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Simulations may improve intraoperative handoffs
SAN FRANCISCO – A 1-day course with simulated intraoperative handoffs improved the rate of failed communications from 30% before the course to 17% immediately after the course, with a further improvement 1 year later to a 13% failure rate in a study of 10 anesthesiology residents.
The course combined simulation-based education, which has been used previously to train residents on postoperative handoffs, and deliberate practice, an educational strategy that has been used previously to teach technical skills to residents. Each resident in the study performed a simulated intraoperative handoff, followed by a debriefing with the whole group and individual feedback on the handoff performance. Participants together discussed barriers to effective communication and created an intraoperative handoff checklist. Each resident then repeated a simulated handoff to practice with the checklist.
One year later, 7 of the 10 residents did another simulated intraoperative handoff that was recorded on video and scored by trained raters using a handoff assessment tool to characterize the type and frequency of communication failures.
Before the course, none of the 10 residents knew the Joint Commission definition of a handoff, and none knew that patient handoff communication was a patient safety goal of the Joint Commission. A year later, all seven residents could accurately define the Joint Commission goal, Dr. Erin W. Pukenas reported in a poster presentation at the annual meeting of the American Society of Anesthesiologists.
At the beginning of the course, residents had set individual communication goals for handoffs. Forty-six percent said they wanted to develop a more systematic approach to their handoffs, and 31% wanted to be more thorough in their handoffs. A year later, all residents said they had met or exceeded their goals, reported Dr. Pukenas of Rowan University, Camden, N.J.
The study was the first to assess retention of knowledge and skills 1 year after the course was added to the curriculum, she said.
Investigators may next study the effects of simulation-based handoff education and deliberate practice on handoff communications in clinical settings, she said.
The Accreditation Council for Graduate Medical Education requires handoff training for all medical residents.
Dr. Pukenas reported having no relevant financial disclosures.
On Twitter @sherryboschert
SAN FRANCISCO – A 1-day course with simulated intraoperative handoffs improved the rate of failed communications from 30% before the course to 17% immediately after the course, with a further improvement 1 year later to a 13% failure rate in a study of 10 anesthesiology residents.
The course combined simulation-based education, which has been used previously to train residents on postoperative handoffs, and deliberate practice, an educational strategy that has been used previously to teach technical skills to residents. Each resident in the study performed a simulated intraoperative handoff, followed by a debriefing with the whole group and individual feedback on the handoff performance. Participants together discussed barriers to effective communication and created an intraoperative handoff checklist. Each resident then repeated a simulated handoff to practice with the checklist.
One year later, 7 of the 10 residents did another simulated intraoperative handoff that was recorded on video and scored by trained raters using a handoff assessment tool to characterize the type and frequency of communication failures.
Before the course, none of the 10 residents knew the Joint Commission definition of a handoff, and none knew that patient handoff communication was a patient safety goal of the Joint Commission. A year later, all seven residents could accurately define the Joint Commission goal, Dr. Erin W. Pukenas reported in a poster presentation at the annual meeting of the American Society of Anesthesiologists.
At the beginning of the course, residents had set individual communication goals for handoffs. Forty-six percent said they wanted to develop a more systematic approach to their handoffs, and 31% wanted to be more thorough in their handoffs. A year later, all residents said they had met or exceeded their goals, reported Dr. Pukenas of Rowan University, Camden, N.J.
The study was the first to assess retention of knowledge and skills 1 year after the course was added to the curriculum, she said.
Investigators may next study the effects of simulation-based handoff education and deliberate practice on handoff communications in clinical settings, she said.
The Accreditation Council for Graduate Medical Education requires handoff training for all medical residents.
Dr. Pukenas reported having no relevant financial disclosures.
On Twitter @sherryboschert
SAN FRANCISCO – A 1-day course with simulated intraoperative handoffs improved the rate of failed communications from 30% before the course to 17% immediately after the course, with a further improvement 1 year later to a 13% failure rate in a study of 10 anesthesiology residents.
The course combined simulation-based education, which has been used previously to train residents on postoperative handoffs, and deliberate practice, an educational strategy that has been used previously to teach technical skills to residents. Each resident in the study performed a simulated intraoperative handoff, followed by a debriefing with the whole group and individual feedback on the handoff performance. Participants together discussed barriers to effective communication and created an intraoperative handoff checklist. Each resident then repeated a simulated handoff to practice with the checklist.
One year later, 7 of the 10 residents did another simulated intraoperative handoff that was recorded on video and scored by trained raters using a handoff assessment tool to characterize the type and frequency of communication failures.
Before the course, none of the 10 residents knew the Joint Commission definition of a handoff, and none knew that patient handoff communication was a patient safety goal of the Joint Commission. A year later, all seven residents could accurately define the Joint Commission goal, Dr. Erin W. Pukenas reported in a poster presentation at the annual meeting of the American Society of Anesthesiologists.
At the beginning of the course, residents had set individual communication goals for handoffs. Forty-six percent said they wanted to develop a more systematic approach to their handoffs, and 31% wanted to be more thorough in their handoffs. A year later, all residents said they had met or exceeded their goals, reported Dr. Pukenas of Rowan University, Camden, N.J.
The study was the first to assess retention of knowledge and skills 1 year after the course was added to the curriculum, she said.
Investigators may next study the effects of simulation-based handoff education and deliberate practice on handoff communications in clinical settings, she said.
The Accreditation Council for Graduate Medical Education requires handoff training for all medical residents.
Dr. Pukenas reported having no relevant financial disclosures.
On Twitter @sherryboschert
AT THE ASA ANNUAL MEETING
Major finding: The rate of communication failures during simulated intraoperative handoffs decreased from 30% before the course to 17% at course completion and to 13% a year later.
Data source: A prospective study of 10 residents who took a 1-day course on intraoperative handoffs that combined simulations and deliberate practice techniques, 7 of whom repeated a simulated handoff a year later.
Disclosures: Dr. Pukenas reported having no relevant financial disclosures.
Drug-eluting stent edges drug-eluting balloon
SAN FRANCISCO – Treating bare metal stent in-stent restenosis using a drug-eluting stent yielded a significantly larger minimal lumen diameter 1 year later, compared with treatment using a drug-eluting balloon in a study of 189 patients.
A second-generation everolimus-eluting stent bested a paclitaxel-eluting balloon in the primary outcome of the prospective, randomized trial after adjusting for age, smoking history, stenosis, and the presence of diabetes.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The in-segment minimal lumen diameter was 2.36 mm for the 94 patients in the stent group and 2.01 mm for the 95 patients in the balloon group. The in-lesion minimal lumen diameter was 2.44 mm in the stent group and 2.03 mm in the balloon group. Both differences were statistically significant, Dr. Fernando Alfonso and his associates reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
The rate of restenosis (greater than 50% lumen diameter narrowing) at the 1-year follow-up point was very low in both groups: 4.7% in the stent group and 9.5% in the balloon group. That difference was not statistically significant between groups.
Median in-segment late loss (the difference between minimal lumen diameter at completion of the procedure and at 1 year follow-up) was strikingly small and did not differ significantly between groups, reported Dr. Alfonso, an interventional cardiologist at Hospital Universitario Clinico San Carlos, Madrid.
Late loss in the stent group was 0.04 mm and in the balloon group was 0.14 mm, he added.
Rates of major adverse cardiac events were similar between groups: 94% in the stent group and 91% in the balloon group died of cardiac-related causes or had an MI or target vessel revascularization within a year of treatment. Rates of major adverse events also were statistically similar between groups in the RIBS V (Restenosis Intra-Stent of Bare Metal Stents: Paclitaxel-Eluting Balloon vs. Everolimus-Eluting Stent) trial.
A total of 6% of patients in the stent group and 12% in the balloon group developed a major adverse event; these rates were statistically similar. Four patients in the balloon group and none in the stent group died; three of the deaths were from noncardiac causes. Four patients in the stent group and three in the balloon group had an acute MI. Two patients in the stent group and six in the balloon group underwent target vessel revascularization. (Some patients had more than one adverse event.)
"In patients with bare metal stent in-stent restenosis, both drug-eluting balloons and everolimus-eluting stents provide excellent clinical outcomes" and excellent angiographic findings with very low late loss and low restenosis rates, Dr. Alfonso said at the meeting, cosponsored by the American College of Cardiology. "Further studies with larger numbers of patients and longer follow-up are required to elucidate if these superior late angiographic findings may eventually translate into a clinical benefit." In the meantime, drug-eluting balloons appear to offer "a very good alternative" for patients who may not be good candidates for drug-eluting stents, he said.
The study included patients aged 20-85 years at 25 Spanish centers who had more than 50% stenosis in a bare metal stent and angina or silent ischemia. In-segment quantitative coronary angiography measurements were similar between groups at baseline: the reference diameter was 2.63 mm in the stent group and 2.62 mm in the balloon group, and the lesion length was 13.8 mm in the stent group and 13.7 mm in the balloon group.
Patients who were randomized in 2010-2012 to receive Xience Prime everolimus-eluting stents (by Abbott Vascular) were significantly younger, compared with those who got SeQuent Please paclitaxel-eluting balloons (by B. Braun Surgical) – 64 vs. 67 years, respectively. Those in the stent group also were more likely to have ever smoked (75% vs. 59%, respectively). Eight patients in the balloon group eventually crossed over to stent implantation, and no patients in the stent group crossed over to balloons.
One-year follow-up was available for 170 patients (92%), and results were calculated in intent-to-treat analyses.
Dr. Alfonso reported having no financial disclosures.
On Twitter @sherryboschert
It seemed to me, as I was looking at the data, that drug-eluting balloons were pretty much going to be stuck in the peripheries. Yet these data, which are probably the best set of data that I’ve seen, tend to open the door. Maybe drug-eluting balloons have a role in the coronaries. There are lots of times that we don’t want to put in a drug-eluting stent, particularly in small vessels with long lesions. So I view this as a positive sign that there may be more choices for us that are meaningful.
Dr. Michael R. Mooney of the Minneapolis Heart Institute gave these comments during a panel discussion of the study at the meeting. He reported having no financial disclosures.
It seemed to me, as I was looking at the data, that drug-eluting balloons were pretty much going to be stuck in the peripheries. Yet these data, which are probably the best set of data that I’ve seen, tend to open the door. Maybe drug-eluting balloons have a role in the coronaries. There are lots of times that we don’t want to put in a drug-eluting stent, particularly in small vessels with long lesions. So I view this as a positive sign that there may be more choices for us that are meaningful.
Dr. Michael R. Mooney of the Minneapolis Heart Institute gave these comments during a panel discussion of the study at the meeting. He reported having no financial disclosures.
It seemed to me, as I was looking at the data, that drug-eluting balloons were pretty much going to be stuck in the peripheries. Yet these data, which are probably the best set of data that I’ve seen, tend to open the door. Maybe drug-eluting balloons have a role in the coronaries. There are lots of times that we don’t want to put in a drug-eluting stent, particularly in small vessels with long lesions. So I view this as a positive sign that there may be more choices for us that are meaningful.
Dr. Michael R. Mooney of the Minneapolis Heart Institute gave these comments during a panel discussion of the study at the meeting. He reported having no financial disclosures.
SAN FRANCISCO – Treating bare metal stent in-stent restenosis using a drug-eluting stent yielded a significantly larger minimal lumen diameter 1 year later, compared with treatment using a drug-eluting balloon in a study of 189 patients.
A second-generation everolimus-eluting stent bested a paclitaxel-eluting balloon in the primary outcome of the prospective, randomized trial after adjusting for age, smoking history, stenosis, and the presence of diabetes.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The in-segment minimal lumen diameter was 2.36 mm for the 94 patients in the stent group and 2.01 mm for the 95 patients in the balloon group. The in-lesion minimal lumen diameter was 2.44 mm in the stent group and 2.03 mm in the balloon group. Both differences were statistically significant, Dr. Fernando Alfonso and his associates reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
The rate of restenosis (greater than 50% lumen diameter narrowing) at the 1-year follow-up point was very low in both groups: 4.7% in the stent group and 9.5% in the balloon group. That difference was not statistically significant between groups.
Median in-segment late loss (the difference between minimal lumen diameter at completion of the procedure and at 1 year follow-up) was strikingly small and did not differ significantly between groups, reported Dr. Alfonso, an interventional cardiologist at Hospital Universitario Clinico San Carlos, Madrid.
Late loss in the stent group was 0.04 mm and in the balloon group was 0.14 mm, he added.
Rates of major adverse cardiac events were similar between groups: 94% in the stent group and 91% in the balloon group died of cardiac-related causes or had an MI or target vessel revascularization within a year of treatment. Rates of major adverse events also were statistically similar between groups in the RIBS V (Restenosis Intra-Stent of Bare Metal Stents: Paclitaxel-Eluting Balloon vs. Everolimus-Eluting Stent) trial.
A total of 6% of patients in the stent group and 12% in the balloon group developed a major adverse event; these rates were statistically similar. Four patients in the balloon group and none in the stent group died; three of the deaths were from noncardiac causes. Four patients in the stent group and three in the balloon group had an acute MI. Two patients in the stent group and six in the balloon group underwent target vessel revascularization. (Some patients had more than one adverse event.)
"In patients with bare metal stent in-stent restenosis, both drug-eluting balloons and everolimus-eluting stents provide excellent clinical outcomes" and excellent angiographic findings with very low late loss and low restenosis rates, Dr. Alfonso said at the meeting, cosponsored by the American College of Cardiology. "Further studies with larger numbers of patients and longer follow-up are required to elucidate if these superior late angiographic findings may eventually translate into a clinical benefit." In the meantime, drug-eluting balloons appear to offer "a very good alternative" for patients who may not be good candidates for drug-eluting stents, he said.
The study included patients aged 20-85 years at 25 Spanish centers who had more than 50% stenosis in a bare metal stent and angina or silent ischemia. In-segment quantitative coronary angiography measurements were similar between groups at baseline: the reference diameter was 2.63 mm in the stent group and 2.62 mm in the balloon group, and the lesion length was 13.8 mm in the stent group and 13.7 mm in the balloon group.
Patients who were randomized in 2010-2012 to receive Xience Prime everolimus-eluting stents (by Abbott Vascular) were significantly younger, compared with those who got SeQuent Please paclitaxel-eluting balloons (by B. Braun Surgical) – 64 vs. 67 years, respectively. Those in the stent group also were more likely to have ever smoked (75% vs. 59%, respectively). Eight patients in the balloon group eventually crossed over to stent implantation, and no patients in the stent group crossed over to balloons.
One-year follow-up was available for 170 patients (92%), and results were calculated in intent-to-treat analyses.
Dr. Alfonso reported having no financial disclosures.
On Twitter @sherryboschert
SAN FRANCISCO – Treating bare metal stent in-stent restenosis using a drug-eluting stent yielded a significantly larger minimal lumen diameter 1 year later, compared with treatment using a drug-eluting balloon in a study of 189 patients.
