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Official Newspaper of the American College of Surgeons
ACS NSQIP data: Laparoscopic sleeve gastrectomy is at least as safe as gastric bypass
Laparoscopic sleeve gastrectomy is associated with lower rates of morbidity and similar mortality when compared with laparoscopic Roux-en-Y gastric bypass, according to an analysis of 2010-2011 data from the American College of Surgeons National Surgical Quality Improvement Program database.
Of 24,117 patients included in the analysis, 79.5% underwent laparoscopic Roux-en-Y gastric bypass (LGB), and 20.5% had laparoscopic sleeve gastrectomy (LSG). Of note, the proportion of LSG cases increased from 14.6% in 2010 to 24.8% in 2011, Dr. Monica T. Young of the University of California Irvine Medical Center, Orange, Calif., and her colleagues reported.
Those who underwent LGB had a significantly higher rate of 30-day risk-adjusted morbidity (odds ratio, 1.32). The 30-day mortality rate was 0.15% with bypass and 0.10% for sleeve gastrectomy, the investigators said (J. Am. Coll. Surg. 2015 [doi:
10.1016/j.jamcollsurg.2015.01.059]).
Further, sleeve gastrectomy was associated with shorter operative time (101 vs. 133 minutes) and with lower rates of blood loss requiring transfusion (0.65% vs. 1.5%), deep wound infections (0.06% vs. 0.20%), sepsis (0.34% vs. 0.58%), overall serious morbidity (3.8% vs. 5.8%), and reoperations within 30 days (1.6% vs. 2.5%).
The rate of deep venous thrombosis, however, was significantly higher with sleeve gastrectomy (0.47% vs. 0.21%). Deep vein thrombosis was the only complication found to be higher after LSG, they noted.
Older patients, those with a higher body mass index, and those who smoked or had hypertension were at significantly greater risk of serious morbidity.
Given the increasing popularity and use of sleeve gastrectomy as seen both in this study and nationally – with a reported increase in utilization from 0.9% in 2008 to 36.3% in 2012, it is important to compare outcomes with LSG with those for the preferred Roux-en-Y bypass surgery, the investigators said, noting that few large-scale studies have compared outcomes with the two procedures.
“Over the past decade, laparoscopic sleeve gastrectomy has emerged as a common utilized bariatric procedure. LSG has several advantages over LGB including preservation of endoscopic access to the upper gastrointestinal tract, avoidance of intestinal anastomosis, and prevention of dumping syndrome by pylorus preservation,” they wrote, adding that studies increasingly demonstrate its efficacy for weight loss.
The current findings support those of other recent studies, and a comparison of the data with those from 2007 to 2010 from the ACS NSQIP database showed that while reoperation rates after gastric bypass and sleeve gastrectomy have declined dramatically over time, readmission rates remain elevated.
“Therefore, it appears that further quality improvement initiatives are necessary to reduce the rate of readmissions after bariatric surgery,” the investigators wrote, noting that a national collaborative to reduce 30-day readmissions by 20% (the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program, or MBSAQIP) is currently enrolling.
Additional randomized controlled trials are also needed to evaluate differences in long-term outcomes between the two procedures, they concluded.
The authors reported having no relevant financial disclosures.
Laparoscopic sleeve gastrectomy is associated with lower rates of morbidity and similar mortality when compared with laparoscopic Roux-en-Y gastric bypass, according to an analysis of 2010-2011 data from the American College of Surgeons National Surgical Quality Improvement Program database.
Of 24,117 patients included in the analysis, 79.5% underwent laparoscopic Roux-en-Y gastric bypass (LGB), and 20.5% had laparoscopic sleeve gastrectomy (LSG). Of note, the proportion of LSG cases increased from 14.6% in 2010 to 24.8% in 2011, Dr. Monica T. Young of the University of California Irvine Medical Center, Orange, Calif., and her colleagues reported.
Those who underwent LGB had a significantly higher rate of 30-day risk-adjusted morbidity (odds ratio, 1.32). The 30-day mortality rate was 0.15% with bypass and 0.10% for sleeve gastrectomy, the investigators said (J. Am. Coll. Surg. 2015 [doi:
10.1016/j.jamcollsurg.2015.01.059]).
Further, sleeve gastrectomy was associated with shorter operative time (101 vs. 133 minutes) and with lower rates of blood loss requiring transfusion (0.65% vs. 1.5%), deep wound infections (0.06% vs. 0.20%), sepsis (0.34% vs. 0.58%), overall serious morbidity (3.8% vs. 5.8%), and reoperations within 30 days (1.6% vs. 2.5%).
The rate of deep venous thrombosis, however, was significantly higher with sleeve gastrectomy (0.47% vs. 0.21%). Deep vein thrombosis was the only complication found to be higher after LSG, they noted.
Older patients, those with a higher body mass index, and those who smoked or had hypertension were at significantly greater risk of serious morbidity.
Given the increasing popularity and use of sleeve gastrectomy as seen both in this study and nationally – with a reported increase in utilization from 0.9% in 2008 to 36.3% in 2012, it is important to compare outcomes with LSG with those for the preferred Roux-en-Y bypass surgery, the investigators said, noting that few large-scale studies have compared outcomes with the two procedures.
“Over the past decade, laparoscopic sleeve gastrectomy has emerged as a common utilized bariatric procedure. LSG has several advantages over LGB including preservation of endoscopic access to the upper gastrointestinal tract, avoidance of intestinal anastomosis, and prevention of dumping syndrome by pylorus preservation,” they wrote, adding that studies increasingly demonstrate its efficacy for weight loss.
The current findings support those of other recent studies, and a comparison of the data with those from 2007 to 2010 from the ACS NSQIP database showed that while reoperation rates after gastric bypass and sleeve gastrectomy have declined dramatically over time, readmission rates remain elevated.
“Therefore, it appears that further quality improvement initiatives are necessary to reduce the rate of readmissions after bariatric surgery,” the investigators wrote, noting that a national collaborative to reduce 30-day readmissions by 20% (the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program, or MBSAQIP) is currently enrolling.
Additional randomized controlled trials are also needed to evaluate differences in long-term outcomes between the two procedures, they concluded.
The authors reported having no relevant financial disclosures.
Laparoscopic sleeve gastrectomy is associated with lower rates of morbidity and similar mortality when compared with laparoscopic Roux-en-Y gastric bypass, according to an analysis of 2010-2011 data from the American College of Surgeons National Surgical Quality Improvement Program database.
Of 24,117 patients included in the analysis, 79.5% underwent laparoscopic Roux-en-Y gastric bypass (LGB), and 20.5% had laparoscopic sleeve gastrectomy (LSG). Of note, the proportion of LSG cases increased from 14.6% in 2010 to 24.8% in 2011, Dr. Monica T. Young of the University of California Irvine Medical Center, Orange, Calif., and her colleagues reported.
Those who underwent LGB had a significantly higher rate of 30-day risk-adjusted morbidity (odds ratio, 1.32). The 30-day mortality rate was 0.15% with bypass and 0.10% for sleeve gastrectomy, the investigators said (J. Am. Coll. Surg. 2015 [doi:
10.1016/j.jamcollsurg.2015.01.059]).
Further, sleeve gastrectomy was associated with shorter operative time (101 vs. 133 minutes) and with lower rates of blood loss requiring transfusion (0.65% vs. 1.5%), deep wound infections (0.06% vs. 0.20%), sepsis (0.34% vs. 0.58%), overall serious morbidity (3.8% vs. 5.8%), and reoperations within 30 days (1.6% vs. 2.5%).
The rate of deep venous thrombosis, however, was significantly higher with sleeve gastrectomy (0.47% vs. 0.21%). Deep vein thrombosis was the only complication found to be higher after LSG, they noted.
Older patients, those with a higher body mass index, and those who smoked or had hypertension were at significantly greater risk of serious morbidity.
Given the increasing popularity and use of sleeve gastrectomy as seen both in this study and nationally – with a reported increase in utilization from 0.9% in 2008 to 36.3% in 2012, it is important to compare outcomes with LSG with those for the preferred Roux-en-Y bypass surgery, the investigators said, noting that few large-scale studies have compared outcomes with the two procedures.
“Over the past decade, laparoscopic sleeve gastrectomy has emerged as a common utilized bariatric procedure. LSG has several advantages over LGB including preservation of endoscopic access to the upper gastrointestinal tract, avoidance of intestinal anastomosis, and prevention of dumping syndrome by pylorus preservation,” they wrote, adding that studies increasingly demonstrate its efficacy for weight loss.
The current findings support those of other recent studies, and a comparison of the data with those from 2007 to 2010 from the ACS NSQIP database showed that while reoperation rates after gastric bypass and sleeve gastrectomy have declined dramatically over time, readmission rates remain elevated.
“Therefore, it appears that further quality improvement initiatives are necessary to reduce the rate of readmissions after bariatric surgery,” the investigators wrote, noting that a national collaborative to reduce 30-day readmissions by 20% (the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program, or MBSAQIP) is currently enrolling.
Additional randomized controlled trials are also needed to evaluate differences in long-term outcomes between the two procedures, they concluded.
The authors reported having no relevant financial disclosures.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF SURGEONS
Key clinical point: Laparoscopic sleeve gastrectomy appears to have numerous advantages over laparoscopic Roux-en-Y gastric bypass.
Major finding: Patients who underwent LGB had a significantly higher rate of 30-day risk-adjusted morbidity (odds ratio, 1.32).
Data source: An analysis of data from the ACS NSQIP database.
Disclosures: The authors reported having no relevant financial disclosures.
Algorithm may predict intracranial pressure swings after TBI
LAKE BUENA VISTA, FLA. – An algorithm might predict whether patients with severe traumatic brain injury are recovering well or need interventions to preempt evolving intracranial hypertension.
“Valid predictive algorithms have the potential to revolutionize the care of patients with traumatic brain injury [TBI] and transform physiologic data from just a pure numeric value buried in a never-ending nursing flow sheet into a useful triage and decision-assist tool,” study author Dr. Brandon Bonds said at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.
A minimum of 10 hours of continuous data on vital signs (intracranial pressure, heart rate, systolic blood pressure, shock index, and mean arterial pressure) were used to predict intracranial pressure (ICP) values for a retrospective cohort of 132 adults with severe TBI, 97% of which was the result of blunt trauma. Even relatively brief episodes of elevated ICP have been shown to be associated with poor outcomes in TBI patients, while marked elevation of ICP may lead to herniation and death, said Dr. Bonds of the R. Adams Cowley Shock Trauma Center, University of Maryland, Baltimore.
At the trauma center, vital signs are automatically collected every 6 seconds, 24 hours a day, on all TBI patients. This granularity of data was used to map patterns in the patients’ physiology. The approach used a nearest neighbor regression (NNR) method: A model was constructed that predicts future numerical values for an individual based on comparisons to data from historical subjects.
The same mathematical principal is used by a variety of industries to predict likely responses. NetFlix, for example, uses a system similar to the NNR method to predict future television and movie picks based on prior selections, Dr. Bonds explained.
