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New ICU sedation protocols linked to fewer ventilator days
AUSTIN, TEX. – Patients given propofol-based sedation in the intensive care unit were more likely to have daily dose optimization, stay at their target Richmond Agitation Sedation Scale rate, and be intubated for fewer days, compared with patients given benzodiazepine-based regimens, a retrospective study has shown. Being on propofol at the time of extubation, however, was associated with a significantly higher risk of being reintubated.
In 2013, the American College of Critical Care Medicine updated its guidelines for sedation in the ICU. The changes reflected what Dr. Steven J. Campbell, a presenter at this year’s annual meeting of the American College of Chest Physicians, said was the new paradigm in ICU sedation – namely, to use the least amount of sedation in patients and for the shortest amount of time possible. “We’ve also seen a shift away from benzodiazepines in recent years, and that when patients are given them, they stay in ICUs longer and have longer ventilation times,” Dr. Campbell said. The updated guidelines also suggest not relying on benzodiazepines as a first-line sedative.
To investigate how the updated sedation protocols have impacted the multiple ICUs at Ohio State University’s tertiary medical center, where Dr. Campbell is a third-year medical resident, and to assess the relationship of the changes with reintubation risk, Dr. Campbell and his colleagues retrospectively analyzed data on 988 intubated patients and 6,359 ventilator days recorded at the medical center during a 10-month period in 2013, after the new protocols were in place.
Considering either single sedation drips or combined sedation drips in the 988 unique intubations, about 69% of patients received at least 1 day of propofol, and roughly a third were given at least 1 day of a narcotic.
For 373 patients, the most commonly used drip was propofol only. Propofol combined with a narcotic was used in 141 patients, whereas the a combination of the two with a benzodiazepine was used in 140 patients.
A quarter of all intubated patients received at least 1 day of a continuous benzodiazepine drip, although only 7% of these received this sedation regimen as a first-line agent. Data were not presented on what previous benzodiazepine sedation rates were at the center before the protocol change.
The number of ventilator days for the propofol-only group was between 5.6 days plus or minus another 5.8 days, nearly half of the total propofol/narcotic/benzodiazepine ventilator days which came to 10.5 days give or take another 8 days.
“It intuitively makes sense that the more drips the patients were on, the more they would be on a ventilator,” Dr. Campbell said.
However, for patients given benzodiazepines only, the number of ventilator days was 4.3, plus or minus 4.2 days. Dr. Campbell theorized this was attributable to there being a number of patients withdrawing from alcohol and so needing to rely on an infusion of the benzodiazepine to help them through the process.
Propofol-based regimens were associated with improved dose optimization compliance if patients were eligible (P less than .0001).
Patients given narcotic drips were more likely to meet their targeted RASS levels of –1 to +1, compared with either benzodiazepines or propofol, although propofol patient RASS targets were higher than those of the benzodiazepine group (43% for narcotics, 22% for benzodiazepines, and 37% for propofol, P less than .0001).
The study also found a relationship between failed extubation rates and sedative use. There were 953 patients extubated in all. Seven percent of the extubated patients who had received continuous sedation on the day of extubation had to be reintubated within 48 hours. A significant risk of reintubation was found for patients who’d been given propofol alone since nearly half of that cohort were among those reintubated (P = .01).
Although Dr. Campbell and his colleagues wrote in their study that this could have been due to either lower levels of sedation to begin with, and so being more likely to have earlier extubation, or that the respiratory physiology of this group was altered by the propofol.
“The most important take-away here was that being on any sedative within 24 hours of extubation meant you had a high rate of failing that extubation,” Dr. Campbell said.
The investigators were not able to determine precisely when the sedation was terminated in each patient, only that it had occurred within a 24-hour period prior to extubation.
Dr. Campbell also noted that since dexmedetomidine was not widely used at the site ICUs as an alternative sedative, a future inquiry into the reasons why not would be worthwhile. “I suspect it’s because it’s still one of the newer agents,” he said.
On Twitter @whitneymcknight
AUSTIN, TEX. – Patients given propofol-based sedation in the intensive care unit were more likely to have daily dose optimization, stay at their target Richmond Agitation Sedation Scale rate, and be intubated for fewer days, compared with patients given benzodiazepine-based regimens, a retrospective study has shown. Being on propofol at the time of extubation, however, was associated with a significantly higher risk of being reintubated.
In 2013, the American College of Critical Care Medicine updated its guidelines for sedation in the ICU. The changes reflected what Dr. Steven J. Campbell, a presenter at this year’s annual meeting of the American College of Chest Physicians, said was the new paradigm in ICU sedation – namely, to use the least amount of sedation in patients and for the shortest amount of time possible. “We’ve also seen a shift away from benzodiazepines in recent years, and that when patients are given them, they stay in ICUs longer and have longer ventilation times,” Dr. Campbell said. The updated guidelines also suggest not relying on benzodiazepines as a first-line sedative.
To investigate how the updated sedation protocols have impacted the multiple ICUs at Ohio State University’s tertiary medical center, where Dr. Campbell is a third-year medical resident, and to assess the relationship of the changes with reintubation risk, Dr. Campbell and his colleagues retrospectively analyzed data on 988 intubated patients and 6,359 ventilator days recorded at the medical center during a 10-month period in 2013, after the new protocols were in place.
Considering either single sedation drips or combined sedation drips in the 988 unique intubations, about 69% of patients received at least 1 day of propofol, and roughly a third were given at least 1 day of a narcotic.
For 373 patients, the most commonly used drip was propofol only. Propofol combined with a narcotic was used in 141 patients, whereas the a combination of the two with a benzodiazepine was used in 140 patients.
A quarter of all intubated patients received at least 1 day of a continuous benzodiazepine drip, although only 7% of these received this sedation regimen as a first-line agent. Data were not presented on what previous benzodiazepine sedation rates were at the center before the protocol change.
The number of ventilator days for the propofol-only group was between 5.6 days plus or minus another 5.8 days, nearly half of the total propofol/narcotic/benzodiazepine ventilator days which came to 10.5 days give or take another 8 days.
“It intuitively makes sense that the more drips the patients were on, the more they would be on a ventilator,” Dr. Campbell said.
However, for patients given benzodiazepines only, the number of ventilator days was 4.3, plus or minus 4.2 days. Dr. Campbell theorized this was attributable to there being a number of patients withdrawing from alcohol and so needing to rely on an infusion of the benzodiazepine to help them through the process.
Propofol-based regimens were associated with improved dose optimization compliance if patients were eligible (P less than .0001).
Patients given narcotic drips were more likely to meet their targeted RASS levels of –1 to +1, compared with either benzodiazepines or propofol, although propofol patient RASS targets were higher than those of the benzodiazepine group (43% for narcotics, 22% for benzodiazepines, and 37% for propofol, P less than .0001).
The study also found a relationship between failed extubation rates and sedative use. There were 953 patients extubated in all. Seven percent of the extubated patients who had received continuous sedation on the day of extubation had to be reintubated within 48 hours. A significant risk of reintubation was found for patients who’d been given propofol alone since nearly half of that cohort were among those reintubated (P = .01).
Although Dr. Campbell and his colleagues wrote in their study that this could have been due to either lower levels of sedation to begin with, and so being more likely to have earlier extubation, or that the respiratory physiology of this group was altered by the propofol.
“The most important take-away here was that being on any sedative within 24 hours of extubation meant you had a high rate of failing that extubation,” Dr. Campbell said.
The investigators were not able to determine precisely when the sedation was terminated in each patient, only that it had occurred within a 24-hour period prior to extubation.
Dr. Campbell also noted that since dexmedetomidine was not widely used at the site ICUs as an alternative sedative, a future inquiry into the reasons why not would be worthwhile. “I suspect it’s because it’s still one of the newer agents,” he said.
On Twitter @whitneymcknight
AUSTIN, TEX. – Patients given propofol-based sedation in the intensive care unit were more likely to have daily dose optimization, stay at their target Richmond Agitation Sedation Scale rate, and be intubated for fewer days, compared with patients given benzodiazepine-based regimens, a retrospective study has shown. Being on propofol at the time of extubation, however, was associated with a significantly higher risk of being reintubated.
In 2013, the American College of Critical Care Medicine updated its guidelines for sedation in the ICU. The changes reflected what Dr. Steven J. Campbell, a presenter at this year’s annual meeting of the American College of Chest Physicians, said was the new paradigm in ICU sedation – namely, to use the least amount of sedation in patients and for the shortest amount of time possible. “We’ve also seen a shift away from benzodiazepines in recent years, and that when patients are given them, they stay in ICUs longer and have longer ventilation times,” Dr. Campbell said. The updated guidelines also suggest not relying on benzodiazepines as a first-line sedative.
To investigate how the updated sedation protocols have impacted the multiple ICUs at Ohio State University’s tertiary medical center, where Dr. Campbell is a third-year medical resident, and to assess the relationship of the changes with reintubation risk, Dr. Campbell and his colleagues retrospectively analyzed data on 988 intubated patients and 6,359 ventilator days recorded at the medical center during a 10-month period in 2013, after the new protocols were in place.
Considering either single sedation drips or combined sedation drips in the 988 unique intubations, about 69% of patients received at least 1 day of propofol, and roughly a third were given at least 1 day of a narcotic.
For 373 patients, the most commonly used drip was propofol only. Propofol combined with a narcotic was used in 141 patients, whereas the a combination of the two with a benzodiazepine was used in 140 patients.
A quarter of all intubated patients received at least 1 day of a continuous benzodiazepine drip, although only 7% of these received this sedation regimen as a first-line agent. Data were not presented on what previous benzodiazepine sedation rates were at the center before the protocol change.
The number of ventilator days for the propofol-only group was between 5.6 days plus or minus another 5.8 days, nearly half of the total propofol/narcotic/benzodiazepine ventilator days which came to 10.5 days give or take another 8 days.
“It intuitively makes sense that the more drips the patients were on, the more they would be on a ventilator,” Dr. Campbell said.
However, for patients given benzodiazepines only, the number of ventilator days was 4.3, plus or minus 4.2 days. Dr. Campbell theorized this was attributable to there being a number of patients withdrawing from alcohol and so needing to rely on an infusion of the benzodiazepine to help them through the process.
Propofol-based regimens were associated with improved dose optimization compliance if patients were eligible (P less than .0001).
Patients given narcotic drips were more likely to meet their targeted RASS levels of –1 to +1, compared with either benzodiazepines or propofol, although propofol patient RASS targets were higher than those of the benzodiazepine group (43% for narcotics, 22% for benzodiazepines, and 37% for propofol, P less than .0001).
The study also found a relationship between failed extubation rates and sedative use. There were 953 patients extubated in all. Seven percent of the extubated patients who had received continuous sedation on the day of extubation had to be reintubated within 48 hours. A significant risk of reintubation was found for patients who’d been given propofol alone since nearly half of that cohort were among those reintubated (P = .01).
Although Dr. Campbell and his colleagues wrote in their study that this could have been due to either lower levels of sedation to begin with, and so being more likely to have earlier extubation, or that the respiratory physiology of this group was altered by the propofol.
“The most important take-away here was that being on any sedative within 24 hours of extubation meant you had a high rate of failing that extubation,” Dr. Campbell said.
The investigators were not able to determine precisely when the sedation was terminated in each patient, only that it had occurred within a 24-hour period prior to extubation.
Dr. Campbell also noted that since dexmedetomidine was not widely used at the site ICUs as an alternative sedative, a future inquiry into the reasons why not would be worthwhile. “I suspect it’s because it’s still one of the newer agents,” he said.
On Twitter @whitneymcknight
AT CHEST 2014
Key clinical point: Physicians are preferentially avoiding benzodiazepines in the ICU with better results overall.
Major finding: ICU patients sedated with propofol-based regimens were more likely to undergo daily dose optimization, maintain target RASS, compared with benzodiazepines, and be intubated fewer days.
Data source: Retrospective study of 988 intubated patients and 6,359 ventilation days over 10 months at a single tertiary, academic medical center.
Disclosures: Dr. Campbell said neither he nor his coauthors had relevant disclosures.
Giving patients ownership of data key to solving health IT woes
Mandating that patients “own” their health care data could open the road to true interoperability of electronic health records and might even help solve other tough health IT problems.
“As a consumer, if I pay for my health care, I go see a provider, and I [should] get my data, whatever it is – doctor’s note, lab test, CT or an MRI, Dr. Samson Jesudass, senior vice president and clinical leader at Ascension Health, said at a panel discussion at the Washington, D.C.,–based Bipartisan Policy Center. “That provider should be able to give that to me at the end of that visit, or whenever at whatever time, in a format that I can probably take and put it anywhere else into any other system.”