A second-generation everolimus-eluting stent bested a paclitaxel-eluting balloon in the primary outcome of the prospective, randomized trial after adjusting for age, smoking history, stenosis, and the presence of diabetes.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The in-segment minimal lumen diameter was 2.36 mm for the 94 patients in the stent group and 2.01 mm for the 95 patients in the balloon group. The in-lesion minimal lumen diameter was 2.44 mm in the stent group and 2.03 mm in the balloon group. Both differences were statistically significant, Dr. Fernando Alfonso and his associates reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
The rate of restenosis (greater than 50% lumen diameter narrowing) at the 1-year follow-up point was very low in both groups: 4.7% in the stent group and 9.5% in the balloon group. That difference was not statistically significant between groups.
Median in-segment late loss (the difference between minimal lumen diameter at completion of the procedure and at 1 year follow-up) was strikingly small and did not differ significantly between groups, reported Dr. Alfonso, an interventional cardiologist at Hospital Universitario Clinico San Carlos, Madrid.
Late loss in the stent group was 0.04 mm and in the balloon group was 0.14 mm, he added.
Rates of major adverse cardiac events were similar between groups: 94% in the stent group and 91% in the balloon group died of cardiac-related causes or had an MI or target vessel revascularization within a year of treatment. Rates of major adverse events also were statistically similar between groups in the RIBS V (Restenosis Intra-Stent of Bare Metal Stents: Paclitaxel-Eluting Balloon vs. Everolimus-Eluting Stent) trial.
A total of 6% of patients in the stent group and 12% in the balloon group developed a major adverse event; these rates were statistically similar. Four patients in the balloon group and none in the stent group died; three of the deaths were from noncardiac causes. Four patients in the stent group and three in the balloon group had an acute MI. Two patients in the stent group and six in the balloon group underwent target vessel revascularization. (Some patients had more than one adverse event.)
"In patients with bare metal stent in-stent restenosis, both drug-eluting balloons and everolimus-eluting stents provide excellent clinical outcomes" and excellent angiographic findings with very low late loss and low restenosis rates, Dr. Alfonso said at the meeting, cosponsored by the American College of Cardiology. "Further studies with larger numbers of patients and longer follow-up are required to elucidate if these superior late angiographic findings may eventually translate into a clinical benefit." In the meantime, drug-eluting balloons appear to offer "a very good alternative" for patients who may not be good candidates for drug-eluting stents, he said.
The study included patients aged 20-85 years at 25 Spanish centers who had more than 50% stenosis in a bare metal stent and angina or silent ischemia. In-segment quantitative coronary angiography measurements were similar between groups at baseline: the reference diameter was 2.63 mm in the stent group and 2.62 mm in the balloon group, and the lesion length was 13.8 mm in the stent group and 13.7 mm in the balloon group.
Patients who were randomized in 2010-2012 to receive Xience Prime everolimus-eluting stents (by Abbott Vascular) were significantly younger, compared with those who got SeQuent Please paclitaxel-eluting balloons (by B. Braun Surgical) – 64 vs. 67 years, respectively. Those in the stent group also were more likely to have ever smoked (75% vs. 59%, respectively). Eight patients in the balloon group eventually crossed over to stent implantation, and no patients in the stent group crossed over to balloons.
One-year follow-up was available for 170 patients (92%), and results were calculated in intent-to-treat analyses.
Dr. Alfonso reported having no financial disclosures.
On Twitter @sherryboschert
AT TCT 2013
Major finding: The in-segment minimal lumen diameter at 1 year was 2.36 mm with the second-generation everolimus-eluting stent and 2.01 mm with the paclitaxel-eluting balloon.
Data source: A prospective, multicenter, randomized trial in 189 patients treated for bare-metal stent in-stent restenosis.
Disclosures: Dr. Alfonso reported having no financial disclosures.
Trauma surgeons placed intracranial pressure monitors safely
SAN FRANCISCO – Complications developed with 3% of 298 intracranial pressure monitors inserted by trauma surgeons and with 0.8% of 112 monitors placed by neurosurgeons in patients with traumatic brain injury, a statistically insignificant difference.
Mortality rates were 37% for patients in the trauma surgeon group and 30% for patients in the neurosurgeon group, a difference that also was not significant, Dr. Sadia Ilyas and her associates reported at the annual meeting of the American Association for the Surgery of Trauma.
They retrospectively studied data for patients with traumatic brain injury (TBI) who received intracranial pressure monitors in 2006 through 2011 at one Level I trauma center. The trauma surgeons there had undergone training and credentialing in 2005 by neurosurgeons at the same facility for insertion of the monitors because neurosurgery coverage is not always available, explained Dr. Ilyas of Wright State University, Dayton, Ohio.
Complications in this series consisted of device malfunction or dislodgement, with no major or life-threatening complications.
Trauma surgeons in the training program each viewed two 10-minute instructional videos, were proctored by a neurosurgeon in a cadaver lab, and placed three monitors in patients under proctoring by a neurosurgeon. General surgery residents received similar training but were not credentialed to place intracranial pressure monitors without direct supervision.
Guidelines from the Brain Trauma Foundation recommend intracranial pressure monitoring in patients with severe TBI who have a Glasgow Coma Scale score of 8 or lower and an abnormal CT scan. Monitoring typically involves placement of a ventriculostomy or an intracranial pressure intraparenchymal monitor (bolt monitor).
In the study, 97% of all monitors placed were parenchymal monitors. Among those placed by neurosurgeons, 12% were ventriculostomies, which have the added advantage of therapeutic use but are more challenging to insert. "It is our view that placement of ICP parenchymal monitors is a more reasonable alternative for non-neurosurgeons," she said.
Six previous studies of 904 intracranial pressure monitors inserted by non-neurosurgeons found complication rates of 0%-8% with parenchymal monitors and 15% with ventriculostomy.
Each year in the United States approximately 200,000 people are hospitalized for TBI and 50,000 die from TBI. In 2010, an estimated 4,400 neurosurgeons were actively practicing in the United States (1.4 for every 100,000 residents), not all practiced trauma care, and a third were older than 55 years, she said.
Dr. Ilyas reported having no financial disclosures.
On Twitter @sherryboschert
These results have essentially been published before in other studies, and this paper doesn’t break any new ground.
I want to drive home the point that it is important, at least in my practice, to try to use ventriculostomy as the first line of monitoring because you can use it as a therapeutic tool to drain cerebrospinal fluid as well as just monitor. I do use parenchymal monitors but I can’t cannulate the ventricle.
A bigger issue is what to do with the information that you get from these monitors. Regardless of who puts these things in, someone needs to know how to treat the patients. Personally, I’ve been dismayed by the trend in recent years for so-called neuro critical care doctors to focus on things like temperature and serum sodium. It seems like very few intensivists who care for TBI patients really understand cerebral metabolism, cerebral blood flow, cerebral pathophysiology, and related processes.
As Dr. Ilyas and her colleagues have shown, the technical insertion of these devices is really not that difficult, but knowing the indications for when to put them in and when not to put them in, knowing how to interpret the data, and integrating the care of these patients into the neuro service are much more difficult things to do.
One problem with this paper is that it describes only short-term periprocedural complications. The real standard for measuring efficacy of interventions in TBI patients is long-term follow-up, which historically has been 6 months from injury and now more recent trials are using 12 months or even longer.
Dr. Alex B. Valadka is a neurosurgeon at the Seton Brain and Spine Institute, Austin, Tex. These are excerpts of his remarks as discussant of the study at the meeting. He reported having no financial disclosures.
These results have essentially been published before in other studies, and this paper doesn’t break any new ground.
I want to drive home the point that it is important, at least in my practice, to try to use ventriculostomy as the first line of monitoring because you can use it as a therapeutic tool to drain cerebrospinal fluid as well as just monitor. I do use parenchymal monitors but I can’t cannulate the ventricle.
A bigger issue is what to do with the information that you get from these monitors. Regardless of who puts these things in, someone needs to know how to treat the patients. Personally, I’ve been dismayed by the trend in recent years for so-called neuro critical care doctors to focus on things like temperature and serum sodium. It seems like very few intensivists who care for TBI patients really understand cerebral metabolism, cerebral blood flow, cerebral pathophysiology, and related processes.
As Dr. Ilyas and her colleagues have shown, the technical insertion of these devices is really not that difficult, but knowing the indications for when to put them in and when not to put them in, knowing how to interpret the data, and integrating the care of these patients into the neuro service are much more difficult things to do.
One problem with this paper is that it describes only short-term periprocedural complications. The real standard for measuring efficacy of interventions in TBI patients is long-term follow-up, which historically has been 6 months from injury and now more recent trials are using 12 months or even longer.
Dr. Alex B. Valadka is a neurosurgeon at the Seton Brain and Spine Institute, Austin, Tex. These are excerpts of his remarks as discussant of the study at the meeting. He reported having no financial disclosures.
These results have essentially been published before in other studies, and this paper doesn’t break any new ground.
I want to drive home the point that it is important, at least in my practice, to try to use ventriculostomy as the first line of monitoring because you can use it as a therapeutic tool to drain cerebrospinal fluid as well as just monitor. I do use parenchymal monitors but I can’t cannulate the ventricle.
A bigger issue is what to do with the information that you get from these monitors. Regardless of who puts these things in, someone needs to know how to treat the patients. Personally, I’ve been dismayed by the trend in recent years for so-called neuro critical care doctors to focus on things like temperature and serum sodium. It seems like very few intensivists who care for TBI patients really understand cerebral metabolism, cerebral blood flow, cerebral pathophysiology, and related processes.
As Dr. Ilyas and her colleagues have shown, the technical insertion of these devices is really not that difficult, but knowing the indications for when to put them in and when not to put them in, knowing how to interpret the data, and integrating the care of these patients into the neuro service are much more difficult things to do.
One problem with this paper is that it describes only short-term periprocedural complications. The real standard for measuring efficacy of interventions in TBI patients is long-term follow-up, which historically has been 6 months from injury and now more recent trials are using 12 months or even longer.
Dr. Alex B. Valadka is a neurosurgeon at the Seton Brain and Spine Institute, Austin, Tex. These are excerpts of his remarks as discussant of the study at the meeting. He reported having no financial disclosures.
SAN FRANCISCO – Complications developed with 3% of 298 intracranial pressure monitors inserted by trauma surgeons and with 0.8% of 112 monitors placed by neurosurgeons in patients with traumatic brain injury, a statistically insignificant difference.
Mortality rates were 37% for patients in the trauma surgeon group and 30% for patients in the neurosurgeon group, a difference that also was not significant, Dr. Sadia Ilyas and her associates reported at the annual meeting of the American Association for the Surgery of Trauma.
They retrospectively studied data for patients with traumatic brain injury (TBI) who received intracranial pressure monitors in 2006 through 2011 at one Level I trauma center. The trauma surgeons there had undergone training and credentialing in 2005 by neurosurgeons at the same facility for insertion of the monitors because neurosurgery coverage is not always available, explained Dr. Ilyas of Wright State University, Dayton, Ohio.
Complications in this series consisted of device malfunction or dislodgement, with no major or life-threatening complications.
Trauma surgeons in the training program each viewed two 10-minute instructional videos, were proctored by a neurosurgeon in a cadaver lab, and placed three monitors in patients under proctoring by a neurosurgeon. General surgery residents received similar training but were not credentialed to place intracranial pressure monitors without direct supervision.
Guidelines from the Brain Trauma Foundation recommend intracranial pressure monitoring in patients with severe TBI who have a Glasgow Coma Scale score of 8 or lower and an abnormal CT scan. Monitoring typically involves placement of a ventriculostomy or an intracranial pressure intraparenchymal monitor (bolt monitor).
In the study, 97% of all monitors placed were parenchymal monitors. Among those placed by neurosurgeons, 12% were ventriculostomies, which have the added advantage of therapeutic use but are more challenging to insert. "It is our view that placement of ICP parenchymal monitors is a more reasonable alternative for non-neurosurgeons," she said.
Six previous studies of 904 intracranial pressure monitors inserted by non-neurosurgeons found complication rates of 0%-8% with parenchymal monitors and 15% with ventriculostomy.
Each year in the United States approximately 200,000 people are hospitalized for TBI and 50,000 die from TBI. In 2010, an estimated 4,400 neurosurgeons were actively practicing in the United States (1.4 for every 100,000 residents), not all practiced trauma care, and a third were older than 55 years, she said.
Dr. Ilyas reported having no financial disclosures.
On Twitter @sherryboschert
SAN FRANCISCO – Complications developed with 3% of 298 intracranial pressure monitors inserted by trauma surgeons and with 0.8% of 112 monitors placed by neurosurgeons in patients with traumatic brain injury, a statistically insignificant difference.
Mortality rates were 37% for patients in the trauma surgeon group and 30% for patients in the neurosurgeon group, a difference that also was not significant, Dr. Sadia Ilyas and her associates reported at the annual meeting of the American Association for the Surgery of Trauma.
They retrospectively studied data for patients with traumatic brain injury (TBI) who received intracranial pressure monitors in 2006 through 2011 at one Level I trauma center. The trauma surgeons there had undergone training and credentialing in 2005 by neurosurgeons at the same facility for insertion of the monitors because neurosurgery coverage is not always available, explained Dr. Ilyas of Wright State University, Dayton, Ohio.
Complications in this series consisted of device malfunction or dislodgement, with no major or life-threatening complications.
Trauma surgeons in the training program each viewed two 10-minute instructional videos, were proctored by a neurosurgeon in a cadaver lab, and placed three monitors in patients under proctoring by a neurosurgeon. General surgery residents received similar training but were not credentialed to place intracranial pressure monitors without direct supervision.
Guidelines from the Brain Trauma Foundation recommend intracranial pressure monitoring in patients with severe TBI who have a Glasgow Coma Scale score of 8 or lower and an abnormal CT scan. Monitoring typically involves placement of a ventriculostomy or an intracranial pressure intraparenchymal monitor (bolt monitor).
In the study, 97% of all monitors placed were parenchymal monitors. Among those placed by neurosurgeons, 12% were ventriculostomies, which have the added advantage of therapeutic use but are more challenging to insert. "It is our view that placement of ICP parenchymal monitors is a more reasonable alternative for non-neurosurgeons," she said.
Six previous studies of 904 intracranial pressure monitors inserted by non-neurosurgeons found complication rates of 0%-8% with parenchymal monitors and 15% with ventriculostomy.
Each year in the United States approximately 200,000 people are hospitalized for TBI and 50,000 die from TBI. In 2010, an estimated 4,400 neurosurgeons were actively practicing in the United States (1.4 for every 100,000 residents), not all practiced trauma care, and a third were older than 55 years, she said.
Dr. Ilyas reported having no financial disclosures.
On Twitter @sherryboschert
AT THE AAST ANNUAL MEETING
Major finding: Complications developed with 3% of monitors placed by trauma surgeons and 0.8% placed by neurosurgeons.