About 20 minutes of continuously collected, automated vital sign data were then used to test the algorithm on a per-patient basis. The algorithm was used to predict future ICP values at 5 minutes to 2 hours from that time. The predictions are made on a rolling basis, with patient data updates every 5 minutes.
The NNR model was good at predicting actual ICP at 5 minutes, with a bias of 0.02 (± 2 standard deviations of 4 mm Hg). As expected, agreement was somewhat lessened at 2 hours (± 2 standard deviations of 10 mm Hg), “but this may still represent a clinically significant value,” Dr. Bonds said.
The next step is a prospective study of the algorithm’s utility.
Dr. Bonds said that NNR research really isn’t all that alien to medicine. Think about the experienced emergency physician who can look out into the wait room and “tell the nurse to bring back [a certain patient] because he didn’t look good,” Dr. Bonds said. Such a physician uses “the minimum amount of data he has and compares that patient to the historic data set of the thousands of patients that he’s seen previously to identify a patient that’s not going to do well. What we’re trying to do with this model is take this subjective skill and turn it into an objective tool.”
In an interview, session comoderator Dr. David A. Hampton, M.Eng., of Oregon Health and Science University in Portland, commented that he could definitely see the NNR method eventually having utility in severe TBI.
Future work will need to address outliers in the data because the standard deviation of 4 mm Hg “is pretty big for ICP swings” and to determine whether multiple libraries of data will need to be created based upon the different types of patients who come in, he said.
The study was funded by the United States Air Force. Dr. Bonds and his coauthors reported no financial disclosures.
LAKE BUENA VISTA, FLA. – An algorithm might predict whether patients with severe traumatic brain injury are recovering well or need interventions to preempt evolving intracranial hypertension.
“Valid predictive algorithms have the potential to revolutionize the care of patients with traumatic brain injury [TBI] and transform physiologic data from just a pure numeric value buried in a never-ending nursing flow sheet into a useful triage and decision-assist tool,” study author Dr. Brandon Bonds said at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.
A minimum of 10 hours of continuous data on vital signs (intracranial pressure, heart rate, systolic blood pressure, shock index, and mean arterial pressure) were used to predict intracranial pressure (ICP) values for a retrospective cohort of 132 adults with severe TBI, 97% of which was the result of blunt trauma. Even relatively brief episodes of elevated ICP have been shown to be associated with poor outcomes in TBI patients, while marked elevation of ICP may lead to herniation and death, said Dr. Bonds of the R. Adams Cowley Shock Trauma Center, University of Maryland, Baltimore.
At the trauma center, vital signs are automatically collected every 6 seconds, 24 hours a day, on all TBI patients. This granularity of data was used to map patterns in the patients’ physiology. The approach used a nearest neighbor regression (NNR) method: A model was constructed that predicts future numerical values for an individual based on comparisons to data from historical subjects.
The same mathematical principal is used by a variety of industries to predict likely responses. NetFlix, for example, uses a system similar to the NNR method to predict future television and movie picks based on prior selections, Dr. Bonds explained.
About 20 minutes of continuously collected, automated vital sign data were then used to test the algorithm on a per-patient basis. The algorithm was used to predict future ICP values at 5 minutes to 2 hours from that time. The predictions are made on a rolling basis, with patient data updates every 5 minutes.
The NNR model was good at predicting actual ICP at 5 minutes, with a bias of 0.02 (± 2 standard deviations of 4 mm Hg). As expected, agreement was somewhat lessened at 2 hours (± 2 standard deviations of 10 mm Hg), “but this may still represent a clinically significant value,” Dr. Bonds said.
The next step is a prospective study of the algorithm’s utility.
Dr. Bonds said that NNR research really isn’t all that alien to medicine. Think about the experienced emergency physician who can look out into the wait room and “tell the nurse to bring back [a certain patient] because he didn’t look good,” Dr. Bonds said. Such a physician uses “the minimum amount of data he has and compares that patient to the historic data set of the thousands of patients that he’s seen previously to identify a patient that’s not going to do well. What we’re trying to do with this model is take this subjective skill and turn it into an objective tool.”
In an interview, session comoderator Dr. David A. Hampton, M.Eng., of Oregon Health and Science University in Portland, commented that he could definitely see the NNR method eventually having utility in severe TBI.
Future work will need to address outliers in the data because the standard deviation of 4 mm Hg “is pretty big for ICP swings” and to determine whether multiple libraries of data will need to be created based upon the different types of patients who come in, he said.
The study was funded by the United States Air Force. Dr. Bonds and his coauthors reported no financial disclosures.
LAKE BUENA VISTA, FLA. – An algorithm might predict whether patients with severe traumatic brain injury are recovering well or need interventions to preempt evolving intracranial hypertension.
“Valid predictive algorithms have the potential to revolutionize the care of patients with traumatic brain injury [TBI] and transform physiologic data from just a pure numeric value buried in a never-ending nursing flow sheet into a useful triage and decision-assist tool,” study author Dr. Brandon Bonds said at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.
A minimum of 10 hours of continuous data on vital signs (intracranial pressure, heart rate, systolic blood pressure, shock index, and mean arterial pressure) were used to predict intracranial pressure (ICP) values for a retrospective cohort of 132 adults with severe TBI, 97% of which was the result of blunt trauma. Even relatively brief episodes of elevated ICP have been shown to be associated with poor outcomes in TBI patients, while marked elevation of ICP may lead to herniation and death, said Dr. Bonds of the R. Adams Cowley Shock Trauma Center, University of Maryland, Baltimore.
At the trauma center, vital signs are automatically collected every 6 seconds, 24 hours a day, on all TBI patients. This granularity of data was used to map patterns in the patients’ physiology. The approach used a nearest neighbor regression (NNR) method: A model was constructed that predicts future numerical values for an individual based on comparisons to data from historical subjects.
The same mathematical principal is used by a variety of industries to predict likely responses. NetFlix, for example, uses a system similar to the NNR method to predict future television and movie picks based on prior selections, Dr. Bonds explained.
About 20 minutes of continuously collected, automated vital sign data were then used to test the algorithm on a per-patient basis. The algorithm was used to predict future ICP values at 5 minutes to 2 hours from that time. The predictions are made on a rolling basis, with patient data updates every 5 minutes.
The NNR model was good at predicting actual ICP at 5 minutes, with a bias of 0.02 (± 2 standard deviations of 4 mm Hg). As expected, agreement was somewhat lessened at 2 hours (± 2 standard deviations of 10 mm Hg), “but this may still represent a clinically significant value,” Dr. Bonds said.
The next step is a prospective study of the algorithm’s utility.
Dr. Bonds said that NNR research really isn’t all that alien to medicine. Think about the experienced emergency physician who can look out into the wait room and “tell the nurse to bring back [a certain patient] because he didn’t look good,” Dr. Bonds said. Such a physician uses “the minimum amount of data he has and compares that patient to the historic data set of the thousands of patients that he’s seen previously to identify a patient that’s not going to do well. What we’re trying to do with this model is take this subjective skill and turn it into an objective tool.”
In an interview, session comoderator Dr. David A. Hampton, M.Eng., of Oregon Health and Science University in Portland, commented that he could definitely see the NNR method eventually having utility in severe TBI.
Future work will need to address outliers in the data because the standard deviation of 4 mm Hg “is pretty big for ICP swings” and to determine whether multiple libraries of data will need to be created based upon the different types of patients who come in, he said.
The study was funded by the United States Air Force. Dr. Bonds and his coauthors reported no financial disclosures.
AT THE EAST SCIENTIFIC ASSEMBLY
Key clinical point: A short duration of vital sign data might prove useful for forecasting secondary intracranial pressure swings after traumatic brain injury.
Major finding: A model based on data from severe TBI patients predicted fluctuations in ICP at 5 minutes with a standard deviation of 4 mm Hg.
Data source: Retrospective study in 132 patients.
Disclosures: The study was funded by the United States Air Force. Dr. Bonds and his coauthors reported no financial disclosures.
Experts: New ACO model positive for physicians
The new Next Generation Accountable Care Organization (ACO) model improves upon other ACO models and allows for greater success for physicians, according to ACO experts.
“It’s a really good sign generally that CMS is willing and able to adapt to some of the major structural problems with the Medicare ACO model,” said Julian D. “Bo” Bobbitt Jr., a health law attorney in Raleigh, N.C. “Changing incentives to reward higher quality at lower cost and to align those is extraordinarily promising.”
The Next Generation ACO model offers predictable financial targets, enables providers and patients greater opportunities to coordinate care, and aims to attain the highest standards of care, according to a March 10 announcement from the Centers for Medicare & Medicaid Services. The new model means greater financial risks for doctors and hospitals in exchange for greater shared savings for high performance. To support the increased risk sharing, the new ACOs will have a stable, predictable benchmark and flexible payment options that support investments in care improvement infrastructure that provide high quality care to patients, CMS said in its release.
Like the Pioneer ACO Model and the Medicare Shared Savings Program, ACOs that successfully reduce the cost of care may keep some of the savings. But the next generation model uses a new formula to calculate savings targets that do not exclusively rely on historical performance. Physicians have criticized that older method as unfair to health providers who already deliver lower-cost care. The new formula will take into account regional and national efficiency, and ACOs that have already attained cost efficiency, compared with their regions, will receive a more favorable discount, according to CMS.
Beneficiaries, too, will have the chance to voluntarily align with the Next Generation ACO model by confirming their care relationship with specific ACO providers. Patients can also receive rewards, such as waived or reduced copays, for receiving their care from ACO physicians as well as coverage of skilled nursing care without prior hospitalization, and expanded coverage of telehealth and postdischarge home services. In any event, patients retain the freedom to seek services and providers of their choice.
Beneficiary incentives are a key contributor to successful care management, said Larry Kocot, a health law attorney in Washington.
“It’s really hard for a provider to be able to deliver coordinated care to a beneficiary if the beneficiary is not a full participant,” Mr. Kocot said in an interview. “In order for the beneficiary to be a full participant, [he or she] should for instance, be able to select [his or her] provider. This model will allow for that.”
Dr. Patrick Conway, chief medical officer at CMS, said the next generation ACO is a response to physicians’ feedback and requests.
“The ACO model responds to stakeholder requests for ... greater engagement of beneficiaries; a more predictable, prospective financial model; and the flexibility to utilize additional tools to coordinate care for beneficiaries,” he said in a statement.
CMS will accept ACOs into the next generation program through two rounds of applications in 2015 and 2016, with participation expected to last up to 5 years. Participants in the Medicare Shared Savings Program and the Pioneer ACO Model may apply, as well as all other groups that meet
eligibility requirements. CMS expects about 15-20 ACOs to participate in the Next Generation ACO Model.
Mr. Kocot notes that the new model will not be the best choice for physicians new to ACOs or for those in smaller communities, who cannot take on the extra risk.
“This is really limited to a small subset of providers who are able to accept a higher amount of risk,” he said in an interview. “Physician practices vary across the country; they’re not all homogeneous. It’s not going to be the option for all providers.”
