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Recurrent DKA episodes found to trigger cognitive changes
NEW ORLEANS – Recurrent episodes of diabetic ketoacidosis (DKA) resulted in altered brain metabolite concentration, as well as differences in mental processing speed, compared with healthy controls, judging from the results from a small pilot study.
While previous work examining the relationship of DKA to cognition and neural structure has focused upon children and adolescents, researchers at Emory University and the Georgia Institute of Technology, both in Atlanta, set out of evaluate for the first time acute neuroanatomical and cognitive changes in adult patients with first and recurrent episodes of DKA. In an interview in advance of the annual scientific sessions of the American Diabetes Association, one of the researchers, Gilda E. Ennis, Ph.D., said that DKA is the most serious diabetic emergency in patients with type 1 and 2 diabetes and results in an estimated health care cost of $2.4 billion annually. “While we know that one of the major precipitating causes of DKA in adult patients is poor adherence to insulin therapy, we do not understand why patients are noncompliant,” said Dr. Ennis, who is a postdoctoral fellow in the Georgia Institute of Technology’s school of psychology.
She and her associates conducted a pilot study examining advanced MRI metrics and cognitive measures 72 hours after resolution of DKA in 10 patients with a first episode of DKA and 11 patients with three or more episodes of DKA. The same MRI and cognitive measures were collected from 10 healthy controls and 10 patients with type 1 diabetes and no history of DKA.
MRI spectroscopy revealed reduced N-acetylaspartate concentrations in diabetes patients with multiple episodes of DKA, compared with healthy controls, but no significant differences were seen between diabetes patients with and without DKA. Cognitive testing revealed that patients with recurrent DKA had significantly worse processing speed, compared with healthy controls (P = .02), while processing speed deficits in patients with a single DKA and those with diabetes and no DKA was intermediate between healthy controls and those with recurrent DKA.
“We were surprised to find significant cognitive and neural deficits in the recurrent DKA group relative to healthy controls in such a small sample,” Dr. Ennis said. “This suggests that statistical differences in cognition and neural structure between patients with recurrent DKA and healthy controls may be large. We found that recurrent DKA was associated with significant deficits in processing speed and memory, decreases in right putamen volume, regionally decreased white matter integrity, and altered brain metabolite concentrations, suggestive of CNS inflammatory changes and neuronal injury.”
The findings may explain the high rates of medication noncompliance commonly seen in this patient population. “If this proposition is true, conventional education and standard care approaches to the treatment of type 1 diabetes, especially in patients with a history of DKA, may need to change,” she said. “Strategies to improve insulin adherence may require a special insulin compliance intervention that includes persistent medication adherence reminders, such as text messaging and nurse-telephone follow-up.”
Dr. Ennis acknowledged that the findings require replication in a prospective longitudinal study with a larger sample size. “It will be important to determine if acute neuroanatomical and cognitive deficits in patients with recurrent DKA persist over time,” she said. “Duration of type 1 diabetes could produce similar findings and would need to be controlled in future research.” She reported having no financial disclosures.
NEW ORLEANS – Recurrent episodes of diabetic ketoacidosis (DKA) resulted in altered brain metabolite concentration, as well as differences in mental processing speed, compared with healthy controls, judging from the results from a small pilot study.
While previous work examining the relationship of DKA to cognition and neural structure has focused upon children and adolescents, researchers at Emory University and the Georgia Institute of Technology, both in Atlanta, set out of evaluate for the first time acute neuroanatomical and cognitive changes in adult patients with first and recurrent episodes of DKA. In an interview in advance of the annual scientific sessions of the American Diabetes Association, one of the researchers, Gilda E. Ennis, Ph.D., said that DKA is the most serious diabetic emergency in patients with type 1 and 2 diabetes and results in an estimated health care cost of $2.4 billion annually. “While we know that one of the major precipitating causes of DKA in adult patients is poor adherence to insulin therapy, we do not understand why patients are noncompliant,” said Dr. Ennis, who is a postdoctoral fellow in the Georgia Institute of Technology’s school of psychology.
She and her associates conducted a pilot study examining advanced MRI metrics and cognitive measures 72 hours after resolution of DKA in 10 patients with a first episode of DKA and 11 patients with three or more episodes of DKA. The same MRI and cognitive measures were collected from 10 healthy controls and 10 patients with type 1 diabetes and no history of DKA.
MRI spectroscopy revealed reduced N-acetylaspartate concentrations in diabetes patients with multiple episodes of DKA, compared with healthy controls, but no significant differences were seen between diabetes patients with and without DKA. Cognitive testing revealed that patients with recurrent DKA had significantly worse processing speed, compared with healthy controls (P = .02), while processing speed deficits in patients with a single DKA and those with diabetes and no DKA was intermediate between healthy controls and those with recurrent DKA.
“We were surprised to find significant cognitive and neural deficits in the recurrent DKA group relative to healthy controls in such a small sample,” Dr. Ennis said. “This suggests that statistical differences in cognition and neural structure between patients with recurrent DKA and healthy controls may be large. We found that recurrent DKA was associated with significant deficits in processing speed and memory, decreases in right putamen volume, regionally decreased white matter integrity, and altered brain metabolite concentrations, suggestive of CNS inflammatory changes and neuronal injury.”
The findings may explain the high rates of medication noncompliance commonly seen in this patient population. “If this proposition is true, conventional education and standard care approaches to the treatment of type 1 diabetes, especially in patients with a history of DKA, may need to change,” she said. “Strategies to improve insulin adherence may require a special insulin compliance intervention that includes persistent medication adherence reminders, such as text messaging and nurse-telephone follow-up.”
Dr. Ennis acknowledged that the findings require replication in a prospective longitudinal study with a larger sample size. “It will be important to determine if acute neuroanatomical and cognitive deficits in patients with recurrent DKA persist over time,” she said. “Duration of type 1 diabetes could produce similar findings and would need to be controlled in future research.” She reported having no financial disclosures.
NEW ORLEANS – Recurrent episodes of diabetic ketoacidosis (DKA) resulted in altered brain metabolite concentration, as well as differences in mental processing speed, compared with healthy controls, judging from the results from a small pilot study.
While previous work examining the relationship of DKA to cognition and neural structure has focused upon children and adolescents, researchers at Emory University and the Georgia Institute of Technology, both in Atlanta, set out of evaluate for the first time acute neuroanatomical and cognitive changes in adult patients with first and recurrent episodes of DKA. In an interview in advance of the annual scientific sessions of the American Diabetes Association, one of the researchers, Gilda E. Ennis, Ph.D., said that DKA is the most serious diabetic emergency in patients with type 1 and 2 diabetes and results in an estimated health care cost of $2.4 billion annually. “While we know that one of the major precipitating causes of DKA in adult patients is poor adherence to insulin therapy, we do not understand why patients are noncompliant,” said Dr. Ennis, who is a postdoctoral fellow in the Georgia Institute of Technology’s school of psychology.
She and her associates conducted a pilot study examining advanced MRI metrics and cognitive measures 72 hours after resolution of DKA in 10 patients with a first episode of DKA and 11 patients with three or more episodes of DKA. The same MRI and cognitive measures were collected from 10 healthy controls and 10 patients with type 1 diabetes and no history of DKA.
MRI spectroscopy revealed reduced N-acetylaspartate concentrations in diabetes patients with multiple episodes of DKA, compared with healthy controls, but no significant differences were seen between diabetes patients with and without DKA. Cognitive testing revealed that patients with recurrent DKA had significantly worse processing speed, compared with healthy controls (P = .02), while processing speed deficits in patients with a single DKA and those with diabetes and no DKA was intermediate between healthy controls and those with recurrent DKA.
“We were surprised to find significant cognitive and neural deficits in the recurrent DKA group relative to healthy controls in such a small sample,” Dr. Ennis said. “This suggests that statistical differences in cognition and neural structure between patients with recurrent DKA and healthy controls may be large. We found that recurrent DKA was associated with significant deficits in processing speed and memory, decreases in right putamen volume, regionally decreased white matter integrity, and altered brain metabolite concentrations, suggestive of CNS inflammatory changes and neuronal injury.”
The findings may explain the high rates of medication noncompliance commonly seen in this patient population. “If this proposition is true, conventional education and standard care approaches to the treatment of type 1 diabetes, especially in patients with a history of DKA, may need to change,” she said. “Strategies to improve insulin adherence may require a special insulin compliance intervention that includes persistent medication adherence reminders, such as text messaging and nurse-telephone follow-up.”
Dr. Ennis acknowledged that the findings require replication in a prospective longitudinal study with a larger sample size. “It will be important to determine if acute neuroanatomical and cognitive deficits in patients with recurrent DKA persist over time,” she said. “Duration of type 1 diabetes could produce similar findings and would need to be controlled in future research.” She reported having no financial disclosures.
AT THE ADA SCIENTIFIC SESSIONS
Key clinical point: Recurrent episodes of diabetic ketoacidosis were found to cause certain cognitive changes in adults with type 1 diabetes.
Major finding: Cognitive testing revealed that patients with recurrent DKA had significantly worse processing speed, compared with healthy controls (P = .02), while processing speed deficits in patients with a single DKA and those with diabetes and no DKA was intermediate between healthy controls and those with recurrent DKA.
Data source: A pilot study examining advanced MRI metrics and cognitive measures 72 hours after resolution of DKA in 10 patients with a first episode of DKA and 11 patients with three or more episodes of DKA. The same measures were collected from 10 healthy controls and 10 patients with type 1 diabetes and no history of DKA.
Disclosures: Dr. Ennis reported having no financial disclosures.
Prepare early for peer review hearings to avoid negative outcomes
CHICAGO – Being targeted for a peer review can be unnerving for physicians, but proper preparation can help doctors smoothly navigate the process and increase their chances for a favorable outcome.
The first step is taking the situation seriously and remaining calm, said Janet L. Pulliam, a Little Rock, Ark.–based attorney who specializes in health law and employment and labor. Next, hire an experienced attorney and refrain from signing anything without consulting counsel, Ms. Pulliam said at a conference held by the American Bar Association. She also suggested that physicians request an individual meeting with each reviewer before the hearing.
“That’s not to be a lobbying meeting; that’s to be a meeting where you simply, one on one, ask someone who is going to be in judgment of you [to] please keep an open mind until they have heard all of the evidence,” Ms. Pulliam said at the meeting. “Trust me, they’ve already had plenty of information provided to them from the [hospital] administration, so that’s not asking any favors.”
If the peer review stems from a patient interaction or treatment decision, review the patient record in question, but don’t change any documentation, she noted. You can always argue during the hearing that the patient record does not adequately illustrate the encounter or that the charting was inaccurate.
Speak up during peer review meetings and ensure that your case is heard, added Elizabeth A. Snelson, a St. Paul, Minn.–based health law attorney who represents medical staffs, medical societies, and other health professionals.
“Not that it’s easy to put a lawyer in a room and tell her to not talk, but the fact of the matter is that the case will be more successful if it’s the doctor who is addressing the panel, which is usually comprised completely of doctors,” Ms. Snelson said.
Educate the committee, Ms. Pulliam advised. Use the opportunity to explain the protocols specific to your specialty and how they may differ from other specialties.
“It’s your time to educate them,” she said. “The physicians on the committee generally, genuinely want to know what they don’t know, and this is the only shot that you’re going to have to tell them.”
Attend every meeting and be on time. This may sound obvious, but Ms. Pulliam has seen the negative effects a tardy appearance can have on a committee’s perceptions. Making the peer review process a priority and scheduling accordingly is paramount. In addition, ask the hospital for a court reporter to transcribe the hearing. If the hospital refuses, offer to pay for half of the cost, Ms. Pulliam suggested. Accurate documentation is critical and can later be challenged if no record exists. If the hospital declines to share the cost, Ms. Pulliam recommended that doctors foot the entire bill. Make every effort to have a complete transcript, she said.
Be an advocate for a solution when possible, Ms. Pulliam added. Discuss with your attorney potential resolutions, but also know your litigation options. Be prepared to go to court if necessary.
“This is when you need to litigate because procedures and fairness have not been followed in the process,” she said during her presentation. “Courts do allow for equity, declaratory judgments, and injunctions when rights guaranteed to a physician are not followed.”
Knowing those rights and regulations beforehand is key, Ms. Snelson said. States’ peer review laws widely differ. Arkansas law for example, enables physicians to request a hearing officer who is independent and not employed by the hospital and also protects communications by physicians during peer review proceedings. Other states have different features, and some states have nothing regarding peer review on the books, Ms. Snelson said.
“In some states it’s real clear where the peer review requirements are,” she said. “In other states, you really have to go hunting. It could be in the evidence code. It could be all over the place.”
Be aware of appeal rights. Usually, medical staff bylaws allow for an appeal to the governing body of the hospital if a doctor disagrees with a panel’s recommendation. However, sometimes bylaws are silent on appeals, Ms. Snelson said. She noted that the Joint Commission standards refer to peer review hearings and appeals. Thus, if a hospital is accredited by the Joint Commission, and its bylaws do not address appeals, physicians and their attorneys can argue that an appeals process should be in place.
Remember that peer review is not limited to “bad doctors,” and that the process can arise from minor issues, Ms. Snelson said at the meeting.
“Usually when doctors hear ‘peer review,’ they hear ‘discipline,’ ” she said. “[However], It’s not always the ‘bad doctors’; it can be something that is quite minimal that can be escalated. It can be entirely appropriate. What peer review should be is educational ... but sometimes it can be used as a weapon.”
On Twitter @legal_med
CHICAGO – Being targeted for a peer review can be unnerving for physicians, but proper preparation can help doctors smoothly navigate the process and increase their chances for a favorable outcome.
The first step is taking the situation seriously and remaining calm, said Janet L. Pulliam, a Little Rock, Ark.–based attorney who specializes in health law and employment and labor. Next, hire an experienced attorney and refrain from signing anything without consulting counsel, Ms. Pulliam said at a conference held by the American Bar Association. She also suggested that physicians request an individual meeting with each reviewer before the hearing.
“That’s not to be a lobbying meeting; that’s to be a meeting where you simply, one on one, ask someone who is going to be in judgment of you [to] please keep an open mind until they have heard all of the evidence,” Ms. Pulliam said at the meeting. “Trust me, they’ve already had plenty of information provided to them from the [hospital] administration, so that’s not asking any favors.”
If the peer review stems from a patient interaction or treatment decision, review the patient record in question, but don’t change any documentation, she noted. You can always argue during the hearing that the patient record does not adequately illustrate the encounter or that the charting was inaccurate.
Speak up during peer review meetings and ensure that your case is heard, added Elizabeth A. Snelson, a St. Paul, Minn.–based health law attorney who represents medical staffs, medical societies, and other health professionals.
