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AMA’s Stack ‘cautiously optimistic’ about MACRA implementation
WASHINGTON – Coming regulations to implement the MACRA legislation also could include sweeping reforms to meaningful use and quality reporting programs, said Dr. Steven J. Stack, president of the American Medical Association.
Dr. Stack expressed “cautious optimism” that the regulations would help doctors to return to focusing on treating patients and away from meeting the myriad of regulatory requirements that have piled up in recent years.
The AMA has been working closely with the Centers for Medicare & Medicaid Services “very candidly and very constructively” and the agency has “demonstrated a willingness to reconsider things,” Dr. Stack said at the AMA National Advocacy Conference.
The regulations to implement MACRA (the Medicare Access and CHIP Reauthorization Act of 2015) “offers CMS an uncommonly robust opportunity to take things like [the Physician Quality Reporting System], meaningful use, value-based purchasing and reconceptualize, now that we have the opportunity under one rulemaking, to say how should all of these really work together,” Dr. Stack said.
Indeed, during a keynote address at the AMA conference, CMS Administrator Andy Slavitt said one of the goals for the agency this year was to simplify things for doctors.
“We must reduce burden and give physicians back more time to spend with patients,” Mr. Slavitt said. “Several years ago, we launched an initiative that is reducing regulatory burden and saving hospitals $3.2 billion over 5 years. But we are barely scratching the surface. We have a strategic effort this year designed to reduce burden and create efficiencies in the physician’s office.”
He hinted that the MACRA regulations would be used to redefine how health IT is utilized, noting the emphasis will be on rewarding outcomes that technology helps achieve, rather than simply incentivizing the use of it; providing more flexibility to meet physician needs; leveling the playing field to allow more competition from vendors; and to address ongoing interoperability issues.
The concern Dr. Stack addressed during the press meeting was the ongoing opioid epidemic, one of the few things he expects to see legislative action on during this presidential election year.
He called for thoughtful, comprehensive solutions to addressing the problem so that it allows patients with a true medical need for chronic pain management to be able to continue to have access to needed prescription pain medications. Arbitrary prescribing caps and other fixes that, on the surface, are simple and easy to implement, should be avoided, he said.
“Those kinds of approaches for this problem could have the really undesired consequences of rather than solving the problem,” Dr. Stack said, adding that they could drive even more people from prescription pills to heroin. That “causes deaths far more rapidly than the other stuff, which takes tens of millions of Americans with legitimate chronic pain who are legitimately suffering and throwing them into horrific life problems without access to care they need.”
As an adjunct to that, Dr. Stack also addressed drug pricing, using naloxone, which is used to help patients experiencing and opioid overdose, as something that has skyrocketed in price.
In looking at 5 years of drug prices in his state of Kentucky, naloxone has gone up from just over $4.50 a pill in 2010 to $38 a pill in 2015.
“If there is one thing that I will be absolutely clear on as a physician in the United States, this is not the time for the pharmaceutical industry to play games in the midst of an epidemic that taking over a quarter-million people’s lives over the documented course of this problem,” Dr. Stack said. “This is the time for the pharmaceutical industry to do its part and make sure that naloxone is as cheap as water from a tap so that patients in need can get the care they need and have this life-saving drug. This is not a profiteering opportunity for anyone.”
WASHINGTON – Coming regulations to implement the MACRA legislation also could include sweeping reforms to meaningful use and quality reporting programs, said Dr. Steven J. Stack, president of the American Medical Association.
Dr. Stack expressed “cautious optimism” that the regulations would help doctors to return to focusing on treating patients and away from meeting the myriad of regulatory requirements that have piled up in recent years.
The AMA has been working closely with the Centers for Medicare & Medicaid Services “very candidly and very constructively” and the agency has “demonstrated a willingness to reconsider things,” Dr. Stack said at the AMA National Advocacy Conference.
The regulations to implement MACRA (the Medicare Access and CHIP Reauthorization Act of 2015) “offers CMS an uncommonly robust opportunity to take things like [the Physician Quality Reporting System], meaningful use, value-based purchasing and reconceptualize, now that we have the opportunity under one rulemaking, to say how should all of these really work together,” Dr. Stack said.
Indeed, during a keynote address at the AMA conference, CMS Administrator Andy Slavitt said one of the goals for the agency this year was to simplify things for doctors.
“We must reduce burden and give physicians back more time to spend with patients,” Mr. Slavitt said. “Several years ago, we launched an initiative that is reducing regulatory burden and saving hospitals $3.2 billion over 5 years. But we are barely scratching the surface. We have a strategic effort this year designed to reduce burden and create efficiencies in the physician’s office.”
He hinted that the MACRA regulations would be used to redefine how health IT is utilized, noting the emphasis will be on rewarding outcomes that technology helps achieve, rather than simply incentivizing the use of it; providing more flexibility to meet physician needs; leveling the playing field to allow more competition from vendors; and to address ongoing interoperability issues.
The concern Dr. Stack addressed during the press meeting was the ongoing opioid epidemic, one of the few things he expects to see legislative action on during this presidential election year.
He called for thoughtful, comprehensive solutions to addressing the problem so that it allows patients with a true medical need for chronic pain management to be able to continue to have access to needed prescription pain medications. Arbitrary prescribing caps and other fixes that, on the surface, are simple and easy to implement, should be avoided, he said.
“Those kinds of approaches for this problem could have the really undesired consequences of rather than solving the problem,” Dr. Stack said, adding that they could drive even more people from prescription pills to heroin. That “causes deaths far more rapidly than the other stuff, which takes tens of millions of Americans with legitimate chronic pain who are legitimately suffering and throwing them into horrific life problems without access to care they need.”
As an adjunct to that, Dr. Stack also addressed drug pricing, using naloxone, which is used to help patients experiencing and opioid overdose, as something that has skyrocketed in price.
In looking at 5 years of drug prices in his state of Kentucky, naloxone has gone up from just over $4.50 a pill in 2010 to $38 a pill in 2015.
“If there is one thing that I will be absolutely clear on as a physician in the United States, this is not the time for the pharmaceutical industry to play games in the midst of an epidemic that taking over a quarter-million people’s lives over the documented course of this problem,” Dr. Stack said. “This is the time for the pharmaceutical industry to do its part and make sure that naloxone is as cheap as water from a tap so that patients in need can get the care they need and have this life-saving drug. This is not a profiteering opportunity for anyone.”
WASHINGTON – Coming regulations to implement the MACRA legislation also could include sweeping reforms to meaningful use and quality reporting programs, said Dr. Steven J. Stack, president of the American Medical Association.
Dr. Stack expressed “cautious optimism” that the regulations would help doctors to return to focusing on treating patients and away from meeting the myriad of regulatory requirements that have piled up in recent years.
The AMA has been working closely with the Centers for Medicare & Medicaid Services “very candidly and very constructively” and the agency has “demonstrated a willingness to reconsider things,” Dr. Stack said at the AMA National Advocacy Conference.
The regulations to implement MACRA (the Medicare Access and CHIP Reauthorization Act of 2015) “offers CMS an uncommonly robust opportunity to take things like [the Physician Quality Reporting System], meaningful use, value-based purchasing and reconceptualize, now that we have the opportunity under one rulemaking, to say how should all of these really work together,” Dr. Stack said.
Indeed, during a keynote address at the AMA conference, CMS Administrator Andy Slavitt said one of the goals for the agency this year was to simplify things for doctors.
“We must reduce burden and give physicians back more time to spend with patients,” Mr. Slavitt said. “Several years ago, we launched an initiative that is reducing regulatory burden and saving hospitals $3.2 billion over 5 years. But we are barely scratching the surface. We have a strategic effort this year designed to reduce burden and create efficiencies in the physician’s office.”
He hinted that the MACRA regulations would be used to redefine how health IT is utilized, noting the emphasis will be on rewarding outcomes that technology helps achieve, rather than simply incentivizing the use of it; providing more flexibility to meet physician needs; leveling the playing field to allow more competition from vendors; and to address ongoing interoperability issues.
The concern Dr. Stack addressed during the press meeting was the ongoing opioid epidemic, one of the few things he expects to see legislative action on during this presidential election year.
He called for thoughtful, comprehensive solutions to addressing the problem so that it allows patients with a true medical need for chronic pain management to be able to continue to have access to needed prescription pain medications. Arbitrary prescribing caps and other fixes that, on the surface, are simple and easy to implement, should be avoided, he said.
“Those kinds of approaches for this problem could have the really undesired consequences of rather than solving the problem,” Dr. Stack said, adding that they could drive even more people from prescription pills to heroin. That “causes deaths far more rapidly than the other stuff, which takes tens of millions of Americans with legitimate chronic pain who are legitimately suffering and throwing them into horrific life problems without access to care they need.”
As an adjunct to that, Dr. Stack also addressed drug pricing, using naloxone, which is used to help patients experiencing and opioid overdose, as something that has skyrocketed in price.
In looking at 5 years of drug prices in his state of Kentucky, naloxone has gone up from just over $4.50 a pill in 2010 to $38 a pill in 2015.
“If there is one thing that I will be absolutely clear on as a physician in the United States, this is not the time for the pharmaceutical industry to play games in the midst of an epidemic that taking over a quarter-million people’s lives over the documented course of this problem,” Dr. Stack said. “This is the time for the pharmaceutical industry to do its part and make sure that naloxone is as cheap as water from a tap so that patients in need can get the care they need and have this life-saving drug. This is not a profiteering opportunity for anyone.”
AT THE AMA NATIONAL ADVOCACY CONFERENCE
Robotic PCI succeeds in patients with acute MI
WASHINGTON – Robotic angioplasty may deliver the same advantages when percutaneous coronary intervention is indicated for acute myocardial infarction as currently claimed for an elective PCI, according to results from a proof-of-principle study.
The first robotic PCI system, CorPath 200, was approved by the U.S. Food and Drug Administration in 2012, but the registration trial, called PRECISE (Percutaneous Robotically Enhanced Coronary Intervention), excluded patients with coronary thrombosis, according to a team of investigators at the Frederik Meijer Cardiovascular Institute, Grand Rapids, Mich. The current study focused exclusively on this population.
In “an initial experience” with robotic PCI in 17 acute MI patients led by Dr. Ryan D. Madder, an interventional cardiologist, “technical success” was achieved in 100% of patients with no repeat revascularizations in follow-up so far.
“These preliminary observations support the performance of larger studies to determine the role of robotic PCI in the treatment of acute MI,” said Andrew O’Brien, a medical student at Michigan State University, Ann Arbor, who presented the data at the meeting, sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
The major proven advantage of robotic PCI is that it reduces radiation exposure to the operator, Mr. O’Brien said. While the procedure was performed in this study behind a lead-lined cockpit, it was noted that the operator works solely on the basis of imaging and could be anywhere, including at another facility. In addition, robotic PCI has at least a theoretical advantage of greater precision relative to conventional PCI.
In this study, technical success was defined as less than 30% residual stenosis after PCI in the absence of a PCI-associated death or the need for a repeat revascularization prior to hospital discharge. The median age of the 17 acute MI patients was 59 years with a range of about 10 years younger or older. Most (71%) were male. Radial arterial access was used in all cases.
Only 23% of the patients met criteria for relatively simple lesions (class A or B1). Just over half (53%) had class B2 lesions, which require at least two complicating characteristics, such as moderate tortuosity, irregular contour, or moderate to heavy calcification, and the remainder had class C lesions. In 10 cases (59%), an angiographic filling defect consistent with thrombus was present at the culprit lesion site.
In addition to achieving the goal reduction in residual stenosis without major adverse cardiovascular events in all patients, the investigators reported that procedural time, which averaged 69 minutes from the time of sheath insertion to removal of the guide catheter, was “acceptable.” The longest procedural time was under 100 minutes.
“We used the same criteria for evaluating outcomes as employed in the original PRECISE study,” Mr. O’Brien said. He explained that acute MI patients were excluded in the published PRECISE trial data because there was no protocol at that time for converting to a conventional procedure on an urgent basis in the case of unexpected problems. With more experience, there was greater confidence that urgent complications could be addressed.
In the multicenter PRECISE trial, which led to approval of the robotic system, 164 candidates for elective PCI were enrolled (J Am Coll Cardiol. 2013;61[15]:1596-1600). Technical success was 98.8%. Although there was no control arm, radiation exposure was reported to be 95% lower for operators participating in that study than levels found at the traditional table position.
Data from the current study provide preliminary evidence that robotic PCI is feasible for management of acute MI. While confirmatory studies are needed for this indication, the Michigan investigators also advocated more studies to evaluate whether robotic PCI improves outcome. They cited the potential for more precise placement of stents to reduce the risk of complications.
