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The Official Newspaper of the American Association for Thoracic Surgery
VIDEO: Stenting to improve quality of life in esophageal cancer
PHILADELPHIA – An esophageal stent can improve quality of life for patients with advanced esophageal cancer, according to Dr. Sushil Ahlawat, director of endoscopy at Rutgers University, New Brunswick, N.J.
“An esophageal stent can be an important modality for palliating patients’ dysphagia, [which] can happen because the tumor is obstructing the esophagus,” says Dr. Ahlawat in this video. He also discusses how this minimally invasive procedure can support those undergoing chemoradiation therapy or surgery for esophageal cancer.
The video was recorded at this year’s meeting, held by Global Academy for Medical Education and Rutgers, the State University of New Jersey. Global Academy for Medical Education and this news organization are owned by the same company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @whitneymcknight
PHILADELPHIA – An esophageal stent can improve quality of life for patients with advanced esophageal cancer, according to Dr. Sushil Ahlawat, director of endoscopy at Rutgers University, New Brunswick, N.J.
“An esophageal stent can be an important modality for palliating patients’ dysphagia, [which] can happen because the tumor is obstructing the esophagus,” says Dr. Ahlawat in this video. He also discusses how this minimally invasive procedure can support those undergoing chemoradiation therapy or surgery for esophageal cancer.
The video was recorded at this year’s meeting, held by Global Academy for Medical Education and Rutgers, the State University of New Jersey. Global Academy for Medical Education and this news organization are owned by the same company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @whitneymcknight
PHILADELPHIA – An esophageal stent can improve quality of life for patients with advanced esophageal cancer, according to Dr. Sushil Ahlawat, director of endoscopy at Rutgers University, New Brunswick, N.J.
“An esophageal stent can be an important modality for palliating patients’ dysphagia, [which] can happen because the tumor is obstructing the esophagus,” says Dr. Ahlawat in this video. He also discusses how this minimally invasive procedure can support those undergoing chemoradiation therapy or surgery for esophageal cancer.
The video was recorded at this year’s meeting, held by Global Academy for Medical Education and Rutgers, the State University of New Jersey. Global Academy for Medical Education and this news organization are owned by the same company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @whitneymcknight
EXPERT ANALYSIS FROM DIGESTIVE DISEASES: NEW ADVANCES
Angina rates similar across metal stents
WASHINGTON – In patients with coronary artery disease, there is no increased risk of angina 1 year after percutaneous coronary intervention for bare metal stents relative to drug-eluting metal stents, according to data presented at Cardiovascular Research Technologies 2016.
“Angina pectoris in the first year after PCI [percutaneous coronary intervention] is remarkably common, affecting 32.3% of patients,” but “metallic stent type is not independently associated with the occurrence of angina,” reported Dr. Michael A. Gaglia Jr., an interventional cardiologist at MedStar Heart and Vascular Institute in Washington.
This conclusion was based on a study in which 8,804 patients who underwent PCI with metal stents were questioned about angina and its severity. The incidence of angina was compared for bare-metal stents relative to five drug-eluting metal stents: Cypher (sirolimus-eluting, Johnson & Johnson), Taxus Express2 (paclitaxel, Boston Scientific), Xience V (everolimus, Abbott Vascular), Promus Element (everolimus, Boston Scientific), and Resolute Integrity (zotarolimus, Medtronic).
For nearly 3 months, the cumulative incidence of angina remained tightly grouped at 5% or less across stent types. Incidence rates began climbing slowly through the first 9 months of follow-up and then more steeply at about 10 months. When depicted graphically, the incidence of angina appeared higher after placement of the Cypher stent, which was discontinued in 2011, but multivariate analysis found “no significant association between stent type and angina at 1 year after PCI,” Dr. Gaglia reported.
Although risk of angina was not correlated with type of metal stent, angina was highly correlated with risk of a major adverse cardiovascular event (MACE). When angina severity was stratified by the Canadian Cardiovascular Society system, MACE, defined as a composite of all-cause mortality, target vessel revascularization, and Q-wave myocardial infarction, occurred in 6.8% of those without angina, 10.0% of those with class 1 or 2 angina, and 19.7% of those with class 3 or 4 angina (P less than .001 for this trend) over the course of follow-up.
Independent of stent type, angina was more common in patients with a history of severe angina prior to PCI, a prior PCI, or prior coronary artery bypass grafting. A reduced likelihood of angina was independently associated with older age, male sex, a presentation of acute coronary syndrome, and a longer stented length.
Other studies have also shown that angina after PCI is associated with an increased risk of MACE relative to the absence of ischemia, but the contribution of this study is that it is the first set of data to suggest that drug eluting stents provide no advantage over bare metal stents for controlling angina, according to the authors. In the graphic representation of angina incidence for different stent types over 1-year of follow-up, four of the six lines, including the line representing bare metal stents, were essentially superimposable. In addition to the line representing angina incidence in those receiving the Cypher stent, the line representing angina incidence on the Promus Element stent climbed higher at 9 months relative to the remaining four stent types, but this line had rejoined the others at 12 months.
“Metallic coronary stents alter vessel geometry, shear stress, and hemodynamics. Stents also vary in design and architecture,” Dr. Gaglia observed. Although protection from angina is one of the major indications for the placement of stents, Dr. Gaglia emphasized that data comparing different metallic stents in regards to the incidence of angina pectoris at long-term follow-up have until this study “been lacking.”
The meeting was sponsored by the Cardiovascular Research Institute at Washington Hospital Center. Dr. Gaglia reports no relevant financial relationships. Abbott Vascular funded the study.
WASHINGTON – In patients with coronary artery disease, there is no increased risk of angina 1 year after percutaneous coronary intervention for bare metal stents relative to drug-eluting metal stents, according to data presented at Cardiovascular Research Technologies 2016.
“Angina pectoris in the first year after PCI [percutaneous coronary intervention] is remarkably common, affecting 32.3% of patients,” but “metallic stent type is not independently associated with the occurrence of angina,” reported Dr. Michael A. Gaglia Jr., an interventional cardiologist at MedStar Heart and Vascular Institute in Washington.
This conclusion was based on a study in which 8,804 patients who underwent PCI with metal stents were questioned about angina and its severity. The incidence of angina was compared for bare-metal stents relative to five drug-eluting metal stents: Cypher (sirolimus-eluting, Johnson & Johnson), Taxus Express2 (paclitaxel, Boston Scientific), Xience V (everolimus, Abbott Vascular), Promus Element (everolimus, Boston Scientific), and Resolute Integrity (zotarolimus, Medtronic).
For nearly 3 months, the cumulative incidence of angina remained tightly grouped at 5% or less across stent types. Incidence rates began climbing slowly through the first 9 months of follow-up and then more steeply at about 10 months. When depicted graphically, the incidence of angina appeared higher after placement of the Cypher stent, which was discontinued in 2011, but multivariate analysis found “no significant association between stent type and angina at 1 year after PCI,” Dr. Gaglia reported.
Although risk of angina was not correlated with type of metal stent, angina was highly correlated with risk of a major adverse cardiovascular event (MACE). When angina severity was stratified by the Canadian Cardiovascular Society system, MACE, defined as a composite of all-cause mortality, target vessel revascularization, and Q-wave myocardial infarction, occurred in 6.8% of those without angina, 10.0% of those with class 1 or 2 angina, and 19.7% of those with class 3 or 4 angina (P less than .001 for this trend) over the course of follow-up.
Independent of stent type, angina was more common in patients with a history of severe angina prior to PCI, a prior PCI, or prior coronary artery bypass grafting. A reduced likelihood of angina was independently associated with older age, male sex, a presentation of acute coronary syndrome, and a longer stented length.
Other studies have also shown that angina after PCI is associated with an increased risk of MACE relative to the absence of ischemia, but the contribution of this study is that it is the first set of data to suggest that drug eluting stents provide no advantage over bare metal stents for controlling angina, according to the authors. In the graphic representation of angina incidence for different stent types over 1-year of follow-up, four of the six lines, including the line representing bare metal stents, were essentially superimposable. In addition to the line representing angina incidence in those receiving the Cypher stent, the line representing angina incidence on the Promus Element stent climbed higher at 9 months relative to the remaining four stent types, but this line had rejoined the others at 12 months.
“Metallic coronary stents alter vessel geometry, shear stress, and hemodynamics. Stents also vary in design and architecture,” Dr. Gaglia observed. Although protection from angina is one of the major indications for the placement of stents, Dr. Gaglia emphasized that data comparing different metallic stents in regards to the incidence of angina pectoris at long-term follow-up have until this study “been lacking.”
The meeting was sponsored by the Cardiovascular Research Institute at Washington Hospital Center. Dr. Gaglia reports no relevant financial relationships. Abbott Vascular funded the study.
WASHINGTON – In patients with coronary artery disease, there is no increased risk of angina 1 year after percutaneous coronary intervention for bare metal stents relative to drug-eluting metal stents, according to data presented at Cardiovascular Research Technologies 2016.
“Angina pectoris in the first year after PCI [percutaneous coronary intervention] is remarkably common, affecting 32.3% of patients,” but “metallic stent type is not independently associated with the occurrence of angina,” reported Dr. Michael A. Gaglia Jr., an interventional cardiologist at MedStar Heart and Vascular Institute in Washington.
This conclusion was based on a study in which 8,804 patients who underwent PCI with metal stents were questioned about angina and its severity. The incidence of angina was compared for bare-metal stents relative to five drug-eluting metal stents: Cypher (sirolimus-eluting, Johnson & Johnson), Taxus Express2 (paclitaxel, Boston Scientific), Xience V (everolimus, Abbott Vascular), Promus Element (everolimus, Boston Scientific), and Resolute Integrity (zotarolimus, Medtronic).
For nearly 3 months, the cumulative incidence of angina remained tightly grouped at 5% or less across stent types. Incidence rates began climbing slowly through the first 9 months of follow-up and then more steeply at about 10 months. When depicted graphically, the incidence of angina appeared higher after placement of the Cypher stent, which was discontinued in 2011, but multivariate analysis found “no significant association between stent type and angina at 1 year after PCI,” Dr. Gaglia reported.
Although risk of angina was not correlated with type of metal stent, angina was highly correlated with risk of a major adverse cardiovascular event (MACE). When angina severity was stratified by the Canadian Cardiovascular Society system, MACE, defined as a composite of all-cause mortality, target vessel revascularization, and Q-wave myocardial infarction, occurred in 6.8% of those without angina, 10.0% of those with class 1 or 2 angina, and 19.7% of those with class 3 or 4 angina (P less than .001 for this trend) over the course of follow-up.
Independent of stent type, angina was more common in patients with a history of severe angina prior to PCI, a prior PCI, or prior coronary artery bypass grafting. A reduced likelihood of angina was independently associated with older age, male sex, a presentation of acute coronary syndrome, and a longer stented length.
Other studies have also shown that angina after PCI is associated with an increased risk of MACE relative to the absence of ischemia, but the contribution of this study is that it is the first set of data to suggest that drug eluting stents provide no advantage over bare metal stents for controlling angina, according to the authors. In the graphic representation of angina incidence for different stent types over 1-year of follow-up, four of the six lines, including the line representing bare metal stents, were essentially superimposable. In addition to the line representing angina incidence in those receiving the Cypher stent, the line representing angina incidence on the Promus Element stent climbed higher at 9 months relative to the remaining four stent types, but this line had rejoined the others at 12 months.