The unveiling of the next generation ACO comes on the heels of an effort by the Obama administration to shift payments away from fee for service by having half of all Medicare dollars paid to doctors through alternative payment models by the end of 2018.
The new ACO model is a likely reflection of how other accountable care organizations will be structured in the future, notes Dr. Farzad Mostashari, cofounder and CEO of Aledade, an ACO consultancy. Dr. Mostashari is the former national coordinator for health information technology.
“It is a glimpse of what the whole program is going to look like in a few years’ time,” Dr. Mostashari said in an interview. “This is directionally, absolutely where the Medicare Shared Savings Program is headed.”
Those interested in applying to the next generation models in 2015 must submit a Letter of Intent by May 1 and an application by June 1. Second-round Letters of Intent and applications will be available in spring 2016. More information on the Next Generation model can be found on CMS’ Web page.
On Twitter @legal_med
The new Next Generation Accountable Care Organization (ACO) model improves upon other ACO models and allows for greater success for physicians, according to ACO experts.
“It’s a really good sign generally that CMS is willing and able to adapt to some of the major structural problems with the Medicare ACO model,” said Julian D. “Bo” Bobbitt Jr., a health law attorney in Raleigh, N.C. “Changing incentives to reward higher quality at lower cost and to align those is extraordinarily promising.”
The Next Generation ACO model offers predictable financial targets, enables providers and patients greater opportunities to coordinate care, and aims to attain the highest standards of care, according to a March 10 announcement from the Centers for Medicare & Medicaid Services. The new model means greater financial risks for doctors and hospitals in exchange for greater shared savings for high performance. To support the increased risk sharing, the new ACOs will have a stable, predictable benchmark and flexible payment options that support investments in care improvement infrastructure that provide high quality care to patients, CMS said in its release.
Like the Pioneer ACO Model and the Medicare Shared Savings Program, ACOs that successfully reduce the cost of care may keep some of the savings. But the next generation model uses a new formula to calculate savings targets that do not exclusively rely on historical performance. Physicians have criticized that older method as unfair to health providers who already deliver lower-cost care. The new formula will take into account regional and national efficiency, and ACOs that have already attained cost efficiency, compared with their regions, will receive a more favorable discount, according to CMS.
Beneficiaries, too, will have the chance to voluntarily align with the Next Generation ACO model by confirming their care relationship with specific ACO providers. Patients can also receive rewards, such as waived or reduced copays, for receiving their care from ACO physicians as well as coverage of skilled nursing care without prior hospitalization, and expanded coverage of telehealth and postdischarge home services. In any event, patients retain the freedom to seek services and providers of their choice.
Beneficiary incentives are a key contributor to successful care management, said Larry Kocot, a health law attorney in Washington.
“It’s really hard for a provider to be able to deliver coordinated care to a beneficiary if the beneficiary is not a full participant,” Mr. Kocot said in an interview. “In order for the beneficiary to be a full participant, [he or she] should for instance, be able to select [his or her] provider. This model will allow for that.”
Dr. Patrick Conway, chief medical officer at CMS, said the next generation ACO is a response to physicians’ feedback and requests.
“The ACO model responds to stakeholder requests for ... greater engagement of beneficiaries; a more predictable, prospective financial model; and the flexibility to utilize additional tools to coordinate care for beneficiaries,” he said in a statement.
CMS will accept ACOs into the next generation program through two rounds of applications in 2015 and 2016, with participation expected to last up to 5 years. Participants in the Medicare Shared Savings Program and the Pioneer ACO Model may apply, as well as all other groups that meet
eligibility requirements. CMS expects about 15-20 ACOs to participate in the Next Generation ACO Model.
Mr. Kocot notes that the new model will not be the best choice for physicians new to ACOs or for those in smaller communities, who cannot take on the extra risk.
“This is really limited to a small subset of providers who are able to accept a higher amount of risk,” he said in an interview. “Physician practices vary across the country; they’re not all homogeneous. It’s not going to be the option for all providers.”
The unveiling of the next generation ACO comes on the heels of an effort by the Obama administration to shift payments away from fee for service by having half of all Medicare dollars paid to doctors through alternative payment models by the end of 2018.
The new ACO model is a likely reflection of how other accountable care organizations will be structured in the future, notes Dr. Farzad Mostashari, cofounder and CEO of Aledade, an ACO consultancy. Dr. Mostashari is the former national coordinator for health information technology.
“It is a glimpse of what the whole program is going to look like in a few years’ time,” Dr. Mostashari said in an interview. “This is directionally, absolutely where the Medicare Shared Savings Program is headed.”
Those interested in applying to the next generation models in 2015 must submit a Letter of Intent by May 1 and an application by June 1. Second-round Letters of Intent and applications will be available in spring 2016. More information on the Next Generation model can be found on CMS’ Web page.
On Twitter @legal_med
The new Next Generation Accountable Care Organization (ACO) model improves upon other ACO models and allows for greater success for physicians, according to ACO experts.
“It’s a really good sign generally that CMS is willing and able to adapt to some of the major structural problems with the Medicare ACO model,” said Julian D. “Bo” Bobbitt Jr., a health law attorney in Raleigh, N.C. “Changing incentives to reward higher quality at lower cost and to align those is extraordinarily promising.”
The Next Generation ACO model offers predictable financial targets, enables providers and patients greater opportunities to coordinate care, and aims to attain the highest standards of care, according to a March 10 announcement from the Centers for Medicare & Medicaid Services. The new model means greater financial risks for doctors and hospitals in exchange for greater shared savings for high performance. To support the increased risk sharing, the new ACOs will have a stable, predictable benchmark and flexible payment options that support investments in care improvement infrastructure that provide high quality care to patients, CMS said in its release.
Like the Pioneer ACO Model and the Medicare Shared Savings Program, ACOs that successfully reduce the cost of care may keep some of the savings. But the next generation model uses a new formula to calculate savings targets that do not exclusively rely on historical performance. Physicians have criticized that older method as unfair to health providers who already deliver lower-cost care. The new formula will take into account regional and national efficiency, and ACOs that have already attained cost efficiency, compared with their regions, will receive a more favorable discount, according to CMS.
Beneficiaries, too, will have the chance to voluntarily align with the Next Generation ACO model by confirming their care relationship with specific ACO providers. Patients can also receive rewards, such as waived or reduced copays, for receiving their care from ACO physicians as well as coverage of skilled nursing care without prior hospitalization, and expanded coverage of telehealth and postdischarge home services. In any event, patients retain the freedom to seek services and providers of their choice.
Beneficiary incentives are a key contributor to successful care management, said Larry Kocot, a health law attorney in Washington.
“It’s really hard for a provider to be able to deliver coordinated care to a beneficiary if the beneficiary is not a full participant,” Mr. Kocot said in an interview. “In order for the beneficiary to be a full participant, [he or she] should for instance, be able to select [his or her] provider. This model will allow for that.”
Dr. Patrick Conway, chief medical officer at CMS, said the next generation ACO is a response to physicians’ feedback and requests.
“The ACO model responds to stakeholder requests for ... greater engagement of beneficiaries; a more predictable, prospective financial model; and the flexibility to utilize additional tools to coordinate care for beneficiaries,” he said in a statement.
CMS will accept ACOs into the next generation program through two rounds of applications in 2015 and 2016, with participation expected to last up to 5 years. Participants in the Medicare Shared Savings Program and the Pioneer ACO Model may apply, as well as all other groups that meet
eligibility requirements. CMS expects about 15-20 ACOs to participate in the Next Generation ACO Model.
Mr. Kocot notes that the new model will not be the best choice for physicians new to ACOs or for those in smaller communities, who cannot take on the extra risk.
“This is really limited to a small subset of providers who are able to accept a higher amount of risk,” he said in an interview. “Physician practices vary across the country; they’re not all homogeneous. It’s not going to be the option for all providers.”
The unveiling of the next generation ACO comes on the heels of an effort by the Obama administration to shift payments away from fee for service by having half of all Medicare dollars paid to doctors through alternative payment models by the end of 2018.
The new ACO model is a likely reflection of how other accountable care organizations will be structured in the future, notes Dr. Farzad Mostashari, cofounder and CEO of Aledade, an ACO consultancy. Dr. Mostashari is the former national coordinator for health information technology.
“It is a glimpse of what the whole program is going to look like in a few years’ time,” Dr. Mostashari said in an interview. “This is directionally, absolutely where the Medicare Shared Savings Program is headed.”
Those interested in applying to the next generation models in 2015 must submit a Letter of Intent by May 1 and an application by June 1. Second-round Letters of Intent and applications will be available in spring 2016. More information on the Next Generation model can be found on CMS’ Web page.
On Twitter @legal_med
Despite requirement, only 13% of clinical trials report results
Only 13% of the clinical trials legally required since 2007 to report their findings to ClinicalTrials.gov actually do so, according to a report published online in the New England Journal of Medicine.
The Food and Drug Administration Amendments Act requires sponsors of most clinical trials to register and report their basic summary results within 1 year of either completing data collection for the primary outcome or of terminating. Failure to report study findings is punishable by sanctions including civil penalties of up to $10,000 per day and loss of funding.
The reporting regulation “reflect[s] the ethical obligation of researchers and sponsors to respect human trial participants through fidelity to commitments made explicit in informed consent: namely, to make results of trials available to contribute to generalizable knowledge,” said Dr. Monique L. Anderson of the Duke Clinical Research Institute, Durham, N.C., and her associates.
The law was enacted because of public concern that sponsors and investigators were “selectively publishing trials that favored interests of the sponsors, and that journals were selectively reporting positive findings.” Among other detriments, the failure to report results could harm participants in similar studies by failing to warn them of possible risks, the investigators noted.
They assessed compliance with the law more than 5 years after it was enacted, using a National Library of Medicine algorithm to identify 13,327 eligible clinical trials that were either completed or terminated during 2008-2012.
Only 13.4% of them reported their results within 1 year, and only 38.3% reported their results at any time during the study period (N. Engl. J. Med. 2015;372:1031-9). Moreover, “despite ethical mandates, statutory obligations, and considerable societal pressure, most trials that were funded by the NIH or other government or academic institutions ... have yet to report results at ClinicalTrials.gov, whereas the medical-products industry has been more responsive to the legal mandate,” the researchers explained.
At 1 year, the rate of reporting was 17.0% for industry-sponsored trials, 8.1% for NIH-funded trials, and 5.7% for other government- or academically funded trials. The corresponding rates of reporting at 5 years were only slightly better, at 41.5%, 38.9%, and 27.7%, respectively.
Phase I, II, and III clinical trials were the less likely than phase IV trials were to report their results in a timely fashion. These earlier-phase studies “are primarily focused on proof-of-concept demonstrations and as such represent valuable, closely guarded intellectual property,” Dr. Anderson and her associates said.
Despite the regulation’s threat of penalties, no enforcement has yet occurred, the researchers noted, in part because this portion of the FDA Administration and Amendments Act is still under public discussion and hasn’t been finalized.