Data source: Retrospective review of 410 patients with TBI who received intracranial pressure monitors in 2006-2011.
Disclosures: Dr. Ilyas reported having no financial disclosures.
Axillary treatment unnecessary after some total mastectomies
SAN FRANCISCO – Regional recurrence and recurrence-free survival rates were statistically similar in subgroups of 730 patients who had sentinel lymph node–positive, invasive breast cancer and underwent total mastectomy.
The outcomes were comparable regardless of whether or not patients had a subsequent completion axillary lymph node dissection and radiation therapy. A marginally higher 10-year regional recurrence rate of 4.9% in patients who did not have completion lymphadenectomy was not significantly different from rates seen in patients who had completion lymphadenectomy but not radiation therapy (1.4% of whom had a regional recurrence) or in patients who had completion lymphadenectomy plus radiation therapy (3.1% had a regional recurrence), in the retrospective institutional study.
Recurrence-free survival rates also did not differ between groups, reported Dr. Elizabeth FitzSullivan and her associates.
Using the M.D. Anderson Cancer Center nomogram to predict whether lymph nodes other than the sentinel node will have cancer, the investigators predicted a significantly lower probability of additional lymph node positivity in the 98 patients who did not undergo completion lymphadenectomy (a median 10% probability), compared with the 632 patients who had a completion lymphadenectomy (23% probability), reported Dr. FitzSullivan of the University of Texas M.D. Anderson Cancer Center, Houston.
"In select patients with early-stage breast cancer treated with mastectomy with a positive sentinel lymph node biopsy, completion lymphadenectomy may be avoided without adversely affecting recurrence or recurrence-free survival," the investigators concluded in a poster presentation at a breast cancer symposium sponsored by the American Society of Clinical Oncology. The study won a Merit Award at the meeting.
The retrospective analysis of data from patients treated at the M.D. Anderson Cancer Center during 1994-2010 defined completion lymphadenectomy as removal of 10 or more lymph nodes. Median follow-up was 66 months.
In general, patients with early-stage breast cancer who are treated with conserving therapy and who have minimal axillary disease on sentinel lymph node biopsy often don’t undergo completion lymphadenectomy. The increasing rate of total mastectomies heightens the need to identify patients who undergo total mastectomy who may not benefit from completion lymphadenectomy and axillary radiation therapy, the researchers noted.
There were several baseline characteristics that differed significantly between patients who did or did not undergo completion lymphadenectomy in the study. Compared with patients who did have completion lymphadenectomy, those who did not undergo the additional axillary surgery were older (57 years vs. 53 years, respectively); had smaller tumors (a median of 2 cm vs. 2.3 cm); and were less likely to have stage T3 disease (8% vs. 17%), lymphovascular invasion (25% vs. 41%), or extranodal extension of disease (4% vs. 24%). The median size of sentinel node metastasis was smaller in patients who did not have completion lymphadenectomy (1.1 mm) compared with those who did (4 mm).
The symposium was cosponsored by the American Society of Breast Disease, the American Society of Breast Surgeons, the National Consortium of Breast Centers, the Society of Surgical Oncology, and the American Society for Radiation Oncology.
Dr. FitzSullivan reported having no financial disclosures.
On Twitter @sherryboschert
SAN FRANCISCO – Regional recurrence and recurrence-free survival rates were statistically similar in subgroups of 730 patients who had sentinel lymph node–positive, invasive breast cancer and underwent total mastectomy.
The outcomes were comparable regardless of whether or not patients had a subsequent completion axillary lymph node dissection and radiation therapy. A marginally higher 10-year regional recurrence rate of 4.9% in patients who did not have completion lymphadenectomy was not significantly different from rates seen in patients who had completion lymphadenectomy but not radiation therapy (1.4% of whom had a regional recurrence) or in patients who had completion lymphadenectomy plus radiation therapy (3.1% had a regional recurrence), in the retrospective institutional study.
Recurrence-free survival rates also did not differ between groups, reported Dr. Elizabeth FitzSullivan and her associates.
Using the M.D. Anderson Cancer Center nomogram to predict whether lymph nodes other than the sentinel node will have cancer, the investigators predicted a significantly lower probability of additional lymph node positivity in the 98 patients who did not undergo completion lymphadenectomy (a median 10% probability), compared with the 632 patients who had a completion lymphadenectomy (23% probability), reported Dr. FitzSullivan of the University of Texas M.D. Anderson Cancer Center, Houston.
"In select patients with early-stage breast cancer treated with mastectomy with a positive sentinel lymph node biopsy, completion lymphadenectomy may be avoided without adversely affecting recurrence or recurrence-free survival," the investigators concluded in a poster presentation at a breast cancer symposium sponsored by the American Society of Clinical Oncology. The study won a Merit Award at the meeting.
The retrospective analysis of data from patients treated at the M.D. Anderson Cancer Center during 1994-2010 defined completion lymphadenectomy as removal of 10 or more lymph nodes. Median follow-up was 66 months.
In general, patients with early-stage breast cancer who are treated with conserving therapy and who have minimal axillary disease on sentinel lymph node biopsy often don’t undergo completion lymphadenectomy. The increasing rate of total mastectomies heightens the need to identify patients who undergo total mastectomy who may not benefit from completion lymphadenectomy and axillary radiation therapy, the researchers noted.
There were several baseline characteristics that differed significantly between patients who did or did not undergo completion lymphadenectomy in the study. Compared with patients who did have completion lymphadenectomy, those who did not undergo the additional axillary surgery were older (57 years vs. 53 years, respectively); had smaller tumors (a median of 2 cm vs. 2.3 cm); and were less likely to have stage T3 disease (8% vs. 17%), lymphovascular invasion (25% vs. 41%), or extranodal extension of disease (4% vs. 24%). The median size of sentinel node metastasis was smaller in patients who did not have completion lymphadenectomy (1.1 mm) compared with those who did (4 mm).
The symposium was cosponsored by the American Society of Breast Disease, the American Society of Breast Surgeons, the National Consortium of Breast Centers, the Society of Surgical Oncology, and the American Society for Radiation Oncology.
Dr. FitzSullivan reported having no financial disclosures.
On Twitter @sherryboschert
SAN FRANCISCO – Regional recurrence and recurrence-free survival rates were statistically similar in subgroups of 730 patients who had sentinel lymph node–positive, invasive breast cancer and underwent total mastectomy.
The outcomes were comparable regardless of whether or not patients had a subsequent completion axillary lymph node dissection and radiation therapy. A marginally higher 10-year regional recurrence rate of 4.9% in patients who did not have completion lymphadenectomy was not significantly different from rates seen in patients who had completion lymphadenectomy but not radiation therapy (1.4% of whom had a regional recurrence) or in patients who had completion lymphadenectomy plus radiation therapy (3.1% had a regional recurrence), in the retrospective institutional study.
Recurrence-free survival rates also did not differ between groups, reported Dr. Elizabeth FitzSullivan and her associates.
Using the M.D. Anderson Cancer Center nomogram to predict whether lymph nodes other than the sentinel node will have cancer, the investigators predicted a significantly lower probability of additional lymph node positivity in the 98 patients who did not undergo completion lymphadenectomy (a median 10% probability), compared with the 632 patients who had a completion lymphadenectomy (23% probability), reported Dr. FitzSullivan of the University of Texas M.D. Anderson Cancer Center, Houston.
"In select patients with early-stage breast cancer treated with mastectomy with a positive sentinel lymph node biopsy, completion lymphadenectomy may be avoided without adversely affecting recurrence or recurrence-free survival," the investigators concluded in a poster presentation at a breast cancer symposium sponsored by the American Society of Clinical Oncology. The study won a Merit Award at the meeting.
The retrospective analysis of data from patients treated at the M.D. Anderson Cancer Center during 1994-2010 defined completion lymphadenectomy as removal of 10 or more lymph nodes. Median follow-up was 66 months.
In general, patients with early-stage breast cancer who are treated with conserving therapy and who have minimal axillary disease on sentinel lymph node biopsy often don’t undergo completion lymphadenectomy. The increasing rate of total mastectomies heightens the need to identify patients who undergo total mastectomy who may not benefit from completion lymphadenectomy and axillary radiation therapy, the researchers noted.
There were several baseline characteristics that differed significantly between patients who did or did not undergo completion lymphadenectomy in the study. Compared with patients who did have completion lymphadenectomy, those who did not undergo the additional axillary surgery were older (57 years vs. 53 years, respectively); had smaller tumors (a median of 2 cm vs. 2.3 cm); and were less likely to have stage T3 disease (8% vs. 17%), lymphovascular invasion (25% vs. 41%), or extranodal extension of disease (4% vs. 24%). The median size of sentinel node metastasis was smaller in patients who did not have completion lymphadenectomy (1.1 mm) compared with those who did (4 mm).
The symposium was cosponsored by the American Society of Breast Disease, the American Society of Breast Surgeons, the National Consortium of Breast Centers, the Society of Surgical Oncology, and the American Society for Radiation Oncology.
Dr. FitzSullivan reported having no financial disclosures.
On Twitter @sherryboschert
AT THE ASCO BREAST CANCER SYMPOSIUM
Major finding: Median 10-year regional recurrence rates were 4.9% in patients who did not undergo completion lymphadenectomy, 3.1% for patients who had completion lymphadenectomy plus radiation therapy, and 1.4% for patients with completion lymphadenectomy but not radiation therapy.
Data source: A retrospective study of 730 patients with invasive breast cancer and a positive sentinel lymph node biopsy, treated with total mastectomy, between 1994 and 2010 at the University of Texas M.D. Anderson Cancer Center, Houston.
Disclosures: Dr. FitzSullivan reported having no financial disclosures.
Platelet inhibition test helps predict surgical bleeding
SAN FRANCISCO – Preoperative light transmission aggregometry assessments of platelet aggregation may help identify which patients on dual antiplatelet therapy are at greater risk of sustained bleeding from noncardiac surgery, a prospective study of 147 consecutive patients suggests.
The light transmission aggregometry (LTA) assessments of blood drawn immediately before noncardiac surgery were significantly lower in the 32% of patients with sustained bleeding than in the other patients.
All patients were on dual antiplatelet therapy, 95% of them on maintenance therapy with aspirin plus clopidogrel. The timing of the surgery was at the discretion of the surgeons. Treating physicians were blinded to LTA results. The average preoperative washout period for dual antiplatelet therapy was 1.5 days (range, 0-6 days).
The findings of the ongoing study might help define a "bleeding cutoff" measure by LTA to better individualize the timing of surgery, Dr. Wolfgang Toller and his associates suggested in a poster presentation at the annual meeting of the American Society of Anesthesiologists.
In general, approximately 5% of patients in their first year of dual antiplatelet therapy undergo noncardiac surgery, which creates a conundrum for management. Discontinuing dual antiplatelet therapy before noncardiac surgery has been associated with a 20% risk of major adverse cardiac events, but there’s a 20%-40% risk of moderate to severe bleeding if dual antiplatelet therapy is continued during noncardiac surgery, said Dr. Toller of the Medical University of Graz, Austria.
The 147 patients in the study underwent vascular surgery (76%), orthopedic surgery (10%), abdominal surgery (7%), or other surgical procedures (7%). All had been on P2Y12 receptor inhibitors within 7 days before surgery.
Investigators used the Chronolog 700 Lumi-Aggregometer to assess platelet aggregation in preoperative blood, using 5 mcm of adenosine diphosphate as the specific inductor for platelet aggregation.
Overall, they found an average 40% maximum change in light transmission from baseline after adding the adenosine diphosphate to blood samples. In patients with increased bleeding, however, the mean maximum change in light transmission was approximately 30% (suggesting less platelet aggregation), compared with a more than 40% change in patients who bled less from the surgery.
The study used a composite definition of increased bleeding that included TIMI (Thrombolysis in Myocardial Infarction) criteria for major or minor bleeding, any postoperative bleeding requiring reoperation, any platelet transfusion, or at least two packed red blood cells more than the average surgery-specific transfusion requirements at the surgical site.
Dr. Toller reported having no financial disclosures.
On Twitter @sherryboschert
SAN FRANCISCO – Preoperative light transmission aggregometry assessments of platelet aggregation may help identify which patients on dual antiplatelet therapy are at greater risk of sustained bleeding from noncardiac surgery, a prospective study of 147 consecutive patients suggests.
The light transmission aggregometry (LTA) assessments of blood drawn immediately before noncardiac surgery were significantly lower in the 32% of patients with sustained bleeding than in the other patients.
All patients were on dual antiplatelet therapy, 95% of them on maintenance therapy with aspirin plus clopidogrel. The timing of the surgery was at the discretion of the surgeons. Treating physicians were blinded to LTA results. The average preoperative washout period for dual antiplatelet therapy was 1.5 days (range, 0-6 days).
The findings of the ongoing study might help define a "bleeding cutoff" measure by LTA to better individualize the timing of surgery, Dr. Wolfgang Toller and his associates suggested in a poster presentation at the annual meeting of the American Society of Anesthesiologists.
In general, approximately 5% of patients in their first year of dual antiplatelet therapy undergo noncardiac surgery, which creates a conundrum for management. Discontinuing dual antiplatelet therapy before noncardiac surgery has been associated with a 20% risk of major adverse cardiac events, but there’s a 20%-40% risk of moderate to severe bleeding if dual antiplatelet therapy is continued during noncardiac surgery, said Dr. Toller of the Medical University of Graz, Austria.
The 147 patients in the study underwent vascular surgery (76%), orthopedic surgery (10%), abdominal surgery (7%), or other surgical procedures (7%). All had been on P2Y12 receptor inhibitors within 7 days before surgery.
Investigators used the Chronolog 700 Lumi-Aggregometer to assess platelet aggregation in preoperative blood, using 5 mcm of adenosine diphosphate as the specific inductor for platelet aggregation.
Overall, they found an average 40% maximum change in light transmission from baseline after adding the adenosine diphosphate to blood samples. In patients with increased bleeding, however, the mean maximum change in light transmission was approximately 30% (suggesting less platelet aggregation), compared with a more than 40% change in patients who bled less from the surgery.
The study used a composite definition of increased bleeding that included TIMI (Thrombolysis in Myocardial Infarction) criteria for major or minor bleeding, any postoperative bleeding requiring reoperation, any platelet transfusion, or at least two packed red blood cells more than the average surgery-specific transfusion requirements at the surgical site.
Dr. Toller reported having no financial disclosures.
On Twitter @sherryboschert
SAN FRANCISCO – Preoperative light transmission aggregometry assessments of platelet aggregation may help identify which patients on dual antiplatelet therapy are at greater risk of sustained bleeding from noncardiac surgery, a prospective study of 147 consecutive patients suggests.
The light transmission aggregometry (LTA) assessments of blood drawn immediately before noncardiac surgery were significantly lower in the 32% of patients with sustained bleeding than in the other patients.
