Doug Brunk

SAN FRANCISCO – The ACURATE neo transcatheter aortic valve replacement (TAVR) device failed to meet noninferiority, compared with the SAPIEN 3 device, in terms of the primary composite safety and efficacy endpoint at 30 days, a randomized, comparative trial showed.

Doug Brunk/MDedge News

“TAVR has become an indispensable treatment option for patients with symptomatic severe aortic stenosis across all risk categories,” Jonas Lanz, MD, MSc, said at the Transcatheter Cardiovascular Therapeutics annual meeting. “The generalizability of outcomes observed in landmark trials comparing TAVR with SAVR [surgical aortic valve replacement] to other commercial TAVR systems is limited by differences in device properties and lack of head-to-head device comparisons. Iterations of the SAPIEN balloon-expandable TAVR system have been extensively investigated in several large-scale, high-quality, randomized trials and registries setting the current benchmark in terms of safety and efficacy.”

The ACURATE neo is a novel self-expanding TAVR system associated with favorable outcomes in nonrandomized studies. It has been available in Europe since 2014 but has not gained Food and Drug Administration approval.

Between February 2017 and February 2019, in a randomized trial known as SCOPE I, Dr. Lanz and colleagues at 20 European sites enrolled 739 patients with severe, symptomatic aortic stenosis at increased surgical risk. Of these, 372 were assigned to transfemoral TAVR with the ACURATE neo and 367 were assigned to the SAPIEN 3 system. The researchers designed the study to investigate noninferiority of the primary endpoint, which was a composite of safety and efficacy derived from the Valve Academic Research Consortium–2 criteria and included all-cause death, any stroke, life-threatening or disabling bleeding, major vascular complications, coronary artery obstruction requiring intervention, acute kidney injury stage 2 or higher, valve-related dysfunction requiring repeat procedure, rehospitalization for valve-related symptoms or heart failure, moderate or severe prosthetic valve regurgitation, or prosthetic valve stenosis at 30 days.

Clinical follow-up information at 30 days was available for 99% and ECG follow-up for about 98% of the total study population. The mean age of the study participants was 82 years, 57% were female, their median STS Risk Score was 3.5, and their mean transvalvular aortic gradient was 42.2 mm Hg. Dr. Lanz, with the department of cardiology at Bern (Switzerland) University Hospital, reported that the primary endpoint rate in the intention-to-treat cohort for ACURATE neo was 23.7%, compared with 16.5% with SAPIEN 3, falling short of the threshold for noninferiority (P for noninferiority = 0.42).

“I think this speaks to the fact of how high the bar is right now – how good the procedure is [and] how good the devices are,” invited discussant Michael J. Mack, MD, a cardiac surgeon at Baylor Scott & White Health, Dallas, said during the media briefing. “It’s an incredibly high bar to meet for any new device.”

Certain single components of the primary endpoint were similar in the ACURATE neo group, compared with the SAPIEN 3 group, including all-cause death (2.5% vs. 0.8%, respectively) and stroke (1.9% vs. 3%), but acute kidney injury was more common in the ACURATE neo group (3% vs. 0.8%, as was paravalvular aortic regurgitation (9.4% vs. 2.8%). “The differences between the two TAVR devices were mainly driven by moderate or severe paravalvular regurgitation and stage 2 or 3 acute kidney injury in favor of the SAPIEN 3 device,” Dr. Lanz said at the meeting sponsored by the Cardiovascular Research Foundation. “An early composite safety and efficacy endpoint proved useful in discriminating the performance of different TAVR systems.”

He pointed out that a trial called SCOPE II is underway in Europe, with a new iteration of the ACURATE neo designed to reduce the risk of paravalvular leak.

The results of SCOPE I were published online at the time of presentation (Lancet. 2019 Sep 27. doi: 10.1016/S0140-6736[19]32220-2). SCOPE I was an investigator-initiated and -conducted study funded by a dedicated research grant from Symetis in Ecublens, Switzerland (part of Boston Scientific). Dr. Lanz had no relevant disclosures.

[email protected]

SAN FRANCISCO – The ACURATE neo transcatheter aortic valve replacement (TAVR) device failed to meet noninferiority, compared with the SAPIEN 3 device, in terms of the primary composite safety and efficacy endpoint at 30 days, a randomized, comparative trial showed.

Doug Brunk/MDedge News

“TAVR has become an indispensable treatment option for patients with symptomatic severe aortic stenosis across all risk categories,” Jonas Lanz, MD, MSc, said at the Transcatheter Cardiovascular Therapeutics annual meeting. “The generalizability of outcomes observed in landmark trials comparing TAVR with SAVR [surgical aortic valve replacement] to other commercial TAVR systems is limited by differences in device properties and lack of head-to-head device comparisons. Iterations of the SAPIEN balloon-expandable TAVR system have been extensively investigated in several large-scale, high-quality, randomized trials and registries setting the current benchmark in terms of safety and efficacy.”