Only 13% of the clinical trials legally required since 2007 to report their findings to ClinicalTrials.gov actually do so, according to a report published online in the New England Journal of Medicine.
The Food and Drug Administration Amendments Act requires sponsors of most clinical trials to register and report their basic summary results within 1 year of either completing data collection for the primary outcome or of terminating. Failure to report study findings is punishable by sanctions including civil penalties of up to $10,000 per day and loss of funding.
The reporting regulation “reflect[s] the ethical obligation of researchers and sponsors to respect human trial participants through fidelity to commitments made explicit in informed consent: namely, to make results of trials available to contribute to generalizable knowledge,” said Dr. Monique L. Anderson of the Duke Clinical Research Institute, Durham, N.C., and her associates.
The law was enacted because of public concern that sponsors and investigators were “selectively publishing trials that favored interests of the sponsors, and that journals were selectively reporting positive findings.” Among other detriments, the failure to report results could harm participants in similar studies by failing to warn them of possible risks, the investigators noted.
They assessed compliance with the law more than 5 years after it was enacted, using a National Library of Medicine algorithm to identify 13,327 eligible clinical trials that were either completed or terminated during 2008-2012.
Only 13.4% of them reported their results within 1 year, and only 38.3% reported their results at any time during the study period (N. Engl. J. Med. 2015;372:1031-9). Moreover, “despite ethical mandates, statutory obligations, and considerable societal pressure, most trials that were funded by the NIH or other government or academic institutions ... have yet to report results at ClinicalTrials.gov, whereas the medical-products industry has been more responsive to the legal mandate,” the researchers explained.
At 1 year, the rate of reporting was 17.0% for industry-sponsored trials, 8.1% for NIH-funded trials, and 5.7% for other government- or academically funded trials. The corresponding rates of reporting at 5 years were only slightly better, at 41.5%, 38.9%, and 27.7%, respectively.
Phase I, II, and III clinical trials were the less likely than phase IV trials were to report their results in a timely fashion. These earlier-phase studies “are primarily focused on proof-of-concept demonstrations and as such represent valuable, closely guarded intellectual property,” Dr. Anderson and her associates said.
Despite the regulation’s threat of penalties, no enforcement has yet occurred, the researchers noted, in part because this portion of the FDA Administration and Amendments Act is still under public discussion and hasn’t been finalized.
Only 13% of the clinical trials legally required since 2007 to report their findings to ClinicalTrials.gov actually do so, according to a report published online in the New England Journal of Medicine.
The Food and Drug Administration Amendments Act requires sponsors of most clinical trials to register and report their basic summary results within 1 year of either completing data collection for the primary outcome or of terminating. Failure to report study findings is punishable by sanctions including civil penalties of up to $10,000 per day and loss of funding.
The reporting regulation “reflect[s] the ethical obligation of researchers and sponsors to respect human trial participants through fidelity to commitments made explicit in informed consent: namely, to make results of trials available to contribute to generalizable knowledge,” said Dr. Monique L. Anderson of the Duke Clinical Research Institute, Durham, N.C., and her associates.
The law was enacted because of public concern that sponsors and investigators were “selectively publishing trials that favored interests of the sponsors, and that journals were selectively reporting positive findings.” Among other detriments, the failure to report results could harm participants in similar studies by failing to warn them of possible risks, the investigators noted.
They assessed compliance with the law more than 5 years after it was enacted, using a National Library of Medicine algorithm to identify 13,327 eligible clinical trials that were either completed or terminated during 2008-2012.
Only 13.4% of them reported their results within 1 year, and only 38.3% reported their results at any time during the study period (N. Engl. J. Med. 2015;372:1031-9). Moreover, “despite ethical mandates, statutory obligations, and considerable societal pressure, most trials that were funded by the NIH or other government or academic institutions ... have yet to report results at ClinicalTrials.gov, whereas the medical-products industry has been more responsive to the legal mandate,” the researchers explained.
At 1 year, the rate of reporting was 17.0% for industry-sponsored trials, 8.1% for NIH-funded trials, and 5.7% for other government- or academically funded trials. The corresponding rates of reporting at 5 years were only slightly better, at 41.5%, 38.9%, and 27.7%, respectively.
Phase I, II, and III clinical trials were the less likely than phase IV trials were to report their results in a timely fashion. These earlier-phase studies “are primarily focused on proof-of-concept demonstrations and as such represent valuable, closely guarded intellectual property,” Dr. Anderson and her associates said.
Despite the regulation’s threat of penalties, no enforcement has yet occurred, the researchers noted, in part because this portion of the FDA Administration and Amendments Act is still under public discussion and hasn’t been finalized.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: Only 13% of clinical trials legally required to report their findings to ClinicalTrials.gov actually do so.
Major finding: Only 13.4% of 13,327 clinical trials reported their results within 1 year, and only 38.3% of those trials reported results at any time during the 5-year study period.
Data source: An analysis of 13,327 clinical trials completed between 2008 and 2012 that were required to report their results to ClinicalTrials.gov within 1 year.
Disclosures: The study was supported by the Clinical Trials Transformation Initiative and the NIH Common Fund. Dr. Anderson reported having no financial disclosures; two of her associates reported ties to numerous industry sources.
Heparin, warfarin tied to similar VTE rates after radical cystectomy
Venous thromboembolisms affected 6.4% of patients who underwent radical cystectomy, even though all patients received heparin in the hospital as recommended by the American Urological Association, researchers reported.
“Using an in-house, heparin-based anticoagulation protocol consistent with current AUA guidelines has not decreased the rate of venous thromboembolism compared to historical warfarin use,” wrote Dr. Andrew Sun and his colleagues at the University of Southern California Institute of Urology in Los Angeles. Most episodes of VTE occurred after patients were discharged home, and “future studies are needed to establish the benefits of extended-duration [VTE] prophylaxis regimens that cover the critical posthospitalization period,” the researchers added (J. UroL 2015;193:565-9).
Previous studies have reported venous thromboembolism rates of 3%-6% in cystectomy patients, a rate that is more than double that reported for nephrectomy or prostatectomy patients. For their study, the investigators retrospectively assessed 2,316 patients who underwent open radical cystectomy and extended pelvic lymph node dissection for urothelial bladder cancer between 1971 and 2012. Symptomatic VTE developed among 109 patients overall (4.7%), compared with 6.4% of those who received the modern, heparin-based protocol implemented in 2009 (P = .089).
Furthermore, 58% of all cases occurred after patients stopped anticoagulation therapy and were discharged home. The median time of onset was 20 days after surgery (range, 2-91 days), and VTE was significantly more common among patients with a higher body mass index, prolonged hospital stays, positive surgical margins and orthotopic diversion procedures, compared with other patients. Surgical techniques remained consistent throughout the study.
The study was retrospective, and thus “could not prove any cause and effect relationships. This underscores the need for additional prospective data in this area of research,” said the investigators. “We focused only on open radical cystectomy, and thus, findings may not be generalizable to minimally invasive modalities, on which there is even a greater paucity of data.”
Senior author Dr. Siamak Daneshmand reported financial or other relationships with Endo and Cubist. The authors reported no funding sources or other relevant conflicts of interest.
Venous thromboembolisms affected 6.4% of patients who underwent radical cystectomy, even though all patients received heparin in the hospital as recommended by the American Urological Association, researchers reported.
“Using an in-house, heparin-based anticoagulation protocol consistent with current AUA guidelines has not decreased the rate of venous thromboembolism compared to historical warfarin use,” wrote Dr. Andrew Sun and his colleagues at the University of Southern California Institute of Urology in Los Angeles. Most episodes of VTE occurred after patients were discharged home, and “future studies are needed to establish the benefits of extended-duration [VTE] prophylaxis regimens that cover the critical posthospitalization period,” the researchers added (J. UroL 2015;193:565-9).
Previous studies have reported venous thromboembolism rates of 3%-6% in cystectomy patients, a rate that is more than double that reported for nephrectomy or prostatectomy patients. For their study, the investigators retrospectively assessed 2,316 patients who underwent open radical cystectomy and extended pelvic lymph node dissection for urothelial bladder cancer between 1971 and 2012. Symptomatic VTE developed among 109 patients overall (4.7%), compared with 6.4% of those who received the modern, heparin-based protocol implemented in 2009 (P = .089).
Furthermore, 58% of all cases occurred after patients stopped anticoagulation therapy and were discharged home. The median time of onset was 20 days after surgery (range, 2-91 days), and VTE was significantly more common among patients with a higher body mass index, prolonged hospital stays, positive surgical margins and orthotopic diversion procedures, compared with other patients. Surgical techniques remained consistent throughout the study.
The study was retrospective, and thus “could not prove any cause and effect relationships. This underscores the need for additional prospective data in this area of research,” said the investigators. “We focused only on open radical cystectomy, and thus, findings may not be generalizable to minimally invasive modalities, on which there is even a greater paucity of data.”
Senior author Dr. Siamak Daneshmand reported financial or other relationships with Endo and Cubist. The authors reported no funding sources or other relevant conflicts of interest.
Venous thromboembolisms affected 6.4% of patients who underwent radical cystectomy, even though all patients received heparin in the hospital as recommended by the American Urological Association, researchers reported.
“Using an in-house, heparin-based anticoagulation protocol consistent with current AUA guidelines has not decreased the rate of venous thromboembolism compared to historical warfarin use,” wrote Dr. Andrew Sun and his colleagues at the University of Southern California Institute of Urology in Los Angeles. Most episodes of VTE occurred after patients were discharged home, and “future studies are needed to establish the benefits of extended-duration [VTE] prophylaxis regimens that cover the critical posthospitalization period,” the researchers added (J. UroL 2015;193:565-9).
Previous studies have reported venous thromboembolism rates of 3%-6% in cystectomy patients, a rate that is more than double that reported for nephrectomy or prostatectomy patients. For their study, the investigators retrospectively assessed 2,316 patients who underwent open radical cystectomy and extended pelvic lymph node dissection for urothelial bladder cancer between 1971 and 2012. Symptomatic VTE developed among 109 patients overall (4.7%), compared with 6.4% of those who received the modern, heparin-based protocol implemented in 2009 (P = .089).
Furthermore, 58% of all cases occurred after patients stopped anticoagulation therapy and were discharged home. The median time of onset was 20 days after surgery (range, 2-91 days), and VTE was significantly more common among patients with a higher body mass index, prolonged hospital stays, positive surgical margins and orthotopic diversion procedures, compared with other patients. Surgical techniques remained consistent throughout the study.
The study was retrospective, and thus “could not prove any cause and effect relationships. This underscores the need for additional prospective data in this area of research,” said the investigators. “We focused only on open radical cystectomy, and thus, findings may not be generalizable to minimally invasive modalities, on which there is even a greater paucity of data.”
Senior author Dr. Siamak Daneshmand reported financial or other relationships with Endo and Cubist. The authors reported no funding sources or other relevant conflicts of interest.
FROM THE JOURNAL OF UROLOGY
Key clinical point: Heparin and warfarin were linked to similar rates of postcystectomy venous thromboembolism.
