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The Official Newspaper of the American Association for Thoracic Surgery
DAPT produces better CABG outcomes than aspirin alone
ANAHEIM, CALIF. – Treatment with dual-antiplatelet therapy following coronary artery bypass grafting with a saphenous vein maintained vein-graft patency better than aspirin alone in a randomized, multicenter trial with 500 patients.
After 1 year of dual-antiplatelet therapy (DAPT) with ticagrelor (Brilinta) and aspirin, 89% of saphenous-vein grafts remained patent, compared with a 77% patency rate in saphenous-vein grafts in patients treated with aspirin alone, a statistically significant difference for the study’s primary endpoint, Qiang Zhao, MD, said at the American Hart Association scientific sessions. The data, collected at six Chinese centers, also showed a nominal decrease in the combined rate of cardiovascular death, MI, and stroke: 2% with DAPT and 5% with aspirin alone. It further showed an increase in major or bypass-related bleeds: 2% with DAPT and none with aspirin alone, reported Dr. Zhao, professor and director of cardiac surgery at Ruijin Hospital in Shanghai, China.
“If this result were repeated in a larger study it would be important,” John H. Alexander, MD, professor of medicine at Duke University in Durham, N.C., commented in a video interview.
The Compare the Efficacy of Different Antiplatelet Therapy Strategy After Coronary Artery Bypass Graft Surgery (DACAB) trial randomized patients who underwent coronary artery bypass grafting (CABG). They averaged about 64 years of age, and received an average of nearly four grafts each including an average of nearly three saphenous vein grafts. The study assigned patients to one of three treatment arms starting within 24 hours after surgery: 168 received ticagrelor 90 mg twice daily plus aspirin 100 mg once daily, 166 got ticagrelor alone, and 166 received aspirin alone. Treatment continued for 1 year.
“Some surgeons and physicians currently prescribe DAPT to CABG patients, but there is not much evidence of its benefit. The DACAB trial is useful, but you need to show that it does not just improve patency but that patients also have better outcomes. The excess of major bleeds is a big deal. It gives one pause about adopting DAPT as standard treatment,” Dr. Gardner said.
DACAB received no commercial funding. Dr. Zhao has been a speaker on behalf of and has received research funding from AstraZeneca, the company that markets ticagrelor (Brilinta). He has also been a speaker for Johnson & Johnson and Medtronic and has received research funding from Bayer, Novartis, and Sanofi. Dr. Gardner had no disclosures.
[email protected]
On Twitter @mitchelzoler
Results from the DACAB trial showed that using aspirin and ticagrelor improved vein-graft patency, compared with using aspirin alone. It was a compelling result, but for the intermediate, imaging-based outcome of graft patency at 1 year after surgery. This finding is conclusive evidence that dual-antiplatelet therapy has some benefit.
But the findings from this trial, modestly sized with 500 patients, failed to prove that the clinical benefit from dual-antiplatelet therapy was worth the adverse effect of an increase in the rate of major and bypass-related bleeding. The study was underpowered to prove that dual-antiplatelet therapy had a clear beneficial impact on clinical outcomes such as cardiovascular death, MI, and stroke, although this combined rate went in the right direction with dual therapy, compared with aspirin alone. We need to see proof of a benefit for these clinical outcomes to justify using a treatment that causes an increase in major bleeds.
The DACAB results alone are not enough to justify a change in practice. It would be an important finding if the results could be replicated in a larger study. And if dual-antiplatelet therapy was proven to have a net clinical benefit for patients, we would still want to target it to patients with a higher ischemic risk and, in general, avoid using it in patients with a high bleeding risk.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
John H. Alexander, MD , is a cardiologist and professor of medicine at Duke University in Durham, N.C. He has been a consultant to and has received research funding from several companies, including AstraZeneca, the company that markets ticagrelor (Brilinta). He made these comments as designated discussant for the DACAB study and in a video interview .
Results from the DACAB trial showed that using aspirin and ticagrelor improved vein-graft patency, compared with using aspirin alone. It was a compelling result, but for the intermediate, imaging-based outcome of graft patency at 1 year after surgery. This finding is conclusive evidence that dual-antiplatelet therapy has some benefit.
But the findings from this trial, modestly sized with 500 patients, failed to prove that the clinical benefit from dual-antiplatelet therapy was worth the adverse effect of an increase in the rate of major and bypass-related bleeding. The study was underpowered to prove that dual-antiplatelet therapy had a clear beneficial impact on clinical outcomes such as cardiovascular death, MI, and stroke, although this combined rate went in the right direction with dual therapy, compared with aspirin alone. We need to see proof of a benefit for these clinical outcomes to justify using a treatment that causes an increase in major bleeds.
The DACAB results alone are not enough to justify a change in practice. It would be an important finding if the results could be replicated in a larger study. And if dual-antiplatelet therapy was proven to have a net clinical benefit for patients, we would still want to target it to patients with a higher ischemic risk and, in general, avoid using it in patients with a high bleeding risk.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
John H. Alexander, MD , is a cardiologist and professor of medicine at Duke University in Durham, N.C. He has been a consultant to and has received research funding from several companies, including AstraZeneca, the company that markets ticagrelor (Brilinta). He made these comments as designated discussant for the DACAB study and in a video interview .
Results from the DACAB trial showed that using aspirin and ticagrelor improved vein-graft patency, compared with using aspirin alone. It was a compelling result, but for the intermediate, imaging-based outcome of graft patency at 1 year after surgery. This finding is conclusive evidence that dual-antiplatelet therapy has some benefit.
But the findings from this trial, modestly sized with 500 patients, failed to prove that the clinical benefit from dual-antiplatelet therapy was worth the adverse effect of an increase in the rate of major and bypass-related bleeding. The study was underpowered to prove that dual-antiplatelet therapy had a clear beneficial impact on clinical outcomes such as cardiovascular death, MI, and stroke, although this combined rate went in the right direction with dual therapy, compared with aspirin alone. We need to see proof of a benefit for these clinical outcomes to justify using a treatment that causes an increase in major bleeds.
The DACAB results alone are not enough to justify a change in practice. It would be an important finding if the results could be replicated in a larger study. And if dual-antiplatelet therapy was proven to have a net clinical benefit for patients, we would still want to target it to patients with a higher ischemic risk and, in general, avoid using it in patients with a high bleeding risk.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
John H. Alexander, MD , is a cardiologist and professor of medicine at Duke University in Durham, N.C. He has been a consultant to and has received research funding from several companies, including AstraZeneca, the company that markets ticagrelor (Brilinta). He made these comments as designated discussant for the DACAB study and in a video interview .
ANAHEIM, CALIF. – Treatment with dual-antiplatelet therapy following coronary artery bypass grafting with a saphenous vein maintained vein-graft patency better than aspirin alone in a randomized, multicenter trial with 500 patients.
After 1 year of dual-antiplatelet therapy (DAPT) with ticagrelor (Brilinta) and aspirin, 89% of saphenous-vein grafts remained patent, compared with a 77% patency rate in saphenous-vein grafts in patients treated with aspirin alone, a statistically significant difference for the study’s primary endpoint, Qiang Zhao, MD, said at the American Hart Association scientific sessions. The data, collected at six Chinese centers, also showed a nominal decrease in the combined rate of cardiovascular death, MI, and stroke: 2% with DAPT and 5% with aspirin alone. It further showed an increase in major or bypass-related bleeds: 2% with DAPT and none with aspirin alone, reported Dr. Zhao, professor and director of cardiac surgery at Ruijin Hospital in Shanghai, China.
“If this result were repeated in a larger study it would be important,” John H. Alexander, MD, professor of medicine at Duke University in Durham, N.C., commented in a video interview.
The Compare the Efficacy of Different Antiplatelet Therapy Strategy After Coronary Artery Bypass Graft Surgery (DACAB) trial randomized patients who underwent coronary artery bypass grafting (CABG). They averaged about 64 years of age, and received an average of nearly four grafts each including an average of nearly three saphenous vein grafts. The study assigned patients to one of three treatment arms starting within 24 hours after surgery: 168 received ticagrelor 90 mg twice daily plus aspirin 100 mg once daily, 166 got ticagrelor alone, and 166 received aspirin alone. Treatment continued for 1 year.
“Some surgeons and physicians currently prescribe DAPT to CABG patients, but there is not much evidence of its benefit. The DACAB trial is useful, but you need to show that it does not just improve patency but that patients also have better outcomes. The excess of major bleeds is a big deal. It gives one pause about adopting DAPT as standard treatment,” Dr. Gardner said.
DACAB received no commercial funding. Dr. Zhao has been a speaker on behalf of and has received research funding from AstraZeneca, the company that markets ticagrelor (Brilinta). He has also been a speaker for Johnson & Johnson and Medtronic and has received research funding from Bayer, Novartis, and Sanofi. Dr. Gardner had no disclosures.
[email protected]
On Twitter @mitchelzoler
ANAHEIM, CALIF. – Treatment with dual-antiplatelet therapy following coronary artery bypass grafting with a saphenous vein maintained vein-graft patency better than aspirin alone in a randomized, multicenter trial with 500 patients.
After 1 year of dual-antiplatelet therapy (DAPT) with ticagrelor (Brilinta) and aspirin, 89% of saphenous-vein grafts remained patent, compared with a 77% patency rate in saphenous-vein grafts in patients treated with aspirin alone, a statistically significant difference for the study’s primary endpoint, Qiang Zhao, MD, said at the American Hart Association scientific sessions. The data, collected at six Chinese centers, also showed a nominal decrease in the combined rate of cardiovascular death, MI, and stroke: 2% with DAPT and 5% with aspirin alone. It further showed an increase in major or bypass-related bleeds: 2% with DAPT and none with aspirin alone, reported Dr. Zhao, professor and director of cardiac surgery at Ruijin Hospital in Shanghai, China.
“If this result were repeated in a larger study it would be important,” John H. Alexander, MD, professor of medicine at Duke University in Durham, N.C., commented in a video interview.
The Compare the Efficacy of Different Antiplatelet Therapy Strategy After Coronary Artery Bypass Graft Surgery (DACAB) trial randomized patients who underwent coronary artery bypass grafting (CABG). They averaged about 64 years of age, and received an average of nearly four grafts each including an average of nearly three saphenous vein grafts. The study assigned patients to one of three treatment arms starting within 24 hours after surgery: 168 received ticagrelor 90 mg twice daily plus aspirin 100 mg once daily, 166 got ticagrelor alone, and 166 received aspirin alone. Treatment continued for 1 year.
“Some surgeons and physicians currently prescribe DAPT to CABG patients, but there is not much evidence of its benefit. The DACAB trial is useful, but you need to show that it does not just improve patency but that patients also have better outcomes. The excess of major bleeds is a big deal. It gives one pause about adopting DAPT as standard treatment,” Dr. Gardner said.
DACAB received no commercial funding. Dr. Zhao has been a speaker on behalf of and has received research funding from AstraZeneca, the company that markets ticagrelor (Brilinta). He has also been a speaker for Johnson & Johnson and Medtronic and has received research funding from Bayer, Novartis, and Sanofi. Dr. Gardner had no disclosures.
[email protected]
On Twitter @mitchelzoler
AT THE AHA SCIENTIFIC SESSIONS
Key clinical point:
Major finding: The 1-year saphenous-vein graft patency rate was 89% with DAPT treatment and 77% with aspirin alone. Data source: DACAB, a multicenter, randomized trial with 500 Chinese patients.
Disclosures: DACAB received no commercial funding. Dr. Zhao has been a speaker on behalf of and has received research funding from AstraZeneca, the company that markets ticagrelor (Brilinta). He has also been a speaker for Johnson & Johnson and Medtronic and has received research funding from Bayer, Novartis, and Sanofi.
Former pharma exec nominated for top HHS post
Alex M. Azar II, a former pharmaceutical executive and member of the George W. Bush administration, has been selected by President Donald Trump to lead the Department of Health & Human Services.
Mr. Azar served as president of Eli Lilly in the United States for 5 years from 2012 to 2017, after joining the company in 2007. Prior to that, he served President Bush at HHS from 2001 to 2007, serving first as general counsel and later as deputy secretary under Secretary Michael O. Leavitt.