“Robotic PCI is still not very widely performed,” said coinvestigator Andrew LaCombe, who suggested that its potential advantages deserve broader evaluation.
Dr. Madder disclosed a financial relationship with InfraRedx.
WASHINGTON – Robotic angioplasty may deliver the same advantages when percutaneous coronary intervention is indicated for acute myocardial infarction as currently claimed for an elective PCI, according to results from a proof-of-principle study.
The first robotic PCI system, CorPath 200, was approved by the U.S. Food and Drug Administration in 2012, but the registration trial, called PRECISE (Percutaneous Robotically Enhanced Coronary Intervention), excluded patients with coronary thrombosis, according to a team of investigators at the Frederik Meijer Cardiovascular Institute, Grand Rapids, Mich. The current study focused exclusively on this population.
In “an initial experience” with robotic PCI in 17 acute MI patients led by Dr. Ryan D. Madder, an interventional cardiologist, “technical success” was achieved in 100% of patients with no repeat revascularizations in follow-up so far.
“These preliminary observations support the performance of larger studies to determine the role of robotic PCI in the treatment of acute MI,” said Andrew O’Brien, a medical student at Michigan State University, Ann Arbor, who presented the data at the meeting, sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
The major proven advantage of robotic PCI is that it reduces radiation exposure to the operator, Mr. O’Brien said. While the procedure was performed in this study behind a lead-lined cockpit, it was noted that the operator works solely on the basis of imaging and could be anywhere, including at another facility. In addition, robotic PCI has at least a theoretical advantage of greater precision relative to conventional PCI.
In this study, technical success was defined as less than 30% residual stenosis after PCI in the absence of a PCI-associated death or the need for a repeat revascularization prior to hospital discharge. The median age of the 17 acute MI patients was 59 years with a range of about 10 years younger or older. Most (71%) were male. Radial arterial access was used in all cases.
Only 23% of the patients met criteria for relatively simple lesions (class A or B1). Just over half (53%) had class B2 lesions, which require at least two complicating characteristics, such as moderate tortuosity, irregular contour, or moderate to heavy calcification, and the remainder had class C lesions. In 10 cases (59%), an angiographic filling defect consistent with thrombus was present at the culprit lesion site.
In addition to achieving the goal reduction in residual stenosis without major adverse cardiovascular events in all patients, the investigators reported that procedural time, which averaged 69 minutes from the time of sheath insertion to removal of the guide catheter, was “acceptable.” The longest procedural time was under 100 minutes.
“We used the same criteria for evaluating outcomes as employed in the original PRECISE study,” Mr. O’Brien said. He explained that acute MI patients were excluded in the published PRECISE trial data because there was no protocol at that time for converting to a conventional procedure on an urgent basis in the case of unexpected problems. With more experience, there was greater confidence that urgent complications could be addressed.
In the multicenter PRECISE trial, which led to approval of the robotic system, 164 candidates for elective PCI were enrolled (J Am Coll Cardiol. 2013;61[15]:1596-1600). Technical success was 98.8%. Although there was no control arm, radiation exposure was reported to be 95% lower for operators participating in that study than levels found at the traditional table position.
Data from the current study provide preliminary evidence that robotic PCI is feasible for management of acute MI. While confirmatory studies are needed for this indication, the Michigan investigators also advocated more studies to evaluate whether robotic PCI improves outcome. They cited the potential for more precise placement of stents to reduce the risk of complications.
“Robotic PCI is still not very widely performed,” said coinvestigator Andrew LaCombe, who suggested that its potential advantages deserve broader evaluation.
Dr. Madder disclosed a financial relationship with InfraRedx.
WASHINGTON – Robotic angioplasty may deliver the same advantages when percutaneous coronary intervention is indicated for acute myocardial infarction as currently claimed for an elective PCI, according to results from a proof-of-principle study.
The first robotic PCI system, CorPath 200, was approved by the U.S. Food and Drug Administration in 2012, but the registration trial, called PRECISE (Percutaneous Robotically Enhanced Coronary Intervention), excluded patients with coronary thrombosis, according to a team of investigators at the Frederik Meijer Cardiovascular Institute, Grand Rapids, Mich. The current study focused exclusively on this population.
In “an initial experience” with robotic PCI in 17 acute MI patients led by Dr. Ryan D. Madder, an interventional cardiologist, “technical success” was achieved in 100% of patients with no repeat revascularizations in follow-up so far.
“These preliminary observations support the performance of larger studies to determine the role of robotic PCI in the treatment of acute MI,” said Andrew O’Brien, a medical student at Michigan State University, Ann Arbor, who presented the data at the meeting, sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
The major proven advantage of robotic PCI is that it reduces radiation exposure to the operator, Mr. O’Brien said. While the procedure was performed in this study behind a lead-lined cockpit, it was noted that the operator works solely on the basis of imaging and could be anywhere, including at another facility. In addition, robotic PCI has at least a theoretical advantage of greater precision relative to conventional PCI.
In this study, technical success was defined as less than 30% residual stenosis after PCI in the absence of a PCI-associated death or the need for a repeat revascularization prior to hospital discharge. The median age of the 17 acute MI patients was 59 years with a range of about 10 years younger or older. Most (71%) were male. Radial arterial access was used in all cases.
Only 23% of the patients met criteria for relatively simple lesions (class A or B1). Just over half (53%) had class B2 lesions, which require at least two complicating characteristics, such as moderate tortuosity, irregular contour, or moderate to heavy calcification, and the remainder had class C lesions. In 10 cases (59%), an angiographic filling defect consistent with thrombus was present at the culprit lesion site.
In addition to achieving the goal reduction in residual stenosis without major adverse cardiovascular events in all patients, the investigators reported that procedural time, which averaged 69 minutes from the time of sheath insertion to removal of the guide catheter, was “acceptable.” The longest procedural time was under 100 minutes.
“We used the same criteria for evaluating outcomes as employed in the original PRECISE study,” Mr. O’Brien said. He explained that acute MI patients were excluded in the published PRECISE trial data because there was no protocol at that time for converting to a conventional procedure on an urgent basis in the case of unexpected problems. With more experience, there was greater confidence that urgent complications could be addressed.
In the multicenter PRECISE trial, which led to approval of the robotic system, 164 candidates for elective PCI were enrolled (J Am Coll Cardiol. 2013;61[15]:1596-1600). Technical success was 98.8%. Although there was no control arm, radiation exposure was reported to be 95% lower for operators participating in that study than levels found at the traditional table position.
Data from the current study provide preliminary evidence that robotic PCI is feasible for management of acute MI. While confirmatory studies are needed for this indication, the Michigan investigators also advocated more studies to evaluate whether robotic PCI improves outcome. They cited the potential for more precise placement of stents to reduce the risk of complications.
“Robotic PCI is still not very widely performed,” said coinvestigator Andrew LaCombe, who suggested that its potential advantages deserve broader evaluation.
Dr. Madder disclosed a financial relationship with InfraRedx.
AT CARDIOVASCULAR RESEARCH TECHNOLOGIES 2016
Key clinical point: A proof-of-principle study suggests that procedural success with robotic angioplasty is at least as good in patients with acute myocardial infarction as previously shown in elective percutaneous coronary intervention.
Major finding: In a series of 17 consecutive patients with acute MI, procedural success was 100%.
Data source: A cohort study.
Disclosures: Dr. Madder disclosed a financial relationship with InfraRedx.
Dr. Robert Califf confirmed as FDA commissioner
Dr. Robert M. Califf was confirmed as Commissioner of the Food and Drug Administration by an 89-4 vote of the full Senate on Feb. 24.
Physician associations praised the Senate’s confirmation, calling Dr. Califf a strong voice in the cardiovascular community who will bring valuable perspective to the FDA role.
“Dr. Califf is an acclaimed leader in the cardiovascular community who brings impressive medical knowledge, clinical research experience and leadership capabilities to the FDA,” Dr. Kim Allan Williams Sr., American College of Cardiology president, said in a statement. “He has made important contributions to the field of medicine and has the vision required to lead the FDA in its efforts to promote and protect public health.”
Dr. Califf has served as FDA deputy commissioner for medical products and tobacco since February 2015. He is a former vice chancellor of clinical and translational research and professor of medicine in the division of cardiology at Duke University, Durham, N.C. He served as director of the Duke Translational Medicine Institute and founding director of the Duke Clinical Research Institute. Dr. Califf has led countless landmark clinical trials and is one of the most frequently cited authors in biomedical science, with more than 1,200 publications in the peer-reviewed literature, according to his biography on the FDA website.
The New England Journal of Medicine endorsed Dr. Califf’s nomination in an editorial published online in October 2015. They noted that Dr. Califf’s experience with clinical trials and drug data should be considered advantages to the FDA and would further the agency’s aim to improve drug safety (N Engl J Med. 2016 Jan 14; 374:176-7).
“Califf’s experience, his proven leadership abilities, his record of robust research to guide clinical practice, and his unwavering dedication to improving patient outcomes are unsurpassed qualifications for the post of commissioner of the FDA,” according to the editorial signed by Dr. Jeffrey M. Drazen, editor in chief.
Dr. Califf’s nomination was contested by legislators including Sen. Bernie Sanders (I-Vt.), who opposed Dr. Califf’s ties to the pharmaceutical industry. Dr. Califf is founding director of the Duke Clinical Research Institute, which has conducted extensive clinical trials for the drug industry. Dr. Califf, in the past, disclosed receiving consulting fees from pharmaceutical manufactures.
Sen. Joe Manchin (D-W.Va.) and Sen. Edward Markey (D-Mass.) also opposed the nomination. They, however, said they wished to block Dr. Califf’s nomination because they believe the FDA is failing to adequately regulate opioids entering the U.S. market. Sen. Manchin and Sen. Markey were joined by Sen. Kelly Ayotte (R-N.H.) and Sen. Richard Blumenthal (D-Conn.) in voting against Dr. Califf.
“The FDA is supposed to be our nation’s pharmacist, but right now, it is prescribing dangerous and addictive painkillers without limits, without supervision and without consequence,” Sen. Markey said in a Feb. 22 statement. “We need the leader of the FDA to be a tough cop on the beat, not a rubber stamp approving the latest Big Pharma painkillers that are the cause of this deadly scourge of opioid addiction and overdoses.”
On Feb. 4, Dr. Califf called for a sweeping overhaul of the FDA’s approach to opioid medications, including renewed efforts to improve how opioids are approved, labeled, and prescribed. Under the new plan, the FDA will convene an advisory committee before approving new drug applications for opioids that do not have abuse-deterrent properties and develop changes to immediate-release opioid labeling. The agency also plans to expand access to abuse-deterrent formulations of opioid products and improve the availability of naloxone and medication-assisted treatment options for patients with opioid use disorders.
“Things are getting worse, not better, with the epidemic of opioid misuse, abuse and dependence,” Dr. Califf said in a statement. “It’s time we all took a step back to look at what is working and what we need to change to impact this crisis.”
Just prior to the full Senate vote, Sen. Patty Murray (D-Wash.), ranking member of the Health, Education, Labor, and Pensions Committee, spoke in support of Dr. Califf’s nomination.
“After careful review, I believe Dr. Califf’s experience and expertise will allow him to lead the FDA in a way that puts patients and families first and upholds the highest standards of patient and consumer safety,” Sen. Murray said on the Senate floor. “Dr. Califf has led one of our country’s largest clinical research organizations and has a record of advancing medical breakthroughs on especially difficult-to-treat illnesses.”
Senators opposing Dr. Califf’s nomination attempted to filibuster the body’s consideration and vote on Dr. Califf’s nomination on Feb. 22. Their efforts were voted down 80-6.
On Twitter @legal_med
Dr. Robert M. Califf was confirmed as Commissioner of the Food and Drug Administration by an 89-4 vote of the full Senate on Feb. 24.
Physician associations praised the Senate’s confirmation, calling Dr. Califf a strong voice in the cardiovascular community who will bring valuable perspective to the FDA role.
“Dr. Califf is an acclaimed leader in the cardiovascular community who brings impressive medical knowledge, clinical research experience and leadership capabilities to the FDA,” Dr. Kim Allan Williams Sr., American College of Cardiology president, said in a statement. “He has made important contributions to the field of medicine and has the vision required to lead the FDA in its efforts to promote and protect public health.”
Dr. Califf has served as FDA deputy commissioner for medical products and tobacco since February 2015. He is a former vice chancellor of clinical and translational research and professor of medicine in the division of cardiology at Duke University, Durham, N.C. He served as director of the Duke Translational Medicine Institute and founding director of the Duke Clinical Research Institute. Dr. Califf has led countless landmark clinical trials and is one of the most frequently cited authors in biomedical science, with more than 1,200 publications in the peer-reviewed literature, according to his biography on the FDA website.