Making data portable and, more importantly, giving ownership of it to patients, “might be able to solve the issues” that are affecting the health IT environment, he said. “At the end of the day, if a patient is able to take his or her own data and be able to use it in whatever form or fashion, you actually democratize the whole process of information.”
During the discussion, ownership of data was often cited as a barrier to advancing health IT, particularly with physicians protecting their own data in an effort to protect their practices. But participants noted that language included in the year-end federal continuing resolution and budget bill provides a good opportunity to discuss some of these issues, specifically wording that urges the Office of the National Coordinator for Health Information Technology to exercise its authority to decertify EHR systems from the meaningful use program that block the transfer of data.
“This is a prime opportunity to get the physician’s, health care provider’s, [and] health care facility’s input on what’s going to make this an easier change,” especially for those that have invested in systems that are no longer certified to allow for meaningful use incentive payments, Dr. Rhonda Medows, chief medical officer at Optum, the research arm of UnitedHealth.
Vendors should “listen and serve” more, according to Jon Zimmerman, vice president and general manager of clinical business solutions at GE Healthcare. “We have to engage the clinicians and the business people in the health care delivery systems differently. We have to ask them, not tell them. We have to observe them. We have to assist them. And we really have to dig a little deeper to understand what it is they need to do.”
Mandating that patients “own” their health care data could open the road to true interoperability of electronic health records and might even help solve other tough health IT problems.
“As a consumer, if I pay for my health care, I go see a provider, and I [should] get my data, whatever it is – doctor’s note, lab test, CT or an MRI, Dr. Samson Jesudass, senior vice president and clinical leader at Ascension Health, said at a panel discussion at the Washington, D.C.,–based Bipartisan Policy Center. “That provider should be able to give that to me at the end of that visit, or whenever at whatever time, in a format that I can probably take and put it anywhere else into any other system.”
Making data portable and, more importantly, giving ownership of it to patients, “might be able to solve the issues” that are affecting the health IT environment, he said. “At the end of the day, if a patient is able to take his or her own data and be able to use it in whatever form or fashion, you actually democratize the whole process of information.”
During the discussion, ownership of data was often cited as a barrier to advancing health IT, particularly with physicians protecting their own data in an effort to protect their practices. But participants noted that language included in the year-end federal continuing resolution and budget bill provides a good opportunity to discuss some of these issues, specifically wording that urges the Office of the National Coordinator for Health Information Technology to exercise its authority to decertify EHR systems from the meaningful use program that block the transfer of data.
“This is a prime opportunity to get the physician’s, health care provider’s, [and] health care facility’s input on what’s going to make this an easier change,” especially for those that have invested in systems that are no longer certified to allow for meaningful use incentive payments, Dr. Rhonda Medows, chief medical officer at Optum, the research arm of UnitedHealth.
Vendors should “listen and serve” more, according to Jon Zimmerman, vice president and general manager of clinical business solutions at GE Healthcare. “We have to engage the clinicians and the business people in the health care delivery systems differently. We have to ask them, not tell them. We have to observe them. We have to assist them. And we really have to dig a little deeper to understand what it is they need to do.”
Mandating that patients “own” their health care data could open the road to true interoperability of electronic health records and might even help solve other tough health IT problems.
“As a consumer, if I pay for my health care, I go see a provider, and I [should] get my data, whatever it is – doctor’s note, lab test, CT or an MRI, Dr. Samson Jesudass, senior vice president and clinical leader at Ascension Health, said at a panel discussion at the Washington, D.C.,–based Bipartisan Policy Center. “That provider should be able to give that to me at the end of that visit, or whenever at whatever time, in a format that I can probably take and put it anywhere else into any other system.”
Making data portable and, more importantly, giving ownership of it to patients, “might be able to solve the issues” that are affecting the health IT environment, he said. “At the end of the day, if a patient is able to take his or her own data and be able to use it in whatever form or fashion, you actually democratize the whole process of information.”
During the discussion, ownership of data was often cited as a barrier to advancing health IT, particularly with physicians protecting their own data in an effort to protect their practices. But participants noted that language included in the year-end federal continuing resolution and budget bill provides a good opportunity to discuss some of these issues, specifically wording that urges the Office of the National Coordinator for Health Information Technology to exercise its authority to decertify EHR systems from the meaningful use program that block the transfer of data.
“This is a prime opportunity to get the physician’s, health care provider’s, [and] health care facility’s input on what’s going to make this an easier change,” especially for those that have invested in systems that are no longer certified to allow for meaningful use incentive payments, Dr. Rhonda Medows, chief medical officer at Optum, the research arm of UnitedHealth.
Vendors should “listen and serve” more, according to Jon Zimmerman, vice president and general manager of clinical business solutions at GE Healthcare. “We have to engage the clinicians and the business people in the health care delivery systems differently. We have to ask them, not tell them. We have to observe them. We have to assist them. And we really have to dig a little deeper to understand what it is they need to do.”
Nerve monitoring linked to higher risk of vocal cord paralysis
SAN FRANCISCO – Use of intraoperative nerve monitoring during thyroidectomy to avoid injuring the recurrent laryngeal nerve is counterintuitively associated with a higher risk of vocal cord paralysis, in a cohort study of data from the Nationwide Inpatient Sample.
“We do caution against perhaps the broad adoption of nerve monitoring until we can really study this further,” said Dr. Thomas K. Chung, a research fellow in the department of surgery, division of otolaryngology, at the University of Alabama at Birmingham, and the study’s lead investigator.
He and his colleagues compared outcomes between 12,742 patients who had nerve monitoring and 230,433 patients who did not (the conventional practice) while undergoing thyroidectomy between 2008 and 2011.
The proportion of patients who developed vocal cord paralysis was significantly higher with monitoring than without it (1.9% vs. 1.4%), he reported at the annual clinical congress of the American College of Surgeons. The findings were essentially the same in propensity-adjusted analyses that took into account differences between groups in preoperative factors (1.8% vs. 1.3%).
There was no evidence that the difference was related to differences in the use of laryngoscopy to check for paralysis, in hospitals’ coding and billing for monitoring, or in payers’ coverage of this surgical adjunct.
Stratified analyses looking at the extent of surgery showed total thyroidectomy with neck dissection to be the exception, as patients monitored during these more complex operations were significantly less likely to develop vocal cord paralysis than were nonmonitored counterparts (2.8% vs. 4.5%).
The more often hospitals used nerve monitoring as indicated by the volume of thyroidectomy cases, the lower the rate of vocal cord paralysis – with the exception of cases of partial thyroidectomy, in which more frequent use was associated with a counterintuitive increase in the rate of this complication, according to Dr. Chung, who disclosed that he had no relevant conflicts of interest.
“Nerve monitoring demonstrates a significant benefit particularly in complex cases such as total thyroidectomy with neck dissection,” he said. “Low nerve monitoring and utilization with partial thyroidectomy appears to be associated with higher vocal cord paralysis; with respect to the partial thyroidectomies, this may be due to the fact that the burden of complication is already so low, with vocal cord paralysis rates of about 0.8%, that additional use of nerve monitoring may not confer any benefit.”
Dr. Chung offered several possible reasons as to why monitoring may be associated with a higher risk of vocal cord paralysis, including presence of a learning curve, substitution of monitoring for direct visualization of the nerve, and false-negatives whereby a lack of signal from the monitor may lead to more aggressive ablation when the nerve is in fact nearby.
The study had its limitations, he acknowledged. “Nerve monitoring may not be coded all the time,” he said. Information about prior neck radiation and surgery, which increase the risk of vocal cord paralysis, was unavailable. “In the group with thyroidectomy with neck dissection, there is no code for central neck dissection. And even if it is a partial thyroidectomy with neck dissection, the central neck dissection would put both nerves at risk and therefore certainly increase the risk of vocal cord paralysis,” he noted.
Invited discussant Julie Ann Sosa, chief of endocrine surgery at the Duke Cancer Institute in Durham, N.C., said, “I would like to congratulate you and your whole group for tackling what is perhaps one of the most highly contested and contentious issues within endocrine surgery and otolaryngology. It’s also I think a very important area for study because there is a relative paucity of data demonstrating for or against the use of this technology as an adjunct. Current guidelines basically say it’s a wash: We can’t say one way or the other whether folks should be using it. And the anticipated guidelines, those coming out from the American Thyroid Association, similarly will say that more data are needed. So I think you are filling a clear vacuum.”
Dr. Sosa questioned the generalizability of the findings, noting that nearly two-thirds of thyroid procedures are now done in the ambulatory setting. “You used the Nationwide Inpatient Sample, so I think you are looking at a minority of cases and highly complex cases, with a length of stay on the order of 2-3 days, which is really exceptional. Most of us send home patients the same day. So how generalizable do you think your conclusions are, and have you thought about potentially using some of the ambulatory surgery databases to try to ask similar questions?” she queried.
The investigators plan to repeat analyses using the Nationwide Inpatient Sample’s ambulatory data set next, according to Dr. Chung. “Being able to see whether or not this still holds true in an outpatient setting is definitely worthwhile,” he agreed.
Dr. Sosa further wondered about the roles of bilateral versus unilateral monitoring, and continuous versus intermittent monitoring, saying, “I think the approach an individual surgeon takes could definitely result in different outcomes. So I wonder, were you able to address at a more granular level the specific technologies employed?”
The Nationwide Inpatient Sample unfortunately does not capture information on these aspects of monitoring, said Dr. Chung. However, “with respect to continuous versus intermittent, we do think that that’s actually an important variable. It is possible that those who are using nerve monitoring are doing this in a continuous fashion, so when they perhaps injure the first side of the vocal cords, they may stop. So what was originally planned to be a total thyroidectomy from the get-go that had an intraoperative nerve injury may be aborted so as to not create any disastrous airway complications. That may also artificially increase the partial thyroidectomy results, thereby increasing vocal cord paralysis complications in the partial thyroidectomy group.”
Recurrent laryngeal nerve injury resulting in vocal cord paralysis, voice, and swallowing dysfunction is a dreaded complication of thyroid surgery.
Fortunately, this is a relatively rare event, occurring anywhere from 0.5% to 2%, in experienced hands. The utilization of nerve monitoring has been proposed to potentially help decrease nerve injury, however, its real strength may be in helping to identify recurrent nerve injury intraoperatively. Knowing the recurrent laryngeal nerve is injured on one side may lead the surgeon to perform a partial thyroidectomy to avoid major airway issues.
The surgeon may choose to wait for nerve function to return before operating on the contralateral side. Utilization of nerve monitoring allows the surgeon to alter the course of the operation potentially leading to better patient outcomes.
Dr. Chung and colleagues have done an excellent job in adding valuable data to the controversial area of nerve monitoring during thyroid surgery. As they point out, their study is subject to the inherent limitations of large national database reviews. Since most thyroid surgeries are performed in the outpatient setting, it is likely that the Nationwide Inpatient Sample does not capture majority of the cases and reflects the more complicated cases, which required a longer length of stay. Recent data also suggest that the percentage of surgeons using nerve monitoring has increased significantly and that more than 70% of all fellows in training programs use nerve monitoring. This technology is not a substitute for an experienced surgeon but in the proper setting can be useful in making critical operative decisions.
Dr. Kepal N. Patel is an ACS Fellow; chief, Division of Endocrine Surgery; associate professor of surgery, biochemistry and otolaryngology; and director, Thyroid Cancer Interdisciplinary Program, New York University Langone Medical Center.
Recurrent laryngeal nerve injury resulting in vocal cord paralysis, voice, and swallowing dysfunction is a dreaded complication of thyroid surgery.
Fortunately, this is a relatively rare event, occurring anywhere from 0.5% to 2%, in experienced hands. The utilization of nerve monitoring has been proposed to potentially help decrease nerve injury, however, its real strength may be in helping to identify recurrent nerve injury intraoperatively. Knowing the recurrent laryngeal nerve is injured on one side may lead the surgeon to perform a partial thyroidectomy to avoid major airway issues.
The surgeon may choose to wait for nerve function to return before operating on the contralateral side. Utilization of nerve monitoring allows the surgeon to alter the course of the operation potentially leading to better patient outcomes.