“The challenges plaguing the American health care system are serious. For too long, hardworking, middle-class families have been forced to bear the brunt of Obamacare’s failures in the form of higher premiums and fewer choices,” Senate Finance Committee Chairman Orrin Hatch (R-Utah) said in a statement. “The leader of HHS will be at the tip of the spear, working to not only right the wrongs of this deeply flawed law but also ensure the long-term sustainability of both Medicare and Medicaid.”
The Senate Finance Committee must first approve the nomination before it is considered by the full chamber.
“We commend President Trump for nominating Alex Azar for secretary of Health & Human Services,” House Energy & Commerce Committee Chairman Greg Walden (R-Ore.) and Health Subcommittee Chairman Michael Burgess, MD, (R-Texas) said in a joint statement. “He is a veteran of HHS, bringing with him a wealth of institutional knowledge that will be instrumental in delivering patient-centered health care and combating the opioid crisis. We look forward to working with Mr. Azar on these critical issues and many others in the future.”
The Campaign for Sustainable Rx Pricing, a coalition of physicians and other stakeholders across the health care industry, was more measured in its reaction to the news.
“We sincerely hope that Secretary-nominee Azar will follow through on the President’s commitment to achieve lower drug prices for all Americans,” according to a statement from CSRxP. “We look forward to working with him, once confirmed, to end anticompetitive practices that artificially inflate drug prices, restore a functioning prescription drug market, and rein in the exorbitant price hikes that harm patients, job creators, and taxpayers alike.”
The nomination process could be bumpy, as Mr. Azar has made statements in the news in the past that were in support the dismantling of the Affordable Care Act. But keeping him from the post will be difficult, as he would only need a simple majority vote in the Senate to gain approval. With Republicans holding 52 seats, it would only require three dissenting GOP senators, assuming the Democrats vote against the appointment. If two crossed the aisle, Vice President Mike Pence would cast the deciding vote.
Finance Committee Democrats boycotted the committee vote on Mr. Azar’s predecessor, Secretary Tom Price, MD, forcing committee Chairman Hatch to suspend rules in order to move the appointment to the full chamber for consideration.
Alex M. Azar II, a former pharmaceutical executive and member of the George W. Bush administration, has been selected by President Donald Trump to lead the Department of Health & Human Services.
Mr. Azar served as president of Eli Lilly in the United States for 5 years from 2012 to 2017, after joining the company in 2007. Prior to that, he served President Bush at HHS from 2001 to 2007, serving first as general counsel and later as deputy secretary under Secretary Michael O. Leavitt.
“The challenges plaguing the American health care system are serious. For too long, hardworking, middle-class families have been forced to bear the brunt of Obamacare’s failures in the form of higher premiums and fewer choices,” Senate Finance Committee Chairman Orrin Hatch (R-Utah) said in a statement. “The leader of HHS will be at the tip of the spear, working to not only right the wrongs of this deeply flawed law but also ensure the long-term sustainability of both Medicare and Medicaid.”
The Senate Finance Committee must first approve the nomination before it is considered by the full chamber.
“We commend President Trump for nominating Alex Azar for secretary of Health & Human Services,” House Energy & Commerce Committee Chairman Greg Walden (R-Ore.) and Health Subcommittee Chairman Michael Burgess, MD, (R-Texas) said in a joint statement. “He is a veteran of HHS, bringing with him a wealth of institutional knowledge that will be instrumental in delivering patient-centered health care and combating the opioid crisis. We look forward to working with Mr. Azar on these critical issues and many others in the future.”
The Campaign for Sustainable Rx Pricing, a coalition of physicians and other stakeholders across the health care industry, was more measured in its reaction to the news.
“We sincerely hope that Secretary-nominee Azar will follow through on the President’s commitment to achieve lower drug prices for all Americans,” according to a statement from CSRxP. “We look forward to working with him, once confirmed, to end anticompetitive practices that artificially inflate drug prices, restore a functioning prescription drug market, and rein in the exorbitant price hikes that harm patients, job creators, and taxpayers alike.”
The nomination process could be bumpy, as Mr. Azar has made statements in the news in the past that were in support the dismantling of the Affordable Care Act. But keeping him from the post will be difficult, as he would only need a simple majority vote in the Senate to gain approval. With Republicans holding 52 seats, it would only require three dissenting GOP senators, assuming the Democrats vote against the appointment. If two crossed the aisle, Vice President Mike Pence would cast the deciding vote.
Finance Committee Democrats boycotted the committee vote on Mr. Azar’s predecessor, Secretary Tom Price, MD, forcing committee Chairman Hatch to suspend rules in order to move the appointment to the full chamber for consideration.
Alex M. Azar II, a former pharmaceutical executive and member of the George W. Bush administration, has been selected by President Donald Trump to lead the Department of Health & Human Services.
Mr. Azar served as president of Eli Lilly in the United States for 5 years from 2012 to 2017, after joining the company in 2007. Prior to that, he served President Bush at HHS from 2001 to 2007, serving first as general counsel and later as deputy secretary under Secretary Michael O. Leavitt.
“The challenges plaguing the American health care system are serious. For too long, hardworking, middle-class families have been forced to bear the brunt of Obamacare’s failures in the form of higher premiums and fewer choices,” Senate Finance Committee Chairman Orrin Hatch (R-Utah) said in a statement. “The leader of HHS will be at the tip of the spear, working to not only right the wrongs of this deeply flawed law but also ensure the long-term sustainability of both Medicare and Medicaid.”
The Senate Finance Committee must first approve the nomination before it is considered by the full chamber.
“We commend President Trump for nominating Alex Azar for secretary of Health & Human Services,” House Energy & Commerce Committee Chairman Greg Walden (R-Ore.) and Health Subcommittee Chairman Michael Burgess, MD, (R-Texas) said in a joint statement. “He is a veteran of HHS, bringing with him a wealth of institutional knowledge that will be instrumental in delivering patient-centered health care and combating the opioid crisis. We look forward to working with Mr. Azar on these critical issues and many others in the future.”
The Campaign for Sustainable Rx Pricing, a coalition of physicians and other stakeholders across the health care industry, was more measured in its reaction to the news.
“We sincerely hope that Secretary-nominee Azar will follow through on the President’s commitment to achieve lower drug prices for all Americans,” according to a statement from CSRxP. “We look forward to working with him, once confirmed, to end anticompetitive practices that artificially inflate drug prices, restore a functioning prescription drug market, and rein in the exorbitant price hikes that harm patients, job creators, and taxpayers alike.”
The nomination process could be bumpy, as Mr. Azar has made statements in the news in the past that were in support the dismantling of the Affordable Care Act. But keeping him from the post will be difficult, as he would only need a simple majority vote in the Senate to gain approval. With Republicans holding 52 seats, it would only require three dissenting GOP senators, assuming the Democrats vote against the appointment. If two crossed the aisle, Vice President Mike Pence would cast the deciding vote.
Finance Committee Democrats boycotted the committee vote on Mr. Azar’s predecessor, Secretary Tom Price, MD, forcing committee Chairman Hatch to suspend rules in order to move the appointment to the full chamber for consideration.
Delay predicting outcome in comatose cardiac arrest
ANAHEIM, CALIF. – Withdrawal of life-sustaining systemic therapies in comatose patients after out-of-hospital cardiac arrest as advised in current guidelines often occurs too early, resulting in the death of many patients who could potentially survive with good outcome, according to the results of NORCAST, the Norwegian Cardiorespiratory Arrest Study.
“The take-home message is to be patient and wait. Three days may be too early to make decisions on the patient,” Kjetil Sunde, MD, said in presenting the study findings at the Resuscitation Science Symposium held during the American Heart Association scientific sessions.
The European Resuscitation Council and European Society of Intensive Care Medicine have jointly recommended a prognostic algorithm in which a multimodal assessment is made on patients who are still comatose on day 3 after cardiac arrest. But this advice is based on expert opinion and has never been validated. This was the impetus for the prospective NORCAST study.
Current practice in the management of out-of-hospital cardiac arrest patients who are comatose upon hospital admission is to induce therapeutic hypothermia, with targeted temperature management to 33° C for 24 hours under deep sedation. The study hypothesis was that this strategy delays the time to awakening and that, as a consequence, the recommended prognostic tests that are usually done on day 3 after withdrawal of sedation are rendered insufficiently reliable. Thus, decisions to withdraw life-supporting therapies at that point will reduce the survival potential of this population, Dr. Sunde explained.
NORCAST was a prospective observational study that included 259 patients admitted to Oslo University Hospital in a comatose state after out-of-hospital cardiac arrest. In this unselected group, 81% had a cardiac cause for their arrest; the remainder had hypoxic arrest. All patients underwent therapeutic hypothermia, then a period of nonhypothermia followed by sedation withdrawal.
All of the widely used multimodal prognostic tests were ordered, including serial measurement of serum neuron-specific enolase; neurophysiologic testing using EEG and sensory-evoked potential readings obtained both during hypothermia and again at least 3 days after sedation withdrawal; a standardized clinical neurologic exam including assessment of brainstem reflexes and a Glasgow Coma Scale rating 3 days after sedation withdrawal; and a transcranial Doppler study and cerebral MRI on day 5-7. However, the treatment team was blinded to the results of these tests and was encouraged to delay withdrawal of life-supporting therapies as long as possible.
Key findings
Out of 259 patients who were comatose upon admission, 54% were alive at 6 months – and 91% of them had a CPC of 1 or 2.
The final tally at 6 months: 44% of patients were CPC 1, 5.5% were CPC 2, 4% were CPC 3, meaning severely disabled, and 46.5% were CPC 5, which is brain dead.
Withdrawal of life-supporting therapies occurred in 73 patients, or 28%, and 71% of those patients died, few of them in the early days.
Among patients with a CPC score of 1 or 2 at 6 months, only 20% were awake on day 1-3 following admission. Fifty-seven percent awoke on day 4-7, but importantly, 23% of patients with a good outcome at 6 months were not yet awake on day 8.
Three days after withdrawal of sedation, 49% of patients were rated as having a Glasgow Coma Scale score of 3-8, while 51% were Glasgow Coma Scale 9-15. Moreover, at that time 26% of patients with a good outcome as defined by a CPC of 1 or 2 at 6 months were still in a coma.
“So a lot of patients were still affected by their disease or by sedation at that point. That’s an important finding,” Dr. Sunde said.
Some prognostic tests were highly unreliable
A standout in poor performance was the widely utilized standard of a time to return of spontaneous circulation greater than 25 minutes as a predictor of poor cerebral outcome. In fact, it had a 34% false-positive rate.
“I think it’s really useless to use that. I would rather have return to spontaneous circulation after 40 minutes of good-quality CPR than not have it with 25 minutes of lesser-quality CPR,” he commented.
Similarly, a Glasgow Coma Scale score of 9 or less or a Glasgow Coma Scale-Motor score of 1-3 upon assessment 3 days after sedation withdrawal had false-positive rates of 30% and 34%, respectively.
During hypothermia, EEG abnormalities had a high false-positive rate, and sensory-evoked potential findings were difficult to interpret.
Predictors showing utility
Several clinical factors predicted poor cerebral outcome with low false-positive rates: Unwitnessed cardiac arrest had a false-positive rate of only 4%; initial presentation in asystole or with pulseless electrical activity had a false-positive rate of 6%; and no bystander CPR had a false-positive rate of 13%.
Abnormal sensory-evoked potential or EEG findings 3 days after sedation withdrawal had low false-positive rates as prognosticators of poor cerebral outcome. An EEG showing burst suppression or epileptiform activity had a “pretty good” false-positive rate of only 7%, Dr. Sunde noted. Bilaterally absent N20 sensory-evoked potential findings, while uncommon, had a false-positive rate of zero. A serum neuron-specific enolase level greater than 80 mcg/mL had a 3% false-positive rate, in sharp contrast to the previously recommended cutoff of more than 33 mcg/mL, which had an unacceptable 38% false-positive rate.
“We should avoid using single predictors in decision making and be patient, especially if we have a witnessed ventricular fibrillation with bystander CPR, independent of time to return of spontaneous circulation,” he concluded.