The New England Journal of Medicine endorsed Dr. Califf’s nomination in an editorial published online in October 2015. They noted that Dr. Califf’s experience with clinical trials and drug data should be considered advantages to the FDA and would further the agency’s aim to improve drug safety (N Engl J Med. 2016 Jan 14; 374:176-7).
“Califf’s experience, his proven leadership abilities, his record of robust research to guide clinical practice, and his unwavering dedication to improving patient outcomes are unsurpassed qualifications for the post of commissioner of the FDA,” according to the editorial signed by Dr. Jeffrey M. Drazen, editor in chief.
Dr. Califf’s nomination was contested by legislators including Sen. Bernie Sanders (I-Vt.), who opposed Dr. Califf’s ties to the pharmaceutical industry. Dr. Califf is founding director of the Duke Clinical Research Institute, which has conducted extensive clinical trials for the drug industry. Dr. Califf, in the past, disclosed receiving consulting fees from pharmaceutical manufactures.
Sen. Joe Manchin (D-W.Va.) and Sen. Edward Markey (D-Mass.) also opposed the nomination. They, however, said they wished to block Dr. Califf’s nomination because they believe the FDA is failing to adequately regulate opioids entering the U.S. market. Sen. Manchin and Sen. Markey were joined by Sen. Kelly Ayotte (R-N.H.) and Sen. Richard Blumenthal (D-Conn.) in voting against Dr. Califf.
“The FDA is supposed to be our nation’s pharmacist, but right now, it is prescribing dangerous and addictive painkillers without limits, without supervision and without consequence,” Sen. Markey said in a Feb. 22 statement. “We need the leader of the FDA to be a tough cop on the beat, not a rubber stamp approving the latest Big Pharma painkillers that are the cause of this deadly scourge of opioid addiction and overdoses.”
On Feb. 4, Dr. Califf called for a sweeping overhaul of the FDA’s approach to opioid medications, including renewed efforts to improve how opioids are approved, labeled, and prescribed. Under the new plan, the FDA will convene an advisory committee before approving new drug applications for opioids that do not have abuse-deterrent properties and develop changes to immediate-release opioid labeling. The agency also plans to expand access to abuse-deterrent formulations of opioid products and improve the availability of naloxone and medication-assisted treatment options for patients with opioid use disorders.
“Things are getting worse, not better, with the epidemic of opioid misuse, abuse and dependence,” Dr. Califf said in a statement. “It’s time we all took a step back to look at what is working and what we need to change to impact this crisis.”
Just prior to the full Senate vote, Sen. Patty Murray (D-Wash.), ranking member of the Health, Education, Labor, and Pensions Committee, spoke in support of Dr. Califf’s nomination.
“After careful review, I believe Dr. Califf’s experience and expertise will allow him to lead the FDA in a way that puts patients and families first and upholds the highest standards of patient and consumer safety,” Sen. Murray said on the Senate floor. “Dr. Califf has led one of our country’s largest clinical research organizations and has a record of advancing medical breakthroughs on especially difficult-to-treat illnesses.”
Senators opposing Dr. Califf’s nomination attempted to filibuster the body’s consideration and vote on Dr. Califf’s nomination on Feb. 22. Their efforts were voted down 80-6.
On Twitter @legal_med
Dr. Robert M. Califf was confirmed as Commissioner of the Food and Drug Administration by an 89-4 vote of the full Senate on Feb. 24.
Physician associations praised the Senate’s confirmation, calling Dr. Califf a strong voice in the cardiovascular community who will bring valuable perspective to the FDA role.
“Dr. Califf is an acclaimed leader in the cardiovascular community who brings impressive medical knowledge, clinical research experience and leadership capabilities to the FDA,” Dr. Kim Allan Williams Sr., American College of Cardiology president, said in a statement. “He has made important contributions to the field of medicine and has the vision required to lead the FDA in its efforts to promote and protect public health.”
Dr. Califf has served as FDA deputy commissioner for medical products and tobacco since February 2015. He is a former vice chancellor of clinical and translational research and professor of medicine in the division of cardiology at Duke University, Durham, N.C. He served as director of the Duke Translational Medicine Institute and founding director of the Duke Clinical Research Institute. Dr. Califf has led countless landmark clinical trials and is one of the most frequently cited authors in biomedical science, with more than 1,200 publications in the peer-reviewed literature, according to his biography on the FDA website.
The New England Journal of Medicine endorsed Dr. Califf’s nomination in an editorial published online in October 2015. They noted that Dr. Califf’s experience with clinical trials and drug data should be considered advantages to the FDA and would further the agency’s aim to improve drug safety (N Engl J Med. 2016 Jan 14; 374:176-7).
“Califf’s experience, his proven leadership abilities, his record of robust research to guide clinical practice, and his unwavering dedication to improving patient outcomes are unsurpassed qualifications for the post of commissioner of the FDA,” according to the editorial signed by Dr. Jeffrey M. Drazen, editor in chief.
Dr. Califf’s nomination was contested by legislators including Sen. Bernie Sanders (I-Vt.), who opposed Dr. Califf’s ties to the pharmaceutical industry. Dr. Califf is founding director of the Duke Clinical Research Institute, which has conducted extensive clinical trials for the drug industry. Dr. Califf, in the past, disclosed receiving consulting fees from pharmaceutical manufactures.
Sen. Joe Manchin (D-W.Va.) and Sen. Edward Markey (D-Mass.) also opposed the nomination. They, however, said they wished to block Dr. Califf’s nomination because they believe the FDA is failing to adequately regulate opioids entering the U.S. market. Sen. Manchin and Sen. Markey were joined by Sen. Kelly Ayotte (R-N.H.) and Sen. Richard Blumenthal (D-Conn.) in voting against Dr. Califf.
“The FDA is supposed to be our nation’s pharmacist, but right now, it is prescribing dangerous and addictive painkillers without limits, without supervision and without consequence,” Sen. Markey said in a Feb. 22 statement. “We need the leader of the FDA to be a tough cop on the beat, not a rubber stamp approving the latest Big Pharma painkillers that are the cause of this deadly scourge of opioid addiction and overdoses.”
On Feb. 4, Dr. Califf called for a sweeping overhaul of the FDA’s approach to opioid medications, including renewed efforts to improve how opioids are approved, labeled, and prescribed. Under the new plan, the FDA will convene an advisory committee before approving new drug applications for opioids that do not have abuse-deterrent properties and develop changes to immediate-release opioid labeling. The agency also plans to expand access to abuse-deterrent formulations of opioid products and improve the availability of naloxone and medication-assisted treatment options for patients with opioid use disorders.
“Things are getting worse, not better, with the epidemic of opioid misuse, abuse and dependence,” Dr. Califf said in a statement. “It’s time we all took a step back to look at what is working and what we need to change to impact this crisis.”
Just prior to the full Senate vote, Sen. Patty Murray (D-Wash.), ranking member of the Health, Education, Labor, and Pensions Committee, spoke in support of Dr. Califf’s nomination.
“After careful review, I believe Dr. Califf’s experience and expertise will allow him to lead the FDA in a way that puts patients and families first and upholds the highest standards of patient and consumer safety,” Sen. Murray said on the Senate floor. “Dr. Califf has led one of our country’s largest clinical research organizations and has a record of advancing medical breakthroughs on especially difficult-to-treat illnesses.”
Senators opposing Dr. Califf’s nomination attempted to filibuster the body’s consideration and vote on Dr. Califf’s nomination on Feb. 22. Their efforts were voted down 80-6.
On Twitter @legal_med
No survival benefit with prehospital transfusions
SAN ANTONIO – Prehospital blood transfusions during air medical transport did not improve 24-hour or in-hospital mortality at Vanderbilt University Medical Center, Nashville.
Investigators there reviewed 5,581 patients transported by helicopter to Vanderbilt from the scene of injury from the period of 2007-2013; they excluded patients who died on the helipad or in the ED. Average flight time was 48 minutes; 231 patients (4%) received prehospital blood transfusions (PBT) of up to two units of O negative packed red blood cells, which is all that the helicopters carried. The decision to transfuse was up to helicopter personnel who were advised to transfuse hemodynamically unstable patients and those who had lost more than a half liter of blood.
Vanderbilt reviewed its data because although PBT has become widespread in air medical transport, results from military and civilian studies are mixed. “A lot of evidence indicates that early, aggressive resuscitation with blood products improves survival once patients arrive at the hospital. It makes sense that starting the process early would improve outcomes, but relatively little is known about the prehospital environment,” said investigator and general surgery resident Dr. Benjamin Miller.
PBT didn’t seem to help at Vanderbilt. On multivariable regression, in-flight transfusion did not improve 24-hour mortality (OR 1.22; 95% CI 0.61-2.44) or overall in-hospital mortality (OR 1.20; 95% CI 0.55-1.79). It was the same story when 195 transfused patients were matched to 195 who were not transfused, based on mechanism of injury, scene vital signs, injury severity, travel duration, and other measures. Even with matching, PBT did not improve 24-hour mortality (OR 1.04; 95% CI 0.54-1.98) or overall mortality (OR 1.05; 95% CI 0.56-1.96).
There was a trend for improved 24-hour survival with transfusion when injury severity scores were below 20, but it wasn’t statistically significant, perhaps because few of the less injured patients died.
“Our results show no effect of PBT on 24-hour and overall in-hospital mortality. It’s puzzling to us because it’s counterintuitive to the damage control resuscitation strategy,” Dr. Miller said at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.
The findings aren’t robust enough for Vanderbilt to cancel PBT, but they do suggest possible areas for improvement.
Maybe “one or two units of blood are not enough for patients who are severely injured and rapidly exsanguinating, or [maybe] fresh frozen plasma or platelets are needed. Maybe the trigger for transfusion is too low, or too high. It’s time from a prospective study,” Dr. Miller said.
Vanderbilt doesn’t use tranexamic acid to control trauma bleeding. The study didn’t capture volume of crystalloid infused, serum markers of shock, or coagulation study results.
Subjects were in their late 30s, on average, and 70% were men. Transfusions were more likely in younger patients and those with penetrating injuries, poorer at-scene vital signs and Glasgow coma scores, more severe injuries, and lower hematocrits. With the exception of younger age, those factors were also associated with death.
The investigators had no disclosures.
SAN ANTONIO – Prehospital blood transfusions during air medical transport did not improve 24-hour or in-hospital mortality at Vanderbilt University Medical Center, Nashville.
Investigators there reviewed 5,581 patients transported by helicopter to Vanderbilt from the scene of injury from the period of 2007-2013; they excluded patients who died on the helipad or in the ED. Average flight time was 48 minutes; 231 patients (4%) received prehospital blood transfusions (PBT) of up to two units of O negative packed red blood cells, which is all that the helicopters carried. The decision to transfuse was up to helicopter personnel who were advised to transfuse hemodynamically unstable patients and those who had lost more than a half liter of blood.
Vanderbilt reviewed its data because although PBT has become widespread in air medical transport, results from military and civilian studies are mixed. “A lot of evidence indicates that early, aggressive resuscitation with blood products improves survival once patients arrive at the hospital. It makes sense that starting the process early would improve outcomes, but relatively little is known about the prehospital environment,” said investigator and general surgery resident Dr. Benjamin Miller.
PBT didn’t seem to help at Vanderbilt. On multivariable regression, in-flight transfusion did not improve 24-hour mortality (OR 1.22; 95% CI 0.61-2.44) or overall in-hospital mortality (OR 1.20; 95% CI 0.55-1.79). It was the same story when 195 transfused patients were matched to 195 who were not transfused, based on mechanism of injury, scene vital signs, injury severity, travel duration, and other measures. Even with matching, PBT did not improve 24-hour mortality (OR 1.04; 95% CI 0.54-1.98) or overall mortality (OR 1.05; 95% CI 0.56-1.96).
There was a trend for improved 24-hour survival with transfusion when injury severity scores were below 20, but it wasn’t statistically significant, perhaps because few of the less injured patients died.
“Our results show no effect of PBT on 24-hour and overall in-hospital mortality. It’s puzzling to us because it’s counterintuitive to the damage control resuscitation strategy,” Dr. Miller said at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.
The findings aren’t robust enough for Vanderbilt to cancel PBT, but they do suggest possible areas for improvement.
Maybe “one or two units of blood are not enough for patients who are severely injured and rapidly exsanguinating, or [maybe] fresh frozen plasma or platelets are needed. Maybe the trigger for transfusion is too low, or too high. It’s time from a prospective study,” Dr. Miller said.