“Not that it’s easy to put a lawyer in a room and tell her to not talk, but the fact of the matter is that the case will be more successful if it’s the doctor who is addressing the panel, which is usually comprised completely of doctors,” Ms. Snelson said.
Educate the committee, Ms. Pulliam advised. Use the opportunity to explain the protocols specific to your specialty and how they may differ from other specialties.
“It’s your time to educate them,” she said. “The physicians on the committee generally, genuinely want to know what they don’t know, and this is the only shot that you’re going to have to tell them.”
Attend every meeting and be on time. This may sound obvious, but Ms. Pulliam has seen the negative effects a tardy appearance can have on a committee’s perceptions. Making the peer review process a priority and scheduling accordingly is paramount. In addition, ask the hospital for a court reporter to transcribe the hearing. If the hospital refuses, offer to pay for half of the cost, Ms. Pulliam suggested. Accurate documentation is critical and can later be challenged if no record exists. If the hospital declines to share the cost, Ms. Pulliam recommended that doctors foot the entire bill. Make every effort to have a complete transcript, she said.
Be an advocate for a solution when possible, Ms. Pulliam added. Discuss with your attorney potential resolutions, but also know your litigation options. Be prepared to go to court if necessary.
“This is when you need to litigate because procedures and fairness have not been followed in the process,” she said during her presentation. “Courts do allow for equity, declaratory judgments, and injunctions when rights guaranteed to a physician are not followed.”
Knowing those rights and regulations beforehand is key, Ms. Snelson said. States’ peer review laws widely differ. Arkansas law for example, enables physicians to request a hearing officer who is independent and not employed by the hospital and also protects communications by physicians during peer review proceedings. Other states have different features, and some states have nothing regarding peer review on the books, Ms. Snelson said.
“In some states it’s real clear where the peer review requirements are,” she said. “In other states, you really have to go hunting. It could be in the evidence code. It could be all over the place.”
Be aware of appeal rights. Usually, medical staff bylaws allow for an appeal to the governing body of the hospital if a doctor disagrees with a panel’s recommendation. However, sometimes bylaws are silent on appeals, Ms. Snelson said. She noted that the Joint Commission standards refer to peer review hearings and appeals. Thus, if a hospital is accredited by the Joint Commission, and its bylaws do not address appeals, physicians and their attorneys can argue that an appeals process should be in place.
Remember that peer review is not limited to “bad doctors,” and that the process can arise from minor issues, Ms. Snelson said at the meeting.
“Usually when doctors hear ‘peer review,’ they hear ‘discipline,’ ” she said. “[However], It’s not always the ‘bad doctors’; it can be something that is quite minimal that can be escalated. It can be entirely appropriate. What peer review should be is educational ... but sometimes it can be used as a weapon.”
On Twitter @legal_med
CHICAGO – Being targeted for a peer review can be unnerving for physicians, but proper preparation can help doctors smoothly navigate the process and increase their chances for a favorable outcome.
The first step is taking the situation seriously and remaining calm, said Janet L. Pulliam, a Little Rock, Ark.–based attorney who specializes in health law and employment and labor. Next, hire an experienced attorney and refrain from signing anything without consulting counsel, Ms. Pulliam said at a conference held by the American Bar Association. She also suggested that physicians request an individual meeting with each reviewer before the hearing.
“That’s not to be a lobbying meeting; that’s to be a meeting where you simply, one on one, ask someone who is going to be in judgment of you [to] please keep an open mind until they have heard all of the evidence,” Ms. Pulliam said at the meeting. “Trust me, they’ve already had plenty of information provided to them from the [hospital] administration, so that’s not asking any favors.”
If the peer review stems from a patient interaction or treatment decision, review the patient record in question, but don’t change any documentation, she noted. You can always argue during the hearing that the patient record does not adequately illustrate the encounter or that the charting was inaccurate.
Speak up during peer review meetings and ensure that your case is heard, added Elizabeth A. Snelson, a St. Paul, Minn.–based health law attorney who represents medical staffs, medical societies, and other health professionals.
“Not that it’s easy to put a lawyer in a room and tell her to not talk, but the fact of the matter is that the case will be more successful if it’s the doctor who is addressing the panel, which is usually comprised completely of doctors,” Ms. Snelson said.
Educate the committee, Ms. Pulliam advised. Use the opportunity to explain the protocols specific to your specialty and how they may differ from other specialties.
“It’s your time to educate them,” she said. “The physicians on the committee generally, genuinely want to know what they don’t know, and this is the only shot that you’re going to have to tell them.”
Attend every meeting and be on time. This may sound obvious, but Ms. Pulliam has seen the negative effects a tardy appearance can have on a committee’s perceptions. Making the peer review process a priority and scheduling accordingly is paramount. In addition, ask the hospital for a court reporter to transcribe the hearing. If the hospital refuses, offer to pay for half of the cost, Ms. Pulliam suggested. Accurate documentation is critical and can later be challenged if no record exists. If the hospital declines to share the cost, Ms. Pulliam recommended that doctors foot the entire bill. Make every effort to have a complete transcript, she said.
Be an advocate for a solution when possible, Ms. Pulliam added. Discuss with your attorney potential resolutions, but also know your litigation options. Be prepared to go to court if necessary.
“This is when you need to litigate because procedures and fairness have not been followed in the process,” she said during her presentation. “Courts do allow for equity, declaratory judgments, and injunctions when rights guaranteed to a physician are not followed.”
Knowing those rights and regulations beforehand is key, Ms. Snelson said. States’ peer review laws widely differ. Arkansas law for example, enables physicians to request a hearing officer who is independent and not employed by the hospital and also protects communications by physicians during peer review proceedings. Other states have different features, and some states have nothing regarding peer review on the books, Ms. Snelson said.
“In some states it’s real clear where the peer review requirements are,” she said. “In other states, you really have to go hunting. It could be in the evidence code. It could be all over the place.”
Be aware of appeal rights. Usually, medical staff bylaws allow for an appeal to the governing body of the hospital if a doctor disagrees with a panel’s recommendation. However, sometimes bylaws are silent on appeals, Ms. Snelson said. She noted that the Joint Commission standards refer to peer review hearings and appeals. Thus, if a hospital is accredited by the Joint Commission, and its bylaws do not address appeals, physicians and their attorneys can argue that an appeals process should be in place.
Remember that peer review is not limited to “bad doctors,” and that the process can arise from minor issues, Ms. Snelson said at the meeting.
“Usually when doctors hear ‘peer review,’ they hear ‘discipline,’ ” she said. “[However], It’s not always the ‘bad doctors’; it can be something that is quite minimal that can be escalated. It can be entirely appropriate. What peer review should be is educational ... but sometimes it can be used as a weapon.”
On Twitter @legal_med
AT THE PHYSICIANS LEGAL ISSUES CONFERENCE
How to defeat radial artery spasm in transradial PCI
PARIS – The threat of radial artery spasm is the chief impediment to broader use of transradial access cardiac catheterization and percutaneous coronary intervention, but Dr. Julien Adjedj has a series of tips and tricks to defeat it.
At Cochin University Hospital in Paris, where he is chief of the interventional cardiology clinic, 95% of all PCIs are done transradially.
“With the tips and tricks we use, we have a transradial approach failure rate of only 1.5% at our center,” Dr. Adjedj said at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
He and his colleagues have conducted a series of prospective, randomized studies of various prophylactic vasodilator regimens in 1,950 patients undergoing transradial PCI.
The winning strategy? Place 2.5-5.0 mg of the calcium channel blocker verapamil in the arterial sheath as first-line preventive therapy.
In a multivariate analysis adjusted for potential confounders – for example, the investigators found that the incidence of radial artery spasm (RAS) is higher in women and younger patients – the use of prophylactic verapamil placed in the arterial sheath reduced the likelihood of RAS by 75% and 72%, respectively, compared with placebo.
Intra-arterial diltiazem at 5 mg, isosorbide dinitrate at 1 mg, and molsidomine at 1 mg were also more effective than placebo. However, diltiazem and isosorbide dinitrate were associated with an unacceptable increased risk of severe hypotension compared to placebo, and molsidomine is not widely available outside France.
In contrast, verapamil was not linked to severe hypotension.
Overall, RAS occurred in 22.2 % of patients on placebo, 7.1% of those on verapamil at 2.5 mg, 7.9% with verapamil at 5 mg, 6.5% with isosorbide dinitrate at 1 mg, 9.1% of those on diltiazem at 5 mg, 13.3% with molsidomine at 1 mg, and 4.8% with verapamil 2.5 mg plus molsidomine 1 mg.
When it proves difficult to advance the catheter during a transradial PCI despite prophylactic verapamil, the first thing to do is check whether the problem really is RAS or is instead a matter of having entered a remnant artery. This is accomplished by supplementing the verapamil with 1 mg of intra-arterial isosorbide dinitrate; if the catheter still won’t pass, seriously consider the possibility of a remnant artery.
Among Dr. Adjedj’s tips on how to successfully pass the catheter through a drug-refractory RAS: Use a hydrophilic 0.035-inch guide wire, switch from a 6 Fr to a smaller 5 or 4 Fr catheter, or use a long multipurpose 5 Fr catheter inside the 6 Fr guiding catheter.
“It’s like nested Russian dolls. It can pass through the spasm without any pain,” said Dr. Adjedj.
He reported having no financial conflicts regarding his presentation.
PARIS – The threat of radial artery spasm is the chief impediment to broader use of transradial access cardiac catheterization and percutaneous coronary intervention, but Dr. Julien Adjedj has a series of tips and tricks to defeat it.
At Cochin University Hospital in Paris, where he is chief of the interventional cardiology clinic, 95% of all PCIs are done transradially.
“With the tips and tricks we use, we have a transradial approach failure rate of only 1.5% at our center,” Dr. Adjedj said at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
He and his colleagues have conducted a series of prospective, randomized studies of various prophylactic vasodilator regimens in 1,950 patients undergoing transradial PCI.
The winning strategy? Place 2.5-5.0 mg of the calcium channel blocker verapamil in the arterial sheath as first-line preventive therapy.
In a multivariate analysis adjusted for potential confounders – for example, the investigators found that the incidence of radial artery spasm (RAS) is higher in women and younger patients – the use of prophylactic verapamil placed in the arterial sheath reduced the likelihood of RAS by 75% and 72%, respectively, compared with placebo.
Intra-arterial diltiazem at 5 mg, isosorbide dinitrate at 1 mg, and molsidomine at 1 mg were also more effective than placebo. However, diltiazem and isosorbide dinitrate were associated with an unacceptable increased risk of severe hypotension compared to placebo, and molsidomine is not widely available outside France.
In contrast, verapamil was not linked to severe hypotension.
Overall, RAS occurred in 22.2 % of patients on placebo, 7.1% of those on verapamil at 2.5 mg, 7.9% with verapamil at 5 mg, 6.5% with isosorbide dinitrate at 1 mg, 9.1% of those on diltiazem at 5 mg, 13.3% with molsidomine at 1 mg, and 4.8% with verapamil 2.5 mg plus molsidomine 1 mg.
When it proves difficult to advance the catheter during a transradial PCI despite prophylactic verapamil, the first thing to do is check whether the problem really is RAS or is instead a matter of having entered a remnant artery. This is accomplished by supplementing the verapamil with 1 mg of intra-arterial isosorbide dinitrate; if the catheter still won’t pass, seriously consider the possibility of a remnant artery.
Among Dr. Adjedj’s tips on how to successfully pass the catheter through a drug-refractory RAS: Use a hydrophilic 0.035-inch guide wire, switch from a 6 Fr to a smaller 5 or 4 Fr catheter, or use a long multipurpose 5 Fr catheter inside the 6 Fr guiding catheter.
“It’s like nested Russian dolls. It can pass through the spasm without any pain,” said Dr. Adjedj.
He reported having no financial conflicts regarding his presentation.
PARIS – The threat of radial artery spasm is the chief impediment to broader use of transradial access cardiac catheterization and percutaneous coronary intervention, but Dr. Julien Adjedj has a series of tips and tricks to defeat it.
At Cochin University Hospital in Paris, where he is chief of the interventional cardiology clinic, 95% of all PCIs are done transradially.
“With the tips and tricks we use, we have a transradial approach failure rate of only 1.5% at our center,” Dr. Adjedj said at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
He and his colleagues have conducted a series of prospective, randomized studies of various prophylactic vasodilator regimens in 1,950 patients undergoing transradial PCI.
The winning strategy? Place 2.5-5.0 mg of the calcium channel blocker verapamil in the arterial sheath as first-line preventive therapy.
In a multivariate analysis adjusted for potential confounders – for example, the investigators found that the incidence of radial artery spasm (RAS) is higher in women and younger patients – the use of prophylactic verapamil placed in the arterial sheath reduced the likelihood of RAS by 75% and 72%, respectively, compared with placebo.
Intra-arterial diltiazem at 5 mg, isosorbide dinitrate at 1 mg, and molsidomine at 1 mg were also more effective than placebo. However, diltiazem and isosorbide dinitrate were associated with an unacceptable increased risk of severe hypotension compared to placebo, and molsidomine is not widely available outside France.
In contrast, verapamil was not linked to severe hypotension.
Overall, RAS occurred in 22.2 % of patients on placebo, 7.1% of those on verapamil at 2.5 mg, 7.9% with verapamil at 5 mg, 6.5% with isosorbide dinitrate at 1 mg, 9.1% of those on diltiazem at 5 mg, 13.3% with molsidomine at 1 mg, and 4.8% with verapamil 2.5 mg plus molsidomine 1 mg.
When it proves difficult to advance the catheter during a transradial PCI despite prophylactic verapamil, the first thing to do is check whether the problem really is RAS or is instead a matter of having entered a remnant artery. This is accomplished by supplementing the verapamil with 1 mg of intra-arterial isosorbide dinitrate; if the catheter still won’t pass, seriously consider the possibility of a remnant artery.
Among Dr. Adjedj’s tips on how to successfully pass the catheter through a drug-refractory RAS: Use a hydrophilic 0.035-inch guide wire, switch from a 6 Fr to a smaller 5 or 4 Fr catheter, or use a long multipurpose 5 Fr catheter inside the 6 Fr guiding catheter.
“It’s like nested Russian dolls. It can pass through the spasm without any pain,” said Dr. Adjedj.
He reported having no financial conflicts regarding his presentation.
AT EUROPCR 2016
Key clinical point: Placing 2.5-5.0 mg of verapamil in the arterial sheath when performing transradial access PCI reduces the risk of radial artery spasm by three-quarters compared with placebo.
Major finding: The incidence of radial artery spasm during transradial access PCI was 7.1% when 2.5 mg of verapamil was introduced through the arterial sheath, compared with 22.2% with placebo.
Data source: This series of prospective randomized studies comprised 1,950 patients undergoing transradial access PCI by way of various intra-arterial vasodilators or placebo.
Disclosures: The presenter reported having no financial conflicts regarding the study, conducted free of commercial support.