Dr. Sunde and his coinvestigators plan to present numerous further follow-up studies from NORCAST, including the results of comprehensive cognitive function testing 6-9 months after cardiac arrest in all survivors, coupled with interviews with their close relatives, as well as cognitive function and quality-of-life measurements 3-6 years after cardiac arrest along with interviews with relatives.
Several audience members rose to declare that they’ve been waiting for data such as this for a long time. Session chair Karl B. Kern, MD, professor of medicine at the University of Arizona, Tucson, and codirector of the University of Arizona Sarver Heart Center, commented, “We’ve been talking about whether 3 days is too early for a number of years, and clearly from your data it is. It was twice as long before most of them woke up.”
Dr. Sunde reported having no financial conflicts of interest regarding the NORCAST study, which was sponsored by Oslo University Hospital.
ANAHEIM, CALIF. – Withdrawal of life-sustaining systemic therapies in comatose patients after out-of-hospital cardiac arrest as advised in current guidelines often occurs too early, resulting in the death of many patients who could potentially survive with good outcome, according to the results of NORCAST, the Norwegian Cardiorespiratory Arrest Study.
“The take-home message is to be patient and wait. Three days may be too early to make decisions on the patient,” Kjetil Sunde, MD, said in presenting the study findings at the Resuscitation Science Symposium held during the American Heart Association scientific sessions.
The European Resuscitation Council and European Society of Intensive Care Medicine have jointly recommended a prognostic algorithm in which a multimodal assessment is made on patients who are still comatose on day 3 after cardiac arrest. But this advice is based on expert opinion and has never been validated. This was the impetus for the prospective NORCAST study.
Current practice in the management of out-of-hospital cardiac arrest patients who are comatose upon hospital admission is to induce therapeutic hypothermia, with targeted temperature management to 33° C for 24 hours under deep sedation. The study hypothesis was that this strategy delays the time to awakening and that, as a consequence, the recommended prognostic tests that are usually done on day 3 after withdrawal of sedation are rendered insufficiently reliable. Thus, decisions to withdraw life-supporting therapies at that point will reduce the survival potential of this population, Dr. Sunde explained.
NORCAST was a prospective observational study that included 259 patients admitted to Oslo University Hospital in a comatose state after out-of-hospital cardiac arrest. In this unselected group, 81% had a cardiac cause for their arrest; the remainder had hypoxic arrest. All patients underwent therapeutic hypothermia, then a period of nonhypothermia followed by sedation withdrawal.
All of the widely used multimodal prognostic tests were ordered, including serial measurement of serum neuron-specific enolase; neurophysiologic testing using EEG and sensory-evoked potential readings obtained both during hypothermia and again at least 3 days after sedation withdrawal; a standardized clinical neurologic exam including assessment of brainstem reflexes and a Glasgow Coma Scale rating 3 days after sedation withdrawal; and a transcranial Doppler study and cerebral MRI on day 5-7. However, the treatment team was blinded to the results of these tests and was encouraged to delay withdrawal of life-supporting therapies as long as possible.
Key findings
Out of 259 patients who were comatose upon admission, 54% were alive at 6 months – and 91% of them had a CPC of 1 or 2.
The final tally at 6 months: 44% of patients were CPC 1, 5.5% were CPC 2, 4% were CPC 3, meaning severely disabled, and 46.5% were CPC 5, which is brain dead.
Withdrawal of life-supporting therapies occurred in 73 patients, or 28%, and 71% of those patients died, few of them in the early days.
Among patients with a CPC score of 1 or 2 at 6 months, only 20% were awake on day 1-3 following admission. Fifty-seven percent awoke on day 4-7, but importantly, 23% of patients with a good outcome at 6 months were not yet awake on day 8.
Three days after withdrawal of sedation, 49% of patients were rated as having a Glasgow Coma Scale score of 3-8, while 51% were Glasgow Coma Scale 9-15. Moreover, at that time 26% of patients with a good outcome as defined by a CPC of 1 or 2 at 6 months were still in a coma.
“So a lot of patients were still affected by their disease or by sedation at that point. That’s an important finding,” Dr. Sunde said.
Some prognostic tests were highly unreliable
A standout in poor performance was the widely utilized standard of a time to return of spontaneous circulation greater than 25 minutes as a predictor of poor cerebral outcome. In fact, it had a 34% false-positive rate.
“I think it’s really useless to use that. I would rather have return to spontaneous circulation after 40 minutes of good-quality CPR than not have it with 25 minutes of lesser-quality CPR,” he commented.
Similarly, a Glasgow Coma Scale score of 9 or less or a Glasgow Coma Scale-Motor score of 1-3 upon assessment 3 days after sedation withdrawal had false-positive rates of 30% and 34%, respectively.
During hypothermia, EEG abnormalities had a high false-positive rate, and sensory-evoked potential findings were difficult to interpret.
Predictors showing utility
Several clinical factors predicted poor cerebral outcome with low false-positive rates: Unwitnessed cardiac arrest had a false-positive rate of only 4%; initial presentation in asystole or with pulseless electrical activity had a false-positive rate of 6%; and no bystander CPR had a false-positive rate of 13%.
Abnormal sensory-evoked potential or EEG findings 3 days after sedation withdrawal had low false-positive rates as prognosticators of poor cerebral outcome. An EEG showing burst suppression or epileptiform activity had a “pretty good” false-positive rate of only 7%, Dr. Sunde noted. Bilaterally absent N20 sensory-evoked potential findings, while uncommon, had a false-positive rate of zero. A serum neuron-specific enolase level greater than 80 mcg/mL had a 3% false-positive rate, in sharp contrast to the previously recommended cutoff of more than 33 mcg/mL, which had an unacceptable 38% false-positive rate.
“We should avoid using single predictors in decision making and be patient, especially if we have a witnessed ventricular fibrillation with bystander CPR, independent of time to return of spontaneous circulation,” he concluded.
Dr. Sunde and his coinvestigators plan to present numerous further follow-up studies from NORCAST, including the results of comprehensive cognitive function testing 6-9 months after cardiac arrest in all survivors, coupled with interviews with their close relatives, as well as cognitive function and quality-of-life measurements 3-6 years after cardiac arrest along with interviews with relatives.
Several audience members rose to declare that they’ve been waiting for data such as this for a long time. Session chair Karl B. Kern, MD, professor of medicine at the University of Arizona, Tucson, and codirector of the University of Arizona Sarver Heart Center, commented, “We’ve been talking about whether 3 days is too early for a number of years, and clearly from your data it is. It was twice as long before most of them woke up.”
Dr. Sunde reported having no financial conflicts of interest regarding the NORCAST study, which was sponsored by Oslo University Hospital.
ANAHEIM, CALIF. – Withdrawal of life-sustaining systemic therapies in comatose patients after out-of-hospital cardiac arrest as advised in current guidelines often occurs too early, resulting in the death of many patients who could potentially survive with good outcome, according to the results of NORCAST, the Norwegian Cardiorespiratory Arrest Study.
“The take-home message is to be patient and wait. Three days may be too early to make decisions on the patient,” Kjetil Sunde, MD, said in presenting the study findings at the Resuscitation Science Symposium held during the American Heart Association scientific sessions.
The European Resuscitation Council and European Society of Intensive Care Medicine have jointly recommended a prognostic algorithm in which a multimodal assessment is made on patients who are still comatose on day 3 after cardiac arrest. But this advice is based on expert opinion and has never been validated. This was the impetus for the prospective NORCAST study.
Current practice in the management of out-of-hospital cardiac arrest patients who are comatose upon hospital admission is to induce therapeutic hypothermia, with targeted temperature management to 33° C for 24 hours under deep sedation. The study hypothesis was that this strategy delays the time to awakening and that, as a consequence, the recommended prognostic tests that are usually done on day 3 after withdrawal of sedation are rendered insufficiently reliable. Thus, decisions to withdraw life-supporting therapies at that point will reduce the survival potential of this population, Dr. Sunde explained.
NORCAST was a prospective observational study that included 259 patients admitted to Oslo University Hospital in a comatose state after out-of-hospital cardiac arrest. In this unselected group, 81% had a cardiac cause for their arrest; the remainder had hypoxic arrest. All patients underwent therapeutic hypothermia, then a period of nonhypothermia followed by sedation withdrawal.
All of the widely used multimodal prognostic tests were ordered, including serial measurement of serum neuron-specific enolase; neurophysiologic testing using EEG and sensory-evoked potential readings obtained both during hypothermia and again at least 3 days after sedation withdrawal; a standardized clinical neurologic exam including assessment of brainstem reflexes and a Glasgow Coma Scale rating 3 days after sedation withdrawal; and a transcranial Doppler study and cerebral MRI on day 5-7. However, the treatment team was blinded to the results of these tests and was encouraged to delay withdrawal of life-supporting therapies as long as possible.
Key findings
Out of 259 patients who were comatose upon admission, 54% were alive at 6 months – and 91% of them had a CPC of 1 or 2.
The final tally at 6 months: 44% of patients were CPC 1, 5.5% were CPC 2, 4% were CPC 3, meaning severely disabled, and 46.5% were CPC 5, which is brain dead.
Withdrawal of life-supporting therapies occurred in 73 patients, or 28%, and 71% of those patients died, few of them in the early days.
Among patients with a CPC score of 1 or 2 at 6 months, only 20% were awake on day 1-3 following admission. Fifty-seven percent awoke on day 4-7, but importantly, 23% of patients with a good outcome at 6 months were not yet awake on day 8.
Three days after withdrawal of sedation, 49% of patients were rated as having a Glasgow Coma Scale score of 3-8, while 51% were Glasgow Coma Scale 9-15. Moreover, at that time 26% of patients with a good outcome as defined by a CPC of 1 or 2 at 6 months were still in a coma.
“So a lot of patients were still affected by their disease or by sedation at that point. That’s an important finding,” Dr. Sunde said.
Some prognostic tests were highly unreliable
A standout in poor performance was the widely utilized standard of a time to return of spontaneous circulation greater than 25 minutes as a predictor of poor cerebral outcome. In fact, it had a 34% false-positive rate.
“I think it’s really useless to use that. I would rather have return to spontaneous circulation after 40 minutes of good-quality CPR than not have it with 25 minutes of lesser-quality CPR,” he commented.
Similarly, a Glasgow Coma Scale score of 9 or less or a Glasgow Coma Scale-Motor score of 1-3 upon assessment 3 days after sedation withdrawal had false-positive rates of 30% and 34%, respectively.
During hypothermia, EEG abnormalities had a high false-positive rate, and sensory-evoked potential findings were difficult to interpret.
Predictors showing utility
Several clinical factors predicted poor cerebral outcome with low false-positive rates: Unwitnessed cardiac arrest had a false-positive rate of only 4%; initial presentation in asystole or with pulseless electrical activity had a false-positive rate of 6%; and no bystander CPR had a false-positive rate of 13%.
Abnormal sensory-evoked potential or EEG findings 3 days after sedation withdrawal had low false-positive rates as prognosticators of poor cerebral outcome. An EEG showing burst suppression or epileptiform activity had a “pretty good” false-positive rate of only 7%, Dr. Sunde noted. Bilaterally absent N20 sensory-evoked potential findings, while uncommon, had a false-positive rate of zero. A serum neuron-specific enolase level greater than 80 mcg/mL had a 3% false-positive rate, in sharp contrast to the previously recommended cutoff of more than 33 mcg/mL, which had an unacceptable 38% false-positive rate.
“We should avoid using single predictors in decision making and be patient, especially if we have a witnessed ventricular fibrillation with bystander CPR, independent of time to return of spontaneous circulation,” he concluded.
Dr. Sunde and his coinvestigators plan to present numerous further follow-up studies from NORCAST, including the results of comprehensive cognitive function testing 6-9 months after cardiac arrest in all survivors, coupled with interviews with their close relatives, as well as cognitive function and quality-of-life measurements 3-6 years after cardiac arrest along with interviews with relatives.
Several audience members rose to declare that they’ve been waiting for data such as this for a long time. Session chair Karl B. Kern, MD, professor of medicine at the University of Arizona, Tucson, and codirector of the University of Arizona Sarver Heart Center, commented, “We’ve been talking about whether 3 days is too early for a number of years, and clearly from your data it is. It was twice as long before most of them woke up.”
