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Frequent bronchiectasis exacerbations linked to higher mortality
WASHINGTON – Bronchiectasis patients with three or more exacerbations per year had twice the mortality during 5-year follow-up as patients with no recent exacerbations, in a prospective registry of nearly 2,600 European bronchiectasis patients.
A multivariate analysis showed this statistically significant doubled death rate after adjustment for baseline demographic and clinical differences between patients with no exacerbations during the year before they entered the registry, James D. Chalmers, MD, said at an international conference of the American Thoracic Society.
This 37% prevalence contrasted with a 19% U.S. prevalence of bronchiectasis patients having two or more exacerbations per year among 2,114 patients enrolled in a 13-center U.S. registry that was reported during the same session by Timothy R. Aksamit, MD, a pulmonologist at the Mayo Clinic in Rochester, Minn. During his talk, Dr. Aksamit suggested that the European cohort might include more patients with asthma, chronic obstructive pulmonary disease, or other complications in addition to bronchiectasis. Dr. Aksamit contended that the U.S. registry tried to exclusively enroll patients with bronchiectasis and no other disorder, possibly explaining the prevalence difference between Europe and the United States.
The European registry included patients with bronchiectasis seen in 10 centers in seven European countries and Israel. They averaged 67 years of age. While more than a third had a history of at least three exacerbations a year, one-quarter had no exacerbations during the year before they entered the study.
The U.S. registry reported by Dr. Aksamit had 2-year follow-up data for 1,049 of the enrolled patients, a subgroup that closely matched the entire population initially enrolled. The 2-year follow-up showed an overall average exacerbation rate of 0.75 episodes per year, but this was driven largely by the subgroup of patients who entered the registry with a history of two or more exacerbations per year, who then averaged about 2.6 exacerbations during follow-up. In contrast, patients who entered the registry with a history of fewer than two exacerbations per year averaged fewer than a third of an exacerbation per year during follow-up, Dr. Aksamit reported.
The European bronchiectasis registry was partially funded by Bayer. Dr. Chalmers has been a consultant to Bayer and to AstraZeneca, Basilea, Grifols, Napp, and Raptor and has received research funding from Aradigm, AstraZeneca, Bayer, GlaxoSmithKline, and Pfizer. Dr. Aksamit had no disclosures.
[email protected]
On Twitter @mitchelzoler
WASHINGTON – Bronchiectasis patients with three or more exacerbations per year had twice the mortality during 5-year follow-up as patients with no recent exacerbations, in a prospective registry of nearly 2,600 European bronchiectasis patients.
A multivariate analysis showed this statistically significant doubled death rate after adjustment for baseline demographic and clinical differences between patients with no exacerbations during the year before they entered the registry, James D. Chalmers, MD, said at an international conference of the American Thoracic Society.
This 37% prevalence contrasted with a 19% U.S. prevalence of bronchiectasis patients having two or more exacerbations per year among 2,114 patients enrolled in a 13-center U.S. registry that was reported during the same session by Timothy R. Aksamit, MD, a pulmonologist at the Mayo Clinic in Rochester, Minn. During his talk, Dr. Aksamit suggested that the European cohort might include more patients with asthma, chronic obstructive pulmonary disease, or other complications in addition to bronchiectasis. Dr. Aksamit contended that the U.S. registry tried to exclusively enroll patients with bronchiectasis and no other disorder, possibly explaining the prevalence difference between Europe and the United States.
The European registry included patients with bronchiectasis seen in 10 centers in seven European countries and Israel. They averaged 67 years of age. While more than a third had a history of at least three exacerbations a year, one-quarter had no exacerbations during the year before they entered the study.
The U.S. registry reported by Dr. Aksamit had 2-year follow-up data for 1,049 of the enrolled patients, a subgroup that closely matched the entire population initially enrolled. The 2-year follow-up showed an overall average exacerbation rate of 0.75 episodes per year, but this was driven largely by the subgroup of patients who entered the registry with a history of two or more exacerbations per year, who then averaged about 2.6 exacerbations during follow-up. In contrast, patients who entered the registry with a history of fewer than two exacerbations per year averaged fewer than a third of an exacerbation per year during follow-up, Dr. Aksamit reported.
The European bronchiectasis registry was partially funded by Bayer. Dr. Chalmers has been a consultant to Bayer and to AstraZeneca, Basilea, Grifols, Napp, and Raptor and has received research funding from Aradigm, AstraZeneca, Bayer, GlaxoSmithKline, and Pfizer. Dr. Aksamit had no disclosures.
[email protected]
On Twitter @mitchelzoler
WASHINGTON – Bronchiectasis patients with three or more exacerbations per year had twice the mortality during 5-year follow-up as patients with no recent exacerbations, in a prospective registry of nearly 2,600 European bronchiectasis patients.
A multivariate analysis showed this statistically significant doubled death rate after adjustment for baseline demographic and clinical differences between patients with no exacerbations during the year before they entered the registry, James D. Chalmers, MD, said at an international conference of the American Thoracic Society.
This 37% prevalence contrasted with a 19% U.S. prevalence of bronchiectasis patients having two or more exacerbations per year among 2,114 patients enrolled in a 13-center U.S. registry that was reported during the same session by Timothy R. Aksamit, MD, a pulmonologist at the Mayo Clinic in Rochester, Minn. During his talk, Dr. Aksamit suggested that the European cohort might include more patients with asthma, chronic obstructive pulmonary disease, or other complications in addition to bronchiectasis. Dr. Aksamit contended that the U.S. registry tried to exclusively enroll patients with bronchiectasis and no other disorder, possibly explaining the prevalence difference between Europe and the United States.
The European registry included patients with bronchiectasis seen in 10 centers in seven European countries and Israel. They averaged 67 years of age. While more than a third had a history of at least three exacerbations a year, one-quarter had no exacerbations during the year before they entered the study.
The U.S. registry reported by Dr. Aksamit had 2-year follow-up data for 1,049 of the enrolled patients, a subgroup that closely matched the entire population initially enrolled. The 2-year follow-up showed an overall average exacerbation rate of 0.75 episodes per year, but this was driven largely by the subgroup of patients who entered the registry with a history of two or more exacerbations per year, who then averaged about 2.6 exacerbations during follow-up. In contrast, patients who entered the registry with a history of fewer than two exacerbations per year averaged fewer than a third of an exacerbation per year during follow-up, Dr. Aksamit reported.
The European bronchiectasis registry was partially funded by Bayer. Dr. Chalmers has been a consultant to Bayer and to AstraZeneca, Basilea, Grifols, Napp, and Raptor and has received research funding from Aradigm, AstraZeneca, Bayer, GlaxoSmithKline, and Pfizer. Dr. Aksamit had no disclosures.
[email protected]
On Twitter @mitchelzoler
AT ATS 2017
Key clinical point:
Major finding: Patients with frequent exacerbations had twice the mortality rate, compared with bronchiectasis patients with no recent exacerbations.
Data source: A registry of 2,596 bronchiectasis patients from 10 centers in Europe and Israel.
Disclosures: The European bronchiectasis registry was partially funded by Bayer. Dr. Chalmers has been a consultant to Bayer and to AstraZeneca, Basilea, Grifols, Napp, and Raptor and has received research funding from Aradigm, AstraZeneca, Bayer, GlaxoSmithKline, and Pfizer. Dr. Aksamit had no disclosures.
Age, anticoagulation prime issues in choice of mechanical valves
NEW YORK – While bioprosthetic valves have become the predominant choice for cardiothoracic surgeons performing heart valve replacement, situations exist in which a mechanical valve may be a better choice. Young and middle-aged adults are the ideal candidates for mechanical valves, but achieving long-term success with mechanical valves also depends on a patient’s circumstances, according to an expert panel at the American Association for Thoracic Surgery Mitral Conclave 2017 here.
“I think we should put in more mechanical valves,” said panel chair Thoralf M. Sundt III, MD, of Massachusetts General Hospital, Boston and former AATS president. “I think mechanical valves have gotten a bad rap. If patients have a supportive, stable social structure and they can manage their anticoagulation, I don’t think there’s anything wrong with a mechanical valve. I think the pendulum has swung too far.”
Anelechi C. Anyanwu, MD, of Mount Sinai Health System, New York, acknowledged another patient factor that would enter his calculus for recommending a mechanical mitral valve. “We would consider a mechanical valve in the patient who is compliant [and] well informed and understands well the requirements and implications of long-term anticoagulation,” he said. In another scenario – “the patient who’s had multiple reoperations – we may consider a mechanical valve.” Particularly, the patient who has had a reoperation for a bioprosthetic valve resulting from early degeneration will merit consideration of a mechanical prosthesis, Dr. Anyanwu said.
Michael A. Borger, MD, of Columbia University Medical Center, New York, agreed that the younger patient who has had a series of operations is a good candidate for a mechanical mitral valve. “In addition, the mechanical valve does have some hemodynamic advantages over bioprosthetic valves,” Dr. Borger said. “If a surgeon implants a 25-mm tissue valve with a plan for the patient to undergo a series of valve-in-valve operations in the future, mitral stenosis will definitely become a factor at some point.”
Pedro J. del Nido, MD, a pediatric cardiac surgeon at Children’s Hospital, Boston, expanded on that point. “We very, very rarely use mechanical valves in young patients,” Dr. del Nido said. “In very young patients, the reoperation rates for mechanical or biological valves are not much different. We still have to reoperate on both sets of patients. But, the reoperation itself for a mechanical valve is more difficult, and there is the need for full anticoagulation.”
Instead, Dr. del Nido has used the bovine Melody valve (Medtronic) in the mitral position for these patients because it accommodates some growth. Typically, the only time Dr. del Nido considers a mechanical valve in these young patients is for an aortic valve replacement.
Another younger patient that may be a good candidate for a mechanical valve is the 25-year-old male with rheumatic mitral stenosis. “I would err on the side of the mechanical valve in this patient if I were to make a choice, but I would present the patient with informed data on the outcomes of both mechanical valve and bioprosthesis,” according to Dr. Anyanwu
For even younger patients, Dr. del Nido bases his valve choice on their activity level. “I have a lot of young teenagers, and my decision is entirely based on what their background is like – what their regular life is like,” he said. “If they have a support structure than can help them manage anticoagulation, absolutely the mechanical valve is probably the best thing.”
However, there are exceptions because the couching of the device can change over time. “Eventually that 12-year-old [or] that 15-year-old is going to decide he can still snowboard or ride a motorcycle, and that’s when he’s going to get into trouble,” Dr. del Nido said. “If a reoperation is not problematic, I would still say it’s a tossup between the mechanical and biological valve. I would still offer the possibility of a bioprosthesis knowing that they’ll be back in 6, 8, or 10 years.”
Bleeding risk is another factor that can influence valve choice, as mechanical valve recipients must stay on anticoagulation. “The bleeding complication rates are very low when patients are younger, in their 40s or 50s, but the bleeding rates increase exponentially with warfarin for patients in their 80s and 90s,” Dr. Borger said. “The older you are, the more difficult it is to manage anticoagulation. In addition, the ability to stop anticoagulants because of bleeding is different for the two types of prostheses. If a patient develops bleeding during anticoagulation for leaflet immobility after a tissue valve-in-valve procedure, the physician can simply stop the warfarin. But, if you have a mechanical mitral valve in place that’s not an option.”
That’s not necessarily a bad problem to have, Dr. Sundt said, quoting Steven Bolling, MD, of the University of Michigan. “If you’re 25 and you’ve had your valve replaced and you’re worried about bleeding at the age of 80, I call that a success.”
Dr. Borger disclosed he is a speaker for and consultant to Edwards Lifesciences, Medtronic, and CryoLife; a speaker for St. Jude; and a recipient of research support from NeoChord. Dr. Lange disclosed he is a consultant and speaker for Medtronic, St. Jude/Abbott, LivaNova and NeoChord and cofounder of HighLife. Dr. Anyanwu, Dr. del Nido, and Dr. Sundt reported no relevant financial relationships.
NEW YORK – While bioprosthetic valves have become the predominant choice for cardiothoracic surgeons performing heart valve replacement, situations exist in which a mechanical valve may be a better choice. Young and middle-aged adults are the ideal candidates for mechanical valves, but achieving long-term success with mechanical valves also depends on a patient’s circumstances, according to an expert panel at the American Association for Thoracic Surgery Mitral Conclave 2017 here.
“I think we should put in more mechanical valves,” said panel chair Thoralf M. Sundt III, MD, of Massachusetts General Hospital, Boston and former AATS president. “I think mechanical valves have gotten a bad rap. If patients have a supportive, stable social structure and they can manage their anticoagulation, I don’t think there’s anything wrong with a mechanical valve. I think the pendulum has swung too far.”
Anelechi C. Anyanwu, MD, of Mount Sinai Health System, New York, acknowledged another patient factor that would enter his calculus for recommending a mechanical mitral valve. “We would consider a mechanical valve in the patient who is compliant [and] well informed and understands well the requirements and implications of long-term anticoagulation,” he said. In another scenario – “the patient who’s had multiple reoperations – we may consider a mechanical valve.” Particularly, the patient who has had a reoperation for a bioprosthetic valve resulting from early degeneration will merit consideration of a mechanical prosthesis, Dr. Anyanwu said.
Michael A. Borger, MD, of Columbia University Medical Center, New York, agreed that the younger patient who has had a series of operations is a good candidate for a mechanical mitral valve. “In addition, the mechanical valve does have some hemodynamic advantages over bioprosthetic valves,” Dr. Borger said. “If a surgeon implants a 25-mm tissue valve with a plan for the patient to undergo a series of valve-in-valve operations in the future, mitral stenosis will definitely become a factor at some point.”
Pedro J. del Nido, MD, a pediatric cardiac surgeon at Children’s Hospital, Boston, expanded on that point. “We very, very rarely use mechanical valves in young patients,” Dr. del Nido said. “In very young patients, the reoperation rates for mechanical or biological valves are not much different. We still have to reoperate on both sets of patients. But, the reoperation itself for a mechanical valve is more difficult, and there is the need for full anticoagulation.”