Vanderbilt doesn’t use tranexamic acid to control trauma bleeding. The study didn’t capture volume of crystalloid infused, serum markers of shock, or coagulation study results.
Subjects were in their late 30s, on average, and 70% were men. Transfusions were more likely in younger patients and those with penetrating injuries, poorer at-scene vital signs and Glasgow coma scores, more severe injuries, and lower hematocrits. With the exception of younger age, those factors were also associated with death.
The investigators had no disclosures.
SAN ANTONIO – Prehospital blood transfusions during air medical transport did not improve 24-hour or in-hospital mortality at Vanderbilt University Medical Center, Nashville.
Investigators there reviewed 5,581 patients transported by helicopter to Vanderbilt from the scene of injury from the period of 2007-2013; they excluded patients who died on the helipad or in the ED. Average flight time was 48 minutes; 231 patients (4%) received prehospital blood transfusions (PBT) of up to two units of O negative packed red blood cells, which is all that the helicopters carried. The decision to transfuse was up to helicopter personnel who were advised to transfuse hemodynamically unstable patients and those who had lost more than a half liter of blood.
Vanderbilt reviewed its data because although PBT has become widespread in air medical transport, results from military and civilian studies are mixed. “A lot of evidence indicates that early, aggressive resuscitation with blood products improves survival once patients arrive at the hospital. It makes sense that starting the process early would improve outcomes, but relatively little is known about the prehospital environment,” said investigator and general surgery resident Dr. Benjamin Miller.
PBT didn’t seem to help at Vanderbilt. On multivariable regression, in-flight transfusion did not improve 24-hour mortality (OR 1.22; 95% CI 0.61-2.44) or overall in-hospital mortality (OR 1.20; 95% CI 0.55-1.79). It was the same story when 195 transfused patients were matched to 195 who were not transfused, based on mechanism of injury, scene vital signs, injury severity, travel duration, and other measures. Even with matching, PBT did not improve 24-hour mortality (OR 1.04; 95% CI 0.54-1.98) or overall mortality (OR 1.05; 95% CI 0.56-1.96).
There was a trend for improved 24-hour survival with transfusion when injury severity scores were below 20, but it wasn’t statistically significant, perhaps because few of the less injured patients died.
“Our results show no effect of PBT on 24-hour and overall in-hospital mortality. It’s puzzling to us because it’s counterintuitive to the damage control resuscitation strategy,” Dr. Miller said at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.
The findings aren’t robust enough for Vanderbilt to cancel PBT, but they do suggest possible areas for improvement.
Maybe “one or two units of blood are not enough for patients who are severely injured and rapidly exsanguinating, or [maybe] fresh frozen plasma or platelets are needed. Maybe the trigger for transfusion is too low, or too high. It’s time from a prospective study,” Dr. Miller said.
Vanderbilt doesn’t use tranexamic acid to control trauma bleeding. The study didn’t capture volume of crystalloid infused, serum markers of shock, or coagulation study results.
Subjects were in their late 30s, on average, and 70% were men. Transfusions were more likely in younger patients and those with penetrating injuries, poorer at-scene vital signs and Glasgow coma scores, more severe injuries, and lower hematocrits. With the exception of younger age, those factors were also associated with death.
The investigators had no disclosures.
AT The EAST SCIENTIFIC ASSEMBLY
Key clinical point: Air transport teams may need to carry more than two units of packed red blood cells.
Major finding: On multivariable regression, in-flight transfusion did not improve 24-hour survival (OR 1.22; 95% CI 0.61-2.44) or overall mortality (OR 1.20; 95% CI 0.55-1.79).
Data source: Retrospective cohort involving 5,581 trauma patients.
Disclosures: The investigators had no disclosures.
Damage to nearby structure common cause of hernia malpractice claim
JACKSONVILLE, FLA. – General surgeons are among the most sued physicians, and hernia repair is one of the most common operations they perform, so a study was conducted to drill down into the legal data on hernia repair to determine what about the operation is most likely to get surgeons in trouble.
They found that a failure to diagnose a complication caused by damage to a nearby structure during the operation was the most common cause for a malpractice suit for hernia repair, Dr. Nadeem Haddad of the Mayo Clinic in Rochester, Minn., reported at the Association for Academic Surgery/Society of University Surgeons Academic Surgical Congress.
“Hernia repair with more than 1 million cases annually is one of the most common surgical procedures,” Dr. Haddad said. “The most common type of operation for malpractice was inguinal hernia repair. The majority of cases were elective cases where the informed consent was not breached.”
The researchers sampled data on 250 malpractice cases arising from hernia surgery filed with the Westlaw Next legal database between 1985 and 2015, Dr. Haddad said. He added that the sample is not inclusive of all malpractice cases related to hernia repair in that time. “Our objective was to analyze reasons for litigation related to hernia repairs,” he said.
Among the hernia cases from the database, physicians (defendants) won 59%, patients (plaintiffs) won around 27%, and the remainder went to settlement before a verdict. Award payments ranged from $10,000 for a case where a Penrose drain was left in the patient to $16 million in the case of death of an infant due to perioperative hyperkalemia.
Eighty-four percent of the cases in the study involved inguinal or ventral hernia repair, Dr. Haddad said, but the Westlaw Next database did not differentiate between the two types of procedures. Nor did it separate out pediatric or adult repairs. Westlaw Next provides the alleged reason for litigation and gives details about lawsuits. The researchers classified the alleged reasons for the lawsuits based on the time period in which they happened: preoperatively, intraoperatively, and postoperatively.
“The single most common reason for malpractice in hernia repair was failure to diagnose a complication following damage to a surrounding structure,” Dr. Haddad said.
The state of New York had the highest number of medical malpractice cases (46), followed closely by California (42). In 15% of cases (38) the patients claimed a breach of informed consent by the surgeon
“While understanding the reasons why surgeons go to trial, the risk of future lawsuits may lessen if measures are enacted to prevent such outcomes,” Dr. Haddad said. “Following protocols in diagnosis and management, attention to good surgical technique, and keeping a checklist of possible complications are some of the ways to improve patients safety and decrease chances of litigation.”
Dr. Haddad and coauthors had no financial relationships to disclose.
JACKSONVILLE, FLA. – General surgeons are among the most sued physicians, and hernia repair is one of the most common operations they perform, so a study was conducted to drill down into the legal data on hernia repair to determine what about the operation is most likely to get surgeons in trouble.
They found that a failure to diagnose a complication caused by damage to a nearby structure during the operation was the most common cause for a malpractice suit for hernia repair, Dr. Nadeem Haddad of the Mayo Clinic in Rochester, Minn., reported at the Association for Academic Surgery/Society of University Surgeons Academic Surgical Congress.
“Hernia repair with more than 1 million cases annually is one of the most common surgical procedures,” Dr. Haddad said. “The most common type of operation for malpractice was inguinal hernia repair. The majority of cases were elective cases where the informed consent was not breached.”
The researchers sampled data on 250 malpractice cases arising from hernia surgery filed with the Westlaw Next legal database between 1985 and 2015, Dr. Haddad said. He added that the sample is not inclusive of all malpractice cases related to hernia repair in that time. “Our objective was to analyze reasons for litigation related to hernia repairs,” he said.
Among the hernia cases from the database, physicians (defendants) won 59%, patients (plaintiffs) won around 27%, and the remainder went to settlement before a verdict. Award payments ranged from $10,000 for a case where a Penrose drain was left in the patient to $16 million in the case of death of an infant due to perioperative hyperkalemia.
Eighty-four percent of the cases in the study involved inguinal or ventral hernia repair, Dr. Haddad said, but the Westlaw Next database did not differentiate between the two types of procedures. Nor did it separate out pediatric or adult repairs. Westlaw Next provides the alleged reason for litigation and gives details about lawsuits. The researchers classified the alleged reasons for the lawsuits based on the time period in which they happened: preoperatively, intraoperatively, and postoperatively.
“The single most common reason for malpractice in hernia repair was failure to diagnose a complication following damage to a surrounding structure,” Dr. Haddad said.
The state of New York had the highest number of medical malpractice cases (46), followed closely by California (42). In 15% of cases (38) the patients claimed a breach of informed consent by the surgeon
“While understanding the reasons why surgeons go to trial, the risk of future lawsuits may lessen if measures are enacted to prevent such outcomes,” Dr. Haddad said. “Following protocols in diagnosis and management, attention to good surgical technique, and keeping a checklist of possible complications are some of the ways to improve patients safety and decrease chances of litigation.”
Dr. Haddad and coauthors had no financial relationships to disclose.
JACKSONVILLE, FLA. – General surgeons are among the most sued physicians, and hernia repair is one of the most common operations they perform, so a study was conducted to drill down into the legal data on hernia repair to determine what about the operation is most likely to get surgeons in trouble.
They found that a failure to diagnose a complication caused by damage to a nearby structure during the operation was the most common cause for a malpractice suit for hernia repair, Dr. Nadeem Haddad of the Mayo Clinic in Rochester, Minn., reported at the Association for Academic Surgery/Society of University Surgeons Academic Surgical Congress.
“Hernia repair with more than 1 million cases annually is one of the most common surgical procedures,” Dr. Haddad said. “The most common type of operation for malpractice was inguinal hernia repair. The majority of cases were elective cases where the informed consent was not breached.”
The researchers sampled data on 250 malpractice cases arising from hernia surgery filed with the Westlaw Next legal database between 1985 and 2015, Dr. Haddad said. He added that the sample is not inclusive of all malpractice cases related to hernia repair in that time. “Our objective was to analyze reasons for litigation related to hernia repairs,” he said.
Among the hernia cases from the database, physicians (defendants) won 59%, patients (plaintiffs) won around 27%, and the remainder went to settlement before a verdict. Award payments ranged from $10,000 for a case where a Penrose drain was left in the patient to $16 million in the case of death of an infant due to perioperative hyperkalemia.
Eighty-four percent of the cases in the study involved inguinal or ventral hernia repair, Dr. Haddad said, but the Westlaw Next database did not differentiate between the two types of procedures. Nor did it separate out pediatric or adult repairs. Westlaw Next provides the alleged reason for litigation and gives details about lawsuits. The researchers classified the alleged reasons for the lawsuits based on the time period in which they happened: preoperatively, intraoperatively, and postoperatively.
“The single most common reason for malpractice in hernia repair was failure to diagnose a complication following damage to a surrounding structure,” Dr. Haddad said.
The state of New York had the highest number of medical malpractice cases (46), followed closely by California (42). In 15% of cases (38) the patients claimed a breach of informed consent by the surgeon
“While understanding the reasons why surgeons go to trial, the risk of future lawsuits may lessen if measures are enacted to prevent such outcomes,” Dr. Haddad said. “Following protocols in diagnosis and management, attention to good surgical technique, and keeping a checklist of possible complications are some of the ways to improve patients safety and decrease chances of litigation.”
Dr. Haddad and coauthors had no financial relationships to disclose.
AT THE ANNUAL ACADEMIC SURGICAL CONGRESS
Key clinical point: Failure to diagnose a complication caused by damage to a nearby structure during hernia repair surgery is the most common cause for a malpractice claim for hernia repair.
Major finding: In malpractice cases involving hernia surgery that go to trial, 59% of the rulings are for the plaintiff physicians and about 14% go to settlement before a judge or jury decision.
Data source: Sample of 250 hernia surgical malpractice cases from 1985 to 2015 in the Westlaw Next legal database.
Disclosures: The study authors reported having no financial disclosures.
CABG with ITA for moderate stenosis improved long-term survival
The overall use of coronary artery bypass grafting for angiographically moderate stenosis was found to be not harmful in a large, single-institution analysis of patients who were operated upon from 1972 to 2011.
In addition, the use of internal thoracic artery (ITA) grafting as compared with saphenous vein grafting or no grafting at all was positively associated with lower long-term mortality, according Dr. Joseph F. Sabik III and his colleagues at the Cleveland Clinic. Their study was published in the March issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151:806-11).
The researchers assessed 8,531 patients from the Cleveland Clinic Cardiovascular Information Registry diagnosed with a single coronary artery that was moderately stenosed (50%-60%) that was bypassed in 6,598 cases (77%) and not bypassed in 1,933 (23%). Of those patients with bypasses, arteries were grafted with ITAs in 1,806 patients and saphenous veins (SVs) in 4,625 patients. The mean follow-up of all patients for all-cause mortality was 13 years.
Most ITA grafts went to the left anterior descending coronary artery (LAD) followed by diagonals and the left circumflex coronary artery (LC). Most SV grafts went to the right coronary artery, followed by the LCs and diagonals.