The ACURATE neo is a novel self-expanding TAVR system associated with favorable outcomes in nonrandomized studies. It has been available in Europe since 2014 but has not gained Food and Drug Administration approval.

Between February 2017 and February 2019, in a randomized trial known as SCOPE I, Dr. Lanz and colleagues at 20 European sites enrolled 739 patients with severe, symptomatic aortic stenosis at increased surgical risk. Of these, 372 were assigned to transfemoral TAVR with the ACURATE neo and 367 were assigned to the SAPIEN 3 system. The researchers designed the study to investigate noninferiority of the primary endpoint, which was a composite of safety and efficacy derived from the Valve Academic Research Consortium–2 criteria and included all-cause death, any stroke, life-threatening or disabling bleeding, major vascular complications, coronary artery obstruction requiring intervention, acute kidney injury stage 2 or higher, valve-related dysfunction requiring repeat procedure, rehospitalization for valve-related symptoms or heart failure, moderate or severe prosthetic valve regurgitation, or prosthetic valve stenosis at 30 days.

Clinical follow-up information at 30 days was available for 99% and ECG follow-up for about 98% of the total study population. The mean age of the study participants was 82 years, 57% were female, their median STS Risk Score was 3.5, and their mean transvalvular aortic gradient was 42.2 mm Hg. Dr. Lanz, with the department of cardiology at Bern (Switzerland) University Hospital, reported that the primary endpoint rate in the intention-to-treat cohort for ACURATE neo was 23.7%, compared with 16.5% with SAPIEN 3, falling short of the threshold for noninferiority (P for noninferiority = 0.42).

“I think this speaks to the fact of how high the bar is right now – how good the procedure is [and] how good the devices are,” invited discussant Michael J. Mack, MD, a cardiac surgeon at Baylor Scott & White Health, Dallas, said during the media briefing. “It’s an incredibly high bar to meet for any new device.”

Certain single components of the primary endpoint were similar in the ACURATE neo group, compared with the SAPIEN 3 group, including all-cause death (2.5% vs. 0.8%, respectively) and stroke (1.9% vs. 3%), but acute kidney injury was more common in the ACURATE neo group (3% vs. 0.8%, as was paravalvular aortic regurgitation (9.4% vs. 2.8%). “The differences between the two TAVR devices were mainly driven by moderate or severe paravalvular regurgitation and stage 2 or 3 acute kidney injury in favor of the SAPIEN 3 device,” Dr. Lanz said at the meeting sponsored by the Cardiovascular Research Foundation. “An early composite safety and efficacy endpoint proved useful in discriminating the performance of different TAVR systems.”

He pointed out that a trial called SCOPE II is underway in Europe, with a new iteration of the ACURATE neo designed to reduce the risk of paravalvular leak.

The results of SCOPE I were published online at the time of presentation (Lancet. 2019 Sep 27. doi: 10.1016/S0140-6736[19]32220-2). SCOPE I was an investigator-initiated and -conducted study funded by a dedicated research grant from Symetis in Ecublens, Switzerland (part of Boston Scientific). Dr. Lanz had no relevant disclosures.

[email protected]

SAN FRANCISCO – The ACURATE neo transcatheter aortic valve replacement (TAVR) device failed to meet noninferiority, compared with the SAPIEN 3 device, in terms of the primary composite safety and efficacy endpoint at 30 days, a randomized, comparative trial showed.

Doug Brunk/MDedge News

“TAVR has become an indispensable treatment option for patients with symptomatic severe aortic stenosis across all risk categories,” Jonas Lanz, MD, MSc, said at the Transcatheter Cardiovascular Therapeutics annual meeting. “The generalizability of outcomes observed in landmark trials comparing TAVR with SAVR [surgical aortic valve replacement] to other commercial TAVR systems is limited by differences in device properties and lack of head-to-head device comparisons. Iterations of the SAPIEN balloon-expandable TAVR system have been extensively investigated in several large-scale, high-quality, randomized trials and registries setting the current benchmark in terms of safety and efficacy.”

The ACURATE neo is a novel self-expanding TAVR system associated with favorable outcomes in nonrandomized studies. It has been available in Europe since 2014 but has not gained Food and Drug Administration approval.