Instead, Dr. del Nido has used the bovine Melody valve (Medtronic) in the mitral position for these patients because it accommodates some growth. Typically, the only time Dr. del Nido considers a mechanical valve in these young patients is for an aortic valve replacement.
Another younger patient that may be a good candidate for a mechanical valve is the 25-year-old male with rheumatic mitral stenosis. “I would err on the side of the mechanical valve in this patient if I were to make a choice, but I would present the patient with informed data on the outcomes of both mechanical valve and bioprosthesis,” according to Dr. Anyanwu
For even younger patients, Dr. del Nido bases his valve choice on their activity level. “I have a lot of young teenagers, and my decision is entirely based on what their background is like – what their regular life is like,” he said. “If they have a support structure than can help them manage anticoagulation, absolutely the mechanical valve is probably the best thing.”
However, there are exceptions because the couching of the device can change over time. “Eventually that 12-year-old [or] that 15-year-old is going to decide he can still snowboard or ride a motorcycle, and that’s when he’s going to get into trouble,” Dr. del Nido said. “If a reoperation is not problematic, I would still say it’s a tossup between the mechanical and biological valve. I would still offer the possibility of a bioprosthesis knowing that they’ll be back in 6, 8, or 10 years.”
Bleeding risk is another factor that can influence valve choice, as mechanical valve recipients must stay on anticoagulation. “The bleeding complication rates are very low when patients are younger, in their 40s or 50s, but the bleeding rates increase exponentially with warfarin for patients in their 80s and 90s,” Dr. Borger said. “The older you are, the more difficult it is to manage anticoagulation. In addition, the ability to stop anticoagulants because of bleeding is different for the two types of prostheses. If a patient develops bleeding during anticoagulation for leaflet immobility after a tissue valve-in-valve procedure, the physician can simply stop the warfarin. But, if you have a mechanical mitral valve in place that’s not an option.”
That’s not necessarily a bad problem to have, Dr. Sundt said, quoting Steven Bolling, MD, of the University of Michigan. “If you’re 25 and you’ve had your valve replaced and you’re worried about bleeding at the age of 80, I call that a success.”
Dr. Borger disclosed he is a speaker for and consultant to Edwards Lifesciences, Medtronic, and CryoLife; a speaker for St. Jude; and a recipient of research support from NeoChord. Dr. Lange disclosed he is a consultant and speaker for Medtronic, St. Jude/Abbott, LivaNova and NeoChord and cofounder of HighLife. Dr. Anyanwu, Dr. del Nido, and Dr. Sundt reported no relevant financial relationships.
NEW YORK – While bioprosthetic valves have become the predominant choice for cardiothoracic surgeons performing heart valve replacement, situations exist in which a mechanical valve may be a better choice. Young and middle-aged adults are the ideal candidates for mechanical valves, but achieving long-term success with mechanical valves also depends on a patient’s circumstances, according to an expert panel at the American Association for Thoracic Surgery Mitral Conclave 2017 here.
“I think we should put in more mechanical valves,” said panel chair Thoralf M. Sundt III, MD, of Massachusetts General Hospital, Boston and former AATS president. “I think mechanical valves have gotten a bad rap. If patients have a supportive, stable social structure and they can manage their anticoagulation, I don’t think there’s anything wrong with a mechanical valve. I think the pendulum has swung too far.”
Anelechi C. Anyanwu, MD, of Mount Sinai Health System, New York, acknowledged another patient factor that would enter his calculus for recommending a mechanical mitral valve. “We would consider a mechanical valve in the patient who is compliant [and] well informed and understands well the requirements and implications of long-term anticoagulation,” he said. In another scenario – “the patient who’s had multiple reoperations – we may consider a mechanical valve.” Particularly, the patient who has had a reoperation for a bioprosthetic valve resulting from early degeneration will merit consideration of a mechanical prosthesis, Dr. Anyanwu said.
Michael A. Borger, MD, of Columbia University Medical Center, New York, agreed that the younger patient who has had a series of operations is a good candidate for a mechanical mitral valve. “In addition, the mechanical valve does have some hemodynamic advantages over bioprosthetic valves,” Dr. Borger said. “If a surgeon implants a 25-mm tissue valve with a plan for the patient to undergo a series of valve-in-valve operations in the future, mitral stenosis will definitely become a factor at some point.”
Pedro J. del Nido, MD, a pediatric cardiac surgeon at Children’s Hospital, Boston, expanded on that point. “We very, very rarely use mechanical valves in young patients,” Dr. del Nido said. “In very young patients, the reoperation rates for mechanical or biological valves are not much different. We still have to reoperate on both sets of patients. But, the reoperation itself for a mechanical valve is more difficult, and there is the need for full anticoagulation.”
Instead, Dr. del Nido has used the bovine Melody valve (Medtronic) in the mitral position for these patients because it accommodates some growth. Typically, the only time Dr. del Nido considers a mechanical valve in these young patients is for an aortic valve replacement.
Another younger patient that may be a good candidate for a mechanical valve is the 25-year-old male with rheumatic mitral stenosis. “I would err on the side of the mechanical valve in this patient if I were to make a choice, but I would present the patient with informed data on the outcomes of both mechanical valve and bioprosthesis,” according to Dr. Anyanwu
For even younger patients, Dr. del Nido bases his valve choice on their activity level. “I have a lot of young teenagers, and my decision is entirely based on what their background is like – what their regular life is like,” he said. “If they have a support structure than can help them manage anticoagulation, absolutely the mechanical valve is probably the best thing.”
However, there are exceptions because the couching of the device can change over time. “Eventually that 12-year-old [or] that 15-year-old is going to decide he can still snowboard or ride a motorcycle, and that’s when he’s going to get into trouble,” Dr. del Nido said. “If a reoperation is not problematic, I would still say it’s a tossup between the mechanical and biological valve. I would still offer the possibility of a bioprosthesis knowing that they’ll be back in 6, 8, or 10 years.”
Bleeding risk is another factor that can influence valve choice, as mechanical valve recipients must stay on anticoagulation. “The bleeding complication rates are very low when patients are younger, in their 40s or 50s, but the bleeding rates increase exponentially with warfarin for patients in their 80s and 90s,” Dr. Borger said. “The older you are, the more difficult it is to manage anticoagulation. In addition, the ability to stop anticoagulants because of bleeding is different for the two types of prostheses. If a patient develops bleeding during anticoagulation for leaflet immobility after a tissue valve-in-valve procedure, the physician can simply stop the warfarin. But, if you have a mechanical mitral valve in place that’s not an option.”
That’s not necessarily a bad problem to have, Dr. Sundt said, quoting Steven Bolling, MD, of the University of Michigan. “If you’re 25 and you’ve had your valve replaced and you’re worried about bleeding at the age of 80, I call that a success.”
Dr. Borger disclosed he is a speaker for and consultant to Edwards Lifesciences, Medtronic, and CryoLife; a speaker for St. Jude; and a recipient of research support from NeoChord. Dr. Lange disclosed he is a consultant and speaker for Medtronic, St. Jude/Abbott, LivaNova and NeoChord and cofounder of HighLife. Dr. Anyanwu, Dr. del Nido, and Dr. Sundt reported no relevant financial relationships.
EXPERT ANALYSIS FROM THE 2017 MITRAL VALVE CONCLAVE
IDegLira equals basal-bolus insulin in HbA1c, lowers hypoglycemia risk
SAN DIEGO – When basal insulin alone does not achieve glucose targets in type 2 diabetes, a single fixed-dose injection of insulin degludec and liraglutide (IDegLira) is as effective as multiple insulin injections and has a significantly lower risk of hypoglycemia, according to a randomized, multicenter, open-label, industry-sponsored trial.
After 26 weeks of treatment, average hemoglobin A1c levels dropped similarly with once-daily IDegLira (1.48%) as with basal insulin glargine U100 plus mealtime injections of short-acting insulin aspart (1.46%; P less than .0001 for noninferiority), reported Liana K. Billings, MD, at the annual scientific sessions of the American Diabetes Association.
Patients also needed significantly less insulin and lost significantly more weight on IDegLira, compared with the basal-bolus regimen. “This is some of the most robust, most impressive data I’ve seen in years,” Julio Rosenstock, MD, director of the Dallas Diabetes and Endocrine Center in Texas, commented from the audience. Dr. Rosenstock was not involved in the trial and has studied other combination regimens for type 2 diabetes.
The advent of new insulins and adjunct therapies gives clinicians many potential algorithms for treating type 2 diabetes patients. The ADA recommends that health care professionals consider dual or triple therapy if patients do not meet glycemic targets with lifestyle changes and metformin alone. However, weight gain, hypoglycemia, and complex treatment regimens can make it difficult to intensify treatment in the real world, Dr. Billings said.
Insulin degludec is an ultra–long-acting basal insulin analogue, while liraglutide is a GLP-1 receptor agonist. The open-label, phase III DUAL VII study compared once-daily IDegLira injection (Xultophy, Novo Nordisk) with once-daily basal insulin glargine (Lantus, Sanofi) U100 plus bolus insulin aspart (NovoLog, Novo Nordisk) at mealtimes in 506 adults with type 2 diabetes. All patients were on metformin and glargine (typically 34 U) at baseline. Most were in their late 50s and obese, with an average 13-year duration of type 2 diabetes and HbA1c levels of 8.2% despite treatment. The IDegLira group started at 16 U and titrated by 2 U twice weekly to reach a fasting glucose target of 72-90 mg/dL. Basal-bolus patients maintained their baseline glargine dose and added 4 U mealtime bolus insulin aspart, titrating to target by 1 U twice weekly. The primary endpoint was change in HbA1c levels after 26 weeks. More than 98% of patients completed the trial. Approximately two-thirds of patients in both arms achieved an HbA1c level below 7%, but IDegLira recipients were significantly more likely to do so without gaining weight or experiencing hypoglycemia during the last 12 weeks of treatment (odds ratio, 10.39; 95% CI, 5.76-18.75). The IDegLira arm received significantly less daily insulin than the basal-bolus arm (40 U versus 84 U; P less than .0001), and IDegLira patients lost an average of 0.93 kg, while the comparison group gained 2.64 kg. Rates of serious adverse events were low and similar between arms. The cumulative rate of nausea was higher with IDegLira (11.1%) than with basal-bolus therapy (1.6%), Dr. Billings said. There were no deaths or unexpected adverse events.
Novo Nordisk makes Xultophy and funded the trial. Dr. Billings reported having served on advisory panels and speaker bureaus for Novo Nordisk.
SAN DIEGO – When basal insulin alone does not achieve glucose targets in type 2 diabetes, a single fixed-dose injection of insulin degludec and liraglutide (IDegLira) is as effective as multiple insulin injections and has a significantly lower risk of hypoglycemia, according to a randomized, multicenter, open-label, industry-sponsored trial.
After 26 weeks of treatment, average hemoglobin A1c levels dropped similarly with once-daily IDegLira (1.48%) as with basal insulin glargine U100 plus mealtime injections of short-acting insulin aspart (1.46%; P less than .0001 for noninferiority), reported Liana K. Billings, MD, at the annual scientific sessions of the American Diabetes Association.
Patients also needed significantly less insulin and lost significantly more weight on IDegLira, compared with the basal-bolus regimen. “This is some of the most robust, most impressive data I’ve seen in years,” Julio Rosenstock, MD, director of the Dallas Diabetes and Endocrine Center in Texas, commented from the audience. Dr. Rosenstock was not involved in the trial and has studied other combination regimens for type 2 diabetes.
The advent of new insulins and adjunct therapies gives clinicians many potential algorithms for treating type 2 diabetes patients. The ADA recommends that health care professionals consider dual or triple therapy if patients do not meet glycemic targets with lifestyle changes and metformin alone. However, weight gain, hypoglycemia, and complex treatment regimens can make it difficult to intensify treatment in the real world, Dr. Billings said.
Insulin degludec is an ultra–long-acting basal insulin analogue, while liraglutide is a GLP-1 receptor agonist. The open-label, phase III DUAL VII study compared once-daily IDegLira injection (Xultophy, Novo Nordisk) with once-daily basal insulin glargine (Lantus, Sanofi) U100 plus bolus insulin aspart (NovoLog, Novo Nordisk) at mealtimes in 506 adults with type 2 diabetes. All patients were on metformin and glargine (typically 34 U) at baseline. Most were in their late 50s and obese, with an average 13-year duration of type 2 diabetes and HbA1c levels of 8.2% despite treatment. The IDegLira group started at 16 U and titrated by 2 U twice weekly to reach a fasting glucose target of 72-90 mg/dL. Basal-bolus patients maintained their baseline glargine dose and added 4 U mealtime bolus insulin aspart, titrating to target by 1 U twice weekly. The primary endpoint was change in HbA1c levels after 26 weeks. More than 98% of patients completed the trial. Approximately two-thirds of patients in both arms achieved an HbA1c level below 7%, but IDegLira recipients were significantly more likely to do so without gaining weight or experiencing hypoglycemia during the last 12 weeks of treatment (odds ratio, 10.39; 95% CI, 5.76-18.75). The IDegLira arm received significantly less daily insulin than the basal-bolus arm (40 U versus 84 U; P less than .0001), and IDegLira patients lost an average of 0.93 kg, while the comparison group gained 2.64 kg. Rates of serious adverse events were low and similar between arms. The cumulative rate of nausea was higher with IDegLira (11.1%) than with basal-bolus therapy (1.6%), Dr. Billings said. There were no deaths or unexpected adverse events.
Novo Nordisk makes Xultophy and funded the trial. Dr. Billings reported having served on advisory panels and speaker bureaus for Novo Nordisk.
SAN DIEGO – When basal insulin alone does not achieve glucose targets in type 2 diabetes, a single fixed-dose injection of insulin degludec and liraglutide (IDegLira) is as effective as multiple insulin injections and has a significantly lower risk of hypoglycemia, according to a randomized, multicenter, open-label, industry-sponsored trial.