End-of-life aggressive cancer care continues despite recommendations
CHICAGO – Aggressive care for most patients with incurable solid tumors continued in the final 30 days of life, and one-third died in the hospital, a recent, large retrospective study of health claims data on more than 28,000 patients shows, and there was no decrease in this practice over a recent 7-year period, despite recommendations to the contrary.
“Aggressive medical care for patients with incurable cancers at the end of life is widely recognized to be harmful to patients and their families,” Dr. Ronald Chen of the University of North Carolina at Chapel Hill said at the annual meeting of the American Society of Clinical Oncology.
As part of the Choosing Wisely campaign in 2012, the American Society of Clinical Oncology’s first recommendation was not to use cancer-directed therapy for patients with solid tumors when there is no strong evidence supporting the clinical value of further anticancer treatment. It also recommended more use of palliative and supportive care. However, the impact of these recommendations on clinical care in younger cancer populations was unknown.
In a study of patients younger than 65 years with solid tumors who died in 2007-2014, Dr. Chen and his associates studied the use of several items that could be considered to be aggressive therapy. They included chemotherapy, radiotherapy, invasive procedures, emergency room visits, hospitalization, intensive care use, and in-hospital death. Patients had any of five common metastatic diseases: breast, lung, prostate, colorectal, or pancreatic cancers (n = 5,855; 12,764; 1,508; 5,207; 3,397, respectively).
The source material for the study was large commercial insurance claims data on patients across 14 states. Investigators evaluated the proportion of patients who received forms of aggressive care in the final 30 days of life.
“Overall, the findings are remarkably consistent across the five diseases. And overall, about three-quarters of patients received at least one form of aggressive care in the last 30 days of life,” Dr. Chen said (range, 71.2%-75.9% of patients). Almost two-thirds of patients (61.6%-65.1%) were admitted to the hospital or went to the emergency department, about 20% of patients (15.9%-20.6%) received intensive care, and one-third of patients (30.3%-35.4%) died in the hospital instead of at home. About 25%-30% of patients received chemotherapy or an invasive procedure, such as a biopsy or a form of surgery. Radiation therapy was used the least and was administered to about 5%-20% of patients.
Looking at the overall use of aggressive care for each of the cancers studied, the researchers found virtually no trend over time, that is, from the second quarter of 2012, when ASCO issued its Choosing Wisely guidelines, through the fourth quarter of 2014. For each of the cancers, aggressive care was delivered to just about 75% of patients across all quarters. Looking further back, the investigators found the same proportions of patients receiving aggressive care in the last 30 days of life during the years 2007-2011.
They also looked specifically at the use of chemotherapy and did not find a change after the Choosing Wisely recommendations, “nor did we find a significant increase in the use of hospice from before 2012 to afterward,” Dr. Chen said. “Additional efforts are critically needed to improve end-of-life care for patients with terminal cancers to ensure that the care provided meets the goals and preferences of patients and their families.” Fewer than one-fifth of patients used hospice care.
Press conference moderator Dr. Patricia Ganz, director of cancer prevention and control research at the Jonsson Comprehensive Cancer Center of the University of California, Los Angeles, called the study “interesting and important for several reasons.” First, there have been very few studies on the topic on the younger (up to age 65) cancer population although the SEER-Medicare database has been used as a source of claims data for older cancer patients. One may like to know if the younger population is being treated more aggressively than the older population is, as well as other patterns of care.
“Giving chemotherapy in the last 30 days of life has been a coping measure for a very long time,” she said. “It’s been nationally looked at as one of our failures in giving good end-of-life care, and so the fact that there wasn’t any dramatic change at 2012 doesn’t bother me in the sense that we’ve been talking about this for a very long time, and we haven’t seen any movement.” She said there is a lot left to do in delivering high quality end-of-life care.
Dr. Chen said more education of both patients and physicians is needed to improve conversations about goals and expectations, as well as palliative care and hospice. These types of care need to be made more accessible, he said.
Limitations of the study include a lack of information on the cause of death (whether related to the cancer, the treatment received, or other), and researchers did not review the medical records to investigate the medical reasons for the use of aggressive care near the end of life.
CHICAGO – Aggressive care for most patients with incurable solid tumors continued in the final 30 days of life, and one-third died in the hospital, a recent, large retrospective study of health claims data on more than 28,000 patients shows, and there was no decrease in this practice over a recent 7-year period, despite recommendations to the contrary.
“Aggressive medical care for patients with incurable cancers at the end of life is widely recognized to be harmful to patients and their families,” Dr. Ronald Chen of the University of North Carolina at Chapel Hill said at the annual meeting of the American Society of Clinical Oncology.
As part of the Choosing Wisely campaign in 2012, the American Society of Clinical Oncology’s first recommendation was not to use cancer-directed therapy for patients with solid tumors when there is no strong evidence supporting the clinical value of further anticancer treatment. It also recommended more use of palliative and supportive care. However, the impact of these recommendations on clinical care in younger cancer populations was unknown.
In a study of patients younger than 65 years with solid tumors who died in 2007-2014, Dr. Chen and his associates studied the use of several items that could be considered to be aggressive therapy. They included chemotherapy, radiotherapy, invasive procedures, emergency room visits, hospitalization, intensive care use, and in-hospital death. Patients had any of five common metastatic diseases: breast, lung, prostate, colorectal, or pancreatic cancers (n = 5,855; 12,764; 1,508; 5,207; 3,397, respectively).
The source material for the study was large commercial insurance claims data on patients across 14 states. Investigators evaluated the proportion of patients who received forms of aggressive care in the final 30 days of life.
“Overall, the findings are remarkably consistent across the five diseases. And overall, about three-quarters of patients received at least one form of aggressive care in the last 30 days of life,” Dr. Chen said (range, 71.2%-75.9% of patients). Almost two-thirds of patients (61.6%-65.1%) were admitted to the hospital or went to the emergency department, about 20% of patients (15.9%-20.6%) received intensive care, and one-third of patients (30.3%-35.4%) died in the hospital instead of at home. About 25%-30% of patients received chemotherapy or an invasive procedure, such as a biopsy or a form of surgery. Radiation therapy was used the least and was administered to about 5%-20% of patients.
Looking at the overall use of aggressive care for each of the cancers studied, the researchers found virtually no trend over time, that is, from the second quarter of 2012, when ASCO issued its Choosing Wisely guidelines, through the fourth quarter of 2014. For each of the cancers, aggressive care was delivered to just about 75% of patients across all quarters. Looking further back, the investigators found the same proportions of patients receiving aggressive care in the last 30 days of life during the years 2007-2011.
They also looked specifically at the use of chemotherapy and did not find a change after the Choosing Wisely recommendations, “nor did we find a significant increase in the use of hospice from before 2012 to afterward,” Dr. Chen said. “Additional efforts are critically needed to improve end-of-life care for patients with terminal cancers to ensure that the care provided meets the goals and preferences of patients and their families.” Fewer than one-fifth of patients used hospice care.
Press conference moderator Dr. Patricia Ganz, director of cancer prevention and control research at the Jonsson Comprehensive Cancer Center of the University of California, Los Angeles, called the study “interesting and important for several reasons.” First, there have been very few studies on the topic on the younger (up to age 65) cancer population although the SEER-Medicare database has been used as a source of claims data for older cancer patients. One may like to know if the younger population is being treated more aggressively than the older population is, as well as other patterns of care.
“Giving chemotherapy in the last 30 days of life has been a coping measure for a very long time,” she said. “It’s been nationally looked at as one of our failures in giving good end-of-life care, and so the fact that there wasn’t any dramatic change at 2012 doesn’t bother me in the sense that we’ve been talking about this for a very long time, and we haven’t seen any movement.” She said there is a lot left to do in delivering high quality end-of-life care.
Dr. Chen said more education of both patients and physicians is needed to improve conversations about goals and expectations, as well as palliative care and hospice. These types of care need to be made more accessible, he said.
Limitations of the study include a lack of information on the cause of death (whether related to the cancer, the treatment received, or other), and researchers did not review the medical records to investigate the medical reasons for the use of aggressive care near the end of life.
CHICAGO – Aggressive care for most patients with incurable solid tumors continued in the final 30 days of life, and one-third died in the hospital, a recent, large retrospective study of health claims data on more than 28,000 patients shows, and there was no decrease in this practice over a recent 7-year period, despite recommendations to the contrary.
“Aggressive medical care for patients with incurable cancers at the end of life is widely recognized to be harmful to patients and their families,” Dr. Ronald Chen of the University of North Carolina at Chapel Hill said at the annual meeting of the American Society of Clinical Oncology.
As part of the Choosing Wisely campaign in 2012, the American Society of Clinical Oncology’s first recommendation was not to use cancer-directed therapy for patients with solid tumors when there is no strong evidence supporting the clinical value of further anticancer treatment. It also recommended more use of palliative and supportive care. However, the impact of these recommendations on clinical care in younger cancer populations was unknown.
In a study of patients younger than 65 years with solid tumors who died in 2007-2014, Dr. Chen and his associates studied the use of several items that could be considered to be aggressive therapy. They included chemotherapy, radiotherapy, invasive procedures, emergency room visits, hospitalization, intensive care use, and in-hospital death. Patients had any of five common metastatic diseases: breast, lung, prostate, colorectal, or pancreatic cancers (n = 5,855; 12,764; 1,508; 5,207; 3,397, respectively).
The source material for the study was large commercial insurance claims data on patients across 14 states. Investigators evaluated the proportion of patients who received forms of aggressive care in the final 30 days of life.
“Overall, the findings are remarkably consistent across the five diseases. And overall, about three-quarters of patients received at least one form of aggressive care in the last 30 days of life,” Dr. Chen said (range, 71.2%-75.9% of patients). Almost two-thirds of patients (61.6%-65.1%) were admitted to the hospital or went to the emergency department, about 20% of patients (15.9%-20.6%) received intensive care, and one-third of patients (30.3%-35.4%) died in the hospital instead of at home. About 25%-30% of patients received chemotherapy or an invasive procedure, such as a biopsy or a form of surgery. Radiation therapy was used the least and was administered to about 5%-20% of patients.
Looking at the overall use of aggressive care for each of the cancers studied, the researchers found virtually no trend over time, that is, from the second quarter of 2012, when ASCO issued its Choosing Wisely guidelines, through the fourth quarter of 2014. For each of the cancers, aggressive care was delivered to just about 75% of patients across all quarters. Looking further back, the investigators found the same proportions of patients receiving aggressive care in the last 30 days of life during the years 2007-2011.
They also looked specifically at the use of chemotherapy and did not find a change after the Choosing Wisely recommendations, “nor did we find a significant increase in the use of hospice from before 2012 to afterward,” Dr. Chen said. “Additional efforts are critically needed to improve end-of-life care for patients with terminal cancers to ensure that the care provided meets the goals and preferences of patients and their families.” Fewer than one-fifth of patients used hospice care.
Press conference moderator Dr. Patricia Ganz, director of cancer prevention and control research at the Jonsson Comprehensive Cancer Center of the University of California, Los Angeles, called the study “interesting and important for several reasons.” First, there have been very few studies on the topic on the younger (up to age 65) cancer population although the SEER-Medicare database has been used as a source of claims data for older cancer patients. One may like to know if the younger population is being treated more aggressively than the older population is, as well as other patterns of care.
“Giving chemotherapy in the last 30 days of life has been a coping measure for a very long time,” she said. “It’s been nationally looked at as one of our failures in giving good end-of-life care, and so the fact that there wasn’t any dramatic change at 2012 doesn’t bother me in the sense that we’ve been talking about this for a very long time, and we haven’t seen any movement.” She said there is a lot left to do in delivering high quality end-of-life care.
Dr. Chen said more education of both patients and physicians is needed to improve conversations about goals and expectations, as well as palliative care and hospice. These types of care need to be made more accessible, he said.
Limitations of the study include a lack of information on the cause of death (whether related to the cancer, the treatment received, or other), and researchers did not review the medical records to investigate the medical reasons for the use of aggressive care near the end of life.
AT THE 2016 ASCO ANNUAL MEETING
Key clinical point: End-of-life aggressive cancer care continues unabated despite Choosing Wisely recommendations.
Major finding: Three-quarters of cancer patients received aggressive therapies at end of life.
Data source: Retrospective study of health claims data on 28,731 patients younger than 65 years with incurable cancers.
Disclosures: The study received funding from the North Carolina Translational and Clinical Sciences Institute. Dr. Chen reported consulting or advisory roles with Medivation/Astellas and research funding from Accuray. Dr. Patricia Ganz reported stock and other ownership interest in Abbott Laboratories, GlaxoSmithKline, Johnson & Johnson, Merck, Novartis, Pfizer, and Teva.
ICD same-day discharge safe, but not a money saver
San Francisco – Same day discharge is generally safe after cardioverter defibrillator implantation for primary prevention, but it doesn’t save money.
Furthermore, guidelines are needed to standardize the practice as it becomes increasingly common in the United States, according to a 25-site investigation.
After implantable cardioverter defibrillator (ICD) procedures, patients were monitored for 3-4 hours, and their devices were checked for proper functioning; 129 patients who were stable at that point were randomized to early discharge and 136 to next day discharge (NDD).
The overall 30-day procedural complication rate was 3.1% in the same day discharge (SDD) group and 1.6% in the NDD group, a nonsignificant difference (P = .37). Three patients in the SDD group developed hematomas that resolved on their own, and one had a cardiac perforation. One NDD patient dislodged a lead and another developed an infection. There were no differences in quality of life measures between the two groups at 30 days.
However, there were also no differences in procedural and perioperative direct costs, which was surprising because saving money is a major driver of SDD, and the most expensive part of ICD implantation is the first 24 hours. Direct per-patient medical costs in the study – estimated by applying hospital cost-to-charge ratios to the Medicare-reported charge – were $31,771 for SDD and $30,437 for NDD, but NDD was more expensive than SDD at several sites. The investigators suspect a flaw in their analysis related to the opaque nature of hospital accounting, and plan to look into the matter further with modeling to identify savings opportunities with SDD.
“We can insert ICDs on an outpatient basis, but this study will be difficult to replicate because clinical practice is moving towards SDD. In view of this, we think professional societies should be thinking of standardizing criteria for SDD; guidelines would help with the adoption of this approach. There are clinicians who are astute and have great clinical judgment, but there are others who need a scoring system. We believe that by using the 270,000 patients in the [American College of Cardiology’s ICD Registry], there is the ability to identify patients who have low periprocedural risk,” said lead investigator Dr. Ranjit Suri, a cardiologist at Mt. Sinai Hospital in New York.
The study excluded patients receiving an ICD for secondary prevention, as well as those on periprocedural heparin and patients who were pacemaker dependent. SDD seemed safe otherwise, but it’s unknown “if our concept of low risk is acceptable to all implanting physicians,” Dr. Suri said at the annual scientific sessions of the Heart Rhythm Society.