“Metallic coronary stents alter vessel geometry, shear stress, and hemodynamics. Stents also vary in design and architecture,” Dr. Gaglia observed. Although protection from angina is one of the major indications for the placement of stents, Dr. Gaglia emphasized that data comparing different metallic stents in regards to the incidence of angina pectoris at long-term follow-up have until this study “been lacking.”
The meeting was sponsored by the Cardiovascular Research Institute at Washington Hospital Center. Dr. Gaglia reports no relevant financial relationships. Abbott Vascular funded the study.
AT CARDIOVASCULAR RESEARCH TECHNOLOGIES 2016
Key clinical point: One year after stent placement, angina rates are no higher with bare metal stents than with drug-eluting metal stents.
Major finding: One year after stenting, the incidence of angina was 32.3%.
Data source: Observational study with 8,804 patients.
Disclosures: Dr. Gaglia reports no relevant financial relationships. Abbott Vascular funded the study.
Cardiac cath lab work carries multiple risks
Workers performing fluoroscopically guided cardiovascular procedures are at significantly higher risk of a diverse array of health disorders compared with nonexposed subjects, according to a survey.
Though cancers and ocular, skin, and thyroid disorders are recognized risks of working with low-dose radiation, as are orthopedic problems associated with wearing heavy lead aprons, the new study, published online April 12 in Circulation: Cardiovascular Interventions, adds weight to emerging concerns about lesser-known risks.
In addition to higher prevalence of skin lesions, cataracts, thyroid disorders, cancer, and orthopedic problems, exposed workers saw significantly higher prevalence of hypertension, hypercholesterolemia, and depression or anxiety, compared with controls.
Maria Grazia Andreassi, Ph.D., of the CNR Institute of Clinical Physiology, in Pisa, Italy, led the study, which used questionnaires to collect health, exposure, and demographic information from 466 workers in cardiac catheterization laboratories in Italy: 218 interventional cardiologists and electrophysiologists, 191 nurses, and 57 technicians. Radiation exposure was estimated based on subjects’ occupational radiological risk score (ORRS), which takes into consideration years of work, caseloads, and proximity to the radiation source in the lab.
The researchers administered the same questionnaires to 280 health workers who did not have occupational radiation exposure. The two groups were well matched for age, sex, education level, alcohol use, and body mass index, though current smoking differed significantly (27% of lab staff vs. 23% of unexposed workers).
As expected, orthopedic injuries were markedly higher among the lab workers, with 30% reporting disorders compared with 5% of controls (P less than .001). Nearly 5% of the lab workers had cataracts, compared with less than 1% of the nonexposed (P = .003), and risk increased for subjects with more years in the lab. Cancer was higher among exposed participants (2.6% vs. 0.7%), a difference that did not reach statistical significance. However, a significant trend was seen for cancer risk increasing across duration of exposure (Circ Cardiovasc Interv. 2016;9:e003273).
In the composite endpoint of cataract and cancer, a surrogate for disease associated with occupational exposure to radiation, the researchers found that the interventional cardiologists and electrophysiologists had a significantly higher prevalence than did the nurses and technicians (69% vs. 22% and 9%, respectively; P = .03).
Furthermore, the cancer in physicians occurred more often in the left side, when laterality was applicable, in 67% of cases, whereas the malignancy was left-sided in 33% of cancers occurring in nurses and technicians.
No significant differences in cardiovascular events were seen between the groups. However, hypertension and high cholesterol were more prevalent in cath lab workers, with adjusted odds ratios of 1.7 (95% confidence interval, 1-3; P = .05) and 2.9 (CI, 1-5; P = .004), respectively, for highly exposed subjects, compared with controls.
Last year, in a separate study, Dr. Andreassi’s group reported that exposure to low-dose radiation over time may increase carotid intima-media thickness, an early indicator of vascular injury, among cath lab workers (J Am Coll Cardiol Intv. 2015;8:616-27).
Anxiety and depression occurred in 12% of exposed subjects, compared with 2% of controls. The finding could reflect high occupational stress, the researchers wrote in their analysis, or may be an effect of radiation, “which is especially relevant on the unprotected head of the first operator and at chronic low doses may impact detrimentally on hippocampal neurogenesis and neuronal plasticity.”
The researchers acknowledged the possibility of selection bias in their study, favoring “a possible disproportionate contribution of respondents with existing health issues, who may reasonably think that their complaints are occupationally related,” they wrote. They also noted that the study was not designed to directly assess radiation dose, in part because dosimeters were not regularly worn in some of the settings where subjects worked. Finally, the radiation-exposed group had more cardiovascular risk factors. Nonetheless, the findings highlight the need to “spread the culture of safety” in cardiac cath labs, the researchers wrote.
There is now “more than enough information for us to conclude that the interventional catheterization laboratory is not a healthy workplace,” Dr. Lloyd W. Klein and Dr. Mugurel Bazavan of Advocate Illinois Masonic Medical Center, and Rush Medical College in Chicago, wrote in an accompanying editorial.
Finding “the courage to change business practice,” they wrote, “is the only path to innovative cath laboratory design and shielding techniques that can prevent these occupational hazards” (Circ Cardiovasc Interv. 2016;9:e003742).
Dr. Andreassi and colleagues disclosed no conflicts of interest related to their study, and Dr. Klein and Dr. Bazavan disclosed no conflicts related to their editorial.
The field of interventional cardiology is tremendously exciting, and yet the long-term risks are not as well defined as they should be for the protection of cath lab personnel.
|
Dr. Charles E. Chambers |
This study shows strikingly that both physicians and nonphysicians are at increased risk of a diverse group of medical conditions. Quantifying the contribution of radiation exposure to CV risk and separating it from smoking, dietary, and other factors, will require studies using dosimetry data in lieu of the estimated exposure measures seen in this study.
However, as these findings underscore, there is no doubt that we must be concerned about radiation and that manufacturers, hospitals, and providers need to come to the table to address these urgent questions of personal liability and workplace safety, particularly with so many young people entering the field.
Dr. Charles E. Chambers is professor of medicine and radiology at Pennsylvania State University, Hershey, and past president of the Society for Cardiovascular Angiography and Interventions. He made these comments in an interview, and reports no conflicts of interest.
The field of interventional cardiology is tremendously exciting, and yet the long-term risks are not as well defined as they should be for the protection of cath lab personnel.
|
|
Dr. Charles E. Chambers |
This study shows strikingly that both physicians and nonphysicians are at increased risk of a diverse group of medical conditions. Quantifying the contribution of radiation exposure to CV risk and separating it from smoking, dietary, and other factors, will require studies using dosimetry data in lieu of the estimated exposure measures seen in this study.
However, as these findings underscore, there is no doubt that we must be concerned about radiation and that manufacturers, hospitals, and providers need to come to the table to address these urgent questions of personal liability and workplace safety, particularly with so many young people entering the field.
Dr. Charles E. Chambers is professor of medicine and radiology at Pennsylvania State University, Hershey, and past president of the Society for Cardiovascular Angiography and Interventions. He made these comments in an interview, and reports no conflicts of interest.
The field of interventional cardiology is tremendously exciting, and yet the long-term risks are not as well defined as they should be for the protection of cath lab personnel.
|
|
Dr. Charles E. Chambers |
This study shows strikingly that both physicians and nonphysicians are at increased risk of a diverse group of medical conditions. Quantifying the contribution of radiation exposure to CV risk and separating it from smoking, dietary, and other factors, will require studies using dosimetry data in lieu of the estimated exposure measures seen in this study.
However, as these findings underscore, there is no doubt that we must be concerned about radiation and that manufacturers, hospitals, and providers need to come to the table to address these urgent questions of personal liability and workplace safety, particularly with so many young people entering the field.
Dr. Charles E. Chambers is professor of medicine and radiology at Pennsylvania State University, Hershey, and past president of the Society for Cardiovascular Angiography and Interventions. He made these comments in an interview, and reports no conflicts of interest.
Workers performing fluoroscopically guided cardiovascular procedures are at significantly higher risk of a diverse array of health disorders compared with nonexposed subjects, according to a survey.
Though cancers and ocular, skin, and thyroid disorders are recognized risks of working with low-dose radiation, as are orthopedic problems associated with wearing heavy lead aprons, the new study, published online April 12 in Circulation: Cardiovascular Interventions, adds weight to emerging concerns about lesser-known risks.
In addition to higher prevalence of skin lesions, cataracts, thyroid disorders, cancer, and orthopedic problems, exposed workers saw significantly higher prevalence of hypertension, hypercholesterolemia, and depression or anxiety, compared with controls.
Maria Grazia Andreassi, Ph.D., of the CNR Institute of Clinical Physiology, in Pisa, Italy, led the study, which used questionnaires to collect health, exposure, and demographic information from 466 workers in cardiac catheterization laboratories in Italy: 218 interventional cardiologists and electrophysiologists, 191 nurses, and 57 technicians. Radiation exposure was estimated based on subjects’ occupational radiological risk score (ORRS), which takes into consideration years of work, caseloads, and proximity to the radiation source in the lab.
The researchers administered the same questionnaires to 280 health workers who did not have occupational radiation exposure. The two groups were well matched for age, sex, education level, alcohol use, and body mass index, though current smoking differed significantly (27% of lab staff vs. 23% of unexposed workers).
As expected, orthopedic injuries were markedly higher among the lab workers, with 30% reporting disorders compared with 5% of controls (P less than .001). Nearly 5% of the lab workers had cataracts, compared with less than 1% of the nonexposed (P = .003), and risk increased for subjects with more years in the lab. Cancer was higher among exposed participants (2.6% vs. 0.7%), a difference that did not reach statistical significance. However, a significant trend was seen for cancer risk increasing across duration of exposure (Circ Cardiovasc Interv. 2016;9:e003273).
In the composite endpoint of cataract and cancer, a surrogate for disease associated with occupational exposure to radiation, the researchers found that the interventional cardiologists and electrophysiologists had a significantly higher prevalence than did the nurses and technicians (69% vs. 22% and 9%, respectively; P = .03).
Furthermore, the cancer in physicians occurred more often in the left side, when laterality was applicable, in 67% of cases, whereas the malignancy was left-sided in 33% of cancers occurring in nurses and technicians.
No significant differences in cardiovascular events were seen between the groups. However, hypertension and high cholesterol were more prevalent in cath lab workers, with adjusted odds ratios of 1.7 (95% confidence interval, 1-3; P = .05) and 2.9 (CI, 1-5; P = .004), respectively, for highly exposed subjects, compared with controls.
Last year, in a separate study, Dr. Andreassi’s group reported that exposure to low-dose radiation over time may increase carotid intima-media thickness, an early indicator of vascular injury, among cath lab workers (J Am Coll Cardiol Intv. 2015;8:616-27).
Anxiety and depression occurred in 12% of exposed subjects, compared with 2% of controls. The finding could reflect high occupational stress, the researchers wrote in their analysis, or may be an effect of radiation, “which is especially relevant on the unprotected head of the first operator and at chronic low doses may impact detrimentally on hippocampal neurogenesis and neuronal plasticity.”