After 26 weeks of treatment, average hemoglobin A1c levels dropped similarly with once-daily IDegLira (1.48%) as with basal insulin glargine U100 plus mealtime injections of short-acting insulin aspart (1.46%; P less than .0001 for noninferiority), reported Liana K. Billings, MD, at the annual scientific sessions of the American Diabetes Association.
Patients also needed significantly less insulin and lost significantly more weight on IDegLira, compared with the basal-bolus regimen. “This is some of the most robust, most impressive data I’ve seen in years,” Julio Rosenstock, MD, director of the Dallas Diabetes and Endocrine Center in Texas, commented from the audience. Dr. Rosenstock was not involved in the trial and has studied other combination regimens for type 2 diabetes.
The advent of new insulins and adjunct therapies gives clinicians many potential algorithms for treating type 2 diabetes patients. The ADA recommends that health care professionals consider dual or triple therapy if patients do not meet glycemic targets with lifestyle changes and metformin alone. However, weight gain, hypoglycemia, and complex treatment regimens can make it difficult to intensify treatment in the real world, Dr. Billings said.
Insulin degludec is an ultra–long-acting basal insulin analogue, while liraglutide is a GLP-1 receptor agonist. The open-label, phase III DUAL VII study compared once-daily IDegLira injection (Xultophy, Novo Nordisk) with once-daily basal insulin glargine (Lantus, Sanofi) U100 plus bolus insulin aspart (NovoLog, Novo Nordisk) at mealtimes in 506 adults with type 2 diabetes. All patients were on metformin and glargine (typically 34 U) at baseline. Most were in their late 50s and obese, with an average 13-year duration of type 2 diabetes and HbA1c levels of 8.2% despite treatment. The IDegLira group started at 16 U and titrated by 2 U twice weekly to reach a fasting glucose target of 72-90 mg/dL. Basal-bolus patients maintained their baseline glargine dose and added 4 U mealtime bolus insulin aspart, titrating to target by 1 U twice weekly. The primary endpoint was change in HbA1c levels after 26 weeks. More than 98% of patients completed the trial. Approximately two-thirds of patients in both arms achieved an HbA1c level below 7%, but IDegLira recipients were significantly more likely to do so without gaining weight or experiencing hypoglycemia during the last 12 weeks of treatment (odds ratio, 10.39; 95% CI, 5.76-18.75). The IDegLira arm received significantly less daily insulin than the basal-bolus arm (40 U versus 84 U; P less than .0001), and IDegLira patients lost an average of 0.93 kg, while the comparison group gained 2.64 kg. Rates of serious adverse events were low and similar between arms. The cumulative rate of nausea was higher with IDegLira (11.1%) than with basal-bolus therapy (1.6%), Dr. Billings said. There were no deaths or unexpected adverse events.
Novo Nordisk makes Xultophy and funded the trial. Dr. Billings reported having served on advisory panels and speaker bureaus for Novo Nordisk.
AT THE ADA ANNUAL SCIENTIFIC SESSIONS
Key clinical point: A single daily injection of fixed-dose insulin degludec and liraglutide (IDegLira) improved hemoglobin A1c levels as much as basal-bolus insulin therapy while producing significantly less hypoglycemia.
Major finding: HbA1c levels dropped similarly with IDegLira (1.48%) or basal insulin glargine U100 plus mealtime injections of short-acting insulin aspart (1.46%; P less than .0001 for noninferiority).
Data source: DUAL VII, a multicenter, randomized, open-label, phase III trial of 506 adults with type 2 diabetes who did not reach glucose targets on basal insulin glargine and metformin.
Disclosures: Novo Nordisk makes Xultophy and funded the trial. Dr. Billings reported having served on advisory panels and speaker bureaus for Novo Nordisk.
Telemonitoring with feedback improves CPAP
BOSTON – Remote monitoring of continuous positive airway pressure (CPAP) use with feedback messaging to patients improves adherence but only when patients opt to receive continual feedback on their usage, according to a study.
Dennis Hwang, MD, medical director of Kaiser Permanent Fontana Medical Center in California and his colleagues designed the four-arm Tele-OSA study to evaluate the impact of two automated telemedicine interventions: an obstructive sleep apnea (OSA) education program (provided by Emmi Solutions) and a CPAP remote monitoring system with automated patient feedback (U-Sleep, ResMed). Dr. Hwang, who is also cochair of sleep medicine at Southern California Permanente Medical Group, presented his findings at the annual meeting of the Associated Professional Sleep Societies.
CPAP adherence was compared at 3 months and 1 year for patients in all four groups. Dr. Hwang reported findings from 556 patients who completed one-year follow-up.
At 90 days, patients assigned to either of the telemonitoring arms had significantly higher CPAP usage than those who did not receive telemonitoring.
However, at 3 months when the study protocol called for the automated messaging to be turned off, CPAP adherence dropped off. By 8 months, adherence in patients using the telemonitoring system was no different from that in those who never received the automated messaging. That would have been the end of the story, except that there was a glitch in the system.
“Perhaps serendipitously, we had a group of patients, about one-third, for whom we inadvertently did not turn off the messaging,” explained Dr. Hwang. “In these patients who continued to receive feedback, CPAP usage remained elevated throughout the course of the year and, at 12 months, was significantly higher than in the patients who were not receiving any kind of messaging.”
Dr. Hwang added that the telemonitoring required no additional provider intervention, “suggesting that this could be a cost-effective strategy.”
Only one-third of patients (66.7%) assigned to one of the tele-education groups viewed the video. Additionally, the researchers found that, whether patients used the tele-education alone or in combination with the telemonitoring, tele-education use had no impact on 90-day compliance with CPAP.
Dr. Hwang received support from the American Sleep Medicine Foundation and ResMed Science.
BOSTON – Remote monitoring of continuous positive airway pressure (CPAP) use with feedback messaging to patients improves adherence but only when patients opt to receive continual feedback on their usage, according to a study.
Dennis Hwang, MD, medical director of Kaiser Permanent Fontana Medical Center in California and his colleagues designed the four-arm Tele-OSA study to evaluate the impact of two automated telemedicine interventions: an obstructive sleep apnea (OSA) education program (provided by Emmi Solutions) and a CPAP remote monitoring system with automated patient feedback (U-Sleep, ResMed). Dr. Hwang, who is also cochair of sleep medicine at Southern California Permanente Medical Group, presented his findings at the annual meeting of the Associated Professional Sleep Societies.
CPAP adherence was compared at 3 months and 1 year for patients in all four groups. Dr. Hwang reported findings from 556 patients who completed one-year follow-up.
At 90 days, patients assigned to either of the telemonitoring arms had significantly higher CPAP usage than those who did not receive telemonitoring.
However, at 3 months when the study protocol called for the automated messaging to be turned off, CPAP adherence dropped off. By 8 months, adherence in patients using the telemonitoring system was no different from that in those who never received the automated messaging. That would have been the end of the story, except that there was a glitch in the system.
“Perhaps serendipitously, we had a group of patients, about one-third, for whom we inadvertently did not turn off the messaging,” explained Dr. Hwang. “In these patients who continued to receive feedback, CPAP usage remained elevated throughout the course of the year and, at 12 months, was significantly higher than in the patients who were not receiving any kind of messaging.”
Dr. Hwang added that the telemonitoring required no additional provider intervention, “suggesting that this could be a cost-effective strategy.”
Only one-third of patients (66.7%) assigned to one of the tele-education groups viewed the video. Additionally, the researchers found that, whether patients used the tele-education alone or in combination with the telemonitoring, tele-education use had no impact on 90-day compliance with CPAP.
Dr. Hwang received support from the American Sleep Medicine Foundation and ResMed Science.
BOSTON – Remote monitoring of continuous positive airway pressure (CPAP) use with feedback messaging to patients improves adherence but only when patients opt to receive continual feedback on their usage, according to a study.
Dennis Hwang, MD, medical director of Kaiser Permanent Fontana Medical Center in California and his colleagues designed the four-arm Tele-OSA study to evaluate the impact of two automated telemedicine interventions: an obstructive sleep apnea (OSA) education program (provided by Emmi Solutions) and a CPAP remote monitoring system with automated patient feedback (U-Sleep, ResMed). Dr. Hwang, who is also cochair of sleep medicine at Southern California Permanente Medical Group, presented his findings at the annual meeting of the Associated Professional Sleep Societies.
CPAP adherence was compared at 3 months and 1 year for patients in all four groups. Dr. Hwang reported findings from 556 patients who completed one-year follow-up.
At 90 days, patients assigned to either of the telemonitoring arms had significantly higher CPAP usage than those who did not receive telemonitoring.
However, at 3 months when the study protocol called for the automated messaging to be turned off, CPAP adherence dropped off. By 8 months, adherence in patients using the telemonitoring system was no different from that in those who never received the automated messaging. That would have been the end of the story, except that there was a glitch in the system.
“Perhaps serendipitously, we had a group of patients, about one-third, for whom we inadvertently did not turn off the messaging,” explained Dr. Hwang. “In these patients who continued to receive feedback, CPAP usage remained elevated throughout the course of the year and, at 12 months, was significantly higher than in the patients who were not receiving any kind of messaging.”
Dr. Hwang added that the telemonitoring required no additional provider intervention, “suggesting that this could be a cost-effective strategy.”
Only one-third of patients (66.7%) assigned to one of the tele-education groups viewed the video. Additionally, the researchers found that, whether patients used the tele-education alone or in combination with the telemonitoring, tele-education use had no impact on 90-day compliance with CPAP.
Dr. Hwang received support from the American Sleep Medicine Foundation and ResMed Science.
AT SLEEP 2017
Key clinical point: CPAP telemonitoring with feedback messaging improved CPAP adherence with no additional provider intervention needed.
Major finding: CPAP adherence was significantly higher at 3 months in patients who had remote monitoring of usage with subsequent continuous automated feedback. At one year, usage was only higher in those patients who continued to receive messaging during usage of the telemonitoring system and not in those who had the messaging component “turned off.”
Data source: A four-arm, randomized clinical trial that tested tele-education and CPAP telemonitoring interventions in 1,455 patients.
Disclosures: Dr. Hwang received support from the American Sleep Medicine Foundation and ResMed Science Center.
FDA approves daratumumab-POM-Dex combo for MM
The US Food and Drug Administration (FDA) has approved daratumumab (Darzalex®) in combination with pomalidomide (POM) and dexamethasone (dex) for the treatment of multiple myeloma (MM) in patients who have received at least 2 prior therapies, including lenalidomide and a proteasome inhibitor (PI).
The FDA previously approved daratumumab in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with MM who had at least 1 prior therapy.
Daratumumab is also approved by the FDA as monotherapy in MM patients who had at least 3 prior lines of therapy, including a PI and an immunomodulatory (IMiD) agent, or who are double refractory to a PI and an IMiD.
The latest indication is based on the results of the phase 1b MMY1001 EQUULEUS study, which demonstrated that daratumumab produced an overall response (OR) rate of 59% in combination with pomalidomide and dexamethasone, and a very good partial response (VGPR) in 28% of patients.
EQUULEUS study
The daratumumab-POM-Dex arm of the phase 1 open-label EQUULEUS study included 103 MM patients who had received prior treatment with a PI and an immunomodulatory agent.
Patients were a median age of 64 years, and 8% were older than 75.
They had received a median of 4 prior lines of therapy, and 74% had received prior autologous stem cell transplant.
Most (89%) were refractory to lenalidomide and 71% were refractory to bortezomib. Almost two thirds (64%) were refractory to bortezomib and lenalidomide.
Patients were treated with 16 mg/kg of daratumumab in combination with POM and Dex, and 6% achieved a complete response (CR) and 8% achieved a stringent CR.
The median time to response was 1 month (range, 0.9 to 2.8), and the median duration of response was 13.6 months (range, 0.9+ to 14.6+ months).
The most frequent adverse events (AEs) reported in more than 20% of patients were infusion reactions, fatigue, and upper respiratory tract infections (50% each), cough (43%), diarrhea (38%), dyspnea (33%), nausea (30%), muscle spasms (26%), pyrexia (25%), and vomiting (21%).
The overall incidence of serious adverse reactions was 49%.
Grade 3/4 serious AEs reported in 5% of patients or more included pneumonia (7%).
The most common treatment-emergent hematologic laboratory abnormalities included lymphopenia (94%), neutropenia (95%), thrombocytopenia (75%), and anemia (57%).
And the most common grade 3/4 treatment-emergent hematology laboratory abnormalities were neutropenia (82%), lymphopenia (71%), anemia (30%), and thrombocytopenia (20%).
Daratumumab is being developed by Janssen Biotech, Inc., under an exclusive worldwide license to develop, manufacture, and commercialize daratumumab from Genmab.
See the package insert for full prescribing information. 
The US Food and Drug Administration (FDA) has approved daratumumab (Darzalex®) in combination with pomalidomide (POM) and dexamethasone (dex) for the treatment of multiple myeloma (MM) in patients who have received at least 2 prior therapies, including lenalidomide and a proteasome inhibitor (PI).
The FDA previously approved daratumumab in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with MM who had at least 1 prior therapy.
Daratumumab is also approved by the FDA as monotherapy in MM patients who had at least 3 prior lines of therapy, including a PI and an immunomodulatory (IMiD) agent, or who are double refractory to a PI and an IMiD.
The latest indication is based on the results of the phase 1b MMY1001 EQUULEUS study, which demonstrated that daratumumab produced an overall response (OR) rate of 59% in combination with pomalidomide and dexamethasone, and a very good partial response (VGPR) in 28% of patients.
EQUULEUS study
The daratumumab-POM-Dex arm of the phase 1 open-label EQUULEUS study included 103 MM patients who had received prior treatment with a PI and an immunomodulatory agent.
Patients were a median age of 64 years, and 8% were older than 75.