Dr. Chung and colleagues have done an excellent job in adding valuable data to the controversial area of nerve monitoring during thyroid surgery. As they point out, their study is subject to the inherent limitations of large national database reviews. Since most thyroid surgeries are performed in the outpatient setting, it is likely that the Nationwide Inpatient Sample does not capture majority of the cases and reflects the more complicated cases, which required a longer length of stay. Recent data also suggest that the percentage of surgeons using nerve monitoring has increased significantly and that more than 70% of all fellows in training programs use nerve monitoring. This technology is not a substitute for an experienced surgeon but in the proper setting can be useful in making critical operative decisions.
Dr. Kepal N. Patel is an ACS Fellow; chief, Division of Endocrine Surgery; associate professor of surgery, biochemistry and otolaryngology; and director, Thyroid Cancer Interdisciplinary Program, New York University Langone Medical Center.
Recurrent laryngeal nerve injury resulting in vocal cord paralysis, voice, and swallowing dysfunction is a dreaded complication of thyroid surgery.
Fortunately, this is a relatively rare event, occurring anywhere from 0.5% to 2%, in experienced hands. The utilization of nerve monitoring has been proposed to potentially help decrease nerve injury, however, its real strength may be in helping to identify recurrent nerve injury intraoperatively. Knowing the recurrent laryngeal nerve is injured on one side may lead the surgeon to perform a partial thyroidectomy to avoid major airway issues.
The surgeon may choose to wait for nerve function to return before operating on the contralateral side. Utilization of nerve monitoring allows the surgeon to alter the course of the operation potentially leading to better patient outcomes.
Dr. Chung and colleagues have done an excellent job in adding valuable data to the controversial area of nerve monitoring during thyroid surgery. As they point out, their study is subject to the inherent limitations of large national database reviews. Since most thyroid surgeries are performed in the outpatient setting, it is likely that the Nationwide Inpatient Sample does not capture majority of the cases and reflects the more complicated cases, which required a longer length of stay. Recent data also suggest that the percentage of surgeons using nerve monitoring has increased significantly and that more than 70% of all fellows in training programs use nerve monitoring. This technology is not a substitute for an experienced surgeon but in the proper setting can be useful in making critical operative decisions.
Dr. Kepal N. Patel is an ACS Fellow; chief, Division of Endocrine Surgery; associate professor of surgery, biochemistry and otolaryngology; and director, Thyroid Cancer Interdisciplinary Program, New York University Langone Medical Center.
SAN FRANCISCO – Use of intraoperative nerve monitoring during thyroidectomy to avoid injuring the recurrent laryngeal nerve is counterintuitively associated with a higher risk of vocal cord paralysis, in a cohort study of data from the Nationwide Inpatient Sample.
“We do caution against perhaps the broad adoption of nerve monitoring until we can really study this further,” said Dr. Thomas K. Chung, a research fellow in the department of surgery, division of otolaryngology, at the University of Alabama at Birmingham, and the study’s lead investigator.
He and his colleagues compared outcomes between 12,742 patients who had nerve monitoring and 230,433 patients who did not (the conventional practice) while undergoing thyroidectomy between 2008 and 2011.
The proportion of patients who developed vocal cord paralysis was significantly higher with monitoring than without it (1.9% vs. 1.4%), he reported at the annual clinical congress of the American College of Surgeons. The findings were essentially the same in propensity-adjusted analyses that took into account differences between groups in preoperative factors (1.8% vs. 1.3%).
There was no evidence that the difference was related to differences in the use of laryngoscopy to check for paralysis, in hospitals’ coding and billing for monitoring, or in payers’ coverage of this surgical adjunct.
Stratified analyses looking at the extent of surgery showed total thyroidectomy with neck dissection to be the exception, as patients monitored during these more complex operations were significantly less likely to develop vocal cord paralysis than were nonmonitored counterparts (2.8% vs. 4.5%).
The more often hospitals used nerve monitoring as indicated by the volume of thyroidectomy cases, the lower the rate of vocal cord paralysis – with the exception of cases of partial thyroidectomy, in which more frequent use was associated with a counterintuitive increase in the rate of this complication, according to Dr. Chung, who disclosed that he had no relevant conflicts of interest.
“Nerve monitoring demonstrates a significant benefit particularly in complex cases such as total thyroidectomy with neck dissection,” he said. “Low nerve monitoring and utilization with partial thyroidectomy appears to be associated with higher vocal cord paralysis; with respect to the partial thyroidectomies, this may be due to the fact that the burden of complication is already so low, with vocal cord paralysis rates of about 0.8%, that additional use of nerve monitoring may not confer any benefit.”
Dr. Chung offered several possible reasons as to why monitoring may be associated with a higher risk of vocal cord paralysis, including presence of a learning curve, substitution of monitoring for direct visualization of the nerve, and false-negatives whereby a lack of signal from the monitor may lead to more aggressive ablation when the nerve is in fact nearby.
The study had its limitations, he acknowledged. “Nerve monitoring may not be coded all the time,” he said. Information about prior neck radiation and surgery, which increase the risk of vocal cord paralysis, was unavailable. “In the group with thyroidectomy with neck dissection, there is no code for central neck dissection. And even if it is a partial thyroidectomy with neck dissection, the central neck dissection would put both nerves at risk and therefore certainly increase the risk of vocal cord paralysis,” he noted.
Invited discussant Julie Ann Sosa, chief of endocrine surgery at the Duke Cancer Institute in Durham, N.C., said, “I would like to congratulate you and your whole group for tackling what is perhaps one of the most highly contested and contentious issues within endocrine surgery and otolaryngology. It’s also I think a very important area for study because there is a relative paucity of data demonstrating for or against the use of this technology as an adjunct. Current guidelines basically say it’s a wash: We can’t say one way or the other whether folks should be using it. And the anticipated guidelines, those coming out from the American Thyroid Association, similarly will say that more data are needed. So I think you are filling a clear vacuum.”
Dr. Sosa questioned the generalizability of the findings, noting that nearly two-thirds of thyroid procedures are now done in the ambulatory setting. “You used the Nationwide Inpatient Sample, so I think you are looking at a minority of cases and highly complex cases, with a length of stay on the order of 2-3 days, which is really exceptional. Most of us send home patients the same day. So how generalizable do you think your conclusions are, and have you thought about potentially using some of the ambulatory surgery databases to try to ask similar questions?” she queried.
The investigators plan to repeat analyses using the Nationwide Inpatient Sample’s ambulatory data set next, according to Dr. Chung. “Being able to see whether or not this still holds true in an outpatient setting is definitely worthwhile,” he agreed.
Dr. Sosa further wondered about the roles of bilateral versus unilateral monitoring, and continuous versus intermittent monitoring, saying, “I think the approach an individual surgeon takes could definitely result in different outcomes. So I wonder, were you able to address at a more granular level the specific technologies employed?”
The Nationwide Inpatient Sample unfortunately does not capture information on these aspects of monitoring, said Dr. Chung. However, “with respect to continuous versus intermittent, we do think that that’s actually an important variable. It is possible that those who are using nerve monitoring are doing this in a continuous fashion, so when they perhaps injure the first side of the vocal cords, they may stop. So what was originally planned to be a total thyroidectomy from the get-go that had an intraoperative nerve injury may be aborted so as to not create any disastrous airway complications. That may also artificially increase the partial thyroidectomy results, thereby increasing vocal cord paralysis complications in the partial thyroidectomy group.”
SAN FRANCISCO – Use of intraoperative nerve monitoring during thyroidectomy to avoid injuring the recurrent laryngeal nerve is counterintuitively associated with a higher risk of vocal cord paralysis, in a cohort study of data from the Nationwide Inpatient Sample.
“We do caution against perhaps the broad adoption of nerve monitoring until we can really study this further,” said Dr. Thomas K. Chung, a research fellow in the department of surgery, division of otolaryngology, at the University of Alabama at Birmingham, and the study’s lead investigator.
He and his colleagues compared outcomes between 12,742 patients who had nerve monitoring and 230,433 patients who did not (the conventional practice) while undergoing thyroidectomy between 2008 and 2011.
The proportion of patients who developed vocal cord paralysis was significantly higher with monitoring than without it (1.9% vs. 1.4%), he reported at the annual clinical congress of the American College of Surgeons. The findings were essentially the same in propensity-adjusted analyses that took into account differences between groups in preoperative factors (1.8% vs. 1.3%).
There was no evidence that the difference was related to differences in the use of laryngoscopy to check for paralysis, in hospitals’ coding and billing for monitoring, or in payers’ coverage of this surgical adjunct.
Stratified analyses looking at the extent of surgery showed total thyroidectomy with neck dissection to be the exception, as patients monitored during these more complex operations were significantly less likely to develop vocal cord paralysis than were nonmonitored counterparts (2.8% vs. 4.5%).
The more often hospitals used nerve monitoring as indicated by the volume of thyroidectomy cases, the lower the rate of vocal cord paralysis – with the exception of cases of partial thyroidectomy, in which more frequent use was associated with a counterintuitive increase in the rate of this complication, according to Dr. Chung, who disclosed that he had no relevant conflicts of interest.
“Nerve monitoring demonstrates a significant benefit particularly in complex cases such as total thyroidectomy with neck dissection,” he said. “Low nerve monitoring and utilization with partial thyroidectomy appears to be associated with higher vocal cord paralysis; with respect to the partial thyroidectomies, this may be due to the fact that the burden of complication is already so low, with vocal cord paralysis rates of about 0.8%, that additional use of nerve monitoring may not confer any benefit.”
Dr. Chung offered several possible reasons as to why monitoring may be associated with a higher risk of vocal cord paralysis, including presence of a learning curve, substitution of monitoring for direct visualization of the nerve, and false-negatives whereby a lack of signal from the monitor may lead to more aggressive ablation when the nerve is in fact nearby.
The study had its limitations, he acknowledged. “Nerve monitoring may not be coded all the time,” he said. Information about prior neck radiation and surgery, which increase the risk of vocal cord paralysis, was unavailable. “In the group with thyroidectomy with neck dissection, there is no code for central neck dissection. And even if it is a partial thyroidectomy with neck dissection, the central neck dissection would put both nerves at risk and therefore certainly increase the risk of vocal cord paralysis,” he noted.
Invited discussant Julie Ann Sosa, chief of endocrine surgery at the Duke Cancer Institute in Durham, N.C., said, “I would like to congratulate you and your whole group for tackling what is perhaps one of the most highly contested and contentious issues within endocrine surgery and otolaryngology. It’s also I think a very important area for study because there is a relative paucity of data demonstrating for or against the use of this technology as an adjunct. Current guidelines basically say it’s a wash: We can’t say one way or the other whether folks should be using it. And the anticipated guidelines, those coming out from the American Thyroid Association, similarly will say that more data are needed. So I think you are filling a clear vacuum.”
Dr. Sosa questioned the generalizability of the findings, noting that nearly two-thirds of thyroid procedures are now done in the ambulatory setting. “You used the Nationwide Inpatient Sample, so I think you are looking at a minority of cases and highly complex cases, with a length of stay on the order of 2-3 days, which is really exceptional. Most of us send home patients the same day. So how generalizable do you think your conclusions are, and have you thought about potentially using some of the ambulatory surgery databases to try to ask similar questions?” she queried.
The investigators plan to repeat analyses using the Nationwide Inpatient Sample’s ambulatory data set next, according to Dr. Chung. “Being able to see whether or not this still holds true in an outpatient setting is definitely worthwhile,” he agreed.
Dr. Sosa further wondered about the roles of bilateral versus unilateral monitoring, and continuous versus intermittent monitoring, saying, “I think the approach an individual surgeon takes could definitely result in different outcomes. So I wonder, were you able to address at a more granular level the specific technologies employed?”
The Nationwide Inpatient Sample unfortunately does not capture information on these aspects of monitoring, said Dr. Chung. However, “with respect to continuous versus intermittent, we do think that that’s actually an important variable. It is possible that those who are using nerve monitoring are doing this in a continuous fashion, so when they perhaps injure the first side of the vocal cords, they may stop. So what was originally planned to be a total thyroidectomy from the get-go that had an intraoperative nerve injury may be aborted so as to not create any disastrous airway complications. That may also artificially increase the partial thyroidectomy results, thereby increasing vocal cord paralysis complications in the partial thyroidectomy group.”
AT THE ACS CLINICAL CONGRESS
Key clinical point: Patients who had intraoperative nerve monitoring were more likely to develop vocal cord paralysis.
Major finding: The propensity-adjusted rate of vocal cord paralysis was 1.3% without monitoring and 1.8% with monitoring.
Data source: A retrospective cohort study of 243,175 patients undergoing thyroidectomy.