Major finding: Symptomatic VTE affected 4.7% of patients in the overall cohort, compared with 6.4% of those treated with the modern, heparin-based protocol (P = .089).
Data source: A single-center retrospective cohort study of 2,316 patients who underwent open radical cystectomy and extended pelvic lymph node dissection.
Disclosures: Senior author Dr. Siamak Daneshmand reported financial or other relationships with Endo and Cubist. The authors reported no funding sources or other relevant conflicts of interest.
Venous thromboembolism common after heart transplant
For every 1,000 patients who underwent heart transplantation, about 45 had an episode of venous thromboembolism within a year after surgery, according to a retrospective study reported in the February issue of the Journal of Heart and Lung Transplantation.
Furthermore, patients who had a single VTE episode after transplant had a “high” risk of recurrent VTE, said Dr. Rolando Alvarez, a cardiologist at Complejo Hospitalario Universitario A Coruna in A Coruna, Spain, and his associates.
“Our opinion is that long-term oral anticoagulation should be maintained in these patients, especially if other risk factors are present and provided that the bleeding risk is not excessive,” said the researchers.
Venous thromboembolism is a common complication of lung, kidney, and liver transplantation, but less is known about VTE after heart transplant. The researchers found that “classic” risk factors for VTE, such as being older, obese, or having renal dysfunction, also increased the risk of VTE after heart transplant (J. Heart Lung Transplant. 2015;34:167-74).
The study included data from 635 consecutive patients who underwent heart transplantation at a single hospital between 1991 and 2013. During a median of 8.4 years of follow-up, the cumulative incidence of VTE was 8.5%, for an annual incidence rate of 12.7 episodes per year for every 1,000 patients, the researchers reported. The risk of VTE was far higher during the first year after transplant (45.1 episodes per 1,000 patients), but even after excluding these episodes, VTE was six times more common among heart transplant recipients than among the general population. Furthermore, VTE recurred an estimated 30.5 times/1,000 patient-years, and 50.8 times/1,000 patients-years among patients who had stopped anticoagulants.
The cumulative incidence rate of DVT and PE were 8.4 and 8.7 episodes per 1,000 patient-years.
In the multivariate analysis, significant risk factors for VTE at less than 1 year after transplantation included age, obesity, chronic kidney disease, and emergency transplantation, the investigators said. More than a year after transplantation, only use of the mammalian target of rapamycin (mTOR) inhibitors sirolimus and everolimus significantly increased VTE risk.
“The evidence that supports a potential association between mTOR inhibitors and an increased risk of VTE events is still weak, and might be confounded by a high prevalence of comorbid conditions such as chronic renal failure, dyslipidemia, or malignancy in patients taking these kinds of drugs,” the investigators cautioned.
The authors suggested that in view of the high recurrence rate, long-term anticoagulation should be considered in heart transplant patients after their first VTE episode.
The Fundacion BBVA-Carolina funded the study. Four coauthors reported receiving travel support from Novartis Pharma and Astellas Pharma. The other authors reported no relevant conflicts of interest.
For every 1,000 patients who underwent heart transplantation, about 45 had an episode of venous thromboembolism within a year after surgery, according to a retrospective study reported in the February issue of the Journal of Heart and Lung Transplantation.
Furthermore, patients who had a single VTE episode after transplant had a “high” risk of recurrent VTE, said Dr. Rolando Alvarez, a cardiologist at Complejo Hospitalario Universitario A Coruna in A Coruna, Spain, and his associates.
“Our opinion is that long-term oral anticoagulation should be maintained in these patients, especially if other risk factors are present and provided that the bleeding risk is not excessive,” said the researchers.
Venous thromboembolism is a common complication of lung, kidney, and liver transplantation, but less is known about VTE after heart transplant. The researchers found that “classic” risk factors for VTE, such as being older, obese, or having renal dysfunction, also increased the risk of VTE after heart transplant (J. Heart Lung Transplant. 2015;34:167-74).
The study included data from 635 consecutive patients who underwent heart transplantation at a single hospital between 1991 and 2013. During a median of 8.4 years of follow-up, the cumulative incidence of VTE was 8.5%, for an annual incidence rate of 12.7 episodes per year for every 1,000 patients, the researchers reported. The risk of VTE was far higher during the first year after transplant (45.1 episodes per 1,000 patients), but even after excluding these episodes, VTE was six times more common among heart transplant recipients than among the general population. Furthermore, VTE recurred an estimated 30.5 times/1,000 patient-years, and 50.8 times/1,000 patients-years among patients who had stopped anticoagulants.
The cumulative incidence rate of DVT and PE were 8.4 and 8.7 episodes per 1,000 patient-years.
In the multivariate analysis, significant risk factors for VTE at less than 1 year after transplantation included age, obesity, chronic kidney disease, and emergency transplantation, the investigators said. More than a year after transplantation, only use of the mammalian target of rapamycin (mTOR) inhibitors sirolimus and everolimus significantly increased VTE risk.
“The evidence that supports a potential association between mTOR inhibitors and an increased risk of VTE events is still weak, and might be confounded by a high prevalence of comorbid conditions such as chronic renal failure, dyslipidemia, or malignancy in patients taking these kinds of drugs,” the investigators cautioned.
The authors suggested that in view of the high recurrence rate, long-term anticoagulation should be considered in heart transplant patients after their first VTE episode.
The Fundacion BBVA-Carolina funded the study. Four coauthors reported receiving travel support from Novartis Pharma and Astellas Pharma. The other authors reported no relevant conflicts of interest.
For every 1,000 patients who underwent heart transplantation, about 45 had an episode of venous thromboembolism within a year after surgery, according to a retrospective study reported in the February issue of the Journal of Heart and Lung Transplantation.
Furthermore, patients who had a single VTE episode after transplant had a “high” risk of recurrent VTE, said Dr. Rolando Alvarez, a cardiologist at Complejo Hospitalario Universitario A Coruna in A Coruna, Spain, and his associates.
“Our opinion is that long-term oral anticoagulation should be maintained in these patients, especially if other risk factors are present and provided that the bleeding risk is not excessive,” said the researchers.
Venous thromboembolism is a common complication of lung, kidney, and liver transplantation, but less is known about VTE after heart transplant. The researchers found that “classic” risk factors for VTE, such as being older, obese, or having renal dysfunction, also increased the risk of VTE after heart transplant (J. Heart Lung Transplant. 2015;34:167-74).
The study included data from 635 consecutive patients who underwent heart transplantation at a single hospital between 1991 and 2013. During a median of 8.4 years of follow-up, the cumulative incidence of VTE was 8.5%, for an annual incidence rate of 12.7 episodes per year for every 1,000 patients, the researchers reported. The risk of VTE was far higher during the first year after transplant (45.1 episodes per 1,000 patients), but even after excluding these episodes, VTE was six times more common among heart transplant recipients than among the general population. Furthermore, VTE recurred an estimated 30.5 times/1,000 patient-years, and 50.8 times/1,000 patients-years among patients who had stopped anticoagulants.
The cumulative incidence rate of DVT and PE were 8.4 and 8.7 episodes per 1,000 patient-years.
In the multivariate analysis, significant risk factors for VTE at less than 1 year after transplantation included age, obesity, chronic kidney disease, and emergency transplantation, the investigators said. More than a year after transplantation, only use of the mammalian target of rapamycin (mTOR) inhibitors sirolimus and everolimus significantly increased VTE risk.
“The evidence that supports a potential association between mTOR inhibitors and an increased risk of VTE events is still weak, and might be confounded by a high prevalence of comorbid conditions such as chronic renal failure, dyslipidemia, or malignancy in patients taking these kinds of drugs,” the investigators cautioned.
The authors suggested that in view of the high recurrence rate, long-term anticoagulation should be considered in heart transplant patients after their first VTE episode.
The Fundacion BBVA-Carolina funded the study. Four coauthors reported receiving travel support from Novartis Pharma and Astellas Pharma. The other authors reported no relevant conflicts of interest.
Key clinical point: Venous thromboembolism (VTE) was common after heart transplant, especially when patients had relevant risk factors and were not on anticoagulants.
Major finding: Cumulative incidence of VTE was 8.5% during eight years of follow-up and was much higher during the first year after transplant.
Data source: Single-center retrospective cohort study of 635 heart transplant recipients.
Disclosures: The Fundacion BBVA-Carolina funded the study. Four coauthors reported receiving travel support from Novartis Pharma and Astellas Pharma. The other authors reported no relevant conflicts of interest.
Fast-track protocol cuts lung resection complications, LOS
CHICAGO – An enhanced recovery pathway reduces short-term complications and hospital stays following cancer-related lung resection without raising readmissions or emergency visits after discharge, a study showed.
“A multimodal pathway for open, elective lobectomy seems to improve efficiency and quality of care,” Dr. Amin Madani, from McGill University in Montreal, said at the annual meeting of the Central Surgical Association (CSA).
Prior research suggests that an enhanced recovery pathway (ERP), also known as fast-track protocols, can improve surgical outcomes, but there is little evidence to support its use and effectiveness in lung resection.
Surgeons at McGill established an integrated, multimodal approach to perioperative care of these patients after creating a written, evidence-based, step-by-step pathway. Key elements are standardized preoperative patient education; removal of urine drains on postoperative day 1; removal of the last chest tube by postop (POD) day 3, if there is <300 cc of drainage in 24 hours and no air leak; ambulation goals of more than 75 m thrice-daily by POD 3; introduction of solid food on POD 1; and a target discharge of POD 4; Dr. Madani explained.
To examine the effectiveness of the pathway, the authors retrospectively analyzed outcomes in 127 patients undergoing elective lung resection for primary or secondary lung cancer receiving traditional care and 107 patients treated after the ERP was implemented in September 2012. At baseline, the two groups were similar with respect to age, sex, body mass index (BMI), American Society of Anesthesiologists (ASA) scores, pulmonary function, and smoking history.
Hospital length of stay was significantly reduced after the ERP from a median of 7 days with traditional care to 6 days (P < .01), driven largely by patients with an uncomplicated hospital course who were discharged after a median of 5 days after the pathway was implemented, Dr. Madani said.
It was not the case that patients went home too early, as readmissions (5% vs. 6%) and ED visits (3% vs. 5%) were similar between both groups, he added.
After the pathway was implemented, patients had earlier Foley catheter removal (POD 2 vs. 1), IV discontinuation (POD 3 vs. 2), ambulation (POD 2 vs. 1), last chest tube removal (POD 5 vs. 4), and epidural removal (POD 5 vs. 4).
The enhanced recovery pathway group had fewer overall complications than did the traditional care group (37% vs. 50%; P = .03), a threefold decrease in urinary tract infections (3% vs. 12%; P < .01), and a trend toward fewer pulmonary complications (25% vs. 31%; P = .38) and surgical site infections (1% vs. 6%; P = .07), he said.
Despite significantly earlier removal of chest tubes after the pathway, there was no difference in the incidence of pneumothorax or pleural effusion requiring tube re-insertion, affirming that “Chest tubes were not being removed too early, causing harm to patients,” Dr. Madani said.