The researchers acknowledged the possibility of selection bias in their study, favoring “a possible disproportionate contribution of respondents with existing health issues, who may reasonably think that their complaints are occupationally related,” they wrote. They also noted that the study was not designed to directly assess radiation dose, in part because dosimeters were not regularly worn in some of the settings where subjects worked. Finally, the radiation-exposed group had more cardiovascular risk factors. Nonetheless, the findings highlight the need to “spread the culture of safety” in cardiac cath labs, the researchers wrote.
There is now “more than enough information for us to conclude that the interventional catheterization laboratory is not a healthy workplace,” Dr. Lloyd W. Klein and Dr. Mugurel Bazavan of Advocate Illinois Masonic Medical Center, and Rush Medical College in Chicago, wrote in an accompanying editorial.
Finding “the courage to change business practice,” they wrote, “is the only path to innovative cath laboratory design and shielding techniques that can prevent these occupational hazards” (Circ Cardiovasc Interv. 2016;9:e003742).
Dr. Andreassi and colleagues disclosed no conflicts of interest related to their study, and Dr. Klein and Dr. Bazavan disclosed no conflicts related to their editorial.
Workers performing fluoroscopically guided cardiovascular procedures are at significantly higher risk of a diverse array of health disorders compared with nonexposed subjects, according to a survey.
Though cancers and ocular, skin, and thyroid disorders are recognized risks of working with low-dose radiation, as are orthopedic problems associated with wearing heavy lead aprons, the new study, published online April 12 in Circulation: Cardiovascular Interventions, adds weight to emerging concerns about lesser-known risks.
In addition to higher prevalence of skin lesions, cataracts, thyroid disorders, cancer, and orthopedic problems, exposed workers saw significantly higher prevalence of hypertension, hypercholesterolemia, and depression or anxiety, compared with controls.
Maria Grazia Andreassi, Ph.D., of the CNR Institute of Clinical Physiology, in Pisa, Italy, led the study, which used questionnaires to collect health, exposure, and demographic information from 466 workers in cardiac catheterization laboratories in Italy: 218 interventional cardiologists and electrophysiologists, 191 nurses, and 57 technicians. Radiation exposure was estimated based on subjects’ occupational radiological risk score (ORRS), which takes into consideration years of work, caseloads, and proximity to the radiation source in the lab.
The researchers administered the same questionnaires to 280 health workers who did not have occupational radiation exposure. The two groups were well matched for age, sex, education level, alcohol use, and body mass index, though current smoking differed significantly (27% of lab staff vs. 23% of unexposed workers).
As expected, orthopedic injuries were markedly higher among the lab workers, with 30% reporting disorders compared with 5% of controls (P less than .001). Nearly 5% of the lab workers had cataracts, compared with less than 1% of the nonexposed (P = .003), and risk increased for subjects with more years in the lab. Cancer was higher among exposed participants (2.6% vs. 0.7%), a difference that did not reach statistical significance. However, a significant trend was seen for cancer risk increasing across duration of exposure (Circ Cardiovasc Interv. 2016;9:e003273).
In the composite endpoint of cataract and cancer, a surrogate for disease associated with occupational exposure to radiation, the researchers found that the interventional cardiologists and electrophysiologists had a significantly higher prevalence than did the nurses and technicians (69% vs. 22% and 9%, respectively; P = .03).
Furthermore, the cancer in physicians occurred more often in the left side, when laterality was applicable, in 67% of cases, whereas the malignancy was left-sided in 33% of cancers occurring in nurses and technicians.
No significant differences in cardiovascular events were seen between the groups. However, hypertension and high cholesterol were more prevalent in cath lab workers, with adjusted odds ratios of 1.7 (95% confidence interval, 1-3; P = .05) and 2.9 (CI, 1-5; P = .004), respectively, for highly exposed subjects, compared with controls.
Last year, in a separate study, Dr. Andreassi’s group reported that exposure to low-dose radiation over time may increase carotid intima-media thickness, an early indicator of vascular injury, among cath lab workers (J Am Coll Cardiol Intv. 2015;8:616-27).
Anxiety and depression occurred in 12% of exposed subjects, compared with 2% of controls. The finding could reflect high occupational stress, the researchers wrote in their analysis, or may be an effect of radiation, “which is especially relevant on the unprotected head of the first operator and at chronic low doses may impact detrimentally on hippocampal neurogenesis and neuronal plasticity.”
The researchers acknowledged the possibility of selection bias in their study, favoring “a possible disproportionate contribution of respondents with existing health issues, who may reasonably think that their complaints are occupationally related,” they wrote. They also noted that the study was not designed to directly assess radiation dose, in part because dosimeters were not regularly worn in some of the settings where subjects worked. Finally, the radiation-exposed group had more cardiovascular risk factors. Nonetheless, the findings highlight the need to “spread the culture of safety” in cardiac cath labs, the researchers wrote.
There is now “more than enough information for us to conclude that the interventional catheterization laboratory is not a healthy workplace,” Dr. Lloyd W. Klein and Dr. Mugurel Bazavan of Advocate Illinois Masonic Medical Center, and Rush Medical College in Chicago, wrote in an accompanying editorial.
Finding “the courage to change business practice,” they wrote, “is the only path to innovative cath laboratory design and shielding techniques that can prevent these occupational hazards” (Circ Cardiovasc Interv. 2016;9:e003742).
Dr. Andreassi and colleagues disclosed no conflicts of interest related to their study, and Dr. Klein and Dr. Bazavan disclosed no conflicts related to their editorial.
FROM CIRCULATION: CARDIOVASCULAR INTERVENTIONS
Key clinical point: Workers in cardiac catheterization labs exposed to ionizing radiation are at risk of a wide array of health disorders.
Major finding: Prevalences of skin lesions, orthopedic illness, cataract, hypertension, hypercholesterolemia, and anxiety/depression were significantly higher in exposed cath lab workers, compared with other health care workers.
Data source: A multicenter, controlled study of 746 Italian physicians and staff (466 exposed to radiation and 280 matched unexposed controls) completing self-administered questionnaires.
Disclosures: None.
Surgeons commonly off the mark in estimating blood loss
MONTREAL – Surgeons, nurses, and anesthesia providers were all pretty bad at estimating surgical blood loss in a small study. And more experience doesn’t improve accuracy, though experienced providers were more confident in their estimates.
These were the findings from a study that simulated operating room scenarios and asked providers to estimate blood loss. “Estimation of blood loss is inaccurate and unreliable,” Dr. Luke Rothermel said at the Central Surgical Association’s annual meeting.
Dr. Rothermel, a resident at Case Western Reserve University, Cleveland, noted that although the Joint Commission requires operative notes to contain estimated blood loss, “no study in the United States has compared the characteristics of operating room personnel or conditions associated with improved accuracy or reliability of blood loss estimation.”
Beyond the required reporting, estimating blood loss (EBL) also provides important guidance in perioperative care. Still, said Dr. Rothermel, previous studies have shown that EBL is typically inaccurate.
To assess providers’ ability to be accurate and reliable in estimating blood loss, Dr. Rothermel and his collaborator, Dr. Jeremy Lipman, assistant residency director at MetroHealth, Cleveland, designed a study to simulate three different operating room scenarios, involving high, medium, and low blood loss volumes. The materials used, such as blood-soaked sponges and suction canisters, were identical to what’s actually used in the operating room (porcine blood was used in the simulations).
Before the study, Dr. Rothermel said that he and Dr. Lipman hypothesized that those providers who had more experience and those who were working at the operating field would be more accurate in estimating blood loss. They also hypothesized that estimations in procedures with lower volumes of blood loss would be more accurate.
The study recruited providers from the surgery, anesthesia, and nursing services at an urban level 1 trauma center. Each scenario included a written description of the procedure performed and the course of surgery, and participants could handle study materials for each scenario under the supervision of study staff.
A total of 60 participants (22 from surgery, 17 from anesthesia, and 21 from nursing) participated; they had an average of 12.8 years of experience. The surgical participants included surgical scrub techs, trainees, and attending physicians. Anesthesia participants included anesthesia assistants, CRNAs, trainees, and attending physicians. Nursing participants were all RNs.
The findings? All over the board: “There was no association between specialty, years of experience, or confidence in ability with the consistency or accuracy of estimated blood loss,” said Dr. Rothermel.
Most participants were far shy of the mark, with just 5% of study participants overall able to come within 25% accuracy in judging EBL in all scenarios. Just over a quarter were consistent in over- or underestimating blood loss.
These findings held true across scenarios, across disciplines, and regardless of the number of years of experience. “Increased years of experience trended toward increased error,” said Dr. Rothermel, though the difference was not statistically significant. However, those with more years of experience tended to be more confident of their judgments.
Dr. Rothermel noted the small study size and single institution studied as limitations. Also, “this model was not a high fidelity representation of the OR experience, “ he said, explaining that during surgery, caregivers continually assess intraoperative blood loss and may form an estimate in a different – and potentially more accurate – manner than occurs when presented with the contrived presentation of a scenario.
The study calls into question the validity of using EBL as a quality indicator in assessing physician performance and patient outcomes, said Dr. Rothermel, who had no financial disclosures.
On Twitter @karioakes
MONTREAL – Surgeons, nurses, and anesthesia providers were all pretty bad at estimating surgical blood loss in a small study. And more experience doesn’t improve accuracy, though experienced providers were more confident in their estimates.
These were the findings from a study that simulated operating room scenarios and asked providers to estimate blood loss. “Estimation of blood loss is inaccurate and unreliable,” Dr. Luke Rothermel said at the Central Surgical Association’s annual meeting.
Dr. Rothermel, a resident at Case Western Reserve University, Cleveland, noted that although the Joint Commission requires operative notes to contain estimated blood loss, “no study in the United States has compared the characteristics of operating room personnel or conditions associated with improved accuracy or reliability of blood loss estimation.”
Beyond the required reporting, estimating blood loss (EBL) also provides important guidance in perioperative care. Still, said Dr. Rothermel, previous studies have shown that EBL is typically inaccurate.
To assess providers’ ability to be accurate and reliable in estimating blood loss, Dr. Rothermel and his collaborator, Dr. Jeremy Lipman, assistant residency director at MetroHealth, Cleveland, designed a study to simulate three different operating room scenarios, involving high, medium, and low blood loss volumes. The materials used, such as blood-soaked sponges and suction canisters, were identical to what’s actually used in the operating room (porcine blood was used in the simulations).
Before the study, Dr. Rothermel said that he and Dr. Lipman hypothesized that those providers who had more experience and those who were working at the operating field would be more accurate in estimating blood loss. They also hypothesized that estimations in procedures with lower volumes of blood loss would be more accurate.
The study recruited providers from the surgery, anesthesia, and nursing services at an urban level 1 trauma center. Each scenario included a written description of the procedure performed and the course of surgery, and participants could handle study materials for each scenario under the supervision of study staff.
A total of 60 participants (22 from surgery, 17 from anesthesia, and 21 from nursing) participated; they had an average of 12.8 years of experience. The surgical participants included surgical scrub techs, trainees, and attending physicians. Anesthesia participants included anesthesia assistants, CRNAs, trainees, and attending physicians. Nursing participants were all RNs.
The findings? All over the board: “There was no association between specialty, years of experience, or confidence in ability with the consistency or accuracy of estimated blood loss,” said Dr. Rothermel.
