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ENGAGE AF-TIMI: Insulin linked to greater risk for stroke, CV death, bleeding
LOS ANGELES – Patients with diabetes had significantly higher adjusted risk of bleeding, cardiovascular-related death, and poorer net outcomes, particularly those treated with insulin, a subanalysis of the ENGAGE AF-TIMI 48 trial has shown.
In addition, the pharmacokinetic and pharmacodynamic profile of the study drug, edoxaban – a novel oral anticoagulant drug and a direct factor Xa inhibitor – was generally similar in patients with and without diabetes.
“We know that atrial fibrillation is associated with a fivefold increased risk of stroke,” Anna Plitt, MD, said at the World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease. “Type 2 diabetes is associated with a twofold increased risk of stroke, and longer duration of diabetes is associated with even higher ischemic event rates. The coexistence of [atrial fibrillation] and type 2 diabetes further increases thromboembolic risk.”
Dr. Plitt, a cardiology fellow at Mount Sinai Hospital, New York, noted that, although type 2 diabetes is characterized by a prothrombotic and inflammatory state, the mechanism of action by which hyperglycemia and/or insulin resistance leads to the development of atrial fibrillation (AFib) remains unknown. “Given the complex clinical interactions between AFib and type 2 diabetes, care for these patients remains challenging,” she said. “Recommendations for anticoagulation managements vary based on the presence of additional risk factors and which guidelines are followed.”
In the ENGAGE AF-TIMI 48 trial, 21,105 patients with documented AFib within the previous 12 months were randomized to standard-care warfarin or high-dose edoxaban (60 mg daily) or low-dose edoxaban (30 mg daily). The edoxaban dose was reduced by 50% if creatinine clearance reached 30-50 mL/min, patient weight reached 60 kg or less, or there was concomitant use of a P-glycoprotein inhibitor (N Engl J Med. 2013;369:2093-104). The median follow-up was 2.8 years, and the primary efficacy endpoint was stroke or systemic embolic events (SEEs). The primary safety endpoint was major bleeding, as defined by the International Society on Thrombosis and Haemostasis criteria.
The findings showed that edoxaban was noninferior to warfarin in preventing stroke/SEEs. It also significantly reduced major bleeding, cardiovascular death, and net outcomes. “Therefore, the higher dose of edoxaban was approved globally for treating patients with AFib,” Dr. Plitt said. “The lower-dose regimen was not approved because there was less protection from ischemic stroke, compared with warfarin.”
For the current subanalysis, Dr. Plitt and colleagues set out to further evaluate outcomes of patients enrolled in the ENGAGE AF-TIMI 48 trial, excluding those who were in the low-dose edoxaban group. The presence or absence of diabetes was determined by the local investigator at randomization. The investigators further stratified patients into insulin-treated and non–insulin treated groups and used multivariate Cox regression models to adjust for baseline characteristics across the groups stratified by diabetes status. Next, they analyzed edoxaban concentration, anti–factor Xa activity, and international normalized ratio data and compared outcomes of high-dose edoxaban with those of warfarin.
The primary endpoint and the primary safety endpoint of interest were the same as in the main ENGAGE AF-TIMI 48 trial. Key secondary endpoints included in the subanalysis were cardiovascular death, stroke/SEE, major adverse cardiovascular events (MACE, a composite of myocardial infarction, stroke, SEE, or death because of cardiovascular cause or bleeding), and all-cause death.
In all, 7,624 of the 21,105 patients in the ENGAGE AF-TIMI 48 trial had diabetes, for a rate of 36%. Most of the patients with diabetes did not require insulin (30%), while 6% did. There were fewer female patients with diabetes than without (37% vs. 39%, respectively). Of note was that history of prior stroke/transient ischemic attack was higher in the no-diabetes group than in the diabetes group (33% vs. 21%), as was congestive heart failure (63% vs. 48%).
The mean CHA2DS2-VASc score for predicting thromboembolic risk (0, low risk; greater than 1, high risk) was 4.6 in the diabetes group and 4.2 in the no-diabetes group. When diabetes was not included in the score, the mean CHA2DS2-VASc score was 3.6 in the diabetes group. “Because the trial entry criteria required a minimum CHADS2 score of 2, patients without diabetes were enriched with stroke risk factors other than diabetes,” Dr. Plitt said.
Adjusted outcomes from the subanalysis showed that the risk of stroke/SEE was similar between patients with and without diabetes (hazard ratio, 1.08). However, patients with diabetes were at higher adjusted risk for cardiovascular death than patients without diabetes (HR, 1.29), MACE (HR, 1.28), major bleed (HR, 1.28), and the net outcome of stroke, SEE, major bleed, or all-cause death (HR, 1.25).
The researchers also analyzed the pharmacodynamic and pharmacokinetic data of high-dose edoxaban, stratified by diabetes status. They found that the parameters were generally similar between patients with and without diabetes, including trough concentrations of edoxaban (34.3 and 37.2 ng/mL, respectively; P = .04), trough exogenous anti–factor Xa activity (0.59 and 0.68 IU/mL; P = .11), and the percentage change from baseline in the peak endogenous anti–factor Xa activity (P = .66). The percentage changes from baseline of the trough endogenous anti–factor Xa activity was slightly lower in patients with diabetes, compared with patients without diabetes (P less than .001). “However, these modest differences between the two groups are of unclear clinical significance,” Dr. Plitt said.
Results from the main ENGAGE AF-TIMI 48 showed that the rates of stroke/SEE were reduced by 13% on high-dose edoxaban. However, the subanalysis found no significant effect modification in the reduction in stroke/SEE with edoxaban, compared with warfarin, when stratified by diabetes status (reductions of 16% vs. 7% in the no-diabetes and diabetes groups, respectively; P for interaction = .54). The researchers also observed similar reductions with edoxaban in the risks of secondary outcomes when patients were stratified by diabetes status.
In another finding, patients with diabetes who were treated with insulin were at a higher adjusted risk for all outcomes, compared with those with diabetes who were not treated with insulin. This included stroke/SEE (HR, 1.44), cardiovascular-related death (HR, 1.83), MACE (HR, 1.78), major bleed (HR, 1.31), and net outcome (HR, 1.57).
Next, the researchers compared the study endpoints of high-dose edoxaban and warfarin, with and without insulin. “None of the efficacy, safety, or net outcomes demonstrated evidence of treatment effect modification related to the use of insulin among [patients with diabetes],” she said.
Dr. Plitt disclosed having received honoraria for educational activities from Bristol-Myers Squibb.
LOS ANGELES – Patients with diabetes had significantly higher adjusted risk of bleeding, cardiovascular-related death, and poorer net outcomes, particularly those treated with insulin, a subanalysis of the ENGAGE AF-TIMI 48 trial has shown.
In addition, the pharmacokinetic and pharmacodynamic profile of the study drug, edoxaban – a novel oral anticoagulant drug and a direct factor Xa inhibitor – was generally similar in patients with and without diabetes.
“We know that atrial fibrillation is associated with a fivefold increased risk of stroke,” Anna Plitt, MD, said at the World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease. “Type 2 diabetes is associated with a twofold increased risk of stroke, and longer duration of diabetes is associated with even higher ischemic event rates. The coexistence of [atrial fibrillation] and type 2 diabetes further increases thromboembolic risk.”
Dr. Plitt, a cardiology fellow at Mount Sinai Hospital, New York, noted that, although type 2 diabetes is characterized by a prothrombotic and inflammatory state, the mechanism of action by which hyperglycemia and/or insulin resistance leads to the development of atrial fibrillation (AFib) remains unknown. “Given the complex clinical interactions between AFib and type 2 diabetes, care for these patients remains challenging,” she said. “Recommendations for anticoagulation managements vary based on the presence of additional risk factors and which guidelines are followed.”
In the ENGAGE AF-TIMI 48 trial, 21,105 patients with documented AFib within the previous 12 months were randomized to standard-care warfarin or high-dose edoxaban (60 mg daily) or low-dose edoxaban (30 mg daily). The edoxaban dose was reduced by 50% if creatinine clearance reached 30-50 mL/min, patient weight reached 60 kg or less, or there was concomitant use of a P-glycoprotein inhibitor (N Engl J Med. 2013;369:2093-104). The median follow-up was 2.8 years, and the primary efficacy endpoint was stroke or systemic embolic events (SEEs). The primary safety endpoint was major bleeding, as defined by the International Society on Thrombosis and Haemostasis criteria.
The findings showed that edoxaban was noninferior to warfarin in preventing stroke/SEEs. It also significantly reduced major bleeding, cardiovascular death, and net outcomes. “Therefore, the higher dose of edoxaban was approved globally for treating patients with AFib,” Dr. Plitt said. “The lower-dose regimen was not approved because there was less protection from ischemic stroke, compared with warfarin.”
For the current subanalysis, Dr. Plitt and colleagues set out to further evaluate outcomes of patients enrolled in the ENGAGE AF-TIMI 48 trial, excluding those who were in the low-dose edoxaban group. The presence or absence of diabetes was determined by the local investigator at randomization. The investigators further stratified patients into insulin-treated and non–insulin treated groups and used multivariate Cox regression models to adjust for baseline characteristics across the groups stratified by diabetes status. Next, they analyzed edoxaban concentration, anti–factor Xa activity, and international normalized ratio data and compared outcomes of high-dose edoxaban with those of warfarin.
The primary endpoint and the primary safety endpoint of interest were the same as in the main ENGAGE AF-TIMI 48 trial. Key secondary endpoints included in the subanalysis were cardiovascular death, stroke/SEE, major adverse cardiovascular events (MACE, a composite of myocardial infarction, stroke, SEE, or death because of cardiovascular cause or bleeding), and all-cause death.
In all, 7,624 of the 21,105 patients in the ENGAGE AF-TIMI 48 trial had diabetes, for a rate of 36%. Most of the patients with diabetes did not require insulin (30%), while 6% did. There were fewer female patients with diabetes than without (37% vs. 39%, respectively). Of note was that history of prior stroke/transient ischemic attack was higher in the no-diabetes group than in the diabetes group (33% vs. 21%), as was congestive heart failure (63% vs. 48%).
The mean CHA2DS2-VASc score for predicting thromboembolic risk (0, low risk; greater than 1, high risk) was 4.6 in the diabetes group and 4.2 in the no-diabetes group. When diabetes was not included in the score, the mean CHA2DS2-VASc score was 3.6 in the diabetes group. “Because the trial entry criteria required a minimum CHADS2 score of 2, patients without diabetes were enriched with stroke risk factors other than diabetes,” Dr. Plitt said.
Adjusted outcomes from the subanalysis showed that the risk of stroke/SEE was similar between patients with and without diabetes (hazard ratio, 1.08). However, patients with diabetes were at higher adjusted risk for cardiovascular death than patients without diabetes (HR, 1.29), MACE (HR, 1.28), major bleed (HR, 1.28), and the net outcome of stroke, SEE, major bleed, or all-cause death (HR, 1.25).
The researchers also analyzed the pharmacodynamic and pharmacokinetic data of high-dose edoxaban, stratified by diabetes status. They found that the parameters were generally similar between patients with and without diabetes, including trough concentrations of edoxaban (34.3 and 37.2 ng/mL, respectively; P = .04), trough exogenous anti–factor Xa activity (0.59 and 0.68 IU/mL; P = .11), and the percentage change from baseline in the peak endogenous anti–factor Xa activity (P = .66). The percentage changes from baseline of the trough endogenous anti–factor Xa activity was slightly lower in patients with diabetes, compared with patients without diabetes (P less than .001). “However, these modest differences between the two groups are of unclear clinical significance,” Dr. Plitt said.
Results from the main ENGAGE AF-TIMI 48 showed that the rates of stroke/SEE were reduced by 13% on high-dose edoxaban. However, the subanalysis found no significant effect modification in the reduction in stroke/SEE with edoxaban, compared with warfarin, when stratified by diabetes status (reductions of 16% vs. 7% in the no-diabetes and diabetes groups, respectively; P for interaction = .54). The researchers also observed similar reductions with edoxaban in the risks of secondary outcomes when patients were stratified by diabetes status.
In another finding, patients with diabetes who were treated with insulin were at a higher adjusted risk for all outcomes, compared with those with diabetes who were not treated with insulin. This included stroke/SEE (HR, 1.44), cardiovascular-related death (HR, 1.83), MACE (HR, 1.78), major bleed (HR, 1.31), and net outcome (HR, 1.57).
Next, the researchers compared the study endpoints of high-dose edoxaban and warfarin, with and without insulin. “None of the efficacy, safety, or net outcomes demonstrated evidence of treatment effect modification related to the use of insulin among [patients with diabetes],” she said.
Dr. Plitt disclosed having received honoraria for educational activities from Bristol-Myers Squibb.
LOS ANGELES – Patients with diabetes had significantly higher adjusted risk of bleeding, cardiovascular-related death, and poorer net outcomes, particularly those treated with insulin, a subanalysis of the ENGAGE AF-TIMI 48 trial has shown.
In addition, the pharmacokinetic and pharmacodynamic profile of the study drug, edoxaban – a novel oral anticoagulant drug and a direct factor Xa inhibitor – was generally similar in patients with and without diabetes.
“We know that atrial fibrillation is associated with a fivefold increased risk of stroke,” Anna Plitt, MD, said at the World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease. “Type 2 diabetes is associated with a twofold increased risk of stroke, and longer duration of diabetes is associated with even higher ischemic event rates. The coexistence of [atrial fibrillation] and type 2 diabetes further increases thromboembolic risk.”
Dr. Plitt, a cardiology fellow at Mount Sinai Hospital, New York, noted that, although type 2 diabetes is characterized by a prothrombotic and inflammatory state, the mechanism of action by which hyperglycemia and/or insulin resistance leads to the development of atrial fibrillation (AFib) remains unknown. “Given the complex clinical interactions between AFib and type 2 diabetes, care for these patients remains challenging,” she said. “Recommendations for anticoagulation managements vary based on the presence of additional risk factors and which guidelines are followed.”
In the ENGAGE AF-TIMI 48 trial, 21,105 patients with documented AFib within the previous 12 months were randomized to standard-care warfarin or high-dose edoxaban (60 mg daily) or low-dose edoxaban (30 mg daily). The edoxaban dose was reduced by 50% if creatinine clearance reached 30-50 mL/min, patient weight reached 60 kg or less, or there was concomitant use of a P-glycoprotein inhibitor (N Engl J Med. 2013;369:2093-104). The median follow-up was 2.8 years, and the primary efficacy endpoint was stroke or systemic embolic events (SEEs). The primary safety endpoint was major bleeding, as defined by the International Society on Thrombosis and Haemostasis criteria.
The findings showed that edoxaban was noninferior to warfarin in preventing stroke/SEEs. It also significantly reduced major bleeding, cardiovascular death, and net outcomes. “Therefore, the higher dose of edoxaban was approved globally for treating patients with AFib,” Dr. Plitt said. “The lower-dose regimen was not approved because there was less protection from ischemic stroke, compared with warfarin.”