Dr. Sabik and his colleagues found that survival was similar for patients with or without a graft to the moderately stenosed artery: 97%, 76%, 43%, and 18% at 1, 10, 20, and 30 years for patients receiving no graft, versus 97%, 74%, 41%, and 18% among those receiving a saphenous vein graft, and 98%, 82%, 51%, and 23% among those receiving an ITA graft (P = .3).
However, when the researchers examined risk – adjusted based on patient characteristics, patients receiving an SV graft and no grafting had similar survival (P = .2), while the use of ITA grafting was found to be associated with a 22% lower long-term mortality (hazard ratio, 0.78; P less than .0001).
“ITA grafting of such [moderately stenosed] coronary arteries is associated with lower long-term mortality. Therefore, after placing the first ITA to the LAD, the second ITA should be placed to the second most important coronary artery, even if it is only moderately stenosed,” Dr. Sabik and his colleagues concluded.
The study was sponsored by the Cleveland Clinic and the Gus P. Karos Registry Fund. Dr. Sabik is the North American principal investigator for the Abbott Laboratories–sponsored left main coronary disease randomized trial and is on the scientific advisory board for Medtronic. The other authors had no disclosures.
Revascularizing a vessel with a moderate lesion should be considered only in the context of future disease progression, according to Dr. Leora B. Balsam and Dr. Abe DeAnda, Jr., who provided invited commentary on the article. However, “it seems reasonable to consider bypassing a vessel with a moderate coronary lesion when CABG or cardiac surgery is otherwise indicated.” However, they point out that the choice of conduit for a vessel with a moderate lesion is a separate question.
Dr. Sabik and his colleagues found that survival was the same for grafted and nongrafted patients; however, when stratified according to type of graft (ITA vs. saphenous vein), there was improved long-term survival with the ITA graft when compared with saphenous vein grafting and nongrafting. The researchers concluded that grafting coronary arteries with moderate stenosis is not harmful, that ITA grafting is associated with improved survival, and finally that bilateral ITA grafting should be performed even if the non-LAD target is only moderately stenosed. This final conclusion demands more consideration, according to Dr. Balsam and Dr. DeAnda, Jr. (J Thorac Cardiovasc Surg. 2016;151:812-4).
“Sabik and colleagues’ final assertion, that ‘after placing the first ITA to the left anterior descending, the second ITA should be placed to the second most important coronary artery, even if it is moderately stenosed,’ is provocative when taken in the context of prior published work in this area, including their own. At first glance, one might conclude that the survival benefit seen with ITA grafting was due to patients who received a single ITA to a moderately stenosed LAD,” Dr. Balsam and Dr. DeAnda, Jr. wrote.
“As we look to the future in coronary surgery, the art will continue to be challenged by new scientific discovery. Sabik and colleagues have provided yet another contribution to the science, and their work reminds us that we are still reaching for the tools to answer fundamental questions in coronary surgery,” they concluded.
Dr. Balsam and Dr. DeAnda, Jr. are from the department of cardiothoracic surgery, New York University.
Revascularizing a vessel with a moderate lesion should be considered only in the context of future disease progression, according to Dr. Leora B. Balsam and Dr. Abe DeAnda, Jr., who provided invited commentary on the article. However, “it seems reasonable to consider bypassing a vessel with a moderate coronary lesion when CABG or cardiac surgery is otherwise indicated.” However, they point out that the choice of conduit for a vessel with a moderate lesion is a separate question.
Dr. Sabik and his colleagues found that survival was the same for grafted and nongrafted patients; however, when stratified according to type of graft (ITA vs. saphenous vein), there was improved long-term survival with the ITA graft when compared with saphenous vein grafting and nongrafting. The researchers concluded that grafting coronary arteries with moderate stenosis is not harmful, that ITA grafting is associated with improved survival, and finally that bilateral ITA grafting should be performed even if the non-LAD target is only moderately stenosed. This final conclusion demands more consideration, according to Dr. Balsam and Dr. DeAnda, Jr. (J Thorac Cardiovasc Surg. 2016;151:812-4).
“Sabik and colleagues’ final assertion, that ‘after placing the first ITA to the left anterior descending, the second ITA should be placed to the second most important coronary artery, even if it is moderately stenosed,’ is provocative when taken in the context of prior published work in this area, including their own. At first glance, one might conclude that the survival benefit seen with ITA grafting was due to patients who received a single ITA to a moderately stenosed LAD,” Dr. Balsam and Dr. DeAnda, Jr. wrote.
“As we look to the future in coronary surgery, the art will continue to be challenged by new scientific discovery. Sabik and colleagues have provided yet another contribution to the science, and their work reminds us that we are still reaching for the tools to answer fundamental questions in coronary surgery,” they concluded.
Dr. Balsam and Dr. DeAnda, Jr. are from the department of cardiothoracic surgery, New York University.
Revascularizing a vessel with a moderate lesion should be considered only in the context of future disease progression, according to Dr. Leora B. Balsam and Dr. Abe DeAnda, Jr., who provided invited commentary on the article. However, “it seems reasonable to consider bypassing a vessel with a moderate coronary lesion when CABG or cardiac surgery is otherwise indicated.” However, they point out that the choice of conduit for a vessel with a moderate lesion is a separate question.
Dr. Sabik and his colleagues found that survival was the same for grafted and nongrafted patients; however, when stratified according to type of graft (ITA vs. saphenous vein), there was improved long-term survival with the ITA graft when compared with saphenous vein grafting and nongrafting. The researchers concluded that grafting coronary arteries with moderate stenosis is not harmful, that ITA grafting is associated with improved survival, and finally that bilateral ITA grafting should be performed even if the non-LAD target is only moderately stenosed. This final conclusion demands more consideration, according to Dr. Balsam and Dr. DeAnda, Jr. (J Thorac Cardiovasc Surg. 2016;151:812-4).
“Sabik and colleagues’ final assertion, that ‘after placing the first ITA to the left anterior descending, the second ITA should be placed to the second most important coronary artery, even if it is moderately stenosed,’ is provocative when taken in the context of prior published work in this area, including their own. At first glance, one might conclude that the survival benefit seen with ITA grafting was due to patients who received a single ITA to a moderately stenosed LAD,” Dr. Balsam and Dr. DeAnda, Jr. wrote.
“As we look to the future in coronary surgery, the art will continue to be challenged by new scientific discovery. Sabik and colleagues have provided yet another contribution to the science, and their work reminds us that we are still reaching for the tools to answer fundamental questions in coronary surgery,” they concluded.
Dr. Balsam and Dr. DeAnda, Jr. are from the department of cardiothoracic surgery, New York University.
The overall use of coronary artery bypass grafting for angiographically moderate stenosis was found to be not harmful in a large, single-institution analysis of patients who were operated upon from 1972 to 2011.
In addition, the use of internal thoracic artery (ITA) grafting as compared with saphenous vein grafting or no grafting at all was positively associated with lower long-term mortality, according Dr. Joseph F. Sabik III and his colleagues at the Cleveland Clinic. Their study was published in the March issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151:806-11).
The researchers assessed 8,531 patients from the Cleveland Clinic Cardiovascular Information Registry diagnosed with a single coronary artery that was moderately stenosed (50%-60%) that was bypassed in 6,598 cases (77%) and not bypassed in 1,933 (23%). Of those patients with bypasses, arteries were grafted with ITAs in 1,806 patients and saphenous veins (SVs) in 4,625 patients. The mean follow-up of all patients for all-cause mortality was 13 years.
Most ITA grafts went to the left anterior descending coronary artery (LAD) followed by diagonals and the left circumflex coronary artery (LC). Most SV grafts went to the right coronary artery, followed by the LCs and diagonals.
Dr. Sabik and his colleagues found that survival was similar for patients with or without a graft to the moderately stenosed artery: 97%, 76%, 43%, and 18% at 1, 10, 20, and 30 years for patients receiving no graft, versus 97%, 74%, 41%, and 18% among those receiving a saphenous vein graft, and 98%, 82%, 51%, and 23% among those receiving an ITA graft (P = .3).
However, when the researchers examined risk – adjusted based on patient characteristics, patients receiving an SV graft and no grafting had similar survival (P = .2), while the use of ITA grafting was found to be associated with a 22% lower long-term mortality (hazard ratio, 0.78; P less than .0001).
“ITA grafting of such [moderately stenosed] coronary arteries is associated with lower long-term mortality. Therefore, after placing the first ITA to the LAD, the second ITA should be placed to the second most important coronary artery, even if it is only moderately stenosed,” Dr. Sabik and his colleagues concluded.
The study was sponsored by the Cleveland Clinic and the Gus P. Karos Registry Fund. Dr. Sabik is the North American principal investigator for the Abbott Laboratories–sponsored left main coronary disease randomized trial and is on the scientific advisory board for Medtronic. The other authors had no disclosures.
The overall use of coronary artery bypass grafting for angiographically moderate stenosis was found to be not harmful in a large, single-institution analysis of patients who were operated upon from 1972 to 2011.
In addition, the use of internal thoracic artery (ITA) grafting as compared with saphenous vein grafting or no grafting at all was positively associated with lower long-term mortality, according Dr. Joseph F. Sabik III and his colleagues at the Cleveland Clinic. Their study was published in the March issue of the Journal of Thoracic and Cardiovascular Surgery (2016;151:806-11).
The researchers assessed 8,531 patients from the Cleveland Clinic Cardiovascular Information Registry diagnosed with a single coronary artery that was moderately stenosed (50%-60%) that was bypassed in 6,598 cases (77%) and not bypassed in 1,933 (23%). Of those patients with bypasses, arteries were grafted with ITAs in 1,806 patients and saphenous veins (SVs) in 4,625 patients. The mean follow-up of all patients for all-cause mortality was 13 years.
Most ITA grafts went to the left anterior descending coronary artery (LAD) followed by diagonals and the left circumflex coronary artery (LC). Most SV grafts went to the right coronary artery, followed by the LCs and diagonals.
Dr. Sabik and his colleagues found that survival was similar for patients with or without a graft to the moderately stenosed artery: 97%, 76%, 43%, and 18% at 1, 10, 20, and 30 years for patients receiving no graft, versus 97%, 74%, 41%, and 18% among those receiving a saphenous vein graft, and 98%, 82%, 51%, and 23% among those receiving an ITA graft (P = .3).
However, when the researchers examined risk – adjusted based on patient characteristics, patients receiving an SV graft and no grafting had similar survival (P = .2), while the use of ITA grafting was found to be associated with a 22% lower long-term mortality (hazard ratio, 0.78; P less than .0001).
“ITA grafting of such [moderately stenosed] coronary arteries is associated with lower long-term mortality. Therefore, after placing the first ITA to the LAD, the second ITA should be placed to the second most important coronary artery, even if it is only moderately stenosed,” Dr. Sabik and his colleagues concluded.
The study was sponsored by the Cleveland Clinic and the Gus P. Karos Registry Fund. Dr. Sabik is the North American principal investigator for the Abbott Laboratories–sponsored left main coronary disease randomized trial and is on the scientific advisory board for Medtronic. The other authors had no disclosures.
FROM JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: Grafting moderately stenosed coronary arteries using with internal thoracic arteries improved long-term survival.
Major finding: ITA grafting, compared with no grafting or use of a saphenous vein graft, yielded a 22% lower long-term mortality.
Data source: Researchers performed a prospective study of 8,531 patients from the Cleveland Clinic Cardiovascular Information Registry who had a single coronary artery with moderate stenosis.
Disclosures: The study was sponsored by the Cleveland Clinic and the Gus P. Karos Registry Fund. Dr. Sabik is the North American principal investigator for the Abbott Laboratories–sponsored left main coronary disease randomized trial and is on the scientific advisory board for Medtronic. The other authors had no disclosures.
TAMIS for rectal cancer holds its own vs. TEM
JACKSONVILLE, FLA. – Over the past 30 years, transanal endoscopic microsurgery (TEM) has emerged as a technique for localized rectal cancer, but the need for expensive specialized equipment put it beyond the reach of most hospitals.
Now, early results with transanal minimally invasive surgery (TAMIS) may open the door to an option that achieves the benefits of TEM while using commonly available and less expensive equipment, according to a study presented at the Association for Academic Surgery/Society of University Surgeons Academic Surgical Congress.
Dr. John Costello, general surgery resident at Georgetown University, Washington, presented a poster summarizing the findings of a systematic literature review of TEM and TAMIS studies. The experience with TAMIS is more limited since Dr. Sam Atallah of Sebring, Fla., first introduced it in 2010. The review included the only head-to-head study of the technical aspects of TAMIS and TEM to date.