Dr. Sunde reported having no financial conflicts of interest regarding the NORCAST study, which was sponsored by Oslo University Hospital.
AT THE AHA SCIENTIFIC SESSIONS
Key clinical point:
Major finding: Patients with good cerebral function 6 months after admission in a comatose state stemming from out-of-hospital cardiac arrest awoke a mean of 6.2 days post cardiac arrest, far later than most prognostic assessments take place.
Data source: NORCAST, a prospective observational study, included 259 patients who were comatose upon hospital admission after out-of-hospital cardiac arrest.
Disclosures: NORCAST was sponsored by Oslo University Hospital. The presenter reported having no financial conflicts.
Low-sodium DASH benefits increase with higher blood pressures
ANAHEIM, CALIF. – The low-sodium DASH diet lowered systolic BP a mean of 20.8 mm Hg among patients with a baseline systolic pressure of 150-159 mm Hg, and did so in just 4 weeks, according to a new analysis of the DASH-Sodium trial.
The original 2001 study found that combining low sodium and the DASH [Dietary Approaches to Stop Hypertension] diet lowered blood pressure more than either alone, but results were not broken out by hypertension severity (N Engl J Med. 2001 Jan 4;344[1]:3-10).
It found that there were “progressively greater reductions at higher levels of baseline systolic BP (SBP). Among participants with baseline SBP at or above 150 mm Hg, “mean SBP reduction was striking,” said Dr. Juraschek, of Harvard Medical School/Beth Israel Deaconess Medical Center, Boston.
The original trial randomized 208 subjects to the DASH diet and 204 to a control diet similar to what most Americans eat. While on their diets, the subjects cycled through three sodium levels for 4 weeks each: 1.5 g/d, 2.4 g/d, and 3.3 g/d. Although deemed high sodium in the study, 3.3 g/d is typical of the American diet.
The new study analyzed outcomes according to four baseline SBP categories: 120-129, 130-139, 140-149, and 150-159 mm Hg.
Among subjects on the control diet, reducing sodium from high to low intake reduced SBP 3.20, 8.56, 8.99, and 7.04 mm Hg across the four baseline SBP categories (P = .004). Among patients consuming high sodium, the DASH diet, compared with the control diet, reduced SBP 4.5, 4.3, 4.7, and 10.6 mm Hg, but the trend was not statistically significant.
The low-sodium DASH diet, versus the high-sodium control diet, reduced SBP 5.3, 7.5, 9.7, and 20.8 mm Hg in subjects with baseline SBP at or above 150 mmHg (P < .001).
“The DASH diet with low sodium, compared with the control diet with high sodium, lowered SBP by nearly 10 mm Hg among those with a baseline SBP of 140-149 mm Hg and [greater than] 20 mm Hg among those with a baseline systolic BP [at or above] 150 mm Hg. SBP levels between 140 and 159 mm Hg represent the majority of patients with hypertension. Thus, our findings suggest that most adults with uncontrolled BP can experience substantial reductions in SBP from dietary changes alone,” the investigator said.
“To place our results in context, compared to placebo, angiotensin-converting enzyme inhibitors reduce SBP by 12 mm Hg, beta-blockers reduce SBP by 13 mm Hg, and calcium-channel blockers reduce SBP by 16 mm Hg,” he said.
“For many patients, it’s hard to take that step to be on a chronic medication. A lot of them want to talk about diet, but” find it hard to believe that something as simple as changing what you eat could beat drugs. “It’s important for both patients and physicians to realize that if you take this seriously, you can have significant reductions in your blood pressure. We should take it seriously as the first step. That’s the key take away,” Dr. Juraschek said in an interview.
None of the participants were on blood pressure medications; 57% were women, and 57% were black. The mean age was 48 years, and mean baseline BP was 135/86 mm Hg. The DASH diet includes whole grains, poultry, fish, and nuts, with reductions in red meat, sweets, and sugary drinks.
The results were published, online simultaneously with Dr. Juraschek’s presentation (J Am Coll Cardiol. 2017 Nov 12;doi: 10.1016/j.jacc.2017.10.011).
The original study was funded by the National Institutes of Health. Dr. Juraschek had no relevant disclosures.
ANAHEIM, CALIF. – The low-sodium DASH diet lowered systolic BP a mean of 20.8 mm Hg among patients with a baseline systolic pressure of 150-159 mm Hg, and did so in just 4 weeks, according to a new analysis of the DASH-Sodium trial.
The original 2001 study found that combining low sodium and the DASH [Dietary Approaches to Stop Hypertension] diet lowered blood pressure more than either alone, but results were not broken out by hypertension severity (N Engl J Med. 2001 Jan 4;344[1]:3-10).
It found that there were “progressively greater reductions at higher levels of baseline systolic BP (SBP). Among participants with baseline SBP at or above 150 mm Hg, “mean SBP reduction was striking,” said Dr. Juraschek, of Harvard Medical School/Beth Israel Deaconess Medical Center, Boston.
The original trial randomized 208 subjects to the DASH diet and 204 to a control diet similar to what most Americans eat. While on their diets, the subjects cycled through three sodium levels for 4 weeks each: 1.5 g/d, 2.4 g/d, and 3.3 g/d. Although deemed high sodium in the study, 3.3 g/d is typical of the American diet.
The new study analyzed outcomes according to four baseline SBP categories: 120-129, 130-139, 140-149, and 150-159 mm Hg.
Among subjects on the control diet, reducing sodium from high to low intake reduced SBP 3.20, 8.56, 8.99, and 7.04 mm Hg across the four baseline SBP categories (P = .004). Among patients consuming high sodium, the DASH diet, compared with the control diet, reduced SBP 4.5, 4.3, 4.7, and 10.6 mm Hg, but the trend was not statistically significant.
The low-sodium DASH diet, versus the high-sodium control diet, reduced SBP 5.3, 7.5, 9.7, and 20.8 mm Hg in subjects with baseline SBP at or above 150 mmHg (P < .001).
“The DASH diet with low sodium, compared with the control diet with high sodium, lowered SBP by nearly 10 mm Hg among those with a baseline SBP of 140-149 mm Hg and [greater than] 20 mm Hg among those with a baseline systolic BP [at or above] 150 mm Hg. SBP levels between 140 and 159 mm Hg represent the majority of patients with hypertension. Thus, our findings suggest that most adults with uncontrolled BP can experience substantial reductions in SBP from dietary changes alone,” the investigator said.
“To place our results in context, compared to placebo, angiotensin-converting enzyme inhibitors reduce SBP by 12 mm Hg, beta-blockers reduce SBP by 13 mm Hg, and calcium-channel blockers reduce SBP by 16 mm Hg,” he said.
“For many patients, it’s hard to take that step to be on a chronic medication. A lot of them want to talk about diet, but” find it hard to believe that something as simple as changing what you eat could beat drugs. “It’s important for both patients and physicians to realize that if you take this seriously, you can have significant reductions in your blood pressure. We should take it seriously as the first step. That’s the key take away,” Dr. Juraschek said in an interview.
None of the participants were on blood pressure medications; 57% were women, and 57% were black. The mean age was 48 years, and mean baseline BP was 135/86 mm Hg. The DASH diet includes whole grains, poultry, fish, and nuts, with reductions in red meat, sweets, and sugary drinks.
The results were published, online simultaneously with Dr. Juraschek’s presentation (J Am Coll Cardiol. 2017 Nov 12;doi: 10.1016/j.jacc.2017.10.011).
The original study was funded by the National Institutes of Health. Dr. Juraschek had no relevant disclosures.
ANAHEIM, CALIF. – The low-sodium DASH diet lowered systolic BP a mean of 20.8 mm Hg among patients with a baseline systolic pressure of 150-159 mm Hg, and did so in just 4 weeks, according to a new analysis of the DASH-Sodium trial.
The original 2001 study found that combining low sodium and the DASH [Dietary Approaches to Stop Hypertension] diet lowered blood pressure more than either alone, but results were not broken out by hypertension severity (N Engl J Med. 2001 Jan 4;344[1]:3-10).
It found that there were “progressively greater reductions at higher levels of baseline systolic BP (SBP). Among participants with baseline SBP at or above 150 mm Hg, “mean SBP reduction was striking,” said Dr. Juraschek, of Harvard Medical School/Beth Israel Deaconess Medical Center, Boston.
The original trial randomized 208 subjects to the DASH diet and 204 to a control diet similar to what most Americans eat. While on their diets, the subjects cycled through three sodium levels for 4 weeks each: 1.5 g/d, 2.4 g/d, and 3.3 g/d. Although deemed high sodium in the study, 3.3 g/d is typical of the American diet.
The new study analyzed outcomes according to four baseline SBP categories: 120-129, 130-139, 140-149, and 150-159 mm Hg.
Among subjects on the control diet, reducing sodium from high to low intake reduced SBP 3.20, 8.56, 8.99, and 7.04 mm Hg across the four baseline SBP categories (P = .004). Among patients consuming high sodium, the DASH diet, compared with the control diet, reduced SBP 4.5, 4.3, 4.7, and 10.6 mm Hg, but the trend was not statistically significant.
The low-sodium DASH diet, versus the high-sodium control diet, reduced SBP 5.3, 7.5, 9.7, and 20.8 mm Hg in subjects with baseline SBP at or above 150 mmHg (P < .001).
“The DASH diet with low sodium, compared with the control diet with high sodium, lowered SBP by nearly 10 mm Hg among those with a baseline SBP of 140-149 mm Hg and [greater than] 20 mm Hg among those with a baseline systolic BP [at or above] 150 mm Hg. SBP levels between 140 and 159 mm Hg represent the majority of patients with hypertension. Thus, our findings suggest that most adults with uncontrolled BP can experience substantial reductions in SBP from dietary changes alone,” the investigator said.
“To place our results in context, compared to placebo, angiotensin-converting enzyme inhibitors reduce SBP by 12 mm Hg, beta-blockers reduce SBP by 13 mm Hg, and calcium-channel blockers reduce SBP by 16 mm Hg,” he said.
“For many patients, it’s hard to take that step to be on a chronic medication. A lot of them want to talk about diet, but” find it hard to believe that something as simple as changing what you eat could beat drugs. “It’s important for both patients and physicians to realize that if you take this seriously, you can have significant reductions in your blood pressure. We should take it seriously as the first step. That’s the key take away,” Dr. Juraschek said in an interview.
None of the participants were on blood pressure medications; 57% were women, and 57% were black. The mean age was 48 years, and mean baseline BP was 135/86 mm Hg. The DASH diet includes whole grains, poultry, fish, and nuts, with reductions in red meat, sweets, and sugary drinks.
The results were published, online simultaneously with Dr. Juraschek’s presentation (J Am Coll Cardiol. 2017 Nov 12;doi: 10.1016/j.jacc.2017.10.011).
The original study was funded by the National Institutes of Health. Dr. Juraschek had no relevant disclosures.
AT THE AHA SCIENTIFIC SESSIONS
Key clinical point:
Major finding: The low-sodium DASH diet lowered systolic BP a mean of 20.8 mm Hg among patients with a baseline systolic pressure of 150-159 mm Hg, and did so in just 4 weeks.
Data source: New analysis of the landmark DASH-Sodium trial.
Disclosures: The original study was funded by the National Institutes of Health. The lead investigator in the new analysis didn’t have any relevant disclosures.
MACRA Monday: Documenting current medications
If you haven’t started reporting quality data for the Merit-Based Incentive Payment System (MIPS), there’s still time to avoid a 4% cut to your Medicare payments.
Under the Pick Your Pace approach being offered this year, Centers for Medicare & Medicaid Services allows clinicians to test the system by reporting on one quality measure for one patient through paper-based claims. Be sure to append a Quality Data Code (QDC) to the claim form for care provided up to Dec. 31, 2017, in order to avoid a penalty in payment year 2019.
Consider this measure:
Measure #130: Documentation of Current Medications in the Medical Record
This measure is aimed at capturing the percentage of patients aged 18 years and older who had their current medications documented in the medical record, including nonprescription drugs, vitamins, and supplements.