They had received a median of 4 prior lines of therapy, and 74% had received prior autologous stem cell transplant.
Most (89%) were refractory to lenalidomide and 71% were refractory to bortezomib. Almost two thirds (64%) were refractory to bortezomib and lenalidomide.
Patients were treated with 16 mg/kg of daratumumab in combination with POM and Dex, and 6% achieved a complete response (CR) and 8% achieved a stringent CR.
The median time to response was 1 month (range, 0.9 to 2.8), and the median duration of response was 13.6 months (range, 0.9+ to 14.6+ months).
The most frequent adverse events (AEs) reported in more than 20% of patients were infusion reactions, fatigue, and upper respiratory tract infections (50% each), cough (43%), diarrhea (38%), dyspnea (33%), nausea (30%), muscle spasms (26%), pyrexia (25%), and vomiting (21%).
The overall incidence of serious adverse reactions was 49%.
Grade 3/4 serious AEs reported in 5% of patients or more included pneumonia (7%).
The most common treatment-emergent hematologic laboratory abnormalities included lymphopenia (94%), neutropenia (95%), thrombocytopenia (75%), and anemia (57%).
And the most common grade 3/4 treatment-emergent hematology laboratory abnormalities were neutropenia (82%), lymphopenia (71%), anemia (30%), and thrombocytopenia (20%).
Daratumumab is being developed by Janssen Biotech, Inc., under an exclusive worldwide license to develop, manufacture, and commercialize daratumumab from Genmab.
See the package insert for full prescribing information.
The US Food and Drug Administration (FDA) has approved daratumumab (Darzalex®) in combination with pomalidomide (POM) and dexamethasone (dex) for the treatment of multiple myeloma (MM) in patients who have received at least 2 prior therapies, including lenalidomide and a proteasome inhibitor (PI).
The FDA previously approved daratumumab in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with MM who had at least 1 prior therapy.
Daratumumab is also approved by the FDA as monotherapy in MM patients who had at least 3 prior lines of therapy, including a PI and an immunomodulatory (IMiD) agent, or who are double refractory to a PI and an IMiD.
The latest indication is based on the results of the phase 1b MMY1001 EQUULEUS study, which demonstrated that daratumumab produced an overall response (OR) rate of 59% in combination with pomalidomide and dexamethasone, and a very good partial response (VGPR) in 28% of patients.
EQUULEUS study
The daratumumab-POM-Dex arm of the phase 1 open-label EQUULEUS study included 103 MM patients who had received prior treatment with a PI and an immunomodulatory agent.
Patients were a median age of 64 years, and 8% were older than 75.
They had received a median of 4 prior lines of therapy, and 74% had received prior autologous stem cell transplant.
Most (89%) were refractory to lenalidomide and 71% were refractory to bortezomib. Almost two thirds (64%) were refractory to bortezomib and lenalidomide.
Patients were treated with 16 mg/kg of daratumumab in combination with POM and Dex, and 6% achieved a complete response (CR) and 8% achieved a stringent CR.
The median time to response was 1 month (range, 0.9 to 2.8), and the median duration of response was 13.6 months (range, 0.9+ to 14.6+ months).
The most frequent adverse events (AEs) reported in more than 20% of patients were infusion reactions, fatigue, and upper respiratory tract infections (50% each), cough (43%), diarrhea (38%), dyspnea (33%), nausea (30%), muscle spasms (26%), pyrexia (25%), and vomiting (21%).
The overall incidence of serious adverse reactions was 49%.
Grade 3/4 serious AEs reported in 5% of patients or more included pneumonia (7%).
The most common treatment-emergent hematologic laboratory abnormalities included lymphopenia (94%), neutropenia (95%), thrombocytopenia (75%), and anemia (57%).
And the most common grade 3/4 treatment-emergent hematology laboratory abnormalities were neutropenia (82%), lymphopenia (71%), anemia (30%), and thrombocytopenia (20%).
Daratumumab is being developed by Janssen Biotech, Inc., under an exclusive worldwide license to develop, manufacture, and commercialize daratumumab from Genmab.
See the package insert for full prescribing information.
Large MM trial finds denosumab non-inferior to ZA for SRE
CHICAGO—The largest international multiple myeloma (MM) trial ever conducted, according to the trial sponsor, met its primary endpoint, demonstrating that denosumab is non-inferior to zoledronic acid (ZA) in delaying the time to first on-study skeletal-related event (SRE) in patients with MM.
In addition to bone-specific benefits, denosumab-treated patients had significantly fewer renal adverse events and possible prolongation of progression-free survival.
Denosumab “may in fact be a new standard of care for multiple myeloma-related bone disease,” according to one of the investigators.
“The other important thing to note,” Noopur S. Raje, MD, said during her presentation at the ASCO 2017 Annual Meeting, “is denosumab can be administered despite renal function in patients with myeloma.” It does not need to be dose-adjusted, unlike bisphosphonates.
Dr Raje, of the Massachusetts General Hospital Cancer Center in Boston, Massachusetts, presented the study results as abstract 8005.
Study design
The international, phase 3, randomized, double-blind study is evaluating the safety of denosumab compared with ZA in newly diagnosed MM patients.
Investigators enrolled 1718 patients from 259 sites and 29 countries.
They randomized 859 patients to receive denosumab 120 mg subcutaneously every 4 weeks plus intravenous placebo every 4 weeks, and 859 patients to the standard ZA dose of 4 mg intravenously plus subcutaneous placebo every 4 weeks.
Patients were stratified by whether they were on novel-based anti-myeloma therapy, whether they planned to have an autologous peripheral blood stem cell (PBSC) transplant, disease stage, and previous SRE.
“We were looking for 676 on-study SREs, and if we saw a benefit, patients would be offered open-label denosumab for up to 2 years after this,” Dr Raje said.
“Patients had to have radiographic evidence of bone disease, and this is different from some of the other bone disease studies that you’ve seen in the recent past,” she added.
In addition to documented evidence of MM, patients had to be 18 years or older, be ECOG status of 2 or better, have adequate organ function, and plan to receive or be receiving primary frontline anti-myeloma therapy.
Patients were excluded if they had nonsecretory MM, more than 30 days of previous treatment with anti-myeloma therapy prior to screening, prior use of denosumab, use of oral bisphosphonates with a cumulative dose of more than 1 year, more than 1 previous dose of intravenous bisphosphonate, or prior history or current evidence of osteonecrosis/osteomyelitis of the jaw.
The primary endpoint was time to first on-study SRE, “and the idea here was to look for non-inferiority,” Dr Raje explained.
Secondary endpoints included time to the first on-study SRE (superiority), time to the first-and-subsequent on-study SRE (superiority), and overall survival.
Investigators also included the exploratory objective of progression-free survival (PFS).
Patient demographics
Patients were well balanced across the 2 arms, Dr Raje noted, and the breakdown of myeloma disease stage at diagnosis was comparable between the ZA and denosumab arms.
About 32% of patients were stage I, 37% stage II, and 29% stage III. Stage was not available for 49 patients.
A little more than half (54%) were male, mean age was 63 years, and 82% were white.
Two thirds had prior SRE history, and 54% of patients intended to undergo autologous PBSC transplant.
Enrollment began May 2012 and continued through the end of March 2016. The primary analysis cutoff was July 19, 2016.
Results
The primary endpoint for non-inferiority for time to first on-study SRE was met by denosumab (HR=0.98, 95%CI: 0.85, 1.14; P=0.01).
“When we looked at the secondary endpoints for superiority, we were not able to confirm superiority in this analysis, either for time to first SRE or time to first-and subsequent SRE on this study,” Dr Raje said.
The investigators also did not observe a survival difference between denosumab and ZA, with a hazard ratio (HR) (95% CI) of 0.90 (0.70, 1.16), P=0.41.
“Importantly, we had an exploratory endpoint where we looked at progression-free survival in this newly diagnosed patient population,” she added, “and we saw an interestingly increased or prolonged progression-free survival in patients getting denosumab.”
“And that survival difference was more than 10 months between denosumab and zoledronic acid, favoring the denosumab arm,” she affirmed. The HR was 0.82, 95% CI: 0.68, 0.99, P=0.036 (descriptive).
Safety
“[I]f you look at all treatment-emergent adverse events between denosumab and zoledronic acid, we really could not find a big difference in either of these 2 groups of patients,” Dr Raje said.
“We saw that in general both denosumab and zoledronic acid were extremely well tolerated between the 2 groups of patients.”
The investigators “drilled down” on certain toxicity issues of interest and examined events such as atypical stress fractures, hypersensitivity reactions, musculoskeletal pain, infections and infestations, new primary malignancies, and acute phase reactions.
They observed no atypical femur fractures on the study, nor did they see any big differences with respect to hypersensitivity or acute phase reactions.
The investigators examined closely any renal issues because dosing of ZA specifically is impacted by renal function.
The data showed that treatment-emergent adverse event (TEAE) renal toxicity was significantly higher in the ZA group compared to the denosumab group, 17% and 10%, respectively (P<0.001).
“When you look at patients who had a creatinine clearance less than 60 mL per minute,” Dr Raje emphasized, “we saw an almost doubling of renal toxicity in the zoledronic acid arm (26.4%) compared to the denosumab arm (12.9%).”
Patients with a creatinine level greater than 2 mg/dL had a significant increase in creatinine in the ZA arm (P=0.010), which was also significantly increased if their creatinine clearance was less than 60 mL/minute (P=0.054).
“There was a doubling of creatinine from baseline, more so in the zoledronic acid arm compared to the patients with denosumab,” Dr Raje said. “And this was again more pronounced if you had a creatinine clearance of less than 60.”
Hypocalcemia was “not surprisingly” more common in the denosumab arm than the ZA arm (P=0.009) for all patients, and osteonecrosis of the jaw was equal in both arms (P=0.147), although numerically slightly higher with denosumab treatment.
Dr Raje summarized that there was no difference in overall survival at the time of this analysis, “but I will say that the follow-up for a newly diagnosed patient population is fairly short right now.”
“Progression-free survival, which we saw [cut] off 10.7 months, was actually quite striking when denosumab was compared to zoledronic acid, and this was statistically highly significant.”
“The bone-specific benefits in combination with significantly fewer renal adverse events and possible prolongation of PFS with denosumab therapy we do think is very promising,” she said, “and may in fact be a new standard of care for multiple myeloma-related bone disease.”
The study was funded by Amgen Inc.
Denosumab (XGEVA®) is indicated by the US Food and Drug Administration for the prevention of fractures and other SREs in patients with bone metastases from solid tumors. It is currently not indicated for the prevention of SREs in patients with MM.
CHICAGO—The largest international multiple myeloma (MM) trial ever conducted, according to the trial sponsor, met its primary endpoint, demonstrating that denosumab is non-inferior to zoledronic acid (ZA) in delaying the time to first on-study skeletal-related event (SRE) in patients with MM.
In addition to bone-specific benefits, denosumab-treated patients had significantly fewer renal adverse events and possible prolongation of progression-free survival.
Denosumab “may in fact be a new standard of care for multiple myeloma-related bone disease,” according to one of the investigators.
“The other important thing to note,” Noopur S. Raje, MD, said during her presentation at the ASCO 2017 Annual Meeting, “is denosumab can be administered despite renal function in patients with myeloma.” It does not need to be dose-adjusted, unlike bisphosphonates.
Dr Raje, of the Massachusetts General Hospital Cancer Center in Boston, Massachusetts, presented the study results as abstract 8005.
Study design
The international, phase 3, randomized, double-blind study is evaluating the safety of denosumab compared with ZA in newly diagnosed MM patients.
Investigators enrolled 1718 patients from 259 sites and 29 countries.
They randomized 859 patients to receive denosumab 120 mg subcutaneously every 4 weeks plus intravenous placebo every 4 weeks, and 859 patients to the standard ZA dose of 4 mg intravenously plus subcutaneous placebo every 4 weeks.
Patients were stratified by whether they were on novel-based anti-myeloma therapy, whether they planned to have an autologous peripheral blood stem cell (PBSC) transplant, disease stage, and previous SRE.
“We were looking for 676 on-study SREs, and if we saw a benefit, patients would be offered open-label denosumab for up to 2 years after this,” Dr Raje said.
“Patients had to have radiographic evidence of bone disease, and this is different from some of the other bone disease studies that you’ve seen in the recent past,” she added.
In addition to documented evidence of MM, patients had to be 18 years or older, be ECOG status of 2 or better, have adequate organ function, and plan to receive or be receiving primary frontline anti-myeloma therapy.
Patients were excluded if they had nonsecretory MM, more than 30 days of previous treatment with anti-myeloma therapy prior to screening, prior use of denosumab, use of oral bisphosphonates with a cumulative dose of more than 1 year, more than 1 previous dose of intravenous bisphosphonate, or prior history or current evidence of osteonecrosis/osteomyelitis of the jaw.
The primary endpoint was time to first on-study SRE, “and the idea here was to look for non-inferiority,” Dr Raje explained.
Secondary endpoints included time to the first on-study SRE (superiority), time to the first-and-subsequent on-study SRE (superiority), and overall survival.
Investigators also included the exploratory objective of progression-free survival (PFS).
Patient demographics
Patients were well balanced across the 2 arms, Dr Raje noted, and the breakdown of myeloma disease stage at diagnosis was comparable between the ZA and denosumab arms.
About 32% of patients were stage I, 37% stage II, and 29% stage III. Stage was not available for 49 patients.
A little more than half (54%) were male, mean age was 63 years, and 82% were white.
Two thirds had prior SRE history, and 54% of patients intended to undergo autologous PBSC transplant.
Enrollment began May 2012 and continued through the end of March 2016. The primary analysis cutoff was July 19, 2016.
Results
The primary endpoint for non-inferiority for time to first on-study SRE was met by denosumab (HR=0.98, 95%CI: 0.85, 1.14; P=0.01).
“When we looked at the secondary endpoints for superiority, we were not able to confirm superiority in this analysis, either for time to first SRE or time to first-and subsequent SRE on this study,” Dr Raje said.