For the current subanalysis, Dr. Plitt and colleagues set out to further evaluate outcomes of patients enrolled in the ENGAGE AF-TIMI 48 trial, excluding those who were in the low-dose edoxaban group. The presence or absence of diabetes was determined by the local investigator at randomization. The investigators further stratified patients into insulin-treated and non–insulin treated groups and used multivariate Cox regression models to adjust for baseline characteristics across the groups stratified by diabetes status. Next, they analyzed edoxaban concentration, anti–factor Xa activity, and international normalized ratio data and compared outcomes of high-dose edoxaban with those of warfarin.
The primary endpoint and the primary safety endpoint of interest were the same as in the main ENGAGE AF-TIMI 48 trial. Key secondary endpoints included in the subanalysis were cardiovascular death, stroke/SEE, major adverse cardiovascular events (MACE, a composite of myocardial infarction, stroke, SEE, or death because of cardiovascular cause or bleeding), and all-cause death.
In all, 7,624 of the 21,105 patients in the ENGAGE AF-TIMI 48 trial had diabetes, for a rate of 36%. Most of the patients with diabetes did not require insulin (30%), while 6% did. There were fewer female patients with diabetes than without (37% vs. 39%, respectively). Of note was that history of prior stroke/transient ischemic attack was higher in the no-diabetes group than in the diabetes group (33% vs. 21%), as was congestive heart failure (63% vs. 48%).
The mean CHA2DS2-VASc score for predicting thromboembolic risk (0, low risk; greater than 1, high risk) was 4.6 in the diabetes group and 4.2 in the no-diabetes group. When diabetes was not included in the score, the mean CHA2DS2-VASc score was 3.6 in the diabetes group. “Because the trial entry criteria required a minimum CHADS2 score of 2, patients without diabetes were enriched with stroke risk factors other than diabetes,” Dr. Plitt said.
Adjusted outcomes from the subanalysis showed that the risk of stroke/SEE was similar between patients with and without diabetes (hazard ratio, 1.08). However, patients with diabetes were at higher adjusted risk for cardiovascular death than patients without diabetes (HR, 1.29), MACE (HR, 1.28), major bleed (HR, 1.28), and the net outcome of stroke, SEE, major bleed, or all-cause death (HR, 1.25).
The researchers also analyzed the pharmacodynamic and pharmacokinetic data of high-dose edoxaban, stratified by diabetes status. They found that the parameters were generally similar between patients with and without diabetes, including trough concentrations of edoxaban (34.3 and 37.2 ng/mL, respectively; P = .04), trough exogenous anti–factor Xa activity (0.59 and 0.68 IU/mL; P = .11), and the percentage change from baseline in the peak endogenous anti–factor Xa activity (P = .66). The percentage changes from baseline of the trough endogenous anti–factor Xa activity was slightly lower in patients with diabetes, compared with patients without diabetes (P less than .001). “However, these modest differences between the two groups are of unclear clinical significance,” Dr. Plitt said.
Results from the main ENGAGE AF-TIMI 48 showed that the rates of stroke/SEE were reduced by 13% on high-dose edoxaban. However, the subanalysis found no significant effect modification in the reduction in stroke/SEE with edoxaban, compared with warfarin, when stratified by diabetes status (reductions of 16% vs. 7% in the no-diabetes and diabetes groups, respectively; P for interaction = .54). The researchers also observed similar reductions with edoxaban in the risks of secondary outcomes when patients were stratified by diabetes status.
In another finding, patients with diabetes who were treated with insulin were at a higher adjusted risk for all outcomes, compared with those with diabetes who were not treated with insulin. This included stroke/SEE (HR, 1.44), cardiovascular-related death (HR, 1.83), MACE (HR, 1.78), major bleed (HR, 1.31), and net outcome (HR, 1.57).
Next, the researchers compared the study endpoints of high-dose edoxaban and warfarin, with and without insulin. “None of the efficacy, safety, or net outcomes demonstrated evidence of treatment effect modification related to the use of insulin among [patients with diabetes],” she said.
Dr. Plitt disclosed having received honoraria for educational activities from Bristol-Myers Squibb.
REPORTING FROM THE WCIRDC 2019
CvLPRIT: Complete revascularization benefits persist long term
The greater reduction in major adverse cardiovascular events with complete revascularization for ST-segment elevation myocardial infarction, compared with target-lesion only, persists for many years after the procedure, a study has found.
In the Journal of the American College of Cardiology, researchers report the outcomes of long-term follow-up of 272 patients admitted with ST-segment elevation myocardial infarction, who were enrolled in CvLPRIT (Complete Versus Lesion-Only Primary PCI Trial).
The trial randomized patients to complete revascularization or infarct-related artery revascularization only, with a median follow-up of 5.6 years after randomization.
Anthony H. Gershlick, MD, from the University of Leicester (England) and NIHR Leicester Biomedical Research Centre, and coauthors highlighted conflicting evidence on the relative benefit of complete revascularization, compared with revascularization focused on the culprit artery only.
“The aim of this study was, for the first time, to determine if there is a sustained benefit in favor of multivessel percutaneous coronary intervention [PCI] in the longer term,” they wrote.
In the group of patients who underwent complete revascularization, the composite major adverse cardiovascular event rate at 5.6 years was 43% lower than in the infarct-related artery revascularization group (24.0 vs. 37.7%; P = .0079), according to the intention-to-treat analysis.
The complete revascularization group also showed a significantly lower rate of the secondary composite endpoint of death or MI, which was 10% in the complete revascularization group and 18.5% in the target lesion group (hazard ratio, 0.47; P = .0175).
“Our data suggest that total revascularization, known to have benefits in various cohorts with coronary artery disease, should now probably be considered the standard of care in suitable patients with STEMI with multivessel disease,” they wrote.
However they did find that the rates of ischemia-driven revascularization were not significantly different between the two groups at the long-term follow-up.
The authors also did an analysis of outcomes from the end of the original 12-month study to the final follow-up point. This showed a nonsignificant trend toward a lower rate of major adverse cardiovascular events in the group who underwent complete revascularization; 17.1%, compared with 23.3% in the infarct-related artery revascularization group. The rates of the individual components of that primary endpoint also trended toward lower rates in individuals with complete revascularization.
Similarly, the rates of ischemia-driven revascularization were similar in both groups when analyzed after the 12-month mark, and the authors noted that the need for ischemia-driven revascularization was equally spread between infarct-related arteries and non–infarct-related arteries.
The authors commented that the event rate curves for the two groups remained separated even to the median follow-up point of 5.6 years, showing that the highly significant difference in major adverse cardiovascular event rates between the two groups persists.
“All of these data suggest that lower rates of events seen within 12 months do translate into longer-term benefit, predominantly through nonattenuation of benefit,” they wrote.
They speculated that the longer-term benefit of early complete revascularization could be the result of improvement in blood flow to areas around the original site of ischemia, and because it managed lesions in nontarget vessels in patients with disease in multiple arteries.
“Certainly, given that both the MRI and nuclear medicine substudies of CvLPRIT showed no difference between the groups in infarct size (at 1 week) and no difference in ischemic burden at 6 weeks, the benefit we have demonstrated does not appear to be explained simply in terms of ischemic burden being dealt with prophylactically in the complete group,” they wrote.
Commenting on the study’s limitations, the authors noted that the overall numbers of patients were small, and that the use of all-cause mortality rather than cardiovascular mortality may affect the interpretation of results.
The CvLPRIT study was funded by the British Heart Foundation, with support from the National Institute for Health Research Comprehensive Local Research Networks. No conflicts of interest were declared.
SOURCE: Gershlick A et al. J Am Coll Cardiol. 2019 Dec 16;74:3083-9.
Multivessel coronary artery disease is present in around half of all patients presenting with STEMI and is associated with worse outcomes. However the decision about whether to revascularize beyond the culprit lesions – including lesions that may be asymptomatic and cause no ischemia – has been a matter of debate.
This longer-term follow-up from the CvLPRIT trial, along with evidence from other studies, has confirmed that complete revascularization should be considered in STEMI patients with multivessel disease. However, we suggest an individualized approach, rather than one-size-fits-all. This should also take into account factors such as the patient’s age and comorbidities, to avoid futile complex procedures in very old or frail patients. It is also important not to underestimate the importance of revascularization of the target lesion only.
There also remain questions about the best timing for complete revascularization and how to select the nonculprit lesions for revascularization.
Guillaume Cayla, MD, and Benoit Lattuca, MD, are from the Service de cardiologie, CHU de Nimes, ACTION Study Group at the Université de Montpellier, Nimes, France. These comments are adapted from an accompanying editorial (J Am Coll Cardiol. 2019; 74:3095-8. doi. org/10.1016/j.jacc.2019.10.037). Both authors declared research grants and lecture or consultancy fees from the pharmaceutical sector.
Multivessel coronary artery disease is present in around half of all patients presenting with STEMI and is associated with worse outcomes. However the decision about whether to revascularize beyond the culprit lesions – including lesions that may be asymptomatic and cause no ischemia – has been a matter of debate.
This longer-term follow-up from the CvLPRIT trial, along with evidence from other studies, has confirmed that complete revascularization should be considered in STEMI patients with multivessel disease. However, we suggest an individualized approach, rather than one-size-fits-all. This should also take into account factors such as the patient’s age and comorbidities, to avoid futile complex procedures in very old or frail patients. It is also important not to underestimate the importance of revascularization of the target lesion only.
There also remain questions about the best timing for complete revascularization and how to select the nonculprit lesions for revascularization.
Guillaume Cayla, MD, and Benoit Lattuca, MD, are from the Service de cardiologie, CHU de Nimes, ACTION Study Group at the Université de Montpellier, Nimes, France. These comments are adapted from an accompanying editorial (J Am Coll Cardiol. 2019; 74:3095-8. doi. org/10.1016/j.jacc.2019.10.037). Both authors declared research grants and lecture or consultancy fees from the pharmaceutical sector.
Multivessel coronary artery disease is present in around half of all patients presenting with STEMI and is associated with worse outcomes. However the decision about whether to revascularize beyond the culprit lesions – including lesions that may be asymptomatic and cause no ischemia – has been a matter of debate.
This longer-term follow-up from the CvLPRIT trial, along with evidence from other studies, has confirmed that complete revascularization should be considered in STEMI patients with multivessel disease. However, we suggest an individualized approach, rather than one-size-fits-all. This should also take into account factors such as the patient’s age and comorbidities, to avoid futile complex procedures in very old or frail patients. It is also important not to underestimate the importance of revascularization of the target lesion only.
There also remain questions about the best timing for complete revascularization and how to select the nonculprit lesions for revascularization.
Guillaume Cayla, MD, and Benoit Lattuca, MD, are from the Service de cardiologie, CHU de Nimes, ACTION Study Group at the Université de Montpellier, Nimes, France. These comments are adapted from an accompanying editorial (J Am Coll Cardiol. 2019; 74:3095-8. doi. org/10.1016/j.jacc.2019.10.037). Both authors declared research grants and lecture or consultancy fees from the pharmaceutical sector.
The greater reduction in major adverse cardiovascular events with complete revascularization for ST-segment elevation myocardial infarction, compared with target-lesion only, persists for many years after the procedure, a study has found.
In the Journal of the American College of Cardiology, researchers report the outcomes of long-term follow-up of 272 patients admitted with ST-segment elevation myocardial infarction, who were enrolled in CvLPRIT (Complete Versus Lesion-Only Primary PCI Trial).
The trial randomized patients to complete revascularization or infarct-related artery revascularization only, with a median follow-up of 5.6 years after randomization.
Anthony H. Gershlick, MD, from the University of Leicester (England) and NIHR Leicester Biomedical Research Centre, and coauthors highlighted conflicting evidence on the relative benefit of complete revascularization, compared with revascularization focused on the culprit artery only.
“The aim of this study was, for the first time, to determine if there is a sustained benefit in favor of multivessel percutaneous coronary intervention [PCI] in the longer term,” they wrote.
In the group of patients who underwent complete revascularization, the composite major adverse cardiovascular event rate at 5.6 years was 43% lower than in the infarct-related artery revascularization group (24.0 vs. 37.7%; P = .0079), according to the intention-to-treat analysis.
The complete revascularization group also showed a significantly lower rate of the secondary composite endpoint of death or MI, which was 10% in the complete revascularization group and 18.5% in the target lesion group (hazard ratio, 0.47; P = .0175).
“Our data suggest that total revascularization, known to have benefits in various cohorts with coronary artery disease, should now probably be considered the standard of care in suitable patients with STEMI with multivessel disease,” they wrote.
However they did find that the rates of ischemia-driven revascularization were not significantly different between the two groups at the long-term follow-up.
The authors also did an analysis of outcomes from the end of the original 12-month study to the final follow-up point. This showed a nonsignificant trend toward a lower rate of major adverse cardiovascular events in the group who underwent complete revascularization; 17.1%, compared with 23.3% in the infarct-related artery revascularization group. The rates of the individual components of that primary endpoint also trended toward lower rates in individuals with complete revascularization.
Similarly, the rates of ischemia-driven revascularization were similar in both groups when analyzed after the 12-month mark, and the authors noted that the need for ischemia-driven revascularization was equally spread between infarct-related arteries and non–infarct-related arteries.
The authors commented that the event rate curves for the two groups remained separated even to the median follow-up point of 5.6 years, showing that the highly significant difference in major adverse cardiovascular event rates between the two groups persists.
“All of these data suggest that lower rates of events seen within 12 months do translate into longer-term benefit, predominantly through nonattenuation of benefit,” they wrote.
They speculated that the longer-term benefit of early complete revascularization could be the result of improvement in blood flow to areas around the original site of ischemia, and because it managed lesions in nontarget vessels in patients with disease in multiple arteries.
“Certainly, given that both the MRI and nuclear medicine substudies of CvLPRIT showed no difference between the groups in infarct size (at 1 week) and no difference in ischemic burden at 6 weeks, the benefit we have demonstrated does not appear to be explained simply in terms of ischemic burden being dealt with prophylactically in the complete group,” they wrote.
Commenting on the study’s limitations, the authors noted that the overall numbers of patients were small, and that the use of all-cause mortality rather than cardiovascular mortality may affect the interpretation of results.
The CvLPRIT study was funded by the British Heart Foundation, with support from the National Institute for Health Research Comprehensive Local Research Networks. No conflicts of interest were declared.
SOURCE: Gershlick A et al. J Am Coll Cardiol. 2019 Dec 16;74:3083-9.
The greater reduction in major adverse cardiovascular events with complete revascularization for ST-segment elevation myocardial infarction, compared with target-lesion only, persists for many years after the procedure, a study has found.
In the Journal of the American College of Cardiology, researchers report the outcomes of long-term follow-up of 272 patients admitted with ST-segment elevation myocardial infarction, who were enrolled in CvLPRIT (Complete Versus Lesion-Only Primary PCI Trial).
The trial randomized patients to complete revascularization or infarct-related artery revascularization only, with a median follow-up of 5.6 years after randomization.
Anthony H. Gershlick, MD, from the University of Leicester (England) and NIHR Leicester Biomedical Research Centre, and coauthors highlighted conflicting evidence on the relative benefit of complete revascularization, compared with revascularization focused on the culprit artery only.