Disclosures: Dr. Chung disclosed that he had no relevant conflicts of interest.
VTE risk models target a formidable surgery foe
CHICAGO – Implementation of preoperative venous thromboembolism prophylaxis requires a highly individualized approach and a little boost from information technology, one expert suggested.
“What may not be appreciated by some vascular surgeons is that for certain procedures we do, our patients actually have a high VTE [venous thromboembolism] risk. I know people think, ‘We use heparin, so our patients aren’t at high risk,’ but they actually are,” Dr. Melina Kibbe said at a symposium on vascular surgery sponsored by Northwestern University.
The VTE risk is 4.2% for open thoracoabdominal aortic aneurysm repair and 2.2% for thoracic endovascular aortic repair in the American College of Surgeons National Surgical Quality Improvement Program database. That may be an underestimation, however, because the NSQIP database captures only symptomatic events documented by imaging and those events occurring in the first 30 days after surgery.
Smaller studies looking at the problem prospectively suggest the VTE risk is closer to 2%-12% after open aortic surgery and 5.3% after endovascular aortic repair, she said.
Add to that the U.S. Surgeon General’s 2008 call to action to prevent VTE and the Institute of Medicine’s stance that failure to provide VTE prophylaxis qualifies as a medical error, and it would be tempting for vascular surgeons to prescribe pharmacologic prophylaxis for all of their patients, or at least do so based on the type of procedure.
“But VTE formation is really secondary to patient-specific and procedure-related factors,” said Dr. Kibbe, a professor of vascular surgery at Northwestern University in Chicago.
She highlighted five current VTE risk assessment models (RAMs) and the potential returns when RAMs are incorporated into clinical decision support systems.
• Kucher model. One of the earlier and most straightforward RAMs is the Kucher model. It assessed eight weighted risk factors (advanced age, obesity, bed rest, hormone replacement therapy/oral contraceptives, major surgery, cancer, prior VTE, and hypercoagulability) and provided surgeons with electronic alerts regarding prophylaxis.
VTE rates dropped from 8.2% to 4.9% in the high-risk category (score ≥ 4) with the use of the simple physician reminders (N. Engl. J. Med. 2005;352:969-77). Prospective validation showed that VTE increased proportionally with higher scores, Dr. Kibbe said. On the other hand, the model lacked sensitivity at low VTE risk, because 20% of patients with a score of 4 or less actually had VTEs.
“So, while it was simple, it only works well for the high-risk category,” she said.
• Rogers model. One of the most vigorously studied and developed RAMs is the Rogers model (J. Am. Coll. Surg. 2007;204:1211-21). It identified 15 variables (including lab values, patient characteristics, disease states, work relative-value unit, and type of operation) that were independently associated with VTE formation among 183,609 patients undergoing general, vascular, or thoracic procedures at 142 Veterans Health Administration and private hospitals. Each variable is assigned a value from 0 to 9 and added together to create a Rogers score.
Validation showed that VTE risk correlates with the Rogers score, rising from 0.11% for patients with a low score (< 7) to 1.32% for those with a high score (> 10), Dr. Kibbe said. Criticisms of the model are that it is complex, VTE incidence in the entire cohort was low at just 0.63%, the type of VTE prophylaxis used was unclear, and the model lacks prospective validation in a vascular surgery cohort.
• Caprini model. The most commonly used RAM is the 2005 Caprini model (Dis. Mon. 2005;51:70-8), which assigns a weighted score based on more than 30 VTE risk factors compiled by the authors. It has been prospectively validated in numerous studies and shown to accurately stratify 30-day VTE risk at 0.5% for patients at very low risk, 1.5% for low risk, 3% for moderate risk, and 6% for high risk.
The Caprini model, however, was not developed with the same rigor as the Rogers RAM, some of the risk factors have been shown not to be a risk for VTE, and it is complex, Dr. Kibbe observed.
• Pannucci model. The Pannucci model was created specifically to counteract the complexity of the Rogers and Caprini RAMs and incorporates only seven risk factors (personal history of VTE, current cancer, age ≥ 60 years, body mass index ≥ 40 kg/m2, male sex, sepsis/septic shock/systemic inflammatory response syndrome, and family history of VTE) into a weighted index for 90-day VTE risk (Chest 2014;145:567-73). The model was developed using a statewide database and a derivation cohort made up of 20% vascular surgery patients.
Both the derivation and validation cohorts identified an 18-fold variation in VTE risk from the lowest- to highest-risk surgical population, showing that the model stratifies patients correctly. Further prospective validation is needed, Dr. Kibbe said.
• Scarborough model. Finally, in an attempt to develop a RAM specific to vascular surgery patients, Dr. John Scarborough and colleagues examined 6,035 patients undergoing open AAA repair in the NSQIP database. The 30-day VTE rate was 2.4% for the entire cohort. Eight independent perioperative risk factors were identified and used to create a nonweighted scoring system (J. Am. Coll. Surg. 2012;214:620-6).
Overall, 65% of patients had 0-1 risk factor and a VTE incidence of 1.5%, while 15% had 3 or more risk factors and a VTE incidence of 6.1%. The Scarborough model has good risk stratification, Dr. Kibbe said, but it is limited by the aforementioned criticisms regarding the NSQIP database, and it also needs prospective validation.
“We all know that proper VTE prophylaxis is very important for our patients; but we need mechanisms by which the attention given to this need for prophylaxis, which is a lot, is turned into proper implementation,” she said.
For Dr. Kibbe and her colleagues, proper implementation meant developing a RAM that was incorporated into the electronic medical record system for all surgical patients at the Jesse Brown VA Medical Center in Chicago. Clinicians were prompted to complete the RAM upon placing orders for preanesthesia testing clearance, and the clinical decision support system would provide a recommended prophylaxis regimen and easily selected electronic orders that could be signed.
A pre- and postimplementation analysis involving 400 consecutive patients revealed an 82% increase in patients with preoperative VTE prophylaxis ordered (22% vs. 40%), a 75% decrease in inappropriate cancellation of orders more than 12 hours before surgery (37% vs. 9%), and a nearly sevenfold increase in the number of patients receiving pharmacologic and mechanical prophylaxis (5% vs. 32%), she said. There was an 80% and 36% decline in DVT rates at 30 and 90 days postoperative, but event rates were too low to detect a significant difference (J. Vasc. Surg. 2010;51:648-54).
Dr. Kibbe reported having no financial disclosures.
CHICAGO – Implementation of preoperative venous thromboembolism prophylaxis requires a highly individualized approach and a little boost from information technology, one expert suggested.
“What may not be appreciated by some vascular surgeons is that for certain procedures we do, our patients actually have a high VTE [venous thromboembolism] risk. I know people think, ‘We use heparin, so our patients aren’t at high risk,’ but they actually are,” Dr. Melina Kibbe said at a symposium on vascular surgery sponsored by Northwestern University.
The VTE risk is 4.2% for open thoracoabdominal aortic aneurysm repair and 2.2% for thoracic endovascular aortic repair in the American College of Surgeons National Surgical Quality Improvement Program database. That may be an underestimation, however, because the NSQIP database captures only symptomatic events documented by imaging and those events occurring in the first 30 days after surgery.
Smaller studies looking at the problem prospectively suggest the VTE risk is closer to 2%-12% after open aortic surgery and 5.3% after endovascular aortic repair, she said.
Add to that the U.S. Surgeon General’s 2008 call to action to prevent VTE and the Institute of Medicine’s stance that failure to provide VTE prophylaxis qualifies as a medical error, and it would be tempting for vascular surgeons to prescribe pharmacologic prophylaxis for all of their patients, or at least do so based on the type of procedure.
“But VTE formation is really secondary to patient-specific and procedure-related factors,” said Dr. Kibbe, a professor of vascular surgery at Northwestern University in Chicago.
She highlighted five current VTE risk assessment models (RAMs) and the potential returns when RAMs are incorporated into clinical decision support systems.
• Kucher model. One of the earlier and most straightforward RAMs is the Kucher model. It assessed eight weighted risk factors (advanced age, obesity, bed rest, hormone replacement therapy/oral contraceptives, major surgery, cancer, prior VTE, and hypercoagulability) and provided surgeons with electronic alerts regarding prophylaxis.
VTE rates dropped from 8.2% to 4.9% in the high-risk category (score ≥ 4) with the use of the simple physician reminders (N. Engl. J. Med. 2005;352:969-77). Prospective validation showed that VTE increased proportionally with higher scores, Dr. Kibbe said. On the other hand, the model lacked sensitivity at low VTE risk, because 20% of patients with a score of 4 or less actually had VTEs.
“So, while it was simple, it only works well for the high-risk category,” she said.
• Rogers model. One of the most vigorously studied and developed RAMs is the Rogers model (J. Am. Coll. Surg. 2007;204:1211-21). It identified 15 variables (including lab values, patient characteristics, disease states, work relative-value unit, and type of operation) that were independently associated with VTE formation among 183,609 patients undergoing general, vascular, or thoracic procedures at 142 Veterans Health Administration and private hospitals. Each variable is assigned a value from 0 to 9 and added together to create a Rogers score.
Validation showed that VTE risk correlates with the Rogers score, rising from 0.11% for patients with a low score (< 7) to 1.32% for those with a high score (> 10), Dr. Kibbe said. Criticisms of the model are that it is complex, VTE incidence in the entire cohort was low at just 0.63%, the type of VTE prophylaxis used was unclear, and the model lacks prospective validation in a vascular surgery cohort.
• Caprini model. The most commonly used RAM is the 2005 Caprini model (Dis. Mon. 2005;51:70-8), which assigns a weighted score based on more than 30 VTE risk factors compiled by the authors. It has been prospectively validated in numerous studies and shown to accurately stratify 30-day VTE risk at 0.5% for patients at very low risk, 1.5% for low risk, 3% for moderate risk, and 6% for high risk.
The Caprini model, however, was not developed with the same rigor as the Rogers RAM, some of the risk factors have been shown not to be a risk for VTE, and it is complex, Dr. Kibbe observed.
• Pannucci model. The Pannucci model was created specifically to counteract the complexity of the Rogers and Caprini RAMs and incorporates only seven risk factors (personal history of VTE, current cancer, age ≥ 60 years, body mass index ≥ 40 kg/m2, male sex, sepsis/septic shock/systemic inflammatory response syndrome, and family history of VTE) into a weighted index for 90-day VTE risk (Chest 2014;145:567-73). The model was developed using a statewide database and a derivation cohort made up of 20% vascular surgery patients.
Both the derivation and validation cohorts identified an 18-fold variation in VTE risk from the lowest- to highest-risk surgical population, showing that the model stratifies patients correctly. Further prospective validation is needed, Dr. Kibbe said.
• Scarborough model. Finally, in an attempt to develop a RAM specific to vascular surgery patients, Dr. John Scarborough and colleagues examined 6,035 patients undergoing open AAA repair in the NSQIP database. The 30-day VTE rate was 2.4% for the entire cohort. Eight independent perioperative risk factors were identified and used to create a nonweighted scoring system (J. Am. Coll. Surg. 2012;214:620-6).
Overall, 65% of patients had 0-1 risk factor and a VTE incidence of 1.5%, while 15% had 3 or more risk factors and a VTE incidence of 6.1%. The Scarborough model has good risk stratification, Dr. Kibbe said, but it is limited by the aforementioned criticisms regarding the NSQIP database, and it also needs prospective validation.
“We all know that proper VTE prophylaxis is very important for our patients; but we need mechanisms by which the attention given to this need for prophylaxis, which is a lot, is turned into proper implementation,” she said.
For Dr. Kibbe and her colleagues, proper implementation meant developing a RAM that was incorporated into the electronic medical record system for all surgical patients at the Jesse Brown VA Medical Center in Chicago. Clinicians were prompted to complete the RAM upon placing orders for preanesthesia testing clearance, and the clinical decision support system would provide a recommended prophylaxis regimen and easily selected electronic orders that could be signed.
A pre- and postimplementation analysis involving 400 consecutive patients revealed an 82% increase in patients with preoperative VTE prophylaxis ordered (22% vs. 40%), a 75% decrease in inappropriate cancellation of orders more than 12 hours before surgery (37% vs. 9%), and a nearly sevenfold increase in the number of patients receiving pharmacologic and mechanical prophylaxis (5% vs. 32%), she said. There was an 80% and 36% decline in DVT rates at 30 and 90 days postoperative, but event rates were too low to detect a significant difference (J. Vasc. Surg. 2010;51:648-54).
Dr. Kibbe reported having no financial disclosures.