The study groups were well matched. About 75% in each arm were men, and ischemic cardiomyopathy was the leading ICD indication. Patients were amenable to the idea of SDD; the advent of remote monitoring “adds a certain sense of safety” for both patients and physicians, he said.
Dr. Suri is a speaker for Boehringer Ingelheim and St. Jude Medical. He is also a consultant for Biosense Webster and Zoll, and receives research funding from St. Jude.
Dr. Thomas Deering |
The vast majority of primary prevention patients who are clinically stable enough to come in as outpatients can go home as outpatients if you watch them for a short period of time and make sure they are clinically stable. Most patients don’t want to be in the hospital, and many hospitals are crunched for available beds. It would be great to have guidelines on how to handle this, but we have to allow for clinical judgment.
Dr. Thomas Deering is chief of the Arrhythmia Center at the Piedmont Heart Institute in Atlanta, where he is also chairman of the Executive Council and the Clinical Centers for Excellence. He moderated Dr. Suri’s presentation and was not involved in the work.
Dr. Thomas Deering |
The vast majority of primary prevention patients who are clinically stable enough to come in as outpatients can go home as outpatients if you watch them for a short period of time and make sure they are clinically stable. Most patients don’t want to be in the hospital, and many hospitals are crunched for available beds. It would be great to have guidelines on how to handle this, but we have to allow for clinical judgment.
Dr. Thomas Deering is chief of the Arrhythmia Center at the Piedmont Heart Institute in Atlanta, where he is also chairman of the Executive Council and the Clinical Centers for Excellence. He moderated Dr. Suri’s presentation and was not involved in the work.
Dr. Thomas Deering |
The vast majority of primary prevention patients who are clinically stable enough to come in as outpatients can go home as outpatients if you watch them for a short period of time and make sure they are clinically stable. Most patients don’t want to be in the hospital, and many hospitals are crunched for available beds. It would be great to have guidelines on how to handle this, but we have to allow for clinical judgment.
Dr. Thomas Deering is chief of the Arrhythmia Center at the Piedmont Heart Institute in Atlanta, where he is also chairman of the Executive Council and the Clinical Centers for Excellence. He moderated Dr. Suri’s presentation and was not involved in the work.
San Francisco – Same day discharge is generally safe after cardioverter defibrillator implantation for primary prevention, but it doesn’t save money.
Furthermore, guidelines are needed to standardize the practice as it becomes increasingly common in the United States, according to a 25-site investigation.
After implantable cardioverter defibrillator (ICD) procedures, patients were monitored for 3-4 hours, and their devices were checked for proper functioning; 129 patients who were stable at that point were randomized to early discharge and 136 to next day discharge (NDD).
The overall 30-day procedural complication rate was 3.1% in the same day discharge (SDD) group and 1.6% in the NDD group, a nonsignificant difference (P = .37). Three patients in the SDD group developed hematomas that resolved on their own, and one had a cardiac perforation. One NDD patient dislodged a lead and another developed an infection. There were no differences in quality of life measures between the two groups at 30 days.
However, there were also no differences in procedural and perioperative direct costs, which was surprising because saving money is a major driver of SDD, and the most expensive part of ICD implantation is the first 24 hours. Direct per-patient medical costs in the study – estimated by applying hospital cost-to-charge ratios to the Medicare-reported charge – were $31,771 for SDD and $30,437 for NDD, but NDD was more expensive than SDD at several sites. The investigators suspect a flaw in their analysis related to the opaque nature of hospital accounting, and plan to look into the matter further with modeling to identify savings opportunities with SDD.
“We can insert ICDs on an outpatient basis, but this study will be difficult to replicate because clinical practice is moving towards SDD. In view of this, we think professional societies should be thinking of standardizing criteria for SDD; guidelines would help with the adoption of this approach. There are clinicians who are astute and have great clinical judgment, but there are others who need a scoring system. We believe that by using the 270,000 patients in the [American College of Cardiology’s ICD Registry], there is the ability to identify patients who have low periprocedural risk,” said lead investigator Dr. Ranjit Suri, a cardiologist at Mt. Sinai Hospital in New York.
The study excluded patients receiving an ICD for secondary prevention, as well as those on periprocedural heparin and patients who were pacemaker dependent. SDD seemed safe otherwise, but it’s unknown “if our concept of low risk is acceptable to all implanting physicians,” Dr. Suri said at the annual scientific sessions of the Heart Rhythm Society.
The study groups were well matched. About 75% in each arm were men, and ischemic cardiomyopathy was the leading ICD indication. Patients were amenable to the idea of SDD; the advent of remote monitoring “adds a certain sense of safety” for both patients and physicians, he said.
Dr. Suri is a speaker for Boehringer Ingelheim and St. Jude Medical. He is also a consultant for Biosense Webster and Zoll, and receives research funding from St. Jude.
San Francisco – Same day discharge is generally safe after cardioverter defibrillator implantation for primary prevention, but it doesn’t save money.
Furthermore, guidelines are needed to standardize the practice as it becomes increasingly common in the United States, according to a 25-site investigation.
After implantable cardioverter defibrillator (ICD) procedures, patients were monitored for 3-4 hours, and their devices were checked for proper functioning; 129 patients who were stable at that point were randomized to early discharge and 136 to next day discharge (NDD).
The overall 30-day procedural complication rate was 3.1% in the same day discharge (SDD) group and 1.6% in the NDD group, a nonsignificant difference (P = .37). Three patients in the SDD group developed hematomas that resolved on their own, and one had a cardiac perforation. One NDD patient dislodged a lead and another developed an infection. There were no differences in quality of life measures between the two groups at 30 days.
However, there were also no differences in procedural and perioperative direct costs, which was surprising because saving money is a major driver of SDD, and the most expensive part of ICD implantation is the first 24 hours. Direct per-patient medical costs in the study – estimated by applying hospital cost-to-charge ratios to the Medicare-reported charge – were $31,771 for SDD and $30,437 for NDD, but NDD was more expensive than SDD at several sites. The investigators suspect a flaw in their analysis related to the opaque nature of hospital accounting, and plan to look into the matter further with modeling to identify savings opportunities with SDD.
“We can insert ICDs on an outpatient basis, but this study will be difficult to replicate because clinical practice is moving towards SDD. In view of this, we think professional societies should be thinking of standardizing criteria for SDD; guidelines would help with the adoption of this approach. There are clinicians who are astute and have great clinical judgment, but there are others who need a scoring system. We believe that by using the 270,000 patients in the [American College of Cardiology’s ICD Registry], there is the ability to identify patients who have low periprocedural risk,” said lead investigator Dr. Ranjit Suri, a cardiologist at Mt. Sinai Hospital in New York.
The study excluded patients receiving an ICD for secondary prevention, as well as those on periprocedural heparin and patients who were pacemaker dependent. SDD seemed safe otherwise, but it’s unknown “if our concept of low risk is acceptable to all implanting physicians,” Dr. Suri said at the annual scientific sessions of the Heart Rhythm Society.
The study groups were well matched. About 75% in each arm were men, and ischemic cardiomyopathy was the leading ICD indication. Patients were amenable to the idea of SDD; the advent of remote monitoring “adds a certain sense of safety” for both patients and physicians, he said.
Dr. Suri is a speaker for Boehringer Ingelheim and St. Jude Medical. He is also a consultant for Biosense Webster and Zoll, and receives research funding from St. Jude.
AT HEART RHYTHM 2016
Key clinical point: Same-day discharge is generally safe after cardioverter defibrillator implantation for primary prevention, but it doesn’t save money and guidelines are needed to standardize the practice as it becomes increasingly common in the United States.
Major finding: The overall 30-day procedural complication rate was 3.1% in the same day discharge (SDD) group and 1.5% in the next-day discharge group, a nonsignificant difference (P = .37).
Data source: Randomized trial of 265 ICD patients.
Disclosures: The lead investigator is a speaker for Boehringer Ingelheim and St. Jude Medical. He is also a consultant for Biosense Webster and Zoll, and receives research funding from St. Jude.
A new sort of consultant: Advising doctors, patients on California’s aid-in-dying law
BERKELEY, Calif. – Few people have the unusual set of professional experiences that Dr. Lonny Shavelson does. He worked as an emergency room physician in Berkeley for years – while also working as a journalist. He has written several books and takes hauntingly beautiful photographs.
Now, just as California’s aid-in-dying law takes effect June 9, Dr. Shavelson has added another specialty: A consultant to physicians and terminally ill patients who have questions about how it works.
“Can I just sit back and watch?” Dr. Shavelson asked from his cottage office. “This is really an amazing opportunity to be part of establishing policy and initiating something in medicine. This is a major change … [that] very, very few people know anything about and how to do it.”
Dr. Shavelson is the author of the 1995 book, “A Chosen Death,” which followed five terminally ill people over 2 years as they determined whether to amass drugs on their own and end their lives at a time of their choosing. He was present at the death of all of them.
He followed the issue closely for several years, but ultimately moved on to other projects – among them a book about addiction and a documentary about people who identify as neither male nor female.
Then last fall came the surprising passage of California’s End of Life Option Act, giving terminally ill adults with 6 months to live the right to request lethal medication to end their lives. The law takes effect June 9.
Dr. Shavelson decided he had to act, adding that he feels “quite guilty” about having been away from the issue while others pushed it forward.
His website, Bay Area End of Life Options, went up in April, and he’s outlined the law at “grand rounds” at several Bay Area hospitals this spring. His practice will be focused on consulting not only with physicians whose patients request aid-in-dying, but also with patients themselves. As he indicates on his site, he will offer care to patients who choose him as their “attending End-of-Life physician.”
Dr. Shavelson is adamant that this is “something that has to be done right.” To him, that means starting every patient encounter with a one-word question: “Why?”
“In fact, it’s the only initial approach that I think is acceptable. If somebody calls me and says, ‘I want to take the medication, my first question is, ‘Why? Let me talk to you about all the various alternatives and all the ways that we can think about this.’ ”
Dr. Shavelson worries that patients may seek aid-in-dying because they are in pain. So first, he would like all his patients to be enrolled in hospice care.
“This can only work when you’re sure that the patients have been given the best end-of-life care, which to me is most guaranteed by being a part of hospice or at least having a good palliative care physician. Then this is a rational decision. If you’re doing it otherwise, it’s because of lack of good care.”
California is the fifth state to legalize aid-in-dying, joining Oregon, Washington, Vermont, and Montana. The option is very rarely used. For example, in 2014 in Oregon, just 155 lethal prescriptions were written under the state’s law, and 105 people ultimately took the medicine and died.
Under the California law, two doctors must agree that a patient has 6 months or less to live. The patient must be mentally competent. At least one of the meetings between the patient and his or her doctor must be private, with no one else present, to ensure the patient is acting independently.
Patients must be able to swallow the medication themselves and must affirm in writing, within the 48 hours before taking the medication, that they will do so.
Dr. Shavelson says he has been surprised by the poor understanding of the law among some health care providers. One insisted the law was not taking effect this year; another asked how the law would benefit his patients with Alzheimer’s disease. (Patients with dementia don’t qualify under the law because they are not mentally competent.)
The law does not require that health care providers participate in ending terminally ill patients’ lives. Many physicians are “queasy” about the law, Dr. Shavelson said, and are unwilling to prescribe to patients who request the lethal medication – even when they think having such a law in place is the right thing to do.
“My response to that is as health care providers, you might have been uncomfortable the first time you drew blood. You might have been uncomfortable the first time you took out somebody’s gall bladder,” he said. “If it’s a medical procedure you believe in and you believe it’s the patient’s right, then it’s your obligation to learn how to do it – and do it correctly.”
Dr. Shavelson predicts that many physicians who are initially reluctant to provide this option to their patients may become more comfortable after the law goes into effect and they see how it works.
Dr. Burt Presberg, an East Bay psychiatrist who works with cancer patients and their families, attended a talk by Dr. Shavelson, and it led to some soul searching.
He wrestles with his own comfort level in handling patient requests. When he talks, he often pivots from his initial point to “on the other hand.”
Dr. Presberg says he is concerned that patients suffer from clinical depression at the end of life. Sometimes they feel they are a burden to family members who could “really push for the end of life to happen a little sooner than the patient themselves.”
His experience is that terminally ill patients with clinical depression can be successfully treated. He said he believes Dr. Shavelson will be aware of the need to treat depression,”but I do have concerns about other physicians.”
“On the other hand,” he added, “I think it’s really good that this is an option.”
Dr. Shavelson says he’s already received a handful of calls from patients, but mostly he’s spent his time before the law takes effect talking to other physicians. He needs a consulting physician and a pharmacist who will accept prescriptions for a lethal dose of medicine.
Then his mind returns to the patient. “It’s important … that we’re moving forward,” he said. “It’s crucial that we do that because this is part of the rights of patient care to have a certain level of autonomy in how they die.”
To him, this type of care “isn’t so tangibly different” from other kinds of questions doctors address.
“I’m just one of those docs who sees dying as a process, and [the] method of death is less important than making sure it’s a good death.”
Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation. This story is part of a partnership that includes KQED, NPR, and Kaiser Health News.
BERKELEY, Calif. – Few people have the unusual set of professional experiences that Dr. Lonny Shavelson does. He worked as an emergency room physician in Berkeley for years – while also working as a journalist. He has written several books and takes hauntingly beautiful photographs.
Now, just as California’s aid-in-dying law takes effect June 9, Dr. Shavelson has added another specialty: A consultant to physicians and terminally ill patients who have questions about how it works.
“Can I just sit back and watch?” Dr. Shavelson asked from his cottage office. “This is really an amazing opportunity to be part of establishing policy and initiating something in medicine. This is a major change … [that] very, very few people know anything about and how to do it.”
Dr. Shavelson is the author of the 1995 book, “A Chosen Death,” which followed five terminally ill people over 2 years as they determined whether to amass drugs on their own and end their lives at a time of their choosing. He was present at the death of all of them.
He followed the issue closely for several years, but ultimately moved on to other projects – among them a book about addiction and a documentary about people who identify as neither male nor female.
Then last fall came the surprising passage of California’s End of Life Option Act, giving terminally ill adults with 6 months to live the right to request lethal medication to end their lives. The law takes effect June 9.
Dr. Shavelson decided he had to act, adding that he feels “quite guilty” about having been away from the issue while others pushed it forward.
His website, Bay Area End of Life Options, went up in April, and he’s outlined the law at “grand rounds” at several Bay Area hospitals this spring. His practice will be focused on consulting not only with physicians whose patients request aid-in-dying, but also with patients themselves. As he indicates on his site, he will offer care to patients who choose him as their “attending End-of-Life physician.”
Dr. Shavelson is adamant that this is “something that has to be done right.” To him, that means starting every patient encounter with a one-word question: “Why?”