“The aim of this study was, for the first time, to determine if there is a sustained benefit in favor of multivessel percutaneous coronary intervention [PCI] in the longer term,” they wrote.
In the group of patients who underwent complete revascularization, the composite major adverse cardiovascular event rate at 5.6 years was 43% lower than in the infarct-related artery revascularization group (24.0 vs. 37.7%; P = .0079), according to the intention-to-treat analysis.
The complete revascularization group also showed a significantly lower rate of the secondary composite endpoint of death or MI, which was 10% in the complete revascularization group and 18.5% in the target lesion group (hazard ratio, 0.47; P = .0175).
“Our data suggest that total revascularization, known to have benefits in various cohorts with coronary artery disease, should now probably be considered the standard of care in suitable patients with STEMI with multivessel disease,” they wrote.
However they did find that the rates of ischemia-driven revascularization were not significantly different between the two groups at the long-term follow-up.
The authors also did an analysis of outcomes from the end of the original 12-month study to the final follow-up point. This showed a nonsignificant trend toward a lower rate of major adverse cardiovascular events in the group who underwent complete revascularization; 17.1%, compared with 23.3% in the infarct-related artery revascularization group. The rates of the individual components of that primary endpoint also trended toward lower rates in individuals with complete revascularization.
Similarly, the rates of ischemia-driven revascularization were similar in both groups when analyzed after the 12-month mark, and the authors noted that the need for ischemia-driven revascularization was equally spread between infarct-related arteries and non–infarct-related arteries.
The authors commented that the event rate curves for the two groups remained separated even to the median follow-up point of 5.6 years, showing that the highly significant difference in major adverse cardiovascular event rates between the two groups persists.
“All of these data suggest that lower rates of events seen within 12 months do translate into longer-term benefit, predominantly through nonattenuation of benefit,” they wrote.
They speculated that the longer-term benefit of early complete revascularization could be the result of improvement in blood flow to areas around the original site of ischemia, and because it managed lesions in nontarget vessels in patients with disease in multiple arteries.
“Certainly, given that both the MRI and nuclear medicine substudies of CvLPRIT showed no difference between the groups in infarct size (at 1 week) and no difference in ischemic burden at 6 weeks, the benefit we have demonstrated does not appear to be explained simply in terms of ischemic burden being dealt with prophylactically in the complete group,” they wrote.
Commenting on the study’s limitations, the authors noted that the overall numbers of patients were small, and that the use of all-cause mortality rather than cardiovascular mortality may affect the interpretation of results.
The CvLPRIT study was funded by the British Heart Foundation, with support from the National Institute for Health Research Comprehensive Local Research Networks. No conflicts of interest were declared.
SOURCE: Gershlick A et al. J Am Coll Cardiol. 2019 Dec 16;74:3083-9.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Minimum transcatheter mitral valve intervention case load recommended
U.S. sites that perform transcatheter mitral valve interventions should treat a minimum of 20 such patients each year or at least 40 every 2 years, according to revised recommendations and requirements released on Dec. 16, 2019, by several U.S. cardiology and cardiac surgery societies.
The revised recommendations also for the first time address patient selection for using transcatheter mitral valve (MV) intervention in patients with mitral regurgitation (MR) secondary to heart failure and a left ventricular ejection fraction of 21%-49%, a patient target for transcatheter interventions approved by the Food and Drug Administration in March 2019. The FDA first approved the same transcatheter MV intervention system (MitraClip) in 2013 for patients with primary MR caused by an abnormality of the MV and a prohibitive risk for surgical MV repair or replacement, and the same societies had previously issued their recommendations based on that approval (J Am Coll Cardiol. 2014 Oct; 64[14]:1515-26).
The need for updated recommendations on the delivery of transcatheter MV interventions including the personnel and facilities required for a valid U.S. program was driven by “new transcatheter technology, new trial results, and the new FDA-approved indication” of secondary MR. “We did the update for patients with secondary MR,” said Robert O. Bonow, MD, professor of medicine at Northwestern University, Chicago, and chair of the committee that wrote the revised recommendations.
“Primary and secondary MR are like two different diseases. Primary MR is a disease of the MV leaflets. Secondary MR is a disease of heart failure, left ventricular dysfunction, and left ventricular enlargement.” That makes secondary MR an indication with a potentially huge upside, given how many patients have heart failure today, plus projections for steadily increasing numbers of patients as the geriatric population grows.
“Heart failure is a huge issue, and the numbers are growing, which is why we felt it was important to say which heart failure patients should be candidates. We did not endorse this for all patients, although MR is very common in heart failure,” with estimated prevalence rates as high as two-thirds of all heart failure patients, Dr. Bonow said.
The new recommendations spell out an approach to patient selection that aims to apply transcatheter MV intervention to patients who match those enrolled in the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial, which randomized 614 patients with MR secondary to heart failure and found for that MV intervention cut the rate of heart failure hospitalization by about half during 2 years of follow-up, a statistically significant effect for the study’s primary endpoint (N Engl J Med. 2018 Dec 13;379[24]:2307-18). The new recommendations provide “a way to replicate the COAPT trial” in routine practice, Dr. Bonow said in an interview.”We thought it was important to try to replicate the COAPT results,” and a key step toward trying to accomplish that is to apply the multidisciplinary team concept to evaluating patients and determining their management strategy. Dr. Bonow coauthored a commentary that discussed how the COAPT results should influence routine practice (N Engl J Med. 2018 Dec 13;379[24]:2374-6).
“In this case, perhaps the most important member of the multidisciplinary team is the heart failure specialist, because secondary MR is a disease of heart failure and it’s important to also optimize medical therapy to reduce MR and prolong life,” he said. Treatment optimization before undertaking a transcatheter MV intervention involves not only drug treatment but also treatment with indicated devices, such as biventricular pacing, to optimize left ventricular size and function. The 2019 FDA approval of the transcatheter approach for treating MV disease specified that eligible patients had to continue to have significant MR despite receiving optimal drug and device treatment.
Treatment decisions for patients with MR must be highly individualized, and unlike transcatheter aortic valve replacement (TAVR), which occurs against a background of “really good results” for surgical aortic valve replacement, surgical treatment of MR “has never been shown to prolong life, although it can improve function,” Dr. Bonow said. In addition, open surgical repair or replacement of a faulty MV “is much better than the MitraClip for elimination a MV leak; usually with transcatheter intervention there is some residual leak. And other etiologies of MR, such as atrial fibrillation causing atrial enlargement and dilatation of the mitral annulus, generally have much better results with surgery than with a transcatheter intervention. For both primary and secondary MR, deciding when to use surgery and when to do a transcatheter intervention is very individualized,” concluded Dr. Bonow, and a fact that distinguishes transcatheter MV interventions from TAVR, which has been shown to have efficacy that’s comparable with surgical aortic valve replacement. The MitraClip system is currently the only device with U.S. marketing approval for transcatheter MV intervention, although other devices are in development.
Case volume requirements
The designation of a minimum transcatheter MV intervention case load of 20 procedures a year or 40 every 2 years reflected a “consensus among interventional cardiologists and cardiac surgeons of what the experience had to be for MV repair,” Dr. Bonow said. This number contrasts with a minimum case volume of 50 procedures/year or 100 every 2 years to maintain a TAVR program proposed in 2018 by a similar expert panel organized by U.S. cardiology and cardiac surgery societies (J Am Coll of Cardiol. 2019 Jan;73[3]:340-74). The new MV recommendations “follow a similar template [as the TAVR recommendations], but the numbers are what we thought would be best for optimal transcatheter MV expertise. MV interventions will likely increase, and we felt it would be best to define the transcatheter operators and are the right patients; the volume is unclear. There are a lot of heart failure patients, but we know from COAPT that not everyone is a candidate. The existing MV device does not fit all settings. We thought the numbers we selected were most appropriate, at least when we are starting.”
Dr. Bonow and coauthors who wrote the new recommendations will rely on payers, particularly the Centers for Medicare & Medicaid Services, to adopt the societal recommendations as part of their criteria for reimbursement and thereby give them teeth. In June 2019, CMS announced its Medicare coverage determination for TAVR, which included procedure minimums of 20 per year or 40 over 2 years for TAVR programs, a number that fell substantially below the 50 per year or 100 over 2 years that had been proposed by the societies. “We hope CMS will use our MV recommendations as a starting point,” but the final CMS coverage decision for transcatheter MV intervention could again differ from what the societies proposed, Dr. Bonow acknowledged.
In addition to strongly promoting a multidisciplinary team approach (and spelling out the members of the team) and shared decision making involvement of the patient with the team, the new recommendations also endorse participation of MV intervention programs in the Transcatheter Valve Therapy U.S. patient registry that’s maintained by two of the societies that helped organize the writing committee. The recommendations discuss the need to collect 30-day (and longer) outcomes data from transcatheter MV intervention programs through the registry as is now done for TAVR programs (N Engl J Med. 2019 Jun 27;380[26]:2541-50). Dr. Bonow declined to predict when 30-day outcomes data may start appearing for programs performing transcatheter MV interventions.
Dr. Bonow had no disclosures. The COAPT study was funded by Abbott, the company that markets the MitrClip clip delivery system.
SOURCE: Bonow RO et al. J Am Coll Cardiol. 2019 Dec 16. doi: 10.1016/j.jacc.2019.12.002.
U.S. sites that perform transcatheter mitral valve interventions should treat a minimum of 20 such patients each year or at least 40 every 2 years, according to revised recommendations and requirements released on Dec. 16, 2019, by several U.S. cardiology and cardiac surgery societies.
The revised recommendations also for the first time address patient selection for using transcatheter mitral valve (MV) intervention in patients with mitral regurgitation (MR) secondary to heart failure and a left ventricular ejection fraction of 21%-49%, a patient target for transcatheter interventions approved by the Food and Drug Administration in March 2019. The FDA first approved the same transcatheter MV intervention system (MitraClip) in 2013 for patients with primary MR caused by an abnormality of the MV and a prohibitive risk for surgical MV repair or replacement, and the same societies had previously issued their recommendations based on that approval (J Am Coll Cardiol. 2014 Oct; 64[14]:1515-26).
The need for updated recommendations on the delivery of transcatheter MV interventions including the personnel and facilities required for a valid U.S. program was driven by “new transcatheter technology, new trial results, and the new FDA-approved indication” of secondary MR. “We did the update for patients with secondary MR,” said Robert O. Bonow, MD, professor of medicine at Northwestern University, Chicago, and chair of the committee that wrote the revised recommendations.
“Primary and secondary MR are like two different diseases. Primary MR is a disease of the MV leaflets. Secondary MR is a disease of heart failure, left ventricular dysfunction, and left ventricular enlargement.” That makes secondary MR an indication with a potentially huge upside, given how many patients have heart failure today, plus projections for steadily increasing numbers of patients as the geriatric population grows.
“Heart failure is a huge issue, and the numbers are growing, which is why we felt it was important to say which heart failure patients should be candidates. We did not endorse this for all patients, although MR is very common in heart failure,” with estimated prevalence rates as high as two-thirds of all heart failure patients, Dr. Bonow said.
The new recommendations spell out an approach to patient selection that aims to apply transcatheter MV intervention to patients who match those enrolled in the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial, which randomized 614 patients with MR secondary to heart failure and found for that MV intervention cut the rate of heart failure hospitalization by about half during 2 years of follow-up, a statistically significant effect for the study’s primary endpoint (N Engl J Med. 2018 Dec 13;379[24]:2307-18). The new recommendations provide “a way to replicate the COAPT trial” in routine practice, Dr. Bonow said in an interview.”We thought it was important to try to replicate the COAPT results,” and a key step toward trying to accomplish that is to apply the multidisciplinary team concept to evaluating patients and determining their management strategy. Dr. Bonow coauthored a commentary that discussed how the COAPT results should influence routine practice (N Engl J Med. 2018 Dec 13;379[24]:2374-6).
“In this case, perhaps the most important member of the multidisciplinary team is the heart failure specialist, because secondary MR is a disease of heart failure and it’s important to also optimize medical therapy to reduce MR and prolong life,” he said. Treatment optimization before undertaking a transcatheter MV intervention involves not only drug treatment but also treatment with indicated devices, such as biventricular pacing, to optimize left ventricular size and function. The 2019 FDA approval of the transcatheter approach for treating MV disease specified that eligible patients had to continue to have significant MR despite receiving optimal drug and device treatment.
Treatment decisions for patients with MR must be highly individualized, and unlike transcatheter aortic valve replacement (TAVR), which occurs against a background of “really good results” for surgical aortic valve replacement, surgical treatment of MR “has never been shown to prolong life, although it can improve function,” Dr. Bonow said. In addition, open surgical repair or replacement of a faulty MV “is much better than the MitraClip for elimination a MV leak; usually with transcatheter intervention there is some residual leak. And other etiologies of MR, such as atrial fibrillation causing atrial enlargement and dilatation of the mitral annulus, generally have much better results with surgery than with a transcatheter intervention. For both primary and secondary MR, deciding when to use surgery and when to do a transcatheter intervention is very individualized,” concluded Dr. Bonow, and a fact that distinguishes transcatheter MV interventions from TAVR, which has been shown to have efficacy that’s comparable with surgical aortic valve replacement. The MitraClip system is currently the only device with U.S. marketing approval for transcatheter MV intervention, although other devices are in development.
Case volume requirements
The designation of a minimum transcatheter MV intervention case load of 20 procedures a year or 40 every 2 years reflected a “consensus among interventional cardiologists and cardiac surgeons of what the experience had to be for MV repair,” Dr. Bonow said. This number contrasts with a minimum case volume of 50 procedures/year or 100 every 2 years to maintain a TAVR program proposed in 2018 by a similar expert panel organized by U.S. cardiology and cardiac surgery societies (J Am Coll of Cardiol. 2019 Jan;73[3]:340-74). The new MV recommendations “follow a similar template [as the TAVR recommendations], but the numbers are what we thought would be best for optimal transcatheter MV expertise. MV interventions will likely increase, and we felt it would be best to define the transcatheter operators and are the right patients; the volume is unclear. There are a lot of heart failure patients, but we know from COAPT that not everyone is a candidate. The existing MV device does not fit all settings. We thought the numbers we selected were most appropriate, at least when we are starting.”
Dr. Bonow and coauthors who wrote the new recommendations will rely on payers, particularly the Centers for Medicare & Medicaid Services, to adopt the societal recommendations as part of their criteria for reimbursement and thereby give them teeth. In June 2019, CMS announced its Medicare coverage determination for TAVR, which included procedure minimums of 20 per year or 40 over 2 years for TAVR programs, a number that fell substantially below the 50 per year or 100 over 2 years that had been proposed by the societies. “We hope CMS will use our MV recommendations as a starting point,” but the final CMS coverage decision for transcatheter MV intervention could again differ from what the societies proposed, Dr. Bonow acknowledged.