What you need to do: Review and update the patient’s list of current medications, being sure to document all known prescriptions, over-the-counter medications, herbals, and vitamin/mineral/dietary supplements. This list must include the name, dosages, frequency, and route of administration for each drug.
Eligible cases include patients aged 18 years and older on the date of the encounter and a patient encounter during the performance period. Applicable codes include (CPT or HCPCS): 90791, 90792, 90832, 90834, 90837, 90839, 92002, 92004, 92012, 92014, 92507, 92508, 92526, 92537, 92538, 92540, 92541, 92542, 92544, 92545, 92547, 92548, 92550, 92557, 92567, 92568, 92570, 92585, 92588, 92626, 96116, 96150, 96151, 96152, 97161, 97162, 97163, 97164, 97165, 97166, 97167, 97168, 97532, 97802, 97803, 97804, 98960, 98961, 98962, 99201, 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99215, 99221, 99222, 99223, 99324, 99325, 99326, 99327, 99328, 99334, 99335, 99336, 99337, 99341, 99342, 99343, 99344, 99345, 99347, 99348, 99349, 99350, 99495, 99496, G0101, G0108, G0270, G0402, G0438, G0439.
To get credit under MIPS, be sure to include a QDC that shows that you successfully performed the measure or had a good reason for not doing so. For instance, G8427 indicates that the patient’s medical record was updated with the current medications. Use exception code G8430 if you documented in the medical record that the patient is not eligible for a current list of medications being obtained and reviewed.
CMS has a full list of measures available for claims-based reporting at qpp.cms.gov. The American Medical Association has also created a step-by-step guide for reporting on one quality measure.
Certain clinicians are exempt from reporting and do not face a penalty under MIPS:
- Those who enrolled in Medicare for the first time during a performance period.
- Those who have Medicare Part B allowed charges of $30,000 or less.
- Those who have 100 or fewer Medicare Part B patients.
- Those who are significantly participating in an Advanced Alternative Payment Model (APM).
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
If you haven’t started reporting quality data for the Merit-Based Incentive Payment System (MIPS), there’s still time to avoid a 4% cut to your Medicare payments.
Under the Pick Your Pace approach being offered this year, Centers for Medicare & Medicaid Services allows clinicians to test the system by reporting on one quality measure for one patient through paper-based claims. Be sure to append a Quality Data Code (QDC) to the claim form for care provided up to Dec. 31, 2017, in order to avoid a penalty in payment year 2019.
Consider this measure:
Measure #130: Documentation of Current Medications in the Medical Record
This measure is aimed at capturing the percentage of patients aged 18 years and older who had their current medications documented in the medical record, including nonprescription drugs, vitamins, and supplements.
What you need to do: Review and update the patient’s list of current medications, being sure to document all known prescriptions, over-the-counter medications, herbals, and vitamin/mineral/dietary supplements. This list must include the name, dosages, frequency, and route of administration for each drug.
Eligible cases include patients aged 18 years and older on the date of the encounter and a patient encounter during the performance period. Applicable codes include (CPT or HCPCS): 90791, 90792, 90832, 90834, 90837, 90839, 92002, 92004, 92012, 92014, 92507, 92508, 92526, 92537, 92538, 92540, 92541, 92542, 92544, 92545, 92547, 92548, 92550, 92557, 92567, 92568, 92570, 92585, 92588, 92626, 96116, 96150, 96151, 96152, 97161, 97162, 97163, 97164, 97165, 97166, 97167, 97168, 97532, 97802, 97803, 97804, 98960, 98961, 98962, 99201, 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99215, 99221, 99222, 99223, 99324, 99325, 99326, 99327, 99328, 99334, 99335, 99336, 99337, 99341, 99342, 99343, 99344, 99345, 99347, 99348, 99349, 99350, 99495, 99496, G0101, G0108, G0270, G0402, G0438, G0439.
To get credit under MIPS, be sure to include a QDC that shows that you successfully performed the measure or had a good reason for not doing so. For instance, G8427 indicates that the patient’s medical record was updated with the current medications. Use exception code G8430 if you documented in the medical record that the patient is not eligible for a current list of medications being obtained and reviewed.
CMS has a full list of measures available for claims-based reporting at qpp.cms.gov. The American Medical Association has also created a step-by-step guide for reporting on one quality measure.
Certain clinicians are exempt from reporting and do not face a penalty under MIPS:
- Those who enrolled in Medicare for the first time during a performance period.
- Those who have Medicare Part B allowed charges of $30,000 or less.
- Those who have 100 or fewer Medicare Part B patients.
- Those who are significantly participating in an Advanced Alternative Payment Model (APM).
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
If you haven’t started reporting quality data for the Merit-Based Incentive Payment System (MIPS), there’s still time to avoid a 4% cut to your Medicare payments.
Under the Pick Your Pace approach being offered this year, Centers for Medicare & Medicaid Services allows clinicians to test the system by reporting on one quality measure for one patient through paper-based claims. Be sure to append a Quality Data Code (QDC) to the claim form for care provided up to Dec. 31, 2017, in order to avoid a penalty in payment year 2019.
Consider this measure:
Measure #130: Documentation of Current Medications in the Medical Record
This measure is aimed at capturing the percentage of patients aged 18 years and older who had their current medications documented in the medical record, including nonprescription drugs, vitamins, and supplements.
What you need to do: Review and update the patient’s list of current medications, being sure to document all known prescriptions, over-the-counter medications, herbals, and vitamin/mineral/dietary supplements. This list must include the name, dosages, frequency, and route of administration for each drug.
Eligible cases include patients aged 18 years and older on the date of the encounter and a patient encounter during the performance period. Applicable codes include (CPT or HCPCS): 90791, 90792, 90832, 90834, 90837, 90839, 92002, 92004, 92012, 92014, 92507, 92508, 92526, 92537, 92538, 92540, 92541, 92542, 92544, 92545, 92547, 92548, 92550, 92557, 92567, 92568, 92570, 92585, 92588, 92626, 96116, 96150, 96151, 96152, 97161, 97162, 97163, 97164, 97165, 97166, 97167, 97168, 97532, 97802, 97803, 97804, 98960, 98961, 98962, 99201, 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99215, 99221, 99222, 99223, 99324, 99325, 99326, 99327, 99328, 99334, 99335, 99336, 99337, 99341, 99342, 99343, 99344, 99345, 99347, 99348, 99349, 99350, 99495, 99496, G0101, G0108, G0270, G0402, G0438, G0439.
To get credit under MIPS, be sure to include a QDC that shows that you successfully performed the measure or had a good reason for not doing so. For instance, G8427 indicates that the patient’s medical record was updated with the current medications. Use exception code G8430 if you documented in the medical record that the patient is not eligible for a current list of medications being obtained and reviewed.
CMS has a full list of measures available for claims-based reporting at qpp.cms.gov. The American Medical Association has also created a step-by-step guide for reporting on one quality measure.
Certain clinicians are exempt from reporting and do not face a penalty under MIPS:
- Those who enrolled in Medicare for the first time during a performance period.
- Those who have Medicare Part B allowed charges of $30,000 or less.
- Those who have 100 or fewer Medicare Part B patients.
- Those who are significantly participating in an Advanced Alternative Payment Model (APM).
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
PCI outcomes not better at top-ranked hospitals
Outcomes after percutaneous coronary intervention (PCI) are not superior when performed in U.S. hospitals ranked as “best” in a prominent national rating system as compared with nonranked hospitals, according to results of a recent retrospective analysis.
Rates of in-hospital mortality, acute kidney injury, and bleeding were similar for hospitals in the 2015 U.S. News & World Report’s “Best Hospitals” rankings and nonranked hospitals, Devraj Sukul, MD, reported at the American Heart Association Scientific Sessions.
“These findings should reassure patients that safe and appropriate PCI is being performed across the country,” said Dr. Sukul of the Division of Cardiovascular Medicine, University of Michigan, Ann Arbor.
The findings, published simultaneously (JACC Cardiovasc Interv. 2017 Nov 12. doi: 10.1016/j.jcin.2017.10.042) were based on a retrospective analysis of PCIs documented in the National Cardiovascular Data Registry CathPCI Registry.
Dr. Sukul and his colleagues limited their analysis to hospitals that both participated in that registry and performed at least 400 PCIs during July 2014–June 2015. That narrowed it down to 654 hospitals, including 44 out of the 50 hospitals ranked by U.S. News & World Report in 2015.
A total of 509,153 PCIs were performed over the 1-year study period, including 55,550 (10.9%) performed at the top-ranked hospitals.
After adjusting for patient risk, there was no difference in post-PCI in-hospital mortality between top-ranked and nonranked hospitals investigators reported (adjusted odds ratio, 0.96; P = .64).
There were also no differences in acute kidney injury (adjusted OR, 1.10; P = .1) or bleeding (adjusted OR, 1.15; P = .052) for top-ranked vs. nonranked hospitals, according to investigators.
In addition, top-ranked hospitals had a “slightly lower proportion” of appropriate PCI, Dr. Sukul reported.
Though rates of appropriate PCI were relatively high in both groups, odds of appropriate PCI were nevertheless significantly higher at nonranked hospitals (89.2% for ranked and 92.8% for nonranked hospitals; P less than .001).
Appropriate PCIs – those based on evidence-based indications – have been increasingly emphasized over the past decade.
Although some recent reports suggest hospital-level appropriateness may not necessarily correlate with clinical outcomes, Dr. Sukul remarked, “we believe that PCI appropriateness is an important indicator of quality, serving as a measure of physician decision-making when faced with treating the vast array of coronary artery disease presentations.”
Dr. Sukul is supported by a National Institutes of Health postdoctoral research training grant.
It should be welcome news to the public that outcomes of PCI conducted at top-ranked hospitals were not superior to those of procedures performed at nonranked hospitals.
This study addresses what is often the foremost question of a patient and their family in their hometown: Is my local hospital doing a good job? To the extent measured by the variables in this study, it is reassuring that the answer appears to be “Yes.”
It is hard to argue that health care should be immune from rankings in an era where consumers have access to ratings for just about every product and service available.
However, the public may be confused regarding the multiple national hospital ranking systems that are available today, particularly since these rating systems do not consistently identify hospitals as top performers.
Each rating system uses different data sources, has its own rating methodology, defines different measures of performance, and has a different focus. Many have argued that transparency will improve health care but, for the public, this is getting to the point of “too much information.”
Gregory J. Dehmer, MD, of the Department of Medicine (Cardiology Division) Texas A&M University, and Baylor Scott & White Health, Temple, made the comments above in an accompanying editorial (JACC Cardiovasc Interv. 2017 Nov 1. doi: 10.1016/j.jcin.2017.11.001). He reported no financial relationships relevant to the topic.
It should be welcome news to the public that outcomes of PCI conducted at top-ranked hospitals were not superior to those of procedures performed at nonranked hospitals.
This study addresses what is often the foremost question of a patient and their family in their hometown: Is my local hospital doing a good job? To the extent measured by the variables in this study, it is reassuring that the answer appears to be “Yes.”
It is hard to argue that health care should be immune from rankings in an era where consumers have access to ratings for just about every product and service available.
However, the public may be confused regarding the multiple national hospital ranking systems that are available today, particularly since these rating systems do not consistently identify hospitals as top performers.
Each rating system uses different data sources, has its own rating methodology, defines different measures of performance, and has a different focus. Many have argued that transparency will improve health care but, for the public, this is getting to the point of “too much information.”
Gregory J. Dehmer, MD, of the Department of Medicine (Cardiology Division) Texas A&M University, and Baylor Scott & White Health, Temple, made the comments above in an accompanying editorial (JACC Cardiovasc Interv. 2017 Nov 1. doi: 10.1016/j.jcin.2017.11.001). He reported no financial relationships relevant to the topic.
It should be welcome news to the public that outcomes of PCI conducted at top-ranked hospitals were not superior to those of procedures performed at nonranked hospitals.
This study addresses what is often the foremost question of a patient and their family in their hometown: Is my local hospital doing a good job? To the extent measured by the variables in this study, it is reassuring that the answer appears to be “Yes.”
It is hard to argue that health care should be immune from rankings in an era where consumers have access to ratings for just about every product and service available.