“In fact, it’s the only initial approach that I think is acceptable. If somebody calls me and says, ‘I want to take the medication, my first question is, ‘Why? Let me talk to you about all the various alternatives and all the ways that we can think about this.’ ”
Dr. Shavelson worries that patients may seek aid-in-dying because they are in pain. So first, he would like all his patients to be enrolled in hospice care.
“This can only work when you’re sure that the patients have been given the best end-of-life care, which to me is most guaranteed by being a part of hospice or at least having a good palliative care physician. Then this is a rational decision. If you’re doing it otherwise, it’s because of lack of good care.”
California is the fifth state to legalize aid-in-dying, joining Oregon, Washington, Vermont, and Montana. The option is very rarely used. For example, in 2014 in Oregon, just 155 lethal prescriptions were written under the state’s law, and 105 people ultimately took the medicine and died.
Under the California law, two doctors must agree that a patient has 6 months or less to live. The patient must be mentally competent. At least one of the meetings between the patient and his or her doctor must be private, with no one else present, to ensure the patient is acting independently.
Patients must be able to swallow the medication themselves and must affirm in writing, within the 48 hours before taking the medication, that they will do so.
Dr. Shavelson says he has been surprised by the poor understanding of the law among some health care providers. One insisted the law was not taking effect this year; another asked how the law would benefit his patients with Alzheimer’s disease. (Patients with dementia don’t qualify under the law because they are not mentally competent.)
The law does not require that health care providers participate in ending terminally ill patients’ lives. Many physicians are “queasy” about the law, Dr. Shavelson said, and are unwilling to prescribe to patients who request the lethal medication – even when they think having such a law in place is the right thing to do.
“My response to that is as health care providers, you might have been uncomfortable the first time you drew blood. You might have been uncomfortable the first time you took out somebody’s gall bladder,” he said. “If it’s a medical procedure you believe in and you believe it’s the patient’s right, then it’s your obligation to learn how to do it – and do it correctly.”
Dr. Shavelson predicts that many physicians who are initially reluctant to provide this option to their patients may become more comfortable after the law goes into effect and they see how it works.
Dr. Burt Presberg, an East Bay psychiatrist who works with cancer patients and their families, attended a talk by Dr. Shavelson, and it led to some soul searching.
He wrestles with his own comfort level in handling patient requests. When he talks, he often pivots from his initial point to “on the other hand.”
Dr. Presberg says he is concerned that patients suffer from clinical depression at the end of life. Sometimes they feel they are a burden to family members who could “really push for the end of life to happen a little sooner than the patient themselves.”
His experience is that terminally ill patients with clinical depression can be successfully treated. He said he believes Dr. Shavelson will be aware of the need to treat depression,”but I do have concerns about other physicians.”
“On the other hand,” he added, “I think it’s really good that this is an option.”
Dr. Shavelson says he’s already received a handful of calls from patients, but mostly he’s spent his time before the law takes effect talking to other physicians. He needs a consulting physician and a pharmacist who will accept prescriptions for a lethal dose of medicine.
Then his mind returns to the patient. “It’s important … that we’re moving forward,” he said. “It’s crucial that we do that because this is part of the rights of patient care to have a certain level of autonomy in how they die.”
To him, this type of care “isn’t so tangibly different” from other kinds of questions doctors address.
“I’m just one of those docs who sees dying as a process, and [the] method of death is less important than making sure it’s a good death.”
Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation. This story is part of a partnership that includes KQED, NPR, and Kaiser Health News.
BERKELEY, Calif. – Few people have the unusual set of professional experiences that Dr. Lonny Shavelson does. He worked as an emergency room physician in Berkeley for years – while also working as a journalist. He has written several books and takes hauntingly beautiful photographs.
Now, just as California’s aid-in-dying law takes effect June 9, Dr. Shavelson has added another specialty: A consultant to physicians and terminally ill patients who have questions about how it works.
“Can I just sit back and watch?” Dr. Shavelson asked from his cottage office. “This is really an amazing opportunity to be part of establishing policy and initiating something in medicine. This is a major change … [that] very, very few people know anything about and how to do it.”
Dr. Shavelson is the author of the 1995 book, “A Chosen Death,” which followed five terminally ill people over 2 years as they determined whether to amass drugs on their own and end their lives at a time of their choosing. He was present at the death of all of them.
He followed the issue closely for several years, but ultimately moved on to other projects – among them a book about addiction and a documentary about people who identify as neither male nor female.
Then last fall came the surprising passage of California’s End of Life Option Act, giving terminally ill adults with 6 months to live the right to request lethal medication to end their lives. The law takes effect June 9.
Dr. Shavelson decided he had to act, adding that he feels “quite guilty” about having been away from the issue while others pushed it forward.
His website, Bay Area End of Life Options, went up in April, and he’s outlined the law at “grand rounds” at several Bay Area hospitals this spring. His practice will be focused on consulting not only with physicians whose patients request aid-in-dying, but also with patients themselves. As he indicates on his site, he will offer care to patients who choose him as their “attending End-of-Life physician.”
Dr. Shavelson is adamant that this is “something that has to be done right.” To him, that means starting every patient encounter with a one-word question: “Why?”
“In fact, it’s the only initial approach that I think is acceptable. If somebody calls me and says, ‘I want to take the medication, my first question is, ‘Why? Let me talk to you about all the various alternatives and all the ways that we can think about this.’ ”
Dr. Shavelson worries that patients may seek aid-in-dying because they are in pain. So first, he would like all his patients to be enrolled in hospice care.
“This can only work when you’re sure that the patients have been given the best end-of-life care, which to me is most guaranteed by being a part of hospice or at least having a good palliative care physician. Then this is a rational decision. If you’re doing it otherwise, it’s because of lack of good care.”
California is the fifth state to legalize aid-in-dying, joining Oregon, Washington, Vermont, and Montana. The option is very rarely used. For example, in 2014 in Oregon, just 155 lethal prescriptions were written under the state’s law, and 105 people ultimately took the medicine and died.
Under the California law, two doctors must agree that a patient has 6 months or less to live. The patient must be mentally competent. At least one of the meetings between the patient and his or her doctor must be private, with no one else present, to ensure the patient is acting independently.
Patients must be able to swallow the medication themselves and must affirm in writing, within the 48 hours before taking the medication, that they will do so.
Dr. Shavelson says he has been surprised by the poor understanding of the law among some health care providers. One insisted the law was not taking effect this year; another asked how the law would benefit his patients with Alzheimer’s disease. (Patients with dementia don’t qualify under the law because they are not mentally competent.)
The law does not require that health care providers participate in ending terminally ill patients’ lives. Many physicians are “queasy” about the law, Dr. Shavelson said, and are unwilling to prescribe to patients who request the lethal medication – even when they think having such a law in place is the right thing to do.
“My response to that is as health care providers, you might have been uncomfortable the first time you drew blood. You might have been uncomfortable the first time you took out somebody’s gall bladder,” he said. “If it’s a medical procedure you believe in and you believe it’s the patient’s right, then it’s your obligation to learn how to do it – and do it correctly.”
Dr. Shavelson predicts that many physicians who are initially reluctant to provide this option to their patients may become more comfortable after the law goes into effect and they see how it works.
Dr. Burt Presberg, an East Bay psychiatrist who works with cancer patients and their families, attended a talk by Dr. Shavelson, and it led to some soul searching.
He wrestles with his own comfort level in handling patient requests. When he talks, he often pivots from his initial point to “on the other hand.”
Dr. Presberg says he is concerned that patients suffer from clinical depression at the end of life. Sometimes they feel they are a burden to family members who could “really push for the end of life to happen a little sooner than the patient themselves.”
His experience is that terminally ill patients with clinical depression can be successfully treated. He said he believes Dr. Shavelson will be aware of the need to treat depression,”but I do have concerns about other physicians.”
“On the other hand,” he added, “I think it’s really good that this is an option.”
Dr. Shavelson says he’s already received a handful of calls from patients, but mostly he’s spent his time before the law takes effect talking to other physicians. He needs a consulting physician and a pharmacist who will accept prescriptions for a lethal dose of medicine.
Then his mind returns to the patient. “It’s important … that we’re moving forward,” he said. “It’s crucial that we do that because this is part of the rights of patient care to have a certain level of autonomy in how they die.”
To him, this type of care “isn’t so tangibly different” from other kinds of questions doctors address.
“I’m just one of those docs who sees dying as a process, and [the] method of death is less important than making sure it’s a good death.”
Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation. This story is part of a partnership that includes KQED, NPR, and Kaiser Health News.
Nighttime extubations carry higher risks of reintubation, death
SAN FRANCISCO – Mechanically ventilated patients in the intensive care unit (ICU) have poorer outcomes if extubated during the night instead of during the day, finds a retrospective cohort study reported at an international conference of the American Thoracic Society.
Overall, 20.1% of the nearly 98,000 adult patients studied were extubated during nighttime hours, between 7:00 p.m. and 7:00 a.m., according to data presented in a session and a related press conference.
Compared with patients extubated during daytime hours, patients extubated during nighttime hours had higher rates of ICU and hospital death, with the absolute difference ranging from 1.0% to 5.1%. Additionally, among those mechanically ventilated for at least 12 hours, nighttime extubation was associated with an absolute 2% increase in the risk of reintubation.
“I think this is the first large-scale study that looks at a practice that, although not as common as we thought it was, is still done about a fifth of the time and even with decreasing rates, is not a rare practice on our units,” commented lead author Dr. Hayley B. Gershengorn of the department of medicine (critical care) and the Saul R. Korey department of neurology at the Albert Einstein College of Medicine, New York.
“As we have increasing staffing [overnight] and maybe an increasing push to move people through our ICUs, we need to probably take some care because although we can’t demonstrate a causal link, it is quite concerning, this consistent finding of increased mortality and reintubation in these folks,” she said.
There are several possible reasons for the observed heightened risks of death and reintubation with nighttime extubation that could not be fully explored in the study, Dr. Gershengorn said.
“We were not able to identify the indication for extubation or discontinuation of mechanical ventilation. So one of the concerns that we have is that it’s probably more common that folks unintentionally extubate themselves or someone unintentionally extubates them overnight, when staffing is less,” she explained. “The other part, which we tried to adjust for but we don’t have perfect data on, is what is the staffing overnight,” including factors such as the ratio of nurses to patients and how many units an intensivist is covering, not just whether he or she is present.
“In terms of the reintubation risk being higher in the [group with longer duration of mechanical ventilation], the question I have is whether or not there is less comfort with somebody looking less well when there is less staff around, and whether or not there may be a quicker trigger to reintubate them if they don’t look so great,” she said.
The majority of intubated patients are unlikely to improve enough physiologically to prompt nighttime extubation rather than waiting until daytime, according to Dr. Gershengorn. But there are at least two groups whom clinicians might want to extubate at night.
One group is those who underwent elective surgery during the day. “They are waiting to come out of anesthesia, and the plan is to discontinue mechanical ventilation at the time that that occurs,” she explained. Another group is those who are agitated on the ventilator, require more sedation than usual, and suddenly awake at night. “These patients are really hard to keep comfortable. I can [sedate them] again and try this problem all over again tomorrow morning, or I can just bite the bullet and pull the tube out,” she said.
The investigators analyzed data from the Project IMPACT critical care medicine database, in which data are prospectively collected for benchmarking purposes. In all, they studied 97,844 mechanically ventilated adults from 165 medical and surgical ICUs across the United States between 2000 and 2009.
Results showed that nighttime extubation was more common among elective surgical patients, those coming from the operating room or a postanesthesia care unit, and those mechanically ventilated for less than 12 hours.
In a finding that Dr. Gershengorn described as surprising, there was a temporal trend by which the adjusted proportion of extubations performed at night actually decreased in more recent years during the study period.
The investigators next looked at outcomes among 10,279 propensity-matched pairs of patients, one member of the pair having been extubated during the night and the other having been extubated during the day.
Among those mechanically ventilated for less than 12 hours, nighttime extubation was associated with higher ICU mortality (5.6% vs. 4.6%; P = .025) and hospital mortality (8.3% vs. 7.0%; P = .014). Findings were inconsistent for length of stay, with nighttime extubation associated with a shorter ICU stay but a longer hospital stay.
Among patients mechanically ventilated for 12 hours or longer, those extubated during the night had a higher rate of reintubation (14.6% vs. 12.4%; P less than .001), as well as higher ICU mortality (11.2% vs. 6.1%; P less than .001) and hospital mortality (16.0% vs. 11.1%; P less than .001). Lengths of stay did not differ by extubation time of day in this group.
In sensitivity analyses, findings were similar when the definition of nighttime extubation was altered to the hours of midnight to 5 a.m. and when analyses were restricted to nonpalliative patients, according to Dr. Gershengorn, who disclosed that she had no relevant conflicts of interest.
SAN FRANCISCO – Mechanically ventilated patients in the intensive care unit (ICU) have poorer outcomes if extubated during the night instead of during the day, finds a retrospective cohort study reported at an international conference of the American Thoracic Society.
Overall, 20.1% of the nearly 98,000 adult patients studied were extubated during nighttime hours, between 7:00 p.m. and 7:00 a.m., according to data presented in a session and a related press conference.
Compared with patients extubated during daytime hours, patients extubated during nighttime hours had higher rates of ICU and hospital death, with the absolute difference ranging from 1.0% to 5.1%. Additionally, among those mechanically ventilated for at least 12 hours, nighttime extubation was associated with an absolute 2% increase in the risk of reintubation.
“I think this is the first large-scale study that looks at a practice that, although not as common as we thought it was, is still done about a fifth of the time and even with decreasing rates, is not a rare practice on our units,” commented lead author Dr. Hayley B. Gershengorn of the department of medicine (critical care) and the Saul R. Korey department of neurology at the Albert Einstein College of Medicine, New York.
“As we have increasing staffing [overnight] and maybe an increasing push to move people through our ICUs, we need to probably take some care because although we can’t demonstrate a causal link, it is quite concerning, this consistent finding of increased mortality and reintubation in these folks,” she said.
There are several possible reasons for the observed heightened risks of death and reintubation with nighttime extubation that could not be fully explored in the study, Dr. Gershengorn said.
“We were not able to identify the indication for extubation or discontinuation of mechanical ventilation. So one of the concerns that we have is that it’s probably more common that folks unintentionally extubate themselves or someone unintentionally extubates them overnight, when staffing is less,” she explained. “The other part, which we tried to adjust for but we don’t have perfect data on, is what is the staffing overnight,” including factors such as the ratio of nurses to patients and how many units an intensivist is covering, not just whether he or she is present.
“In terms of the reintubation risk being higher in the [group with longer duration of mechanical ventilation], the question I have is whether or not there is less comfort with somebody looking less well when there is less staff around, and whether or not there may be a quicker trigger to reintubate them if they don’t look so great,” she said.
