific condition (either intestinal metaplasia or dysplasia), Dr. Tian said. Similarly, the mortality rate was not significantly different between the two groups (15% vs. 18%, respectively).

The study included patients with SSBE and high-grade dysplasia or early esophageal cancer who had achieved complete remission of their dysplasia or intestinal metaplasia. Patients with a history of esophagectomy were excluded. Recurrence was defined as finding dysplasia or early esophageal cancer after two consecutive negative esophagogastroduodenoscopy exams with complete response.

The findings suggest that ablation of the gastroesophageal junction may not reduce recurrence, said Dr. Tian. The study was limited by its retrospective design and small size. But the study’s strengths include a relatively long follow-up period, the inclusion of two consecutive negative esophagogastroduodenoscopy exams, and systematic surveillance biopsies from the esophagus and the gastroesophageal junction, he noted.

Areas for further research include validating the findings in a randomized, controlled trial; data collection from patients with long-segment Barrett’s esophagus; and investigating the clinical significance of recurrence at the gastroesophageal junction, he said.

Dr. Tian reported no conflicts. ☐

NATIONAL HARBOR, MD. – Patients with short-segment Barrett’s esophagus who had additional ablative therapies after endoscopic mucosal resection had no significant improvement in recurrence or mortality rates, compared with patients who did not have additional therapies.

The study of 213 patients was presented at the annual meeting of the American College of Gastroenterology. "Endoscopic mucosal resection and ablative therapies are now widely used to remove and ablate the Barrett’s mucosa," said Dr. Jianmin Tian of the Mayo Clinic in Rochester, Minn.

However, it is unclear whether additional ablative therapies after endoscopic mucosal resection (EMR) can improve outcomes for patients with short-segment Barrett’s esophagus (SSBE), defined as less than 3 cm.

To assess the value of additional ablation, Dr. Tian and colleagues conducted a retrospective cohort study of 213 adults with SSBE who were treated in a tertiary referral center. The study population included 93 patients who underwent EMR and 120 patients who underwent EMR plus additional ablative therapies.

The additional ablative therapies included radiofrequency ablation, photodynamic therapy, multipolar/bipolar electrocautery, cryotherapy, and argon plasma coagulation.

The recurrence rate was not significantly different in the EMR-only group, compared with the EMR-plus-ablation group (10% vs. 12%), after control for age, sex, Charlson comorbidity index, and specific condition (either intestinal metaplasia or dysplasia), Dr. Tian said. Similarly, the mortality rate was not significantly different between the two groups (15% vs. 18%, respectively).

The study included patients with SSBE and high-grade dysplasia or early esophageal cancer who had achieved complete remission of their dysplasia or intestinal metaplasia. Patients with a history of esophagectomy were excluded. Recurrence was defined as finding dysplasia or early esophageal cancer after two consecutive negative esophagogastroduodenoscopy exams with complete response.

The findings suggest that ablation of the gastroesophageal junction may not reduce recurrence, said Dr. Tian. The study was limited by its retrospective design and small size. But the study’s strengths include a relatively long follow-up period, the inclusion of two consecutive negative esophagogastroduodenoscopy exams, and systematic surveillance biopsies from the esophagus and the gastroesophageal junction, he noted.

Areas for further research include validating the findings in a randomized, controlled trial; data collection from patients with long-segment Barrett’s esophagus; and investigating the clinical significance of recurrence at the gastroesophageal junction, he said.

Dr. Tian reported no conflicts. ☐

NATIONAL HARBOR, MD. – Patients with short-segment Barrett’s esophagus who had additional ablative therapies after endoscopic mucosal resection had no significant improvement in recurrence or mortality rates, compared with patients who did not have additional therapies.

The study of 213 patients was presented at the annual meeting of the American College of Gastroenterology. "Endoscopic mucosal resection and ablative therapies are now widely used to remove and ablate the Barrett’s mucosa," said Dr. Jianmin Tian of the Mayo Clinic in Rochester, Minn.

However, it is unclear whether additional ablative therapies after endoscopic mucosal resection (EMR) can improve outcomes for patients with short-segment Barrett’s esophagus (SSBE), defined as less than 3 cm.