All patients were on dual antiplatelet therapy, 95% of them on maintenance therapy with aspirin plus clopidogrel. The timing of the surgery was at the discretion of the surgeons. Treating physicians were blinded to LTA results. The average preoperative washout period for dual antiplatelet therapy was 1.5 days (range, 0-6 days).
The findings of the ongoing study might help define a "bleeding cutoff" measure by LTA to better individualize the timing of surgery, Dr. Wolfgang Toller and his associates suggested in a poster presentation at the annual meeting of the American Society of Anesthesiologists.
In general, approximately 5% of patients in their first year of dual antiplatelet therapy undergo noncardiac surgery, which creates a conundrum for management. Discontinuing dual antiplatelet therapy before noncardiac surgery has been associated with a 20% risk of major adverse cardiac events, but there’s a 20%-40% risk of moderate to severe bleeding if dual antiplatelet therapy is continued during noncardiac surgery, said Dr. Toller of the Medical University of Graz, Austria.
The 147 patients in the study underwent vascular surgery (76%), orthopedic surgery (10%), abdominal surgery (7%), or other surgical procedures (7%). All had been on P2Y12 receptor inhibitors within 7 days before surgery.
Investigators used the Chronolog 700 Lumi-Aggregometer to assess platelet aggregation in preoperative blood, using 5 mcm of adenosine diphosphate as the specific inductor for platelet aggregation.
Overall, they found an average 40% maximum change in light transmission from baseline after adding the adenosine diphosphate to blood samples. In patients with increased bleeding, however, the mean maximum change in light transmission was approximately 30% (suggesting less platelet aggregation), compared with a more than 40% change in patients who bled less from the surgery.
The study used a composite definition of increased bleeding that included TIMI (Thrombolysis in Myocardial Infarction) criteria for major or minor bleeding, any postoperative bleeding requiring reoperation, any platelet transfusion, or at least two packed red blood cells more than the average surgery-specific transfusion requirements at the surgical site.
Dr. Toller reported having no financial disclosures.
On Twitter @sherryboschert
AT THE ASA ANNUAL MEETING
Major finding: The mean maximum change in light transmission on LTA assessment of preoperative blood was approximately 30% in patients with increased bleeding from surgery, significantly lower than the more than 40% change in those who bled less.
Data source: Prospective study of 147 patients on dual antiplatelet therapy who underwent noncardiac surgery at one institution.
Disclosures: Dr. Toller reported having no financial disclosures.
Noninvasive coronary test accurate for lesion-specific ischemia
SAN FRANCISCO – A noninvasive test that computes fractional flow reserve from coronary CT angiography images was highly accurate in detecting ischemia, compared with anatomic interpretation from CT angiography or invasive coronary angiography, in a study of 254 patients and 484 vessels.
The primary endpoint was per-patient diagnostic performance as assessed by the area under the receiver operating characteristic curve (AUC) of the test, compared with coronary CT angiography, for the diagnosis of ischemia. The AUC for the new test was 0.82, significantly better than 0.63 for coronary CT angiography, Dr. Bjarne L. Nørgaard reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
The specificity nearly doubled when the HeartFlow test was used to compute fractional flow reserve from coronary CT angiography images (FFRCT), compared with coronary CT angiography assessment. FFRCT correctly reclassified 68% of false positives from CT angiography to true negatives, said Dr. Nørgaard of Aarhus (Denmark) University.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Invasive assessment of FFR is considered the gold standard for diagnosis of lesion-specific functional ischemic disease, but it carries more risk than a noninvasive test. Coronary CT angiography detects anatomic stenosis but is not good at determining the physiologic significance of lesions, he said.
The FFRCT technology builds a quantitative model using data from conventional coronary CT images, and develops a physiological model using left ventricular and coronary anatomy and established form-function principles, Dr. Nørgaard said. A fluid model calculates flow and pressure under simulated hyperemic conditions.
In the 254 patients, FFRCT had an accuracy of 81%, compared with 64% for anatomic assessment using invasive coronary angiography and 53% with CT angiography. The specificity was 79% with FFRCT, 51% with invasive angiography, and 34% with CT angiography. Positive predictive values were 65% with FFRCT, 46% with invasive angiography, and 40% with CT angiography. In each of these categories, FFRCT performed significantly better than CT angiography.
The sensitivity in per-patient diagnosis was 86% with FFRCT, 91% with invasive angiography, and 94% with CT angiography. The negative predictive values were 92% with FFRCT, 93% with invasive angiography, and 92% with CT angiography. Differences between groups were not significant for sensitivity and negative predictive values.
Similar trends were seen in results for the 484 vessels in the study. FFRCT had an accuracy of 86%, compared with 71% for invasive angiography and 65% for CT angiography. The per-vessel specificities were 86%, 66%, and 60%, respectively, and the positive predictive value was 61% with FFRCT, 40% with invasive angiography, and 33% with CT angiography. Again, there was no significant loss in sensitivity (84%, 84%, and 83%, respectively) or in negative predictive value (95%, 94%, and 92%).
The accuracy of FFRCT and invasive assessments of FFR compares favorably with the accuracy of other tests, Dr. Nørgaard said, including stress echo, coronary CT angiography (cCTA), cCTA with transluminal attenuation gradient, single-photon emission CT, and intravenous ultrasound.
"The diagnostic performance of other tests is not impressive," he added. "I think the FFR is a major breakthrough."
The study enrolled patients at 10 centers on three continents who underwent CT and invasive coronary angiography with no more than 60 days between tests.
"I think this will be incorporated into practice," Dr. James B. Hermiller Jr. commented in a panel discussion of the study during a press briefing. A cost analysis is needed, added Dr. Hermiller of St. Vincent Heart Center of Indiana, Indianapolis.
Dr. Philippe Généreux, of Hôpital du Sacré-Coeur de Montréal, called the trial "a brilliant study" and "a breath of fresh air" in the area of noninvasive testing.
Dr. Bernard J. Gersh of the Mayo Clinic, Rochester, Minn., said, "This is a really important trial." He predicted that over the next 2-3 years, great strides will be made in noninvasive assessments of ischemia. "Stay tuned. A number of other methods for evaluating FFR" are being studied, he noted.
The meeting was cosponsored by the American College of Cardiology.
HeartFlow, which markets the FFRCT test, funded the study. Dr. Nørgaard reported having no other financial disclosures. Dr. Hermiller, Dr. Généreux, and Dr. Gersh reported financial associations with multiple companies, but not with HeartFlow.
sboschert@frontlinemedcom.com On Twitter @sherryboschert
SAN FRANCISCO – A noninvasive test that computes fractional flow reserve from coronary CT angiography images was highly accurate in detecting ischemia, compared with anatomic interpretation from CT angiography or invasive coronary angiography, in a study of 254 patients and 484 vessels.
The primary endpoint was per-patient diagnostic performance as assessed by the area under the receiver operating characteristic curve (AUC) of the test, compared with coronary CT angiography, for the diagnosis of ischemia. The AUC for the new test was 0.82, significantly better than 0.63 for coronary CT angiography, Dr. Bjarne L. Nørgaard reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
The specificity nearly doubled when the HeartFlow test was used to compute fractional flow reserve from coronary CT angiography images (FFRCT), compared with coronary CT angiography assessment. FFRCT correctly reclassified 68% of false positives from CT angiography to true negatives, said Dr. Nørgaard of Aarhus (Denmark) University.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Invasive assessment of FFR is considered the gold standard for diagnosis of lesion-specific functional ischemic disease, but it carries more risk than a noninvasive test. Coronary CT angiography detects anatomic stenosis but is not good at determining the physiologic significance of lesions, he said.
The FFRCT technology builds a quantitative model using data from conventional coronary CT images, and develops a physiological model using left ventricular and coronary anatomy and established form-function principles, Dr. Nørgaard said. A fluid model calculates flow and pressure under simulated hyperemic conditions.
In the 254 patients, FFRCT had an accuracy of 81%, compared with 64% for anatomic assessment using invasive coronary angiography and 53% with CT angiography. The specificity was 79% with FFRCT, 51% with invasive angiography, and 34% with CT angiography. Positive predictive values were 65% with FFRCT, 46% with invasive angiography, and 40% with CT angiography. In each of these categories, FFRCT performed significantly better than CT angiography.
The sensitivity in per-patient diagnosis was 86% with FFRCT, 91% with invasive angiography, and 94% with CT angiography. The negative predictive values were 92% with FFRCT, 93% with invasive angiography, and 92% with CT angiography. Differences between groups were not significant for sensitivity and negative predictive values.
Similar trends were seen in results for the 484 vessels in the study. FFRCT had an accuracy of 86%, compared with 71% for invasive angiography and 65% for CT angiography. The per-vessel specificities were 86%, 66%, and 60%, respectively, and the positive predictive value was 61% with FFRCT, 40% with invasive angiography, and 33% with CT angiography. Again, there was no significant loss in sensitivity (84%, 84%, and 83%, respectively) or in negative predictive value (95%, 94%, and 92%).
The accuracy of FFRCT and invasive assessments of FFR compares favorably with the accuracy of other tests, Dr. Nørgaard said, including stress echo, coronary CT angiography (cCTA), cCTA with transluminal attenuation gradient, single-photon emission CT, and intravenous ultrasound.
"The diagnostic performance of other tests is not impressive," he added. "I think the FFR is a major breakthrough."
The study enrolled patients at 10 centers on three continents who underwent CT and invasive coronary angiography with no more than 60 days between tests.
"I think this will be incorporated into practice," Dr. James B. Hermiller Jr. commented in a panel discussion of the study during a press briefing. A cost analysis is needed, added Dr. Hermiller of St. Vincent Heart Center of Indiana, Indianapolis.
Dr. Philippe Généreux, of Hôpital du Sacré-Coeur de Montréal, called the trial "a brilliant study" and "a breath of fresh air" in the area of noninvasive testing.
Dr. Bernard J. Gersh of the Mayo Clinic, Rochester, Minn., said, "This is a really important trial." He predicted that over the next 2-3 years, great strides will be made in noninvasive assessments of ischemia. "Stay tuned. A number of other methods for evaluating FFR" are being studied, he noted.
The meeting was cosponsored by the American College of Cardiology.
HeartFlow, which markets the FFRCT test, funded the study. Dr. Nørgaard reported having no other financial disclosures. Dr. Hermiller, Dr. Généreux, and Dr. Gersh reported financial associations with multiple companies, but not with HeartFlow.
sboschert@frontlinemedcom.com On Twitter @sherryboschert
SAN FRANCISCO – A noninvasive test that computes fractional flow reserve from coronary CT angiography images was highly accurate in detecting ischemia, compared with anatomic interpretation from CT angiography or invasive coronary angiography, in a study of 254 patients and 484 vessels.
The primary endpoint was per-patient diagnostic performance as assessed by the area under the receiver operating characteristic curve (AUC) of the test, compared with coronary CT angiography, for the diagnosis of ischemia. The AUC for the new test was 0.82, significantly better than 0.63 for coronary CT angiography, Dr. Bjarne L. Nørgaard reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
The specificity nearly doubled when the HeartFlow test was used to compute fractional flow reserve from coronary CT angiography images (FFRCT), compared with coronary CT angiography assessment. FFRCT correctly reclassified 68% of false positives from CT angiography to true negatives, said Dr. Nørgaard of Aarhus (Denmark) University.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Invasive assessment of FFR is considered the gold standard for diagnosis of lesion-specific functional ischemic disease, but it carries more risk than a noninvasive test. Coronary CT angiography detects anatomic stenosis but is not good at determining the physiologic significance of lesions, he said.
The FFRCT technology builds a quantitative model using data from conventional coronary CT images, and develops a physiological model using left ventricular and coronary anatomy and established form-function principles, Dr. Nørgaard said. A fluid model calculates flow and pressure under simulated hyperemic conditions.
In the 254 patients, FFRCT had an accuracy of 81%, compared with 64% for anatomic assessment using invasive coronary angiography and 53% with CT angiography. The specificity was 79% with FFRCT, 51% with invasive angiography, and 34% with CT angiography. Positive predictive values were 65% with FFRCT, 46% with invasive angiography, and 40% with CT angiography. In each of these categories, FFRCT performed significantly better than CT angiography.
The sensitivity in per-patient diagnosis was 86% with FFRCT, 91% with invasive angiography, and 94% with CT angiography. The negative predictive values were 92% with FFRCT, 93% with invasive angiography, and 92% with CT angiography. Differences between groups were not significant for sensitivity and negative predictive values.
Similar trends were seen in results for the 484 vessels in the study. FFRCT had an accuracy of 86%, compared with 71% for invasive angiography and 65% for CT angiography. The per-vessel specificities were 86%, 66%, and 60%, respectively, and the positive predictive value was 61% with FFRCT, 40% with invasive angiography, and 33% with CT angiography. Again, there was no significant loss in sensitivity (84%, 84%, and 83%, respectively) or in negative predictive value (95%, 94%, and 92%).
The accuracy of FFRCT and invasive assessments of FFR compares favorably with the accuracy of other tests, Dr. Nørgaard said, including stress echo, coronary CT angiography (cCTA), cCTA with transluminal attenuation gradient, single-photon emission CT, and intravenous ultrasound.
"The diagnostic performance of other tests is not impressive," he added. "I think the FFR is a major breakthrough."
The study enrolled patients at 10 centers on three continents who underwent CT and invasive coronary angiography with no more than 60 days between tests.
"I think this will be incorporated into practice," Dr. James B. Hermiller Jr. commented in a panel discussion of the study during a press briefing. A cost analysis is needed, added Dr. Hermiller of St. Vincent Heart Center of Indiana, Indianapolis.
Dr. Philippe Généreux, of Hôpital du Sacré-Coeur de Montréal, called the trial "a brilliant study" and "a breath of fresh air" in the area of noninvasive testing.
Dr. Bernard J. Gersh of the Mayo Clinic, Rochester, Minn., said, "This is a really important trial." He predicted that over the next 2-3 years, great strides will be made in noninvasive assessments of ischemia. "Stay tuned. A number of other methods for evaluating FFR" are being studied, he noted.
The meeting was cosponsored by the American College of Cardiology.
HeartFlow, which markets the FFRCT test, funded the study. Dr. Nørgaard reported having no other financial disclosures. Dr. Hermiller, Dr. Généreux, and Dr. Gersh reported financial associations with multiple companies, but not with HeartFlow.
sboschert@frontlinemedcom.com On Twitter @sherryboschert
AT TCT 2013
Major finding: The per-patient AUC was 0.82 with the FFRCT test, significantly better than 0.63 with CT angiography.
Data source: A prospective, international study of FFRCT in 254 patients who underwent CT and invasive angiography at 10 centers.
Disclosures: HeartFlow, which markets the FFRCT test, funded the study. Dr. Nørgaard reported having no other financial disclosures. Dr. Hermiller, Dr. Généreux, and Dr. Gersh reported financial associations with multiple companies, but not with HeartFlow.