In multivariate regression analysis adjusted for age, sex, BMI, and ASA score, there was a significant negative association between implementation of an enhanced recovery pathway and length of stay (beta, –0.18; P < .01) and complications (odds ratio, 0.46; P < .01), but not readmissions (OR, 1.59; P = .44).
Early removal of chest tubes and urinary catheter were independent predictors of decreased length of stay.
Dr. L. Michael Brunt, a discussant from Washington University in St. Louis, said the development of care pathways to enhance recovery after surgery is gaining a lot of interest in the surgical community, but went on to ask how much it cost to implement.
The overall cost of the surgeon-driven initiative, involving multiple pathways for various surgical procedures, is about $120,000 annually, or $100/patient for the 1,200 patients undergoing surgery using an ERP program at the McGill University Health Centre each year, Dr. Madani said. This cost also includes a full-time nurse practitioner now serving as the pathway coordinator and roughly $13,000 for patient education booklets, but no additional staff.
An audience member questioned whether the authors have identified factors predicting which patients would fail to meet pathway goals, observing that in the colorectal field, there are patients such as the 80-year-old, narcotic-naive woman with diabetes, who simply won’t progress.
“That’s a very good point, and I agree there are some patients whom you can’t fast track,” Dr. Madani replied. “Part of the deal here is that, yes, we have this protocolized pathway; however, the surgeon still has the right to change that if they feel it is important. We didn’t look at the specifics of which patient [factors] achieved adherence, but we could at some point in the future.”
CSA president and session moderator Christopher McHenry, from MetroHealth Medical Center in Cleveland, said he was impressed with the study and called the findings very believable.
“I think all of these recovery pathways can be very beneficial,” Dr. McHenry said in an interview. “It helps us re-look at how we’re managing our patients and see if there are ways that we can improve on their postoperative management that may lead to earlier discharge.”
The study was funded by an investigator-initiated research grant from Ethicon Canada. Dr. Madani, his coauthors, Dr. Brunt, and Dr. McHenry reported having no financial conflicts.
CHICAGO – An enhanced recovery pathway reduces short-term complications and hospital stays following cancer-related lung resection without raising readmissions or emergency visits after discharge, a study showed.
“A multimodal pathway for open, elective lobectomy seems to improve efficiency and quality of care,” Dr. Amin Madani, from McGill University in Montreal, said at the annual meeting of the Central Surgical Association (CSA).
Prior research suggests that an enhanced recovery pathway (ERP), also known as fast-track protocols, can improve surgical outcomes, but there is little evidence to support its use and effectiveness in lung resection.
Surgeons at McGill established an integrated, multimodal approach to perioperative care of these patients after creating a written, evidence-based, step-by-step pathway. Key elements are standardized preoperative patient education; removal of urine drains on postoperative day 1; removal of the last chest tube by postop (POD) day 3, if there is <300 cc of drainage in 24 hours and no air leak; ambulation goals of more than 75 m thrice-daily by POD 3; introduction of solid food on POD 1; and a target discharge of POD 4; Dr. Madani explained.
To examine the effectiveness of the pathway, the authors retrospectively analyzed outcomes in 127 patients undergoing elective lung resection for primary or secondary lung cancer receiving traditional care and 107 patients treated after the ERP was implemented in September 2012. At baseline, the two groups were similar with respect to age, sex, body mass index (BMI), American Society of Anesthesiologists (ASA) scores, pulmonary function, and smoking history.
Hospital length of stay was significantly reduced after the ERP from a median of 7 days with traditional care to 6 days (P < .01), driven largely by patients with an uncomplicated hospital course who were discharged after a median of 5 days after the pathway was implemented, Dr. Madani said.
It was not the case that patients went home too early, as readmissions (5% vs. 6%) and ED visits (3% vs. 5%) were similar between both groups, he added.
After the pathway was implemented, patients had earlier Foley catheter removal (POD 2 vs. 1), IV discontinuation (POD 3 vs. 2), ambulation (POD 2 vs. 1), last chest tube removal (POD 5 vs. 4), and epidural removal (POD 5 vs. 4).
The enhanced recovery pathway group had fewer overall complications than did the traditional care group (37% vs. 50%; P = .03), a threefold decrease in urinary tract infections (3% vs. 12%; P < .01), and a trend toward fewer pulmonary complications (25% vs. 31%; P = .38) and surgical site infections (1% vs. 6%; P = .07), he said.
Despite significantly earlier removal of chest tubes after the pathway, there was no difference in the incidence of pneumothorax or pleural effusion requiring tube re-insertion, affirming that “Chest tubes were not being removed too early, causing harm to patients,” Dr. Madani said.
In multivariate regression analysis adjusted for age, sex, BMI, and ASA score, there was a significant negative association between implementation of an enhanced recovery pathway and length of stay (beta, –0.18; P < .01) and complications (odds ratio, 0.46; P < .01), but not readmissions (OR, 1.59; P = .44).
Early removal of chest tubes and urinary catheter were independent predictors of decreased length of stay.
Dr. L. Michael Brunt, a discussant from Washington University in St. Louis, said the development of care pathways to enhance recovery after surgery is gaining a lot of interest in the surgical community, but went on to ask how much it cost to implement.
The overall cost of the surgeon-driven initiative, involving multiple pathways for various surgical procedures, is about $120,000 annually, or $100/patient for the 1,200 patients undergoing surgery using an ERP program at the McGill University Health Centre each year, Dr. Madani said. This cost also includes a full-time nurse practitioner now serving as the pathway coordinator and roughly $13,000 for patient education booklets, but no additional staff.
An audience member questioned whether the authors have identified factors predicting which patients would fail to meet pathway goals, observing that in the colorectal field, there are patients such as the 80-year-old, narcotic-naive woman with diabetes, who simply won’t progress.
“That’s a very good point, and I agree there are some patients whom you can’t fast track,” Dr. Madani replied. “Part of the deal here is that, yes, we have this protocolized pathway; however, the surgeon still has the right to change that if they feel it is important. We didn’t look at the specifics of which patient [factors] achieved adherence, but we could at some point in the future.”
CSA president and session moderator Christopher McHenry, from MetroHealth Medical Center in Cleveland, said he was impressed with the study and called the findings very believable.
“I think all of these recovery pathways can be very beneficial,” Dr. McHenry said in an interview. “It helps us re-look at how we’re managing our patients and see if there are ways that we can improve on their postoperative management that may lead to earlier discharge.”
The study was funded by an investigator-initiated research grant from Ethicon Canada. Dr. Madani, his coauthors, Dr. Brunt, and Dr. McHenry reported having no financial conflicts.
CHICAGO – An enhanced recovery pathway reduces short-term complications and hospital stays following cancer-related lung resection without raising readmissions or emergency visits after discharge, a study showed.
“A multimodal pathway for open, elective lobectomy seems to improve efficiency and quality of care,” Dr. Amin Madani, from McGill University in Montreal, said at the annual meeting of the Central Surgical Association (CSA).
Prior research suggests that an enhanced recovery pathway (ERP), also known as fast-track protocols, can improve surgical outcomes, but there is little evidence to support its use and effectiveness in lung resection.
Surgeons at McGill established an integrated, multimodal approach to perioperative care of these patients after creating a written, evidence-based, step-by-step pathway. Key elements are standardized preoperative patient education; removal of urine drains on postoperative day 1; removal of the last chest tube by postop (POD) day 3, if there is <300 cc of drainage in 24 hours and no air leak; ambulation goals of more than 75 m thrice-daily by POD 3; introduction of solid food on POD 1; and a target discharge of POD 4; Dr. Madani explained.
To examine the effectiveness of the pathway, the authors retrospectively analyzed outcomes in 127 patients undergoing elective lung resection for primary or secondary lung cancer receiving traditional care and 107 patients treated after the ERP was implemented in September 2012. At baseline, the two groups were similar with respect to age, sex, body mass index (BMI), American Society of Anesthesiologists (ASA) scores, pulmonary function, and smoking history.
Hospital length of stay was significantly reduced after the ERP from a median of 7 days with traditional care to 6 days (P < .01), driven largely by patients with an uncomplicated hospital course who were discharged after a median of 5 days after the pathway was implemented, Dr. Madani said.
It was not the case that patients went home too early, as readmissions (5% vs. 6%) and ED visits (3% vs. 5%) were similar between both groups, he added.
After the pathway was implemented, patients had earlier Foley catheter removal (POD 2 vs. 1), IV discontinuation (POD 3 vs. 2), ambulation (POD 2 vs. 1), last chest tube removal (POD 5 vs. 4), and epidural removal (POD 5 vs. 4).
The enhanced recovery pathway group had fewer overall complications than did the traditional care group (37% vs. 50%; P = .03), a threefold decrease in urinary tract infections (3% vs. 12%; P < .01), and a trend toward fewer pulmonary complications (25% vs. 31%; P = .38) and surgical site infections (1% vs. 6%; P = .07), he said.
Despite significantly earlier removal of chest tubes after the pathway, there was no difference in the incidence of pneumothorax or pleural effusion requiring tube re-insertion, affirming that “Chest tubes were not being removed too early, causing harm to patients,” Dr. Madani said.
In multivariate regression analysis adjusted for age, sex, BMI, and ASA score, there was a significant negative association between implementation of an enhanced recovery pathway and length of stay (beta, –0.18; P < .01) and complications (odds ratio, 0.46; P < .01), but not readmissions (OR, 1.59; P = .44).
Early removal of chest tubes and urinary catheter were independent predictors of decreased length of stay.
Dr. L. Michael Brunt, a discussant from Washington University in St. Louis, said the development of care pathways to enhance recovery after surgery is gaining a lot of interest in the surgical community, but went on to ask how much it cost to implement.
The overall cost of the surgeon-driven initiative, involving multiple pathways for various surgical procedures, is about $120,000 annually, or $100/patient for the 1,200 patients undergoing surgery using an ERP program at the McGill University Health Centre each year, Dr. Madani said. This cost also includes a full-time nurse practitioner now serving as the pathway coordinator and roughly $13,000 for patient education booklets, but no additional staff.
An audience member questioned whether the authors have identified factors predicting which patients would fail to meet pathway goals, observing that in the colorectal field, there are patients such as the 80-year-old, narcotic-naive woman with diabetes, who simply won’t progress.
“That’s a very good point, and I agree there are some patients whom you can’t fast track,” Dr. Madani replied. “Part of the deal here is that, yes, we have this protocolized pathway; however, the surgeon still has the right to change that if they feel it is important. We didn’t look at the specifics of which patient [factors] achieved adherence, but we could at some point in the future.”
CSA president and session moderator Christopher McHenry, from MetroHealth Medical Center in Cleveland, said he was impressed with the study and called the findings very believable.
“I think all of these recovery pathways can be very beneficial,” Dr. McHenry said in an interview. “It helps us re-look at how we’re managing our patients and see if there are ways that we can improve on their postoperative management that may lead to earlier discharge.”