CHICAGO – Implementation of preoperative venous thromboembolism prophylaxis requires a highly individualized approach and a little boost from information technology, one expert suggested.
“What may not be appreciated by some vascular surgeons is that for certain procedures we do, our patients actually have a high VTE [venous thromboembolism] risk. I know people think, ‘We use heparin, so our patients aren’t at high risk,’ but they actually are,” Dr. Melina Kibbe said at a symposium on vascular surgery sponsored by Northwestern University.
The VTE risk is 4.2% for open thoracoabdominal aortic aneurysm repair and 2.2% for thoracic endovascular aortic repair in the American College of Surgeons National Surgical Quality Improvement Program database. That may be an underestimation, however, because the NSQIP database captures only symptomatic events documented by imaging and those events occurring in the first 30 days after surgery.
Smaller studies looking at the problem prospectively suggest the VTE risk is closer to 2%-12% after open aortic surgery and 5.3% after endovascular aortic repair, she said.
Add to that the U.S. Surgeon General’s 2008 call to action to prevent VTE and the Institute of Medicine’s stance that failure to provide VTE prophylaxis qualifies as a medical error, and it would be tempting for vascular surgeons to prescribe pharmacologic prophylaxis for all of their patients, or at least do so based on the type of procedure.
“But VTE formation is really secondary to patient-specific and procedure-related factors,” said Dr. Kibbe, a professor of vascular surgery at Northwestern University in Chicago.
She highlighted five current VTE risk assessment models (RAMs) and the potential returns when RAMs are incorporated into clinical decision support systems.
• Kucher model. One of the earlier and most straightforward RAMs is the Kucher model. It assessed eight weighted risk factors (advanced age, obesity, bed rest, hormone replacement therapy/oral contraceptives, major surgery, cancer, prior VTE, and hypercoagulability) and provided surgeons with electronic alerts regarding prophylaxis.
VTE rates dropped from 8.2% to 4.9% in the high-risk category (score ≥ 4) with the use of the simple physician reminders (N. Engl. J. Med. 2005;352:969-77). Prospective validation showed that VTE increased proportionally with higher scores, Dr. Kibbe said. On the other hand, the model lacked sensitivity at low VTE risk, because 20% of patients with a score of 4 or less actually had VTEs.
“So, while it was simple, it only works well for the high-risk category,” she said.
• Rogers model. One of the most vigorously studied and developed RAMs is the Rogers model (J. Am. Coll. Surg. 2007;204:1211-21). It identified 15 variables (including lab values, patient characteristics, disease states, work relative-value unit, and type of operation) that were independently associated with VTE formation among 183,609 patients undergoing general, vascular, or thoracic procedures at 142 Veterans Health Administration and private hospitals. Each variable is assigned a value from 0 to 9 and added together to create a Rogers score.
Validation showed that VTE risk correlates with the Rogers score, rising from 0.11% for patients with a low score (< 7) to 1.32% for those with a high score (> 10), Dr. Kibbe said. Criticisms of the model are that it is complex, VTE incidence in the entire cohort was low at just 0.63%, the type of VTE prophylaxis used was unclear, and the model lacks prospective validation in a vascular surgery cohort.
• Caprini model. The most commonly used RAM is the 2005 Caprini model (Dis. Mon. 2005;51:70-8), which assigns a weighted score based on more than 30 VTE risk factors compiled by the authors. It has been prospectively validated in numerous studies and shown to accurately stratify 30-day VTE risk at 0.5% for patients at very low risk, 1.5% for low risk, 3% for moderate risk, and 6% for high risk.
The Caprini model, however, was not developed with the same rigor as the Rogers RAM, some of the risk factors have been shown not to be a risk for VTE, and it is complex, Dr. Kibbe observed.
• Pannucci model. The Pannucci model was created specifically to counteract the complexity of the Rogers and Caprini RAMs and incorporates only seven risk factors (personal history of VTE, current cancer, age ≥ 60 years, body mass index ≥ 40 kg/m2, male sex, sepsis/septic shock/systemic inflammatory response syndrome, and family history of VTE) into a weighted index for 90-day VTE risk (Chest 2014;145:567-73). The model was developed using a statewide database and a derivation cohort made up of 20% vascular surgery patients.
Both the derivation and validation cohorts identified an 18-fold variation in VTE risk from the lowest- to highest-risk surgical population, showing that the model stratifies patients correctly. Further prospective validation is needed, Dr. Kibbe said.
• Scarborough model. Finally, in an attempt to develop a RAM specific to vascular surgery patients, Dr. John Scarborough and colleagues examined 6,035 patients undergoing open AAA repair in the NSQIP database. The 30-day VTE rate was 2.4% for the entire cohort. Eight independent perioperative risk factors were identified and used to create a nonweighted scoring system (J. Am. Coll. Surg. 2012;214:620-6).
Overall, 65% of patients had 0-1 risk factor and a VTE incidence of 1.5%, while 15% had 3 or more risk factors and a VTE incidence of 6.1%. The Scarborough model has good risk stratification, Dr. Kibbe said, but it is limited by the aforementioned criticisms regarding the NSQIP database, and it also needs prospective validation.
“We all know that proper VTE prophylaxis is very important for our patients; but we need mechanisms by which the attention given to this need for prophylaxis, which is a lot, is turned into proper implementation,” she said.
For Dr. Kibbe and her colleagues, proper implementation meant developing a RAM that was incorporated into the electronic medical record system for all surgical patients at the Jesse Brown VA Medical Center in Chicago. Clinicians were prompted to complete the RAM upon placing orders for preanesthesia testing clearance, and the clinical decision support system would provide a recommended prophylaxis regimen and easily selected electronic orders that could be signed.
A pre- and postimplementation analysis involving 400 consecutive patients revealed an 82% increase in patients with preoperative VTE prophylaxis ordered (22% vs. 40%), a 75% decrease in inappropriate cancellation of orders more than 12 hours before surgery (37% vs. 9%), and a nearly sevenfold increase in the number of patients receiving pharmacologic and mechanical prophylaxis (5% vs. 32%), she said. There was an 80% and 36% decline in DVT rates at 30 and 90 days postoperative, but event rates were too low to detect a significant difference (J. Vasc. Surg. 2010;51:648-54).
Dr. Kibbe reported having no financial disclosures.
AT THE NORTHWESTERN VASCULAR SYMPOSIUM
Sofosbuvir and ribavirin critical to preventing posttransplantation HCV recurrence
Sofosbuvir and ribavirin treatments should be administered to patients with hepatitis C virus who undergo liver transplantations in order to significantly decrease the risks of posttransplant HCV recurrence, according to two new studies published in the January issue of Gastroenterology (10.1053/j.gastro.2014.09.023 and 10.1053/j.gastro.2014.10.001).
“In clinical trials, administration of sofosbuvir with ribavirin was associated with rapid decreases of HCV RNA to undetectable levels in patients with HCV genotype 1, 2, 3, 4, and 6 infections,” wrote lead author Dr. Michael P. Curry of the Beth Israel Deaconess Medical Center in Boston, and his coauthors on the first of these two studies. “In more than 3,000 patients treated to date, sofosbuvir has been shown to be safe, viral breakthrough during treatment has been rare (and associated with nonadherence), and few drug interactions have been observed.”
In a phase II, open-label study, Dr. Curry and his coinvestigators enrolled 61 patients with HCV of any genotype, and cirrhosis with a Child-Turcotte-Pugh score no greater than 7, who were all wait-listed to receive liver transplantations. Subjects received up to 48 weeks of treatment with 400 mg of sofosbuvir, and a separate dose of ribavirin prior to liver transplantation, while 43 patients received transplantations alone. The primary outcome sought by investigators was HCV-RNA levels less than 25 IU/mL at 12 weeks after transplantation among patients that had this level prior to the operation.
The investigators found that 43 subjects had the desired HCV-RNA levels; of that population, 49% had a posttransplantation virologic response, with the most frequent side effects reported by subjects being fatigue (38%), headache (23%), and anemia (21%). Of the 43 applicable subjects, 30 (70% of the population) had a posttransplantation virologic response at 12 weeks, 10 (23%) had recurrent infection, and 3 (7%) died.
“This study provides proof of concept that virologic suppression without interferon significantly can reduce the rate of recurrent HCV after liver transplantation,” the study says, adding that the results “compare favorably with those observed in other trials of pretransplantation antiviral therapy.”
In the second study, the authors ascertained that combination therapy consisting of sofosbuvir and ribavirin for 24 weeks is effective at preventing hepatitis C virus recurrence in patients who undergo liver transplantations.
“Recurrent HCV infection is the most common cause of mortality and graft loss following transplantation, and up to 30% of patients with recurrent infection develop cirrhosis within 5 years,” wrote the study’s authors, led by Dr. Michael Charlton of the Mayo Clinic in Rochester, Minn.
Using a prospective, multicenter, open-label pilot study, investigators enrolled and treated 40 patients with a 24-week regimen of 400 mg sofosbuvir and ribavirin starting at 400 mg, which was subsequently adjusted per patient based on individual creatinine clearance and hemoglobin levels. Subjects were 78% male and 85% white, with 83% having HCV genotype 1, 40% having cirrhosis, and 88% having been previously treated with interferon. The primary outcome investigators looked for was “sustained virologic response 12 weeks after treatment (SVR12).”
Data showed that SVR12 was achieved by 28 of the 40 subjects that received treatment, or 70%. The most commonly reported adverse effects were fatigue (30%), diarrhea (28%), headache (25%), and anemia (20%). No patients exhibited detectable viral resistance during or after treatment, and although two patients terminated their treatment because of adverse events, investigators reported no deaths, graft losses, or episodes of rejection.
“In contrast,” Dr. Charlton and his coauthors noted, “interferon-based treatments have been associated with posttreatment immunological dysfunction (particularly plasma cell hepatitis) and even hepatic decompensation in LT [liver transplant] recipients.”
The authors of the first study disclosed that Dr. Curry has received grants from and been affiliated with Gilead, which was a sponsor of the study. The authors of the second study reported no relevant financial disclosures.
Sofosbuvir and ribavirin treatments should be administered to patients with hepatitis C virus who undergo liver transplantations in order to significantly decrease the risks of posttransplant HCV recurrence, according to two new studies published in the January issue of Gastroenterology (10.1053/j.gastro.2014.09.023 and 10.1053/j.gastro.2014.10.001).
“In clinical trials, administration of sofosbuvir with ribavirin was associated with rapid decreases of HCV RNA to undetectable levels in patients with HCV genotype 1, 2, 3, 4, and 6 infections,” wrote lead author Dr. Michael P. Curry of the Beth Israel Deaconess Medical Center in Boston, and his coauthors on the first of these two studies. “In more than 3,000 patients treated to date, sofosbuvir has been shown to be safe, viral breakthrough during treatment has been rare (and associated with nonadherence), and few drug interactions have been observed.”
In a phase II, open-label study, Dr. Curry and his coinvestigators enrolled 61 patients with HCV of any genotype, and cirrhosis with a Child-Turcotte-Pugh score no greater than 7, who were all wait-listed to receive liver transplantations. Subjects received up to 48 weeks of treatment with 400 mg of sofosbuvir, and a separate dose of ribavirin prior to liver transplantation, while 43 patients received transplantations alone. The primary outcome sought by investigators was HCV-RNA levels less than 25 IU/mL at 12 weeks after transplantation among patients that had this level prior to the operation.
The investigators found that 43 subjects had the desired HCV-RNA levels; of that population, 49% had a posttransplantation virologic response, with the most frequent side effects reported by subjects being fatigue (38%), headache (23%), and anemia (21%). Of the 43 applicable subjects, 30 (70% of the population) had a posttransplantation virologic response at 12 weeks, 10 (23%) had recurrent infection, and 3 (7%) died.
“This study provides proof of concept that virologic suppression without interferon significantly can reduce the rate of recurrent HCV after liver transplantation,” the study says, adding that the results “compare favorably with those observed in other trials of pretransplantation antiviral therapy.”
In the second study, the authors ascertained that combination therapy consisting of sofosbuvir and ribavirin for 24 weeks is effective at preventing hepatitis C virus recurrence in patients who undergo liver transplantations.
“Recurrent HCV infection is the most common cause of mortality and graft loss following transplantation, and up to 30% of patients with recurrent infection develop cirrhosis within 5 years,” wrote the study’s authors, led by Dr. Michael Charlton of the Mayo Clinic in Rochester, Minn.