No greater risk of lymph node involvement in triple-negative breast cancer
SAN FRANCISCO – Patients with triple-negative breast cancer had no higher risk for metastases in the lymph nodes as compared with patients whose breast cancer was not triple-negative, a review of 2,957 cases found.
The study included patients with invasive breast cancer treated surgically between January 2000 and May 2012. Immunohistochemical identification of markers showed that 2,201 (74%) had luminal A subtype breast cancer (estrogen receptor– and progesterone receptor–positive and HER2 negative), 344 (12%) had luminal B subtype (all three markers positive), 144 (5%) were HER2 positive but estrogen and progesterone receptors–negative, and 278 (9%) were negative for all three markers (the triple-negative group). The study excluded men, patients treated with neoadjuvant therapy, patients with distant metastases, and those who did not undergo nodal sampling.
At least one positive lymph node was found in 35% of patients, and four or more positive nodes were found in 10% of patients.
Patients in the triple-negative group were significantly younger at diagnosis and significantly more likely to have higher-grade tumors, compared with patients with other subtypes of breast cancer. Grade 3 cancer was seen in 87% of the triple-negative group and in 27% of the luminal A group, 51% of the luminal B group, and 80% of the HER2-positive group, Dr. Alexandra Gangi and her associates reported at a breast cancer symposium sponsored by the American Society of Clinical Oncology.
In multivariant analyses, younger age, higher tumor grade, larger tumor size, and lymphovascular invasion predicted increased likelihood of lymph node metastases. The triple-negative phenotype predicted neither a higher risk for lymph node positivity nor a greater likelihood of having four or more positive lymph nodes, which was found in 9% of the triple-negative group, 9% of the luminal A group, 14% of the luminal B group, and 19% of the HER2-positive group, reported Dr. Gangi of Cedars-Sinai Hospital, Los Angeles.
The likelihood of lymph node metastases was 50% higher in patients younger than 50 years as compared with older patients, 70% higher with grade 2 cancer as compared with grade 1 cancer, and 90% higher with grade 3 cancer as compared with grade 1 cancer. Lymphovascular invasion increased the likelihood of lymph node involvement four-fold. The risk of lymph node metastases was three times higher in patients with stage T2 breast cancer and 11 times higher in patients with stage T3 disease as compared with those with stage T1 breast cancer. All of these differences were statistically significant.
The symposium was cosponsored by the American Society of Breast Disease, the American Society of Breast Surgeons, the National Consortium of Breast Centers, the Society of Surgical Oncology, and the American Society for Radiation Oncology.
Dr. Gangi reported having no financial disclosures.
On Twitter @sherryboschert
SAN FRANCISCO – Patients with triple-negative breast cancer had no higher risk for metastases in the lymph nodes as compared with patients whose breast cancer was not triple-negative, a review of 2,957 cases found.
The study included patients with invasive breast cancer treated surgically between January 2000 and May 2012. Immunohistochemical identification of markers showed that 2,201 (74%) had luminal A subtype breast cancer (estrogen receptor– and progesterone receptor–positive and HER2 negative), 344 (12%) had luminal B subtype (all three markers positive), 144 (5%) were HER2 positive but estrogen and progesterone receptors–negative, and 278 (9%) were negative for all three markers (the triple-negative group). The study excluded men, patients treated with neoadjuvant therapy, patients with distant metastases, and those who did not undergo nodal sampling.
At least one positive lymph node was found in 35% of patients, and four or more positive nodes were found in 10% of patients.
Patients in the triple-negative group were significantly younger at diagnosis and significantly more likely to have higher-grade tumors, compared with patients with other subtypes of breast cancer. Grade 3 cancer was seen in 87% of the triple-negative group and in 27% of the luminal A group, 51% of the luminal B group, and 80% of the HER2-positive group, Dr. Alexandra Gangi and her associates reported at a breast cancer symposium sponsored by the American Society of Clinical Oncology.
In multivariant analyses, younger age, higher tumor grade, larger tumor size, and lymphovascular invasion predicted increased likelihood of lymph node metastases. The triple-negative phenotype predicted neither a higher risk for lymph node positivity nor a greater likelihood of having four or more positive lymph nodes, which was found in 9% of the triple-negative group, 9% of the luminal A group, 14% of the luminal B group, and 19% of the HER2-positive group, reported Dr. Gangi of Cedars-Sinai Hospital, Los Angeles.
The likelihood of lymph node metastases was 50% higher in patients younger than 50 years as compared with older patients, 70% higher with grade 2 cancer as compared with grade 1 cancer, and 90% higher with grade 3 cancer as compared with grade 1 cancer. Lymphovascular invasion increased the likelihood of lymph node involvement four-fold. The risk of lymph node metastases was three times higher in patients with stage T2 breast cancer and 11 times higher in patients with stage T3 disease as compared with those with stage T1 breast cancer. All of these differences were statistically significant.
The symposium was cosponsored by the American Society of Breast Disease, the American Society of Breast Surgeons, the National Consortium of Breast Centers, the Society of Surgical Oncology, and the American Society for Radiation Oncology.
Dr. Gangi reported having no financial disclosures.
On Twitter @sherryboschert
SAN FRANCISCO – Patients with triple-negative breast cancer had no higher risk for metastases in the lymph nodes as compared with patients whose breast cancer was not triple-negative, a review of 2,957 cases found.
The study included patients with invasive breast cancer treated surgically between January 2000 and May 2012. Immunohistochemical identification of markers showed that 2,201 (74%) had luminal A subtype breast cancer (estrogen receptor– and progesterone receptor–positive and HER2 negative), 344 (12%) had luminal B subtype (all three markers positive), 144 (5%) were HER2 positive but estrogen and progesterone receptors–negative, and 278 (9%) were negative for all three markers (the triple-negative group). The study excluded men, patients treated with neoadjuvant therapy, patients with distant metastases, and those who did not undergo nodal sampling.
At least one positive lymph node was found in 35% of patients, and four or more positive nodes were found in 10% of patients.
Patients in the triple-negative group were significantly younger at diagnosis and significantly more likely to have higher-grade tumors, compared with patients with other subtypes of breast cancer. Grade 3 cancer was seen in 87% of the triple-negative group and in 27% of the luminal A group, 51% of the luminal B group, and 80% of the HER2-positive group, Dr. Alexandra Gangi and her associates reported at a breast cancer symposium sponsored by the American Society of Clinical Oncology.
In multivariant analyses, younger age, higher tumor grade, larger tumor size, and lymphovascular invasion predicted increased likelihood of lymph node metastases. The triple-negative phenotype predicted neither a higher risk for lymph node positivity nor a greater likelihood of having four or more positive lymph nodes, which was found in 9% of the triple-negative group, 9% of the luminal A group, 14% of the luminal B group, and 19% of the HER2-positive group, reported Dr. Gangi of Cedars-Sinai Hospital, Los Angeles.
The likelihood of lymph node metastases was 50% higher in patients younger than 50 years as compared with older patients, 70% higher with grade 2 cancer as compared with grade 1 cancer, and 90% higher with grade 3 cancer as compared with grade 1 cancer. Lymphovascular invasion increased the likelihood of lymph node involvement four-fold. The risk of lymph node metastases was three times higher in patients with stage T2 breast cancer and 11 times higher in patients with stage T3 disease as compared with those with stage T1 breast cancer. All of these differences were statistically significant.
The symposium was cosponsored by the American Society of Breast Disease, the American Society of Breast Surgeons, the National Consortium of Breast Centers, the Society of Surgical Oncology, and the American Society for Radiation Oncology.
Dr. Gangi reported having no financial disclosures.
On Twitter @sherryboschert
AT THE ASCO BREAST CANCER SYMPOSIUM
Major finding: The likelihood of lymph node metastases was 50% higher in patients younger than 50 years as compared with older patients, 70% higher with grade 2 cancer as compared with grade 1 cancer, and 90% higher with grade 3 cancer as compared with grade 1 cancer.
Data source: A prospect review of 2,957 women treated surgically for breast cancer between January 2000 and May 2012.
Disclosures: Dr. Gangi reported having no financial disclosures.
Women choose mastectomy to gain control
SAN FRANCISCO – Fear and a desire for control over breast cancer may drive women to choose mastectomy over less aggressive management, a qualitative study of 30 patients has shown.
She interviewed 15 women who were candidates for breast-conserving surgery but chose unilateral mastectomy and 15 average-risk women who were candidates for surgery in one breast but also chose prophylactic contralateral mastectomy.
Fear led patients to overestimate their risk of local recurrence and contralateral cancer and to misunderstand their odds of dying of breast cancer. The fear combined with wanting to eliminate and control the risk of cancer resulted in the patient choosing mastectomy or bilateral mastectomy, factors that probably are contributing to increasing rates of mastectomy for early-stage breast cancer, Dr. Andrea M. Covelli reported in a poster at a breast cancer symposium sponsored by the American Society of Clinical Oncology.
When deciding on treatment, the women sought out multiple sources of information but gave greatest weight to the experiences of people they’d known with breast cancer and information from breast cancer survivors. It was the patients, not clinicians, who raised the topic of contralateral prophylactic mastectomy, which some patients chose in an attempt to eliminate any risk of contralateral breast cancer.
"More surgery is seen as more control," reported Dr. Covelli of the University of Toronto. A better understanding of patients’ decision process may help physicians be better able to discuss issues important to their patients in making treatment decisions.
Dr. Covelli conducted semistructured one-on-one interviews with patients with early-stage breast cancer chosen from five hospitals in the greater Toronto area to represent a variety of ages and ethnicities. Twelve were treated at academic cancer centers, 6 were treated at academic noncancer centers, and 12 were treated at community medical centers.
She identified several themes in the results. The diagnosis brought shock and fear. Patients discussed both breast-conserving surgery and unilateral mastectomy during their surgical consultation, during which the physician discouraged contralateral prophylactic mastectomy. Patients relied on multiple sources of information in their decision making, but the greatest impact came from the experiences of others with breast cancer, she reported.
Women who chose unilateral mastectomy did so most often out of fear of recurrence and the misguided notion that it would give them a survival advantage. Occasionally, they chose unilateral mastectomy to avoid radiation therapy.
Women who also chose contralateral prophylactic mastectomy initiated discussions about it, which their surgeons then discouraged. These patients chose it anyway because they overestimated the risk of contralateral cancer and mistakenly believed it would improve their chance of survival. Occasionally they added contralateral prophylactic mastectomy for body symmetry.
In essence, patients chose these more aggressive surgeries because they were actively trying to control their cancer outcomes and ensure that they "never have to go through this again," Dr. Covelli said.
The study cohort had a mean age of 55 years, with ages ranging from 36 to 84 years.
Dr. Covelli has received funding from Roche Canada and the Canadian Breast Cancer Foundation Physician Fellowship Award.
On Twitter @sherryboschert
This study asks the question, What motivates a woman with early-stage breast cancer to choose mastectomy, whether that be a unilateral mastectomy when she’s a candidate for breast conservation or the addition of a contralateral prophylactic mastectomy in the absence of an indication?
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The bottom line is that the diagnosis is met with fear and shock. When we present options in a very neutral, evidence-based way, we are talking to our patients about breast-conserving surgery and mastectomy. And we are, and we should be, talking about whether there’s a role for contralateral prophylactic surgery.
Bearing witness is something that needs to be understood here. A lot of the discussion that you have with your patients is going to be interpreted based on what those patients are hearing, seeing, and witnessing in their own lives. So, if Aunt Judy had breast-conserving surgery and died 5 years later, you’ve got to take that into account.
There is a desire for control. There is a need to reduce risks so it never happens to them again, and there is a desire to increase their odds of surviving. That comes down to patients’ decision-making experience, their reasons for choosing a surgery that is far more aggressive than it possibly should be, and their goal to control cancer. We’re seeing an increasing mastectomy rate – more surgery, more control.
There is a process of deliberation where we take many factors into consideration before determining what we want to do. The implication based on this abstract, I think, is whether clinicians need to identify the deliberations that are leading to a decision before acting surgically.
Dr. Covelli’s preliminary work suggests that decisions around surgery are incredibly complex, and ensuring decisions are informed is complicated. Learning how patients deliberate is important – what experiences and what social networks are informing that decision? (And I don’t mean Twitter and Facebook, I mean in patients’ own real, face-to-face lives.) What is the role of the preoperative work-up in influencing those deliberations? How is that preoperative MRI influencing these decisions, based on anything that potentially might be happening?
I think this is very provocative work that can go further. The take-home points for me: Engage cognitively, engage with evidence, engage with data, but you have to engage practically. You need to know: Where is that person hearing information that I’m not telling her? How is she processing that information with information that I have just given? Engage cognitively; engage affectively.
Dr. Don S. Dizon is a medical gynecologic oncologist and director of the oncology sexual health clinic at Massachusetts General Hospital, Boston. These are excerpts of his remarks as the discussant of Dr. Covelli’s study at the meeting. He disclosed that he has been employed by UpToDate.
This study asks the question, What motivates a woman with early-stage breast cancer to choose mastectomy, whether that be a unilateral mastectomy when she’s a candidate for breast conservation or the addition of a contralateral prophylactic mastectomy in the absence of an indication?
|
|
The bottom line is that the diagnosis is met with fear and shock. When we present options in a very neutral, evidence-based way, we are talking to our patients about breast-conserving surgery and mastectomy. And we are, and we should be, talking about whether there’s a role for contralateral prophylactic surgery.
Bearing witness is something that needs to be understood here. A lot of the discussion that you have with your patients is going to be interpreted based on what those patients are hearing, seeing, and witnessing in their own lives. So, if Aunt Judy had breast-conserving surgery and died 5 years later, you’ve got to take that into account.
There is a desire for control. There is a need to reduce risks so it never happens to them again, and there is a desire to increase their odds of surviving. That comes down to patients’ decision-making experience, their reasons for choosing a surgery that is far more aggressive than it possibly should be, and their goal to control cancer. We’re seeing an increasing mastectomy rate – more surgery, more control.
There is a process of deliberation where we take many factors into consideration before determining what we want to do. The implication based on this abstract, I think, is whether clinicians need to identify the deliberations that are leading to a decision before acting surgically.
Dr. Covelli’s preliminary work suggests that decisions around surgery are incredibly complex, and ensuring decisions are informed is complicated. Learning how patients deliberate is important – what experiences and what social networks are informing that decision? (And I don’t mean Twitter and Facebook, I mean in patients’ own real, face-to-face lives.) What is the role of the preoperative work-up in influencing those deliberations? How is that preoperative MRI influencing these decisions, based on anything that potentially might be happening?
I think this is very provocative work that can go further. The take-home points for me: Engage cognitively, engage with evidence, engage with data, but you have to engage practically. You need to know: Where is that person hearing information that I’m not telling her? How is she processing that information with information that I have just given? Engage cognitively; engage affectively.