In addition to strongly promoting a multidisciplinary team approach (and spelling out the members of the team) and shared decision making involvement of the patient with the team, the new recommendations also endorse participation of MV intervention programs in the Transcatheter Valve Therapy U.S. patient registry that’s maintained by two of the societies that helped organize the writing committee. The recommendations discuss the need to collect 30-day (and longer) outcomes data from transcatheter MV intervention programs through the registry as is now done for TAVR programs (N Engl J Med. 2019 Jun 27;380[26]:2541-50). Dr. Bonow declined to predict when 30-day outcomes data may start appearing for programs performing transcatheter MV interventions.
Dr. Bonow had no disclosures. The COAPT study was funded by Abbott, the company that markets the MitrClip clip delivery system.
SOURCE: Bonow RO et al. J Am Coll Cardiol. 2019 Dec 16. doi: 10.1016/j.jacc.2019.12.002.
U.S. sites that perform transcatheter mitral valve interventions should treat a minimum of 20 such patients each year or at least 40 every 2 years, according to revised recommendations and requirements released on Dec. 16, 2019, by several U.S. cardiology and cardiac surgery societies.
The revised recommendations also for the first time address patient selection for using transcatheter mitral valve (MV) intervention in patients with mitral regurgitation (MR) secondary to heart failure and a left ventricular ejection fraction of 21%-49%, a patient target for transcatheter interventions approved by the Food and Drug Administration in March 2019. The FDA first approved the same transcatheter MV intervention system (MitraClip) in 2013 for patients with primary MR caused by an abnormality of the MV and a prohibitive risk for surgical MV repair or replacement, and the same societies had previously issued their recommendations based on that approval (J Am Coll Cardiol. 2014 Oct; 64[14]:1515-26).
The need for updated recommendations on the delivery of transcatheter MV interventions including the personnel and facilities required for a valid U.S. program was driven by “new transcatheter technology, new trial results, and the new FDA-approved indication” of secondary MR. “We did the update for patients with secondary MR,” said Robert O. Bonow, MD, professor of medicine at Northwestern University, Chicago, and chair of the committee that wrote the revised recommendations.
“Primary and secondary MR are like two different diseases. Primary MR is a disease of the MV leaflets. Secondary MR is a disease of heart failure, left ventricular dysfunction, and left ventricular enlargement.” That makes secondary MR an indication with a potentially huge upside, given how many patients have heart failure today, plus projections for steadily increasing numbers of patients as the geriatric population grows.
“Heart failure is a huge issue, and the numbers are growing, which is why we felt it was important to say which heart failure patients should be candidates. We did not endorse this for all patients, although MR is very common in heart failure,” with estimated prevalence rates as high as two-thirds of all heart failure patients, Dr. Bonow said.
The new recommendations spell out an approach to patient selection that aims to apply transcatheter MV intervention to patients who match those enrolled in the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial, which randomized 614 patients with MR secondary to heart failure and found for that MV intervention cut the rate of heart failure hospitalization by about half during 2 years of follow-up, a statistically significant effect for the study’s primary endpoint (N Engl J Med. 2018 Dec 13;379[24]:2307-18). The new recommendations provide “a way to replicate the COAPT trial” in routine practice, Dr. Bonow said in an interview.”We thought it was important to try to replicate the COAPT results,” and a key step toward trying to accomplish that is to apply the multidisciplinary team concept to evaluating patients and determining their management strategy. Dr. Bonow coauthored a commentary that discussed how the COAPT results should influence routine practice (N Engl J Med. 2018 Dec 13;379[24]:2374-6).
“In this case, perhaps the most important member of the multidisciplinary team is the heart failure specialist, because secondary MR is a disease of heart failure and it’s important to also optimize medical therapy to reduce MR and prolong life,” he said. Treatment optimization before undertaking a transcatheter MV intervention involves not only drug treatment but also treatment with indicated devices, such as biventricular pacing, to optimize left ventricular size and function. The 2019 FDA approval of the transcatheter approach for treating MV disease specified that eligible patients had to continue to have significant MR despite receiving optimal drug and device treatment.
Treatment decisions for patients with MR must be highly individualized, and unlike transcatheter aortic valve replacement (TAVR), which occurs against a background of “really good results” for surgical aortic valve replacement, surgical treatment of MR “has never been shown to prolong life, although it can improve function,” Dr. Bonow said. In addition, open surgical repair or replacement of a faulty MV “is much better than the MitraClip for elimination a MV leak; usually with transcatheter intervention there is some residual leak. And other etiologies of MR, such as atrial fibrillation causing atrial enlargement and dilatation of the mitral annulus, generally have much better results with surgery than with a transcatheter intervention. For both primary and secondary MR, deciding when to use surgery and when to do a transcatheter intervention is very individualized,” concluded Dr. Bonow, and a fact that distinguishes transcatheter MV interventions from TAVR, which has been shown to have efficacy that’s comparable with surgical aortic valve replacement. The MitraClip system is currently the only device with U.S. marketing approval for transcatheter MV intervention, although other devices are in development.
Case volume requirements
The designation of a minimum transcatheter MV intervention case load of 20 procedures a year or 40 every 2 years reflected a “consensus among interventional cardiologists and cardiac surgeons of what the experience had to be for MV repair,” Dr. Bonow said. This number contrasts with a minimum case volume of 50 procedures/year or 100 every 2 years to maintain a TAVR program proposed in 2018 by a similar expert panel organized by U.S. cardiology and cardiac surgery societies (J Am Coll of Cardiol. 2019 Jan;73[3]:340-74). The new MV recommendations “follow a similar template [as the TAVR recommendations], but the numbers are what we thought would be best for optimal transcatheter MV expertise. MV interventions will likely increase, and we felt it would be best to define the transcatheter operators and are the right patients; the volume is unclear. There are a lot of heart failure patients, but we know from COAPT that not everyone is a candidate. The existing MV device does not fit all settings. We thought the numbers we selected were most appropriate, at least when we are starting.”
Dr. Bonow and coauthors who wrote the new recommendations will rely on payers, particularly the Centers for Medicare & Medicaid Services, to adopt the societal recommendations as part of their criteria for reimbursement and thereby give them teeth. In June 2019, CMS announced its Medicare coverage determination for TAVR, which included procedure minimums of 20 per year or 40 over 2 years for TAVR programs, a number that fell substantially below the 50 per year or 100 over 2 years that had been proposed by the societies. “We hope CMS will use our MV recommendations as a starting point,” but the final CMS coverage decision for transcatheter MV intervention could again differ from what the societies proposed, Dr. Bonow acknowledged.
In addition to strongly promoting a multidisciplinary team approach (and spelling out the members of the team) and shared decision making involvement of the patient with the team, the new recommendations also endorse participation of MV intervention programs in the Transcatheter Valve Therapy U.S. patient registry that’s maintained by two of the societies that helped organize the writing committee. The recommendations discuss the need to collect 30-day (and longer) outcomes data from transcatheter MV intervention programs through the registry as is now done for TAVR programs (N Engl J Med. 2019 Jun 27;380[26]:2541-50). Dr. Bonow declined to predict when 30-day outcomes data may start appearing for programs performing transcatheter MV interventions.
Dr. Bonow had no disclosures. The COAPT study was funded by Abbott, the company that markets the MitrClip clip delivery system.
SOURCE: Bonow RO et al. J Am Coll Cardiol. 2019 Dec 16. doi: 10.1016/j.jacc.2019.12.002.
Atopic dermatitis in egg-, milk-allergic kids may up anaphylaxis risk
compared with allergic patients without atopic dermatitis, based on retrospective data from 347 individuals.
Atopic dermatitis has been associated with increased risk of food allergies, but the association and predictive factors of skin reactions to certain foods remain unclear, wrote Bryce C. Hoffman, MD, of National Jewish Health, Denver, and colleagues.
In a letter published in the Annals of Allergy, Asthma & Immunology, the researchers identified children aged 0-18 years with peanut, cow’s milk, and/or egg allergies with or without atopic dermatitis (AD) using an institutional research database and conducted a retrospective study of medical records.
Overall, children with egg and milk allergies plus AD had significantly higher rates of anaphylaxis than allergic children without AD (47% vs. 11% for egg, 50% vs. 19% for milk). Anaphylaxis rates were similar in children with peanut allergies with or without AD (27% vs. 23%).
“This finding may suggest that skin barrier dysfunction plays a role in the severity of [food allergy]. However, this is not universal to all food antigens, and other mechanisms are likely important in the association of anaphylaxis with a particular food,” the researchers noted.
Rates of tolerance for both baked egg and baked milk were similar between AD and non-AD patients (83% vs. 61% for milk; 82% vs. 67% for egg). In addition, levels of total IgE were increased in children with egg and milk allergies plus AD, compared with children without AD. However, children with peanut allergies plus AD had decreased total IgE, compared with children with peanut allergies but no AD. This “may support a link between Th2 polarization and [food allergy] severity, ” Dr. Hoffman and associates wrote.
The findings were limited by several factors, including the retrospective study design, exclusion of many patients, and lack of data on the amount of food that triggered anaphylactic reactions, the researchers noted.
Nonetheless, the results suggest that children with atopic dermatitis and allergies to eggs and milk are at increased risk and that clinicians should counsel these patients and families about the potential for more-severe reactions to oral food challenges, Dr. Hoffman and associates concluded.
The study was supported by National Jewish Health and the Edelstein Family Chair of Pediatric Allergy and Immunology. The researchers had no financial conflicts to disclose.
SOURCE: Hoffman BC et al. Ann Allergy Asthma Immunol. 2019 Sep 11. doi: 10.1016/j.anai.2019.09.008.
compared with allergic patients without atopic dermatitis, based on retrospective data from 347 individuals.
Atopic dermatitis has been associated with increased risk of food allergies, but the association and predictive factors of skin reactions to certain foods remain unclear, wrote Bryce C. Hoffman, MD, of National Jewish Health, Denver, and colleagues.
In a letter published in the Annals of Allergy, Asthma & Immunology, the researchers identified children aged 0-18 years with peanut, cow’s milk, and/or egg allergies with or without atopic dermatitis (AD) using an institutional research database and conducted a retrospective study of medical records.
Overall, children with egg and milk allergies plus AD had significantly higher rates of anaphylaxis than allergic children without AD (47% vs. 11% for egg, 50% vs. 19% for milk). Anaphylaxis rates were similar in children with peanut allergies with or without AD (27% vs. 23%).
“This finding may suggest that skin barrier dysfunction plays a role in the severity of [food allergy]. However, this is not universal to all food antigens, and other mechanisms are likely important in the association of anaphylaxis with a particular food,” the researchers noted.
Rates of tolerance for both baked egg and baked milk were similar between AD and non-AD patients (83% vs. 61% for milk; 82% vs. 67% for egg). In addition, levels of total IgE were increased in children with egg and milk allergies plus AD, compared with children without AD. However, children with peanut allergies plus AD had decreased total IgE, compared with children with peanut allergies but no AD. This “may support a link between Th2 polarization and [food allergy] severity, ” Dr. Hoffman and associates wrote.
The findings were limited by several factors, including the retrospective study design, exclusion of many patients, and lack of data on the amount of food that triggered anaphylactic reactions, the researchers noted.
Nonetheless, the results suggest that children with atopic dermatitis and allergies to eggs and milk are at increased risk and that clinicians should counsel these patients and families about the potential for more-severe reactions to oral food challenges, Dr. Hoffman and associates concluded.
The study was supported by National Jewish Health and the Edelstein Family Chair of Pediatric Allergy and Immunology. The researchers had no financial conflicts to disclose.
SOURCE: Hoffman BC et al. Ann Allergy Asthma Immunol. 2019 Sep 11. doi: 10.1016/j.anai.2019.09.008.
compared with allergic patients without atopic dermatitis, based on retrospective data from 347 individuals.
Atopic dermatitis has been associated with increased risk of food allergies, but the association and predictive factors of skin reactions to certain foods remain unclear, wrote Bryce C. Hoffman, MD, of National Jewish Health, Denver, and colleagues.
In a letter published in the Annals of Allergy, Asthma & Immunology, the researchers identified children aged 0-18 years with peanut, cow’s milk, and/or egg allergies with or without atopic dermatitis (AD) using an institutional research database and conducted a retrospective study of medical records.
Overall, children with egg and milk allergies plus AD had significantly higher rates of anaphylaxis than allergic children without AD (47% vs. 11% for egg, 50% vs. 19% for milk). Anaphylaxis rates were similar in children with peanut allergies with or without AD (27% vs. 23%).
“This finding may suggest that skin barrier dysfunction plays a role in the severity of [food allergy]. However, this is not universal to all food antigens, and other mechanisms are likely important in the association of anaphylaxis with a particular food,” the researchers noted.
Rates of tolerance for both baked egg and baked milk were similar between AD and non-AD patients (83% vs. 61% for milk; 82% vs. 67% for egg). In addition, levels of total IgE were increased in children with egg and milk allergies plus AD, compared with children without AD. However, children with peanut allergies plus AD had decreased total IgE, compared with children with peanut allergies but no AD. This “may support a link between Th2 polarization and [food allergy] severity, ” Dr. Hoffman and associates wrote.
The findings were limited by several factors, including the retrospective study design, exclusion of many patients, and lack of data on the amount of food that triggered anaphylactic reactions, the researchers noted.
Nonetheless, the results suggest that children with atopic dermatitis and allergies to eggs and milk are at increased risk and that clinicians should counsel these patients and families about the potential for more-severe reactions to oral food challenges, Dr. Hoffman and associates concluded.
The study was supported by National Jewish Health and the Edelstein Family Chair of Pediatric Allergy and Immunology. The researchers had no financial conflicts to disclose.
SOURCE: Hoffman BC et al. Ann Allergy Asthma Immunol. 2019 Sep 11. doi: 10.1016/j.anai.2019.09.008.
FROM THE ANNALS OF ALLERGY, ASTHMA & IMMUNOLOGY
Ambulatory surgery centers 101: What new GIs need to know
Almost 20 years ago, I joined Digestive Disease Specialists in Oklahoma, where I am an owner in two ambulatory endoscopy centers (AECs). Through this experience, I’ve learned a thing or two about the advantages of these centers and what to consider when joining a practice that has ownership in an endoscopy center or an ambulatory surgery center (ASC).
ASCs – or in my case AECs – are highly specialized, modern health care facilities in which physicians provide safe, high-quality procedures to millions of Americans each year, including diagnostic and preventive procedures. ASCs and AECs allow us to provide a more convenient and cost-effective alternative to performing GI procedures in a hospital. As you can imagine, these facilities are a vital part of being an independent gastroenterologist.
Quality care at a lower cost
When looking into practices with ownership in surgery centers, quality of care is one of the most critical considerations. Each center must enter into an agreement with Medicare and meet its certification requirements, which are similar to those required for hospital outpatient departments. We also undergo accreditation by the Accreditation Association for Ambulatory Healthcare. And while not everyone participates in quality registries such as GIquic – which helps us define and refine our endoscopic outcomes – our AEC does because we put patient care first.
This focus on quality leads to better care. A 2016 study of Medicare claims in the Journal of Health Economics shows that ASCs and AECs, on average, provide higher-quality care for outpatient procedures than hospitals.1
We get into medicine because we care about patients and want to provide them with the best and most convenient care possible. Because we don’t have to operate in the context of a large hospital, we can be nimbler when it comes to patient needs. As is true in other areas, the more you specialize, the more effective and efficient you can become performing certain procedures. For instance, our practice is highly specialized in endoscopy. As a result, we can be highly efficient in the turnaround time in between patient procedures. This helps people get back to their daily lives as soon as possible, whereas patients may spend a lot more time waiting to have their procedure in the hospital setting.