The study was funded by an investigator-initiated research grant from Ethicon Canada. Dr. Madani, his coauthors, Dr. Brunt, and Dr. McHenry reported having no financial conflicts.
AT THE ANNUAL MEETING OF THE CENTRAL SURGICAL ASSOCIATION
Key clinical point: An enhanced recovery pathway reduces complications and hospital stay following lung cancer resection without raising readmissions or ED visits.
Major finding: Patients in the enhanced recovery pathway vs. traditional care had fewer overall complications (37% vs. 50%; P = .03) and threefold fewer UTIs (3% vs. 12%; P < .01).
Data source: Observational study of 234 patients undergoing lung resection.
Disclosures: The study was funded by an investigator-initiated research grant from Ethicon Canada. Dr. Madani, his coauthors, Dr. Brunt, and Dr. McHenry reported having no financial conflicts.
Ranolazine plus beta-blockers might prevent postop AF
PHOENIX – Twice-daily ranolazine following adult cardiac surgery seemed to protect against atrial fibrillation, based on a retrospective cohort study at the University of Florida Jacksonville Medical Center.
Ranolazine (Ranexa) was dosed orally at 1,000 mg the morning of surgery, and then resumed after extubation, generally the night of surgery. The goal was 1,000 mg orally twice a day, for a maximum of 7 hospital days; patients usually went home before then, so they received an average of nine doses. The drug was discontinued at discharge.
Six (10.5%) of 57 patients in the ranolazine group developed postoperative atrial fibrillation (POAF) versus 26 (45.6%) of 57 matched controls (P < .0001). The first case came at postop day 3 in the ranolazine group, but within 24 hours in the control group. One person in the ranolazine group and one in the control group had a history of AF.
There was no statistical difference in ICU length of stay, 30-day readmission for cardiac causes, or 30-day cardiovascular mortality; the one cardiovascular death was in the control group.
Two-thirds of the patients had coronary artery bypass grafts, and the rest had either valve surgery or a combination of both surgeries. Patients were 60 years old on average, and two-thirds were men, Drayton Hammond, Pharm.D., said at the Critical Care Congress, sponsored by the Society for Critical Care Medicine.
Ranolazine is indicated for chronic angina, not POAF prevention, but some previous investigations have suggested a possible benefit. A randomized, controlled clinical trial is currently looking into the matter.
At least retrospectively, the drug was “beneficial, definitely. There is about a 35% absolute-risk reduction,” said Dr. Hammond, who conducted the study while at the Jacksonville hospital.
Doctors there continue to use ranolazine for postop AF prophylaxis, as they see fit, said Dr. Hammond, now an assistant professor of pharmacy practice at the University of Arkansas for Medical Sciences, in Little Rock.
Gilead, the maker of the Ranexa, is also working on a ranolazine-dronedarone combination for paroxysmal AF.
More than half of the ranolazine patients in the study developed symptomatic hypotension within 72 hours of surgery, versus about a third in the control group (P = .0004). The drug was discontinued in one ranolazine patient because of hypotension. The problem resolved after 72 hours.
“We don’t have a good explanation” for the side effect. Perhaps there were differences in myocardial stunning or vasopressor use between the groups, but “we had the same three surgeons” for all the cases, Dr. Hammond said.
Ranolazine labeling notes the risk of hypotension and orthostatic hypotension. Labeling also warns of QT interval prolongation and renal failure in susceptible patients. The investigators found no between-group differences in bradycardia, new renal failure, or neurological events.
Overall, 53 (93%) patients in the ranolazine group were on postoperative beta-blockers, and 54 (94.7%) on postop statins; 48 (84.2%) in the control group were on beta-blockers postop and 47 (82.5%) on statins. Beta-blockers are first-line treatment to prevent postop AF; patients on any other antiarrhythmic were excluded from the trial, as were those who died during surgery.
PHOENIX – Twice-daily ranolazine following adult cardiac surgery seemed to protect against atrial fibrillation, based on a retrospective cohort study at the University of Florida Jacksonville Medical Center.
Ranolazine (Ranexa) was dosed orally at 1,000 mg the morning of surgery, and then resumed after extubation, generally the night of surgery. The goal was 1,000 mg orally twice a day, for a maximum of 7 hospital days; patients usually went home before then, so they received an average of nine doses. The drug was discontinued at discharge.
Six (10.5%) of 57 patients in the ranolazine group developed postoperative atrial fibrillation (POAF) versus 26 (45.6%) of 57 matched controls (P < .0001). The first case came at postop day 3 in the ranolazine group, but within 24 hours in the control group. One person in the ranolazine group and one in the control group had a history of AF.
There was no statistical difference in ICU length of stay, 30-day readmission for cardiac causes, or 30-day cardiovascular mortality; the one cardiovascular death was in the control group.
Two-thirds of the patients had coronary artery bypass grafts, and the rest had either valve surgery or a combination of both surgeries. Patients were 60 years old on average, and two-thirds were men, Drayton Hammond, Pharm.D., said at the Critical Care Congress, sponsored by the Society for Critical Care Medicine.
Ranolazine is indicated for chronic angina, not POAF prevention, but some previous investigations have suggested a possible benefit. A randomized, controlled clinical trial is currently looking into the matter.
At least retrospectively, the drug was “beneficial, definitely. There is about a 35% absolute-risk reduction,” said Dr. Hammond, who conducted the study while at the Jacksonville hospital.
Doctors there continue to use ranolazine for postop AF prophylaxis, as they see fit, said Dr. Hammond, now an assistant professor of pharmacy practice at the University of Arkansas for Medical Sciences, in Little Rock.
Gilead, the maker of the Ranexa, is also working on a ranolazine-dronedarone combination for paroxysmal AF.
More than half of the ranolazine patients in the study developed symptomatic hypotension within 72 hours of surgery, versus about a third in the control group (P = .0004). The drug was discontinued in one ranolazine patient because of hypotension. The problem resolved after 72 hours.
“We don’t have a good explanation” for the side effect. Perhaps there were differences in myocardial stunning or vasopressor use between the groups, but “we had the same three surgeons” for all the cases, Dr. Hammond said.
Ranolazine labeling notes the risk of hypotension and orthostatic hypotension. Labeling also warns of QT interval prolongation and renal failure in susceptible patients. The investigators found no between-group differences in bradycardia, new renal failure, or neurological events.
Overall, 53 (93%) patients in the ranolazine group were on postoperative beta-blockers, and 54 (94.7%) on postop statins; 48 (84.2%) in the control group were on beta-blockers postop and 47 (82.5%) on statins. Beta-blockers are first-line treatment to prevent postop AF; patients on any other antiarrhythmic were excluded from the trial, as were those who died during surgery.
PHOENIX – Twice-daily ranolazine following adult cardiac surgery seemed to protect against atrial fibrillation, based on a retrospective cohort study at the University of Florida Jacksonville Medical Center.
Ranolazine (Ranexa) was dosed orally at 1,000 mg the morning of surgery, and then resumed after extubation, generally the night of surgery. The goal was 1,000 mg orally twice a day, for a maximum of 7 hospital days; patients usually went home before then, so they received an average of nine doses. The drug was discontinued at discharge.
Six (10.5%) of 57 patients in the ranolazine group developed postoperative atrial fibrillation (POAF) versus 26 (45.6%) of 57 matched controls (P < .0001). The first case came at postop day 3 in the ranolazine group, but within 24 hours in the control group. One person in the ranolazine group and one in the control group had a history of AF.
There was no statistical difference in ICU length of stay, 30-day readmission for cardiac causes, or 30-day cardiovascular mortality; the one cardiovascular death was in the control group.
Two-thirds of the patients had coronary artery bypass grafts, and the rest had either valve surgery or a combination of both surgeries. Patients were 60 years old on average, and two-thirds were men, Drayton Hammond, Pharm.D., said at the Critical Care Congress, sponsored by the Society for Critical Care Medicine.
Ranolazine is indicated for chronic angina, not POAF prevention, but some previous investigations have suggested a possible benefit. A randomized, controlled clinical trial is currently looking into the matter.
At least retrospectively, the drug was “beneficial, definitely. There is about a 35% absolute-risk reduction,” said Dr. Hammond, who conducted the study while at the Jacksonville hospital.
Doctors there continue to use ranolazine for postop AF prophylaxis, as they see fit, said Dr. Hammond, now an assistant professor of pharmacy practice at the University of Arkansas for Medical Sciences, in Little Rock.
Gilead, the maker of the Ranexa, is also working on a ranolazine-dronedarone combination for paroxysmal AF.
More than half of the ranolazine patients in the study developed symptomatic hypotension within 72 hours of surgery, versus about a third in the control group (P = .0004). The drug was discontinued in one ranolazine patient because of hypotension. The problem resolved after 72 hours.
“We don’t have a good explanation” for the side effect. Perhaps there were differences in myocardial stunning or vasopressor use between the groups, but “we had the same three surgeons” for all the cases, Dr. Hammond said.
Ranolazine labeling notes the risk of hypotension and orthostatic hypotension. Labeling also warns of QT interval prolongation and renal failure in susceptible patients. The investigators found no between-group differences in bradycardia, new renal failure, or neurological events.
Overall, 53 (93%) patients in the ranolazine group were on postoperative beta-blockers, and 54 (94.7%) on postop statins; 48 (84.2%) in the control group were on beta-blockers postop and 47 (82.5%) on statins. Beta-blockers are first-line treatment to prevent postop AF; patients on any other antiarrhythmic were excluded from the trial, as were those who died during surgery.
AT THE CRITICAL CARE CONGRESS
Key clinical point: Ranolazine’s protective effect seems to come at the cost of symptomatic hypotension in the first 3 days after surgery.
Major finding: Postop atrial fibrillation occurred in 6 (10.5%) of 57 patients in the ranolazine group and 26 (45.6%) of 57 matched controls (P < .0001).
Data source: Retrospective cohort study of postop follow-up in 114 adults who had cardiac surgery.
Disclosures: There was no outside funding for the work. The investigators said they have no financial relationship with Gilead, maker of ranolazine (Ranexa).
CHADS2 predicts postop atrial fibrillation
PHOENIX – For every unit increase in baseline CHADS2 score, the risk of postop atrial fibrillation increases by 17%, according to a retrospective chart review of 1,550 adults who had major vascular or thoracic surgery at the Mayo Clinic in Rochester, Minn.
On multivariate analysis, postop day 1 Sequential Organ Failure Assessment score (HR 1.08, 95% CI 1.03-1.12, per unit increase) and cumulative fluid balance (HR 1.03, 95% CI 1.01-1.06, per 1,000 mL) also correlated with the risk for new-onset atrial fibrillation (AF).
Baseline calcium channel blockers protected against new-onset AF (HR 0.52, 95% CI 0.37-0.73), but, paradoxically, the risk increased with baseline (HR 1.78, 95% CI 1.24-2.56) and postop (HR 1.44, 95% CI 1.05-1.99) beta-blocker use.