Using a prospective, multicenter, open-label pilot study, investigators enrolled and treated 40 patients with a 24-week regimen of 400 mg sofosbuvir and ribavirin starting at 400 mg, which was subsequently adjusted per patient based on individual creatinine clearance and hemoglobin levels. Subjects were 78% male and 85% white, with 83% having HCV genotype 1, 40% having cirrhosis, and 88% having been previously treated with interferon. The primary outcome investigators looked for was “sustained virologic response 12 weeks after treatment (SVR12).”
Data showed that SVR12 was achieved by 28 of the 40 subjects that received treatment, or 70%. The most commonly reported adverse effects were fatigue (30%), diarrhea (28%), headache (25%), and anemia (20%). No patients exhibited detectable viral resistance during or after treatment, and although two patients terminated their treatment because of adverse events, investigators reported no deaths, graft losses, or episodes of rejection.
“In contrast,” Dr. Charlton and his coauthors noted, “interferon-based treatments have been associated with posttreatment immunological dysfunction (particularly plasma cell hepatitis) and even hepatic decompensation in LT [liver transplant] recipients.”
The authors of the first study disclosed that Dr. Curry has received grants from and been affiliated with Gilead, which was a sponsor of the study. The authors of the second study reported no relevant financial disclosures.
Sofosbuvir and ribavirin treatments should be administered to patients with hepatitis C virus who undergo liver transplantations in order to significantly decrease the risks of posttransplant HCV recurrence, according to two new studies published in the January issue of Gastroenterology (10.1053/j.gastro.2014.09.023 and 10.1053/j.gastro.2014.10.001).
“In clinical trials, administration of sofosbuvir with ribavirin was associated with rapid decreases of HCV RNA to undetectable levels in patients with HCV genotype 1, 2, 3, 4, and 6 infections,” wrote lead author Dr. Michael P. Curry of the Beth Israel Deaconess Medical Center in Boston, and his coauthors on the first of these two studies. “In more than 3,000 patients treated to date, sofosbuvir has been shown to be safe, viral breakthrough during treatment has been rare (and associated with nonadherence), and few drug interactions have been observed.”
In a phase II, open-label study, Dr. Curry and his coinvestigators enrolled 61 patients with HCV of any genotype, and cirrhosis with a Child-Turcotte-Pugh score no greater than 7, who were all wait-listed to receive liver transplantations. Subjects received up to 48 weeks of treatment with 400 mg of sofosbuvir, and a separate dose of ribavirin prior to liver transplantation, while 43 patients received transplantations alone. The primary outcome sought by investigators was HCV-RNA levels less than 25 IU/mL at 12 weeks after transplantation among patients that had this level prior to the operation.
The investigators found that 43 subjects had the desired HCV-RNA levels; of that population, 49% had a posttransplantation virologic response, with the most frequent side effects reported by subjects being fatigue (38%), headache (23%), and anemia (21%). Of the 43 applicable subjects, 30 (70% of the population) had a posttransplantation virologic response at 12 weeks, 10 (23%) had recurrent infection, and 3 (7%) died.
“This study provides proof of concept that virologic suppression without interferon significantly can reduce the rate of recurrent HCV after liver transplantation,” the study says, adding that the results “compare favorably with those observed in other trials of pretransplantation antiviral therapy.”
In the second study, the authors ascertained that combination therapy consisting of sofosbuvir and ribavirin for 24 weeks is effective at preventing hepatitis C virus recurrence in patients who undergo liver transplantations.
“Recurrent HCV infection is the most common cause of mortality and graft loss following transplantation, and up to 30% of patients with recurrent infection develop cirrhosis within 5 years,” wrote the study’s authors, led by Dr. Michael Charlton of the Mayo Clinic in Rochester, Minn.
Using a prospective, multicenter, open-label pilot study, investigators enrolled and treated 40 patients with a 24-week regimen of 400 mg sofosbuvir and ribavirin starting at 400 mg, which was subsequently adjusted per patient based on individual creatinine clearance and hemoglobin levels. Subjects were 78% male and 85% white, with 83% having HCV genotype 1, 40% having cirrhosis, and 88% having been previously treated with interferon. The primary outcome investigators looked for was “sustained virologic response 12 weeks after treatment (SVR12).”
Data showed that SVR12 was achieved by 28 of the 40 subjects that received treatment, or 70%. The most commonly reported adverse effects were fatigue (30%), diarrhea (28%), headache (25%), and anemia (20%). No patients exhibited detectable viral resistance during or after treatment, and although two patients terminated their treatment because of adverse events, investigators reported no deaths, graft losses, or episodes of rejection.
“In contrast,” Dr. Charlton and his coauthors noted, “interferon-based treatments have been associated with posttreatment immunological dysfunction (particularly plasma cell hepatitis) and even hepatic decompensation in LT [liver transplant] recipients.”
The authors of the first study disclosed that Dr. Curry has received grants from and been affiliated with Gilead, which was a sponsor of the study. The authors of the second study reported no relevant financial disclosures.
FROM GASTROENTEROLOGY
FDA approves IV antibacterial for complicated UTIs, abdominal infections
A combination of a cephalosporin and a beta-lactamase inhibitor in an intravenous formulation has been approved for treating complicated intra-abdominal infections and complicated urinary tract infections in adults, the Food and Drug Administration announced on Dec. 19.
The cephalosporin is ceftolozane and the beta-lactamase inhibitor is tazobactam; it will be marketed as Zerbaxa by Cubist Pharmaceuticals.
This is the fourth antibacterial drug product approved by the FDA in 2014 and, like the other three, it was designated as a Qualified Infectious Disease Product (QIDP) and was given priority review, according to the FDA statement. Zerbaxa was granted a QIDP designation under the Generating Antibiotic Incentives Now (GAIN) Act of the FDA Safety and Innovation Act, “because it is an antibacterial or antifungal human drug intended to treat a serious or life-threatening infection,” the statement said.
As part of the QIDP program, the manufacturer has also been granted an extra 5 years of “exclusivity” – exclusive marketing rights – by the FDA.
Ceftolozane-tazobactam was approved for treating complicated intra-abdominal infections in combination with metronidazole; approval for this indication was based on a study of 979 adults, randomized to the combination or to meropenem.
Approval for complicated urinary tract infections, including pyelonephritis, was based on a study of 1,068 adults, randomized to treatment with ceftolozane-tazobactam or levofloxacin.
The prescribing information includes a warning about decreased efficacy in patients with renal impairment (a baseline creatinine clearance of 30-50 mL/min or less, and the recommendation to monitor creatinine clearance “at least daily in patients with changing renal function,” and to adjust dose accordingly. Nausea, diarrhea, headache, and fever were the most common adverse events in studies, according to the FDA statement.
The other antibacterials approved by the FDA in 2014 were approved for treating acute bacterial skin and skin structure infections caused by certain susceptible bacteria. They were dalbavancin (Dalvance), approved in May; tedizolid (Sivextro), approved in June; and oritavancin (Orbactiv), approved in August.
Serious adverse events associated with Zerbaxa should be reported to the FDA’s MedWatch program at 800-332-1088 or http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm.
A combination of a cephalosporin and a beta-lactamase inhibitor in an intravenous formulation has been approved for treating complicated intra-abdominal infections and complicated urinary tract infections in adults, the Food and Drug Administration announced on Dec. 19.
The cephalosporin is ceftolozane and the beta-lactamase inhibitor is tazobactam; it will be marketed as Zerbaxa by Cubist Pharmaceuticals.
This is the fourth antibacterial drug product approved by the FDA in 2014 and, like the other three, it was designated as a Qualified Infectious Disease Product (QIDP) and was given priority review, according to the FDA statement. Zerbaxa was granted a QIDP designation under the Generating Antibiotic Incentives Now (GAIN) Act of the FDA Safety and Innovation Act, “because it is an antibacterial or antifungal human drug intended to treat a serious or life-threatening infection,” the statement said.
As part of the QIDP program, the manufacturer has also been granted an extra 5 years of “exclusivity” – exclusive marketing rights – by the FDA.
Ceftolozane-tazobactam was approved for treating complicated intra-abdominal infections in combination with metronidazole; approval for this indication was based on a study of 979 adults, randomized to the combination or to meropenem.
Approval for complicated urinary tract infections, including pyelonephritis, was based on a study of 1,068 adults, randomized to treatment with ceftolozane-tazobactam or levofloxacin.
The prescribing information includes a warning about decreased efficacy in patients with renal impairment (a baseline creatinine clearance of 30-50 mL/min or less, and the recommendation to monitor creatinine clearance “at least daily in patients with changing renal function,” and to adjust dose accordingly. Nausea, diarrhea, headache, and fever were the most common adverse events in studies, according to the FDA statement.
The other antibacterials approved by the FDA in 2014 were approved for treating acute bacterial skin and skin structure infections caused by certain susceptible bacteria. They were dalbavancin (Dalvance), approved in May; tedizolid (Sivextro), approved in June; and oritavancin (Orbactiv), approved in August.
Serious adverse events associated with Zerbaxa should be reported to the FDA’s MedWatch program at 800-332-1088 or http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm.
A combination of a cephalosporin and a beta-lactamase inhibitor in an intravenous formulation has been approved for treating complicated intra-abdominal infections and complicated urinary tract infections in adults, the Food and Drug Administration announced on Dec. 19.
The cephalosporin is ceftolozane and the beta-lactamase inhibitor is tazobactam; it will be marketed as Zerbaxa by Cubist Pharmaceuticals.
This is the fourth antibacterial drug product approved by the FDA in 2014 and, like the other three, it was designated as a Qualified Infectious Disease Product (QIDP) and was given priority review, according to the FDA statement. Zerbaxa was granted a QIDP designation under the Generating Antibiotic Incentives Now (GAIN) Act of the FDA Safety and Innovation Act, “because it is an antibacterial or antifungal human drug intended to treat a serious or life-threatening infection,” the statement said.
As part of the QIDP program, the manufacturer has also been granted an extra 5 years of “exclusivity” – exclusive marketing rights – by the FDA.
Ceftolozane-tazobactam was approved for treating complicated intra-abdominal infections in combination with metronidazole; approval for this indication was based on a study of 979 adults, randomized to the combination or to meropenem.
Approval for complicated urinary tract infections, including pyelonephritis, was based on a study of 1,068 adults, randomized to treatment with ceftolozane-tazobactam or levofloxacin.
The prescribing information includes a warning about decreased efficacy in patients with renal impairment (a baseline creatinine clearance of 30-50 mL/min or less, and the recommendation to monitor creatinine clearance “at least daily in patients with changing renal function,” and to adjust dose accordingly. Nausea, diarrhea, headache, and fever were the most common adverse events in studies, according to the FDA statement.
The other antibacterials approved by the FDA in 2014 were approved for treating acute bacterial skin and skin structure infections caused by certain susceptible bacteria. They were dalbavancin (Dalvance), approved in May; tedizolid (Sivextro), approved in June; and oritavancin (Orbactiv), approved in August.
Serious adverse events associated with Zerbaxa should be reported to the FDA’s MedWatch program at 800-332-1088 or http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm.
Feds release quality data on diabetes, heart disease, infections
Medicare officials have released a slew of new data demonstrating physicians’ and hospitals’ performance on quality measures related to diabetes, cardiovascular care, and hospital-acquired infections and injuries.
The quality data were posted on Medicare’s Physician Compare and Hospital Compare websites, which aim to provide consumers with the information they need to help them select physicians and other health care providers. The information is also available on data.medicare.gov.
“The Compare sites empower consumers with information to help with health care decisions, encourage providers to strive for higher levels of quality, drive overall health system improvement,” Dr. Patrick Conway, chief medical officer and deputy administrator for innovation and quality at the Center for Medicare & Medicaid Services, wrote in a blog post.
For physicians, CMS is posting four measures related to diabetes and heart disease: controlling hemoglobin A1c (less than 8%); controlling blood pressure; prescribing aspirin to patients with diabetes and ischemic vascular disease; and prescribing ACE inhibitors or angiotensin receptor blockers for patients with coronary artery disease and diabetes or left ventricular systolic dysfunction.
The data come from 139 physician group practices, 214 shared savings program accountable care organizations, and 23 Pioneer ACOs.
To make the data more user-friendly, CMS uses stars, followed by a percentage score, to show group performance on individual measures. For instance, if a practice scored 80% on a measure, four stars would be shown along with the 80% score.
This is the second time that CMS officials have added quality data to Physician Compare – the first posting was in February 2014. CMS plans to expand the number of quality measures and the number of providers who are listed on the website. By late 2015, CMS plans to post quality data for group practices of all sizes and some data on individual physicians.