Most participants were far shy of the mark, with just 5% of study participants overall able to come within 25% accuracy in judging EBL in all scenarios. Just over a quarter were consistent in over- or underestimating blood loss.
These findings held true across scenarios, across disciplines, and regardless of the number of years of experience. “Increased years of experience trended toward increased error,” said Dr. Rothermel, though the difference was not statistically significant. However, those with more years of experience tended to be more confident of their judgments.
Dr. Rothermel noted the small study size and single institution studied as limitations. Also, “this model was not a high fidelity representation of the OR experience, “ he said, explaining that during surgery, caregivers continually assess intraoperative blood loss and may form an estimate in a different – and potentially more accurate – manner than occurs when presented with the contrived presentation of a scenario.
The study calls into question the validity of using EBL as a quality indicator in assessing physician performance and patient outcomes, said Dr. Rothermel, who had no financial disclosures.
On Twitter @karioakes
MONTREAL – Surgeons, nurses, and anesthesia providers were all pretty bad at estimating surgical blood loss in a small study. And more experience doesn’t improve accuracy, though experienced providers were more confident in their estimates.
These were the findings from a study that simulated operating room scenarios and asked providers to estimate blood loss. “Estimation of blood loss is inaccurate and unreliable,” Dr. Luke Rothermel said at the Central Surgical Association’s annual meeting.
Dr. Rothermel, a resident at Case Western Reserve University, Cleveland, noted that although the Joint Commission requires operative notes to contain estimated blood loss, “no study in the United States has compared the characteristics of operating room personnel or conditions associated with improved accuracy or reliability of blood loss estimation.”
Beyond the required reporting, estimating blood loss (EBL) also provides important guidance in perioperative care. Still, said Dr. Rothermel, previous studies have shown that EBL is typically inaccurate.
To assess providers’ ability to be accurate and reliable in estimating blood loss, Dr. Rothermel and his collaborator, Dr. Jeremy Lipman, assistant residency director at MetroHealth, Cleveland, designed a study to simulate three different operating room scenarios, involving high, medium, and low blood loss volumes. The materials used, such as blood-soaked sponges and suction canisters, were identical to what’s actually used in the operating room (porcine blood was used in the simulations).
Before the study, Dr. Rothermel said that he and Dr. Lipman hypothesized that those providers who had more experience and those who were working at the operating field would be more accurate in estimating blood loss. They also hypothesized that estimations in procedures with lower volumes of blood loss would be more accurate.
The study recruited providers from the surgery, anesthesia, and nursing services at an urban level 1 trauma center. Each scenario included a written description of the procedure performed and the course of surgery, and participants could handle study materials for each scenario under the supervision of study staff.
A total of 60 participants (22 from surgery, 17 from anesthesia, and 21 from nursing) participated; they had an average of 12.8 years of experience. The surgical participants included surgical scrub techs, trainees, and attending physicians. Anesthesia participants included anesthesia assistants, CRNAs, trainees, and attending physicians. Nursing participants were all RNs.
The findings? All over the board: “There was no association between specialty, years of experience, or confidence in ability with the consistency or accuracy of estimated blood loss,” said Dr. Rothermel.
Most participants were far shy of the mark, with just 5% of study participants overall able to come within 25% accuracy in judging EBL in all scenarios. Just over a quarter were consistent in over- or underestimating blood loss.
These findings held true across scenarios, across disciplines, and regardless of the number of years of experience. “Increased years of experience trended toward increased error,” said Dr. Rothermel, though the difference was not statistically significant. However, those with more years of experience tended to be more confident of their judgments.
Dr. Rothermel noted the small study size and single institution studied as limitations. Also, “this model was not a high fidelity representation of the OR experience, “ he said, explaining that during surgery, caregivers continually assess intraoperative blood loss and may form an estimate in a different – and potentially more accurate – manner than occurs when presented with the contrived presentation of a scenario.
The study calls into question the validity of using EBL as a quality indicator in assessing physician performance and patient outcomes, said Dr. Rothermel, who had no financial disclosures.
On Twitter @karioakes
AT THE ANNUAL MEETING OF THE CENTRAL SURGICAL ASSOCIATION
Key clinical point: Surgery, anesthesia, and nursing providers were inaccurate and unreliable in estimating surgical blood loss.
Major finding: Only 5% of providers could come within 25% accuracy of simulated surgical blood loss.
Data source: Simulations of surgical scenarios depicting varying amounts of blood loss using porcine blood, presented to 60 providers.
Disclosures: The study authors reported no relevant disclosures.
VIDEO: STICHES trial update boosts CABG in ischemic cardiomyopathy
CHICAGO – The results of the Surgical Treatment for Ischemic Heart Failure Extension Study (STICHES) presented at the annual meeting of the American College of Cardiology ought to change the clinical management of patients with coronary artery disease and heart failure with severe left ventricular dysfunction, according to Dr. Robert O. Bonow.
STICHES is the 10-year follow-up of 1,212 such patients who were randomized to coronary artery bypass graft surgery plus optimal guideline-directed medical therapy or to the medical therapy alone. At 10 years, the CABG group showed a significant survival advantage: an all-cause mortality rate of 58.9%, a significant 16% relative risk reduction compared with the 66.1% rate in the medically managed group. Secondary endpoints were also strongly in favor of the CABG group.
These findings indicate CABG is beneficial in patients with ischemic cardiomyopathy, and patients deserve to be so informed, according to Dr. Bonow, a member of the STICHES publication committee and professor of cardiology and director of the Center for Cardiovascular Innovation at Northwestern University in Chicago, who discussed the findings in this video interview.
He reported having no financial conflicts regarding this National Institutes of Health–funded study.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
CHICAGO – The results of the Surgical Treatment for Ischemic Heart Failure Extension Study (STICHES) presented at the annual meeting of the American College of Cardiology ought to change the clinical management of patients with coronary artery disease and heart failure with severe left ventricular dysfunction, according to Dr. Robert O. Bonow.
STICHES is the 10-year follow-up of 1,212 such patients who were randomized to coronary artery bypass graft surgery plus optimal guideline-directed medical therapy or to the medical therapy alone. At 10 years, the CABG group showed a significant survival advantage: an all-cause mortality rate of 58.9%, a significant 16% relative risk reduction compared with the 66.1% rate in the medically managed group. Secondary endpoints were also strongly in favor of the CABG group.
These findings indicate CABG is beneficial in patients with ischemic cardiomyopathy, and patients deserve to be so informed, according to Dr. Bonow, a member of the STICHES publication committee and professor of cardiology and director of the Center for Cardiovascular Innovation at Northwestern University in Chicago, who discussed the findings in this video interview.
He reported having no financial conflicts regarding this National Institutes of Health–funded study.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
CHICAGO – The results of the Surgical Treatment for Ischemic Heart Failure Extension Study (STICHES) presented at the annual meeting of the American College of Cardiology ought to change the clinical management of patients with coronary artery disease and heart failure with severe left ventricular dysfunction, according to Dr. Robert O. Bonow.
STICHES is the 10-year follow-up of 1,212 such patients who were randomized to coronary artery bypass graft surgery plus optimal guideline-directed medical therapy or to the medical therapy alone. At 10 years, the CABG group showed a significant survival advantage: an all-cause mortality rate of 58.9%, a significant 16% relative risk reduction compared with the 66.1% rate in the medically managed group. Secondary endpoints were also strongly in favor of the CABG group.
These findings indicate CABG is beneficial in patients with ischemic cardiomyopathy, and patients deserve to be so informed, according to Dr. Bonow, a member of the STICHES publication committee and professor of cardiology and director of the Center for Cardiovascular Innovation at Northwestern University in Chicago, who discussed the findings in this video interview.
He reported having no financial conflicts regarding this National Institutes of Health–funded study.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT ACC 16
VIDEO: STICHES trial update boosts CABG in ischemic cardiomyopathy
CHICAGO – The results of the Surgical Treatment for Ischemic Heart Failure Extension Study (STICHES) presented at the annual meeting of the American College of Cardiology ought to change the clinical management of patients with coronary artery disease and heart failure with severe left ventricular dysfunction, according to Dr. Robert O. Bonow.
STICHES is the 10-year follow-up of 1,212 such patients who were randomized to coronary artery bypass graft surgery plus optimal guideline-directed medical therapy or to the medical therapy alone. At 10 years, the CABG group showed a significant survival advantage: an all-cause mortality rate of 58.9%, a significant 16% relative risk reduction compared with the 66.1% rate in the medically managed group. Secondary endpoints were also strongly in favor of the CABG group.
These findings indicate CABG is beneficial in patients with ischemic cardiomyopathy, and patients deserve to be so informed, according to Dr. Bonow, a member of the STICHES publication committee and professor of cardiology and director of the Center for Cardiovascular Innovation at Northwestern University in Chicago, who discussed the findings in this video interview.
He reported having no financial conflicts regarding this National Institutes of Health–funded study.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
CHICAGO – The results of the Surgical Treatment for Ischemic Heart Failure Extension Study (STICHES) presented at the annual meeting of the American College of Cardiology ought to change the clinical management of patients with coronary artery disease and heart failure with severe left ventricular dysfunction, according to Dr. Robert O. Bonow.
STICHES is the 10-year follow-up of 1,212 such patients who were randomized to coronary artery bypass graft surgery plus optimal guideline-directed medical therapy or to the medical therapy alone. At 10 years, the CABG group showed a significant survival advantage: an all-cause mortality rate of 58.9%, a significant 16% relative risk reduction compared with the 66.1% rate in the medically managed group. Secondary endpoints were also strongly in favor of the CABG group.
These findings indicate CABG is beneficial in patients with ischemic cardiomyopathy, and patients deserve to be so informed, according to Dr. Bonow, a member of the STICHES publication committee and professor of cardiology and director of the Center for Cardiovascular Innovation at Northwestern University in Chicago, who discussed the findings in this video interview.
He reported having no financial conflicts regarding this National Institutes of Health–funded study.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
CHICAGO – The results of the Surgical Treatment for Ischemic Heart Failure Extension Study (STICHES) presented at the annual meeting of the American College of Cardiology ought to change the clinical management of patients with coronary artery disease and heart failure with severe left ventricular dysfunction, according to Dr. Robert O. Bonow.
STICHES is the 10-year follow-up of 1,212 such patients who were randomized to coronary artery bypass graft surgery plus optimal guideline-directed medical therapy or to the medical therapy alone. At 10 years, the CABG group showed a significant survival advantage: an all-cause mortality rate of 58.9%, a significant 16% relative risk reduction compared with the 66.1% rate in the medically managed group. Secondary endpoints were also strongly in favor of the CABG group.
These findings indicate CABG is beneficial in patients with ischemic cardiomyopathy, and patients deserve to be so informed, according to Dr. Bonow, a member of the STICHES publication committee and professor of cardiology and director of the Center for Cardiovascular Innovation at Northwestern University in Chicago, who discussed the findings in this video interview.
He reported having no financial conflicts regarding this National Institutes of Health–funded study.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT ACC 16
Adding mitral valve repair to CABG found risky, with limited benefits
In patients with moderate ischemic mitral regurgitation, adding mitral valve repair to coronary artery bypass graft did not significantly affect the extent of left ventricular remodeling at 2 years, according to a randomized multicenter trial.