The investigators also did not observe a survival difference between denosumab and ZA, with a hazard ratio (HR) (95% CI) of 0.90 (0.70, 1.16), P=0.41.
“Importantly, we had an exploratory endpoint where we looked at progression-free survival in this newly diagnosed patient population,” she added, “and we saw an interestingly increased or prolonged progression-free survival in patients getting denosumab.”
“And that survival difference was more than 10 months between denosumab and zoledronic acid, favoring the denosumab arm,” she affirmed. The HR was 0.82, 95% CI: 0.68, 0.99, P=0.036 (descriptive).
Safety
“[I]f you look at all treatment-emergent adverse events between denosumab and zoledronic acid, we really could not find a big difference in either of these 2 groups of patients,” Dr Raje said.
“We saw that in general both denosumab and zoledronic acid were extremely well tolerated between the 2 groups of patients.”
The investigators “drilled down” on certain toxicity issues of interest and examined events such as atypical stress fractures, hypersensitivity reactions, musculoskeletal pain, infections and infestations, new primary malignancies, and acute phase reactions.
They observed no atypical femur fractures on the study, nor did they see any big differences with respect to hypersensitivity or acute phase reactions.
The investigators examined closely any renal issues because dosing of ZA specifically is impacted by renal function.
The data showed that treatment-emergent adverse event (TEAE) renal toxicity was significantly higher in the ZA group compared to the denosumab group, 17% and 10%, respectively (P<0.001).
“When you look at patients who had a creatinine clearance less than 60 mL per minute,” Dr Raje emphasized, “we saw an almost doubling of renal toxicity in the zoledronic acid arm (26.4%) compared to the denosumab arm (12.9%).”
Patients with a creatinine level greater than 2 mg/dL had a significant increase in creatinine in the ZA arm (P=0.010), which was also significantly increased if their creatinine clearance was less than 60 mL/minute (P=0.054).
“There was a doubling of creatinine from baseline, more so in the zoledronic acid arm compared to the patients with denosumab,” Dr Raje said. “And this was again more pronounced if you had a creatinine clearance of less than 60.”
Hypocalcemia was “not surprisingly” more common in the denosumab arm than the ZA arm (P=0.009) for all patients, and osteonecrosis of the jaw was equal in both arms (P=0.147), although numerically slightly higher with denosumab treatment.
Dr Raje summarized that there was no difference in overall survival at the time of this analysis, “but I will say that the follow-up for a newly diagnosed patient population is fairly short right now.”
“Progression-free survival, which we saw [cut] off 10.7 months, was actually quite striking when denosumab was compared to zoledronic acid, and this was statistically highly significant.”
“The bone-specific benefits in combination with significantly fewer renal adverse events and possible prolongation of PFS with denosumab therapy we do think is very promising,” she said, “and may in fact be a new standard of care for multiple myeloma-related bone disease.”
The study was funded by Amgen Inc.
Denosumab (XGEVA®) is indicated by the US Food and Drug Administration for the prevention of fractures and other SREs in patients with bone metastases from solid tumors. It is currently not indicated for the prevention of SREs in patients with MM.
CHICAGO—The largest international multiple myeloma (MM) trial ever conducted, according to the trial sponsor, met its primary endpoint, demonstrating that denosumab is non-inferior to zoledronic acid (ZA) in delaying the time to first on-study skeletal-related event (SRE) in patients with MM.
In addition to bone-specific benefits, denosumab-treated patients had significantly fewer renal adverse events and possible prolongation of progression-free survival.
Denosumab “may in fact be a new standard of care for multiple myeloma-related bone disease,” according to one of the investigators.
“The other important thing to note,” Noopur S. Raje, MD, said during her presentation at the ASCO 2017 Annual Meeting, “is denosumab can be administered despite renal function in patients with myeloma.” It does not need to be dose-adjusted, unlike bisphosphonates.
Dr Raje, of the Massachusetts General Hospital Cancer Center in Boston, Massachusetts, presented the study results as abstract 8005.
Study design
The international, phase 3, randomized, double-blind study is evaluating the safety of denosumab compared with ZA in newly diagnosed MM patients.
Investigators enrolled 1718 patients from 259 sites and 29 countries.
They randomized 859 patients to receive denosumab 120 mg subcutaneously every 4 weeks plus intravenous placebo every 4 weeks, and 859 patients to the standard ZA dose of 4 mg intravenously plus subcutaneous placebo every 4 weeks.
Patients were stratified by whether they were on novel-based anti-myeloma therapy, whether they planned to have an autologous peripheral blood stem cell (PBSC) transplant, disease stage, and previous SRE.
“We were looking for 676 on-study SREs, and if we saw a benefit, patients would be offered open-label denosumab for up to 2 years after this,” Dr Raje said.
“Patients had to have radiographic evidence of bone disease, and this is different from some of the other bone disease studies that you’ve seen in the recent past,” she added.
In addition to documented evidence of MM, patients had to be 18 years or older, be ECOG status of 2 or better, have adequate organ function, and plan to receive or be receiving primary frontline anti-myeloma therapy.
Patients were excluded if they had nonsecretory MM, more than 30 days of previous treatment with anti-myeloma therapy prior to screening, prior use of denosumab, use of oral bisphosphonates with a cumulative dose of more than 1 year, more than 1 previous dose of intravenous bisphosphonate, or prior history or current evidence of osteonecrosis/osteomyelitis of the jaw.
The primary endpoint was time to first on-study SRE, “and the idea here was to look for non-inferiority,” Dr Raje explained.
Secondary endpoints included time to the first on-study SRE (superiority), time to the first-and-subsequent on-study SRE (superiority), and overall survival.
Investigators also included the exploratory objective of progression-free survival (PFS).
Patient demographics
Patients were well balanced across the 2 arms, Dr Raje noted, and the breakdown of myeloma disease stage at diagnosis was comparable between the ZA and denosumab arms.
About 32% of patients were stage I, 37% stage II, and 29% stage III. Stage was not available for 49 patients.
A little more than half (54%) were male, mean age was 63 years, and 82% were white.
Two thirds had prior SRE history, and 54% of patients intended to undergo autologous PBSC transplant.
Enrollment began May 2012 and continued through the end of March 2016. The primary analysis cutoff was July 19, 2016.
Results
The primary endpoint for non-inferiority for time to first on-study SRE was met by denosumab (HR=0.98, 95%CI: 0.85, 1.14; P=0.01).
“When we looked at the secondary endpoints for superiority, we were not able to confirm superiority in this analysis, either for time to first SRE or time to first-and subsequent SRE on this study,” Dr Raje said.
The investigators also did not observe a survival difference between denosumab and ZA, with a hazard ratio (HR) (95% CI) of 0.90 (0.70, 1.16), P=0.41.
“Importantly, we had an exploratory endpoint where we looked at progression-free survival in this newly diagnosed patient population,” she added, “and we saw an interestingly increased or prolonged progression-free survival in patients getting denosumab.”
“And that survival difference was more than 10 months between denosumab and zoledronic acid, favoring the denosumab arm,” she affirmed. The HR was 0.82, 95% CI: 0.68, 0.99, P=0.036 (descriptive).
Safety
“[I]f you look at all treatment-emergent adverse events between denosumab and zoledronic acid, we really could not find a big difference in either of these 2 groups of patients,” Dr Raje said.
“We saw that in general both denosumab and zoledronic acid were extremely well tolerated between the 2 groups of patients.”
The investigators “drilled down” on certain toxicity issues of interest and examined events such as atypical stress fractures, hypersensitivity reactions, musculoskeletal pain, infections and infestations, new primary malignancies, and acute phase reactions.
They observed no atypical femur fractures on the study, nor did they see any big differences with respect to hypersensitivity or acute phase reactions.
The investigators examined closely any renal issues because dosing of ZA specifically is impacted by renal function.
The data showed that treatment-emergent adverse event (TEAE) renal toxicity was significantly higher in the ZA group compared to the denosumab group, 17% and 10%, respectively (P<0.001).
“When you look at patients who had a creatinine clearance less than 60 mL per minute,” Dr Raje emphasized, “we saw an almost doubling of renal toxicity in the zoledronic acid arm (26.4%) compared to the denosumab arm (12.9%).”
Patients with a creatinine level greater than 2 mg/dL had a significant increase in creatinine in the ZA arm (P=0.010), which was also significantly increased if their creatinine clearance was less than 60 mL/minute (P=0.054).
“There was a doubling of creatinine from baseline, more so in the zoledronic acid arm compared to the patients with denosumab,” Dr Raje said. “And this was again more pronounced if you had a creatinine clearance of less than 60.”
Hypocalcemia was “not surprisingly” more common in the denosumab arm than the ZA arm (P=0.009) for all patients, and osteonecrosis of the jaw was equal in both arms (P=0.147), although numerically slightly higher with denosumab treatment.
Dr Raje summarized that there was no difference in overall survival at the time of this analysis, “but I will say that the follow-up for a newly diagnosed patient population is fairly short right now.”
“Progression-free survival, which we saw [cut] off 10.7 months, was actually quite striking when denosumab was compared to zoledronic acid, and this was statistically highly significant.”
“The bone-specific benefits in combination with significantly fewer renal adverse events and possible prolongation of PFS with denosumab therapy we do think is very promising,” she said, “and may in fact be a new standard of care for multiple myeloma-related bone disease.”
The study was funded by Amgen Inc.
Denosumab (XGEVA®) is indicated by the US Food and Drug Administration for the prevention of fractures and other SREs in patients with bone metastases from solid tumors. It is currently not indicated for the prevention of SREs in patients with MM.
Child firearm suicide at highest rate in more than a decade
Boys, older children, and minorities are disproportionately affected when it comes to firearm injuries and deaths in U.S. children and adolescents, and child firearm suicide rates are at the highest they have been in more than a decade, new study results revealed.
Around 19 children are either medically treated for a gunshot wound or killed by one every day in the United States. “The majority of these children are boys 13-17 years old, African American in the case of firearm homicide, and white and American Indian in the case of firearm suicide. Pediatric firearm injuries and deaths are an important public health problem in the United States, contributing substantially each year to premature death, illness, and disability of children,” said Katherine A. Fowler, PhD, of the National Center for Injury Prevention and Control, Atlanta, and her associates. “Finding ways to prevent such injuries and ensure that all children have safe, stable, nurturing relationships and environments remains one of our most important priorities” (Pediatrics. 2017;140(1):e20163486).
“From 2012 to 2014, the average annual case fatality rate was 74% for firearm-related self-harm, 14% for firearm-related assaults, and 6% for unintentional firearm injuries,” the investigators reported.
Boys accounted for 82% of all child firearm deaths from 2012 to 2014. In this time period, the annual rate of firearm death for boys was 4.5 times higher than the annual rate for girls (2.8 vs. 0.6 per 100,000). This difference was even more pronounced by age, with the rate for 13- to 17-year-old boys being six times higher than the rate for same-aged girls. Similarly, boys suffer the majority of nonfatal firearm injuries treated in U.S. emergency departments, accounting for 84% of all nonfatal firearm injuries medically treated each year from 2012 to 2014. The average annual rate of nonfatal firearm injuries for boys was five times the rate for girls at 13 vs. 3 per 100,000.
The annual rate of firearm homicide was 10 times higher among 13- to 17-year-olds versus 0- to 12-year-olds (3 vs. 0.3 per 100,000). Unintentional firearm death rates were approximately twice as high when comparing these two groups (0.2 vs. 0.1 per 100,000).
Dr. Fowler and her associates wrote, “Our findings indicate that most children who died of unintentional firearm injuries were shot by another child in their own age range and most often in the context of playing with a gun or showing it to others. More than one-third of the deaths of older children occurred in incidents in which the shooter thought that the gun was unloaded or thought that the safety was engaged.”
“Child firearm suicide rates showed a significant upward trend between 2007 and 2014, increasing 60% from 1.0 to 1.6 (P less than .05) to the highest rate seen over the period examined,” Dr. Fowler and her associates said.
Firearm suicide rates were 11 times higher among 13- to 17-year-olds vs. 10- to 12-year-olds (2 vs. 0.2 per 100,000). Older children also accounted for 88% of all nonfatal firearm injuries treated in an ED. The overall average annual rate of nonfatal firearm injuries for older children was 19 times that of younger children (24 vs. 1 per 100,000).
The annual firearm homicide rate for African American children was nearly 10 times higher than the rate for white children (4 vs. 0.4 per 100,000). However, the annual rate of firearm suicide among white children was nearly four times higher than the rate for African American children (2. vs. 0.6 per 100,000).
Awareness of the availability of firearms during times of crisis is crucial because suicides are often impulsive in young people, Dr. Fowler and her associates said, “with previous findings indicating that many who attempt suicide spend 10 minutes or less deliberating. Safe storage practices (i.e., unloading and locking all firearms and ammunition) can potentially be lifesaving in these instances,” as the results of previous studies in this age group attest.
Firearm deaths are the third leading cause of death overall among children in the United States aged 1-17 years, beating pediatric congenital anomalies, heart disease, influenza/pneumonia, chronic lower respiratory disease, and cerebrovascular causes. Understanding the nature, scale, and impact of firearm violence against children is an important first step, concluded Dr. Fowler and her associates.
Dr. Fowler and her associates said they had no relevant financial disclosures.
Dr. Fowler’s study brings a lot of uncomfortable statistics to light. Subsequently we are left wondering, What can we do about it? With firearm injury mortality rates in children increasing over the past 2 years according to the CDC’s Web-based Injury Statistics Query and Reporting System, it is crucial that we continue to demand the appropriate support for this public health crisis.
Recognizing the prevalence of guns in homes and the potential dangers of easy access to them makes it essential to ask about firearms as part of our injury prevention guidance and offer counseling to parents and children about safe gun storage, gun locks, or support for legislation to protect children from gun violence.