To assess the value of additional ablation, Dr. Tian and colleagues conducted a retrospective cohort study of 213 adults with SSBE who were treated in a tertiary referral center. The study population included 93 patients who underwent EMR and 120 patients who underwent EMR plus additional ablative therapies.

The additional ablative therapies included radiofrequency ablation, photodynamic therapy, multipolar/bipolar electrocautery, cryotherapy, and argon plasma coagulation.

The recurrence rate was not significantly different in the EMR-only group, compared with the EMR-plus-ablation group (10% vs. 12%), after control for age, sex, Charlson comorbidity index, and specific condition (either intestinal metaplasia or dysplasia), Dr. Tian said. Similarly, the mortality rate was not significantly different between the two groups (15% vs. 18%, respectively).

The study included patients with SSBE and high-grade dysplasia or early esophageal cancer who had achieved complete remission of their dysplasia or intestinal metaplasia. Patients with a history of esophagectomy were excluded. Recurrence was defined as finding dysplasia or early esophageal cancer after two consecutive negative esophagogastroduodenoscopy exams with complete response.

The findings suggest that ablation of the gastroesophageal junction may not reduce recurrence, said Dr. Tian. The study was limited by its retrospective design and small size. But the study’s strengths include a relatively long follow-up period, the inclusion of two consecutive negative esophagogastroduodenoscopy exams, and systematic surveillance biopsies from the esophagus and the gastroesophageal junction, he noted.

Areas for further research include validating the findings in a randomized, controlled trial; data collection from patients with long-segment Barrett’s esophagus; and investigating the clinical significance of recurrence at the gastroesophageal junction, he said.

Dr. Tian reported no conflicts. ☐

As physicians and hospitals gear up to implement electronic health records and other health information technology products, the federal government should increase its scrutiny of these products to ensure that they don’t actually contribute to medical errors.

That was the conclusion of an Institute of Medicine panel, which called on the Health and Human Services Department to assess potential safety risks associated with health IT and come up with a plan to minimize those risks. The plan should be published in 2012, with new reports each year, according to the panel’s recommendations.

But if the HHS secretary determines that the industry is falling short of the safety goals, the Food and Drug Administration should be tasked with regulating electronic health records, personal health records, and health information exchanges, the IOM committee recommended. The IOM study was sponsored by HHS.

The report http://www.iom.edu/Reports/2011/Health-IT-and-Patient-Safety-Building-Safer-Systems-for-Better-Care.aspx comes as physicians and hospitals strive to qualify for federal incentive payments for the use of health IT products to meet certain quality benchmarks. The program includes bonus payments in the early years, followed later by penalties if they fail to adopt health IT.

"Based on the literature, HIT certainly has clear and demonstrated potential to improve the safety and the quality of patient care, but it also can cause harm. We’ve heard about that," said Dr. Paul C. Tang, a member of the IOM committee and vice president and chief innovation and technology officer at Palo Alto (Calif.) Medical Foundation.

Although evidence demonstrates that health IT systems have helped to improve medication safety in some places, the literature is inconclusive about IT’s safety benefits in other areas, Dr. Tang said. And there are reports of harm associated with using these systems, from dosing errors to delays in treatment, according to the report.

But right now it’s difficult to quantify the safety issues because unlike drugs or devices, health IT software is installed and used differently from institution to institution, said Dr. Tang, who also serves as the vice chair on the HIT Policy Committee, which advises the federal government on the development of a nationwide health information infrastructure.

In addition, there is a wide array of different types of health IT products on the market. There are also contractual issues, such as confidentiality clauses, that may make it difficult for users to share safety concerns about the products, according to the IOM report. The IOM panel made a series of recommendations aimed at improving the information available on the safety risks and benefits associated with health IT use.

For instance, the panel called on HHS to develop a way for health IT users and vendors to report adverse events related to health IT. And the panel members urged Congress to establish an independent federal entity charged with investigating those adverse events. The body could be modeled on the National Transportation Safety Board, he said. ☐

As physicians and hospitals gear up to implement electronic health records and other health information technology products, the federal government should increase its scrutiny of these products to ensure that they don’t actually contribute to medical errors.

That was the conclusion of an Institute of Medicine panel, which called on the Health and Human Services Department to assess potential safety risks associated with health IT and come up with a plan to minimize those risks. The plan should be published in 2012, with new reports each year, according to the panel’s recommendations.