Compared with revascularization alone, the combined procedure was associated with a two-thirds lower rate of moderate to severe mitral regurgitation at the end of year 2, reported Dr. Robert Michler at Albert Einstein College of Medicine, New York, together with his associates. But improved durability did not translate to better survival or lower rates of major adverse cardiac and cerebrovascular events, heart failure, or hospital readmissions, they said. Furthermore, adding mitral valve repair to CABG was linked to higher rates of postoperative neurologic events and supraventricular arrhythmias than for CABG alone, the investigators reported at the annual meeting of the American College of Cardiology and simultaneously online April 3 in the New England Journal of Medicine.
Surgeons have debated whether to add restrictive mitral annuloplasty to CABG in patients with moderate ischemic mitral regurgitation. The combined approach requires open-heart exposure and longer aortic cross-clamping and cardiopulmonary bypass time, all of which increase perioperative risk, the researchers noted. To explore the risk-benefit balance of these approaches, they randomly assigned 301 patients to either revascularization alone or to the combined procedure, and assessed clinical and echocardiographic outcomes over 2 years (New Engl. J. Med. 2016 April 3 doi: 10.1056/NEJMoa1602003).
At year 1, the arms resembled each other in terms of survival, rates of major adverse cardiac or cerebrovascular events (MACCEs), and left ventricular reverse remodeling, as measured by left ventricular end-systolic volume index (LVESVI), said the investigators. At year 2, the extent of remodeling remained similar between the arms, with mean LVESVIs of 41.2 mL (standard deviation, 20.0 mL) per square meter of body surface area in the CABG-only group and 43.2 mL (SD, 20.6 mL) in the combined procedure group, for a mean decrease from baseline of 14.1 and 14.6 mL, respectively. About two-thirds of improvements in LVESI occurred during year 1 regardless of procedure type, the researchers noted.
About a third of CABG-only patients had moderate to severe mitral regurgitation at 2 years, compared with only 11% of patients who underwent the combined procedure (P less than .001). Patients who had mild or no mitral regurgitation had more than twice the percentage improvement in the global wall motion index and in the inferior-posterior-lateral regional wall motion score, compared with patients with moderate to severe regurgitation. Although both groups improved on several quality-of-life indices, the combined-procedure group scored more than 5 points higher on the Duke Activity Status Index, which measures self-reported exercise capacity. That difference was not only clinically meaningful, but resembled the increase in peak myocardial oxygen consumption in a similar, smaller trial (New Engl. J. Med. 2016 Jan. 28 doi: 10.1056/NEJMoa151291), the investigators noted.
However, mortality rates were similar between the arms at 2 years – 10.6% for CABG only and 10% for the combined procedure, for a non-significant hazard ratio of 0.9. Likewise, rates of heart failure and other serious adverse events were similar between the arms, while the combined-procedure arm had more than three times more postoperative neurologic events and more than twice as many occurrences of supraventricular arrhythmia. Therefore, treatment choice requires “balancing the risks of adverse perioperative events against the uncertain benefits of a lower incidence of postoperative moderate or severe mitral regurgitation,” said the researchers. “Effective revascularization, as reflected in improved regional and global left ventricular function, plays an important role independent of mitral valve repair.”
The National Institutes of Health and the Canadian Institutes of Health Research funded the study. Disclosures were reported separately at nejm.org.
In patients with moderate ischemic mitral regurgitation, adding mitral valve repair to coronary artery bypass graft did not significantly affect the extent of left ventricular remodeling at 2 years, according to a randomized multicenter trial.
Compared with revascularization alone, the combined procedure was associated with a two-thirds lower rate of moderate to severe mitral regurgitation at the end of year 2, reported Dr. Robert Michler at Albert Einstein College of Medicine, New York, together with his associates. But improved durability did not translate to better survival or lower rates of major adverse cardiac and cerebrovascular events, heart failure, or hospital readmissions, they said. Furthermore, adding mitral valve repair to CABG was linked to higher rates of postoperative neurologic events and supraventricular arrhythmias than for CABG alone, the investigators reported at the annual meeting of the American College of Cardiology and simultaneously online April 3 in the New England Journal of Medicine.
Surgeons have debated whether to add restrictive mitral annuloplasty to CABG in patients with moderate ischemic mitral regurgitation. The combined approach requires open-heart exposure and longer aortic cross-clamping and cardiopulmonary bypass time, all of which increase perioperative risk, the researchers noted. To explore the risk-benefit balance of these approaches, they randomly assigned 301 patients to either revascularization alone or to the combined procedure, and assessed clinical and echocardiographic outcomes over 2 years (New Engl. J. Med. 2016 April 3 doi: 10.1056/NEJMoa1602003).
At year 1, the arms resembled each other in terms of survival, rates of major adverse cardiac or cerebrovascular events (MACCEs), and left ventricular reverse remodeling, as measured by left ventricular end-systolic volume index (LVESVI), said the investigators. At year 2, the extent of remodeling remained similar between the arms, with mean LVESVIs of 41.2 mL (standard deviation, 20.0 mL) per square meter of body surface area in the CABG-only group and 43.2 mL (SD, 20.6 mL) in the combined procedure group, for a mean decrease from baseline of 14.1 and 14.6 mL, respectively. About two-thirds of improvements in LVESI occurred during year 1 regardless of procedure type, the researchers noted.
About a third of CABG-only patients had moderate to severe mitral regurgitation at 2 years, compared with only 11% of patients who underwent the combined procedure (P less than .001). Patients who had mild or no mitral regurgitation had more than twice the percentage improvement in the global wall motion index and in the inferior-posterior-lateral regional wall motion score, compared with patients with moderate to severe regurgitation. Although both groups improved on several quality-of-life indices, the combined-procedure group scored more than 5 points higher on the Duke Activity Status Index, which measures self-reported exercise capacity. That difference was not only clinically meaningful, but resembled the increase in peak myocardial oxygen consumption in a similar, smaller trial (New Engl. J. Med. 2016 Jan. 28 doi: 10.1056/NEJMoa151291), the investigators noted.
However, mortality rates were similar between the arms at 2 years – 10.6% for CABG only and 10% for the combined procedure, for a non-significant hazard ratio of 0.9. Likewise, rates of heart failure and other serious adverse events were similar between the arms, while the combined-procedure arm had more than three times more postoperative neurologic events and more than twice as many occurrences of supraventricular arrhythmia. Therefore, treatment choice requires “balancing the risks of adverse perioperative events against the uncertain benefits of a lower incidence of postoperative moderate or severe mitral regurgitation,” said the researchers. “Effective revascularization, as reflected in improved regional and global left ventricular function, plays an important role independent of mitral valve repair.”
The National Institutes of Health and the Canadian Institutes of Health Research funded the study. Disclosures were reported separately at nejm.org.
In patients with moderate ischemic mitral regurgitation, adding mitral valve repair to coronary artery bypass graft did not significantly affect the extent of left ventricular remodeling at 2 years, according to a randomized multicenter trial.
Compared with revascularization alone, the combined procedure was associated with a two-thirds lower rate of moderate to severe mitral regurgitation at the end of year 2, reported Dr. Robert Michler at Albert Einstein College of Medicine, New York, together with his associates. But improved durability did not translate to better survival or lower rates of major adverse cardiac and cerebrovascular events, heart failure, or hospital readmissions, they said. Furthermore, adding mitral valve repair to CABG was linked to higher rates of postoperative neurologic events and supraventricular arrhythmias than for CABG alone, the investigators reported at the annual meeting of the American College of Cardiology and simultaneously online April 3 in the New England Journal of Medicine.
Surgeons have debated whether to add restrictive mitral annuloplasty to CABG in patients with moderate ischemic mitral regurgitation. The combined approach requires open-heart exposure and longer aortic cross-clamping and cardiopulmonary bypass time, all of which increase perioperative risk, the researchers noted. To explore the risk-benefit balance of these approaches, they randomly assigned 301 patients to either revascularization alone or to the combined procedure, and assessed clinical and echocardiographic outcomes over 2 years (New Engl. J. Med. 2016 April 3 doi: 10.1056/NEJMoa1602003).
At year 1, the arms resembled each other in terms of survival, rates of major adverse cardiac or cerebrovascular events (MACCEs), and left ventricular reverse remodeling, as measured by left ventricular end-systolic volume index (LVESVI), said the investigators. At year 2, the extent of remodeling remained similar between the arms, with mean LVESVIs of 41.2 mL (standard deviation, 20.0 mL) per square meter of body surface area in the CABG-only group and 43.2 mL (SD, 20.6 mL) in the combined procedure group, for a mean decrease from baseline of 14.1 and 14.6 mL, respectively. About two-thirds of improvements in LVESI occurred during year 1 regardless of procedure type, the researchers noted.
About a third of CABG-only patients had moderate to severe mitral regurgitation at 2 years, compared with only 11% of patients who underwent the combined procedure (P less than .001). Patients who had mild or no mitral regurgitation had more than twice the percentage improvement in the global wall motion index and in the inferior-posterior-lateral regional wall motion score, compared with patients with moderate to severe regurgitation. Although both groups improved on several quality-of-life indices, the combined-procedure group scored more than 5 points higher on the Duke Activity Status Index, which measures self-reported exercise capacity. That difference was not only clinically meaningful, but resembled the increase in peak myocardial oxygen consumption in a similar, smaller trial (New Engl. J. Med. 2016 Jan. 28 doi: 10.1056/NEJMoa151291), the investigators noted.
However, mortality rates were similar between the arms at 2 years – 10.6% for CABG only and 10% for the combined procedure, for a non-significant hazard ratio of 0.9. Likewise, rates of heart failure and other serious adverse events were similar between the arms, while the combined-procedure arm had more than three times more postoperative neurologic events and more than twice as many occurrences of supraventricular arrhythmia. Therefore, treatment choice requires “balancing the risks of adverse perioperative events against the uncertain benefits of a lower incidence of postoperative moderate or severe mitral regurgitation,” said the researchers. “Effective revascularization, as reflected in improved regional and global left ventricular function, plays an important role independent of mitral valve repair.”
The National Institutes of Health and the Canadian Institutes of Health Research funded the study. Disclosures were reported separately at nejm.org.
FROM ACC 16
Key clinical point: In patients with moderate ischemic mitral regurgitation, adding mitral valve repair to coronary artery bypass graft did not significantly affect left ventricular remodeling at two years.
Major finding: Mean decreases in left ventricular end systolic volume index were 14.1 mL and 14.6 mL, respectively.
Data source: A multicenter randomized trial of 301 patients with moderate to severe baseline mitral regurgitation.
Disclosures: The National Institutes of Health and the Canadian Institutes of Health Research funded the study. Disclosures were reported separately at nejm.org.
Heart failure severity at AMI predicts long-term CV death risk
CHICAGO – The severity of heart failure in the setting of acute myocardial infarction predicts long-term cardiovascular death risk, according to a post hoc analysis of data from the IMPROVE IT Trial.
Among 11,185 individuals with MI and known Killip Classification who were part of that randomized, double-blind trial, those with Killip Class II or greater had more than double the risk of long-term cardiovascular death, compared with those with Killip Class I heart failure, Dr Michael G. Silverman, a cardiovascular medicine fellow at Brigham and Women’s Hospital, Boston and a research fellow at the Thrombolysis in MI (TIMI) Study Group reported in a poster at the annual meeting of the American College of Cardiology.