The majority of intubated patients are unlikely to improve enough physiologically to prompt nighttime extubation rather than waiting until daytime, according to Dr. Gershengorn. But there are at least two groups whom clinicians might want to extubate at night.
One group is those who underwent elective surgery during the day. “They are waiting to come out of anesthesia, and the plan is to discontinue mechanical ventilation at the time that that occurs,” she explained. Another group is those who are agitated on the ventilator, require more sedation than usual, and suddenly awake at night. “These patients are really hard to keep comfortable. I can [sedate them] again and try this problem all over again tomorrow morning, or I can just bite the bullet and pull the tube out,” she said.
The investigators analyzed data from the Project IMPACT critical care medicine database, in which data are prospectively collected for benchmarking purposes. In all, they studied 97,844 mechanically ventilated adults from 165 medical and surgical ICUs across the United States between 2000 and 2009.
Results showed that nighttime extubation was more common among elective surgical patients, those coming from the operating room or a postanesthesia care unit, and those mechanically ventilated for less than 12 hours.
In a finding that Dr. Gershengorn described as surprising, there was a temporal trend by which the adjusted proportion of extubations performed at night actually decreased in more recent years during the study period.
The investigators next looked at outcomes among 10,279 propensity-matched pairs of patients, one member of the pair having been extubated during the night and the other having been extubated during the day.
Among those mechanically ventilated for less than 12 hours, nighttime extubation was associated with higher ICU mortality (5.6% vs. 4.6%; P = .025) and hospital mortality (8.3% vs. 7.0%; P = .014). Findings were inconsistent for length of stay, with nighttime extubation associated with a shorter ICU stay but a longer hospital stay.
Among patients mechanically ventilated for 12 hours or longer, those extubated during the night had a higher rate of reintubation (14.6% vs. 12.4%; P less than .001), as well as higher ICU mortality (11.2% vs. 6.1%; P less than .001) and hospital mortality (16.0% vs. 11.1%; P less than .001). Lengths of stay did not differ by extubation time of day in this group.
In sensitivity analyses, findings were similar when the definition of nighttime extubation was altered to the hours of midnight to 5 a.m. and when analyses were restricted to nonpalliative patients, according to Dr. Gershengorn, who disclosed that she had no relevant conflicts of interest.
SAN FRANCISCO – Mechanically ventilated patients in the intensive care unit (ICU) have poorer outcomes if extubated during the night instead of during the day, finds a retrospective cohort study reported at an international conference of the American Thoracic Society.
Overall, 20.1% of the nearly 98,000 adult patients studied were extubated during nighttime hours, between 7:00 p.m. and 7:00 a.m., according to data presented in a session and a related press conference.
Compared with patients extubated during daytime hours, patients extubated during nighttime hours had higher rates of ICU and hospital death, with the absolute difference ranging from 1.0% to 5.1%. Additionally, among those mechanically ventilated for at least 12 hours, nighttime extubation was associated with an absolute 2% increase in the risk of reintubation.
“I think this is the first large-scale study that looks at a practice that, although not as common as we thought it was, is still done about a fifth of the time and even with decreasing rates, is not a rare practice on our units,” commented lead author Dr. Hayley B. Gershengorn of the department of medicine (critical care) and the Saul R. Korey department of neurology at the Albert Einstein College of Medicine, New York.
“As we have increasing staffing [overnight] and maybe an increasing push to move people through our ICUs, we need to probably take some care because although we can’t demonstrate a causal link, it is quite concerning, this consistent finding of increased mortality and reintubation in these folks,” she said.
There are several possible reasons for the observed heightened risks of death and reintubation with nighttime extubation that could not be fully explored in the study, Dr. Gershengorn said.
“We were not able to identify the indication for extubation or discontinuation of mechanical ventilation. So one of the concerns that we have is that it’s probably more common that folks unintentionally extubate themselves or someone unintentionally extubates them overnight, when staffing is less,” she explained. “The other part, which we tried to adjust for but we don’t have perfect data on, is what is the staffing overnight,” including factors such as the ratio of nurses to patients and how many units an intensivist is covering, not just whether he or she is present.
“In terms of the reintubation risk being higher in the [group with longer duration of mechanical ventilation], the question I have is whether or not there is less comfort with somebody looking less well when there is less staff around, and whether or not there may be a quicker trigger to reintubate them if they don’t look so great,” she said.
The majority of intubated patients are unlikely to improve enough physiologically to prompt nighttime extubation rather than waiting until daytime, according to Dr. Gershengorn. But there are at least two groups whom clinicians might want to extubate at night.
One group is those who underwent elective surgery during the day. “They are waiting to come out of anesthesia, and the plan is to discontinue mechanical ventilation at the time that that occurs,” she explained. Another group is those who are agitated on the ventilator, require more sedation than usual, and suddenly awake at night. “These patients are really hard to keep comfortable. I can [sedate them] again and try this problem all over again tomorrow morning, or I can just bite the bullet and pull the tube out,” she said.
The investigators analyzed data from the Project IMPACT critical care medicine database, in which data are prospectively collected for benchmarking purposes. In all, they studied 97,844 mechanically ventilated adults from 165 medical and surgical ICUs across the United States between 2000 and 2009.
Results showed that nighttime extubation was more common among elective surgical patients, those coming from the operating room or a postanesthesia care unit, and those mechanically ventilated for less than 12 hours.
In a finding that Dr. Gershengorn described as surprising, there was a temporal trend by which the adjusted proportion of extubations performed at night actually decreased in more recent years during the study period.
The investigators next looked at outcomes among 10,279 propensity-matched pairs of patients, one member of the pair having been extubated during the night and the other having been extubated during the day.
Among those mechanically ventilated for less than 12 hours, nighttime extubation was associated with higher ICU mortality (5.6% vs. 4.6%; P = .025) and hospital mortality (8.3% vs. 7.0%; P = .014). Findings were inconsistent for length of stay, with nighttime extubation associated with a shorter ICU stay but a longer hospital stay.
Among patients mechanically ventilated for 12 hours or longer, those extubated during the night had a higher rate of reintubation (14.6% vs. 12.4%; P less than .001), as well as higher ICU mortality (11.2% vs. 6.1%; P less than .001) and hospital mortality (16.0% vs. 11.1%; P less than .001). Lengths of stay did not differ by extubation time of day in this group.
In sensitivity analyses, findings were similar when the definition of nighttime extubation was altered to the hours of midnight to 5 a.m. and when analyses were restricted to nonpalliative patients, according to Dr. Gershengorn, who disclosed that she had no relevant conflicts of interest.
AT ATS 2016
Key clinical point: Mechanically ventilated ICU patients have poorer outcomes if they are extubated during the night instead of during the day.
Major finding: Compared with patients extubated during daytime hours, patients extubated during nighttime hours had higher rates of ICU and hospital death, with the absolute difference ranging from 1.0% to 5.1%.
Data source: A retrospective cohort study of 97,844 mechanically ventilated adult patients from 165 ICUs in the United States.
Disclosures: Dr. Gershengorn disclosed that she had no relevant conflicts of interest.
LAA occlusion studied for stroke prevention in atrial fib with prior intracerebral hemorrhage
PARIS – Transcatheter left atrial appendage occlusion shows promise in providing a far better stroke prevention strategy than does standard medical management in patients with atrial fibrillation who have had a prior intracerebral hemorrhage, Dr. Jens E. Nielsen-Kudsk reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
“This is a difficult group of patients because there is no consensus on how to treat patients with atrial fibrillation after an intracerebral hemorrhage. They are very often left without any antithrombotic therapy because physicians and the patients themselves fear to resume anticoagulant therapy. Left atrial appendage occlusion is a nice nonpharmacologic way to obtain stroke prevention,” said Dr. Nielsen-Kudsk of Aarhus (Denmark) University.
He presented a propensity-matched follow-up study of 147 pairs of such patients at seven Nordic heart centers. Half received the percutaneously delivered St. Jude Medical Amplatzer Amulet device, which is approved in Europe for stroke prevention in patients with atrial fibrillation (AF). These 147 device recipients were matched for stroke risk by CHA2DS2-VASc score and for bleeding risk by HASBLED score with 147 patients with AF and a prior intracerebral hemorrhage who received standard medical therapy, ranging from warfarin or a novel oral anticoagulant in nearly half of patients to no antithrombotic therapy in 44%. The Amplatzer recipients were most often placed on aspirin for 6 months afterward unless they had an indication for continued aspirin, such as known coronary artery disease.
During a mean of 166 days of follow-up, the primary study endpoint – a composite of ischemic stroke, major bleeding, or death – occurred in the standard medical therapy group at a rate of 278.9 events per 1,000 patient-years, compared with 47.9 per 1,000 patient-years in patients with left atrial appendage occlusion (LAAO). This translates to an 81% relative risk reduction.
Moreover, the risk of ischemic stroke in the LAAO group was reduced by 65%, major bleeding was reduced by 61%, the rate of intracerebral hemorrhage was reduced by 71%, and mortality was decreased by 92%, the cardiologist continued.
On the basis of these encouraging results, a randomized, prospective clinical trial of LAAO using the Amplatzer device versus standard medical therapy in patients with AF and a prior intracerebral hemorrhage will get underway in the Nordic countries within the next several months. It will be called STROKECLOSE, he added.
Asked if the Watchman, the only LAAO device approved in the United States, might be similarly amenable for stroke prevention in this high-stroke-and-bleeding-risk population, Dr. Nielsen-Kudsk said in theory, yes, but the device’s labeling calls for an initial 45 days of anticoagulation therapy. That’s a daunting prospect in patients who’ve already had an intracerebral bleed, he observed.
Dr. Nicolo Piazza, who chaired a press conference where the Nordic study was highlighted, said the Watchman labeling needn’t be a deal breaker.
“Although the Watchman recommendations suggest an anticoagulant for the first 45 days afterward, real-world practice is not necessarily that. Many of those patients are put on dual-antiplatelet therapy or a single antiplatelet agent for a period of 45 days, 3 months, 6 months – it’s very heterogeneous out there,” said Dr. Piazza of McGill University in Montreal.
He added that STROKEBLED will be a very important trial in terms of providing guidance for daily clinical practice. A propensity matched-pairs analysis can’t be considered the final word because of the possibility of unrecognized and unmatched variables that could affect outcomes.
Dr. Nielsen-Kudsk reported receiving research grants from and serving as a consultant to St. Jude Medical.
PARIS – Transcatheter left atrial appendage occlusion shows promise in providing a far better stroke prevention strategy than does standard medical management in patients with atrial fibrillation who have had a prior intracerebral hemorrhage, Dr. Jens E. Nielsen-Kudsk reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
“This is a difficult group of patients because there is no consensus on how to treat patients with atrial fibrillation after an intracerebral hemorrhage. They are very often left without any antithrombotic therapy because physicians and the patients themselves fear to resume anticoagulant therapy. Left atrial appendage occlusion is a nice nonpharmacologic way to obtain stroke prevention,” said Dr. Nielsen-Kudsk of Aarhus (Denmark) University.
He presented a propensity-matched follow-up study of 147 pairs of such patients at seven Nordic heart centers. Half received the percutaneously delivered St. Jude Medical Amplatzer Amulet device, which is approved in Europe for stroke prevention in patients with atrial fibrillation (AF). These 147 device recipients were matched for stroke risk by CHA2DS2-VASc score and for bleeding risk by HASBLED score with 147 patients with AF and a prior intracerebral hemorrhage who received standard medical therapy, ranging from warfarin or a novel oral anticoagulant in nearly half of patients to no antithrombotic therapy in 44%. The Amplatzer recipients were most often placed on aspirin for 6 months afterward unless they had an indication for continued aspirin, such as known coronary artery disease.
During a mean of 166 days of follow-up, the primary study endpoint – a composite of ischemic stroke, major bleeding, or death – occurred in the standard medical therapy group at a rate of 278.9 events per 1,000 patient-years, compared with 47.9 per 1,000 patient-years in patients with left atrial appendage occlusion (LAAO). This translates to an 81% relative risk reduction.
Moreover, the risk of ischemic stroke in the LAAO group was reduced by 65%, major bleeding was reduced by 61%, the rate of intracerebral hemorrhage was reduced by 71%, and mortality was decreased by 92%, the cardiologist continued.
On the basis of these encouraging results, a randomized, prospective clinical trial of LAAO using the Amplatzer device versus standard medical therapy in patients with AF and a prior intracerebral hemorrhage will get underway in the Nordic countries within the next several months. It will be called STROKECLOSE, he added.
Asked if the Watchman, the only LAAO device approved in the United States, might be similarly amenable for stroke prevention in this high-stroke-and-bleeding-risk population, Dr. Nielsen-Kudsk said in theory, yes, but the device’s labeling calls for an initial 45 days of anticoagulation therapy. That’s a daunting prospect in patients who’ve already had an intracerebral bleed, he observed.
Dr. Nicolo Piazza, who chaired a press conference where the Nordic study was highlighted, said the Watchman labeling needn’t be a deal breaker.
“Although the Watchman recommendations suggest an anticoagulant for the first 45 days afterward, real-world practice is not necessarily that. Many of those patients are put on dual-antiplatelet therapy or a single antiplatelet agent for a period of 45 days, 3 months, 6 months – it’s very heterogeneous out there,” said Dr. Piazza of McGill University in Montreal.
He added that STROKEBLED will be a very important trial in terms of providing guidance for daily clinical practice. A propensity matched-pairs analysis can’t be considered the final word because of the possibility of unrecognized and unmatched variables that could affect outcomes.
Dr. Nielsen-Kudsk reported receiving research grants from and serving as a consultant to St. Jude Medical.
PARIS – Transcatheter left atrial appendage occlusion shows promise in providing a far better stroke prevention strategy than does standard medical management in patients with atrial fibrillation who have had a prior intracerebral hemorrhage, Dr. Jens E. Nielsen-Kudsk reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
“This is a difficult group of patients because there is no consensus on how to treat patients with atrial fibrillation after an intracerebral hemorrhage. They are very often left without any antithrombotic therapy because physicians and the patients themselves fear to resume anticoagulant therapy. Left atrial appendage occlusion is a nice nonpharmacologic way to obtain stroke prevention,” said Dr. Nielsen-Kudsk of Aarhus (Denmark) University.
He presented a propensity-matched follow-up study of 147 pairs of such patients at seven Nordic heart centers. Half received the percutaneously delivered St. Jude Medical Amplatzer Amulet device, which is approved in Europe for stroke prevention in patients with atrial fibrillation (AF). These 147 device recipients were matched for stroke risk by CHA2DS2-VASc score and for bleeding risk by HASBLED score with 147 patients with AF and a prior intracerebral hemorrhage who received standard medical therapy, ranging from warfarin or a novel oral anticoagulant in nearly half of patients to no antithrombotic therapy in 44%. The Amplatzer recipients were most often placed on aspirin for 6 months afterward unless they had an indication for continued aspirin, such as known coronary artery disease.