Performing procedures in an ASC or AEC also helps us keep costs down, and we spend a lot of time educating policymakers about the role independent physicians play in lowering health care costs. According to a recent study in Health Affairs, hospital-based outpatient care prices grew at four times the rate of physician prices from 2007 to 2014.2 And the National Institute for Health Care Reform found that the average Medicare facility payment for a basic colonoscopy was more than twice as much in a hospital setting.3
The challenges and benefits of running an ASC or AEC
With consolidation of hospitals and insurance companies, operating an independent ASC or AEC has become more challenging. The players are bigger, providing more competition. Where we practice in Oklahoma, we are the only independent gastroenterologists. The way we have kept up is by diversifying the ancillary services we offer. This includes infusion center services, pathology, anesthesia, and research alongside our standard endoscopic and office/hospital-based practice.
As doctors, we are not typically trained on the business side of medicine, but when you own an ASC, you need to learn to be your own boss. You will need to understand the details of how the business operates, from relevant state and federal regulations to the supportive services that make the center run smoothly.
Gastroenterologists who are new to the field can and should ask questions of any practice they are considering joining about the buy-in process for ASCs and the path to becoming a partner. One of the things to consider is what kind of planning has gone into determining how many investors there are in the ASC. It is possible to have too many physician partners, but having too few could also present challenges. If there are too many physician owners, ownership interests could be diluted. On the flip side, if there aren’t many physician owners, it will be more expensive to buy in and there will be greater risk.
Another question to ask is if the practice partners with a hospital for its ASC or AEC. About one in four surgery centers have a hospital partner. This can be helpful with managed care contracting and concerns physicians may have about being excluded from having hospital privileges. Partnering with a hospital is not an indication of a successful center given there are still many surgery centers with hospital partners that are not run well or underperform.
While I have outlined some of the challenges of owning an ASC or AEC, physician ownership can be very attractive under the right circumstances. There are many benefits including having more control over your life. You get to set your own schedules and determine your patient load.
When physicians own the surgery center, we can control the schedule and the environment in the operating room. In a hospital, there is not much we can do if the operating room is not running efficiently. If our cases are bumped, the care of our patients is undermined. In our own surgery center, we can ensure that these things do not happen. We are able to provide our patients the best care possible.
When I look back over my time in our AEC, I wouldn’t change anything. Even though there may be challenges in running an AEC, I would advise young gastroenterologists to consider this path. Nothing worthwhile is easy, but the ability to provide the best care to our patients is its own reward.
References
1. Munnich E et al. J Health Economics, January 2018;57:147-67. https://doi.org/10.1016/j.jhealeco.2017.11.004.
2. Cooper Z et al. https://doi.org/10.1377/hlthaff.2018.05424. Health Affairs 2019;38(2).
3. Reschovsky J et al. NIHCR Research Brief No. 16. http://nihcr.org/wp-content/uploads/2016/07/Research_Brief_No._16.pdf. National Institute for Health Care Reform; June 2014.
Dr. Stokesberry is a practicing gastroenterologist at Digestive Disease Specialists in Oklahoma City and serves as an executive committee member of the Digestive Health Physicians Association.
Almost 20 years ago, I joined Digestive Disease Specialists in Oklahoma, where I am an owner in two ambulatory endoscopy centers (AECs). Through this experience, I’ve learned a thing or two about the advantages of these centers and what to consider when joining a practice that has ownership in an endoscopy center or an ambulatory surgery center (ASC).
ASCs – or in my case AECs – are highly specialized, modern health care facilities in which physicians provide safe, high-quality procedures to millions of Americans each year, including diagnostic and preventive procedures. ASCs and AECs allow us to provide a more convenient and cost-effective alternative to performing GI procedures in a hospital. As you can imagine, these facilities are a vital part of being an independent gastroenterologist.
Quality care at a lower cost
When looking into practices with ownership in surgery centers, quality of care is one of the most critical considerations. Each center must enter into an agreement with Medicare and meet its certification requirements, which are similar to those required for hospital outpatient departments. We also undergo accreditation by the Accreditation Association for Ambulatory Healthcare. And while not everyone participates in quality registries such as GIquic – which helps us define and refine our endoscopic outcomes – our AEC does because we put patient care first.
This focus on quality leads to better care. A 2016 study of Medicare claims in the Journal of Health Economics shows that ASCs and AECs, on average, provide higher-quality care for outpatient procedures than hospitals.1
We get into medicine because we care about patients and want to provide them with the best and most convenient care possible. Because we don’t have to operate in the context of a large hospital, we can be nimbler when it comes to patient needs. As is true in other areas, the more you specialize, the more effective and efficient you can become performing certain procedures. For instance, our practice is highly specialized in endoscopy. As a result, we can be highly efficient in the turnaround time in between patient procedures. This helps people get back to their daily lives as soon as possible, whereas patients may spend a lot more time waiting to have their procedure in the hospital setting.
Performing procedures in an ASC or AEC also helps us keep costs down, and we spend a lot of time educating policymakers about the role independent physicians play in lowering health care costs. According to a recent study in Health Affairs, hospital-based outpatient care prices grew at four times the rate of physician prices from 2007 to 2014.2 And the National Institute for Health Care Reform found that the average Medicare facility payment for a basic colonoscopy was more than twice as much in a hospital setting.3
The challenges and benefits of running an ASC or AEC
With consolidation of hospitals and insurance companies, operating an independent ASC or AEC has become more challenging. The players are bigger, providing more competition. Where we practice in Oklahoma, we are the only independent gastroenterologists. The way we have kept up is by diversifying the ancillary services we offer. This includes infusion center services, pathology, anesthesia, and research alongside our standard endoscopic and office/hospital-based practice.
As doctors, we are not typically trained on the business side of medicine, but when you own an ASC, you need to learn to be your own boss. You will need to understand the details of how the business operates, from relevant state and federal regulations to the supportive services that make the center run smoothly.
Gastroenterologists who are new to the field can and should ask questions of any practice they are considering joining about the buy-in process for ASCs and the path to becoming a partner. One of the things to consider is what kind of planning has gone into determining how many investors there are in the ASC. It is possible to have too many physician partners, but having too few could also present challenges. If there are too many physician owners, ownership interests could be diluted. On the flip side, if there aren’t many physician owners, it will be more expensive to buy in and there will be greater risk.
Another question to ask is if the practice partners with a hospital for its ASC or AEC. About one in four surgery centers have a hospital partner. This can be helpful with managed care contracting and concerns physicians may have about being excluded from having hospital privileges. Partnering with a hospital is not an indication of a successful center given there are still many surgery centers with hospital partners that are not run well or underperform.
While I have outlined some of the challenges of owning an ASC or AEC, physician ownership can be very attractive under the right circumstances. There are many benefits including having more control over your life. You get to set your own schedules and determine your patient load.
When physicians own the surgery center, we can control the schedule and the environment in the operating room. In a hospital, there is not much we can do if the operating room is not running efficiently. If our cases are bumped, the care of our patients is undermined. In our own surgery center, we can ensure that these things do not happen. We are able to provide our patients the best care possible.
When I look back over my time in our AEC, I wouldn’t change anything. Even though there may be challenges in running an AEC, I would advise young gastroenterologists to consider this path. Nothing worthwhile is easy, but the ability to provide the best care to our patients is its own reward.
References
1. Munnich E et al. J Health Economics, January 2018;57:147-67. https://doi.org/10.1016/j.jhealeco.2017.11.004.
2. Cooper Z et al. https://doi.org/10.1377/hlthaff.2018.05424. Health Affairs 2019;38(2).
3. Reschovsky J et al. NIHCR Research Brief No. 16. http://nihcr.org/wp-content/uploads/2016/07/Research_Brief_No._16.pdf. National Institute for Health Care Reform; June 2014.
Dr. Stokesberry is a practicing gastroenterologist at Digestive Disease Specialists in Oklahoma City and serves as an executive committee member of the Digestive Health Physicians Association.
Almost 20 years ago, I joined Digestive Disease Specialists in Oklahoma, where I am an owner in two ambulatory endoscopy centers (AECs). Through this experience, I’ve learned a thing or two about the advantages of these centers and what to consider when joining a practice that has ownership in an endoscopy center or an ambulatory surgery center (ASC).
ASCs – or in my case AECs – are highly specialized, modern health care facilities in which physicians provide safe, high-quality procedures to millions of Americans each year, including diagnostic and preventive procedures. ASCs and AECs allow us to provide a more convenient and cost-effective alternative to performing GI procedures in a hospital. As you can imagine, these facilities are a vital part of being an independent gastroenterologist.
Quality care at a lower cost
When looking into practices with ownership in surgery centers, quality of care is one of the most critical considerations. Each center must enter into an agreement with Medicare and meet its certification requirements, which are similar to those required for hospital outpatient departments. We also undergo accreditation by the Accreditation Association for Ambulatory Healthcare. And while not everyone participates in quality registries such as GIquic – which helps us define and refine our endoscopic outcomes – our AEC does because we put patient care first.
This focus on quality leads to better care. A 2016 study of Medicare claims in the Journal of Health Economics shows that ASCs and AECs, on average, provide higher-quality care for outpatient procedures than hospitals.1
We get into medicine because we care about patients and want to provide them with the best and most convenient care possible. Because we don’t have to operate in the context of a large hospital, we can be nimbler when it comes to patient needs. As is true in other areas, the more you specialize, the more effective and efficient you can become performing certain procedures. For instance, our practice is highly specialized in endoscopy. As a result, we can be highly efficient in the turnaround time in between patient procedures. This helps people get back to their daily lives as soon as possible, whereas patients may spend a lot more time waiting to have their procedure in the hospital setting.
Performing procedures in an ASC or AEC also helps us keep costs down, and we spend a lot of time educating policymakers about the role independent physicians play in lowering health care costs. According to a recent study in Health Affairs, hospital-based outpatient care prices grew at four times the rate of physician prices from 2007 to 2014.2 And the National Institute for Health Care Reform found that the average Medicare facility payment for a basic colonoscopy was more than twice as much in a hospital setting.3
The challenges and benefits of running an ASC or AEC
With consolidation of hospitals and insurance companies, operating an independent ASC or AEC has become more challenging. The players are bigger, providing more competition. Where we practice in Oklahoma, we are the only independent gastroenterologists. The way we have kept up is by diversifying the ancillary services we offer. This includes infusion center services, pathology, anesthesia, and research alongside our standard endoscopic and office/hospital-based practice.
As doctors, we are not typically trained on the business side of medicine, but when you own an ASC, you need to learn to be your own boss. You will need to understand the details of how the business operates, from relevant state and federal regulations to the supportive services that make the center run smoothly.
Gastroenterologists who are new to the field can and should ask questions of any practice they are considering joining about the buy-in process for ASCs and the path to becoming a partner. One of the things to consider is what kind of planning has gone into determining how many investors there are in the ASC. It is possible to have too many physician partners, but having too few could also present challenges. If there are too many physician owners, ownership interests could be diluted. On the flip side, if there aren’t many physician owners, it will be more expensive to buy in and there will be greater risk.
Another question to ask is if the practice partners with a hospital for its ASC or AEC. About one in four surgery centers have a hospital partner. This can be helpful with managed care contracting and concerns physicians may have about being excluded from having hospital privileges. Partnering with a hospital is not an indication of a successful center given there are still many surgery centers with hospital partners that are not run well or underperform.
While I have outlined some of the challenges of owning an ASC or AEC, physician ownership can be very attractive under the right circumstances. There are many benefits including having more control over your life. You get to set your own schedules and determine your patient load.
When physicians own the surgery center, we can control the schedule and the environment in the operating room. In a hospital, there is not much we can do if the operating room is not running efficiently. If our cases are bumped, the care of our patients is undermined. In our own surgery center, we can ensure that these things do not happen. We are able to provide our patients the best care possible.
When I look back over my time in our AEC, I wouldn’t change anything. Even though there may be challenges in running an AEC, I would advise young gastroenterologists to consider this path. Nothing worthwhile is easy, but the ability to provide the best care to our patients is its own reward.
References
1. Munnich E et al. J Health Economics, January 2018;57:147-67. https://doi.org/10.1016/j.jhealeco.2017.11.004.
2. Cooper Z et al. https://doi.org/10.1377/hlthaff.2018.05424. Health Affairs 2019;38(2).
3. Reschovsky J et al. NIHCR Research Brief No. 16. http://nihcr.org/wp-content/uploads/2016/07/Research_Brief_No._16.pdf. National Institute for Health Care Reform; June 2014.
Dr. Stokesberry is a practicing gastroenterologist at Digestive Disease Specialists in Oklahoma City and serves as an executive committee member of the Digestive Health Physicians Association.
Fertility-sparing surgery is safe for most with epithelial ovarian cancer
Most young women with epithelial ovarian cancer can undergo surgery preserving the unaffected ovary and uterus – and thus their fertility – without compromising their survival, a cohort study of more than 9,000 women in Cancer suggests.
“Loss of reproductive capability and surgical menopause can negatively affect survivorship and quality of life among young women with ovarian cancer,” noted the investigators, who were led by Sarah M. Crafton, MD, division of gynecologic oncology, Allegheny Health Network in Pittsburgh. “ASCO has published guidelines to address the importance of implementing fertility preservation counseling as standard of care for all patients of reproductive age with cancer. However, the safety of such procedures should be thoroughly assessed in ongoing analyses.”
Dr. Crafton and colleagues used the Surveillance, Epidemiology, and End Results (SEER) program database and the National Cancer Database (NCDB) to retrospectively identify women 44 years old or younger with a primary epithelial ovarian cancer. The women were classified as having undergone surgery that spared fertility (unilateral salpingo-oophorectomy with uterine preservation) or surgery that did not (bilateral salpingo-oophorectomy with hysterectomy).
Study results, reported in Cancer, were based on 9,017 women – 3,932 from the SEER database and 5,085 from the NCDB – with epithelial ovarian cancer diagnosed between the ages of 15 and 44 years. Median follow-up was 6.5 years in SEER and 4.6 years in NCDB.
Overall, 26.1% of the SEER cohort and 24.8% of the NCDB cohort had undergone fertility-sparing surgery. In both cohorts, odds of this surgery were higher among younger women, those with a more recent ovarian cancer diagnosis, and those who did not receive adjuvant chemotherapy.
Among women with stage II-IV serous epithelial ovarian cancer in the SEER cohort, those who underwent fertility-sparing surgery had poorer overall survival (hazard ratio for death, 1.61; P = .0008). However, fertility-sparing surgery was not significantly associated with survival in other SEER subgroups defined by stage and grade or by stage and histology or in any NCDB subgroup defined by these parameters.
“In general, our findings regarding survival support the current National Comprehensive Cancer Network recommendation that fertility-sparing surgery can be considered as an alternative for traditional, comprehensive staging for those patients who desire fertility, for whom ovarian retention is technically feasible, and who have early-stage disease,” Dr. Crafton and coinvestigators wrote.