After adjusting for a number of factors, including age, gender, diabetes, hypertension, left ventricular ejection fraction (LVEF), beta blocker and ACE inhibitor/angiotensin receptor blocker use at randomization, and percutaneous coronary intervention at the index event, the 7-year event rate was 14.5% among those with Killip Class II or higher vs. 5.7% those with Killip Class I heart failure (adjusted hazard ratio, 1.9), Dr. Silverman reported on behalf of the TIMI Study Group.
The event rates from 30 days to 6 months were 4.85% and 1.25% in the groups, respectively (adjusted hazard ratio, 1.96), and from 6 months to 7 years they were 1.52% and 0.61%, in the groups, respectively, (adjusted hazard ratio, 1.85).
Further, the increased risk of cardiovascular death associated with Killip Class II or higher was also apparent among important subgroups, including those with ST Segment Elevation MI, those with non-STEMI, those with LVEF of 50 or greater, those with LVEF less than 50, those with diabetes, those without diabetes, men, and women (adjusted hazard ratios ranging from 1.6 to 2.1), Dr Silverman explained in an interview.
The severity of heart failure according to Killip Class is a strong independent predictor of mortality in the setting of acute MI, and the current findings demonstrate that it also predicts cardiovascular death for at least 7 years, suggesting a need for careful attention to the findings of the physical exam in AMI, as it can serve as an important biomarker of long-term cardiovascular death risk, he said.
“AMI patients with Killip Class II or greater warrant continued close medical follow-up and adherence to guideline -directed medial therapy beyond the acute hospitalization to prevent this potentially modifiable outcome,” he concluded.
Dr. Silverman reported having no disclosures.
CHICAGO – The severity of heart failure in the setting of acute myocardial infarction predicts long-term cardiovascular death risk, according to a post hoc analysis of data from the IMPROVE IT Trial.
Among 11,185 individuals with MI and known Killip Classification who were part of that randomized, double-blind trial, those with Killip Class II or greater had more than double the risk of long-term cardiovascular death, compared with those with Killip Class I heart failure, Dr Michael G. Silverman, a cardiovascular medicine fellow at Brigham and Women’s Hospital, Boston and a research fellow at the Thrombolysis in MI (TIMI) Study Group reported in a poster at the annual meeting of the American College of Cardiology.
After adjusting for a number of factors, including age, gender, diabetes, hypertension, left ventricular ejection fraction (LVEF), beta blocker and ACE inhibitor/angiotensin receptor blocker use at randomization, and percutaneous coronary intervention at the index event, the 7-year event rate was 14.5% among those with Killip Class II or higher vs. 5.7% those with Killip Class I heart failure (adjusted hazard ratio, 1.9), Dr. Silverman reported on behalf of the TIMI Study Group.
The event rates from 30 days to 6 months were 4.85% and 1.25% in the groups, respectively (adjusted hazard ratio, 1.96), and from 6 months to 7 years they were 1.52% and 0.61%, in the groups, respectively, (adjusted hazard ratio, 1.85).
Further, the increased risk of cardiovascular death associated with Killip Class II or higher was also apparent among important subgroups, including those with ST Segment Elevation MI, those with non-STEMI, those with LVEF of 50 or greater, those with LVEF less than 50, those with diabetes, those without diabetes, men, and women (adjusted hazard ratios ranging from 1.6 to 2.1), Dr Silverman explained in an interview.
The severity of heart failure according to Killip Class is a strong independent predictor of mortality in the setting of acute MI, and the current findings demonstrate that it also predicts cardiovascular death for at least 7 years, suggesting a need for careful attention to the findings of the physical exam in AMI, as it can serve as an important biomarker of long-term cardiovascular death risk, he said.
“AMI patients with Killip Class II or greater warrant continued close medical follow-up and adherence to guideline -directed medial therapy beyond the acute hospitalization to prevent this potentially modifiable outcome,” he concluded.
Dr. Silverman reported having no disclosures.
CHICAGO – The severity of heart failure in the setting of acute myocardial infarction predicts long-term cardiovascular death risk, according to a post hoc analysis of data from the IMPROVE IT Trial.
Among 11,185 individuals with MI and known Killip Classification who were part of that randomized, double-blind trial, those with Killip Class II or greater had more than double the risk of long-term cardiovascular death, compared with those with Killip Class I heart failure, Dr Michael G. Silverman, a cardiovascular medicine fellow at Brigham and Women’s Hospital, Boston and a research fellow at the Thrombolysis in MI (TIMI) Study Group reported in a poster at the annual meeting of the American College of Cardiology.
After adjusting for a number of factors, including age, gender, diabetes, hypertension, left ventricular ejection fraction (LVEF), beta blocker and ACE inhibitor/angiotensin receptor blocker use at randomization, and percutaneous coronary intervention at the index event, the 7-year event rate was 14.5% among those with Killip Class II or higher vs. 5.7% those with Killip Class I heart failure (adjusted hazard ratio, 1.9), Dr. Silverman reported on behalf of the TIMI Study Group.
The event rates from 30 days to 6 months were 4.85% and 1.25% in the groups, respectively (adjusted hazard ratio, 1.96), and from 6 months to 7 years they were 1.52% and 0.61%, in the groups, respectively, (adjusted hazard ratio, 1.85).
Further, the increased risk of cardiovascular death associated with Killip Class II or higher was also apparent among important subgroups, including those with ST Segment Elevation MI, those with non-STEMI, those with LVEF of 50 or greater, those with LVEF less than 50, those with diabetes, those without diabetes, men, and women (adjusted hazard ratios ranging from 1.6 to 2.1), Dr Silverman explained in an interview.
The severity of heart failure according to Killip Class is a strong independent predictor of mortality in the setting of acute MI, and the current findings demonstrate that it also predicts cardiovascular death for at least 7 years, suggesting a need for careful attention to the findings of the physical exam in AMI, as it can serve as an important biomarker of long-term cardiovascular death risk, he said.
“AMI patients with Killip Class II or greater warrant continued close medical follow-up and adherence to guideline -directed medial therapy beyond the acute hospitalization to prevent this potentially modifiable outcome,” he concluded.
Dr. Silverman reported having no disclosures.
AT ACC 16
Key clinical point: The severity of heart failure in the setting of acute myocardial infarction predicts long-term cardiovascular death risk, according to a post hoc analysis of data from the IMPROVE IT Trial.
Major finding: The 7-year event rate was 14.5% among those with Killip Class II or higher vs. 5.7% among those with Killip Class I heart failure (adjusted hazard ratio, 1.9).
Data source: A post-hoc analysis of data from 11,185 subjects from the IMPROVE IT trial.
Disclosures: Dr. Silverman reported having no disclosures.
Women with suspected CAD classified as lower risk than men
Women with suspected coronary artery disease had similar symptoms and more heart disease risk factors, compared with men, but were assessed as lower risk by their providers and on all standard risk scores, according to a secondary analysis of the PROMISE trial.
The results “highlight the need for sex-specific approaches to coronary artery disease evaluation and testing,” said Kshipra Hemal at Duke Clinical Research Institute in Durham, N.C., and her associates. The findings will be presented April 3 at the annual meeting of the American College of Cardiology and were published online March 23 in the Journal of the American College of Cardiology: Cardiovascular Imaging.
The PROMISE (Prospective Multicenter Imaging Study for the Evaluation of Chest Pain) trial is one of the largest contemporary trials of symptomatic, nonacute suspected CAD. The study included 10,003 stable outpatients, nearly half of whom were women. The researchers calculated the 2008 Framingham score, 2013 Atherosclerotic Cardiovascular Disease score, 1979 Diamond and Forrester score, modified 2011 Diamond and Forrester score, and 2012 combined Diamond-Forrester and Coronary Artery Surgery Study scores for all patients. Patients also were randomly assigned to either anatomical testing with CT angiography or to functional testing with exercise electrocardiogram, stress nuclear imaging, or stress echocardiogram (J Am Coll Cardiol Img. 2016 Mar 23. doi: 10.1016/j.jcmg.2016.02.001).
Women in the study were an average of 3 years older than the men and were significantly more likely to be hypertensive (67% vs. 63%), dyslipidemic (69% vs. 66%), and to have a family history of premature CAD (35% vs. 29%; P less than .01 for all comparisons), the researchers reported. Nonetheless, all five risk scores characterized women as lower risk than men (P less than .001 for mean differences). Moreover, before testing, providers characterized 41% of women having a low (less than 30%) likelihood of CAD, compared with 34% of men (P less than .001).
Women were more likely than men to be referred for stress echocardiography or nuclear stress test, but only 9.7% had a positive noninvasive test, compared with 15% of men (P less than .001), the researchers also reported. “A number of characteristics predicted positive test results, and many characteristics were similar between the sexes,” they added. “However, in multivariable models, key predictors of test positivity were few and varied by sex.” Body mass index and Framingham risk score predicted a positive test for women, while both the Framingham and modified Diamond-Forrester risk scores predicted a positive test for men.
Chest pain was the most common primary symptom reported by nearly three-quarters of women and men and was described as “crushing/pressure/squeezing/tightness” 53% and 46% of the time, respectively (P less than .001). Dyspnea was the second most frequent primary symptom at 15% for both sexes. Women were more likely than men to describe back pain, neck or jaw pain, or palpitations, but only 0.6% to 2.7% of patients ranked these among their main symptoms.
“Further studies are warranted to examine the underlying pathophysiology and implications for clinical care of the sex-based clinical differences observed along the entire diagnostic pathway of suspected CAD, including risk factor burden, presenting symptoms, and testing results,” the researchers concluded.
The PROMISE study was funded by the National Heart, Lung, and Blood Institute. Ms. Hemal had no disclosures. Senior author Dr. Pamela S. Douglas disclosed grant support from HeartFlow and having served on a data and safety monitoring board for General Electric Healthcare. Two of the other 15 coinvestigators also disclosed relationships with industry; the rest had no disclosures.
Despite symptomatic presentation, greater family history of premature coronary artery disease, and higher risk factor burden, including older age and greater prevalence of hypertension and dyslipidemia, the women in PROMISE were more likely to be characterized as low risk based on standard cardiovascular risk assessment scores and thus, not surprisingly, also were considered to be at lower risk by their providers. These findings add credence to the ongoing concerns that women are preferentially likely to receive less intensive management of CAD than their male counterparts.
The 2014 American Heart Association Consensus Statement on noninvasive diagnostic testing in women with suspected ischemic heart disease highlighted the development of novel diagnostic tools that have an expanded role in the evaluation of symptomatic female patients to detect not only focal epicardial coronary stenosis, but also nonobstructive atherosclerosis as well as the identification of ischemia resulting from microvascular dysfunction. Such methods using advanced imaging are making steady progress in the understanding of microvascular disease and its consequences.
We agree with the PROMISE investigators that focused sex-specific diagnostic strategies are needed to reduce the cardiovascular mortality and morbidity in women. With emerging data on the full pathophysiologic spectrum of ischemic heart disease in women, diagnostic algorithms must include functional and anatomic cardiac tests as well as physiologic assessments of endothelial and microvascular function, for accurately establishing the diagnosis and prognosis of women with suspected IHD.