“Overall the results are very similar between the two approaches,” Dr. Costello said. “In many ways there are, at least anecdotally, some benefits potentially toward the TAMIS technique aside from cost: The perioperative morbidity may be a little lower and, particularly, there seemed to be fewer early problems with continence after surgery.”
The review found similar outcomes between the two approaches: low recurrence rates for small tumors (up to 3 cm) of 4% for TAMIS and 5% for TEM, although the study found that the recurrence rate for TEM increased with larger tumors. Surgery-related deaths with TAMIS ranged from 7.4% to19% and TEM from 6% to 31% across the studies reviewed.
The challenge with the systematic review was that the population of patients who had TAMIS was fewer than 500.
Dr. Costello elucidated the reasons that rectal cancer surgery has proved so challenging to surgeons over the years. The choice of operation was either limited to transabdominal or transanal excision, but the transanal approach had limitations anatomically and was found to be oncologically inferior for early stage cancer. Even with the evolution of the TEM approach, its adoption has been slow.
Either TEM or TAMIS would be a good option for patients too frail for the radical resection that low anterior resection or abdominal perineal resection demand, and would offer an option for palliation for advanced disease, Dr. Costello said. “You could locally resect patients in a way that they go home the same day or at most stay one day in the hospital,” he said.
“The challenge with TEM is that, although the oncologic outcomes are quite good with early-stage disease, the adoption has been very poor over 3 decades mainly because it requires specialized equipment with a very large upfront cost that is limited to use in the rectum,” Dr. Costello said. He estimated the initial capital investment cost for TEM equipment at up to $60,000 on average.
The TAMIS approach, on the other hand, carries a per-procedure equipment cost of about $500 over traditional laparoscopic surgery, he said. It can utilize the single-incision laparoscopic port (SILS) for the transanal approach. TAMIS sacrifices the three-dimensional view of TEM for two-dimensional, but it does provide 360-degree visualization. The surgeon must also be facile with the laparoscopic technique. “In the past that was a big challenge, but now all trainees are very familiar with laparoscopic surgery,” Dr. Costello said.
While the paucity of data on the TAMIS approach makes it difficult to make a strong case for the procedure, the path forward is clear, Dr. Costello said.
“We feel, as do a number of authors of the most papers, that the time truly is now for an actual prospective randomized trial to compare these techniques head-to-head, because colorectal surgeons now have the skill set to be facile at both,” Dr. Costello said.
The investigators had no financial relationships to disclose.
JACKSONVILLE, FLA. – Over the past 30 years, transanal endoscopic microsurgery (TEM) has emerged as a technique for localized rectal cancer, but the need for expensive specialized equipment put it beyond the reach of most hospitals.
Now, early results with transanal minimally invasive surgery (TAMIS) may open the door to an option that achieves the benefits of TEM while using commonly available and less expensive equipment, according to a study presented at the Association for Academic Surgery/Society of University Surgeons Academic Surgical Congress.
Dr. John Costello, general surgery resident at Georgetown University, Washington, presented a poster summarizing the findings of a systematic literature review of TEM and TAMIS studies. The experience with TAMIS is more limited since Dr. Sam Atallah of Sebring, Fla., first introduced it in 2010. The review included the only head-to-head study of the technical aspects of TAMIS and TEM to date.
“Overall the results are very similar between the two approaches,” Dr. Costello said. “In many ways there are, at least anecdotally, some benefits potentially toward the TAMIS technique aside from cost: The perioperative morbidity may be a little lower and, particularly, there seemed to be fewer early problems with continence after surgery.”
The review found similar outcomes between the two approaches: low recurrence rates for small tumors (up to 3 cm) of 4% for TAMIS and 5% for TEM, although the study found that the recurrence rate for TEM increased with larger tumors. Surgery-related deaths with TAMIS ranged from 7.4% to19% and TEM from 6% to 31% across the studies reviewed.
The challenge with the systematic review was that the population of patients who had TAMIS was fewer than 500.
Dr. Costello elucidated the reasons that rectal cancer surgery has proved so challenging to surgeons over the years. The choice of operation was either limited to transabdominal or transanal excision, but the transanal approach had limitations anatomically and was found to be oncologically inferior for early stage cancer. Even with the evolution of the TEM approach, its adoption has been slow.
Either TEM or TAMIS would be a good option for patients too frail for the radical resection that low anterior resection or abdominal perineal resection demand, and would offer an option for palliation for advanced disease, Dr. Costello said. “You could locally resect patients in a way that they go home the same day or at most stay one day in the hospital,” he said.
“The challenge with TEM is that, although the oncologic outcomes are quite good with early-stage disease, the adoption has been very poor over 3 decades mainly because it requires specialized equipment with a very large upfront cost that is limited to use in the rectum,” Dr. Costello said. He estimated the initial capital investment cost for TEM equipment at up to $60,000 on average.
The TAMIS approach, on the other hand, carries a per-procedure equipment cost of about $500 over traditional laparoscopic surgery, he said. It can utilize the single-incision laparoscopic port (SILS) for the transanal approach. TAMIS sacrifices the three-dimensional view of TEM for two-dimensional, but it does provide 360-degree visualization. The surgeon must also be facile with the laparoscopic technique. “In the past that was a big challenge, but now all trainees are very familiar with laparoscopic surgery,” Dr. Costello said.
While the paucity of data on the TAMIS approach makes it difficult to make a strong case for the procedure, the path forward is clear, Dr. Costello said.
“We feel, as do a number of authors of the most papers, that the time truly is now for an actual prospective randomized trial to compare these techniques head-to-head, because colorectal surgeons now have the skill set to be facile at both,” Dr. Costello said.
The investigators had no financial relationships to disclose.
JACKSONVILLE, FLA. – Over the past 30 years, transanal endoscopic microsurgery (TEM) has emerged as a technique for localized rectal cancer, but the need for expensive specialized equipment put it beyond the reach of most hospitals.
Now, early results with transanal minimally invasive surgery (TAMIS) may open the door to an option that achieves the benefits of TEM while using commonly available and less expensive equipment, according to a study presented at the Association for Academic Surgery/Society of University Surgeons Academic Surgical Congress.
Dr. John Costello, general surgery resident at Georgetown University, Washington, presented a poster summarizing the findings of a systematic literature review of TEM and TAMIS studies. The experience with TAMIS is more limited since Dr. Sam Atallah of Sebring, Fla., first introduced it in 2010. The review included the only head-to-head study of the technical aspects of TAMIS and TEM to date.
“Overall the results are very similar between the two approaches,” Dr. Costello said. “In many ways there are, at least anecdotally, some benefits potentially toward the TAMIS technique aside from cost: The perioperative morbidity may be a little lower and, particularly, there seemed to be fewer early problems with continence after surgery.”
The review found similar outcomes between the two approaches: low recurrence rates for small tumors (up to 3 cm) of 4% for TAMIS and 5% for TEM, although the study found that the recurrence rate for TEM increased with larger tumors. Surgery-related deaths with TAMIS ranged from 7.4% to19% and TEM from 6% to 31% across the studies reviewed.
The challenge with the systematic review was that the population of patients who had TAMIS was fewer than 500.
Dr. Costello elucidated the reasons that rectal cancer surgery has proved so challenging to surgeons over the years. The choice of operation was either limited to transabdominal or transanal excision, but the transanal approach had limitations anatomically and was found to be oncologically inferior for early stage cancer. Even with the evolution of the TEM approach, its adoption has been slow.
Either TEM or TAMIS would be a good option for patients too frail for the radical resection that low anterior resection or abdominal perineal resection demand, and would offer an option for palliation for advanced disease, Dr. Costello said. “You could locally resect patients in a way that they go home the same day or at most stay one day in the hospital,” he said.
“The challenge with TEM is that, although the oncologic outcomes are quite good with early-stage disease, the adoption has been very poor over 3 decades mainly because it requires specialized equipment with a very large upfront cost that is limited to use in the rectum,” Dr. Costello said. He estimated the initial capital investment cost for TEM equipment at up to $60,000 on average.
The TAMIS approach, on the other hand, carries a per-procedure equipment cost of about $500 over traditional laparoscopic surgery, he said. It can utilize the single-incision laparoscopic port (SILS) for the transanal approach. TAMIS sacrifices the three-dimensional view of TEM for two-dimensional, but it does provide 360-degree visualization. The surgeon must also be facile with the laparoscopic technique. “In the past that was a big challenge, but now all trainees are very familiar with laparoscopic surgery,” Dr. Costello said.
While the paucity of data on the TAMIS approach makes it difficult to make a strong case for the procedure, the path forward is clear, Dr. Costello said.
“We feel, as do a number of authors of the most papers, that the time truly is now for an actual prospective randomized trial to compare these techniques head-to-head, because colorectal surgeons now have the skill set to be facile at both,” Dr. Costello said.
The investigators had no financial relationships to disclose.
AT THE ACADEMIC SURGICAL CONGRESS
Key clinical point: TAMIS for removal of rectal tumors achieved equal outcomes to TEM with measurable cost savings.
Major finding: The review found similar outcomes between the two procedures and low recurrence rates for small tumors (up to 3 cm) of 4% for TAMIS and 5% for TEM.
Data source: Systematic literature review of fewer than 500 cases of TAMIS, compared with results of TEM literature.
Disclosures: The study authors reported having no financial disclosures.
New postop pain guideline: Multiple approaches to target different pain mechanisms
Clinicians should use multiple approaches to target different pain mechanisms when treating postsurgical pain, according to a Clinical Practice Guideline for this aspect of patient care published by the American Pain Society in the February issue of the Journal of Pain.
Postoperative pain management reportedly is inadequate for more than half of the adults and children who undergo surgery each year. In this setting, inadequate pain relief can contribute to impaired recovery, decreased physical function, postoperative complications, and poor quality of life, and it may even set the stage for the development of chronic pain, said Dr. Roger Chou, lead author of the guideline and professor of medicine and of medical informatics and clinical epidemiology, Oregon Health and Science University, Portland, and his associates.
The guideline includes 32 evidence-based recommendations for all clinicians who treat postoperative pain. It was compiled by a 23-member expert panel based on their analysis of 858 primary studies and 107 systematic reviews of the literature. Despite the panel’s efforts to obtain top-level evidence, of 32 recommendations, the panel rated only 4 as supported by high-quality evidence, and 11 recommendations were on the basis of low-quality evidence. The panel members had expertise in anesthesia, pain medicine, surgery, obstetrics and gynecology, primary care, pediatrics, hospital medicine, nursing, physical therapy, and psychology, said Dr. Chou, who is also director of the Pacific Northwest Evidence-Based Practice Center, Portland, and his associates.
The first strong recommendation, based on high-quality evidence, is to use a variety of medications and techniques that act on both the central and peripheral nervous systems and have been associated with both superior pain relief and decreased opioid consumption, compared with single agents or methods. For example, continuous nonopioid analgesia such as acetaminophen or NSAIDs can be combined with opioids that act on different receptors and with nonpharmacologic therapies. The guideline addresses several specific situations, and summarizes in a table the multimodal options for common surgeries such as laparotomy, total hip or knee replacement, coronary artery bypass graft, and cesarean section.
The guideline also strongly recommends that management of postsurgical pain should begin preoperatively, with assessment of the patient’s medical and psychiatric comorbidities; concomitant medications; and history of any chronic pain, substance abuse, and previous postoperative treatments and responses. Clinicians should use a validated pain assessment tool to track patients’ responses to postsurgical pain treatment and adjust treatment plans accordingly.
The guideline suggests that clinicians consider nonpharmacologic techniques including transcutaneous electrical nerve stimulation and cognitive-behavioral modalities such as guided imagery, relaxation methods, hypnosis, and intraoperative suggestion. At the very least, these are noninvasive and don’t appear to be associated with any harm. However, the guideline cautions that the evidence is insufficient to support cognitive-behavioral modalities in children. It also cannot recommend for or against several alternative treatments for which there is not yet sufficient evidence of efficacy, including acupuncture, massage, and cold therapy, Dr. Chou and his associates said (J Pain. 2016;17:131-57).
For adults who have no contraindications, a preoperative dose of celecoxib is strongly recommended because it improves postoperative pain and also reduces the need for opioids. One contraindication to celecoxib is CABG surgery, because of its attendant risk of adverse cardiovascular events. Preoperative doses of gabapentin or pregabalin also are strongly recommended as part of multimodal postsurgical analgesia, particularly for operations associated with substantial pain.
The guideline also strongly recommends epidural or spinal analgesia for major thoracic or abdominal procedures, especially for patients at risk for cardiac complications, pulmonary complications, or prolonged ileus. Compared with systemic analgesia, these forms appear to decrease the risk of death, venous thromboembolism, myocardial infarction, pneumonia, and respiratory depression. However, patients who receive neuraxial analgesia should still be carefully monitored, as they may develop respiratory depression, hypotension, or motor weakness, or the intervention might mask symptoms of compartment syndrome.