It is important to engage gun owners about gun safety and “point out that parents may underestimate kids’ propensity to handle guns unsafely, even when they’ve been taught,” as well as the “impulsivity, risk-taking, and unpredictability of adolescence. ... We pediatric clinicians tend not to discuss firearm injury prevention much,” but a recent review of the problem offers some excellent guidance that “may help us to do more,” according to Dr. Nelson (Adolesc Med State Art Rev. 2016;27[2]:323-40).
However problematic it may be to confront the problem of firearm injuries in children and adolescents, we cannot ignore the scale of this current epidemic.
Eliot W. Nelson, MD, is a pediatrician at the University of Vermont Children’s Hospital. He reported having no relevant financial disclosures. These remarks are adapted from an editorial accompanying the report by Fowler et al. (Pediatrics. 2017. doi: 10.1542/peds.2017-1300).
Dr. Fowler’s study brings a lot of uncomfortable statistics to light. Subsequently we are left wondering, What can we do about it? With firearm injury mortality rates in children increasing over the past 2 years according to the CDC’s Web-based Injury Statistics Query and Reporting System, it is crucial that we continue to demand the appropriate support for this public health crisis.
Recognizing the prevalence of guns in homes and the potential dangers of easy access to them makes it essential to ask about firearms as part of our injury prevention guidance and offer counseling to parents and children about safe gun storage, gun locks, or support for legislation to protect children from gun violence.
It is important to engage gun owners about gun safety and “point out that parents may underestimate kids’ propensity to handle guns unsafely, even when they’ve been taught,” as well as the “impulsivity, risk-taking, and unpredictability of adolescence. ... We pediatric clinicians tend not to discuss firearm injury prevention much,” but a recent review of the problem offers some excellent guidance that “may help us to do more,” according to Dr. Nelson (Adolesc Med State Art Rev. 2016;27[2]:323-40).
However problematic it may be to confront the problem of firearm injuries in children and adolescents, we cannot ignore the scale of this current epidemic.
Eliot W. Nelson, MD, is a pediatrician at the University of Vermont Children’s Hospital. He reported having no relevant financial disclosures. These remarks are adapted from an editorial accompanying the report by Fowler et al. (Pediatrics. 2017. doi: 10.1542/peds.2017-1300).
Dr. Fowler’s study brings a lot of uncomfortable statistics to light. Subsequently we are left wondering, What can we do about it? With firearm injury mortality rates in children increasing over the past 2 years according to the CDC’s Web-based Injury Statistics Query and Reporting System, it is crucial that we continue to demand the appropriate support for this public health crisis.
Recognizing the prevalence of guns in homes and the potential dangers of easy access to them makes it essential to ask about firearms as part of our injury prevention guidance and offer counseling to parents and children about safe gun storage, gun locks, or support for legislation to protect children from gun violence.
It is important to engage gun owners about gun safety and “point out that parents may underestimate kids’ propensity to handle guns unsafely, even when they’ve been taught,” as well as the “impulsivity, risk-taking, and unpredictability of adolescence. ... We pediatric clinicians tend not to discuss firearm injury prevention much,” but a recent review of the problem offers some excellent guidance that “may help us to do more,” according to Dr. Nelson (Adolesc Med State Art Rev. 2016;27[2]:323-40).
However problematic it may be to confront the problem of firearm injuries in children and adolescents, we cannot ignore the scale of this current epidemic.
Eliot W. Nelson, MD, is a pediatrician at the University of Vermont Children’s Hospital. He reported having no relevant financial disclosures. These remarks are adapted from an editorial accompanying the report by Fowler et al. (Pediatrics. 2017. doi: 10.1542/peds.2017-1300).
Boys, older children, and minorities are disproportionately affected when it comes to firearm injuries and deaths in U.S. children and adolescents, and child firearm suicide rates are at the highest they have been in more than a decade, new study results revealed.
Around 19 children are either medically treated for a gunshot wound or killed by one every day in the United States. “The majority of these children are boys 13-17 years old, African American in the case of firearm homicide, and white and American Indian in the case of firearm suicide. Pediatric firearm injuries and deaths are an important public health problem in the United States, contributing substantially each year to premature death, illness, and disability of children,” said Katherine A. Fowler, PhD, of the National Center for Injury Prevention and Control, Atlanta, and her associates. “Finding ways to prevent such injuries and ensure that all children have safe, stable, nurturing relationships and environments remains one of our most important priorities” (Pediatrics. 2017;140(1):e20163486).
“From 2012 to 2014, the average annual case fatality rate was 74% for firearm-related self-harm, 14% for firearm-related assaults, and 6% for unintentional firearm injuries,” the investigators reported.
Boys accounted for 82% of all child firearm deaths from 2012 to 2014. In this time period, the annual rate of firearm death for boys was 4.5 times higher than the annual rate for girls (2.8 vs. 0.6 per 100,000). This difference was even more pronounced by age, with the rate for 13- to 17-year-old boys being six times higher than the rate for same-aged girls. Similarly, boys suffer the majority of nonfatal firearm injuries treated in U.S. emergency departments, accounting for 84% of all nonfatal firearm injuries medically treated each year from 2012 to 2014. The average annual rate of nonfatal firearm injuries for boys was five times the rate for girls at 13 vs. 3 per 100,000.
The annual rate of firearm homicide was 10 times higher among 13- to 17-year-olds versus 0- to 12-year-olds (3 vs. 0.3 per 100,000). Unintentional firearm death rates were approximately twice as high when comparing these two groups (0.2 vs. 0.1 per 100,000).
Dr. Fowler and her associates wrote, “Our findings indicate that most children who died of unintentional firearm injuries were shot by another child in their own age range and most often in the context of playing with a gun or showing it to others. More than one-third of the deaths of older children occurred in incidents in which the shooter thought that the gun was unloaded or thought that the safety was engaged.”
“Child firearm suicide rates showed a significant upward trend between 2007 and 2014, increasing 60% from 1.0 to 1.6 (P less than .05) to the highest rate seen over the period examined,” Dr. Fowler and her associates said.
Firearm suicide rates were 11 times higher among 13- to 17-year-olds vs. 10- to 12-year-olds (2 vs. 0.2 per 100,000). Older children also accounted for 88% of all nonfatal firearm injuries treated in an ED. The overall average annual rate of nonfatal firearm injuries for older children was 19 times that of younger children (24 vs. 1 per 100,000).
The annual firearm homicide rate for African American children was nearly 10 times higher than the rate for white children (4 vs. 0.4 per 100,000). However, the annual rate of firearm suicide among white children was nearly four times higher than the rate for African American children (2. vs. 0.6 per 100,000).
Awareness of the availability of firearms during times of crisis is crucial because suicides are often impulsive in young people, Dr. Fowler and her associates said, “with previous findings indicating that many who attempt suicide spend 10 minutes or less deliberating. Safe storage practices (i.e., unloading and locking all firearms and ammunition) can potentially be lifesaving in these instances,” as the results of previous studies in this age group attest.
Firearm deaths are the third leading cause of death overall among children in the United States aged 1-17 years, beating pediatric congenital anomalies, heart disease, influenza/pneumonia, chronic lower respiratory disease, and cerebrovascular causes. Understanding the nature, scale, and impact of firearm violence against children is an important first step, concluded Dr. Fowler and her associates.
Dr. Fowler and her associates said they had no relevant financial disclosures.
Boys, older children, and minorities are disproportionately affected when it comes to firearm injuries and deaths in U.S. children and adolescents, and child firearm suicide rates are at the highest they have been in more than a decade, new study results revealed.
Around 19 children are either medically treated for a gunshot wound or killed by one every day in the United States. “The majority of these children are boys 13-17 years old, African American in the case of firearm homicide, and white and American Indian in the case of firearm suicide. Pediatric firearm injuries and deaths are an important public health problem in the United States, contributing substantially each year to premature death, illness, and disability of children,” said Katherine A. Fowler, PhD, of the National Center for Injury Prevention and Control, Atlanta, and her associates. “Finding ways to prevent such injuries and ensure that all children have safe, stable, nurturing relationships and environments remains one of our most important priorities” (Pediatrics. 2017;140(1):e20163486).
“From 2012 to 2014, the average annual case fatality rate was 74% for firearm-related self-harm, 14% for firearm-related assaults, and 6% for unintentional firearm injuries,” the investigators reported.
Boys accounted for 82% of all child firearm deaths from 2012 to 2014. In this time period, the annual rate of firearm death for boys was 4.5 times higher than the annual rate for girls (2.8 vs. 0.6 per 100,000). This difference was even more pronounced by age, with the rate for 13- to 17-year-old boys being six times higher than the rate for same-aged girls. Similarly, boys suffer the majority of nonfatal firearm injuries treated in U.S. emergency departments, accounting for 84% of all nonfatal firearm injuries medically treated each year from 2012 to 2014. The average annual rate of nonfatal firearm injuries for boys was five times the rate for girls at 13 vs. 3 per 100,000.
The annual rate of firearm homicide was 10 times higher among 13- to 17-year-olds versus 0- to 12-year-olds (3 vs. 0.3 per 100,000). Unintentional firearm death rates were approximately twice as high when comparing these two groups (0.2 vs. 0.1 per 100,000).
Dr. Fowler and her associates wrote, “Our findings indicate that most children who died of unintentional firearm injuries were shot by another child in their own age range and most often in the context of playing with a gun or showing it to others. More than one-third of the deaths of older children occurred in incidents in which the shooter thought that the gun was unloaded or thought that the safety was engaged.”
“Child firearm suicide rates showed a significant upward trend between 2007 and 2014, increasing 60% from 1.0 to 1.6 (P less than .05) to the highest rate seen over the period examined,” Dr. Fowler and her associates said.
Firearm suicide rates were 11 times higher among 13- to 17-year-olds vs. 10- to 12-year-olds (2 vs. 0.2 per 100,000). Older children also accounted for 88% of all nonfatal firearm injuries treated in an ED. The overall average annual rate of nonfatal firearm injuries for older children was 19 times that of younger children (24 vs. 1 per 100,000).
The annual firearm homicide rate for African American children was nearly 10 times higher than the rate for white children (4 vs. 0.4 per 100,000). However, the annual rate of firearm suicide among white children was nearly four times higher than the rate for African American children (2. vs. 0.6 per 100,000).
Awareness of the availability of firearms during times of crisis is crucial because suicides are often impulsive in young people, Dr. Fowler and her associates said, “with previous findings indicating that many who attempt suicide spend 10 minutes or less deliberating. Safe storage practices (i.e., unloading and locking all firearms and ammunition) can potentially be lifesaving in these instances,” as the results of previous studies in this age group attest.
Firearm deaths are the third leading cause of death overall among children in the United States aged 1-17 years, beating pediatric congenital anomalies, heart disease, influenza/pneumonia, chronic lower respiratory disease, and cerebrovascular causes. Understanding the nature, scale, and impact of firearm violence against children is an important first step, concluded Dr. Fowler and her associates.
Dr. Fowler and her associates said they had no relevant financial disclosures.
FROM PEDIATRICS
Key clinical point:
Major finding: Firearm suicide rates were 11 times higher among 13- to 17-year-olds versus 10- to 12-year-olds (2 vs. 0.2 per 100,000).
Data source: National 2012-2014 data from CDC’s National Vital Statistics System and the National Electronic Injury Surveillance System.
Disclosures: Dr. Fowler and her associates said they had no relevant financial disclosures.
Common Conditions in Persons with Skin of Color
1. This patient is concerned about the numerous long-standing “moles” on her face. Only occasionally pruritic, they are otherwise asymptomatic. Nevertheless, the patient wants them investigated and removed.
Diagnosis: Dermatosis papulosa nigra (DPN) is a benign condition that presents as multiple brown to dark-brown 1- to 5-mm papules on the face, neck, and trunk. The lesions are a sign of aging in darker skinned patients and do not require treatment. They can, however, be safely, easily, and effectively removed. Both electrodesiccation and KTP (532 nm) laser have comparable efficacy in the removal of DPN, according to a 2009 study published in the American Journal of Dermatologic Surgery. Without use of anesthetics, the KTP laser is preferred for patient comfort.
For more information, see “Skin of Color: Dermatosis Papulosa Nigra Removal.” Dermatology News. February 1, 2012.
2. A 17-year-old African-American boy likes to keep his face clean-shaven, but his skin becomes irritated every time he shaves. He states that his father also has this problem, but doesn’t have a solution.
Diagnosis: Pseudofolliculitis is a common skin condition affecting hair-bearing areas of the body that are shaved. It develops when the free end of a tightly coiled hair reenters the skin after shaving, causing a foreign-body–like inflammatory reaction. Tightly curled hair has a greater tendency to pierce the follicle and the surface of the skin, explaining the relative predominance of pseudofolliculitis in patients of African descent; at least half of black men who shave develop the condition.
For more information, see “Bumps in beard area.” J Fam Pract. 2015 November;64(11).
3. A 15-year-old African-American boy presents with a two-month history of hair loss and pruritic papules on the back of his head that developed after a barber shaved the area. There are two dozen 1- to 2-mm papules on his posterior neck and occipital scalp with areas of focal crusting. The patient had a similar episode a year ago after shaving the same area, but those papules cleared after one month of applying rubbing alcohol.
Diagnosis: This patient’s diagnosis is acne keloidalis nuchae (AKN), a chronic folliculitis characterized by smooth, dome-shaped papules on the posterior scalp and neck that become confluent and form firm papules and hairless, keloid-like plaques. Seen almost exclusively in young, postpubescent African-American males, the condition is often asymptomatic, although some patients complain of itching in the affected area.
For more information, see “Scalp papules in a teenage boy.” J Fam Pract. 2017 March;66(3).
4. Several years after a motorcycle accident and resulting road rash, this 23-year-old Hispanic woman is left with complex scars. She experiences pruritus, pain, and hypersensitivity and is seeking relief.