For hospitals, CMS posted performance on reducing hospital-acquired conditions, including central line–associated bloodstream infections, catheter-associated urinary tract infections, pressure ulcers, and accidental punctures and lacerations.
The agency also added data from its Hospital Readmissions Reduction Program, including 30-day readmission rates following elective and primary total hip and/or total knee replacement and the 30-day rate of unplanned readmission for chronic obstructive pulmonary disease.
CMS also released data on payment adjustments made as part of the 2015 Hospital Value-Based Purchasing Program, which ties payment to performance on certain quality measures. In fiscal year 2015 – the third year of the program – 1,714 hospitals will see their payments go up as a result of bonus payments from the program, compared with 1,375 that will see their payments decline, according to CMS.
On Twitter @maryellenny
Medicare officials have released a slew of new data demonstrating physicians’ and hospitals’ performance on quality measures related to diabetes, cardiovascular care, and hospital-acquired infections and injuries.
The quality data were posted on Medicare’s Physician Compare and Hospital Compare websites, which aim to provide consumers with the information they need to help them select physicians and other health care providers. The information is also available on data.medicare.gov.
“The Compare sites empower consumers with information to help with health care decisions, encourage providers to strive for higher levels of quality, drive overall health system improvement,” Dr. Patrick Conway, chief medical officer and deputy administrator for innovation and quality at the Center for Medicare & Medicaid Services, wrote in a blog post.
For physicians, CMS is posting four measures related to diabetes and heart disease: controlling hemoglobin A1c (less than 8%); controlling blood pressure; prescribing aspirin to patients with diabetes and ischemic vascular disease; and prescribing ACE inhibitors or angiotensin receptor blockers for patients with coronary artery disease and diabetes or left ventricular systolic dysfunction.
The data come from 139 physician group practices, 214 shared savings program accountable care organizations, and 23 Pioneer ACOs.
To make the data more user-friendly, CMS uses stars, followed by a percentage score, to show group performance on individual measures. For instance, if a practice scored 80% on a measure, four stars would be shown along with the 80% score.
This is the second time that CMS officials have added quality data to Physician Compare – the first posting was in February 2014. CMS plans to expand the number of quality measures and the number of providers who are listed on the website. By late 2015, CMS plans to post quality data for group practices of all sizes and some data on individual physicians.
For hospitals, CMS posted performance on reducing hospital-acquired conditions, including central line–associated bloodstream infections, catheter-associated urinary tract infections, pressure ulcers, and accidental punctures and lacerations.
The agency also added data from its Hospital Readmissions Reduction Program, including 30-day readmission rates following elective and primary total hip and/or total knee replacement and the 30-day rate of unplanned readmission for chronic obstructive pulmonary disease.
CMS also released data on payment adjustments made as part of the 2015 Hospital Value-Based Purchasing Program, which ties payment to performance on certain quality measures. In fiscal year 2015 – the third year of the program – 1,714 hospitals will see their payments go up as a result of bonus payments from the program, compared with 1,375 that will see their payments decline, according to CMS.
On Twitter @maryellenny
Medicare officials have released a slew of new data demonstrating physicians’ and hospitals’ performance on quality measures related to diabetes, cardiovascular care, and hospital-acquired infections and injuries.
The quality data were posted on Medicare’s Physician Compare and Hospital Compare websites, which aim to provide consumers with the information they need to help them select physicians and other health care providers. The information is also available on data.medicare.gov.
“The Compare sites empower consumers with information to help with health care decisions, encourage providers to strive for higher levels of quality, drive overall health system improvement,” Dr. Patrick Conway, chief medical officer and deputy administrator for innovation and quality at the Center for Medicare & Medicaid Services, wrote in a blog post.
For physicians, CMS is posting four measures related to diabetes and heart disease: controlling hemoglobin A1c (less than 8%); controlling blood pressure; prescribing aspirin to patients with diabetes and ischemic vascular disease; and prescribing ACE inhibitors or angiotensin receptor blockers for patients with coronary artery disease and diabetes or left ventricular systolic dysfunction.
The data come from 139 physician group practices, 214 shared savings program accountable care organizations, and 23 Pioneer ACOs.
To make the data more user-friendly, CMS uses stars, followed by a percentage score, to show group performance on individual measures. For instance, if a practice scored 80% on a measure, four stars would be shown along with the 80% score.
This is the second time that CMS officials have added quality data to Physician Compare – the first posting was in February 2014. CMS plans to expand the number of quality measures and the number of providers who are listed on the website. By late 2015, CMS plans to post quality data for group practices of all sizes and some data on individual physicians.
For hospitals, CMS posted performance on reducing hospital-acquired conditions, including central line–associated bloodstream infections, catheter-associated urinary tract infections, pressure ulcers, and accidental punctures and lacerations.
The agency also added data from its Hospital Readmissions Reduction Program, including 30-day readmission rates following elective and primary total hip and/or total knee replacement and the 30-day rate of unplanned readmission for chronic obstructive pulmonary disease.
CMS also released data on payment adjustments made as part of the 2015 Hospital Value-Based Purchasing Program, which ties payment to performance on certain quality measures. In fiscal year 2015 – the third year of the program – 1,714 hospitals will see their payments go up as a result of bonus payments from the program, compared with 1,375 that will see their payments decline, according to CMS.
On Twitter @maryellenny
Diabetes drug liraglutide approved for weight loss indication
Liraglutide has been approved as a weight loss agent for people who are obese and for people who are overweight and have at least one weight-related comorbidity, the Food and Drug Administration announced on Dec. 23.
The glucagon-like peptide-1 (GLP-1) receptor agonist is approved as an adjunct to a reduced calorie diet and increased physical activity in obese adults with a body mass index (BMI) of 30 kg/m2 or greater and in overweight adults with a BMI of 27 kg/m2 or greater and at least one weight-related condition such as hypertension, type 2 diabetes, or dyslipidemia.
Liraglutide, which is administered subcutaneously, was first approved in 2010 as a treatment for type 2 diabetes and is marketed for that indication as Victoza. Liraglutide will be marketed as Saxenda for the weight loss indication “and should not be used in combination with any other drug belonging to this class, including Victoza,” the FDA statement said. The liraglutide dose in Saxenda will be 3 mg; the dose in Victoza is 1.8 mg.
Approval for the weight loss indication was based on three studies of about 4,800 obese and overweight patients, who also received counseling about a reduced calorie diet and regular physical activity. In one study of patients who did not have diabetes, 62% of those on liraglutide and 34% of those on placebo lost at least 5% of their body weight over the course of a year. In another study of patients with type 2 diabetes, 49% of those on liraglutide and 16% of those on placebo lost at least 5% of their body weight in 1 year. Nausea, diarrhea, constipation, vomiting, and hypoglycemia were among the common adverse events associated with treatment, according to the FDA.
“Patients using Saxenda should be evaluated after 16 weeks to determine if the treatment is working,” the FDA statement said. “If a patient has not lost at least 4% of baseline body weight, Saxenda should be discontinued as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment.”
Approval of Saxenda includes a Risk Evaluation and Mitigation Strategy (REMS), which outlines a plan to inform health care professionals about the risks associated with liraglutide. The drug’s label includes a boxed warning about cases of thyroid C-cell tumors associated with the drug in rat studies, with a recommendation that the drug not be used by patients with a personal or family history of medullary thyroid carcinoma (MTC) or by those with multiple endocrine neoplasia syndrome type 2. The manufacturer also is required to conduct several postmarketing studies, including a registry and at least 15 years of follow-up for MTC cases among patients treated with the drug.
Pancreatitis, gallbladder disease, and renal impairment are among the serious adverse events associated with the drug, which “can also raise heart rate and should be discontinued in patients who experience a sustained increase in resting heart rate,” the FDA statement said.
Liraglutide is manufactured by Novo Nordisk.
Liraglutide has been approved as a weight loss agent for people who are obese and for people who are overweight and have at least one weight-related comorbidity, the Food and Drug Administration announced on Dec. 23.
The glucagon-like peptide-1 (GLP-1) receptor agonist is approved as an adjunct to a reduced calorie diet and increased physical activity in obese adults with a body mass index (BMI) of 30 kg/m2 or greater and in overweight adults with a BMI of 27 kg/m2 or greater and at least one weight-related condition such as hypertension, type 2 diabetes, or dyslipidemia.
Liraglutide, which is administered subcutaneously, was first approved in 2010 as a treatment for type 2 diabetes and is marketed for that indication as Victoza. Liraglutide will be marketed as Saxenda for the weight loss indication “and should not be used in combination with any other drug belonging to this class, including Victoza,” the FDA statement said. The liraglutide dose in Saxenda will be 3 mg; the dose in Victoza is 1.8 mg.
Approval for the weight loss indication was based on three studies of about 4,800 obese and overweight patients, who also received counseling about a reduced calorie diet and regular physical activity. In one study of patients who did not have diabetes, 62% of those on liraglutide and 34% of those on placebo lost at least 5% of their body weight over the course of a year. In another study of patients with type 2 diabetes, 49% of those on liraglutide and 16% of those on placebo lost at least 5% of their body weight in 1 year. Nausea, diarrhea, constipation, vomiting, and hypoglycemia were among the common adverse events associated with treatment, according to the FDA.
“Patients using Saxenda should be evaluated after 16 weeks to determine if the treatment is working,” the FDA statement said. “If a patient has not lost at least 4% of baseline body weight, Saxenda should be discontinued as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment.”
Approval of Saxenda includes a Risk Evaluation and Mitigation Strategy (REMS), which outlines a plan to inform health care professionals about the risks associated with liraglutide. The drug’s label includes a boxed warning about cases of thyroid C-cell tumors associated with the drug in rat studies, with a recommendation that the drug not be used by patients with a personal or family history of medullary thyroid carcinoma (MTC) or by those with multiple endocrine neoplasia syndrome type 2. The manufacturer also is required to conduct several postmarketing studies, including a registry and at least 15 years of follow-up for MTC cases among patients treated with the drug.
Pancreatitis, gallbladder disease, and renal impairment are among the serious adverse events associated with the drug, which “can also raise heart rate and should be discontinued in patients who experience a sustained increase in resting heart rate,” the FDA statement said.
Liraglutide is manufactured by Novo Nordisk.
Liraglutide has been approved as a weight loss agent for people who are obese and for people who are overweight and have at least one weight-related comorbidity, the Food and Drug Administration announced on Dec. 23.
The glucagon-like peptide-1 (GLP-1) receptor agonist is approved as an adjunct to a reduced calorie diet and increased physical activity in obese adults with a body mass index (BMI) of 30 kg/m2 or greater and in overweight adults with a BMI of 27 kg/m2 or greater and at least one weight-related condition such as hypertension, type 2 diabetes, or dyslipidemia.
Liraglutide, which is administered subcutaneously, was first approved in 2010 as a treatment for type 2 diabetes and is marketed for that indication as Victoza. Liraglutide will be marketed as Saxenda for the weight loss indication “and should not be used in combination with any other drug belonging to this class, including Victoza,” the FDA statement said. The liraglutide dose in Saxenda will be 3 mg; the dose in Victoza is 1.8 mg.
Approval for the weight loss indication was based on three studies of about 4,800 obese and overweight patients, who also received counseling about a reduced calorie diet and regular physical activity. In one study of patients who did not have diabetes, 62% of those on liraglutide and 34% of those on placebo lost at least 5% of their body weight over the course of a year. In another study of patients with type 2 diabetes, 49% of those on liraglutide and 16% of those on placebo lost at least 5% of their body weight in 1 year. Nausea, diarrhea, constipation, vomiting, and hypoglycemia were among the common adverse events associated with treatment, according to the FDA.
“Patients using Saxenda should be evaluated after 16 weeks to determine if the treatment is working,” the FDA statement said. “If a patient has not lost at least 4% of baseline body weight, Saxenda should be discontinued as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment.”
Approval of Saxenda includes a Risk Evaluation and Mitigation Strategy (REMS), which outlines a plan to inform health care professionals about the risks associated with liraglutide. The drug’s label includes a boxed warning about cases of thyroid C-cell tumors associated with the drug in rat studies, with a recommendation that the drug not be used by patients with a personal or family history of medullary thyroid carcinoma (MTC) or by those with multiple endocrine neoplasia syndrome type 2. The manufacturer also is required to conduct several postmarketing studies, including a registry and at least 15 years of follow-up for MTC cases among patients treated with the drug.