According to the guideline, all facilities that offer surgery should also provide clinicians with access to a pain specialist. The specialist should be available to consult for patients with inadequately controlled postoperative pain and to assist with diagnosis, interventions, or management of comorbid conditions. They may be especially useful for advising clinicians regarding patients who have opioid tolerance, especially if there is a history of substance abuse or addiction. Pain treatment should not be withheld from such patients “because of fears of worsening addiction or precipitation of relapse. In addition to the ethical requirement to address postoperative pain, poorly treated pain can be a trigger for relapse,” the guideline states.
The guideline also addresses the transition to outpatient care and identifies some research gaps. “Research is urgently needed on optimal methods for managing patients who receive opioids before surgery, effectiveness of opioid-sparing multimodal regimens, optimal methods of pain assessment and monitoring, and a number of areas related to management of perioperative pain in infants and children,” the panel concluded.
Funding for this guideline was provided by the American Pain Society. Dr. Chou’s and his associates’ financial disclosures are available at www.jpain.org.
Clinicians should use multiple approaches to target different pain mechanisms when treating postsurgical pain, according to a Clinical Practice Guideline for this aspect of patient care published by the American Pain Society in the February issue of the Journal of Pain.
Postoperative pain management reportedly is inadequate for more than half of the adults and children who undergo surgery each year. In this setting, inadequate pain relief can contribute to impaired recovery, decreased physical function, postoperative complications, and poor quality of life, and it may even set the stage for the development of chronic pain, said Dr. Roger Chou, lead author of the guideline and professor of medicine and of medical informatics and clinical epidemiology, Oregon Health and Science University, Portland, and his associates.
The guideline includes 32 evidence-based recommendations for all clinicians who treat postoperative pain. It was compiled by a 23-member expert panel based on their analysis of 858 primary studies and 107 systematic reviews of the literature. Despite the panel’s efforts to obtain top-level evidence, of 32 recommendations, the panel rated only 4 as supported by high-quality evidence, and 11 recommendations were on the basis of low-quality evidence. The panel members had expertise in anesthesia, pain medicine, surgery, obstetrics and gynecology, primary care, pediatrics, hospital medicine, nursing, physical therapy, and psychology, said Dr. Chou, who is also director of the Pacific Northwest Evidence-Based Practice Center, Portland, and his associates.
The first strong recommendation, based on high-quality evidence, is to use a variety of medications and techniques that act on both the central and peripheral nervous systems and have been associated with both superior pain relief and decreased opioid consumption, compared with single agents or methods. For example, continuous nonopioid analgesia such as acetaminophen or NSAIDs can be combined with opioids that act on different receptors and with nonpharmacologic therapies. The guideline addresses several specific situations, and summarizes in a table the multimodal options for common surgeries such as laparotomy, total hip or knee replacement, coronary artery bypass graft, and cesarean section.
The guideline also strongly recommends that management of postsurgical pain should begin preoperatively, with assessment of the patient’s medical and psychiatric comorbidities; concomitant medications; and history of any chronic pain, substance abuse, and previous postoperative treatments and responses. Clinicians should use a validated pain assessment tool to track patients’ responses to postsurgical pain treatment and adjust treatment plans accordingly.
The guideline suggests that clinicians consider nonpharmacologic techniques including transcutaneous electrical nerve stimulation and cognitive-behavioral modalities such as guided imagery, relaxation methods, hypnosis, and intraoperative suggestion. At the very least, these are noninvasive and don’t appear to be associated with any harm. However, the guideline cautions that the evidence is insufficient to support cognitive-behavioral modalities in children. It also cannot recommend for or against several alternative treatments for which there is not yet sufficient evidence of efficacy, including acupuncture, massage, and cold therapy, Dr. Chou and his associates said (J Pain. 2016;17:131-57).
For adults who have no contraindications, a preoperative dose of celecoxib is strongly recommended because it improves postoperative pain and also reduces the need for opioids. One contraindication to celecoxib is CABG surgery, because of its attendant risk of adverse cardiovascular events. Preoperative doses of gabapentin or pregabalin also are strongly recommended as part of multimodal postsurgical analgesia, particularly for operations associated with substantial pain.
The guideline also strongly recommends epidural or spinal analgesia for major thoracic or abdominal procedures, especially for patients at risk for cardiac complications, pulmonary complications, or prolonged ileus. Compared with systemic analgesia, these forms appear to decrease the risk of death, venous thromboembolism, myocardial infarction, pneumonia, and respiratory depression. However, patients who receive neuraxial analgesia should still be carefully monitored, as they may develop respiratory depression, hypotension, or motor weakness, or the intervention might mask symptoms of compartment syndrome.
According to the guideline, all facilities that offer surgery should also provide clinicians with access to a pain specialist. The specialist should be available to consult for patients with inadequately controlled postoperative pain and to assist with diagnosis, interventions, or management of comorbid conditions. They may be especially useful for advising clinicians regarding patients who have opioid tolerance, especially if there is a history of substance abuse or addiction. Pain treatment should not be withheld from such patients “because of fears of worsening addiction or precipitation of relapse. In addition to the ethical requirement to address postoperative pain, poorly treated pain can be a trigger for relapse,” the guideline states.
The guideline also addresses the transition to outpatient care and identifies some research gaps. “Research is urgently needed on optimal methods for managing patients who receive opioids before surgery, effectiveness of opioid-sparing multimodal regimens, optimal methods of pain assessment and monitoring, and a number of areas related to management of perioperative pain in infants and children,” the panel concluded.
Funding for this guideline was provided by the American Pain Society. Dr. Chou’s and his associates’ financial disclosures are available at www.jpain.org.
Clinicians should use multiple approaches to target different pain mechanisms when treating postsurgical pain, according to a Clinical Practice Guideline for this aspect of patient care published by the American Pain Society in the February issue of the Journal of Pain.
Postoperative pain management reportedly is inadequate for more than half of the adults and children who undergo surgery each year. In this setting, inadequate pain relief can contribute to impaired recovery, decreased physical function, postoperative complications, and poor quality of life, and it may even set the stage for the development of chronic pain, said Dr. Roger Chou, lead author of the guideline and professor of medicine and of medical informatics and clinical epidemiology, Oregon Health and Science University, Portland, and his associates.
The guideline includes 32 evidence-based recommendations for all clinicians who treat postoperative pain. It was compiled by a 23-member expert panel based on their analysis of 858 primary studies and 107 systematic reviews of the literature. Despite the panel’s efforts to obtain top-level evidence, of 32 recommendations, the panel rated only 4 as supported by high-quality evidence, and 11 recommendations were on the basis of low-quality evidence. The panel members had expertise in anesthesia, pain medicine, surgery, obstetrics and gynecology, primary care, pediatrics, hospital medicine, nursing, physical therapy, and psychology, said Dr. Chou, who is also director of the Pacific Northwest Evidence-Based Practice Center, Portland, and his associates.
The first strong recommendation, based on high-quality evidence, is to use a variety of medications and techniques that act on both the central and peripheral nervous systems and have been associated with both superior pain relief and decreased opioid consumption, compared with single agents or methods. For example, continuous nonopioid analgesia such as acetaminophen or NSAIDs can be combined with opioids that act on different receptors and with nonpharmacologic therapies. The guideline addresses several specific situations, and summarizes in a table the multimodal options for common surgeries such as laparotomy, total hip or knee replacement, coronary artery bypass graft, and cesarean section.
The guideline also strongly recommends that management of postsurgical pain should begin preoperatively, with assessment of the patient’s medical and psychiatric comorbidities; concomitant medications; and history of any chronic pain, substance abuse, and previous postoperative treatments and responses. Clinicians should use a validated pain assessment tool to track patients’ responses to postsurgical pain treatment and adjust treatment plans accordingly.
The guideline suggests that clinicians consider nonpharmacologic techniques including transcutaneous electrical nerve stimulation and cognitive-behavioral modalities such as guided imagery, relaxation methods, hypnosis, and intraoperative suggestion. At the very least, these are noninvasive and don’t appear to be associated with any harm. However, the guideline cautions that the evidence is insufficient to support cognitive-behavioral modalities in children. It also cannot recommend for or against several alternative treatments for which there is not yet sufficient evidence of efficacy, including acupuncture, massage, and cold therapy, Dr. Chou and his associates said (J Pain. 2016;17:131-57).
For adults who have no contraindications, a preoperative dose of celecoxib is strongly recommended because it improves postoperative pain and also reduces the need for opioids. One contraindication to celecoxib is CABG surgery, because of its attendant risk of adverse cardiovascular events. Preoperative doses of gabapentin or pregabalin also are strongly recommended as part of multimodal postsurgical analgesia, particularly for operations associated with substantial pain.
The guideline also strongly recommends epidural or spinal analgesia for major thoracic or abdominal procedures, especially for patients at risk for cardiac complications, pulmonary complications, or prolonged ileus. Compared with systemic analgesia, these forms appear to decrease the risk of death, venous thromboembolism, myocardial infarction, pneumonia, and respiratory depression. However, patients who receive neuraxial analgesia should still be carefully monitored, as they may develop respiratory depression, hypotension, or motor weakness, or the intervention might mask symptoms of compartment syndrome.
According to the guideline, all facilities that offer surgery should also provide clinicians with access to a pain specialist. The specialist should be available to consult for patients with inadequately controlled postoperative pain and to assist with diagnosis, interventions, or management of comorbid conditions. They may be especially useful for advising clinicians regarding patients who have opioid tolerance, especially if there is a history of substance abuse or addiction. Pain treatment should not be withheld from such patients “because of fears of worsening addiction or precipitation of relapse. In addition to the ethical requirement to address postoperative pain, poorly treated pain can be a trigger for relapse,” the guideline states.
The guideline also addresses the transition to outpatient care and identifies some research gaps. “Research is urgently needed on optimal methods for managing patients who receive opioids before surgery, effectiveness of opioid-sparing multimodal regimens, optimal methods of pain assessment and monitoring, and a number of areas related to management of perioperative pain in infants and children,” the panel concluded.
Funding for this guideline was provided by the American Pain Society. Dr. Chou’s and his associates’ financial disclosures are available at www.jpain.org.
FROM THE JOURNAL OF PAIN
Robotic colectomy takes longer, comparable results
JACKSONVILLE, FLA. – Robotic-assisted colectomy took longer than the laparoscopic operation but didn’t result in better surgical outcomes in a large NSQIP data–based study.
As health care moves away from fee-for-service to a value-based model, the longer operative times and comparative outcomes to laparoscopic colectomy suggest that the use of robotic technologies in straightforward colon resections may not be justified at this time, investigators at Duke University concluded.
“This is the largest analysis to date of robotic-assisted vs. laparoscopic colectomy,” Dr. Brian Ezekian, general surgery resident at Duke, reported at the Association for Academic Surgery/Society of University Surgeons Academic Surgical Congress. “While the robotic approach is still in its infancy, the technology is associated with increased operative times without improved clinical outcomes, so our study suggests that the routine use of robotic surgery for colectomy may not be financially justifiable at this time.”
The study sampled the American College of Surgeons’ National Surgical Quality Improvement Program (NSQIP) database for patients who had either a robotic or laparoscopic colectomy from 2012 to 2013. Among the 15,976 patients included, 498 of them (3.1%) had robotic colectomy, Dr. Ezekian said.
“The major finding of our study was that robotic-assisted colectomy was associated with roughly 30-minute longer operative times, whereas the short-term clinical outcomes were comparable between the two groups,” Dr. Ezekian said. “This held true for a subset analysis of patients undergoing segmental colectomy only.”
The analysis found no significant difference between the two approaches in rates of wound complications, urinary tract infections, cardiopulmonary or thromboembolic complications, kidney failure or insufficiency, anastomotic leaks, transfusions, unplanned readmissions, or 30-day death.
The key difference was in the operative times associated with each approach. The median time for robotic-assisted colectomy was 196 minutes vs. 166 minutes for the laparoscopic approach. The study found a similar gap for segmental resections only: 190 minutes for the robotic-assisted approach vs. 153 minutes for the laparoscopic approach.
Dr. Ezekian acknowledged that this observation might merely reflect an early experience with this novel technology. “A future direction for this research is to see if operative times for robotic-assisted surgery decrease over time once there are more years in the NSQIP database or in single-institution studies,” he said.
The authors had no financial relationships to disclose.
JACKSONVILLE, FLA. – Robotic-assisted colectomy took longer than the laparoscopic operation but didn’t result in better surgical outcomes in a large NSQIP data–based study.