However, the public may be confused regarding the multiple national hospital ranking systems that are available today, particularly since these rating systems do not consistently identify hospitals as top performers.
Each rating system uses different data sources, has its own rating methodology, defines different measures of performance, and has a different focus. Many have argued that transparency will improve health care but, for the public, this is getting to the point of “too much information.”
Gregory J. Dehmer, MD, of the Department of Medicine (Cardiology Division) Texas A&M University, and Baylor Scott & White Health, Temple, made the comments above in an accompanying editorial (JACC Cardiovasc Interv. 2017 Nov 1. doi: 10.1016/j.jcin.2017.11.001). He reported no financial relationships relevant to the topic.
Outcomes after percutaneous coronary intervention (PCI) are not superior when performed in U.S. hospitals ranked as “best” in a prominent national rating system as compared with nonranked hospitals, according to results of a recent retrospective analysis.
Rates of in-hospital mortality, acute kidney injury, and bleeding were similar for hospitals in the 2015 U.S. News & World Report’s “Best Hospitals” rankings and nonranked hospitals, Devraj Sukul, MD, reported at the American Heart Association Scientific Sessions.
“These findings should reassure patients that safe and appropriate PCI is being performed across the country,” said Dr. Sukul of the Division of Cardiovascular Medicine, University of Michigan, Ann Arbor.
The findings, published simultaneously (JACC Cardiovasc Interv. 2017 Nov 12. doi: 10.1016/j.jcin.2017.10.042) were based on a retrospective analysis of PCIs documented in the National Cardiovascular Data Registry CathPCI Registry.
Dr. Sukul and his colleagues limited their analysis to hospitals that both participated in that registry and performed at least 400 PCIs during July 2014–June 2015. That narrowed it down to 654 hospitals, including 44 out of the 50 hospitals ranked by U.S. News & World Report in 2015.
A total of 509,153 PCIs were performed over the 1-year study period, including 55,550 (10.9%) performed at the top-ranked hospitals.
After adjusting for patient risk, there was no difference in post-PCI in-hospital mortality between top-ranked and nonranked hospitals investigators reported (adjusted odds ratio, 0.96; P = .64).
There were also no differences in acute kidney injury (adjusted OR, 1.10; P = .1) or bleeding (adjusted OR, 1.15; P = .052) for top-ranked vs. nonranked hospitals, according to investigators.
In addition, top-ranked hospitals had a “slightly lower proportion” of appropriate PCI, Dr. Sukul reported.
Though rates of appropriate PCI were relatively high in both groups, odds of appropriate PCI were nevertheless significantly higher at nonranked hospitals (89.2% for ranked and 92.8% for nonranked hospitals; P less than .001).
Appropriate PCIs – those based on evidence-based indications – have been increasingly emphasized over the past decade.
Although some recent reports suggest hospital-level appropriateness may not necessarily correlate with clinical outcomes, Dr. Sukul remarked, “we believe that PCI appropriateness is an important indicator of quality, serving as a measure of physician decision-making when faced with treating the vast array of coronary artery disease presentations.”
Dr. Sukul is supported by a National Institutes of Health postdoctoral research training grant.
Outcomes after percutaneous coronary intervention (PCI) are not superior when performed in U.S. hospitals ranked as “best” in a prominent national rating system as compared with nonranked hospitals, according to results of a recent retrospective analysis.
Rates of in-hospital mortality, acute kidney injury, and bleeding were similar for hospitals in the 2015 U.S. News & World Report’s “Best Hospitals” rankings and nonranked hospitals, Devraj Sukul, MD, reported at the American Heart Association Scientific Sessions.
“These findings should reassure patients that safe and appropriate PCI is being performed across the country,” said Dr. Sukul of the Division of Cardiovascular Medicine, University of Michigan, Ann Arbor.
The findings, published simultaneously (JACC Cardiovasc Interv. 2017 Nov 12. doi: 10.1016/j.jcin.2017.10.042) were based on a retrospective analysis of PCIs documented in the National Cardiovascular Data Registry CathPCI Registry.
Dr. Sukul and his colleagues limited their analysis to hospitals that both participated in that registry and performed at least 400 PCIs during July 2014–June 2015. That narrowed it down to 654 hospitals, including 44 out of the 50 hospitals ranked by U.S. News & World Report in 2015.
A total of 509,153 PCIs were performed over the 1-year study period, including 55,550 (10.9%) performed at the top-ranked hospitals.
After adjusting for patient risk, there was no difference in post-PCI in-hospital mortality between top-ranked and nonranked hospitals investigators reported (adjusted odds ratio, 0.96; P = .64).
There were also no differences in acute kidney injury (adjusted OR, 1.10; P = .1) or bleeding (adjusted OR, 1.15; P = .052) for top-ranked vs. nonranked hospitals, according to investigators.
In addition, top-ranked hospitals had a “slightly lower proportion” of appropriate PCI, Dr. Sukul reported.
Though rates of appropriate PCI were relatively high in both groups, odds of appropriate PCI were nevertheless significantly higher at nonranked hospitals (89.2% for ranked and 92.8% for nonranked hospitals; P less than .001).
Appropriate PCIs – those based on evidence-based indications – have been increasingly emphasized over the past decade.
Although some recent reports suggest hospital-level appropriateness may not necessarily correlate with clinical outcomes, Dr. Sukul remarked, “we believe that PCI appropriateness is an important indicator of quality, serving as a measure of physician decision-making when faced with treating the vast array of coronary artery disease presentations.”
Dr. Sukul is supported by a National Institutes of Health postdoctoral research training grant.
FROM THE AHA SCIENTIFIC SESSIONS
Key clinical point: Percutaneous coronary intervention (PCI) performed at the 50 “Best Hospitals” in U.S. News & World Report rankings was not associated with better outcomes, compared with PCI at other hospitals.
Major finding: There was no significant difference between ranked and nonranked hospitals for PCI-associated in-hospital mortality (adjusted OR, 0.96; 95% CI, 0.83-1.12; P = 0.64), acute kidney injury, or bleeding.
Data source: A retrospective analysis of 509,153 PCIs included in the National Cardiovascular Data Registry CathPCI Registry.
Disclosures: First author Dr. Devraj Sukul is supported by a National Institutes of Health postdoctoral research training grant. Coauthors reported disclosures including AstraZeneca, Regado Biosciences, and Pfizer, among others.
VIDEO: Revised guidelines raise lung cancer screening age ceiling
TORONTO – A proposed change to CHEST’s lung cancer screening guideline calls for raising the upper age for screening recent cigarette smokers to 77 years of age from 74 years of age.
This proposal is part of draft guideline that was unveiled during the CHEST annual meeting but is still subject to tweaking by peer review until formal release in early 2018. The draft also offers expanded guidance on how to implement screening, containing three times as many recommendations as the current lung cancer screening guidelines (Chest. 2013 May; 143[5 Suppl]:e78S-e92S).
“We want screening to expand in a safe and effective way,” said Peter J. Mazzone, MD, chair of the expert panel that is preparing the revision for CHEST and a pulmonologist at the Cleveland Clinic. “We are less restrictive with these guidelines” than in the 2013 version.
Dr. Mazzone cited two major changes that will produce modest broadening of the criteria that determine which patients can appropriately get screening. The clearest change was the age range, which expanded from 55-74 years of age set in 2013 to reflect the age criterion for enrollment in the National Lung Screening Trial (New Engl J Med. 2011 Aug 4; 365[5]:395-409). Dr. Mazzone explained, though it remains short of the 80-year old ceiling recommended by the U.S. Preventive Services Task Force.
The second, subtler change eased back on the outright ban that the 2013 guidelines placed on screening anyone who falls outside the target age range and smoking history (at least 30 pack years and either being a current smoker or having recently quit within the past 15 years) and who is without severe comorbidities.
The guidelines from 2013 said that screening people who fell outside these limits “should not be performed.” In contrast, the new draft guideline simply said that people who fall outside of the age and smoking-history criteria but who are still considered high risk for lung cancer based on a risk-prediction calculator should not “routinely” undergo screening. Additionally, exceptions could be made for certain patients whose high risk appears to warrant screening, Dr. Mazzone and others from the expert panel noted.
The revision specified that a high-risk person outside of the core criteria might still be a reasonable candidate for screening if this person tallies at least a 1.51% risk of developing lung cancer during the next 6 years according to the PLCOM2012 risk calculator (New Engl J Med. 2013 Feb 21; 368[8]:728-36).
“Some of the evidence allowed us to be a little more flexible,” though not to the point of “opening screening widely” to people who fall outside the core target population; rather, clinicians get to have a little more discretion, said Dr. Mazzone, who directs the Cleveland Clinic’s Lung Cancer Program. “We hope this will lead to more patients being screened in a high quality way,” he said in an interview. The panel strove to “look beyond the National Lung Screening Trial and find other groups of patients who could benefit” from screening. “We say that other high-risk people should not, on the whole, be screened” but that clinicians could consider individuals as appropriate for screening on a case-by-case basis.
The revision “fills in the outline” for screening that was established in the 2013 guidelines, said Gerard A. Silvestri, MD, a member of the revision panel, in a video interview. The updated guideline better detailed who benefits the most from screening and who benefits less, as well as the potential complications screening may cause, said Dr. Silvestri, a professor of medicine and lung cancer pulmonologist at the Medical University of South Carolina in Charleston.
“The sweet spot for screening is patients with a medium lung cancer risk without many comorbidities. We are trying to come up with individualized risk profiling,” explained Dr. Silvestri during the CHEST session. He noted that, in the screening program he runs in Charleston, every person who contacts the program and is interested in screening undergoes risk profiling. Are there people with a risk profile that justifies screening but fall outside the proposed criteria? “Absolutely,” Dr. Silvestri said.
People considering screening also need to recognize its potential harms, noted Renda Soylemez Wiener, MD, another member of the expert panel who spoke at the meeting. She cited five potential harms: death or complications from a biopsy of a screen-detected nodule, surgery for a screen-detected lesion that turns out to be benign, the psychosocial impact of finding a lung nodule, over diagnosis, and the cumulative radiation exposure from serial low-dose chest CT scans. “All of these dangers are real and may be magnified or mitigated as low-dose CT screening is implemented in real world practice,” said Dr. Wiener, a pulmonologist at Boston University.
In addition to four evidence-based recommendations that help define who is and isn’t an appropriate screening candidate, the revised guideline also included 11 mostly consensus-based “suggestions” about how screening programs should ideally operate. These covered issues such as identifying symptomatic patients who require diagnosis rather than screening, having strategies to encourage compliance with annual screening, including smoking cessation treatments in screening programs, and having strategies that minimize overtreatment of potentially indolent cancers.
The goal of these suggestions is to help in the design of high-quality screening programs, said Dr. Mazzone. “It’s not just who you screen but also how you screen.”
On Twitter @mitchelzoler
M. Patricia Rivera, MD, FCCP, comments: The revised ACCP screening guidelines recommend expanding the screening age from 55-74 years (age criterion used in the National Lung Screening Trial) to 55-77 years. While this may be interpreted as raising the screening age ceiling, the new recommendation is in line with the age range approved by Medicare. We should also keep in mind that after modeling studies to predict the benefits and harms of screening programs using different screening intervals, age ranges, and smoking histories (duration and time since quitting), the USPSTF concluded in their final recommendation that screening adults aged 55-80 years with same smoking history and time since quitting used in the National Lung Screening Trial (NLST) had a reasonable balance of benefits and harms. Implementing lung cancer screening has been challenging, and studies have reported many patient-, provider-, and system-based barriers including conflicting upper age range recommendations. 
While age and smoking history are important in identifying individuals at risk for lung cancer, development of lung cancer is likely multifactorial and several other risk factors need to be considered. The ACCP's revised guidelines provide flexibility when evaluating patients who do not meet the age and smoking history criteria for screening but who have a high risk for developing lung cancer based on risk prediction models. Following publication of the NLST results, secondary analysis of the data using a risk prediction model that takes into account additional risk factors for the development of lung cancer (race, COPD, and family history of lung cancer, among others) suggests risk prediction modeling may be helpful at identifying the individuals who are at highest risk for developing lung cancer. As pointed out by Dr. Mazzone and Dr. Silvestri, the ACCP lung cancer screening guidelines promote the expansion of lung cancer screening in a safe and effective way and encourage individualized risk profiling to aid in the selection of all individuals who will benefit from lung cancer screening.