Dr. Jennifer H. Mieres is with Hofstra University, Hempstead, N.Y. Dr. Robert O. Bonow is with Northwestern University, Chicago. They had no disclosures. These comments are from their editorial (J Am Coll Cardiol Img. 2016 Mar 23. doi: 10.1016/j.jcmg.2016.02.0089).
Despite symptomatic presentation, greater family history of premature coronary artery disease, and higher risk factor burden, including older age and greater prevalence of hypertension and dyslipidemia, the women in PROMISE were more likely to be characterized as low risk based on standard cardiovascular risk assessment scores and thus, not surprisingly, also were considered to be at lower risk by their providers. These findings add credence to the ongoing concerns that women are preferentially likely to receive less intensive management of CAD than their male counterparts.
The 2014 American Heart Association Consensus Statement on noninvasive diagnostic testing in women with suspected ischemic heart disease highlighted the development of novel diagnostic tools that have an expanded role in the evaluation of symptomatic female patients to detect not only focal epicardial coronary stenosis, but also nonobstructive atherosclerosis as well as the identification of ischemia resulting from microvascular dysfunction. Such methods using advanced imaging are making steady progress in the understanding of microvascular disease and its consequences.
We agree with the PROMISE investigators that focused sex-specific diagnostic strategies are needed to reduce the cardiovascular mortality and morbidity in women. With emerging data on the full pathophysiologic spectrum of ischemic heart disease in women, diagnostic algorithms must include functional and anatomic cardiac tests as well as physiologic assessments of endothelial and microvascular function, for accurately establishing the diagnosis and prognosis of women with suspected IHD.
Dr. Jennifer H. Mieres is with Hofstra University, Hempstead, N.Y. Dr. Robert O. Bonow is with Northwestern University, Chicago. They had no disclosures. These comments are from their editorial (J Am Coll Cardiol Img. 2016 Mar 23. doi: 10.1016/j.jcmg.2016.02.0089).
Despite symptomatic presentation, greater family history of premature coronary artery disease, and higher risk factor burden, including older age and greater prevalence of hypertension and dyslipidemia, the women in PROMISE were more likely to be characterized as low risk based on standard cardiovascular risk assessment scores and thus, not surprisingly, also were considered to be at lower risk by their providers. These findings add credence to the ongoing concerns that women are preferentially likely to receive less intensive management of CAD than their male counterparts.
The 2014 American Heart Association Consensus Statement on noninvasive diagnostic testing in women with suspected ischemic heart disease highlighted the development of novel diagnostic tools that have an expanded role in the evaluation of symptomatic female patients to detect not only focal epicardial coronary stenosis, but also nonobstructive atherosclerosis as well as the identification of ischemia resulting from microvascular dysfunction. Such methods using advanced imaging are making steady progress in the understanding of microvascular disease and its consequences.
We agree with the PROMISE investigators that focused sex-specific diagnostic strategies are needed to reduce the cardiovascular mortality and morbidity in women. With emerging data on the full pathophysiologic spectrum of ischemic heart disease in women, diagnostic algorithms must include functional and anatomic cardiac tests as well as physiologic assessments of endothelial and microvascular function, for accurately establishing the diagnosis and prognosis of women with suspected IHD.
Dr. Jennifer H. Mieres is with Hofstra University, Hempstead, N.Y. Dr. Robert O. Bonow is with Northwestern University, Chicago. They had no disclosures. These comments are from their editorial (J Am Coll Cardiol Img. 2016 Mar 23. doi: 10.1016/j.jcmg.2016.02.0089).
Women with suspected coronary artery disease had similar symptoms and more heart disease risk factors, compared with men, but were assessed as lower risk by their providers and on all standard risk scores, according to a secondary analysis of the PROMISE trial.
The results “highlight the need for sex-specific approaches to coronary artery disease evaluation and testing,” said Kshipra Hemal at Duke Clinical Research Institute in Durham, N.C., and her associates. The findings will be presented April 3 at the annual meeting of the American College of Cardiology and were published online March 23 in the Journal of the American College of Cardiology: Cardiovascular Imaging.
The PROMISE (Prospective Multicenter Imaging Study for the Evaluation of Chest Pain) trial is one of the largest contemporary trials of symptomatic, nonacute suspected CAD. The study included 10,003 stable outpatients, nearly half of whom were women. The researchers calculated the 2008 Framingham score, 2013 Atherosclerotic Cardiovascular Disease score, 1979 Diamond and Forrester score, modified 2011 Diamond and Forrester score, and 2012 combined Diamond-Forrester and Coronary Artery Surgery Study scores for all patients. Patients also were randomly assigned to either anatomical testing with CT angiography or to functional testing with exercise electrocardiogram, stress nuclear imaging, or stress echocardiogram (J Am Coll Cardiol Img. 2016 Mar 23. doi: 10.1016/j.jcmg.2016.02.001).
Women in the study were an average of 3 years older than the men and were significantly more likely to be hypertensive (67% vs. 63%), dyslipidemic (69% vs. 66%), and to have a family history of premature CAD (35% vs. 29%; P less than .01 for all comparisons), the researchers reported. Nonetheless, all five risk scores characterized women as lower risk than men (P less than .001 for mean differences). Moreover, before testing, providers characterized 41% of women having a low (less than 30%) likelihood of CAD, compared with 34% of men (P less than .001).
Women were more likely than men to be referred for stress echocardiography or nuclear stress test, but only 9.7% had a positive noninvasive test, compared with 15% of men (P less than .001), the researchers also reported. “A number of characteristics predicted positive test results, and many characteristics were similar between the sexes,” they added. “However, in multivariable models, key predictors of test positivity were few and varied by sex.” Body mass index and Framingham risk score predicted a positive test for women, while both the Framingham and modified Diamond-Forrester risk scores predicted a positive test for men.
Chest pain was the most common primary symptom reported by nearly three-quarters of women and men and was described as “crushing/pressure/squeezing/tightness” 53% and 46% of the time, respectively (P less than .001). Dyspnea was the second most frequent primary symptom at 15% for both sexes. Women were more likely than men to describe back pain, neck or jaw pain, or palpitations, but only 0.6% to 2.7% of patients ranked these among their main symptoms.
“Further studies are warranted to examine the underlying pathophysiology and implications for clinical care of the sex-based clinical differences observed along the entire diagnostic pathway of suspected CAD, including risk factor burden, presenting symptoms, and testing results,” the researchers concluded.
The PROMISE study was funded by the National Heart, Lung, and Blood Institute. Ms. Hemal had no disclosures. Senior author Dr. Pamela S. Douglas disclosed grant support from HeartFlow and having served on a data and safety monitoring board for General Electric Healthcare. Two of the other 15 coinvestigators also disclosed relationships with industry; the rest had no disclosures.
Women with suspected coronary artery disease had similar symptoms and more heart disease risk factors, compared with men, but were assessed as lower risk by their providers and on all standard risk scores, according to a secondary analysis of the PROMISE trial.
The results “highlight the need for sex-specific approaches to coronary artery disease evaluation and testing,” said Kshipra Hemal at Duke Clinical Research Institute in Durham, N.C., and her associates. The findings will be presented April 3 at the annual meeting of the American College of Cardiology and were published online March 23 in the Journal of the American College of Cardiology: Cardiovascular Imaging.
The PROMISE (Prospective Multicenter Imaging Study for the Evaluation of Chest Pain) trial is one of the largest contemporary trials of symptomatic, nonacute suspected CAD. The study included 10,003 stable outpatients, nearly half of whom were women. The researchers calculated the 2008 Framingham score, 2013 Atherosclerotic Cardiovascular Disease score, 1979 Diamond and Forrester score, modified 2011 Diamond and Forrester score, and 2012 combined Diamond-Forrester and Coronary Artery Surgery Study scores for all patients. Patients also were randomly assigned to either anatomical testing with CT angiography or to functional testing with exercise electrocardiogram, stress nuclear imaging, or stress echocardiogram (J Am Coll Cardiol Img. 2016 Mar 23. doi: 10.1016/j.jcmg.2016.02.001).
Women in the study were an average of 3 years older than the men and were significantly more likely to be hypertensive (67% vs. 63%), dyslipidemic (69% vs. 66%), and to have a family history of premature CAD (35% vs. 29%; P less than .01 for all comparisons), the researchers reported. Nonetheless, all five risk scores characterized women as lower risk than men (P less than .001 for mean differences). Moreover, before testing, providers characterized 41% of women having a low (less than 30%) likelihood of CAD, compared with 34% of men (P less than .001).
Women were more likely than men to be referred for stress echocardiography or nuclear stress test, but only 9.7% had a positive noninvasive test, compared with 15% of men (P less than .001), the researchers also reported. “A number of characteristics predicted positive test results, and many characteristics were similar between the sexes,” they added. “However, in multivariable models, key predictors of test positivity were few and varied by sex.” Body mass index and Framingham risk score predicted a positive test for women, while both the Framingham and modified Diamond-Forrester risk scores predicted a positive test for men.
Chest pain was the most common primary symptom reported by nearly three-quarters of women and men and was described as “crushing/pressure/squeezing/tightness” 53% and 46% of the time, respectively (P less than .001). Dyspnea was the second most frequent primary symptom at 15% for both sexes. Women were more likely than men to describe back pain, neck or jaw pain, or palpitations, but only 0.6% to 2.7% of patients ranked these among their main symptoms.
“Further studies are warranted to examine the underlying pathophysiology and implications for clinical care of the sex-based clinical differences observed along the entire diagnostic pathway of suspected CAD, including risk factor burden, presenting symptoms, and testing results,” the researchers concluded.
The PROMISE study was funded by the National Heart, Lung, and Blood Institute. Ms. Hemal had no disclosures. Senior author Dr. Pamela S. Douglas disclosed grant support from HeartFlow and having served on a data and safety monitoring board for General Electric Healthcare. Two of the other 15 coinvestigators also disclosed relationships with industry; the rest had no disclosures.
FROM ACC 16
Key clinical point: Women with suspected coronary artery disease had similar symptoms and more risk factors for coronary artery disease, compared with men, but were classified as lower risk on risk scores and by providers.
Major finding: All risk scores assessed women as being at lower risk than men. Providers characterized 41% of pretest women and 34% of men as low risk (P less than .001).
Data source: A prospective, multicenter, randomized trial of 10,003 symptomatic outpatients with suspected coronary artery disease.
Disclosures: The PROMISE study was funded by the National Heart, Lung, and Blood Institute. Dr. Hemal had no disclosures. Senior author Dr. Pamela Douglas disclosed grant support from HeartFlow and having served on a data and safety monitoring board for General Electric Healthcare. Two of the other 15 coinvestigators also disclosed relationships with industry; the rest had no disclosures.
VIDEO: Eight new quality measures key to performance of esophageal manometry
Health care providers performing esophageal manometry should keep in mind eight new quality measures listed and validated in a recent study published in the April issue of Clinical Gastroenterology and Hepatology (Clin Gastroenterol Hepatol. 2015 Oct 20. doi: 10.1016/j.cgh.2015.10.006), which researchers believe will significantly improve the performance of esophageal manometry and interpretation of data culled from such procedures.
“Despite its critical importance in the diagnosis and management of esophageal motility disorders, features of a high-quality esophageal manometry [study] have not been formally defined,” said the study authors, led by Dr. Rena Yadlapati of Northwestern University in Chicago. “Standardizing key aspects of esophageal manometry is imperative to ensure the delivery of high-quality care.”