Pancreatitis, gallbladder disease, and renal impairment are among the serious adverse events associated with the drug, which “can also raise heart rate and should be discontinued in patients who experience a sustained increase in resting heart rate,” the FDA statement said.
Liraglutide is manufactured by Novo Nordisk.
FDA: Ease ban on blood donation by MSM
In 2015, the Food and Drug Administration will issue a draft guidance recommending that men who have sex with men can donate blood 1 year after their last sexual contact with another man, replacing the longstanding policy that this group be deferred from donating blood indefinitely, the agency announced on Dec. 23.
The recommendation, under consideration for several years, is based on available scientific evidence, including epidemiologic data and statistical modeling of the impact of this policy change would have on blood supply safety; as well as recommendations of FDA and Department of Health and Human Services advisory committees, Dr. Peter Marks, deputy director of the FDA Center for Biologics Evaluation and Research, said during a press conference.
“Some of the most compelling data in favor of policy change come from Australia,” where HIV epidemiology is similar to that in the United States, Dr. Marks said.
Studies using a national blood surveillance system during the decade after the policy was changed in Australia from indefinite deferral of men who have sex with men (MSM) to 1 year deferral, as proposed in the United States, “documented no adverse effects” on the safety of the country’s blood supply, Dr. Marks said.
The FDA has also been working with the National Heart, Lung, and Blood Institute to implement a surveillance system to monitor the effect of the policy change on the safety of the blood supply. As the data are collected, the policy will be revisited, Dr. Marks said. The proposed policy change will also better align with the blood donor deferral period recommended for other men and women at increased risk of HIV infection, he noted.
Dr. Marks said that the currently available scientific data do not support shortening the deferral period to less than 1 year.
At a meeting in November, the federal Advisory Committee on Blood and Tissue Safety and Availability voted 16-2 to support the 1 year deferral policy for MSM.
The draft guidance will be published in the Federal Register in 2015 and will allow the public to submit comments. Dr. Marks said he could not predict whether the actual policy change would go into effect in 2015.
In 2015, the Food and Drug Administration will issue a draft guidance recommending that men who have sex with men can donate blood 1 year after their last sexual contact with another man, replacing the longstanding policy that this group be deferred from donating blood indefinitely, the agency announced on Dec. 23.
The recommendation, under consideration for several years, is based on available scientific evidence, including epidemiologic data and statistical modeling of the impact of this policy change would have on blood supply safety; as well as recommendations of FDA and Department of Health and Human Services advisory committees, Dr. Peter Marks, deputy director of the FDA Center for Biologics Evaluation and Research, said during a press conference.
“Some of the most compelling data in favor of policy change come from Australia,” where HIV epidemiology is similar to that in the United States, Dr. Marks said.
Studies using a national blood surveillance system during the decade after the policy was changed in Australia from indefinite deferral of men who have sex with men (MSM) to 1 year deferral, as proposed in the United States, “documented no adverse effects” on the safety of the country’s blood supply, Dr. Marks said.
The FDA has also been working with the National Heart, Lung, and Blood Institute to implement a surveillance system to monitor the effect of the policy change on the safety of the blood supply. As the data are collected, the policy will be revisited, Dr. Marks said. The proposed policy change will also better align with the blood donor deferral period recommended for other men and women at increased risk of HIV infection, he noted.
Dr. Marks said that the currently available scientific data do not support shortening the deferral period to less than 1 year.
At a meeting in November, the federal Advisory Committee on Blood and Tissue Safety and Availability voted 16-2 to support the 1 year deferral policy for MSM.
The draft guidance will be published in the Federal Register in 2015 and will allow the public to submit comments. Dr. Marks said he could not predict whether the actual policy change would go into effect in 2015.
In 2015, the Food and Drug Administration will issue a draft guidance recommending that men who have sex with men can donate blood 1 year after their last sexual contact with another man, replacing the longstanding policy that this group be deferred from donating blood indefinitely, the agency announced on Dec. 23.
The recommendation, under consideration for several years, is based on available scientific evidence, including epidemiologic data and statistical modeling of the impact of this policy change would have on blood supply safety; as well as recommendations of FDA and Department of Health and Human Services advisory committees, Dr. Peter Marks, deputy director of the FDA Center for Biologics Evaluation and Research, said during a press conference.
“Some of the most compelling data in favor of policy change come from Australia,” where HIV epidemiology is similar to that in the United States, Dr. Marks said.
Studies using a national blood surveillance system during the decade after the policy was changed in Australia from indefinite deferral of men who have sex with men (MSM) to 1 year deferral, as proposed in the United States, “documented no adverse effects” on the safety of the country’s blood supply, Dr. Marks said.
The FDA has also been working with the National Heart, Lung, and Blood Institute to implement a surveillance system to monitor the effect of the policy change on the safety of the blood supply. As the data are collected, the policy will be revisited, Dr. Marks said. The proposed policy change will also better align with the blood donor deferral period recommended for other men and women at increased risk of HIV infection, he noted.
Dr. Marks said that the currently available scientific data do not support shortening the deferral period to less than 1 year.
At a meeting in November, the federal Advisory Committee on Blood and Tissue Safety and Availability voted 16-2 to support the 1 year deferral policy for MSM.
The draft guidance will be published in the Federal Register in 2015 and will allow the public to submit comments. Dr. Marks said he could not predict whether the actual policy change would go into effect in 2015.
Care bundle cut emergency laparotomy death rate by 39%
An evidence-based care bundle implemented in four U.K. hospitals almost doubled the proportion of lives saved with emergency laparotomy, researchers reported in the British Journal of Surgery.
In addition, 30-day mortality dropped 39%, from 15.6% to 9.6% (risk ratio, 0.61; 95% confidence interval, 0.45 to 0.83; P = .002) at the four hospitals that undertook the quality improvement measures, said Dr. Sam Huddart of Royal Surrey County Hospital NHS Foundation Trust in Guildford, England.
Although a common procedure, emergency laparotomy recently has been linked to death rates of 14% to 19.5% in the United Kingdom, the United States, and Denmark, the researchers said. In the United Kingdom, contributing factors include lack of consultation with surgical and anesthesia specialists, underuse of fluid therapy during surgery, and insufficient use of postoperative ICUs, they added (Br. J. Surg. 2014 Nov. 10 [doi:10.1002/bjs.9658]).
To address these problems, the researchers bundled key recommendations from the Royal College of Surgeons of England and the Department of Health.
The emergency laparotomy pathway quality improvement care (ELPQuiC) bundle included only implemented practices with a strong evidence base, including using an early warning score for all emergency admissions, with graded escalation policies for referring patients to senior clinicians or to the ICU; giving broad-spectrum antibiotics to all patients with sepsis or suspected peritoneal contamination; performing laparotomies within 6 hours of deciding to do so, or as soon as the next available space opened in the emergency operating suite; using goal-directed resuscitation techniques as soon as possible or within 6 hours of admission; and admitting all patients to the ICU after emergency laparotomy, they said.
Eight months later, the number of lives saved per 100 patients treated had risen from 6.47 (or 299 patients) to 12.44 (P < .001), Dr. Huddart and associates reported. “These results were achieved within existing resources, without adversely affecting the length of hospital stay, while the case-mix profile remained relatively stable,” they wrote.
In the regression analysis, only one hospital significantly cut its risk of 30-day mortality, possibly because the study was underpowered. They did not look at emergency laparotomy mortality rates at other hospitals during the study period, they noted.
The research was supported by the Health Foundation, the South West Strategic Health Authority, and LiDCO Group. One coauthor reported receiving lecture fees from LiDCO. The other investigators declared no financial conflicts.
An evidence-based care bundle implemented in four U.K. hospitals almost doubled the proportion of lives saved with emergency laparotomy, researchers reported in the British Journal of Surgery.
In addition, 30-day mortality dropped 39%, from 15.6% to 9.6% (risk ratio, 0.61; 95% confidence interval, 0.45 to 0.83; P = .002) at the four hospitals that undertook the quality improvement measures, said Dr. Sam Huddart of Royal Surrey County Hospital NHS Foundation Trust in Guildford, England.
Although a common procedure, emergency laparotomy recently has been linked to death rates of 14% to 19.5% in the United Kingdom, the United States, and Denmark, the researchers said. In the United Kingdom, contributing factors include lack of consultation with surgical and anesthesia specialists, underuse of fluid therapy during surgery, and insufficient use of postoperative ICUs, they added (Br. J. Surg. 2014 Nov. 10 [doi:10.1002/bjs.9658]).
To address these problems, the researchers bundled key recommendations from the Royal College of Surgeons of England and the Department of Health.
The emergency laparotomy pathway quality improvement care (ELPQuiC) bundle included only implemented practices with a strong evidence base, including using an early warning score for all emergency admissions, with graded escalation policies for referring patients to senior clinicians or to the ICU; giving broad-spectrum antibiotics to all patients with sepsis or suspected peritoneal contamination; performing laparotomies within 6 hours of deciding to do so, or as soon as the next available space opened in the emergency operating suite; using goal-directed resuscitation techniques as soon as possible or within 6 hours of admission; and admitting all patients to the ICU after emergency laparotomy, they said.
Eight months later, the number of lives saved per 100 patients treated had risen from 6.47 (or 299 patients) to 12.44 (P < .001), Dr. Huddart and associates reported. “These results were achieved within existing resources, without adversely affecting the length of hospital stay, while the case-mix profile remained relatively stable,” they wrote.
In the regression analysis, only one hospital significantly cut its risk of 30-day mortality, possibly because the study was underpowered. They did not look at emergency laparotomy mortality rates at other hospitals during the study period, they noted.
The research was supported by the Health Foundation, the South West Strategic Health Authority, and LiDCO Group. One coauthor reported receiving lecture fees from LiDCO. The other investigators declared no financial conflicts.
An evidence-based care bundle implemented in four U.K. hospitals almost doubled the proportion of lives saved with emergency laparotomy, researchers reported in the British Journal of Surgery.
In addition, 30-day mortality dropped 39%, from 15.6% to 9.6% (risk ratio, 0.61; 95% confidence interval, 0.45 to 0.83; P = .002) at the four hospitals that undertook the quality improvement measures, said Dr. Sam Huddart of Royal Surrey County Hospital NHS Foundation Trust in Guildford, England.
Although a common procedure, emergency laparotomy recently has been linked to death rates of 14% to 19.5% in the United Kingdom, the United States, and Denmark, the researchers said. In the United Kingdom, contributing factors include lack of consultation with surgical and anesthesia specialists, underuse of fluid therapy during surgery, and insufficient use of postoperative ICUs, they added (Br. J. Surg. 2014 Nov. 10 [doi:10.1002/bjs.9658]).
To address these problems, the researchers bundled key recommendations from the Royal College of Surgeons of England and the Department of Health.
The emergency laparotomy pathway quality improvement care (ELPQuiC) bundle included only implemented practices with a strong evidence base, including using an early warning score for all emergency admissions, with graded escalation policies for referring patients to senior clinicians or to the ICU; giving broad-spectrum antibiotics to all patients with sepsis or suspected peritoneal contamination; performing laparotomies within 6 hours of deciding to do so, or as soon as the next available space opened in the emergency operating suite; using goal-directed resuscitation techniques as soon as possible or within 6 hours of admission; and admitting all patients to the ICU after emergency laparotomy, they said.
Eight months later, the number of lives saved per 100 patients treated had risen from 6.47 (or 299 patients) to 12.44 (P < .001), Dr. Huddart and associates reported. “These results were achieved within existing resources, without adversely affecting the length of hospital stay, while the case-mix profile remained relatively stable,” they wrote.
In the regression analysis, only one hospital significantly cut its risk of 30-day mortality, possibly because the study was underpowered. They did not look at emergency laparotomy mortality rates at other hospitals during the study period, they noted.
The research was supported by the Health Foundation, the South West Strategic Health Authority, and LiDCO Group. One coauthor reported receiving lecture fees from LiDCO. The other investigators declared no financial conflicts.
Key clinical point: A set of quality improvement measures cut 30-day emergency laparotomy mortality by about 39%.
Major finding: Thirty-day mortality dropped from 15.6% to 9.6% (risk ratio, 0.61; 95% confidence interval, 0.45 to 0.83; P = .002).
Data source: Prospective, 8-month study of emergency laparotomy outcomes at four hospitals in England.
Disclosures: The research was supported by the Health Foundation, the South West Strategic Health Authority, and LiDCO Group. One coauthor reported receiving lecture fees from LiDCO. The other investigators declared no financial conflicts.