As health care moves away from fee-for-service to a value-based model, the longer operative times and comparative outcomes to laparoscopic colectomy suggest that the use of robotic technologies in straightforward colon resections may not be justified at this time, investigators at Duke University concluded.
“This is the largest analysis to date of robotic-assisted vs. laparoscopic colectomy,” Dr. Brian Ezekian, general surgery resident at Duke, reported at the Association for Academic Surgery/Society of University Surgeons Academic Surgical Congress. “While the robotic approach is still in its infancy, the technology is associated with increased operative times without improved clinical outcomes, so our study suggests that the routine use of robotic surgery for colectomy may not be financially justifiable at this time.”
The study sampled the American College of Surgeons’ National Surgical Quality Improvement Program (NSQIP) database for patients who had either a robotic or laparoscopic colectomy from 2012 to 2013. Among the 15,976 patients included, 498 of them (3.1%) had robotic colectomy, Dr. Ezekian said.
“The major finding of our study was that robotic-assisted colectomy was associated with roughly 30-minute longer operative times, whereas the short-term clinical outcomes were comparable between the two groups,” Dr. Ezekian said. “This held true for a subset analysis of patients undergoing segmental colectomy only.”
The analysis found no significant difference between the two approaches in rates of wound complications, urinary tract infections, cardiopulmonary or thromboembolic complications, kidney failure or insufficiency, anastomotic leaks, transfusions, unplanned readmissions, or 30-day death.
The key difference was in the operative times associated with each approach. The median time for robotic-assisted colectomy was 196 minutes vs. 166 minutes for the laparoscopic approach. The study found a similar gap for segmental resections only: 190 minutes for the robotic-assisted approach vs. 153 minutes for the laparoscopic approach.
Dr. Ezekian acknowledged that this observation might merely reflect an early experience with this novel technology. “A future direction for this research is to see if operative times for robotic-assisted surgery decrease over time once there are more years in the NSQIP database or in single-institution studies,” he said.
The authors had no financial relationships to disclose.
JACKSONVILLE, FLA. – Robotic-assisted colectomy took longer than the laparoscopic operation but didn’t result in better surgical outcomes in a large NSQIP data–based study.
As health care moves away from fee-for-service to a value-based model, the longer operative times and comparative outcomes to laparoscopic colectomy suggest that the use of robotic technologies in straightforward colon resections may not be justified at this time, investigators at Duke University concluded.
“This is the largest analysis to date of robotic-assisted vs. laparoscopic colectomy,” Dr. Brian Ezekian, general surgery resident at Duke, reported at the Association for Academic Surgery/Society of University Surgeons Academic Surgical Congress. “While the robotic approach is still in its infancy, the technology is associated with increased operative times without improved clinical outcomes, so our study suggests that the routine use of robotic surgery for colectomy may not be financially justifiable at this time.”
The study sampled the American College of Surgeons’ National Surgical Quality Improvement Program (NSQIP) database for patients who had either a robotic or laparoscopic colectomy from 2012 to 2013. Among the 15,976 patients included, 498 of them (3.1%) had robotic colectomy, Dr. Ezekian said.
“The major finding of our study was that robotic-assisted colectomy was associated with roughly 30-minute longer operative times, whereas the short-term clinical outcomes were comparable between the two groups,” Dr. Ezekian said. “This held true for a subset analysis of patients undergoing segmental colectomy only.”
The analysis found no significant difference between the two approaches in rates of wound complications, urinary tract infections, cardiopulmonary or thromboembolic complications, kidney failure or insufficiency, anastomotic leaks, transfusions, unplanned readmissions, or 30-day death.
The key difference was in the operative times associated with each approach. The median time for robotic-assisted colectomy was 196 minutes vs. 166 minutes for the laparoscopic approach. The study found a similar gap for segmental resections only: 190 minutes for the robotic-assisted approach vs. 153 minutes for the laparoscopic approach.
Dr. Ezekian acknowledged that this observation might merely reflect an early experience with this novel technology. “A future direction for this research is to see if operative times for robotic-assisted surgery decrease over time once there are more years in the NSQIP database or in single-institution studies,” he said.
The authors had no financial relationships to disclose.
AT THE ACADEMIC SURGICAL CONGRESS
Key clinical point: Robotic-assisted colectomy for straightforward resections involves longer operative times than laparoscopic surgery.
Major finding: Robotic-assisted colectomy was associated with roughly 30-minute longer operative times than laparoscopic surgery with comparable short-term clinical outcomes.
Data source: Analysis of 15,976 cases of colectomy in the American College of Surgeons National Surgical Quality Improvement Program performed from 2012 to 2014.
Disclosures: The study authors reported having no financial disclosures.
Can ‘big data’ predict postop complications?
JACKSONVILLE, FLA. The potential of “big data” to predict surgical complications has long been expected and that potential may now in the process of becoming a reality.
As health care moves to a value-based system that penalizes surgeons and hospitals for readmissions, the inability to predict postop complications remains a problem, but investigators at University of Wisconsin have found a way to use “big data” to create a model that may help surgeons identify at-risk individuals before complications occur.
Shara Feld, Ph.D., a medical student at Wisconsin, reported on the development of a Markov chain model that sequences random variables to calculate varying states over time. “A Markov model represents the patient progression through a series of health states,” Dr. Feld said at the Association for Academic Surgery/Society of University Surgeons Academic Surgical Congress
“A Markov chain model combining information about prior complications and the time to occurrence after surgery can inform our likelihood of specific future complications,” she said. “Understanding these relationships among complications can improve our ability to select targeted interventions, to avoid cascades of multiple complications, counsel patients and family on prognosis, assist with care decisions, and develop quality improvement measures.”
The model draws on 3 million operations in the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) database from 2005 to 2013. Of those, 400,000 cases involved one complication and 132,000 two or more complications, Dr. Feld said. From that, the investigators identified 21 different complications, including superficial, deep and organ surgical site infections, cardiac arrest, and pneumonia. The study accounted for complications within 30 days of the operation.
Dr. Feld pointed to one of the challenges using the existing literature on surgical risk assessment: “We know that patients can have one complication that can snowball into multiple complications, and as this snowball of complications develops, the postoperative risk in patient prognosis can change from what it was based on preoperative risk factors,” she said.
The model was best at predicting death, coma longer than a day, cardiac arrest, septic shock, renal failure, pneumonia, unplanned reintubation, ventilator use of more than 2 days, and bleeding transfusion, Dr. Feld said.
The study also found that complications most likely to cascade to a higher level were cardiac arrest, renal insufficiency or failure, stroke, intubation, septic shock, and coma, Dr. Feld said. For example, a patient who has a coma has an odds ratio greater than 1.5 of dying within 30 days of the operation while the odds ratio for death following a diagnosis of superficial surgical site infection is less than 0.5, the study found.
Evaluating population-based complication risks after surgery was difficult before the large ACS NSQIP database became available to researchers, Dr. Feld said. The model reveals the impact of specific complications, complication timing, and how combinations of multiple postoperative complications change the risk for the development of future complications..
This model has not to date looked at what type of procedure led to the complications but this line of research may be developed in the future, Dr. Feld said.
The authors had no financial relationships to disclose.
JACKSONVILLE, FLA. The potential of “big data” to predict surgical complications has long been expected and that potential may now in the process of becoming a reality.
As health care moves to a value-based system that penalizes surgeons and hospitals for readmissions, the inability to predict postop complications remains a problem, but investigators at University of Wisconsin have found a way to use “big data” to create a model that may help surgeons identify at-risk individuals before complications occur.
Shara Feld, Ph.D., a medical student at Wisconsin, reported on the development of a Markov chain model that sequences random variables to calculate varying states over time. “A Markov model represents the patient progression through a series of health states,” Dr. Feld said at the Association for Academic Surgery/Society of University Surgeons Academic Surgical Congress
“A Markov chain model combining information about prior complications and the time to occurrence after surgery can inform our likelihood of specific future complications,” she said. “Understanding these relationships among complications can improve our ability to select targeted interventions, to avoid cascades of multiple complications, counsel patients and family on prognosis, assist with care decisions, and develop quality improvement measures.”
The model draws on 3 million operations in the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) database from 2005 to 2013. Of those, 400,000 cases involved one complication and 132,000 two or more complications, Dr. Feld said. From that, the investigators identified 21 different complications, including superficial, deep and organ surgical site infections, cardiac arrest, and pneumonia. The study accounted for complications within 30 days of the operation.
Dr. Feld pointed to one of the challenges using the existing literature on surgical risk assessment: “We know that patients can have one complication that can snowball into multiple complications, and as this snowball of complications develops, the postoperative risk in patient prognosis can change from what it was based on preoperative risk factors,” she said.
The model was best at predicting death, coma longer than a day, cardiac arrest, septic shock, renal failure, pneumonia, unplanned reintubation, ventilator use of more than 2 days, and bleeding transfusion, Dr. Feld said.
The study also found that complications most likely to cascade to a higher level were cardiac arrest, renal insufficiency or failure, stroke, intubation, septic shock, and coma, Dr. Feld said. For example, a patient who has a coma has an odds ratio greater than 1.5 of dying within 30 days of the operation while the odds ratio for death following a diagnosis of superficial surgical site infection is less than 0.5, the study found.
Evaluating population-based complication risks after surgery was difficult before the large ACS NSQIP database became available to researchers, Dr. Feld said. The model reveals the impact of specific complications, complication timing, and how combinations of multiple postoperative complications change the risk for the development of future complications..
This model has not to date looked at what type of procedure led to the complications but this line of research may be developed in the future, Dr. Feld said.
The authors had no financial relationships to disclose.
JACKSONVILLE, FLA. The potential of “big data” to predict surgical complications has long been expected and that potential may now in the process of becoming a reality.
As health care moves to a value-based system that penalizes surgeons and hospitals for readmissions, the inability to predict postop complications remains a problem, but investigators at University of Wisconsin have found a way to use “big data” to create a model that may help surgeons identify at-risk individuals before complications occur.
Shara Feld, Ph.D., a medical student at Wisconsin, reported on the development of a Markov chain model that sequences random variables to calculate varying states over time. “A Markov model represents the patient progression through a series of health states,” Dr. Feld said at the Association for Academic Surgery/Society of University Surgeons Academic Surgical Congress
“A Markov chain model combining information about prior complications and the time to occurrence after surgery can inform our likelihood of specific future complications,” she said. “Understanding these relationships among complications can improve our ability to select targeted interventions, to avoid cascades of multiple complications, counsel patients and family on prognosis, assist with care decisions, and develop quality improvement measures.”
The model draws on 3 million operations in the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) database from 2005 to 2013. Of those, 400,000 cases involved one complication and 132,000 two or more complications, Dr. Feld said. From that, the investigators identified 21 different complications, including superficial, deep and organ surgical site infections, cardiac arrest, and pneumonia. The study accounted for complications within 30 days of the operation.
Dr. Feld pointed to one of the challenges using the existing literature on surgical risk assessment: “We know that patients can have one complication that can snowball into multiple complications, and as this snowball of complications develops, the postoperative risk in patient prognosis can change from what it was based on preoperative risk factors,” she said.
The model was best at predicting death, coma longer than a day, cardiac arrest, septic shock, renal failure, pneumonia, unplanned reintubation, ventilator use of more than 2 days, and bleeding transfusion, Dr. Feld said.
The study also found that complications most likely to cascade to a higher level were cardiac arrest, renal insufficiency or failure, stroke, intubation, septic shock, and coma, Dr. Feld said. For example, a patient who has a coma has an odds ratio greater than 1.5 of dying within 30 days of the operation while the odds ratio for death following a diagnosis of superficial surgical site infection is less than 0.5, the study found.
Evaluating population-based complication risks after surgery was difficult before the large ACS NSQIP database became available to researchers, Dr. Feld said. The model reveals the impact of specific complications, complication timing, and how combinations of multiple postoperative complications change the risk for the development of future complications..
This model has not to date looked at what type of procedure led to the complications but this line of research may be developed in the future, Dr. Feld said.
The authors had no financial relationships to disclose.
AT THE ACADEMIC SURGICAL CONGRESS
Key clinical point: A Markov chain model using data from the American College of Surgeons National Surgical Quality Improvement Program may provide a tool for predicting complications after surgery.
Major finding: The model was best at predicting death, coma longer than a day, cardiac arrest, septic shock, renal failure, pneumonia, unplanned reintubation, ventilator use of more than 2 days, and bleeding.
Data source: The model draws on 3 million operations in the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) database from 2005 to 2013.
Disclosures: The study authors reported having no financial disclosures.