“Our observation of an increased risk of death associated with fertility-sparing surgery among women with advanced-stage, serous epithelial ovarian cancer in the SEER population supports the clinical recommendation that the decision to pursue fertility-sparing surgery should be individualized on the basis of patient/provider counseling and disease characteristics,” they concluded.
Dr. Crafton did not report any disclosures. The study was supported by the National Cancer Institute.
SOURCE: Crafton SM et al. Cancer. 2019 Nov 27. doi: 10.1002/cncr.32620.
Most young women with epithelial ovarian cancer can undergo surgery preserving the unaffected ovary and uterus – and thus their fertility – without compromising their survival, a cohort study of more than 9,000 women in Cancer suggests.
“Loss of reproductive capability and surgical menopause can negatively affect survivorship and quality of life among young women with ovarian cancer,” noted the investigators, who were led by Sarah M. Crafton, MD, division of gynecologic oncology, Allegheny Health Network in Pittsburgh. “ASCO has published guidelines to address the importance of implementing fertility preservation counseling as standard of care for all patients of reproductive age with cancer. However, the safety of such procedures should be thoroughly assessed in ongoing analyses.”
Dr. Crafton and colleagues used the Surveillance, Epidemiology, and End Results (SEER) program database and the National Cancer Database (NCDB) to retrospectively identify women 44 years old or younger with a primary epithelial ovarian cancer. The women were classified as having undergone surgery that spared fertility (unilateral salpingo-oophorectomy with uterine preservation) or surgery that did not (bilateral salpingo-oophorectomy with hysterectomy).
Study results, reported in Cancer, were based on 9,017 women – 3,932 from the SEER database and 5,085 from the NCDB – with epithelial ovarian cancer diagnosed between the ages of 15 and 44 years. Median follow-up was 6.5 years in SEER and 4.6 years in NCDB.
Overall, 26.1% of the SEER cohort and 24.8% of the NCDB cohort had undergone fertility-sparing surgery. In both cohorts, odds of this surgery were higher among younger women, those with a more recent ovarian cancer diagnosis, and those who did not receive adjuvant chemotherapy.
Among women with stage II-IV serous epithelial ovarian cancer in the SEER cohort, those who underwent fertility-sparing surgery had poorer overall survival (hazard ratio for death, 1.61; P = .0008). However, fertility-sparing surgery was not significantly associated with survival in other SEER subgroups defined by stage and grade or by stage and histology or in any NCDB subgroup defined by these parameters.
“In general, our findings regarding survival support the current National Comprehensive Cancer Network recommendation that fertility-sparing surgery can be considered as an alternative for traditional, comprehensive staging for those patients who desire fertility, for whom ovarian retention is technically feasible, and who have early-stage disease,” Dr. Crafton and coinvestigators wrote.
“Our observation of an increased risk of death associated with fertility-sparing surgery among women with advanced-stage, serous epithelial ovarian cancer in the SEER population supports the clinical recommendation that the decision to pursue fertility-sparing surgery should be individualized on the basis of patient/provider counseling and disease characteristics,” they concluded.
Dr. Crafton did not report any disclosures. The study was supported by the National Cancer Institute.
SOURCE: Crafton SM et al. Cancer. 2019 Nov 27. doi: 10.1002/cncr.32620.
Most young women with epithelial ovarian cancer can undergo surgery preserving the unaffected ovary and uterus – and thus their fertility – without compromising their survival, a cohort study of more than 9,000 women in Cancer suggests.
“Loss of reproductive capability and surgical menopause can negatively affect survivorship and quality of life among young women with ovarian cancer,” noted the investigators, who were led by Sarah M. Crafton, MD, division of gynecologic oncology, Allegheny Health Network in Pittsburgh. “ASCO has published guidelines to address the importance of implementing fertility preservation counseling as standard of care for all patients of reproductive age with cancer. However, the safety of such procedures should be thoroughly assessed in ongoing analyses.”
Dr. Crafton and colleagues used the Surveillance, Epidemiology, and End Results (SEER) program database and the National Cancer Database (NCDB) to retrospectively identify women 44 years old or younger with a primary epithelial ovarian cancer. The women were classified as having undergone surgery that spared fertility (unilateral salpingo-oophorectomy with uterine preservation) or surgery that did not (bilateral salpingo-oophorectomy with hysterectomy).
Study results, reported in Cancer, were based on 9,017 women – 3,932 from the SEER database and 5,085 from the NCDB – with epithelial ovarian cancer diagnosed between the ages of 15 and 44 years. Median follow-up was 6.5 years in SEER and 4.6 years in NCDB.
Overall, 26.1% of the SEER cohort and 24.8% of the NCDB cohort had undergone fertility-sparing surgery. In both cohorts, odds of this surgery were higher among younger women, those with a more recent ovarian cancer diagnosis, and those who did not receive adjuvant chemotherapy.
Among women with stage II-IV serous epithelial ovarian cancer in the SEER cohort, those who underwent fertility-sparing surgery had poorer overall survival (hazard ratio for death, 1.61; P = .0008). However, fertility-sparing surgery was not significantly associated with survival in other SEER subgroups defined by stage and grade or by stage and histology or in any NCDB subgroup defined by these parameters.
“In general, our findings regarding survival support the current National Comprehensive Cancer Network recommendation that fertility-sparing surgery can be considered as an alternative for traditional, comprehensive staging for those patients who desire fertility, for whom ovarian retention is technically feasible, and who have early-stage disease,” Dr. Crafton and coinvestigators wrote.
“Our observation of an increased risk of death associated with fertility-sparing surgery among women with advanced-stage, serous epithelial ovarian cancer in the SEER population supports the clinical recommendation that the decision to pursue fertility-sparing surgery should be individualized on the basis of patient/provider counseling and disease characteristics,” they concluded.
Dr. Crafton did not report any disclosures. The study was supported by the National Cancer Institute.
SOURCE: Crafton SM et al. Cancer. 2019 Nov 27. doi: 10.1002/cncr.32620.
FROM CANCER
CTS5 score partially validated for predicting late distant breast cancer recurrences
SAN ANTONIO – The Clinical Treatment Score post 5 years (CTS5) has been validated for the prediction of late distant recurrences in a large contemporary cohort of breast cancer patients drawn from the landmark TAILORx study – but only provided they’re over age 50 at the time of their initial breast cancer diagnosis, Ivana Sestak, PhD, reported at the San Antonio Breast Cancer Symposium.
“The CTS5 was much less prognostic in younger patients, and we did not observe good discrimination for the CTS5 in this cohort,” she said. “Further evaluation in premenopausal cohorts is needed before CTS5 can be applied to younger patients.”
She and her coworkers developed the CTS5 as a simple, expeditious tool to identify women at high risk of late distance recurrence of estrogen receptor–positive breast cancer after successfully completing 5 years of endocrine therapy. It’s designed to serve as an aid to physicians and patients in clinical decision making: Women who are CTS5 high risk are likely to benefit from extended endocrine therapy beyond the 5-year mark, while those at low risk are not.
“Trials so far have shown only a modest risk reduction of around 5% with extended endocrine therapy. This may be partly due to the fact that none of these trials had specifically selected patients who were at high risk of developing a late recurrence. It is therefore crucial that we identify those patients who are at high risk of late recurrence, as they will benefit most from extended endocrine therapy,” explained Dr. Sestak, a medical statistician at Queen Mary University, London.
The CTS5 calculator is freely available online at www.cts5-calculator.com. Clinicians simply plug in readily available information on four specific variables for their patients who have completed 5 years of endocrine therapy free of distant recurrence: age at breast cancer diagnosis, tumor size in millimeters, tumor grade, and number of involved nodes. The calculator promptly spits out a CTS5 score and the associated risk of distant recurrence during years 5-10 after initial diagnosis. That risk is categorized as low if it’s 5% or less in years 5-10, and high if it’s greater than 10%.
The CTS5 was developed and validated using long-term follow-up data on more than 11,000 postmenopausal breast cancer patients in the ATAC and BIG1-98 randomized trials. The CTS5 performed well in those tests. But those studies were completed more than a decade ago and were limited to postmenopausal patients. Dr. Sestak and coinvestigators wanted to assess the tool’s discriminatory powers in a contemporary population of breast cancer patients that included large numbers of premenopausal women. So they tapped into the National Cancer Institute–sponsored TAILORx study, which included 7,353 breast cancer patients who were distant recurrence free after 5 years. All had early-stage, hormone receptor–positive, HER2-negative, and axillary node–negative breast cancer. And all underwent baseline testing using Genomic Health’s Oncotype DX Breast Recurrence Score to assess expression of 21 genes associated with breast cancer recurrence.
The CTS5 proved to be highly prognostic in the overall TAILORx population. But upon drilling down further, Dr. Sestak and coworkers determined that CTS5 had only marginal prognostic value in the 2,259 women age 50 years or younger. Indeed, not a single patient in that age group was categorized as CTS5 high risk, and the actual distant recurrence rates during years 5-9 weren’t significantly different between the low- and intermediate-risk CTS5 groups.
In contrast, CTS5 performed well as a prognosticator in the 2,257 TAILORx participants over age 50 who received both chemotherapy and endocrine therapy during their first 5 years following diagnosis. For a fast and simple test with zero cost, it displayed impressive discriminatory power: The 63.8% of women classified as CTS5 low risk had a 2.6% distant recurrence rate – and thus constituted a group who could reasonably avoid extended endocrine therapy – while the 3.5% who were CTS5 high risk had a 9.5% event rate, and the intermediate-risk group had a 7.3% event rate. The prognostic power of CTS5 in the 2,837 women aged over 50 years who received only hormonal therapy was less robust, albeit still statistically significant.
In women classified as being at low risk of recurrence based upon an Oncotype DX score of 0-10, the CTS5 was not a significant prognosticator for the prediction of late distant recurrences. However, in those who were at intermediate or high risk as determined by a score of 11-100 on the Oncotype test, CTS5 was highly prognostic.
A significant limitation of this CTS5 validation study in the TAILORx population was that only a median 2.86 years of follow-up data after the 5-year mark was available – not sufficient time for a large number of distant recurrences. The rate was 3.1% in women treated with only endocrine therapy who had an Oncotype DX score of 0-25, and 3.8% in those with a score of 11-100 who received both chemotherapy and endocrine therapy.
Dr. Sestak shrugged off the less than stellar performance of the CTS5 in women aged age 50 years or younger in the TAILORx analysis.
“We developed the CTS5 specifically in postmenopausal women, so we’re not really surprised that it’s less prognostic in young women,” she said.
Her group next plans to evaluate the CTS5 in another large premenopausal cohort of breast cancer patients.
“If it’s not prognostic there, then we’ll have to adjust the algorithm and recalibrate it specifically for younger patients,” according to Dr. Sestak.
The TAILORx validation study was supported by Breast Cancer Now, Cancer Research UK, Exact Sciences, and the University of London. Dr. Sestak reported having received honoraria from Myriad Genetics, Nanostring Technology, and Pfizer Oncology.
SOURCE: Sestak I et al. SABCS 2019, Abstract GS4-03.
SAN ANTONIO – The Clinical Treatment Score post 5 years (CTS5) has been validated for the prediction of late distant recurrences in a large contemporary cohort of breast cancer patients drawn from the landmark TAILORx study – but only provided they’re over age 50 at the time of their initial breast cancer diagnosis, Ivana Sestak, PhD, reported at the San Antonio Breast Cancer Symposium.
“The CTS5 was much less prognostic in younger patients, and we did not observe good discrimination for the CTS5 in this cohort,” she said. “Further evaluation in premenopausal cohorts is needed before CTS5 can be applied to younger patients.”
She and her coworkers developed the CTS5 as a simple, expeditious tool to identify women at high risk of late distance recurrence of estrogen receptor–positive breast cancer after successfully completing 5 years of endocrine therapy. It’s designed to serve as an aid to physicians and patients in clinical decision making: Women who are CTS5 high risk are likely to benefit from extended endocrine therapy beyond the 5-year mark, while those at low risk are not.
“Trials so far have shown only a modest risk reduction of around 5% with extended endocrine therapy. This may be partly due to the fact that none of these trials had specifically selected patients who were at high risk of developing a late recurrence. It is therefore crucial that we identify those patients who are at high risk of late recurrence, as they will benefit most from extended endocrine therapy,” explained Dr. Sestak, a medical statistician at Queen Mary University, London.
The CTS5 calculator is freely available online at www.cts5-calculator.com. Clinicians simply plug in readily available information on four specific variables for their patients who have completed 5 years of endocrine therapy free of distant recurrence: age at breast cancer diagnosis, tumor size in millimeters, tumor grade, and number of involved nodes. The calculator promptly spits out a CTS5 score and the associated risk of distant recurrence during years 5-10 after initial diagnosis. That risk is categorized as low if it’s 5% or less in years 5-10, and high if it’s greater than 10%.
The CTS5 was developed and validated using long-term follow-up data on more than 11,000 postmenopausal breast cancer patients in the ATAC and BIG1-98 randomized trials. The CTS5 performed well in those tests. But those studies were completed more than a decade ago and were limited to postmenopausal patients. Dr. Sestak and coinvestigators wanted to assess the tool’s discriminatory powers in a contemporary population of breast cancer patients that included large numbers of premenopausal women. So they tapped into the National Cancer Institute–sponsored TAILORx study, which included 7,353 breast cancer patients who were distant recurrence free after 5 years. All had early-stage, hormone receptor–positive, HER2-negative, and axillary node–negative breast cancer. And all underwent baseline testing using Genomic Health’s Oncotype DX Breast Recurrence Score to assess expression of 21 genes associated with breast cancer recurrence.
The CTS5 proved to be highly prognostic in the overall TAILORx population. But upon drilling down further, Dr. Sestak and coworkers determined that CTS5 had only marginal prognostic value in the 2,259 women age 50 years or younger. Indeed, not a single patient in that age group was categorized as CTS5 high risk, and the actual distant recurrence rates during years 5-9 weren’t significantly different between the low- and intermediate-risk CTS5 groups.
In contrast, CTS5 performed well as a prognosticator in the 2,257 TAILORx participants over age 50 who received both chemotherapy and endocrine therapy during their first 5 years following diagnosis. For a fast and simple test with zero cost, it displayed impressive discriminatory power: The 63.8% of women classified as CTS5 low risk had a 2.6% distant recurrence rate – and thus constituted a group who could reasonably avoid extended endocrine therapy – while the 3.5% who were CTS5 high risk had a 9.5% event rate, and the intermediate-risk group had a 7.3% event rate. The prognostic power of CTS5 in the 2,837 women aged over 50 years who received only hormonal therapy was less robust, albeit still statistically significant.
In women classified as being at low risk of recurrence based upon an Oncotype DX score of 0-10, the CTS5 was not a significant prognosticator for the prediction of late distant recurrences. However, in those who were at intermediate or high risk as determined by a score of 11-100 on the Oncotype test, CTS5 was highly prognostic.