During a mean of 166 days of follow-up, the primary study endpoint – a composite of ischemic stroke, major bleeding, or death – occurred in the standard medical therapy group at a rate of 278.9 events per 1,000 patient-years, compared with 47.9 per 1,000 patient-years in patients with left atrial appendage occlusion (LAAO). This translates to an 81% relative risk reduction.
Moreover, the risk of ischemic stroke in the LAAO group was reduced by 65%, major bleeding was reduced by 61%, the rate of intracerebral hemorrhage was reduced by 71%, and mortality was decreased by 92%, the cardiologist continued.
On the basis of these encouraging results, a randomized, prospective clinical trial of LAAO using the Amplatzer device versus standard medical therapy in patients with AF and a prior intracerebral hemorrhage will get underway in the Nordic countries within the next several months. It will be called STROKECLOSE, he added.
Asked if the Watchman, the only LAAO device approved in the United States, might be similarly amenable for stroke prevention in this high-stroke-and-bleeding-risk population, Dr. Nielsen-Kudsk said in theory, yes, but the device’s labeling calls for an initial 45 days of anticoagulation therapy. That’s a daunting prospect in patients who’ve already had an intracerebral bleed, he observed.
Dr. Nicolo Piazza, who chaired a press conference where the Nordic study was highlighted, said the Watchman labeling needn’t be a deal breaker.
“Although the Watchman recommendations suggest an anticoagulant for the first 45 days afterward, real-world practice is not necessarily that. Many of those patients are put on dual-antiplatelet therapy or a single antiplatelet agent for a period of 45 days, 3 months, 6 months – it’s very heterogeneous out there,” said Dr. Piazza of McGill University in Montreal.
He added that STROKEBLED will be a very important trial in terms of providing guidance for daily clinical practice. A propensity matched-pairs analysis can’t be considered the final word because of the possibility of unrecognized and unmatched variables that could affect outcomes.
Dr. Nielsen-Kudsk reported receiving research grants from and serving as a consultant to St. Jude Medical.
AT EUROPCR 2016
Key clinical point: Left atrial appendage occlusion appears to be better than medical management for stroke prevention in patients with AF and prior intracerebral hemorrhage.
Major finding: The risk of a combined endpoint of ischemic stroke, major bleeding, or death during follow-up was 81% lower in patients with atrial fibrillation and a prior intracerebral hemorrhage treated with a transcatheter left atrial appendage occlusion device than in controls on standard medical therapy.
Data source: This study included 147 patient pairs propensity-matched for stroke and bleeding risk.
Disclosures: The study presenter reported receiving research grants from and serving as a consultant to St. Jude Medical.
Optical coherence tomography for PCI gets boost in OPINION trial
PARIS – The first-ever head-to-head randomized trial comparing clinical outcomes of optical coherence tomography and intravascular ultrasound (IVUS) for guidance of percutaneous coronary intervention with a second-generation drug-eluting stent has ended in a draw.
“The clinical outcomes in both OCT-guided PCI and IVUS-guided PCI were excellent in the OPINION study,” Dr. Takashi Kubo reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
The form of OCT used in this randomized trial is called optimal frequency domain imaging (OFDI). On the strength of the OPINION results, OFDI deserves to get an upgrade in the PCI treatment guidelines, said Dr. Kubo of Wakayama (Japan) University.
He noted that the 2014 European Society of Cardiology guidelines give IVUS a Class IIa recommendation in selected patients to optimize stent implantation, with a Level of Evidence of B (Eur Heart J. 2014 Oct 1;35:2541-619). The guidelines give OCT (optimal coherence tomography), the more recent and less-studied technology, a Class IIb, Level of Evidence C.
“Our results might influence the next ESC guidelines,” according to Dr. Kubo. “OCT use during PCI should have a Class IIa recommendation.”
The OPINION trial was a prospective, 42-site Japanese study in which 800 patients scheduled for PCI with the Terumo Nobori biolimus-eluting resorbable polymer stent were randomized to an OFDI- or IVUS-guided procedure. All participants underwent follow-up coronary angiography at 8 months and clinical assessment at 12 months.
The primary study endpoint was target vessel failure at 12 months post-PCI, a composite comprising cardiac death, target vessel–related MI, or clinically driven target vessel revascularization. The rate was 5.2% in the OFDI group and statistically similar at 4.9% in the IVUS arm. No cases of contrast-induced nephropathy occurred in either study arm, and stroke rates in both groups were similarly low.
Also noteworthy was the finding that the two intracoronary imaging technologies resulted in similar rates of procedural change: 38% of patients in the OFDI group had a procedural change as result of the imaging findings, as did 36% of the IVUS group. Examples of these procedural changes included upsizing the pre- or postdilatation balloon size or pressure, addition of an another stent, or the use of a distal protection device.
In Japan, where both OCT and IVUS during PCI are routinely reimbursed, roughly 80% of PCI patients undergo one of the two intracoronary imaging procedures. In the United States and Europe, the situation is reversed, Dr. Kubo observed.
Discussant Dr. Ron Waksman agreed with Dr. Kubo that the OPINION results warrant reconsideration of OCT’s Class IIb recommendation in the ESC PCI guidelines. But he thinks the study has a major limitation.
“In my view, this was a missed opportunity to include an angiographically guided PCI arm to establish the superiority of invasive imaging over angiographically guided PCI,” said Dr. Waksman of the MedStar Heart Institute in Washington. While he noted that a recent meta-analysis of 20 studies in more than 29,000 patients concluded that IVUS-guided implantation of drug-eluting stents was associated with a 38% reduction in the risk of mortality, a 23% decrease in major adverse cardiovascular events, and a 41% reduction in stent thrombosis, compared with angiographically guided PCI (BMC Cardiovasc Disord. 2015 Nov 17;15:153), given the inherent limitations of meta-analyses he’s not convinced that cardiologists really need imaging guidance.
“ILUMIEN III, to my view, is the right study design because it randomizes patients to OCT guidance, IVUS guidance, or angiographic guidance to see if there are important differences. We will have to wait for the ILUMIEN III study results to prove the superiority of invasive imaging over angiographically guided PCI,” according to Dr. Waksman.
It’s anticipated that the ILUMIEN III trial will be ready for presentation at EuroPCR 2017.
The OPINION trial was sponsored by Terumo. Dr. Kubo is a consultant to and recipient of an institutional research grant from the company.
PARIS – The first-ever head-to-head randomized trial comparing clinical outcomes of optical coherence tomography and intravascular ultrasound (IVUS) for guidance of percutaneous coronary intervention with a second-generation drug-eluting stent has ended in a draw.
“The clinical outcomes in both OCT-guided PCI and IVUS-guided PCI were excellent in the OPINION study,” Dr. Takashi Kubo reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
The form of OCT used in this randomized trial is called optimal frequency domain imaging (OFDI). On the strength of the OPINION results, OFDI deserves to get an upgrade in the PCI treatment guidelines, said Dr. Kubo of Wakayama (Japan) University.
He noted that the 2014 European Society of Cardiology guidelines give IVUS a Class IIa recommendation in selected patients to optimize stent implantation, with a Level of Evidence of B (Eur Heart J. 2014 Oct 1;35:2541-619). The guidelines give OCT (optimal coherence tomography), the more recent and less-studied technology, a Class IIb, Level of Evidence C.
“Our results might influence the next ESC guidelines,” according to Dr. Kubo. “OCT use during PCI should have a Class IIa recommendation.”
The OPINION trial was a prospective, 42-site Japanese study in which 800 patients scheduled for PCI with the Terumo Nobori biolimus-eluting resorbable polymer stent were randomized to an OFDI- or IVUS-guided procedure. All participants underwent follow-up coronary angiography at 8 months and clinical assessment at 12 months.
The primary study endpoint was target vessel failure at 12 months post-PCI, a composite comprising cardiac death, target vessel–related MI, or clinically driven target vessel revascularization. The rate was 5.2% in the OFDI group and statistically similar at 4.9% in the IVUS arm. No cases of contrast-induced nephropathy occurred in either study arm, and stroke rates in both groups were similarly low.
Also noteworthy was the finding that the two intracoronary imaging technologies resulted in similar rates of procedural change: 38% of patients in the OFDI group had a procedural change as result of the imaging findings, as did 36% of the IVUS group. Examples of these procedural changes included upsizing the pre- or postdilatation balloon size or pressure, addition of an another stent, or the use of a distal protection device.
In Japan, where both OCT and IVUS during PCI are routinely reimbursed, roughly 80% of PCI patients undergo one of the two intracoronary imaging procedures. In the United States and Europe, the situation is reversed, Dr. Kubo observed.
Discussant Dr. Ron Waksman agreed with Dr. Kubo that the OPINION results warrant reconsideration of OCT’s Class IIb recommendation in the ESC PCI guidelines. But he thinks the study has a major limitation.
“In my view, this was a missed opportunity to include an angiographically guided PCI arm to establish the superiority of invasive imaging over angiographically guided PCI,” said Dr. Waksman of the MedStar Heart Institute in Washington. While he noted that a recent meta-analysis of 20 studies in more than 29,000 patients concluded that IVUS-guided implantation of drug-eluting stents was associated with a 38% reduction in the risk of mortality, a 23% decrease in major adverse cardiovascular events, and a 41% reduction in stent thrombosis, compared with angiographically guided PCI (BMC Cardiovasc Disord. 2015 Nov 17;15:153), given the inherent limitations of meta-analyses he’s not convinced that cardiologists really need imaging guidance.
“ILUMIEN III, to my view, is the right study design because it randomizes patients to OCT guidance, IVUS guidance, or angiographic guidance to see if there are important differences. We will have to wait for the ILUMIEN III study results to prove the superiority of invasive imaging over angiographically guided PCI,” according to Dr. Waksman.
It’s anticipated that the ILUMIEN III trial will be ready for presentation at EuroPCR 2017.
The OPINION trial was sponsored by Terumo. Dr. Kubo is a consultant to and recipient of an institutional research grant from the company.
PARIS – The first-ever head-to-head randomized trial comparing clinical outcomes of optical coherence tomography and intravascular ultrasound (IVUS) for guidance of percutaneous coronary intervention with a second-generation drug-eluting stent has ended in a draw.
“The clinical outcomes in both OCT-guided PCI and IVUS-guided PCI were excellent in the OPINION study,” Dr. Takashi Kubo reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
The form of OCT used in this randomized trial is called optimal frequency domain imaging (OFDI). On the strength of the OPINION results, OFDI deserves to get an upgrade in the PCI treatment guidelines, said Dr. Kubo of Wakayama (Japan) University.
He noted that the 2014 European Society of Cardiology guidelines give IVUS a Class IIa recommendation in selected patients to optimize stent implantation, with a Level of Evidence of B (Eur Heart J. 2014 Oct 1;35:2541-619). The guidelines give OCT (optimal coherence tomography), the more recent and less-studied technology, a Class IIb, Level of Evidence C.
“Our results might influence the next ESC guidelines,” according to Dr. Kubo. “OCT use during PCI should have a Class IIa recommendation.”
The OPINION trial was a prospective, 42-site Japanese study in which 800 patients scheduled for PCI with the Terumo Nobori biolimus-eluting resorbable polymer stent were randomized to an OFDI- or IVUS-guided procedure. All participants underwent follow-up coronary angiography at 8 months and clinical assessment at 12 months.
The primary study endpoint was target vessel failure at 12 months post-PCI, a composite comprising cardiac death, target vessel–related MI, or clinically driven target vessel revascularization. The rate was 5.2% in the OFDI group and statistically similar at 4.9% in the IVUS arm. No cases of contrast-induced nephropathy occurred in either study arm, and stroke rates in both groups were similarly low.
Also noteworthy was the finding that the two intracoronary imaging technologies resulted in similar rates of procedural change: 38% of patients in the OFDI group had a procedural change as result of the imaging findings, as did 36% of the IVUS group. Examples of these procedural changes included upsizing the pre- or postdilatation balloon size or pressure, addition of an another stent, or the use of a distal protection device.
In Japan, where both OCT and IVUS during PCI are routinely reimbursed, roughly 80% of PCI patients undergo one of the two intracoronary imaging procedures. In the United States and Europe, the situation is reversed, Dr. Kubo observed.
Discussant Dr. Ron Waksman agreed with Dr. Kubo that the OPINION results warrant reconsideration of OCT’s Class IIb recommendation in the ESC PCI guidelines. But he thinks the study has a major limitation.
“In my view, this was a missed opportunity to include an angiographically guided PCI arm to establish the superiority of invasive imaging over angiographically guided PCI,” said Dr. Waksman of the MedStar Heart Institute in Washington. While he noted that a recent meta-analysis of 20 studies in more than 29,000 patients concluded that IVUS-guided implantation of drug-eluting stents was associated with a 38% reduction in the risk of mortality, a 23% decrease in major adverse cardiovascular events, and a 41% reduction in stent thrombosis, compared with angiographically guided PCI (BMC Cardiovasc Disord. 2015 Nov 17;15:153), given the inherent limitations of meta-analyses he’s not convinced that cardiologists really need imaging guidance.
“ILUMIEN III, to my view, is the right study design because it randomizes patients to OCT guidance, IVUS guidance, or angiographic guidance to see if there are important differences. We will have to wait for the ILUMIEN III study results to prove the superiority of invasive imaging over angiographically guided PCI,” according to Dr. Waksman.
It’s anticipated that the ILUMIEN III trial will be ready for presentation at EuroPCR 2017.
The OPINION trial was sponsored by Terumo. Dr. Kubo is a consultant to and recipient of an institutional research grant from the company.
AT EUROPCR 2016
Key clinical point: A large, randomized trial shows PCI clinical outcomes are equivalent with optical coherence tomography and intravascular ultrasound guidance.
Major finding: The composite rate of cardiac death, target vessel–related MI, or clinically driven target vessel revascularization within 12 months of PCI was 5.2% in the group whose procedure was guided by optical coherence tomography and statistically similar at 4.9% in patients whose PCI was guided by intravascular ultrasound.
Data source: This was a randomized, prospective, multicenter, 12-month follow-up trial of 800 Japanese patients scheduled for PCI under intracoronary imaging guidance provided by either IVUS or OCT.
Disclosures: The OPINION trial was sponsored by Terumo. The study presenter is a consultant to and recipient of an institutional research grant from the company.
PAWSS tool identifies alcohol withdrawal syndrome risk
ATLANTA – A new scale for predicting complicated alcohol withdrawal syndrome in hospitalized medically ill patients had high sensitivity and specificity in a prospective validation study.