Dr. Don S. Dizon is a medical gynecologic oncologist and director of the oncology sexual health clinic at Massachusetts General Hospital, Boston. These are excerpts of his remarks as the discussant of Dr. Covelli’s study at the meeting. He disclosed that he has been employed by UpToDate.
This study asks the question, What motivates a woman with early-stage breast cancer to choose mastectomy, whether that be a unilateral mastectomy when she’s a candidate for breast conservation or the addition of a contralateral prophylactic mastectomy in the absence of an indication?
|
|
The bottom line is that the diagnosis is met with fear and shock. When we present options in a very neutral, evidence-based way, we are talking to our patients about breast-conserving surgery and mastectomy. And we are, and we should be, talking about whether there’s a role for contralateral prophylactic surgery.
Bearing witness is something that needs to be understood here. A lot of the discussion that you have with your patients is going to be interpreted based on what those patients are hearing, seeing, and witnessing in their own lives. So, if Aunt Judy had breast-conserving surgery and died 5 years later, you’ve got to take that into account.
There is a desire for control. There is a need to reduce risks so it never happens to them again, and there is a desire to increase their odds of surviving. That comes down to patients’ decision-making experience, their reasons for choosing a surgery that is far more aggressive than it possibly should be, and their goal to control cancer. We’re seeing an increasing mastectomy rate – more surgery, more control.
There is a process of deliberation where we take many factors into consideration before determining what we want to do. The implication based on this abstract, I think, is whether clinicians need to identify the deliberations that are leading to a decision before acting surgically.
Dr. Covelli’s preliminary work suggests that decisions around surgery are incredibly complex, and ensuring decisions are informed is complicated. Learning how patients deliberate is important – what experiences and what social networks are informing that decision? (And I don’t mean Twitter and Facebook, I mean in patients’ own real, face-to-face lives.) What is the role of the preoperative work-up in influencing those deliberations? How is that preoperative MRI influencing these decisions, based on anything that potentially might be happening?
I think this is very provocative work that can go further. The take-home points for me: Engage cognitively, engage with evidence, engage with data, but you have to engage practically. You need to know: Where is that person hearing information that I’m not telling her? How is she processing that information with information that I have just given? Engage cognitively; engage affectively.
Dr. Don S. Dizon is a medical gynecologic oncologist and director of the oncology sexual health clinic at Massachusetts General Hospital, Boston. These are excerpts of his remarks as the discussant of Dr. Covelli’s study at the meeting. He disclosed that he has been employed by UpToDate.
SAN FRANCISCO – Fear and a desire for control over breast cancer may drive women to choose mastectomy over less aggressive management, a qualitative study of 30 patients has shown.
She interviewed 15 women who were candidates for breast-conserving surgery but chose unilateral mastectomy and 15 average-risk women who were candidates for surgery in one breast but also chose prophylactic contralateral mastectomy.
Fear led patients to overestimate their risk of local recurrence and contralateral cancer and to misunderstand their odds of dying of breast cancer. The fear combined with wanting to eliminate and control the risk of cancer resulted in the patient choosing mastectomy or bilateral mastectomy, factors that probably are contributing to increasing rates of mastectomy for early-stage breast cancer, Dr. Andrea M. Covelli reported in a poster at a breast cancer symposium sponsored by the American Society of Clinical Oncology.
When deciding on treatment, the women sought out multiple sources of information but gave greatest weight to the experiences of people they’d known with breast cancer and information from breast cancer survivors. It was the patients, not clinicians, who raised the topic of contralateral prophylactic mastectomy, which some patients chose in an attempt to eliminate any risk of contralateral breast cancer.
"More surgery is seen as more control," reported Dr. Covelli of the University of Toronto. A better understanding of patients’ decision process may help physicians be better able to discuss issues important to their patients in making treatment decisions.
Dr. Covelli conducted semistructured one-on-one interviews with patients with early-stage breast cancer chosen from five hospitals in the greater Toronto area to represent a variety of ages and ethnicities. Twelve were treated at academic cancer centers, 6 were treated at academic noncancer centers, and 12 were treated at community medical centers.
She identified several themes in the results. The diagnosis brought shock and fear. Patients discussed both breast-conserving surgery and unilateral mastectomy during their surgical consultation, during which the physician discouraged contralateral prophylactic mastectomy. Patients relied on multiple sources of information in their decision making, but the greatest impact came from the experiences of others with breast cancer, she reported.
Women who chose unilateral mastectomy did so most often out of fear of recurrence and the misguided notion that it would give them a survival advantage. Occasionally, they chose unilateral mastectomy to avoid radiation therapy.
Women who also chose contralateral prophylactic mastectomy initiated discussions about it, which their surgeons then discouraged. These patients chose it anyway because they overestimated the risk of contralateral cancer and mistakenly believed it would improve their chance of survival. Occasionally they added contralateral prophylactic mastectomy for body symmetry.
In essence, patients chose these more aggressive surgeries because they were actively trying to control their cancer outcomes and ensure that they "never have to go through this again," Dr. Covelli said.
The study cohort had a mean age of 55 years, with ages ranging from 36 to 84 years.
Dr. Covelli has received funding from Roche Canada and the Canadian Breast Cancer Foundation Physician Fellowship Award.
On Twitter @sherryboschert
SAN FRANCISCO – Fear and a desire for control over breast cancer may drive women to choose mastectomy over less aggressive management, a qualitative study of 30 patients has shown.
She interviewed 15 women who were candidates for breast-conserving surgery but chose unilateral mastectomy and 15 average-risk women who were candidates for surgery in one breast but also chose prophylactic contralateral mastectomy.
Fear led patients to overestimate their risk of local recurrence and contralateral cancer and to misunderstand their odds of dying of breast cancer. The fear combined with wanting to eliminate and control the risk of cancer resulted in the patient choosing mastectomy or bilateral mastectomy, factors that probably are contributing to increasing rates of mastectomy for early-stage breast cancer, Dr. Andrea M. Covelli reported in a poster at a breast cancer symposium sponsored by the American Society of Clinical Oncology.
When deciding on treatment, the women sought out multiple sources of information but gave greatest weight to the experiences of people they’d known with breast cancer and information from breast cancer survivors. It was the patients, not clinicians, who raised the topic of contralateral prophylactic mastectomy, which some patients chose in an attempt to eliminate any risk of contralateral breast cancer.
"More surgery is seen as more control," reported Dr. Covelli of the University of Toronto. A better understanding of patients’ decision process may help physicians be better able to discuss issues important to their patients in making treatment decisions.
Dr. Covelli conducted semistructured one-on-one interviews with patients with early-stage breast cancer chosen from five hospitals in the greater Toronto area to represent a variety of ages and ethnicities. Twelve were treated at academic cancer centers, 6 were treated at academic noncancer centers, and 12 were treated at community medical centers.
She identified several themes in the results. The diagnosis brought shock and fear. Patients discussed both breast-conserving surgery and unilateral mastectomy during their surgical consultation, during which the physician discouraged contralateral prophylactic mastectomy. Patients relied on multiple sources of information in their decision making, but the greatest impact came from the experiences of others with breast cancer, she reported.
Women who chose unilateral mastectomy did so most often out of fear of recurrence and the misguided notion that it would give them a survival advantage. Occasionally, they chose unilateral mastectomy to avoid radiation therapy.
Women who also chose contralateral prophylactic mastectomy initiated discussions about it, which their surgeons then discouraged. These patients chose it anyway because they overestimated the risk of contralateral cancer and mistakenly believed it would improve their chance of survival. Occasionally they added contralateral prophylactic mastectomy for body symmetry.
In essence, patients chose these more aggressive surgeries because they were actively trying to control their cancer outcomes and ensure that they "never have to go through this again," Dr. Covelli said.
The study cohort had a mean age of 55 years, with ages ranging from 36 to 84 years.
Dr. Covelli has received funding from Roche Canada and the Canadian Breast Cancer Foundation Physician Fellowship Award.
On Twitter @sherryboschert
AT THE ASCO BREAST CANCER SYMPOSIUM
Major finding: Fear and a desire for control over cancer drove women to choose mastectomy.
Data source: A qualitative study of 30 women with early-stage breast cancer who were candidates for breast-conserving surgery but chose unilateral mastectomy with or without contralateral prophylactic mastectomy.
Disclosures: Dr. Covelli has received funding from Roche Canada and the Canadian Breast Cancer Foundation Physician Fellowship Award.
Cardiovascular risk factors common with breast cancer
SAN FRANCISCO – Breast cancer survivors shared several body composition characteristics associated with increased cardiac risk and were referred for cardiac consultation most commonly for a high body mass index, an elevated LDL* level, insufficient exercise, and exposure to anthracycline, two separate studies found.
In the first study, kinesiologists measured various characteristics in 3,674 nononcology female patients and compared them with measurements in 740 women in a breast cancer survivorship clinic who were stratified into 8 groups according to the type of treatment they received. All breast cancer patients underwent surgery: 41 women had surgery alone, 13 also underwent chemotherapy, 51 had surgery and radiotherapy, and 48 had surgery and hormone therapy. Most cancer survivors underwent multiple therapies: surgery, chemotherapy, radiation, and hormone therapy in 244; surgery, radiation, and hormone therapy in 207; surgery, chemotherapy, and radiation in 83; and surgery, chemotherapy, and hormone therapy in 30, David H. Jones and his associates found.
Statistically significant differences were seen between the control group and five of the eight treatment groups. Compared with the control group, patients who underwent surgery, chemotherapy, radiation, and hormone therapy had significantly higher mean diastolic blood pressure (77 vs. 74 mm Hg), mean systolic blood pressure (128 vs. 123 mm Hg), mean arterial pressure (94 vs. 90 mm Hg), A faster mean heart rate (77 vs. 73 beats per minute), a higher percentage of body fat (37% vs. 34%), and a greater waist circumference (88 vs. 85 cm), Mr. Jones reported in a poster at a breast cancer symposium sponsored by the American Society of Clinical Oncology.
Patients who underwent surgery, radiation, and hormone therapy also had a higher mean systolic blood pressure compared with controls (130 mm Hg), a higher mean arterial pressure (94 mm Hg), and greater body fat (37%). Patients who underwent surgery, chemotherapy, and radiotherapy had a higher mean systolic blood pressure (129 mm Hg), mean arterial pressure (94 mm Hg), heart rate (79 bpm), and body fat (38%) compared with controls, reported Mr. Jones of Ville-Marie Medical Center, Montreal.
Patients treated with surgery alone had a higher body mass index (29 vs. 26 kg/mm2), body fat percentage (39%), and waist circumference (90 cm) than did controls. Patients who underwent surgery and chemotherapy had significantly less mean muscle mass compared with controls (9.6 vs. 10.1 kg).
Previous studies have associated these body composition characteristics with increased risk for cardiovascular diseases and metabolic problems, Mr. Jones noted.
In the second study of 365 women with nonmetastatic breast cancer seen at a survivorship center in 2006-2012, 13% already were being followed by a cardiologist, 21% were referred to cardio-oncology after their initial visit to the survivorship center, and 66% were not referred, Jennifer R. Klemp, Ph.D., and her associates found.
Patients who were not referred had an average of four risk factors for cardiovascular disease, significantly fewer than the average of six cardiovascular risk factors in patients referred to cardio-oncology and those already seeing a cardiologist, reported Dr. Klemp, director of cancer survivorship at the University of Kansas, Westwood.
The risk factors considered in the study included exposure to cardiotoxic breast cancer treatment as well as traditional risk factors: a BMI greater than 25, diabetes; hypertension, an elevated HDL level, a history of smoking, a family history of an MI before age 60 years, and exercising fewer than 150 min/wk. Breast cancer treatment–related risk factors included an ejection fraction less than 50%; anti-hormone therapy; use of tamoxifen, anthracycline, or Herceptin (trastuzumab); and left chest wall radiation.
Among patients referred to cardio-oncology, 92% showed up. Most often they received additional diagnostic tests, changes in medications, or return visits for follow-up.
"These findings demonstrate the need to determine how to include treatment-related risk factors along with traditional cardiovascular risk factors in assessing and managing cardiovascular risk in breast cancer survivors," Dr. Klemp said.
Mr. Jones and Dr. Klemp reported having no relevant financial disclosures. Most of Dr. Jones’ associates were employees or leaders of Ville-Marie Medical Center.
On Twitter @sherryboschert
*Correction, 11/20/2013: A previous version of this article misstated one of the symptoms for both increased cardiac risk and increased risk for cardio-oncology referrals.
The study by Mr. Jones and his coinvestigators compared anthropometric baseline and vital sign measurements in 3,674 nononcology female patients with measurements in 740 cancer survivors. They evaluated the patients post treatment by eight different treatment regimens. Compared with a nononcology group, the patients undergoing breast cancer surgery alone had significantly higher blood pressure values, greater amounts of body fat, and larger waist circumferences. Adding two additional therapies such as hormone therapy, radiotherapy, or chemotherapy tended to show worsening parameters. The more therapy the patient had, the more likely she was to have one of these worse parameters.
The investigators concluded that several unfavorable body composition characteristics seemed to be associated with women who had completed treatment for breast cancer. And many of these changes in body composition led to an increased risk of developing cardiovascular diseases and different types of metabolic problems.
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These findings corroborate those from previous studies. For example, these patients have been found to have more high-risk features after they complete their breast cancer therapy. One small study that looked at physical activity in the year after breast cancer was treated found that total activity was reduced after breast cancer treatment – including household, sports, and occupational activities. Across the board, patients remained less active 1 year post treatment, with implications for their cardiovascular health (Breast Cancer Res. Treat. 2010;123:417-25).
This becomes very important when you think about the increased number of risk factors following therapy, and the fact that patients got less exercise the year after treatment. When you put that in perspective, the lifetime risk of death from cardiovascular disease among women aged 55 and older increases dramatically with additional risk factors (N. Engl. J. Med. 2012;366:321-9).
The study by Dr. Klemp and his associates looked at cardiovascular risk factors among 365 breast cancer survivors and the outcomes of cardio-oncology referrals at the university’s survivorship center between 2006 and 2012. The investigators evaluated the number of patients with three or more cardiovascular risk factors, both preexisting and treatment related. The cardiac risk factors were pretty similar to those in the general population. The cardiology referrals accounted for 21% of patients. The most common risk factors associated with cardio-oncology referrals were a high body mass index, an elevated LDL* level, less exercise exposure, and anthracycline exposure. The most common outcomes for those seen by cardio-oncology were additional diagnostic tests and medication changes. Interventions by cardiology referrals correlated with a higher number of risk factors. Patients with the highest number of risk factors were the most likely to continue with the cardiologist, receive medication, and undergo diagnostic tests.
These two studies together demonstrate the important message that cardiovascular disease is a significant risk for breast cancer survivors. With time, as the risk of breast cancer death decreases, the risk of cardiovascular death increases.