M. Patricia Rivera, MD, FCCP, comments: The revised ACCP screening guidelines recommend expanding the screening age from 55-74 years (age criterion used in the National Lung Screening Trial) to 55-77 years. While this may be interpreted as raising the screening age ceiling, the new recommendation is in line with the age range approved by Medicare. We should also keep in mind that after modeling studies to predict the benefits and harms of screening programs using different screening intervals, age ranges, and smoking histories (duration and time since quitting), the USPSTF concluded in their final recommendation that screening adults aged 55-80 years with same smoking history and time since quitting used in the National Lung Screening Trial (NLST) had a reasonable balance of benefits and harms. Implementing lung cancer screening has been challenging, and studies have reported many patient-, provider-, and system-based barriers including conflicting upper age range recommendations.
While age and smoking history are important in identifying individuals at risk for lung cancer, development of lung cancer is likely multifactorial and several other risk factors need to be considered. The ACCP's revised guidelines provide flexibility when evaluating patients who do not meet the age and smoking history criteria for screening but who have a high risk for developing lung cancer based on risk prediction models. Following publication of the NLST results, secondary analysis of the data using a risk prediction model that takes into account additional risk factors for the development of lung cancer (race, COPD, and family history of lung cancer, among others) suggests risk prediction modeling may be helpful at identifying the individuals who are at highest risk for developing lung cancer. As pointed out by Dr. Mazzone and Dr. Silvestri, the ACCP lung cancer screening guidelines promote the expansion of lung cancer screening in a safe and effective way and encourage individualized risk profiling to aid in the selection of all individuals who will benefit from lung cancer screening.
M. Patricia Rivera, MD, FCCP, comments: The revised ACCP screening guidelines recommend expanding the screening age from 55-74 years (age criterion used in the National Lung Screening Trial) to 55-77 years. While this may be interpreted as raising the screening age ceiling, the new recommendation is in line with the age range approved by Medicare. We should also keep in mind that after modeling studies to predict the benefits and harms of screening programs using different screening intervals, age ranges, and smoking histories (duration and time since quitting), the USPSTF concluded in their final recommendation that screening adults aged 55-80 years with same smoking history and time since quitting used in the National Lung Screening Trial (NLST) had a reasonable balance of benefits and harms. Implementing lung cancer screening has been challenging, and studies have reported many patient-, provider-, and system-based barriers including conflicting upper age range recommendations.
While age and smoking history are important in identifying individuals at risk for lung cancer, development of lung cancer is likely multifactorial and several other risk factors need to be considered. The ACCP's revised guidelines provide flexibility when evaluating patients who do not meet the age and smoking history criteria for screening but who have a high risk for developing lung cancer based on risk prediction models. Following publication of the NLST results, secondary analysis of the data using a risk prediction model that takes into account additional risk factors for the development of lung cancer (race, COPD, and family history of lung cancer, among others) suggests risk prediction modeling may be helpful at identifying the individuals who are at highest risk for developing lung cancer. As pointed out by Dr. Mazzone and Dr. Silvestri, the ACCP lung cancer screening guidelines promote the expansion of lung cancer screening in a safe and effective way and encourage individualized risk profiling to aid in the selection of all individuals who will benefit from lung cancer screening.
TORONTO – A proposed change to CHEST’s lung cancer screening guideline calls for raising the upper age for screening recent cigarette smokers to 77 years of age from 74 years of age.
This proposal is part of draft guideline that was unveiled during the CHEST annual meeting but is still subject to tweaking by peer review until formal release in early 2018. The draft also offers expanded guidance on how to implement screening, containing three times as many recommendations as the current lung cancer screening guidelines (Chest. 2013 May; 143[5 Suppl]:e78S-e92S).
“We want screening to expand in a safe and effective way,” said Peter J. Mazzone, MD, chair of the expert panel that is preparing the revision for CHEST and a pulmonologist at the Cleveland Clinic. “We are less restrictive with these guidelines” than in the 2013 version.
Dr. Mazzone cited two major changes that will produce modest broadening of the criteria that determine which patients can appropriately get screening. The clearest change was the age range, which expanded from 55-74 years of age set in 2013 to reflect the age criterion for enrollment in the National Lung Screening Trial (New Engl J Med. 2011 Aug 4; 365[5]:395-409). Dr. Mazzone explained, though it remains short of the 80-year old ceiling recommended by the U.S. Preventive Services Task Force.
The second, subtler change eased back on the outright ban that the 2013 guidelines placed on screening anyone who falls outside the target age range and smoking history (at least 30 pack years and either being a current smoker or having recently quit within the past 15 years) and who is without severe comorbidities.
The guidelines from 2013 said that screening people who fell outside these limits “should not be performed.” In contrast, the new draft guideline simply said that people who fall outside of the age and smoking-history criteria but who are still considered high risk for lung cancer based on a risk-prediction calculator should not “routinely” undergo screening. Additionally, exceptions could be made for certain patients whose high risk appears to warrant screening, Dr. Mazzone and others from the expert panel noted.
The revision specified that a high-risk person outside of the core criteria might still be a reasonable candidate for screening if this person tallies at least a 1.51% risk of developing lung cancer during the next 6 years according to the PLCOM2012 risk calculator (New Engl J Med. 2013 Feb 21; 368[8]:728-36).
“Some of the evidence allowed us to be a little more flexible,” though not to the point of “opening screening widely” to people who fall outside the core target population; rather, clinicians get to have a little more discretion, said Dr. Mazzone, who directs the Cleveland Clinic’s Lung Cancer Program. “We hope this will lead to more patients being screened in a high quality way,” he said in an interview. The panel strove to “look beyond the National Lung Screening Trial and find other groups of patients who could benefit” from screening. “We say that other high-risk people should not, on the whole, be screened” but that clinicians could consider individuals as appropriate for screening on a case-by-case basis.
The revision “fills in the outline” for screening that was established in the 2013 guidelines, said Gerard A. Silvestri, MD, a member of the revision panel, in a video interview. The updated guideline better detailed who benefits the most from screening and who benefits less, as well as the potential complications screening may cause, said Dr. Silvestri, a professor of medicine and lung cancer pulmonologist at the Medical University of South Carolina in Charleston.
“The sweet spot for screening is patients with a medium lung cancer risk without many comorbidities. We are trying to come up with individualized risk profiling,” explained Dr. Silvestri during the CHEST session. He noted that, in the screening program he runs in Charleston, every person who contacts the program and is interested in screening undergoes risk profiling. Are there people with a risk profile that justifies screening but fall outside the proposed criteria? “Absolutely,” Dr. Silvestri said.
People considering screening also need to recognize its potential harms, noted Renda Soylemez Wiener, MD, another member of the expert panel who spoke at the meeting. She cited five potential harms: death or complications from a biopsy of a screen-detected nodule, surgery for a screen-detected lesion that turns out to be benign, the psychosocial impact of finding a lung nodule, over diagnosis, and the cumulative radiation exposure from serial low-dose chest CT scans. “All of these dangers are real and may be magnified or mitigated as low-dose CT screening is implemented in real world practice,” said Dr. Wiener, a pulmonologist at Boston University.
In addition to four evidence-based recommendations that help define who is and isn’t an appropriate screening candidate, the revised guideline also included 11 mostly consensus-based “suggestions” about how screening programs should ideally operate. These covered issues such as identifying symptomatic patients who require diagnosis rather than screening, having strategies to encourage compliance with annual screening, including smoking cessation treatments in screening programs, and having strategies that minimize overtreatment of potentially indolent cancers.
The goal of these suggestions is to help in the design of high-quality screening programs, said Dr. Mazzone. “It’s not just who you screen but also how you screen.”
On Twitter @mitchelzoler
TORONTO – A proposed change to CHEST’s lung cancer screening guideline calls for raising the upper age for screening recent cigarette smokers to 77 years of age from 74 years of age.
This proposal is part of draft guideline that was unveiled during the CHEST annual meeting but is still subject to tweaking by peer review until formal release in early 2018. The draft also offers expanded guidance on how to implement screening, containing three times as many recommendations as the current lung cancer screening guidelines (Chest. 2013 May; 143[5 Suppl]:e78S-e92S).
“We want screening to expand in a safe and effective way,” said Peter J. Mazzone, MD, chair of the expert panel that is preparing the revision for CHEST and a pulmonologist at the Cleveland Clinic. “We are less restrictive with these guidelines” than in the 2013 version.
Dr. Mazzone cited two major changes that will produce modest broadening of the criteria that determine which patients can appropriately get screening. The clearest change was the age range, which expanded from 55-74 years of age set in 2013 to reflect the age criterion for enrollment in the National Lung Screening Trial (New Engl J Med. 2011 Aug 4; 365[5]:395-409). Dr. Mazzone explained, though it remains short of the 80-year old ceiling recommended by the U.S. Preventive Services Task Force.
The second, subtler change eased back on the outright ban that the 2013 guidelines placed on screening anyone who falls outside the target age range and smoking history (at least 30 pack years and either being a current smoker or having recently quit within the past 15 years) and who is without severe comorbidities.
The guidelines from 2013 said that screening people who fell outside these limits “should not be performed.” In contrast, the new draft guideline simply said that people who fall outside of the age and smoking-history criteria but who are still considered high risk for lung cancer based on a risk-prediction calculator should not “routinely” undergo screening. Additionally, exceptions could be made for certain patients whose high risk appears to warrant screening, Dr. Mazzone and others from the expert panel noted.
The revision specified that a high-risk person outside of the core criteria might still be a reasonable candidate for screening if this person tallies at least a 1.51% risk of developing lung cancer during the next 6 years according to the PLCOM2012 risk calculator (New Engl J Med. 2013 Feb 21; 368[8]:728-36).
“Some of the evidence allowed us to be a little more flexible,” though not to the point of “opening screening widely” to people who fall outside the core target population; rather, clinicians get to have a little more discretion, said Dr. Mazzone, who directs the Cleveland Clinic’s Lung Cancer Program. “We hope this will lead to more patients being screened in a high quality way,” he said in an interview. The panel strove to “look beyond the National Lung Screening Trial and find other groups of patients who could benefit” from screening. “We say that other high-risk people should not, on the whole, be screened” but that clinicians could consider individuals as appropriate for screening on a case-by-case basis.
The revision “fills in the outline” for screening that was established in the 2013 guidelines, said Gerard A. Silvestri, MD, a member of the revision panel, in a video interview. The updated guideline better detailed who benefits the most from screening and who benefits less, as well as the potential complications screening may cause, said Dr. Silvestri, a professor of medicine and lung cancer pulmonologist at the Medical University of South Carolina in Charleston.
“The sweet spot for screening is patients with a medium lung cancer risk without many comorbidities. We are trying to come up with individualized risk profiling,” explained Dr. Silvestri during the CHEST session. He noted that, in the screening program he runs in Charleston, every person who contacts the program and is interested in screening undergoes risk profiling. Are there people with a risk profile that justifies screening but fall outside the proposed criteria? “Absolutely,” Dr. Silvestri said.
People considering screening also need to recognize its potential harms, noted Renda Soylemez Wiener, MD, another member of the expert panel who spoke at the meeting. She cited five potential harms: death or complications from a biopsy of a screen-detected nodule, surgery for a screen-detected lesion that turns out to be benign, the psychosocial impact of finding a lung nodule, over diagnosis, and the cumulative radiation exposure from serial low-dose chest CT scans. “All of these dangers are real and may be magnified or mitigated as low-dose CT screening is implemented in real world practice,” said Dr. Wiener, a pulmonologist at Boston University.
In addition to four evidence-based recommendations that help define who is and isn’t an appropriate screening candidate, the revised guideline also included 11 mostly consensus-based “suggestions” about how screening programs should ideally operate. These covered issues such as identifying symptomatic patients who require diagnosis rather than screening, having strategies to encourage compliance with annual screening, including smoking cessation treatments in screening programs, and having strategies that minimize overtreatment of potentially indolent cancers.