The Prediction of Alcohol Withdrawal Severity Scale (PAWSS) can help clinicians identify those at risk for complicated alcohol withdrawal syndrome (AWS), and either prevent or treat complicated AWS in a timely manner, Dr. José R. Maldonado of Stanford (Calif.) University said at the annual meeting of the American Psychiatric Association.
In 403 subjects hospitalized to general medicine and surgery units over a 12-month period, the PAWSS – along with the Clinical Institute Withdrawal Assessment–alcohol revised (CIWA-Ar) and clinical monitoring – was administered daily. Using a cutoff score of 4 on the 0-10 point PAWSS, the tool had sensitivity and positive predictive value of 93.1%, and specificity and negative predictive value of 99.5% for identifying complicated AWS, Dr. Maldonado said, noting that the tool also had excellent inter-rater reliability.
The findings are important because the prevalence of alcohol use disorders among hospitalized medically ill patients exceeds 40%, he said, noting that medically ill patients with AWS tend to have a significant number of complications, which makes them “not only very difficult to treat but also very high risk.”
Importantly, seizures – commonly known as “rum fits,” which occur in 5%-15% of cases – happen very early on in the course of AWS. This is a concern, because it has implications for prescribing, Dr. Maldonado said.
Another concern, and “probably the most dreadful of them all,” is delirium tremens (DTs), a severe symptom of alcohol withdrawal that occurs in about 10% of patients with AWS.
The overall mortality associated with DTs is 1% in non–medically ill patients, but in the medically ill, this figure increases to 20% because of the frequency of comorbidities, such as heart disease and diabetes in this population. Also, DTs tend to occur a few days into withdrawal, peaking on day 5, which could be problematic; a trauma patient who is intubated in the operating room, for example, still could go through withdrawal a few days later, as most medications being used in that patient are not going to prevent it, he explained.
Previously, no tool was available to predict complicated AWS to prevent seizures and DTs. Existing tools such as the CIWA and AWS scale assess AWS severity but do not predict who will withdraw, he noted, explaining that by the time the CIWA scale is positive, the patient already is in withdrawal.
One option is to treat everyone with benzodiazepines or other drugs that facilitate GABA (gamma-aminobutyric acid) transmission in patients at risk of AWS, but this unnecessarily puts 80% of patients at risk of numerous side effects, including excessive sedation, falls, respiratory depression, and medication-induced delirium.
A benzodiazepine-sparing protocol, which involved the use of alpha-2 agonists and anticonvulsants instead of benzodiazepines, was being studied at Stanford, comparing outcomes in patients treated with and without benzodiazepines.
“But before we started to use alpha-2 agonists and anticonvulsants ... we wanted to make sure that we were actually treating the population that really needs it. That was the main motivation for creating this tool,” he said. “The other thing is we wanted to make sure that we don’t scare people away from treating patients with potential alcohol withdrawal, because the consequences of withdrawal are dreadful, not only immediately but also into the future.”
Every time someone goes through withdrawal, it is more severe than before, and it lowers the threshold for DTs, he added.
An extensive literature review for anything associated with the various phases of alcohol withdrawal was performed to help develop the PAWSS, which includes 10 highly predictive questions for any patients who first indicate that they have had alcohol in the prior 30 days, or who is admitted with a positive blood alcohol level test.
A pilot study involving 70 patients yielded a sensitivity and specificity of 100% each, leading to the larger study of hospitalized patients, which was published last year in Alcohol and Alcoholism (2015 May 21. doi: 10.1093/alcalc/agv043).
A check of admission notes would have increased the ultimate sensitivity of the scale to 100%, as false answers provided on the scale were easily identified. Blood alcohol level testing also would help.
But PAWSS is meant to provide timely information, which is important in patients at risk, and another purpose for developing PAWSS was to provide an affordable tool that can be used anywhere, including rural community hospitals or clinics where other tests might not be available, Dr. Maldonado said.
Currently, he and his colleagues are evaluating whether all 10 items on the scale are needed to make a diagnosis, or whether a shorter version would be equally useful.
“The incidence of alcoholism is extremely high. It is the most common drug problem in the United States, and we know that many physicians do not feel comfortable dealing with patients who have alcohol withdrawal,” Dr. Maldonado said, adding that this tool will simplify management.
For the Stanford study, patients with a negative PAWSS (score below 4) receive no treatment specifically for AWS. If they test positive (score of 4 or more), it is assumed that they will withdraw, and the AWS scale is administered to discriminate patients who are withdrawing from those at high risk of withdrawal. Patients with a positive PAWSS and a negative AWS scale or CIWA are directed to a prophylactic treatment arm. Those with a positive PAWSS and a positive AWS scale or CIWA are directed into a treatment arm, which involves more aggressive management.
The validation study was supported by the Chase Research Fund. Dr. Maldonado reported having no disclosures.
ATLANTA – A new scale for predicting complicated alcohol withdrawal syndrome in hospitalized medically ill patients had high sensitivity and specificity in a prospective validation study.
The Prediction of Alcohol Withdrawal Severity Scale (PAWSS) can help clinicians identify those at risk for complicated alcohol withdrawal syndrome (AWS), and either prevent or treat complicated AWS in a timely manner, Dr. José R. Maldonado of Stanford (Calif.) University said at the annual meeting of the American Psychiatric Association.
In 403 subjects hospitalized to general medicine and surgery units over a 12-month period, the PAWSS – along with the Clinical Institute Withdrawal Assessment–alcohol revised (CIWA-Ar) and clinical monitoring – was administered daily. Using a cutoff score of 4 on the 0-10 point PAWSS, the tool had sensitivity and positive predictive value of 93.1%, and specificity and negative predictive value of 99.5% for identifying complicated AWS, Dr. Maldonado said, noting that the tool also had excellent inter-rater reliability.
The findings are important because the prevalence of alcohol use disorders among hospitalized medically ill patients exceeds 40%, he said, noting that medically ill patients with AWS tend to have a significant number of complications, which makes them “not only very difficult to treat but also very high risk.”
Importantly, seizures – commonly known as “rum fits,” which occur in 5%-15% of cases – happen very early on in the course of AWS. This is a concern, because it has implications for prescribing, Dr. Maldonado said.
Another concern, and “probably the most dreadful of them all,” is delirium tremens (DTs), a severe symptom of alcohol withdrawal that occurs in about 10% of patients with AWS.
The overall mortality associated with DTs is 1% in non–medically ill patients, but in the medically ill, this figure increases to 20% because of the frequency of comorbidities, such as heart disease and diabetes in this population. Also, DTs tend to occur a few days into withdrawal, peaking on day 5, which could be problematic; a trauma patient who is intubated in the operating room, for example, still could go through withdrawal a few days later, as most medications being used in that patient are not going to prevent it, he explained.
Previously, no tool was available to predict complicated AWS to prevent seizures and DTs. Existing tools such as the CIWA and AWS scale assess AWS severity but do not predict who will withdraw, he noted, explaining that by the time the CIWA scale is positive, the patient already is in withdrawal.
One option is to treat everyone with benzodiazepines or other drugs that facilitate GABA (gamma-aminobutyric acid) transmission in patients at risk of AWS, but this unnecessarily puts 80% of patients at risk of numerous side effects, including excessive sedation, falls, respiratory depression, and medication-induced delirium.
A benzodiazepine-sparing protocol, which involved the use of alpha-2 agonists and anticonvulsants instead of benzodiazepines, was being studied at Stanford, comparing outcomes in patients treated with and without benzodiazepines.
“But before we started to use alpha-2 agonists and anticonvulsants ... we wanted to make sure that we were actually treating the population that really needs it. That was the main motivation for creating this tool,” he said. “The other thing is we wanted to make sure that we don’t scare people away from treating patients with potential alcohol withdrawal, because the consequences of withdrawal are dreadful, not only immediately but also into the future.”
Every time someone goes through withdrawal, it is more severe than before, and it lowers the threshold for DTs, he added.
An extensive literature review for anything associated with the various phases of alcohol withdrawal was performed to help develop the PAWSS, which includes 10 highly predictive questions for any patients who first indicate that they have had alcohol in the prior 30 days, or who is admitted with a positive blood alcohol level test.
A pilot study involving 70 patients yielded a sensitivity and specificity of 100% each, leading to the larger study of hospitalized patients, which was published last year in Alcohol and Alcoholism (2015 May 21. doi: 10.1093/alcalc/agv043).
A check of admission notes would have increased the ultimate sensitivity of the scale to 100%, as false answers provided on the scale were easily identified. Blood alcohol level testing also would help.
But PAWSS is meant to provide timely information, which is important in patients at risk, and another purpose for developing PAWSS was to provide an affordable tool that can be used anywhere, including rural community hospitals or clinics where other tests might not be available, Dr. Maldonado said.
Currently, he and his colleagues are evaluating whether all 10 items on the scale are needed to make a diagnosis, or whether a shorter version would be equally useful.
“The incidence of alcoholism is extremely high. It is the most common drug problem in the United States, and we know that many physicians do not feel comfortable dealing with patients who have alcohol withdrawal,” Dr. Maldonado said, adding that this tool will simplify management.
For the Stanford study, patients with a negative PAWSS (score below 4) receive no treatment specifically for AWS. If they test positive (score of 4 or more), it is assumed that they will withdraw, and the AWS scale is administered to discriminate patients who are withdrawing from those at high risk of withdrawal. Patients with a positive PAWSS and a negative AWS scale or CIWA are directed to a prophylactic treatment arm. Those with a positive PAWSS and a positive AWS scale or CIWA are directed into a treatment arm, which involves more aggressive management.
The validation study was supported by the Chase Research Fund. Dr. Maldonado reported having no disclosures.
ATLANTA – A new scale for predicting complicated alcohol withdrawal syndrome in hospitalized medically ill patients had high sensitivity and specificity in a prospective validation study.
The Prediction of Alcohol Withdrawal Severity Scale (PAWSS) can help clinicians identify those at risk for complicated alcohol withdrawal syndrome (AWS), and either prevent or treat complicated AWS in a timely manner, Dr. José R. Maldonado of Stanford (Calif.) University said at the annual meeting of the American Psychiatric Association.
In 403 subjects hospitalized to general medicine and surgery units over a 12-month period, the PAWSS – along with the Clinical Institute Withdrawal Assessment–alcohol revised (CIWA-Ar) and clinical monitoring – was administered daily. Using a cutoff score of 4 on the 0-10 point PAWSS, the tool had sensitivity and positive predictive value of 93.1%, and specificity and negative predictive value of 99.5% for identifying complicated AWS, Dr. Maldonado said, noting that the tool also had excellent inter-rater reliability.
The findings are important because the prevalence of alcohol use disorders among hospitalized medically ill patients exceeds 40%, he said, noting that medically ill patients with AWS tend to have a significant number of complications, which makes them “not only very difficult to treat but also very high risk.”
Importantly, seizures – commonly known as “rum fits,” which occur in 5%-15% of cases – happen very early on in the course of AWS. This is a concern, because it has implications for prescribing, Dr. Maldonado said.
Another concern, and “probably the most dreadful of them all,” is delirium tremens (DTs), a severe symptom of alcohol withdrawal that occurs in about 10% of patients with AWS.
The overall mortality associated with DTs is 1% in non–medically ill patients, but in the medically ill, this figure increases to 20% because of the frequency of comorbidities, such as heart disease and diabetes in this population. Also, DTs tend to occur a few days into withdrawal, peaking on day 5, which could be problematic; a trauma patient who is intubated in the operating room, for example, still could go through withdrawal a few days later, as most medications being used in that patient are not going to prevent it, he explained.
Previously, no tool was available to predict complicated AWS to prevent seizures and DTs. Existing tools such as the CIWA and AWS scale assess AWS severity but do not predict who will withdraw, he noted, explaining that by the time the CIWA scale is positive, the patient already is in withdrawal.
One option is to treat everyone with benzodiazepines or other drugs that facilitate GABA (gamma-aminobutyric acid) transmission in patients at risk of AWS, but this unnecessarily puts 80% of patients at risk of numerous side effects, including excessive sedation, falls, respiratory depression, and medication-induced delirium.
A benzodiazepine-sparing protocol, which involved the use of alpha-2 agonists and anticonvulsants instead of benzodiazepines, was being studied at Stanford, comparing outcomes in patients treated with and without benzodiazepines.
“But before we started to use alpha-2 agonists and anticonvulsants ... we wanted to make sure that we were actually treating the population that really needs it. That was the main motivation for creating this tool,” he said. “The other thing is we wanted to make sure that we don’t scare people away from treating patients with potential alcohol withdrawal, because the consequences of withdrawal are dreadful, not only immediately but also into the future.”
Every time someone goes through withdrawal, it is more severe than before, and it lowers the threshold for DTs, he added.
An extensive literature review for anything associated with the various phases of alcohol withdrawal was performed to help develop the PAWSS, which includes 10 highly predictive questions for any patients who first indicate that they have had alcohol in the prior 30 days, or who is admitted with a positive blood alcohol level test.
A pilot study involving 70 patients yielded a sensitivity and specificity of 100% each, leading to the larger study of hospitalized patients, which was published last year in Alcohol and Alcoholism (2015 May 21. doi: 10.1093/alcalc/agv043).
A check of admission notes would have increased the ultimate sensitivity of the scale to 100%, as false answers provided on the scale were easily identified. Blood alcohol level testing also would help.
But PAWSS is meant to provide timely information, which is important in patients at risk, and another purpose for developing PAWSS was to provide an affordable tool that can be used anywhere, including rural community hospitals or clinics where other tests might not be available, Dr. Maldonado said.
Currently, he and his colleagues are evaluating whether all 10 items on the scale are needed to make a diagnosis, or whether a shorter version would be equally useful.
“The incidence of alcoholism is extremely high. It is the most common drug problem in the United States, and we know that many physicians do not feel comfortable dealing with patients who have alcohol withdrawal,” Dr. Maldonado said, adding that this tool will simplify management.
For the Stanford study, patients with a negative PAWSS (score below 4) receive no treatment specifically for AWS. If they test positive (score of 4 or more), it is assumed that they will withdraw, and the AWS scale is administered to discriminate patients who are withdrawing from those at high risk of withdrawal. Patients with a positive PAWSS and a negative AWS scale or CIWA are directed to a prophylactic treatment arm. Those with a positive PAWSS and a positive AWS scale or CIWA are directed into a treatment arm, which involves more aggressive management.
The validation study was supported by the Chase Research Fund. Dr. Maldonado reported having no disclosures.
AT THE APA ANNUAL MEETING
Key clinical point: A new scale for predicting complicated alcohol withdrawal syndrome in hospitalized medically ill patients had high sensitivity and specificity in a prospective validation study.
Major finding: The PAWSS had sensitivity and positive predictive value of 93.1%, and specificity and negative predictive value of 99.5% for identifying complicated AWS.
Data source: A prospective validation study in 403 hospitalized patients.
Disclosures: Dr. Maldonado reported having no disclosures.