But if the HHS secretary determines that the industry is falling short of the safety goals, the Food and Drug Administration should be tasked with regulating electronic health records, personal health records, and health information exchanges, the IOM committee recommended. The IOM study was sponsored by HHS.

The report http://www.iom.edu/Reports/2011/Health-IT-and-Patient-Safety-Building-Safer-Systems-for-Better-Care.aspx comes as physicians and hospitals strive to qualify for federal incentive payments for the use of health IT products to meet certain quality benchmarks. The program includes bonus payments in the early years, followed later by penalties if they fail to adopt health IT.

"Based on the literature, HIT certainly has clear and demonstrated potential to improve the safety and the quality of patient care, but it also can cause harm. We’ve heard about that," said Dr. Paul C. Tang, a member of the IOM committee and vice president and chief innovation and technology officer at Palo Alto (Calif.) Medical Foundation.

Although evidence demonstrates that health IT systems have helped to improve medication safety in some places, the literature is inconclusive about IT’s safety benefits in other areas, Dr. Tang said. And there are reports of harm associated with using these systems, from dosing errors to delays in treatment, according to the report.

But right now it’s difficult to quantify the safety issues because unlike drugs or devices, health IT software is installed and used differently from institution to institution, said Dr. Tang, who also serves as the vice chair on the HIT Policy Committee, which advises the federal government on the development of a nationwide health information infrastructure.

In addition, there is a wide array of different types of health IT products on the market. There are also contractual issues, such as confidentiality clauses, that may make it difficult for users to share safety concerns about the products, according to the IOM report. The IOM panel made a series of recommendations aimed at improving the information available on the safety risks and benefits associated with health IT use.

For instance, the panel called on HHS to develop a way for health IT users and vendors to report adverse events related to health IT. And the panel members urged Congress to establish an independent federal entity charged with investigating those adverse events. The body could be modeled on the National Transportation Safety Board, he said. ☐

As physicians and hospitals gear up to implement electronic health records and other health information technology products, the federal government should increase its scrutiny of these products to ensure that they don’t actually contribute to medical errors.

That was the conclusion of an Institute of Medicine panel, which called on the Health and Human Services Department to assess potential safety risks associated with health IT and come up with a plan to minimize those risks. The plan should be published in 2012, with new reports each year, according to the panel’s recommendations.

But if the HHS secretary determines that the industry is falling short of the safety goals, the Food and Drug Administration should be tasked with regulating electronic health records, personal health records, and health information exchanges, the IOM committee recommended. The IOM study was sponsored by HHS.

The report http://www.iom.edu/Reports/2011/Health-IT-and-Patient-Safety-Building-Safer-Systems-for-Better-Care.aspx comes as physicians and hospitals strive to qualify for federal incentive payments for the use of health IT products to meet certain quality benchmarks. The program includes bonus payments in the early years, followed later by penalties if they fail to adopt health IT.

"Based on the literature, HIT certainly has clear and demonstrated potential to improve the safety and the quality of patient care, but it also can cause harm. We’ve heard about that," said Dr. Paul C. Tang, a member of the IOM committee and vice president and chief innovation and technology officer at Palo Alto (Calif.) Medical Foundation.

Although evidence demonstrates that health IT systems have helped to improve medication safety in some places, the literature is inconclusive about IT’s safety benefits in other areas, Dr. Tang said. And there are reports of harm associated with using these systems, from dosing errors to delays in treatment, according to the report.

But right now it’s difficult to quantify the safety issues because unlike drugs or devices, health IT software is installed and used differently from institution to institution, said Dr. Tang, who also serves as the vice chair on the HIT Policy Committee, which advises the federal government on the development of a nationwide health information infrastructure.

In addition, there is a wide array of different types of health IT products on the market. There are also contractual issues, such as confidentiality clauses, that may make it difficult for users to share safety concerns about the products, according to the IOM report. The IOM panel made a series of recommendations aimed at improving the information available on the safety risks and benefits associated with health IT use.

For instance, the panel called on HHS to develop a way for health IT users and vendors to report adverse events related to health IT. And the panel members urged Congress to establish an independent federal entity charged with investigating those adverse events. The body could be modeled on the National Transportation Safety Board, he said. ☐