The best method for improved outcomes from breast cancer may be the addition of an exercise machine in our waiting rooms.
Dr. Julia White is the director of breast radiation oncology at Ohio State University, Columbus. These are excerpts of her remarks as the discussant of these papers at the meeting. She reported having no financial relevant financial disclosures.
The study by Mr. Jones and his coinvestigators compared anthropometric baseline and vital sign measurements in 3,674 nononcology female patients with measurements in 740 cancer survivors. They evaluated the patients post treatment by eight different treatment regimens. Compared with a nononcology group, the patients undergoing breast cancer surgery alone had significantly higher blood pressure values, greater amounts of body fat, and larger waist circumferences. Adding two additional therapies such as hormone therapy, radiotherapy, or chemotherapy tended to show worsening parameters. The more therapy the patient had, the more likely she was to have one of these worse parameters.
The investigators concluded that several unfavorable body composition characteristics seemed to be associated with women who had completed treatment for breast cancer. And many of these changes in body composition led to an increased risk of developing cardiovascular diseases and different types of metabolic problems.
|
|
These findings corroborate those from previous studies. For example, these patients have been found to have more high-risk features after they complete their breast cancer therapy. One small study that looked at physical activity in the year after breast cancer was treated found that total activity was reduced after breast cancer treatment – including household, sports, and occupational activities. Across the board, patients remained less active 1 year post treatment, with implications for their cardiovascular health (Breast Cancer Res. Treat. 2010;123:417-25).
This becomes very important when you think about the increased number of risk factors following therapy, and the fact that patients got less exercise the year after treatment. When you put that in perspective, the lifetime risk of death from cardiovascular disease among women aged 55 and older increases dramatically with additional risk factors (N. Engl. J. Med. 2012;366:321-9).
The study by Dr. Klemp and his associates looked at cardiovascular risk factors among 365 breast cancer survivors and the outcomes of cardio-oncology referrals at the university’s survivorship center between 2006 and 2012. The investigators evaluated the number of patients with three or more cardiovascular risk factors, both preexisting and treatment related. The cardiac risk factors were pretty similar to those in the general population. The cardiology referrals accounted for 21% of patients. The most common risk factors associated with cardio-oncology referrals were a high body mass index, an elevated LDL* level, less exercise exposure, and anthracycline exposure. The most common outcomes for those seen by cardio-oncology were additional diagnostic tests and medication changes. Interventions by cardiology referrals correlated with a higher number of risk factors. Patients with the highest number of risk factors were the most likely to continue with the cardiologist, receive medication, and undergo diagnostic tests.
These two studies together demonstrate the important message that cardiovascular disease is a significant risk for breast cancer survivors. With time, as the risk of breast cancer death decreases, the risk of cardiovascular death increases.
The best method for improved outcomes from breast cancer may be the addition of an exercise machine in our waiting rooms.
Dr. Julia White is the director of breast radiation oncology at Ohio State University, Columbus. These are excerpts of her remarks as the discussant of these papers at the meeting. She reported having no financial relevant financial disclosures.
The study by Mr. Jones and his coinvestigators compared anthropometric baseline and vital sign measurements in 3,674 nononcology female patients with measurements in 740 cancer survivors. They evaluated the patients post treatment by eight different treatment regimens. Compared with a nononcology group, the patients undergoing breast cancer surgery alone had significantly higher blood pressure values, greater amounts of body fat, and larger waist circumferences. Adding two additional therapies such as hormone therapy, radiotherapy, or chemotherapy tended to show worsening parameters. The more therapy the patient had, the more likely she was to have one of these worse parameters.
The investigators concluded that several unfavorable body composition characteristics seemed to be associated with women who had completed treatment for breast cancer. And many of these changes in body composition led to an increased risk of developing cardiovascular diseases and different types of metabolic problems.
|
|
These findings corroborate those from previous studies. For example, these patients have been found to have more high-risk features after they complete their breast cancer therapy. One small study that looked at physical activity in the year after breast cancer was treated found that total activity was reduced after breast cancer treatment – including household, sports, and occupational activities. Across the board, patients remained less active 1 year post treatment, with implications for their cardiovascular health (Breast Cancer Res. Treat. 2010;123:417-25).
This becomes very important when you think about the increased number of risk factors following therapy, and the fact that patients got less exercise the year after treatment. When you put that in perspective, the lifetime risk of death from cardiovascular disease among women aged 55 and older increases dramatically with additional risk factors (N. Engl. J. Med. 2012;366:321-9).
The study by Dr. Klemp and his associates looked at cardiovascular risk factors among 365 breast cancer survivors and the outcomes of cardio-oncology referrals at the university’s survivorship center between 2006 and 2012. The investigators evaluated the number of patients with three or more cardiovascular risk factors, both preexisting and treatment related. The cardiac risk factors were pretty similar to those in the general population. The cardiology referrals accounted for 21% of patients. The most common risk factors associated with cardio-oncology referrals were a high body mass index, an elevated LDL* level, less exercise exposure, and anthracycline exposure. The most common outcomes for those seen by cardio-oncology were additional diagnostic tests and medication changes. Interventions by cardiology referrals correlated with a higher number of risk factors. Patients with the highest number of risk factors were the most likely to continue with the cardiologist, receive medication, and undergo diagnostic tests.
These two studies together demonstrate the important message that cardiovascular disease is a significant risk for breast cancer survivors. With time, as the risk of breast cancer death decreases, the risk of cardiovascular death increases.
The best method for improved outcomes from breast cancer may be the addition of an exercise machine in our waiting rooms.
Dr. Julia White is the director of breast radiation oncology at Ohio State University, Columbus. These are excerpts of her remarks as the discussant of these papers at the meeting. She reported having no financial relevant financial disclosures.
SAN FRANCISCO – Breast cancer survivors shared several body composition characteristics associated with increased cardiac risk and were referred for cardiac consultation most commonly for a high body mass index, an elevated LDL* level, insufficient exercise, and exposure to anthracycline, two separate studies found.
In the first study, kinesiologists measured various characteristics in 3,674 nononcology female patients and compared them with measurements in 740 women in a breast cancer survivorship clinic who were stratified into 8 groups according to the type of treatment they received. All breast cancer patients underwent surgery: 41 women had surgery alone, 13 also underwent chemotherapy, 51 had surgery and radiotherapy, and 48 had surgery and hormone therapy. Most cancer survivors underwent multiple therapies: surgery, chemotherapy, radiation, and hormone therapy in 244; surgery, radiation, and hormone therapy in 207; surgery, chemotherapy, and radiation in 83; and surgery, chemotherapy, and hormone therapy in 30, David H. Jones and his associates found.
Statistically significant differences were seen between the control group and five of the eight treatment groups. Compared with the control group, patients who underwent surgery, chemotherapy, radiation, and hormone therapy had significantly higher mean diastolic blood pressure (77 vs. 74 mm Hg), mean systolic blood pressure (128 vs. 123 mm Hg), mean arterial pressure (94 vs. 90 mm Hg), A faster mean heart rate (77 vs. 73 beats per minute), a higher percentage of body fat (37% vs. 34%), and a greater waist circumference (88 vs. 85 cm), Mr. Jones reported in a poster at a breast cancer symposium sponsored by the American Society of Clinical Oncology.
Patients who underwent surgery, radiation, and hormone therapy also had a higher mean systolic blood pressure compared with controls (130 mm Hg), a higher mean arterial pressure (94 mm Hg), and greater body fat (37%). Patients who underwent surgery, chemotherapy, and radiotherapy had a higher mean systolic blood pressure (129 mm Hg), mean arterial pressure (94 mm Hg), heart rate (79 bpm), and body fat (38%) compared with controls, reported Mr. Jones of Ville-Marie Medical Center, Montreal.
Patients treated with surgery alone had a higher body mass index (29 vs. 26 kg/mm2), body fat percentage (39%), and waist circumference (90 cm) than did controls. Patients who underwent surgery and chemotherapy had significantly less mean muscle mass compared with controls (9.6 vs. 10.1 kg).
Previous studies have associated these body composition characteristics with increased risk for cardiovascular diseases and metabolic problems, Mr. Jones noted.
In the second study of 365 women with nonmetastatic breast cancer seen at a survivorship center in 2006-2012, 13% already were being followed by a cardiologist, 21% were referred to cardio-oncology after their initial visit to the survivorship center, and 66% were not referred, Jennifer R. Klemp, Ph.D., and her associates found.
Patients who were not referred had an average of four risk factors for cardiovascular disease, significantly fewer than the average of six cardiovascular risk factors in patients referred to cardio-oncology and those already seeing a cardiologist, reported Dr. Klemp, director of cancer survivorship at the University of Kansas, Westwood.
The risk factors considered in the study included exposure to cardiotoxic breast cancer treatment as well as traditional risk factors: a BMI greater than 25, diabetes; hypertension, an elevated HDL level, a history of smoking, a family history of an MI before age 60 years, and exercising fewer than 150 min/wk. Breast cancer treatment–related risk factors included an ejection fraction less than 50%; anti-hormone therapy; use of tamoxifen, anthracycline, or Herceptin (trastuzumab); and left chest wall radiation.
Among patients referred to cardio-oncology, 92% showed up. Most often they received additional diagnostic tests, changes in medications, or return visits for follow-up.
"These findings demonstrate the need to determine how to include treatment-related risk factors along with traditional cardiovascular risk factors in assessing and managing cardiovascular risk in breast cancer survivors," Dr. Klemp said.
Mr. Jones and Dr. Klemp reported having no relevant financial disclosures. Most of Dr. Jones’ associates were employees or leaders of Ville-Marie Medical Center.
On Twitter @sherryboschert
*Correction, 11/20/2013: A previous version of this article misstated one of the symptoms for both increased cardiac risk and increased risk for cardio-oncology referrals.
SAN FRANCISCO – Breast cancer survivors shared several body composition characteristics associated with increased cardiac risk and were referred for cardiac consultation most commonly for a high body mass index, an elevated LDL* level, insufficient exercise, and exposure to anthracycline, two separate studies found.
In the first study, kinesiologists measured various characteristics in 3,674 nononcology female patients and compared them with measurements in 740 women in a breast cancer survivorship clinic who were stratified into 8 groups according to the type of treatment they received. All breast cancer patients underwent surgery: 41 women had surgery alone, 13 also underwent chemotherapy, 51 had surgery and radiotherapy, and 48 had surgery and hormone therapy. Most cancer survivors underwent multiple therapies: surgery, chemotherapy, radiation, and hormone therapy in 244; surgery, radiation, and hormone therapy in 207; surgery, chemotherapy, and radiation in 83; and surgery, chemotherapy, and hormone therapy in 30, David H. Jones and his associates found.
Statistically significant differences were seen between the control group and five of the eight treatment groups. Compared with the control group, patients who underwent surgery, chemotherapy, radiation, and hormone therapy had significantly higher mean diastolic blood pressure (77 vs. 74 mm Hg), mean systolic blood pressure (128 vs. 123 mm Hg), mean arterial pressure (94 vs. 90 mm Hg), A faster mean heart rate (77 vs. 73 beats per minute), a higher percentage of body fat (37% vs. 34%), and a greater waist circumference (88 vs. 85 cm), Mr. Jones reported in a poster at a breast cancer symposium sponsored by the American Society of Clinical Oncology.
Patients who underwent surgery, radiation, and hormone therapy also had a higher mean systolic blood pressure compared with controls (130 mm Hg), a higher mean arterial pressure (94 mm Hg), and greater body fat (37%). Patients who underwent surgery, chemotherapy, and radiotherapy had a higher mean systolic blood pressure (129 mm Hg), mean arterial pressure (94 mm Hg), heart rate (79 bpm), and body fat (38%) compared with controls, reported Mr. Jones of Ville-Marie Medical Center, Montreal.
Patients treated with surgery alone had a higher body mass index (29 vs. 26 kg/mm2), body fat percentage (39%), and waist circumference (90 cm) than did controls. Patients who underwent surgery and chemotherapy had significantly less mean muscle mass compared with controls (9.6 vs. 10.1 kg).
Previous studies have associated these body composition characteristics with increased risk for cardiovascular diseases and metabolic problems, Mr. Jones noted.
In the second study of 365 women with nonmetastatic breast cancer seen at a survivorship center in 2006-2012, 13% already were being followed by a cardiologist, 21% were referred to cardio-oncology after their initial visit to the survivorship center, and 66% were not referred, Jennifer R. Klemp, Ph.D., and her associates found.
Patients who were not referred had an average of four risk factors for cardiovascular disease, significantly fewer than the average of six cardiovascular risk factors in patients referred to cardio-oncology and those already seeing a cardiologist, reported Dr. Klemp, director of cancer survivorship at the University of Kansas, Westwood.
The risk factors considered in the study included exposure to cardiotoxic breast cancer treatment as well as traditional risk factors: a BMI greater than 25, diabetes; hypertension, an elevated HDL level, a history of smoking, a family history of an MI before age 60 years, and exercising fewer than 150 min/wk. Breast cancer treatment–related risk factors included an ejection fraction less than 50%; anti-hormone therapy; use of tamoxifen, anthracycline, or Herceptin (trastuzumab); and left chest wall radiation.
Among patients referred to cardio-oncology, 92% showed up. Most often they received additional diagnostic tests, changes in medications, or return visits for follow-up.
"These findings demonstrate the need to determine how to include treatment-related risk factors along with traditional cardiovascular risk factors in assessing and managing cardiovascular risk in breast cancer survivors," Dr. Klemp said.
Mr. Jones and Dr. Klemp reported having no relevant financial disclosures. Most of Dr. Jones’ associates were employees or leaders of Ville-Marie Medical Center.
On Twitter @sherryboschert
*Correction, 11/20/2013: A previous version of this article misstated one of the symptoms for both increased cardiac risk and increased risk for cardio-oncology referrals.
AT THE ASCO BREAST CANCER SYMPOSIUM
Major finding: Mean blood pressures were 128/77 mm Hg in patients treated with surgery, chemotherapy, radiation, and hormone therapy compared with 123/74 mm Hg in controls, in one study. In a second study, 13% of patients at a survivorship center were seeing a cardiologist and 21% were referred to one.
Data source: A prospective study comparing 740 breast cancer survivors with 3,674 nononcology patients, and a separate retrospective study of 365 women at a survivorship center.
Disclosures: Mr. Jones and Dr. Klemp reported having no relevant financial disclosures. Most of Mr. Jones’ associates were employees or leaders of Ville-Marie Medical Center.
Improved outcomes with CoreValve in extreme-risk patients
SAN FRANCISCO – Transcatheter aortic valve replacement with the self-expanding CoreValve in patients at extreme surgical risk significantly reduced the rate of death or major stroke at 1 year, from 43% to 26%, in a 487-patient pivotal trial.