Diagnosis: Often confused with hypertrophic scars, keloids are benign overgrowths of scar tissue that can occur months to years after skin trauma. They are most common in those ages 10 to 30, with a higher incidence among blacks, Hispanics, and Asians. Although the exact etiology of keloids is unknown, they are related to aberrant collagen production and breakdown in wound healing.
For more information, see “Laser treatment of scars and keloids.” Cosmet Dermatol. 2012;25:318-325.
1. This patient is concerned about the numerous long-standing “moles” on her face. Only occasionally pruritic, they are otherwise asymptomatic. Nevertheless, the patient wants them investigated and removed.
Diagnosis: Dermatosis papulosa nigra (DPN) is a benign condition that presents as multiple brown to dark-brown 1- to 5-mm papules on the face, neck, and trunk. The lesions are a sign of aging in darker skinned patients and do not require treatment. They can, however, be safely, easily, and effectively removed. Both electrodesiccation and KTP (532 nm) laser have comparable efficacy in the removal of DPN, according to a 2009 study published in the American Journal of Dermatologic Surgery. Without use of anesthetics, the KTP laser is preferred for patient comfort.
For more information, see “Skin of Color: Dermatosis Papulosa Nigra Removal.” Dermatology News. February 1, 2012.
2. A 17-year-old African-American boy likes to keep his face clean-shaven, but his skin becomes irritated every time he shaves. He states that his father also has this problem, but doesn’t have a solution.
Diagnosis: Pseudofolliculitis is a common skin condition affecting hair-bearing areas of the body that are shaved. It develops when the free end of a tightly coiled hair reenters the skin after shaving, causing a foreign-body–like inflammatory reaction. Tightly curled hair has a greater tendency to pierce the follicle and the surface of the skin, explaining the relative predominance of pseudofolliculitis in patients of African descent; at least half of black men who shave develop the condition.
For more information, see “Bumps in beard area.” J Fam Pract. 2015 November;64(11).
3. A 15-year-old African-American boy presents with a two-month history of hair loss and pruritic papules on the back of his head that developed after a barber shaved the area. There are two dozen 1- to 2-mm papules on his posterior neck and occipital scalp with areas of focal crusting. The patient had a similar episode a year ago after shaving the same area, but those papules cleared after one month of applying rubbing alcohol.
Diagnosis: This patient’s diagnosis is acne keloidalis nuchae (AKN), a chronic folliculitis characterized by smooth, dome-shaped papules on the posterior scalp and neck that become confluent and form firm papules and hairless, keloid-like plaques. Seen almost exclusively in young, postpubescent African-American males, the condition is often asymptomatic, although some patients complain of itching in the affected area.
For more information, see “Scalp papules in a teenage boy.” J Fam Pract. 2017 March;66(3).
4. Several years after a motorcycle accident and resulting road rash, this 23-year-old Hispanic woman is left with complex scars. She experiences pruritus, pain, and hypersensitivity and is seeking relief.
Diagnosis: Often confused with hypertrophic scars, keloids are benign overgrowths of scar tissue that can occur months to years after skin trauma. They are most common in those ages 10 to 30, with a higher incidence among blacks, Hispanics, and Asians. Although the exact etiology of keloids is unknown, they are related to aberrant collagen production and breakdown in wound healing.
For more information, see “Laser treatment of scars and keloids.” Cosmet Dermatol. 2012;25:318-325.
1. This patient is concerned about the numerous long-standing “moles” on her face. Only occasionally pruritic, they are otherwise asymptomatic. Nevertheless, the patient wants them investigated and removed.
Diagnosis: Dermatosis papulosa nigra (DPN) is a benign condition that presents as multiple brown to dark-brown 1- to 5-mm papules on the face, neck, and trunk. The lesions are a sign of aging in darker skinned patients and do not require treatment. They can, however, be safely, easily, and effectively removed. Both electrodesiccation and KTP (532 nm) laser have comparable efficacy in the removal of DPN, according to a 2009 study published in the American Journal of Dermatologic Surgery. Without use of anesthetics, the KTP laser is preferred for patient comfort.
For more information, see “Skin of Color: Dermatosis Papulosa Nigra Removal.” Dermatology News. February 1, 2012.
2. A 17-year-old African-American boy likes to keep his face clean-shaven, but his skin becomes irritated every time he shaves. He states that his father also has this problem, but doesn’t have a solution.
Diagnosis: Pseudofolliculitis is a common skin condition affecting hair-bearing areas of the body that are shaved. It develops when the free end of a tightly coiled hair reenters the skin after shaving, causing a foreign-body–like inflammatory reaction. Tightly curled hair has a greater tendency to pierce the follicle and the surface of the skin, explaining the relative predominance of pseudofolliculitis in patients of African descent; at least half of black men who shave develop the condition.
For more information, see “Bumps in beard area.” J Fam Pract. 2015 November;64(11).
3. A 15-year-old African-American boy presents with a two-month history of hair loss and pruritic papules on the back of his head that developed after a barber shaved the area. There are two dozen 1- to 2-mm papules on his posterior neck and occipital scalp with areas of focal crusting. The patient had a similar episode a year ago after shaving the same area, but those papules cleared after one month of applying rubbing alcohol.
Diagnosis: This patient’s diagnosis is acne keloidalis nuchae (AKN), a chronic folliculitis characterized by smooth, dome-shaped papules on the posterior scalp and neck that become confluent and form firm papules and hairless, keloid-like plaques. Seen almost exclusively in young, postpubescent African-American males, the condition is often asymptomatic, although some patients complain of itching in the affected area.
For more information, see “Scalp papules in a teenage boy.” J Fam Pract. 2017 March;66(3).
4. Several years after a motorcycle accident and resulting road rash, this 23-year-old Hispanic woman is left with complex scars. She experiences pruritus, pain, and hypersensitivity and is seeking relief.
Diagnosis: Often confused with hypertrophic scars, keloids are benign overgrowths of scar tissue that can occur months to years after skin trauma. They are most common in those ages 10 to 30, with a higher incidence among blacks, Hispanics, and Asians. Although the exact etiology of keloids is unknown, they are related to aberrant collagen production and breakdown in wound healing.
For more information, see “Laser treatment of scars and keloids.” Cosmet Dermatol. 2012;25:318-325.
Shift to minimally invasive MV surgery picks up
NEW YORK – An analysis of a Society of Thoracic Surgeons database has identified a significant increase in volumes for isolated mitral valve surgery and leaflet prolapse this decade, with a shift toward minimally invasive approaches, according to a study of trends in mitral valve surgery in the United States presented here at the American Association for Thoracic Surgery Mitral Conclave 2017.
James Gammie, MD, of the University of Maryland School of Medicine, Baltimore, reported on the analysis of the STS Adult Cardiac Surgery Database in which more than 90% of the adult cardiac surgery centers in North America participate.
“Degenerative disease remains the most common reason patients are referred for surgery,” Dr. Gammie said, noting that 60.7% of patients with an identified etiology had degenerative leaflet prolapse (etiology was unknown in 31% of the patients in the dataset).
“The operative approach has changed and continues to shift toward a less invasive approach,” Dr. Gammie said. Overall, 74.1% of operations involved sternotomy, but only 67.5% of those in the leaflet prolapse subgroup, with less invasive operations comprising 23% of all operations and 29.1% of those in the leaflet prolapse subgroup. From 2011 to 2016, total mitral surgical volume grew at a rate of 1.1% annually, but the volume for isolated MV operations grew 4.4% annually while leaflet prolapse procedures increased 7.6% annually, Dr. Gammie said.
Dr. Gammie described surgeons’ decision to perform ablation for preoperative AF during MV surgery a “coin toss.” One-third (34%) had AF, but only 51.2% of patients with AF in the total cohort and 54.4% of those in the leaflet prolapse subgroup got ablation. The overall MV repair rate was 65% for the total cohort but 83% for those with leaflet prolapse. For those who had MV replacement, the share of bioprosthetic devices increased steadily through the study period, from around 65% to 75.8%, Dr. Gammie said.
In the leaflet prolapse subgroup, 96.1% had annuloplasty and 29.2% had artificial chords implanted, with an average of two chords per operation. “There’s an increasing use of artificial ePTFE chords,” Dr. Gammie said. He noted the leaflet prolapse subgroup was composed of low-risk healthy patients. The mean ejection fraction (EF) for the cohort was 57%, and 47% of patients had EF of less than 60%. The overwhelming majority of patients (88%) had Class I indications for surgery with the remainder having Class IIa indications.
Dr. Gammie noted a few other emerging trends of MV surgery during the study period. “Patients with functional mitral regurgitation are rarely referred for operation: these patients made up fewer than 5% of patients undergoing mitral valve operations during the study period,” he said.;
With regard to outcomes, Dr. Gammie said, “There remain substantial differences between repair and replacement.” Replacement had almost twice the rate of reoperation for bleeding than repair (4.1% vs. 2.1%) and renal failure (3.4% vs. 1.4%).
“We observed that a substantial number of patients have an unsuccessful attempt at mitral valve repair before undergoing replacement – 16 % of the overall replacement group and 27% of patients having replacement for degenerative leaflet prolapse,” he said. “This does not appear to penalize patients in terms of outcome.”
The rate of permanent pacemaker was also significantly higher in the replacement cohort, 9.8% vs. 3.8% for repair operations, as was operative mortality, 3.7% vs. 1.1%. Said Dr. Gammie.
“This is something to think about as we move to less invasive approaches and overall operative mortality remains over threefold higher for replacement than repair.”
The leaflet prolapse subgroup showed similar disparities between replacement and repair groups. “The increased application of repair when feasible will be of value to improve outcomes, as will referral of patients earlier in the disease process ,” Dr. Gammie said.
“In our own STS database, about one-third of patients who were coded as having AF had no evidence of it, and that’s why in our institution they don’t get treated.” He added, “I’m not that surprised at the low repair rate when the average surgeon in the United States does five mitral repairs a year.”
Dr. Gammie disclosed that he is a consultant to Edwards Lifesciences and has an ownership interest in Harpoon Medical. Dr. Damiano disclosed that he is a speaker for LivaNova and a consultant to and a research grant recipient of Atricure.
NEW YORK – An analysis of a Society of Thoracic Surgeons database has identified a significant increase in volumes for isolated mitral valve surgery and leaflet prolapse this decade, with a shift toward minimally invasive approaches, according to a study of trends in mitral valve surgery in the United States presented here at the American Association for Thoracic Surgery Mitral Conclave 2017.
James Gammie, MD, of the University of Maryland School of Medicine, Baltimore, reported on the analysis of the STS Adult Cardiac Surgery Database in which more than 90% of the adult cardiac surgery centers in North America participate.
“Degenerative disease remains the most common reason patients are referred for surgery,” Dr. Gammie said, noting that 60.7% of patients with an identified etiology had degenerative leaflet prolapse (etiology was unknown in 31% of the patients in the dataset).
“The operative approach has changed and continues to shift toward a less invasive approach,” Dr. Gammie said. Overall, 74.1% of operations involved sternotomy, but only 67.5% of those in the leaflet prolapse subgroup, with less invasive operations comprising 23% of all operations and 29.1% of those in the leaflet prolapse subgroup. From 2011 to 2016, total mitral surgical volume grew at a rate of 1.1% annually, but the volume for isolated MV operations grew 4.4% annually while leaflet prolapse procedures increased 7.6% annually, Dr. Gammie said.
Dr. Gammie described surgeons’ decision to perform ablation for preoperative AF during MV surgery a “coin toss.” One-third (34%) had AF, but only 51.2% of patients with AF in the total cohort and 54.4% of those in the leaflet prolapse subgroup got ablation. The overall MV repair rate was 65% for the total cohort but 83% for those with leaflet prolapse. For those who had MV replacement, the share of bioprosthetic devices increased steadily through the study period, from around 65% to 75.8%, Dr. Gammie said.
In the leaflet prolapse subgroup, 96.1% had annuloplasty and 29.2% had artificial chords implanted, with an average of two chords per operation. “There’s an increasing use of artificial ePTFE chords,” Dr. Gammie said. He noted the leaflet prolapse subgroup was composed of low-risk healthy patients. The mean ejection fraction (EF) for the cohort was 57%, and 47% of patients had EF of less than 60%. The overwhelming majority of patients (88%) had Class I indications for surgery with the remainder having Class IIa indications.
Dr. Gammie noted a few other emerging trends of MV surgery during the study period. “Patients with functional mitral regurgitation are rarely referred for operation: these patients made up fewer than 5% of patients undergoing mitral valve operations during the study period,” he said.;
With regard to outcomes, Dr. Gammie said, “There remain substantial differences between repair and replacement.” Replacement had almost twice the rate of reoperation for bleeding than repair (4.1% vs. 2.1%) and renal failure (3.4% vs. 1.4%).
“We observed that a substantial number of patients have an unsuccessful attempt at mitral valve repair before undergoing replacement – 16 % of the overall replacement group and 27% of patients having replacement for degenerative leaflet prolapse,” he said. “This does not appear to penalize patients in terms of outcome.”
The rate of permanent pacemaker was also significantly higher in the replacement cohort, 9.8% vs. 3.8% for repair operations, as was operative mortality, 3.7% vs. 1.1%. Said Dr. Gammie.
“This is something to think about as we move to less invasive approaches and overall operative mortality remains over threefold higher for replacement than repair.”
The leaflet prolapse subgroup showed similar disparities between replacement and repair groups. “The increased application of repair when feasible will be of value to improve outcomes, as will referral of patients earlier in the disease process ,” Dr. Gammie said.
“In our own STS database, about one-third of patients who were coded as having AF had no evidence of it, and that’s why in our institution they don’t get treated.” He added, “I’m not that surprised at the low repair rate when the average surgeon in the United States does five mitral repairs a year.”
Dr. Gammie disclosed that he is a consultant to Edwards Lifesciences and has an ownership interest in Harpoon Medical. Dr. Damiano disclosed that he is a speaker for LivaNova and a consultant to and a research grant recipient of Atricure.