A significant limitation of this CTS5 validation study in the TAILORx population was that only a median 2.86 years of follow-up data after the 5-year mark was available – not sufficient time for a large number of distant recurrences. The rate was 3.1% in women treated with only endocrine therapy who had an Oncotype DX score of 0-25, and 3.8% in those with a score of 11-100 who received both chemotherapy and endocrine therapy.
Dr. Sestak shrugged off the less than stellar performance of the CTS5 in women aged age 50 years or younger in the TAILORx analysis.
“We developed the CTS5 specifically in postmenopausal women, so we’re not really surprised that it’s less prognostic in young women,” she said.
Her group next plans to evaluate the CTS5 in another large premenopausal cohort of breast cancer patients.
“If it’s not prognostic there, then we’ll have to adjust the algorithm and recalibrate it specifically for younger patients,” according to Dr. Sestak.
The TAILORx validation study was supported by Breast Cancer Now, Cancer Research UK, Exact Sciences, and the University of London. Dr. Sestak reported having received honoraria from Myriad Genetics, Nanostring Technology, and Pfizer Oncology.
SOURCE: Sestak I et al. SABCS 2019, Abstract GS4-03.
SAN ANTONIO – The Clinical Treatment Score post 5 years (CTS5) has been validated for the prediction of late distant recurrences in a large contemporary cohort of breast cancer patients drawn from the landmark TAILORx study – but only provided they’re over age 50 at the time of their initial breast cancer diagnosis, Ivana Sestak, PhD, reported at the San Antonio Breast Cancer Symposium.
“The CTS5 was much less prognostic in younger patients, and we did not observe good discrimination for the CTS5 in this cohort,” she said. “Further evaluation in premenopausal cohorts is needed before CTS5 can be applied to younger patients.”
She and her coworkers developed the CTS5 as a simple, expeditious tool to identify women at high risk of late distance recurrence of estrogen receptor–positive breast cancer after successfully completing 5 years of endocrine therapy. It’s designed to serve as an aid to physicians and patients in clinical decision making: Women who are CTS5 high risk are likely to benefit from extended endocrine therapy beyond the 5-year mark, while those at low risk are not.
“Trials so far have shown only a modest risk reduction of around 5% with extended endocrine therapy. This may be partly due to the fact that none of these trials had specifically selected patients who were at high risk of developing a late recurrence. It is therefore crucial that we identify those patients who are at high risk of late recurrence, as they will benefit most from extended endocrine therapy,” explained Dr. Sestak, a medical statistician at Queen Mary University, London.
The CTS5 calculator is freely available online at www.cts5-calculator.com. Clinicians simply plug in readily available information on four specific variables for their patients who have completed 5 years of endocrine therapy free of distant recurrence: age at breast cancer diagnosis, tumor size in millimeters, tumor grade, and number of involved nodes. The calculator promptly spits out a CTS5 score and the associated risk of distant recurrence during years 5-10 after initial diagnosis. That risk is categorized as low if it’s 5% or less in years 5-10, and high if it’s greater than 10%.
The CTS5 was developed and validated using long-term follow-up data on more than 11,000 postmenopausal breast cancer patients in the ATAC and BIG1-98 randomized trials. The CTS5 performed well in those tests. But those studies were completed more than a decade ago and were limited to postmenopausal patients. Dr. Sestak and coinvestigators wanted to assess the tool’s discriminatory powers in a contemporary population of breast cancer patients that included large numbers of premenopausal women. So they tapped into the National Cancer Institute–sponsored TAILORx study, which included 7,353 breast cancer patients who were distant recurrence free after 5 years. All had early-stage, hormone receptor–positive, HER2-negative, and axillary node–negative breast cancer. And all underwent baseline testing using Genomic Health’s Oncotype DX Breast Recurrence Score to assess expression of 21 genes associated with breast cancer recurrence.
The CTS5 proved to be highly prognostic in the overall TAILORx population. But upon drilling down further, Dr. Sestak and coworkers determined that CTS5 had only marginal prognostic value in the 2,259 women age 50 years or younger. Indeed, not a single patient in that age group was categorized as CTS5 high risk, and the actual distant recurrence rates during years 5-9 weren’t significantly different between the low- and intermediate-risk CTS5 groups.
In contrast, CTS5 performed well as a prognosticator in the 2,257 TAILORx participants over age 50 who received both chemotherapy and endocrine therapy during their first 5 years following diagnosis. For a fast and simple test with zero cost, it displayed impressive discriminatory power: The 63.8% of women classified as CTS5 low risk had a 2.6% distant recurrence rate – and thus constituted a group who could reasonably avoid extended endocrine therapy – while the 3.5% who were CTS5 high risk had a 9.5% event rate, and the intermediate-risk group had a 7.3% event rate. The prognostic power of CTS5 in the 2,837 women aged over 50 years who received only hormonal therapy was less robust, albeit still statistically significant.
In women classified as being at low risk of recurrence based upon an Oncotype DX score of 0-10, the CTS5 was not a significant prognosticator for the prediction of late distant recurrences. However, in those who were at intermediate or high risk as determined by a score of 11-100 on the Oncotype test, CTS5 was highly prognostic.
A significant limitation of this CTS5 validation study in the TAILORx population was that only a median 2.86 years of follow-up data after the 5-year mark was available – not sufficient time for a large number of distant recurrences. The rate was 3.1% in women treated with only endocrine therapy who had an Oncotype DX score of 0-25, and 3.8% in those with a score of 11-100 who received both chemotherapy and endocrine therapy.
Dr. Sestak shrugged off the less than stellar performance of the CTS5 in women aged age 50 years or younger in the TAILORx analysis.
“We developed the CTS5 specifically in postmenopausal women, so we’re not really surprised that it’s less prognostic in young women,” she said.
Her group next plans to evaluate the CTS5 in another large premenopausal cohort of breast cancer patients.
“If it’s not prognostic there, then we’ll have to adjust the algorithm and recalibrate it specifically for younger patients,” according to Dr. Sestak.
The TAILORx validation study was supported by Breast Cancer Now, Cancer Research UK, Exact Sciences, and the University of London. Dr. Sestak reported having received honoraria from Myriad Genetics, Nanostring Technology, and Pfizer Oncology.
SOURCE: Sestak I et al. SABCS 2019, Abstract GS4-03.
REPORTING FROM SABCS 2019
Being whole
Medicine is a rewarding but demanding field. Part of being a professional is handling the stresses of the job. That ability is as important as tying strong horizontal mattress sutures, choosing correct antibiotics to treat staph, and gently breaking bad news.
The divorce and suicide rate among physicians are evidence that many physicians handle stress poorly. Our rates of depression, burnout, alcoholism, and substance abuse are further evidence of the suffering caused by unmitigated stress. It is endemic and destructive, harming physicians, their loved ones, and their patients. While this situation has long been true, in the past decade its importance has become better recognized. Some scholars have added physician wellness or fulfillment as a fourth aim of medical care to complement the triple aims of patient outcomes, consumer experience, and financial stewardship.
The sources of stress can be either external or internal. Internally, many physicians feel torn between competing professional roles. Recently one fellow in pediatric intensive care wrote an insightful reflective essay about two conflicting roles (“Virtue and Suffering: Where the Personal and Professional Collide,” Lauren Rissman, MD. reflectivemeded.org). One side is the potential benefits of technology and modern medical interventions. The other side is compassion and knowing when to say enough. Finding that balance – or boundary – or mixture is difficult. Even more difficult is helping patients/parents who are struggling with those choices.
Some old models of the doctor-patient relationship insisted on an emotional detachment to promote objectivity. This often is paired with using nondirective counseling. The admonishment for a physician to be nondirective comes up in end-of-life care choices in the ICU. It comes up in genetic counseling, particularly in the prenatal time frame, and when I do ethics consults requiring values clarification and mediation. But I also have found times during shared decision making when the model of a fully informed consumer choice is not valid. There are situations in which a paradigm of emotional detachment impairs the ability to convey empathy, compassion, and presence. Being detached also may prevent the moments of personal connection between doctor and patient that are the intangible rewards of the vocation. A good physician knows how to choose among these idealized models. It requires being genuine when employing a diverse bag of bedside tools.
High technology and highly invasive care pose dilemmas in assessing outcomes, minimizing suffering, and ensuring financial stewardship. When one addresses those different types of dilemmas happening simultaneously, the initial approach can be to separate the different influences into separate vectors. But when one does this on a regular basis, it fractures one’s self-image. To survive and flourish, the physician juggling these competing, conflicting goals must shun the split personality and seek to live as an integrated moral agent. This integration is not achieved by working harder or longer or even smarter. It requires time and effort directed to self-reflection. When pediatric ethicists get together at conferences, I notice that about one-half of them are neonatal ICU docs and one-quarter are pediatric ICU docs. Many view their work in ethics as a survival mechanism. We all are looking for answers to questions we may not be able to fully articulate.
In this short column I will not endeavor to offer a neat package of advice on how to achieve being whole. Dr. Rissman in her essay is just starting her career while I’m nearing the end of mine. It is a lifelong process to integrate oneself rather than exist in turmoil. It truly is a journey, not a destination. After a career dedicated to considering technology, compassion, and costs, I know there are no simple solutions. I also know that it is important to keep seeking better answers.
To encourage group discussion of ethical problems, I have heard facilitators say that there are no right and wrong answers. I strongly disagree. In ethics, there often is more than one correct answer. Ethicists can write books on why one right answer is slightly better than another right answer for a particular individual or population. We live for debates over such minutiae. In the real world of medical ethics, there also are definitely wrong answers.
Professional athletes know the importance of recovery after an intense workout. Muscles have accumulated microscopic tears that must heal. Professional physicians must develop a personal regimen of caring for overexertion of their own emotional and moral/spiritual muscles in order to remain whole.
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at [email protected].
Medicine is a rewarding but demanding field. Part of being a professional is handling the stresses of the job. That ability is as important as tying strong horizontal mattress sutures, choosing correct antibiotics to treat staph, and gently breaking bad news.
The divorce and suicide rate among physicians are evidence that many physicians handle stress poorly. Our rates of depression, burnout, alcoholism, and substance abuse are further evidence of the suffering caused by unmitigated stress. It is endemic and destructive, harming physicians, their loved ones, and their patients. While this situation has long been true, in the past decade its importance has become better recognized. Some scholars have added physician wellness or fulfillment as a fourth aim of medical care to complement the triple aims of patient outcomes, consumer experience, and financial stewardship.
The sources of stress can be either external or internal. Internally, many physicians feel torn between competing professional roles. Recently one fellow in pediatric intensive care wrote an insightful reflective essay about two conflicting roles (“Virtue and Suffering: Where the Personal and Professional Collide,” Lauren Rissman, MD. reflectivemeded.org). One side is the potential benefits of technology and modern medical interventions. The other side is compassion and knowing when to say enough. Finding that balance – or boundary – or mixture is difficult. Even more difficult is helping patients/parents who are struggling with those choices.
Some old models of the doctor-patient relationship insisted on an emotional detachment to promote objectivity. This often is paired with using nondirective counseling. The admonishment for a physician to be nondirective comes up in end-of-life care choices in the ICU. It comes up in genetic counseling, particularly in the prenatal time frame, and when I do ethics consults requiring values clarification and mediation. But I also have found times during shared decision making when the model of a fully informed consumer choice is not valid. There are situations in which a paradigm of emotional detachment impairs the ability to convey empathy, compassion, and presence. Being detached also may prevent the moments of personal connection between doctor and patient that are the intangible rewards of the vocation. A good physician knows how to choose among these idealized models. It requires being genuine when employing a diverse bag of bedside tools.
High technology and highly invasive care pose dilemmas in assessing outcomes, minimizing suffering, and ensuring financial stewardship. When one addresses those different types of dilemmas happening simultaneously, the initial approach can be to separate the different influences into separate vectors. But when one does this on a regular basis, it fractures one’s self-image. To survive and flourish, the physician juggling these competing, conflicting goals must shun the split personality and seek to live as an integrated moral agent. This integration is not achieved by working harder or longer or even smarter. It requires time and effort directed to self-reflection. When pediatric ethicists get together at conferences, I notice that about one-half of them are neonatal ICU docs and one-quarter are pediatric ICU docs. Many view their work in ethics as a survival mechanism. We all are looking for answers to questions we may not be able to fully articulate.
In this short column I will not endeavor to offer a neat package of advice on how to achieve being whole. Dr. Rissman in her essay is just starting her career while I’m nearing the end of mine. It is a lifelong process to integrate oneself rather than exist in turmoil. It truly is a journey, not a destination. After a career dedicated to considering technology, compassion, and costs, I know there are no simple solutions. I also know that it is important to keep seeking better answers.
To encourage group discussion of ethical problems, I have heard facilitators say that there are no right and wrong answers. I strongly disagree. In ethics, there often is more than one correct answer. Ethicists can write books on why one right answer is slightly better than another right answer for a particular individual or population. We live for debates over such minutiae. In the real world of medical ethics, there also are definitely wrong answers.
Professional athletes know the importance of recovery after an intense workout. Muscles have accumulated microscopic tears that must heal. Professional physicians must develop a personal regimen of caring for overexertion of their own emotional and moral/spiritual muscles in order to remain whole.
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at [email protected].
Medicine is a rewarding but demanding field. Part of being a professional is handling the stresses of the job. That ability is as important as tying strong horizontal mattress sutures, choosing correct antibiotics to treat staph, and gently breaking bad news.
The divorce and suicide rate among physicians are evidence that many physicians handle stress poorly. Our rates of depression, burnout, alcoholism, and substance abuse are further evidence of the suffering caused by unmitigated stress. It is endemic and destructive, harming physicians, their loved ones, and their patients. While this situation has long been true, in the past decade its importance has become better recognized. Some scholars have added physician wellness or fulfillment as a fourth aim of medical care to complement the triple aims of patient outcomes, consumer experience, and financial stewardship.
The sources of stress can be either external or internal. Internally, many physicians feel torn between competing professional roles. Recently one fellow in pediatric intensive care wrote an insightful reflective essay about two conflicting roles (“Virtue and Suffering: Where the Personal and Professional Collide,” Lauren Rissman, MD. reflectivemeded.org). One side is the potential benefits of technology and modern medical interventions. The other side is compassion and knowing when to say enough. Finding that balance – or boundary – or mixture is difficult. Even more difficult is helping patients/parents who are struggling with those choices.
Some old models of the doctor-patient relationship insisted on an emotional detachment to promote objectivity. This often is paired with using nondirective counseling. The admonishment for a physician to be nondirective comes up in end-of-life care choices in the ICU. It comes up in genetic counseling, particularly in the prenatal time frame, and when I do ethics consults requiring values clarification and mediation. But I also have found times during shared decision making when the model of a fully informed consumer choice is not valid. There are situations in which a paradigm of emotional detachment impairs the ability to convey empathy, compassion, and presence. Being detached also may prevent the moments of personal connection between doctor and patient that are the intangible rewards of the vocation. A good physician knows how to choose among these idealized models. It requires being genuine when employing a diverse bag of bedside tools.