The CoreValve Extreme Risk study gathered data from a registry of patients with symptomatic severe aortic stenosis who attempted an iliofemoral implantation procedure with the CoreValve at 40 U.S. sites. Results were compared with an "objective performance goal" derived from two sources: a meta-analysis of five contemporary balloon valvuloplasty series that found a 43% mortality and major stroke rate at 1 year, and the 1-year rate from the PARTNER B trial in inoperable patients (Placement of Aortic Transcatheter Valves, Cohort B), which was 50% but had a lower confidence bound of 43%.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The performance-goal comparison was necessary in the current study because randomizing these patients to medical therapy in a control group is no longer an acceptable option in the United States, Dr. Jeffrey J. Popma said at the Transcatheter Cardiovascular Therapeutics annual meeting.
The 1-year all-cause mortality rate was 24%, and the cardiovascular mortality was 18%, reported Dr. Popma, professor of medicine at Harvard Medical School, Boston.
Two percent of patients developed a major stroke within 1 month and 4% did so within 1 year.
Data from a continued access study involving another 830 extreme-risk patients who received the CoreValve through an iliofemoral approach are showing even better results, with a 16% rate of mortality or major stroke at 6 months, he added.
Among secondary endpoints at 1 year in the main study, 7% of patients developed any kind of stroke, 2% had an MI, 2% need reintervention, 41% had bleeding that met Valve Academic Research Consortium criteria, 8% had major vascular complications, and 27% required implantation of a permanent pacemaker, Dr. Popma reported at the meeting, cosponsored by the American College of Cardiology. Ninety percent of patients improved by at least one New York Heart Association functional class and 60% improved by at least two classes at 1 year of follow-up.
Paravalvular regurgitation of any severity was seen in 53% of patients 1 month after implantation and in 33% at 1 year. Moderate paravalvular leakage (PVL) affected 9% at 1 month and 4% at 1 year, and severe PVL affected 1.6% at 1 month and no patients at 1 year, Dr. Popma said. Among the 11% of patients with moderate PVL at 1 month, 80% of those who survived to 1 year had a reduction in leakage over time.
"We believe that’s why we did not find an association in the study between mild or moderate aortic regurgitation with respect to late-term mortality," though mortality risk was substantially higher with severe regurgitation, he said. One-year mortality rates were 86% with severe PVL and 24% with either moderate or mild PVL, compared with 18% in patients with no PVL.
The improvement in PVL rates over time may be due to use of CT angiography to select appropriate valve sizes for patients and continued expansion of the self-expanding frame over time. "That’s a remarkable finding, and it needs to be confirmed," Dr. Popma said.
The study focused on patients whose severe frailty, comorbidity, or disability put them at extreme risk of at least a 50% chance of death or irreversible morbidity within 30 days had they undergone surgical aortic valve replacement. A second U.S. pivotal trial of the CoreValve is focusing on patients at high (but not extreme) risk.
Most of the sites in the study had no experience with CoreValve before this study, Dr. Michael J. Mack noted at a press briefing. "The results are outstanding, but especially putting it in that light," said Dr. Mack, director of cardiovascular disease for the Baylor Scott & White Health System, Dallas, and a member of the steering committee for the PARTNER trial.
Dr. Popma reported financial associations with Medtronic, which sponsored the study and makes CoreValve, and with six other companies.
On Twitter @sherryboschert
This is a brilliantly executed, rigorously performed study. After doing sham-control studies, as we did, in these extreme-risk patients, it’s difficult to do a randomized trial. I think these investigators did they best that they could. Using a performance goal standard was the right thing to do.
 |
|
I think that the results are good. It’s always difficult to compare study to study. They’re at different points in time, and we learn things over time. The CoreValve device is a lower-profile device, so there were fewer vascular complications, there was less major bleeding. Those things, in fact, can have an impact on 1-year mortality. The overall 1-year mortality was lower than in PARTNER. In PARTNER by intention to treat the mortality rate was 30.7%, and in the CoreValve study it was in the low 20% range. I think that that’s encouraging.
The stroke rates are encouraging. The pacemaker rates are predictable; it’s a by-product of the specific device. The importance of that is debatable, but it’s not really a concern. It was anticipated.
The paravalvular leakage (PVL) rate is interesting. Many studies with CoreValve suggest that either moderate or severe PVL is associated with an increase in late mortality, if not at 1 year later. It’s not a huge sample size; maybe over time with different definitions of PVL we’d begin to see that.
I am surprised by the 30-day to 1-year data that suggest a reduced PVL rate. I can understand how a self-expanding platform might change in the first 30 days; I can’t quite understand how it would change between 1 month and 12 months in a way that PVL would go down.
Martin B. Leon, M.D., is director of the Center for Interventional Vascular Therapy at Columbia University, New York, and served as principal investigator of the PARTNER trial of the competing Sapien valve.
This is a brilliantly executed, rigorously performed study. After doing sham-control studies, as we did, in these extreme-risk patients, it’s difficult to do a randomized trial. I think these investigators did they best that they could. Using a performance goal standard was the right thing to do.
|
|
I think that the results are good. It’s always difficult to compare study to study. They’re at different points in time, and we learn things over time. The CoreValve device is a lower-profile device, so there were fewer vascular complications, there was less major bleeding. Those things, in fact, can have an impact on 1-year mortality. The overall 1-year mortality was lower than in PARTNER. In PARTNER by intention to treat the mortality rate was 30.7%, and in the CoreValve study it was in the low 20% range. I think that that’s encouraging.
The stroke rates are encouraging. The pacemaker rates are predictable; it’s a by-product of the specific device. The importance of that is debatable, but it’s not really a concern. It was anticipated.
The paravalvular leakage (PVL) rate is interesting. Many studies with CoreValve suggest that either moderate or severe PVL is associated with an increase in late mortality, if not at 1 year later. It’s not a huge sample size; maybe over time with different definitions of PVL we’d begin to see that.
I am surprised by the 30-day to 1-year data that suggest a reduced PVL rate. I can understand how a self-expanding platform might change in the first 30 days; I can’t quite understand how it would change between 1 month and 12 months in a way that PVL would go down.
Martin B. Leon, M.D., is director of the Center for Interventional Vascular Therapy at Columbia University, New York, and served as principal investigator of the PARTNER trial of the competing Sapien valve.
This is a brilliantly executed, rigorously performed study. After doing sham-control studies, as we did, in these extreme-risk patients, it’s difficult to do a randomized trial. I think these investigators did they best that they could. Using a performance goal standard was the right thing to do.
|
|
I think that the results are good. It’s always difficult to compare study to study. They’re at different points in time, and we learn things over time. The CoreValve device is a lower-profile device, so there were fewer vascular complications, there was less major bleeding. Those things, in fact, can have an impact on 1-year mortality. The overall 1-year mortality was lower than in PARTNER. In PARTNER by intention to treat the mortality rate was 30.7%, and in the CoreValve study it was in the low 20% range. I think that that’s encouraging.
The stroke rates are encouraging. The pacemaker rates are predictable; it’s a by-product of the specific device. The importance of that is debatable, but it’s not really a concern. It was anticipated.
The paravalvular leakage (PVL) rate is interesting. Many studies with CoreValve suggest that either moderate or severe PVL is associated with an increase in late mortality, if not at 1 year later. It’s not a huge sample size; maybe over time with different definitions of PVL we’d begin to see that.
I am surprised by the 30-day to 1-year data that suggest a reduced PVL rate. I can understand how a self-expanding platform might change in the first 30 days; I can’t quite understand how it would change between 1 month and 12 months in a way that PVL would go down.
Martin B. Leon, M.D., is director of the Center for Interventional Vascular Therapy at Columbia University, New York, and served as principal investigator of the PARTNER trial of the competing Sapien valve.
SAN FRANCISCO – Transcatheter aortic valve replacement with the self-expanding CoreValve in patients at extreme surgical risk significantly reduced the rate of death or major stroke at 1 year, from 43% to 26%, in a 487-patient pivotal trial.
The CoreValve Extreme Risk study gathered data from a registry of patients with symptomatic severe aortic stenosis who attempted an iliofemoral implantation procedure with the CoreValve at 40 U.S. sites. Results were compared with an "objective performance goal" derived from two sources: a meta-analysis of five contemporary balloon valvuloplasty series that found a 43% mortality and major stroke rate at 1 year, and the 1-year rate from the PARTNER B trial in inoperable patients (Placement of Aortic Transcatheter Valves, Cohort B), which was 50% but had a lower confidence bound of 43%.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The performance-goal comparison was necessary in the current study because randomizing these patients to medical therapy in a control group is no longer an acceptable option in the United States, Dr. Jeffrey J. Popma said at the Transcatheter Cardiovascular Therapeutics annual meeting.
The 1-year all-cause mortality rate was 24%, and the cardiovascular mortality was 18%, reported Dr. Popma, professor of medicine at Harvard Medical School, Boston.
Two percent of patients developed a major stroke within 1 month and 4% did so within 1 year.
Data from a continued access study involving another 830 extreme-risk patients who received the CoreValve through an iliofemoral approach are showing even better results, with a 16% rate of mortality or major stroke at 6 months, he added.
Among secondary endpoints at 1 year in the main study, 7% of patients developed any kind of stroke, 2% had an MI, 2% need reintervention, 41% had bleeding that met Valve Academic Research Consortium criteria, 8% had major vascular complications, and 27% required implantation of a permanent pacemaker, Dr. Popma reported at the meeting, cosponsored by the American College of Cardiology. Ninety percent of patients improved by at least one New York Heart Association functional class and 60% improved by at least two classes at 1 year of follow-up.
Paravalvular regurgitation of any severity was seen in 53% of patients 1 month after implantation and in 33% at 1 year. Moderate paravalvular leakage (PVL) affected 9% at 1 month and 4% at 1 year, and severe PVL affected 1.6% at 1 month and no patients at 1 year, Dr. Popma said. Among the 11% of patients with moderate PVL at 1 month, 80% of those who survived to 1 year had a reduction in leakage over time.
"We believe that’s why we did not find an association in the study between mild or moderate aortic regurgitation with respect to late-term mortality," though mortality risk was substantially higher with severe regurgitation, he said. One-year mortality rates were 86% with severe PVL and 24% with either moderate or mild PVL, compared with 18% in patients with no PVL.
The improvement in PVL rates over time may be due to use of CT angiography to select appropriate valve sizes for patients and continued expansion of the self-expanding frame over time. "That’s a remarkable finding, and it needs to be confirmed," Dr. Popma said.
The study focused on patients whose severe frailty, comorbidity, or disability put them at extreme risk of at least a 50% chance of death or irreversible morbidity within 30 days had they undergone surgical aortic valve replacement. A second U.S. pivotal trial of the CoreValve is focusing on patients at high (but not extreme) risk.
Most of the sites in the study had no experience with CoreValve before this study, Dr. Michael J. Mack noted at a press briefing. "The results are outstanding, but especially putting it in that light," said Dr. Mack, director of cardiovascular disease for the Baylor Scott & White Health System, Dallas, and a member of the steering committee for the PARTNER trial.
Dr. Popma reported financial associations with Medtronic, which sponsored the study and makes CoreValve, and with six other companies.
On Twitter @sherryboschert
SAN FRANCISCO – Transcatheter aortic valve replacement with the self-expanding CoreValve in patients at extreme surgical risk significantly reduced the rate of death or major stroke at 1 year, from 43% to 26%, in a 487-patient pivotal trial.
The CoreValve Extreme Risk study gathered data from a registry of patients with symptomatic severe aortic stenosis who attempted an iliofemoral implantation procedure with the CoreValve at 40 U.S. sites. Results were compared with an "objective performance goal" derived from two sources: a meta-analysis of five contemporary balloon valvuloplasty series that found a 43% mortality and major stroke rate at 1 year, and the 1-year rate from the PARTNER B trial in inoperable patients (Placement of Aortic Transcatheter Valves, Cohort B), which was 50% but had a lower confidence bound of 43%.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The performance-goal comparison was necessary in the current study because randomizing these patients to medical therapy in a control group is no longer an acceptable option in the United States, Dr. Jeffrey J. Popma said at the Transcatheter Cardiovascular Therapeutics annual meeting.
The 1-year all-cause mortality rate was 24%, and the cardiovascular mortality was 18%, reported Dr. Popma, professor of medicine at Harvard Medical School, Boston.
Two percent of patients developed a major stroke within 1 month and 4% did so within 1 year.
Data from a continued access study involving another 830 extreme-risk patients who received the CoreValve through an iliofemoral approach are showing even better results, with a 16% rate of mortality or major stroke at 6 months, he added.
Among secondary endpoints at 1 year in the main study, 7% of patients developed any kind of stroke, 2% had an MI, 2% need reintervention, 41% had bleeding that met Valve Academic Research Consortium criteria, 8% had major vascular complications, and 27% required implantation of a permanent pacemaker, Dr. Popma reported at the meeting, cosponsored by the American College of Cardiology. Ninety percent of patients improved by at least one New York Heart Association functional class and 60% improved by at least two classes at 1 year of follow-up.
Paravalvular regurgitation of any severity was seen in 53% of patients 1 month after implantation and in 33% at 1 year. Moderate paravalvular leakage (PVL) affected 9% at 1 month and 4% at 1 year, and severe PVL affected 1.6% at 1 month and no patients at 1 year, Dr. Popma said. Among the 11% of patients with moderate PVL at 1 month, 80% of those who survived to 1 year had a reduction in leakage over time.
"We believe that’s why we did not find an association in the study between mild or moderate aortic regurgitation with respect to late-term mortality," though mortality risk was substantially higher with severe regurgitation, he said. One-year mortality rates were 86% with severe PVL and 24% with either moderate or mild PVL, compared with 18% in patients with no PVL.
The improvement in PVL rates over time may be due to use of CT angiography to select appropriate valve sizes for patients and continued expansion of the self-expanding frame over time. "That’s a remarkable finding, and it needs to be confirmed," Dr. Popma said.
The study focused on patients whose severe frailty, comorbidity, or disability put them at extreme risk of at least a 50% chance of death or irreversible morbidity within 30 days had they undergone surgical aortic valve replacement. A second U.S. pivotal trial of the CoreValve is focusing on patients at high (but not extreme) risk.
Most of the sites in the study had no experience with CoreValve before this study, Dr. Michael J. Mack noted at a press briefing. "The results are outstanding, but especially putting it in that light," said Dr. Mack, director of cardiovascular disease for the Baylor Scott & White Health System, Dallas, and a member of the steering committee for the PARTNER trial.
Dr. Popma reported financial associations with Medtronic, which sponsored the study and makes CoreValve, and with six other companies.
On Twitter @sherryboschert
AT TCT 2013
Major finding: The rate of all-cause mortality or stroke at 1 year was 26%, compared with an objective performance goal of 43%.
Data source: Study of registry data on 487 patients with symptomatic severe aortic stenosis and attempted CoreValve implantation via iliofemoral access.
Disclosures: Dr. Popma reported financial associations with Medtronic, which sponsored the study and makes CoreValve, and with six other companies.