NEW YORK – An analysis of a Society of Thoracic Surgeons database has identified a significant increase in volumes for isolated mitral valve surgery and leaflet prolapse this decade, with a shift toward minimally invasive approaches, according to a study of trends in mitral valve surgery in the United States presented here at the American Association for Thoracic Surgery Mitral Conclave 2017.
James Gammie, MD, of the University of Maryland School of Medicine, Baltimore, reported on the analysis of the STS Adult Cardiac Surgery Database in which more than 90% of the adult cardiac surgery centers in North America participate.
“Degenerative disease remains the most common reason patients are referred for surgery,” Dr. Gammie said, noting that 60.7% of patients with an identified etiology had degenerative leaflet prolapse (etiology was unknown in 31% of the patients in the dataset).
“The operative approach has changed and continues to shift toward a less invasive approach,” Dr. Gammie said. Overall, 74.1% of operations involved sternotomy, but only 67.5% of those in the leaflet prolapse subgroup, with less invasive operations comprising 23% of all operations and 29.1% of those in the leaflet prolapse subgroup. From 2011 to 2016, total mitral surgical volume grew at a rate of 1.1% annually, but the volume for isolated MV operations grew 4.4% annually while leaflet prolapse procedures increased 7.6% annually, Dr. Gammie said.
Dr. Gammie described surgeons’ decision to perform ablation for preoperative AF during MV surgery a “coin toss.” One-third (34%) had AF, but only 51.2% of patients with AF in the total cohort and 54.4% of those in the leaflet prolapse subgroup got ablation. The overall MV repair rate was 65% for the total cohort but 83% for those with leaflet prolapse. For those who had MV replacement, the share of bioprosthetic devices increased steadily through the study period, from around 65% to 75.8%, Dr. Gammie said.
In the leaflet prolapse subgroup, 96.1% had annuloplasty and 29.2% had artificial chords implanted, with an average of two chords per operation. “There’s an increasing use of artificial ePTFE chords,” Dr. Gammie said. He noted the leaflet prolapse subgroup was composed of low-risk healthy patients. The mean ejection fraction (EF) for the cohort was 57%, and 47% of patients had EF of less than 60%. The overwhelming majority of patients (88%) had Class I indications for surgery with the remainder having Class IIa indications.
Dr. Gammie noted a few other emerging trends of MV surgery during the study period. “Patients with functional mitral regurgitation are rarely referred for operation: these patients made up fewer than 5% of patients undergoing mitral valve operations during the study period,” he said.;
With regard to outcomes, Dr. Gammie said, “There remain substantial differences between repair and replacement.” Replacement had almost twice the rate of reoperation for bleeding than repair (4.1% vs. 2.1%) and renal failure (3.4% vs. 1.4%).
“We observed that a substantial number of patients have an unsuccessful attempt at mitral valve repair before undergoing replacement – 16 % of the overall replacement group and 27% of patients having replacement for degenerative leaflet prolapse,” he said. “This does not appear to penalize patients in terms of outcome.”
The rate of permanent pacemaker was also significantly higher in the replacement cohort, 9.8% vs. 3.8% for repair operations, as was operative mortality, 3.7% vs. 1.1%. Said Dr. Gammie.
“This is something to think about as we move to less invasive approaches and overall operative mortality remains over threefold higher for replacement than repair.”
The leaflet prolapse subgroup showed similar disparities between replacement and repair groups. “The increased application of repair when feasible will be of value to improve outcomes, as will referral of patients earlier in the disease process ,” Dr. Gammie said.
“In our own STS database, about one-third of patients who were coded as having AF had no evidence of it, and that’s why in our institution they don’t get treated.” He added, “I’m not that surprised at the low repair rate when the average surgeon in the United States does five mitral repairs a year.”
Dr. Gammie disclosed that he is a consultant to Edwards Lifesciences and has an ownership interest in Harpoon Medical. Dr. Damiano disclosed that he is a speaker for LivaNova and a consultant to and a research grant recipient of Atricure.
AT THE AATS MITRAL CONCLAVE 2017
Key clinical point: The volume of mitral valve surgery has increased substantially, according to an analysis of the Society for Thoracic Surgery database, and an increasing percentage of procedures are minimally invasive in nature.
Major finding: Sternotomy continues to be the most widely used approach for mitral valve surgery, but less invasive options most recently comprised 23% of the overall group and 29.1% of those with isolated leaflet prolapse.
Data source: Retrospective study of 15,360 isolated mitral valve operations performed from July 2011 to September 2016 in the Society of Thoracic Surgeons database.
Disclosures: Dr. Gammie reported being a consultant to Edwards Lifesciences and having an ownership interest in Harpoon Medical.
Urgent surgery said to deserve separate classification
Urgent surgery deserves a separate classification from elective surgery and emergency surgery for assessments of healthcare quality and performance, because the three types of surgery have distinct morbidity and mortality profiles, according to a report published in JAMA Surgery.
Current methods of assessing pay-for-performance reimbursement, surgical outcomes, and value-based care programs all classify surgeries as either elective or emergent procedures. They do not account for the many surgeries that are instead urgent – performed after a trial of nonoperative conservative management or after patients with acute disease processes undergo a brief period of medical optimization.
Common examples of surgeries that occupy this middle ‘urgent’ ground between elective and emergent procedures are those done for cholecystitis, adhesive small-bowel obstruction, and acute diverticulitis, said Matthew G. Mullen, MD, and his associates at the University of Virginia Health System, Charlottesville.
Such urgent surgeries should not be lumped together with elective surgeries, as they usually are at present, because they carry substantially higher complication rates and mortality. “At a time when reimbursement is contingent on value-based outcomes reporting and performance, it is imperative to ensure that appropriate risk adjustment is performed,” the researchers stated.
“Surgeons who commonly operate on an urgent basis, including many acute-care and emergency general surgeons, are at risk of being penalized” in Medicare’s value-based reimbursement for their services.
“These surgeons may even unfairly be labeled as poor performers by current outcome reporting guidelines,” the investigators noted.
Morbidity and mortality rates associated with the “substantial” population of patients undergoing urgent surgery have not been well-studied until now. Dr. Mullen and his associates examined the issue using information from a national database, the American College of Surgeons’ National Quality Improvement Program Participant Use File. They focused on 173,643 general surgeries performed at 435 hospitals during a 1-year period: 130,235 (75%) were categorized as elective, 20,816 (12%) as urgent (nonelective and nonemergency), and 22,592 (13%) as emergency procedures.
Urgent general surgeries carried a 12.3% rate of morbidity and a 2.3% rate of mortality. These rates are much greater than those of elective surgeries (6.7% and 0.4%, respectively), even though urgent surgeries typically fall into the category of “elective.” In fact, the morbidity and mortality rates for urgent surgeries closely approached those of emergency surgeries (13.8% and 3.7%, respectively), the investigators said (JAMA Surg. 2017 May 10 [doi:10.1001/jamasurg.2017.0918]).
In this cohort, patients in the “urgent” surgery category had the highest preoperative rates of congestive heart failure, chronic obstructive pulmonary disease, diabetes, hemodialysis, corticosteroid use, and disseminated cancer – all factors that markedly elevate mortality and morbidity risks.
“We have identified operative urgency as a key consideration for patient risk stratification. If this issue is not recognized, quality outcome reporting and value-based reimbursement will continue to incentivize operating on an elective basis and will make surgeons more reluctant to operate on patients who urgently require care,” Dr. Mullen and his associates said. And such delays in surgical intervention could further increase patient morbidity and mortality.
This study was supported by the National Institutes of Health. Dr. Mullen and his associates reported having no relevant financial disclosures.
Urgent surgery deserves a separate classification from elective surgery and emergency surgery for assessments of healthcare quality and performance, because the three types of surgery have distinct morbidity and mortality profiles, according to a report published in JAMA Surgery.
Current methods of assessing pay-for-performance reimbursement, surgical outcomes, and value-based care programs all classify surgeries as either elective or emergent procedures. They do not account for the many surgeries that are instead urgent – performed after a trial of nonoperative conservative management or after patients with acute disease processes undergo a brief period of medical optimization.
Common examples of surgeries that occupy this middle ‘urgent’ ground between elective and emergent procedures are those done for cholecystitis, adhesive small-bowel obstruction, and acute diverticulitis, said Matthew G. Mullen, MD, and his associates at the University of Virginia Health System, Charlottesville.
Such urgent surgeries should not be lumped together with elective surgeries, as they usually are at present, because they carry substantially higher complication rates and mortality. “At a time when reimbursement is contingent on value-based outcomes reporting and performance, it is imperative to ensure that appropriate risk adjustment is performed,” the researchers stated.
“Surgeons who commonly operate on an urgent basis, including many acute-care and emergency general surgeons, are at risk of being penalized” in Medicare’s value-based reimbursement for their services.
“These surgeons may even unfairly be labeled as poor performers by current outcome reporting guidelines,” the investigators noted.
Morbidity and mortality rates associated with the “substantial” population of patients undergoing urgent surgery have not been well-studied until now. Dr. Mullen and his associates examined the issue using information from a national database, the American College of Surgeons’ National Quality Improvement Program Participant Use File. They focused on 173,643 general surgeries performed at 435 hospitals during a 1-year period: 130,235 (75%) were categorized as elective, 20,816 (12%) as urgent (nonelective and nonemergency), and 22,592 (13%) as emergency procedures.
Urgent general surgeries carried a 12.3% rate of morbidity and a 2.3% rate of mortality. These rates are much greater than those of elective surgeries (6.7% and 0.4%, respectively), even though urgent surgeries typically fall into the category of “elective.” In fact, the morbidity and mortality rates for urgent surgeries closely approached those of emergency surgeries (13.8% and 3.7%, respectively), the investigators said (JAMA Surg. 2017 May 10 [doi:10.1001/jamasurg.2017.0918]).
In this cohort, patients in the “urgent” surgery category had the highest preoperative rates of congestive heart failure, chronic obstructive pulmonary disease, diabetes, hemodialysis, corticosteroid use, and disseminated cancer – all factors that markedly elevate mortality and morbidity risks.
“We have identified operative urgency as a key consideration for patient risk stratification. If this issue is not recognized, quality outcome reporting and value-based reimbursement will continue to incentivize operating on an elective basis and will make surgeons more reluctant to operate on patients who urgently require care,” Dr. Mullen and his associates said. And such delays in surgical intervention could further increase patient morbidity and mortality.
This study was supported by the National Institutes of Health. Dr. Mullen and his associates reported having no relevant financial disclosures.
Urgent surgery deserves a separate classification from elective surgery and emergency surgery for assessments of healthcare quality and performance, because the three types of surgery have distinct morbidity and mortality profiles, according to a report published in JAMA Surgery.
Current methods of assessing pay-for-performance reimbursement, surgical outcomes, and value-based care programs all classify surgeries as either elective or emergent procedures. They do not account for the many surgeries that are instead urgent – performed after a trial of nonoperative conservative management or after patients with acute disease processes undergo a brief period of medical optimization.
Common examples of surgeries that occupy this middle ‘urgent’ ground between elective and emergent procedures are those done for cholecystitis, adhesive small-bowel obstruction, and acute diverticulitis, said Matthew G. Mullen, MD, and his associates at the University of Virginia Health System, Charlottesville.
Such urgent surgeries should not be lumped together with elective surgeries, as they usually are at present, because they carry substantially higher complication rates and mortality. “At a time when reimbursement is contingent on value-based outcomes reporting and performance, it is imperative to ensure that appropriate risk adjustment is performed,” the researchers stated.
“Surgeons who commonly operate on an urgent basis, including many acute-care and emergency general surgeons, are at risk of being penalized” in Medicare’s value-based reimbursement for their services.
“These surgeons may even unfairly be labeled as poor performers by current outcome reporting guidelines,” the investigators noted.
Morbidity and mortality rates associated with the “substantial” population of patients undergoing urgent surgery have not been well-studied until now. Dr. Mullen and his associates examined the issue using information from a national database, the American College of Surgeons’ National Quality Improvement Program Participant Use File. They focused on 173,643 general surgeries performed at 435 hospitals during a 1-year period: 130,235 (75%) were categorized as elective, 20,816 (12%) as urgent (nonelective and nonemergency), and 22,592 (13%) as emergency procedures.
Urgent general surgeries carried a 12.3% rate of morbidity and a 2.3% rate of mortality. These rates are much greater than those of elective surgeries (6.7% and 0.4%, respectively), even though urgent surgeries typically fall into the category of “elective.” In fact, the morbidity and mortality rates for urgent surgeries closely approached those of emergency surgeries (13.8% and 3.7%, respectively), the investigators said (JAMA Surg. 2017 May 10 [doi:10.1001/jamasurg.2017.0918]).
In this cohort, patients in the “urgent” surgery category had the highest preoperative rates of congestive heart failure, chronic obstructive pulmonary disease, diabetes, hemodialysis, corticosteroid use, and disseminated cancer – all factors that markedly elevate mortality and morbidity risks.
“We have identified operative urgency as a key consideration for patient risk stratification. If this issue is not recognized, quality outcome reporting and value-based reimbursement will continue to incentivize operating on an elective basis and will make surgeons more reluctant to operate on patients who urgently require care,” Dr. Mullen and his associates said. And such delays in surgical intervention could further increase patient morbidity and mortality.
This study was supported by the National Institutes of Health. Dr. Mullen and his associates reported having no relevant financial disclosures.
FROM JAMA SURGERY
Key clinical point: Urgent surgery deserves a separate classification from elective and emergency surgeries for assessments of healthcare quality and performance.
Major finding: Urgent general surgeries carried a 12.3% rate of morbidity and a 2.3% rate of mortality, approximately double the morbidity rate and 6 times the mortality rate of elective surgeries (6.7% and 0.4%, respectively).
Data source: A retrospective analysis of outcomes for 173,643 general surgeries performed during a 1-year period at 435 hospitals across U.S.
Disclosures: This study was supported by the National Institutes of Health. Dr. Mullen and his associates reported having no relevant financial disclosures.