High technology and highly invasive care pose dilemmas in assessing outcomes, minimizing suffering, and ensuring financial stewardship. When one addresses those different types of dilemmas happening simultaneously, the initial approach can be to separate the different influences into separate vectors. But when one does this on a regular basis, it fractures one’s self-image. To survive and flourish, the physician juggling these competing, conflicting goals must shun the split personality and seek to live as an integrated moral agent. This integration is not achieved by working harder or longer or even smarter. It requires time and effort directed to self-reflection. When pediatric ethicists get together at conferences, I notice that about one-half of them are neonatal ICU docs and one-quarter are pediatric ICU docs. Many view their work in ethics as a survival mechanism. We all are looking for answers to questions we may not be able to fully articulate.
In this short column I will not endeavor to offer a neat package of advice on how to achieve being whole. Dr. Rissman in her essay is just starting her career while I’m nearing the end of mine. It is a lifelong process to integrate oneself rather than exist in turmoil. It truly is a journey, not a destination. After a career dedicated to considering technology, compassion, and costs, I know there are no simple solutions. I also know that it is important to keep seeking better answers.
To encourage group discussion of ethical problems, I have heard facilitators say that there are no right and wrong answers. I strongly disagree. In ethics, there often is more than one correct answer. Ethicists can write books on why one right answer is slightly better than another right answer for a particular individual or population. We live for debates over such minutiae. In the real world of medical ethics, there also are definitely wrong answers.
Professional athletes know the importance of recovery after an intense workout. Muscles have accumulated microscopic tears that must heal. Professional physicians must develop a personal regimen of caring for overexertion of their own emotional and moral/spiritual muscles in order to remain whole.
Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at [email protected].
Choosing Wisely® and its impact on low-value care
Focus energy on ‘low-hanging fruit’
It is a well-known fact that health care expenditure in the United States occupies a large proportion of its gross domestic product. In fact, it was 17.8% in 2016, almost twice what is expended in other advanced countries. However, this expenditure does not necessarily translate into optimal patient outcomes.
In 2012, the Institute of Medicine reported that the U.S. health care system wastes $750 billion per year in spending that does not provide any meaningful outcome to patients or the system; and patients can also suffer a financial impact from the delivery of low-value care.
In 2013, the Pediatrics Committee of the Society of Hospital Medicine published five recommendations through the Choosing Wisely® campaign aimed to decrease the use of low-value interventions. These recommendations were:
1. Do not order chest radiographs (CXR) in children with asthma or bronchiolitis.
2. Do not use systemic corticosteroids in children aged under 2 years with a lower respiratory tract infection.
3. Do not use bronchodilators in children with bronchiolitis.
4. Do not treat gastroesophageal reflux in infants routinely with acid suppression therapy.
5. Do not use continuous pulse oximetry routinely in children with acute respiratory illness unless they are on supplemental oxygen.
This publication led to the implementation of quality improvement initiatives across different hospitals and institutions nationally. Eventually, a team of hospitalists developed a report card that could help measure the utilization of these interventions in hospitals that were part of the Children’s Hospital Association (CHA). The data stemming from the report card analysis would allow for benchmarking and comparing performance, as well as determining the secular trend in utilization of these procedures across the different institutions of the CHA.
Reyes et al. recently published the impact of utilization of these scorecards among all hospital members of the CHA in the Journal of Hospital Medicine, noting a positive impact of the SHM Choosing Wisely® recommendation in decreasing the utilization of low-value interventions. The authors compared the performance before and after the publication of the recommendations for a 9-year period (2008-2017). The most relevant impact occurred in children with bronchiolitis, with a decrease of 36% of bronchodilator use and of 31% in CXR utilization. In children with asthma, CXR utilization decreased by 20.8%. The authors found that, although there was a steady decrease in the utilization of low-value services, this was still limited.
What factors could impact the effectiveness of high-value quality initiatives? First of all, quality improvement requires a substantial investment of collective effort and time. It requires a change in culture that often involves changing longstanding paradigms. The Choosing Wisely® recommendations target a very specific, low-clinical-severity population – the focus is on “uncomplicated” disease. This is important as you don’t want to pursue aggressive unnecessary intervention in children and potentially cause harm – for example, unnecessary use of steroids in a child with uncomplicated bronchiolitis who may improve with nasal suctioning alone. There is a need to appraise patients with more complex presentation of these diseases (for example, patients that require escalation of care to ICU), and this is beyond the scope of Choosing Wisely®. Further research is needed to see if higher-value care interventions can be implemented among these higher acuity and severity patients.
In our institution, we have created specific care paths that facilitate following these recommendations. Essentially, we have leveraged the EHR order sets to avoid the inclusion of low-value interventions; all stakeholders (respiratory therapy, nursing, etc.) are aware of the care path and ensure compliance. Even further, as a consequence of the change in culture toward high-value care, we have identified low-value interventions in settings where high-value quality improvement can be implemented – for example, we found that at least 20% of noncritically ill children undergoing an appendectomy receive unnecessary antacid prophylaxis treatment.
Changes always start small; quality improvement requires a lot of effort, and we must focus our energy on “low-hanging fruit,” and also begin tackling higher complexity tasks. In the Choosing Wisely® manuscript cited above, the authors found that there was a change in performance with a tendency toward higher-value care, yet the change was not as substantial as originally thought.
How can we tackle higher complexity tasks if we find it difficult to implement solutions for those of lower complexity? My answer is simple. Maintain a consistent and continuous focus on high value, and ensure the message is iterative and redundant with feedback on performance, decrease in costs, and enhanced patient outcomes.
Dr. Auron is the quality improvement and patient safety officer in the department of hospital medicine at the Cleveland Clinic. He also serves as associate professor of medicine and pediatrics in the staff department of hospital medicine and department of pediatric hospital medicine. This article first appeared on the Hospital Leader, SHM’s official blog, at hospitalleader.org.
Focus energy on ‘low-hanging fruit’
Focus energy on ‘low-hanging fruit’
It is a well-known fact that health care expenditure in the United States occupies a large proportion of its gross domestic product. In fact, it was 17.8% in 2016, almost twice what is expended in other advanced countries. However, this expenditure does not necessarily translate into optimal patient outcomes.
In 2012, the Institute of Medicine reported that the U.S. health care system wastes $750 billion per year in spending that does not provide any meaningful outcome to patients or the system; and patients can also suffer a financial impact from the delivery of low-value care.
In 2013, the Pediatrics Committee of the Society of Hospital Medicine published five recommendations through the Choosing Wisely® campaign aimed to decrease the use of low-value interventions. These recommendations were:
1. Do not order chest radiographs (CXR) in children with asthma or bronchiolitis.
2. Do not use systemic corticosteroids in children aged under 2 years with a lower respiratory tract infection.
3. Do not use bronchodilators in children with bronchiolitis.
4. Do not treat gastroesophageal reflux in infants routinely with acid suppression therapy.
5. Do not use continuous pulse oximetry routinely in children with acute respiratory illness unless they are on supplemental oxygen.
This publication led to the implementation of quality improvement initiatives across different hospitals and institutions nationally. Eventually, a team of hospitalists developed a report card that could help measure the utilization of these interventions in hospitals that were part of the Children’s Hospital Association (CHA). The data stemming from the report card analysis would allow for benchmarking and comparing performance, as well as determining the secular trend in utilization of these procedures across the different institutions of the CHA.
Reyes et al. recently published the impact of utilization of these scorecards among all hospital members of the CHA in the Journal of Hospital Medicine, noting a positive impact of the SHM Choosing Wisely® recommendation in decreasing the utilization of low-value interventions. The authors compared the performance before and after the publication of the recommendations for a 9-year period (2008-2017). The most relevant impact occurred in children with bronchiolitis, with a decrease of 36% of bronchodilator use and of 31% in CXR utilization. In children with asthma, CXR utilization decreased by 20.8%. The authors found that, although there was a steady decrease in the utilization of low-value services, this was still limited.
What factors could impact the effectiveness of high-value quality initiatives? First of all, quality improvement requires a substantial investment of collective effort and time. It requires a change in culture that often involves changing longstanding paradigms. The Choosing Wisely® recommendations target a very specific, low-clinical-severity population – the focus is on “uncomplicated” disease. This is important as you don’t want to pursue aggressive unnecessary intervention in children and potentially cause harm – for example, unnecessary use of steroids in a child with uncomplicated bronchiolitis who may improve with nasal suctioning alone. There is a need to appraise patients with more complex presentation of these diseases (for example, patients that require escalation of care to ICU), and this is beyond the scope of Choosing Wisely®. Further research is needed to see if higher-value care interventions can be implemented among these higher acuity and severity patients.
In our institution, we have created specific care paths that facilitate following these recommendations. Essentially, we have leveraged the EHR order sets to avoid the inclusion of low-value interventions; all stakeholders (respiratory therapy, nursing, etc.) are aware of the care path and ensure compliance. Even further, as a consequence of the change in culture toward high-value care, we have identified low-value interventions in settings where high-value quality improvement can be implemented – for example, we found that at least 20% of noncritically ill children undergoing an appendectomy receive unnecessary antacid prophylaxis treatment.
Changes always start small; quality improvement requires a lot of effort, and we must focus our energy on “low-hanging fruit,” and also begin tackling higher complexity tasks. In the Choosing Wisely® manuscript cited above, the authors found that there was a change in performance with a tendency toward higher-value care, yet the change was not as substantial as originally thought.
How can we tackle higher complexity tasks if we find it difficult to implement solutions for those of lower complexity? My answer is simple. Maintain a consistent and continuous focus on high value, and ensure the message is iterative and redundant with feedback on performance, decrease in costs, and enhanced patient outcomes.
Dr. Auron is the quality improvement and patient safety officer in the department of hospital medicine at the Cleveland Clinic. He also serves as associate professor of medicine and pediatrics in the staff department of hospital medicine and department of pediatric hospital medicine. This article first appeared on the Hospital Leader, SHM’s official blog, at hospitalleader.org.
It is a well-known fact that health care expenditure in the United States occupies a large proportion of its gross domestic product. In fact, it was 17.8% in 2016, almost twice what is expended in other advanced countries. However, this expenditure does not necessarily translate into optimal patient outcomes.
In 2012, the Institute of Medicine reported that the U.S. health care system wastes $750 billion per year in spending that does not provide any meaningful outcome to patients or the system; and patients can also suffer a financial impact from the delivery of low-value care.
In 2013, the Pediatrics Committee of the Society of Hospital Medicine published five recommendations through the Choosing Wisely® campaign aimed to decrease the use of low-value interventions. These recommendations were:
1. Do not order chest radiographs (CXR) in children with asthma or bronchiolitis.
2. Do not use systemic corticosteroids in children aged under 2 years with a lower respiratory tract infection.
3. Do not use bronchodilators in children with bronchiolitis.
4. Do not treat gastroesophageal reflux in infants routinely with acid suppression therapy.
5. Do not use continuous pulse oximetry routinely in children with acute respiratory illness unless they are on supplemental oxygen.
This publication led to the implementation of quality improvement initiatives across different hospitals and institutions nationally. Eventually, a team of hospitalists developed a report card that could help measure the utilization of these interventions in hospitals that were part of the Children’s Hospital Association (CHA). The data stemming from the report card analysis would allow for benchmarking and comparing performance, as well as determining the secular trend in utilization of these procedures across the different institutions of the CHA.
Reyes et al. recently published the impact of utilization of these scorecards among all hospital members of the CHA in the Journal of Hospital Medicine, noting a positive impact of the SHM Choosing Wisely® recommendation in decreasing the utilization of low-value interventions. The authors compared the performance before and after the publication of the recommendations for a 9-year period (2008-2017). The most relevant impact occurred in children with bronchiolitis, with a decrease of 36% of bronchodilator use and of 31% in CXR utilization. In children with asthma, CXR utilization decreased by 20.8%. The authors found that, although there was a steady decrease in the utilization of low-value services, this was still limited.
What factors could impact the effectiveness of high-value quality initiatives? First of all, quality improvement requires a substantial investment of collective effort and time. It requires a change in culture that often involves changing longstanding paradigms. The Choosing Wisely® recommendations target a very specific, low-clinical-severity population – the focus is on “uncomplicated” disease. This is important as you don’t want to pursue aggressive unnecessary intervention in children and potentially cause harm – for example, unnecessary use of steroids in a child with uncomplicated bronchiolitis who may improve with nasal suctioning alone. There is a need to appraise patients with more complex presentation of these diseases (for example, patients that require escalation of care to ICU), and this is beyond the scope of Choosing Wisely®. Further research is needed to see if higher-value care interventions can be implemented among these higher acuity and severity patients.
In our institution, we have created specific care paths that facilitate following these recommendations. Essentially, we have leveraged the EHR order sets to avoid the inclusion of low-value interventions; all stakeholders (respiratory therapy, nursing, etc.) are aware of the care path and ensure compliance. Even further, as a consequence of the change in culture toward high-value care, we have identified low-value interventions in settings where high-value quality improvement can be implemented – for example, we found that at least 20% of noncritically ill children undergoing an appendectomy receive unnecessary antacid prophylaxis treatment.
Changes always start small; quality improvement requires a lot of effort, and we must focus our energy on “low-hanging fruit,” and also begin tackling higher complexity tasks. In the Choosing Wisely® manuscript cited above, the authors found that there was a change in performance with a tendency toward higher-value care, yet the change was not as substantial as originally thought.
How can we tackle higher complexity tasks if we find it difficult to implement solutions for those of lower complexity? My answer is simple. Maintain a consistent and continuous focus on high value, and ensure the message is iterative and redundant with feedback on performance, decrease in costs, and enhanced patient outcomes.
Dr. Auron is the quality improvement and patient safety officer in the department of hospital medicine at the Cleveland Clinic. He also serves as associate professor of medicine and pediatrics in the staff department of hospital medicine and department of pediatric hospital medicine. This article first appeared on the Hospital Leader, SHM’s official blog, at hospitalleader.org.
Consider a Donation to the SVS Foundation
The SVS Foundation is a fundamental part of the Society for Vascular Surgery, entrusted with supporting programs that advance our knowledge of vascular disease and improve the care we provide our patients and communities. A little while back the SVS Foundation published its 2019 Annual Report. This year, the report focuses on how past award recipients have used their grants to impact and improve patient care. More than $13 million in grants over the past three decades have given recipients the support they need to impact the lives of patients and those who provide care. Consider a donation today.
The SVS Foundation is a fundamental part of the Society for Vascular Surgery, entrusted with supporting programs that advance our knowledge of vascular disease and improve the care we provide our patients and communities. A little while back the SVS Foundation published its 2019 Annual Report. This year, the report focuses on how past award recipients have used their grants to impact and improve patient care. More than $13 million in grants over the past three decades have given recipients the support they need to impact the lives of patients and those who provide care. Consider a donation today.
The SVS Foundation is a fundamental part of the Society for Vascular Surgery, entrusted with supporting programs that advance our knowledge of vascular disease and improve the care we provide our patients and communities. A little while back the SVS Foundation published its 2019 Annual Report. This year, the report focuses on how past award recipients have used their grants to impact and improve patient care. More than $13 million in grants over the past three decades have given recipients the support they need to impact the lives of patients and those who provide care. Consider a donation today.