SOURCE: AMERICAN GASTROENTEROLOGICAL ASSOCIATION
Dr. Yadlapati and her coinvestigators carried out the study in accordance with guidelines set out by the RAND/UCLA Appropriateness Method (RAM), They began by recruiting a panel of 15 esophageal manometry experts with leadership, geographical diversity, and a wide range of practice settings being the key criteria in their selection.
Investigators then conducted a literature review, selecting the 30 most relevant randomized, controlled trials, retrospective studies, and systematic reviews from the past 10 years. From this review, investigators created a list of 30 possible quality measures, all of which were then sent to each member of the expert panel via email for them to rank on a 9-point interval scale, and modify if necessary.
Those rankings were then used to determine the appropriateness of each proposed quality measure at a face-to-face meeting among the investigators and the 15-member expert panel, at which 17 quality measures were determined to be appropriate. In all, 2 measures dealt with competency, 2 pertained to assessment before procedure, 3 were regarding performance of the procedure itself, and 10 were about interpretation of data obtained from esophageal manometry; the 10 measures concerning interpretation of data were compiled into 1 measure, leaving a total of 8 that were ultimately approved.
The quality measures for competency are as follows:
• “If esophageal manometry is performed, then the technician must be competent to perform esophageal manometry.”
• “If a physician is considered competent to interpret esophageal manometry, then the physician must interpret a minimum number of esophageal manometry studies annually.”
For assessment before procedure, the measures state the following:
• “If a patient is referred for esophageal manometry, then the patient should have undergone an evaluation for structural abnormalities before manometry.”
• “If an esophageal manometry is performed, then informed consent must be obtained and documented.”
Quality measures regarding the procedure itself state the following:
• “If an esophageal manometry study is performed, then a time interval of at least 30 seconds should occur between swallows.”
• “If an esophageal manometry study is performed, then at least 10 wet swallows should be attempted.”
• “If an esophageal manometry study is performed, then at least seven evaluable wet swallows should be included.”
Finally, regarding interpretation of data, the single quality measures states that “If an esophageal manometry study is interpreted, then a complete procedure report should document the following:
• “Reason for referral.”
• “Clinical diagnosis.”
• “Diagnosis according to formally validated classification scheme.”
• “Documentation of formally validated classification scheme used.”
• “Summary of results”
• “Tabulated results including upper esophageal sphincter activity, interpretation of esophagogastric junction relaxation, documentation of pressure inversion point if technically feasible, pressurization pattern and contractile pattern.”
• “Technical limitation (if applicable).”
• “Communication to referring provider.”
“These eight appropriate quality measures are considered absolutely necessary in the performance and interpretation of esophageal manometry,” the authors concluded. “In particular, measures 3-8 are clinically feasible and measurable, and should serve as an initial framework to benchmark quality and reduce variability in esophageal manometry practices.”
This study was funded by the Alumnae of Northwestern University, and a grant to Dr. Yadlapati (T32 DK101363-02). Five coinvestigators disclosed consultancy and speaking relationships with Boston Scientific, Cook Endoscopy, EndoStim, Given Imaging, Covidien, and Sandhill Scientific.
Health care providers performing esophageal manometry should keep in mind eight new quality measures listed and validated in a recent study published in the April issue of Clinical Gastroenterology and Hepatology (Clin Gastroenterol Hepatol. 2015 Oct 20. doi: 10.1016/j.cgh.2015.10.006), which researchers believe will significantly improve the performance of esophageal manometry and interpretation of data culled from such procedures.
“Despite its critical importance in the diagnosis and management of esophageal motility disorders, features of a high-quality esophageal manometry [study] have not been formally defined,” said the study authors, led by Dr. Rena Yadlapati of Northwestern University in Chicago. “Standardizing key aspects of esophageal manometry is imperative to ensure the delivery of high-quality care.”
SOURCE: AMERICAN GASTROENTEROLOGICAL ASSOCIATION
Dr. Yadlapati and her coinvestigators carried out the study in accordance with guidelines set out by the RAND/UCLA Appropriateness Method (RAM), They began by recruiting a panel of 15 esophageal manometry experts with leadership, geographical diversity, and a wide range of practice settings being the key criteria in their selection.
Investigators then conducted a literature review, selecting the 30 most relevant randomized, controlled trials, retrospective studies, and systematic reviews from the past 10 years. From this review, investigators created a list of 30 possible quality measures, all of which were then sent to each member of the expert panel via email for them to rank on a 9-point interval scale, and modify if necessary.
Those rankings were then used to determine the appropriateness of each proposed quality measure at a face-to-face meeting among the investigators and the 15-member expert panel, at which 17 quality measures were determined to be appropriate. In all, 2 measures dealt with competency, 2 pertained to assessment before procedure, 3 were regarding performance of the procedure itself, and 10 were about interpretation of data obtained from esophageal manometry; the 10 measures concerning interpretation of data were compiled into 1 measure, leaving a total of 8 that were ultimately approved.
The quality measures for competency are as follows:
• “If esophageal manometry is performed, then the technician must be competent to perform esophageal manometry.”
• “If a physician is considered competent to interpret esophageal manometry, then the physician must interpret a minimum number of esophageal manometry studies annually.”
For assessment before procedure, the measures state the following:
• “If a patient is referred for esophageal manometry, then the patient should have undergone an evaluation for structural abnormalities before manometry.”
• “If an esophageal manometry is performed, then informed consent must be obtained and documented.”
Quality measures regarding the procedure itself state the following:
• “If an esophageal manometry study is performed, then a time interval of at least 30 seconds should occur between swallows.”
• “If an esophageal manometry study is performed, then at least 10 wet swallows should be attempted.”
• “If an esophageal manometry study is performed, then at least seven evaluable wet swallows should be included.”
Finally, regarding interpretation of data, the single quality measures states that “If an esophageal manometry study is interpreted, then a complete procedure report should document the following:
• “Reason for referral.”
• “Clinical diagnosis.”
• “Diagnosis according to formally validated classification scheme.”
• “Documentation of formally validated classification scheme used.”
• “Summary of results”
• “Tabulated results including upper esophageal sphincter activity, interpretation of esophagogastric junction relaxation, documentation of pressure inversion point if technically feasible, pressurization pattern and contractile pattern.”
• “Technical limitation (if applicable).”
• “Communication to referring provider.”
“These eight appropriate quality measures are considered absolutely necessary in the performance and interpretation of esophageal manometry,” the authors concluded. “In particular, measures 3-8 are clinically feasible and measurable, and should serve as an initial framework to benchmark quality and reduce variability in esophageal manometry practices.”
This study was funded by the Alumnae of Northwestern University, and a grant to Dr. Yadlapati (T32 DK101363-02). Five coinvestigators disclosed consultancy and speaking relationships with Boston Scientific, Cook Endoscopy, EndoStim, Given Imaging, Covidien, and Sandhill Scientific.
Health care providers performing esophageal manometry should keep in mind eight new quality measures listed and validated in a recent study published in the April issue of Clinical Gastroenterology and Hepatology (Clin Gastroenterol Hepatol. 2015 Oct 20. doi: 10.1016/j.cgh.2015.10.006), which researchers believe will significantly improve the performance of esophageal manometry and interpretation of data culled from such procedures.
“Despite its critical importance in the diagnosis and management of esophageal motility disorders, features of a high-quality esophageal manometry [study] have not been formally defined,” said the study authors, led by Dr. Rena Yadlapati of Northwestern University in Chicago. “Standardizing key aspects of esophageal manometry is imperative to ensure the delivery of high-quality care.”
SOURCE: AMERICAN GASTROENTEROLOGICAL ASSOCIATION
Dr. Yadlapati and her coinvestigators carried out the study in accordance with guidelines set out by the RAND/UCLA Appropriateness Method (RAM), They began by recruiting a panel of 15 esophageal manometry experts with leadership, geographical diversity, and a wide range of practice settings being the key criteria in their selection.
Investigators then conducted a literature review, selecting the 30 most relevant randomized, controlled trials, retrospective studies, and systematic reviews from the past 10 years. From this review, investigators created a list of 30 possible quality measures, all of which were then sent to each member of the expert panel via email for them to rank on a 9-point interval scale, and modify if necessary.
Those rankings were then used to determine the appropriateness of each proposed quality measure at a face-to-face meeting among the investigators and the 15-member expert panel, at which 17 quality measures were determined to be appropriate. In all, 2 measures dealt with competency, 2 pertained to assessment before procedure, 3 were regarding performance of the procedure itself, and 10 were about interpretation of data obtained from esophageal manometry; the 10 measures concerning interpretation of data were compiled into 1 measure, leaving a total of 8 that were ultimately approved.
The quality measures for competency are as follows:
• “If esophageal manometry is performed, then the technician must be competent to perform esophageal manometry.”
• “If a physician is considered competent to interpret esophageal manometry, then the physician must interpret a minimum number of esophageal manometry studies annually.”
For assessment before procedure, the measures state the following:
• “If a patient is referred for esophageal manometry, then the patient should have undergone an evaluation for structural abnormalities before manometry.”
• “If an esophageal manometry is performed, then informed consent must be obtained and documented.”
Quality measures regarding the procedure itself state the following:
• “If an esophageal manometry study is performed, then a time interval of at least 30 seconds should occur between swallows.”
• “If an esophageal manometry study is performed, then at least 10 wet swallows should be attempted.”
• “If an esophageal manometry study is performed, then at least seven evaluable wet swallows should be included.”
Finally, regarding interpretation of data, the single quality measures states that “If an esophageal manometry study is interpreted, then a complete procedure report should document the following:
• “Reason for referral.”
• “Clinical diagnosis.”
• “Diagnosis according to formally validated classification scheme.”
• “Documentation of formally validated classification scheme used.”
• “Summary of results”
• “Tabulated results including upper esophageal sphincter activity, interpretation of esophagogastric junction relaxation, documentation of pressure inversion point if technically feasible, pressurization pattern and contractile pattern.”
• “Technical limitation (if applicable).”
• “Communication to referring provider.”
“These eight appropriate quality measures are considered absolutely necessary in the performance and interpretation of esophageal manometry,” the authors concluded. “In particular, measures 3-8 are clinically feasible and measurable, and should serve as an initial framework to benchmark quality and reduce variability in esophageal manometry practices.”
This study was funded by the Alumnae of Northwestern University, and a grant to Dr. Yadlapati (T32 DK101363-02). Five coinvestigators disclosed consultancy and speaking relationships with Boston Scientific, Cook Endoscopy, EndoStim, Given Imaging, Covidien, and Sandhill Scientific.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Key clinical point: Health care providers should consider eight new validated quality measures when performing and interpreting esophageal manometry data.
Major finding: Of 30 possible measures, 10 regarding interpretation of data were compiled into a single quality measure, 2 were classified as competency measures, 2 were classified as assessments necessary prior to an esophageal manometry procedure, and 3 were classified as integral to the procedure of esophageal manometry, for a total of 8.
Data source: Survey of existing literature and expert interviews on validated quality measures on the basis of the RAM.
Disclosures: Study was partly funded by a grant from the Alumnae of Northwestern University; five coauthors reported financial disclosures.