The relationship of CHADS2 to new-onset AF (HR 1.17, 95% CI 1.04-1.31) could prove handy in the surgical ICU because “everyone is familiar with it, and it’s easy to calculate.” CHADS2 (heart failure, hypertension, age, diabetes, prior stroke) has also recently been shown to predict AF after cardiac surgery, said lead investigator Kirstin Kooda, Pharm.D., a critical care pharmacist at Mayo.
The beta-blocker finding was a surprise, since beta-blockers are a standard AF treatment, Dr. Kooda said at the Critical Care Congress, sponsored by the Society for Critical Care Medicine. About 80% (175) of new-onset AF patients were on baseline beta-blockers, versus about 68% (892) who did not develop AF. Patients using beta-blockers received them the morning of surgery, and resumed them a median of 7 hours afterward. There were no significant differences in heart rates during surgery.
The team excluded patients with any history of AF and censored patients if they developed it, so the drugs’ use probably wasn’t related to a concern about the condition. Just under 70% of patients in both groups had baseline hypertension, another indication for the drugs.
Even so, the finding is probably real given the number of patients in the study. Most likely, the drugs were markers for additional risk factors not captured in the study, Dr. Kooda said.
Overall, 112 (20.7%) of the 540 thoracic patients and 107 (11%) of the 1,010 vascular patients developed new-onset AF a median of 55 hours after surgery. The incidence difference and timing are in line with previous reports.
The mean age in the AF group was 70 years, and in the non-AF group it was 66 years. In both, 65% were men, 5% had heart failure, 30% had diabetes, and 10% had prior strokes. Patients with pacemakers and recent myocardial infarctions – also possible settings for beta-blockers – were excluded from the trial.
The majority of the vascular cases were open aortic aneurysms, aortic bypasses, and thrombectomies or endarterectomies of central arteries. Most of the thoracic surgeries were lobectomies, pneumonectomies, and wedge or chest wall resections.
PHOENIX – For every unit increase in baseline CHADS2 score, the risk of postop atrial fibrillation increases by 17%, according to a retrospective chart review of 1,550 adults who had major vascular or thoracic surgery at the Mayo Clinic in Rochester, Minn.
On multivariate analysis, postop day 1 Sequential Organ Failure Assessment score (HR 1.08, 95% CI 1.03-1.12, per unit increase) and cumulative fluid balance (HR 1.03, 95% CI 1.01-1.06, per 1,000 mL) also correlated with the risk for new-onset atrial fibrillation (AF).
Baseline calcium channel blockers protected against new-onset AF (HR 0.52, 95% CI 0.37-0.73), but, paradoxically, the risk increased with baseline (HR 1.78, 95% CI 1.24-2.56) and postop (HR 1.44, 95% CI 1.05-1.99) beta-blocker use.
The relationship of CHADS2 to new-onset AF (HR 1.17, 95% CI 1.04-1.31) could prove handy in the surgical ICU because “everyone is familiar with it, and it’s easy to calculate.” CHADS2 (heart failure, hypertension, age, diabetes, prior stroke) has also recently been shown to predict AF after cardiac surgery, said lead investigator Kirstin Kooda, Pharm.D., a critical care pharmacist at Mayo.
The beta-blocker finding was a surprise, since beta-blockers are a standard AF treatment, Dr. Kooda said at the Critical Care Congress, sponsored by the Society for Critical Care Medicine. About 80% (175) of new-onset AF patients were on baseline beta-blockers, versus about 68% (892) who did not develop AF. Patients using beta-blockers received them the morning of surgery, and resumed them a median of 7 hours afterward. There were no significant differences in heart rates during surgery.
The team excluded patients with any history of AF and censored patients if they developed it, so the drugs’ use probably wasn’t related to a concern about the condition. Just under 70% of patients in both groups had baseline hypertension, another indication for the drugs.
Even so, the finding is probably real given the number of patients in the study. Most likely, the drugs were markers for additional risk factors not captured in the study, Dr. Kooda said.
Overall, 112 (20.7%) of the 540 thoracic patients and 107 (11%) of the 1,010 vascular patients developed new-onset AF a median of 55 hours after surgery. The incidence difference and timing are in line with previous reports.
The mean age in the AF group was 70 years, and in the non-AF group it was 66 years. In both, 65% were men, 5% had heart failure, 30% had diabetes, and 10% had prior strokes. Patients with pacemakers and recent myocardial infarctions – also possible settings for beta-blockers – were excluded from the trial.
The majority of the vascular cases were open aortic aneurysms, aortic bypasses, and thrombectomies or endarterectomies of central arteries. Most of the thoracic surgeries were lobectomies, pneumonectomies, and wedge or chest wall resections.
PHOENIX – For every unit increase in baseline CHADS2 score, the risk of postop atrial fibrillation increases by 17%, according to a retrospective chart review of 1,550 adults who had major vascular or thoracic surgery at the Mayo Clinic in Rochester, Minn.
On multivariate analysis, postop day 1 Sequential Organ Failure Assessment score (HR 1.08, 95% CI 1.03-1.12, per unit increase) and cumulative fluid balance (HR 1.03, 95% CI 1.01-1.06, per 1,000 mL) also correlated with the risk for new-onset atrial fibrillation (AF).
Baseline calcium channel blockers protected against new-onset AF (HR 0.52, 95% CI 0.37-0.73), but, paradoxically, the risk increased with baseline (HR 1.78, 95% CI 1.24-2.56) and postop (HR 1.44, 95% CI 1.05-1.99) beta-blocker use.
The relationship of CHADS2 to new-onset AF (HR 1.17, 95% CI 1.04-1.31) could prove handy in the surgical ICU because “everyone is familiar with it, and it’s easy to calculate.” CHADS2 (heart failure, hypertension, age, diabetes, prior stroke) has also recently been shown to predict AF after cardiac surgery, said lead investigator Kirstin Kooda, Pharm.D., a critical care pharmacist at Mayo.
The beta-blocker finding was a surprise, since beta-blockers are a standard AF treatment, Dr. Kooda said at the Critical Care Congress, sponsored by the Society for Critical Care Medicine. About 80% (175) of new-onset AF patients were on baseline beta-blockers, versus about 68% (892) who did not develop AF. Patients using beta-blockers received them the morning of surgery, and resumed them a median of 7 hours afterward. There were no significant differences in heart rates during surgery.
The team excluded patients with any history of AF and censored patients if they developed it, so the drugs’ use probably wasn’t related to a concern about the condition. Just under 70% of patients in both groups had baseline hypertension, another indication for the drugs.
Even so, the finding is probably real given the number of patients in the study. Most likely, the drugs were markers for additional risk factors not captured in the study, Dr. Kooda said.
Overall, 112 (20.7%) of the 540 thoracic patients and 107 (11%) of the 1,010 vascular patients developed new-onset AF a median of 55 hours after surgery. The incidence difference and timing are in line with previous reports.
The mean age in the AF group was 70 years, and in the non-AF group it was 66 years. In both, 65% were men, 5% had heart failure, 30% had diabetes, and 10% had prior strokes. Patients with pacemakers and recent myocardial infarctions – also possible settings for beta-blockers – were excluded from the trial.
The majority of the vascular cases were open aortic aneurysms, aortic bypasses, and thrombectomies or endarterectomies of central arteries. Most of the thoracic surgeries were lobectomies, pneumonectomies, and wedge or chest wall resections.
AT THE CRITICAL CARE CONGRESS
Key clinical point: Postop atrial fibrillation is more likely if patients go into surgery with an elevated CHADS 2 score.
Major finding: For every unit increase in baseline CHADS2 score, there is a 17% increase in the risk of new-onset AF following major vascular or thoracic surgery (HR 1.17, 95% CI 1.04-1.31).
Data source: Retrospective chart review of 1,550 adult patients.
Disclosures: The investigators said they had no disclosures. No outside funding was reported for the work.
Genetic blood profiles can estimate risk levels of VTE patients
Through genetic analysis, researchers used gene expression profiles to differentiate between several clinical phenotypes of VTE and distinguish high-risk patients from both low-risk patients and healthy controls, in a study published in Thrombosis Research.
Dr. Deborah A. Lewis of Duke University Medical Center and her associates used differential expression analysis to find several genes previously identified as potentially having a role in the development of thrombotic disorders, including SELP, KLKB1, ANXA5, andCD46. They then compared the genetic profiles of 107 patients, separated into low-, moderate-, or high-risk groups based on their clinical presentations of VTE, as well as 25 controls.
The most accurate comparisons were between the high-risk and low-risk groups, the high-risk group and the healthy controls, and the low-risk group and healthy controls, where the AUC levels were 0.81, 0.84 and 0.80 respectively.
“The profiles obtained … provide insights into approaches that might be useful in the identification of individuals with a single thrombotic event who are at highest risk for a recurrent VTE after completing a standard course of therapy,” the investigators wrote.
For the full article, click here (Thromb. Res. 2015 [doi:10.1016/j.thromres.2015.02.003]).
Through genetic analysis, researchers used gene expression profiles to differentiate between several clinical phenotypes of VTE and distinguish high-risk patients from both low-risk patients and healthy controls, in a study published in Thrombosis Research.
Dr. Deborah A. Lewis of Duke University Medical Center and her associates used differential expression analysis to find several genes previously identified as potentially having a role in the development of thrombotic disorders, including SELP, KLKB1, ANXA5, andCD46. They then compared the genetic profiles of 107 patients, separated into low-, moderate-, or high-risk groups based on their clinical presentations of VTE, as well as 25 controls.
The most accurate comparisons were between the high-risk and low-risk groups, the high-risk group and the healthy controls, and the low-risk group and healthy controls, where the AUC levels were 0.81, 0.84 and 0.80 respectively.
“The profiles obtained … provide insights into approaches that might be useful in the identification of individuals with a single thrombotic event who are at highest risk for a recurrent VTE after completing a standard course of therapy,” the investigators wrote.
For the full article, click here (Thromb. Res. 2015 [doi:10.1016/j.thromres.2015.02.003]).
Through genetic analysis, researchers used gene expression profiles to differentiate between several clinical phenotypes of VTE and distinguish high-risk patients from both low-risk patients and healthy controls, in a study published in Thrombosis Research.
Dr. Deborah A. Lewis of Duke University Medical Center and her associates used differential expression analysis to find several genes previously identified as potentially having a role in the development of thrombotic disorders, including SELP, KLKB1, ANXA5, andCD46. They then compared the genetic profiles of 107 patients, separated into low-, moderate-, or high-risk groups based on their clinical presentations of VTE, as well as 25 controls.
The most accurate comparisons were between the high-risk and low-risk groups, the high-risk group and the healthy controls, and the low-risk group and healthy controls, where the AUC levels were 0.81, 0.84 and 0.80 respectively.
“The profiles obtained … provide insights into approaches that might be useful in the identification of individuals with a single thrombotic event who are at highest risk for a recurrent VTE after completing a standard course of therapy,” the investigators wrote.
For the full article, click here (Thromb. Res. 2015 [doi:10.1016/j.thromres.2015.02.003]).