The goal of these suggestions is to help in the design of high-quality screening programs, said Dr. Mazzone. “It’s not just who you screen but also how you screen.”
On Twitter @mitchelzoler
EXPERT ANALYSIS FROM CHEST 2017
Call for Abstracts and Videos for the AATS Aortic Symposium
You are invited to submit abstracts and videos for consideration at the AATS Aortic Symposium, which will take place on April 26-27 in New York. The deadline for submissions is Monday, December 18, 2017, at 11:59 p.m. Eastern Time.
Investigators are invited to submit original work to include BOTH of the following:
- Abstract (maximum of 200 words), accompanied by
- PowerPoint presentation of the material (maximum of 12 slides)
OR
- Abstract (maximum of 200 words), accompanied by
- Video (maximum of 5 minutes, for the Presentation On Demand (POD) system ONLY and must be narrated in English)
Presentation Types Include:
- Plenary Session: PowerPoint Presentation
- Aortic Surgery Forum
- Presentation-On-Demand: Video
- Presentation-On-Demand: PowerPoint Presentation
Submission Categories:
- Aortic Root
- Ascending Aorta
- Aortic Arch
- Cerebral Protection
- Dissection
- Descending/Thoracoabdominal Aorta
- Endoluminal Prostheses
- Natural History/ Follow-up
- Spinal Cord Protection
- Trauma
- Aortic Surgery Forum (Basic Aortic Research; Lab for Residents; Fellows; Junior Attendings)
- Other
For more information, visit: www.aats.org/aortic.
You are invited to submit abstracts and videos for consideration at the AATS Aortic Symposium, which will take place on April 26-27 in New York. The deadline for submissions is Monday, December 18, 2017, at 11:59 p.m. Eastern Time.
Investigators are invited to submit original work to include BOTH of the following:
- Abstract (maximum of 200 words), accompanied by
- PowerPoint presentation of the material (maximum of 12 slides)
OR
- Abstract (maximum of 200 words), accompanied by
- Video (maximum of 5 minutes, for the Presentation On Demand (POD) system ONLY and must be narrated in English)
Presentation Types Include:
- Plenary Session: PowerPoint Presentation
- Aortic Surgery Forum
- Presentation-On-Demand: Video
- Presentation-On-Demand: PowerPoint Presentation
Submission Categories:
- Aortic Root
- Ascending Aorta
- Aortic Arch
- Cerebral Protection
- Dissection
- Descending/Thoracoabdominal Aorta
- Endoluminal Prostheses
- Natural History/ Follow-up
- Spinal Cord Protection
- Trauma
- Aortic Surgery Forum (Basic Aortic Research; Lab for Residents; Fellows; Junior Attendings)
- Other
For more information, visit: www.aats.org/aortic.
You are invited to submit abstracts and videos for consideration at the AATS Aortic Symposium, which will take place on April 26-27 in New York. The deadline for submissions is Monday, December 18, 2017, at 11:59 p.m. Eastern Time.
Investigators are invited to submit original work to include BOTH of the following:
- Abstract (maximum of 200 words), accompanied by
- PowerPoint presentation of the material (maximum of 12 slides)
OR
- Abstract (maximum of 200 words), accompanied by
- Video (maximum of 5 minutes, for the Presentation On Demand (POD) system ONLY and must be narrated in English)
Presentation Types Include:
- Plenary Session: PowerPoint Presentation
- Aortic Surgery Forum
- Presentation-On-Demand: Video
- Presentation-On-Demand: PowerPoint Presentation
Submission Categories:
- Aortic Root
- Ascending Aorta
- Aortic Arch
- Cerebral Protection
- Dissection
- Descending/Thoracoabdominal Aorta
- Endoluminal Prostheses
- Natural History/ Follow-up
- Spinal Cord Protection
- Trauma
- Aortic Surgery Forum (Basic Aortic Research; Lab for Residents; Fellows; Junior Attendings)
- Other
For more information, visit: www.aats.org/aortic.
Look at the 21st Century State of the Art Treatment of Advanced Heart and Lung Failure
March 8-9, 2018
Marriott Marquis Houston
Houston, TX, USA
LVAD/transplant cardiac surgeons, heart failure cardiologists, pulmonologists, anesthesiologists and industry representatives have the opportunity to come together for important discussions. The AATS Mechanical Circulatory Support Symposium - 21st Century State of the Art Treatment of Advanced Heart and Lung Failure focuses on mechanical circulatory support/LVADs, ECMO, and heart and lung transplantation topics such as:
- Applications of ECLS in Thoracic Surgery
- Complications With Durable MCS
- Controversial Topics With Device Therapy
- Controversies in ECLS
- Debates on Controversial Subjects
- ECMO for Out of Hospital Cardiac Arrest
- ECMO for Respiratory Failure
- ECMO in Thoracic Surgery
- Hot Topics in Mechanical Circulatory Support for Heart and Lung
- Lung Transplant
- MCS Device Thrombosis
- MCS Innovation
- Minimally Invasive LVAD Insertion, Concomitant Procedures
- Patient Selection and Optimization for Durable MCS Devices
PROGRAM DIRECTORS
Shaf Keshavjee
Jeffrey A. Morgan
Francis D. Pagani
Mark S. Slaughter
PROGRAM COMMITTEE
Michael A. Acker
Malcolm M. DeCamp Jr.
Jonathan W. Haft
Ranjit John
Robert M. Kormos
Stephan Schueler
Register, reserve housing and view the preliminary program at www.aats.org/mcs
March 8-9, 2018
Marriott Marquis Houston
Houston, TX, USA
LVAD/transplant cardiac surgeons, heart failure cardiologists, pulmonologists, anesthesiologists and industry representatives have the opportunity to come together for important discussions. The AATS Mechanical Circulatory Support Symposium - 21st Century State of the Art Treatment of Advanced Heart and Lung Failure focuses on mechanical circulatory support/LVADs, ECMO, and heart and lung transplantation topics such as:
- Applications of ECLS in Thoracic Surgery
- Complications With Durable MCS
- Controversial Topics With Device Therapy
- Controversies in ECLS
- Debates on Controversial Subjects
- ECMO for Out of Hospital Cardiac Arrest
- ECMO for Respiratory Failure
- ECMO in Thoracic Surgery
- Hot Topics in Mechanical Circulatory Support for Heart and Lung
- Lung Transplant
- MCS Device Thrombosis
- MCS Innovation
- Minimally Invasive LVAD Insertion, Concomitant Procedures
- Patient Selection and Optimization for Durable MCS Devices
PROGRAM DIRECTORS
Shaf Keshavjee
Jeffrey A. Morgan
Francis D. Pagani
Mark S. Slaughter
PROGRAM COMMITTEE
Michael A. Acker
Malcolm M. DeCamp Jr.
Jonathan W. Haft
Ranjit John
Robert M. Kormos
Stephan Schueler
Register, reserve housing and view the preliminary program at www.aats.org/mcs
March 8-9, 2018
Marriott Marquis Houston
Houston, TX, USA
LVAD/transplant cardiac surgeons, heart failure cardiologists, pulmonologists, anesthesiologists and industry representatives have the opportunity to come together for important discussions. The AATS Mechanical Circulatory Support Symposium - 21st Century State of the Art Treatment of Advanced Heart and Lung Failure focuses on mechanical circulatory support/LVADs, ECMO, and heart and lung transplantation topics such as:
- Applications of ECLS in Thoracic Surgery
- Complications With Durable MCS
- Controversial Topics With Device Therapy
- Controversies in ECLS
- Debates on Controversial Subjects
- ECMO for Out of Hospital Cardiac Arrest
- ECMO for Respiratory Failure
- ECMO in Thoracic Surgery
- Hot Topics in Mechanical Circulatory Support for Heart and Lung
- Lung Transplant
- MCS Device Thrombosis
- MCS Innovation
- Minimally Invasive LVAD Insertion, Concomitant Procedures
- Patient Selection and Optimization for Durable MCS Devices
PROGRAM DIRECTORS
Shaf Keshavjee
Jeffrey A. Morgan
Francis D. Pagani
Mark S. Slaughter
PROGRAM COMMITTEE
Michael A. Acker
Malcolm M. DeCamp Jr.
Jonathan W. Haft
Ranjit John
Robert M. Kormos
Stephan Schueler
Register, reserve housing and view the preliminary program at www.aats.org/mcs
Work to Advance Cardiac Surgery Across the Americas at the 2017 AATS International Cardiovascular Symposium
December 8-9, 2017
Renaissance São Paulo Hotel
São Paulo, Brazil
Join Dr. Thoralf M. Sundt III, Past President of the AATS and expert in bicuspid aortopathy, and Dr. David P. Taggart, Great Britain's luminary on coronary artery disease, at the 2017 AATS International Cardiovascular Symposium in São Paulo, Brazil, on December 8-9, 2017. Register to be there as they, and the rest of the esteemed faculty, discuss state-of the-art information on devices, long-term results and surgical techniques with a focus on preventing, diagnosing and treating heart valve disease.
Several faculty members have shared why surgeons should attend the Symposium. Thoralf M. Sundt, III from Massachusetts General Hospital in Boston, MA says, “This is an exciting opportunity for us to come together to discuss and learn about the most up to-date approaches to cardiovascular disease with special focus on the South American perspective.”
David P. Taggart from the University of Oxford in the UK says, “The meeting provides an excellent opportunity to hear focused updates on all aspects of adult cardiothoracic surgery by leading experts both from within and beyond Brazil and with great opportunities for interaction amongst delegates and faculty.”
Program Directors
Joseph S. Coselli
Walter J. Gomes
Marc R. Moon
Thoralf M. Sundt, III
To see the program, register or learn more about the faculty visit: aats.org/ics
December 8-9, 2017
Renaissance São Paulo Hotel
São Paulo, Brazil
Join Dr. Thoralf M. Sundt III, Past President of the AATS and expert in bicuspid aortopathy, and Dr. David P. Taggart, Great Britain's luminary on coronary artery disease, at the 2017 AATS International Cardiovascular Symposium in São Paulo, Brazil, on December 8-9, 2017. Register to be there as they, and the rest of the esteemed faculty, discuss state-of the-art information on devices, long-term results and surgical techniques with a focus on preventing, diagnosing and treating heart valve disease.
Several faculty members have shared why surgeons should attend the Symposium. Thoralf M. Sundt, III from Massachusetts General Hospital in Boston, MA says, “This is an exciting opportunity for us to come together to discuss and learn about the most up to-date approaches to cardiovascular disease with special focus on the South American perspective.”
David P. Taggart from the University of Oxford in the UK says, “The meeting provides an excellent opportunity to hear focused updates on all aspects of adult cardiothoracic surgery by leading experts both from within and beyond Brazil and with great opportunities for interaction amongst delegates and faculty.”
Program Directors
Joseph S. Coselli
Walter J. Gomes
Marc R. Moon
Thoralf M. Sundt, III
To see the program, register or learn more about the faculty visit: aats.org/ics
December 8-9, 2017
Renaissance São Paulo Hotel
São Paulo, Brazil
Join Dr. Thoralf M. Sundt III, Past President of the AATS and expert in bicuspid aortopathy, and Dr. David P. Taggart, Great Britain's luminary on coronary artery disease, at the 2017 AATS International Cardiovascular Symposium in São Paulo, Brazil, on December 8-9, 2017. Register to be there as they, and the rest of the esteemed faculty, discuss state-of the-art information on devices, long-term results and surgical techniques with a focus on preventing, diagnosing and treating heart valve disease.
Several faculty members have shared why surgeons should attend the Symposium. Thoralf M. Sundt, III from Massachusetts General Hospital in Boston, MA says, “This is an exciting opportunity for us to come together to discuss and learn about the most up to-date approaches to cardiovascular disease with special focus on the South American perspective.”
David P. Taggart from the University of Oxford in the UK says, “The meeting provides an excellent opportunity to hear focused updates on all aspects of adult cardiothoracic surgery by leading experts both from within and beyond Brazil and with great opportunities for interaction amongst delegates and faculty.”
Program Directors
Joseph S. Coselli
Walter J. Gomes
Marc R. Moon
Thoralf M. Sundt, III
To see the program, register or learn more about the faculty visit: aats.org/ics