Between February 2017 and February 2019, in a randomized trial known as SCOPE I, Dr. Lanz and colleagues at 20 European sites enrolled 739 patients with severe, symptomatic aortic stenosis at increased surgical risk. Of these, 372 were assigned to transfemoral TAVR with the ACURATE neo and 367 were assigned to the SAPIEN 3 system. The researchers designed the study to investigate noninferiority of the primary endpoint, which was a composite of safety and efficacy derived from the Valve Academic Research Consortium–2 criteria and included all-cause death, any stroke, life-threatening or disabling bleeding, major vascular complications, coronary artery obstruction requiring intervention, acute kidney injury stage 2 or higher, valve-related dysfunction requiring repeat procedure, rehospitalization for valve-related symptoms or heart failure, moderate or severe prosthetic valve regurgitation, or prosthetic valve stenosis at 30 days.

Clinical follow-up information at 30 days was available for 99% and ECG follow-up for about 98% of the total study population. The mean age of the study participants was 82 years, 57% were female, their median STS Risk Score was 3.5, and their mean transvalvular aortic gradient was 42.2 mm Hg. Dr. Lanz, with the department of cardiology at Bern (Switzerland) University Hospital, reported that the primary endpoint rate in the intention-to-treat cohort for ACURATE neo was 23.7%, compared with 16.5% with SAPIEN 3, falling short of the threshold for noninferiority (P for noninferiority = 0.42).

“I think this speaks to the fact of how high the bar is right now – how good the procedure is [and] how good the devices are,” invited discussant Michael J. Mack, MD, a cardiac surgeon at Baylor Scott & White Health, Dallas, said during the media briefing. “It’s an incredibly high bar to meet for any new device.”

Certain single components of the primary endpoint were similar in the ACURATE neo group, compared with the SAPIEN 3 group, including all-cause death (2.5% vs. 0.8%, respectively) and stroke (1.9% vs. 3%), but acute kidney injury was more common in the ACURATE neo group (3% vs. 0.8%, as was paravalvular aortic regurgitation (9.4% vs. 2.8%). “The differences between the two TAVR devices were mainly driven by moderate or severe paravalvular regurgitation and stage 2 or 3 acute kidney injury in favor of the SAPIEN 3 device,” Dr. Lanz said at the meeting sponsored by the Cardiovascular Research Foundation. “An early composite safety and efficacy endpoint proved useful in discriminating the performance of different TAVR systems.”

He pointed out that a trial called SCOPE II is underway in Europe, with a new iteration of the ACURATE neo designed to reduce the risk of paravalvular leak.

The results of SCOPE I were published online at the time of presentation (Lancet. 2019 Sep 27. doi: 10.1016/S0140-6736[19]32220-2). SCOPE I was an investigator-initiated and -conducted study funded by a dedicated research grant from Symetis in Ecublens, Switzerland (part of Boston Scientific). Dr. Lanz had no relevant disclosures.

[email protected]

LOS ANGELES – Until the recent approval of liraglutide for the treatment of children and adolescents with type 2 diabetes, investigators like Sonia Caprio, MD, were at their wits’ end watching the beta-cell function of their patients decline on metformin treatment.

Doug Brunk/MDedge News

“The kids were not doing well. It was like they were being treated with water,” Dr. Caprio, a pediatric endocrinologist at Yale University, New Haven, Conn., said at the annual World Congress on Insulin Resistance, Diabetes and Cardiovascular Disease.

For example, in the NIH-funded TODAY (Treatment Options for Type 2 Diabetes in Adolescents and Youth) study that began enrollment in 2004, 699 patients aged between 10 and 17 years and with type 2 diabetes were treated with metformin (1,000 mg, twice daily) to attain a glycated hemoglobin level of less than 8% and were then randomly assigned to continued treatment with metformin alone or to metformin combined with rosiglitazone (4 mg, twice a day) or a lifestyle-intervention program that focused on weight loss through modifying eating and activity behaviors (N Engl J Med. 2012;366:2247-56).

Over the course of 11 months, the researchers found that 46% of the children were failing treatment. “The worst arm was the metformin arm,” said Dr. Caprio, who was involved with the study. “Kids were not responding to the drug at all. About 52% of children failed to do better using metformin – a classic drug that we all start kids on when we diagnose them with type 2 diabetes.”

Findings from a follow-up study, TODAY2, showed that these young patients were prone to serious diabetes-related events, such as heart attacks, chronic kidney disease, retinal disease, neuropathy, and complications in the offspring of pregnancies.

In addition, results from the RISE (Restoring Insulin Secretion) Pediatric Medication Study found that, in youth with impaired glucose tolerance or recently diagnosed type 2 diabetes, neither 3 months of insulin glargine followed by 9 months of metformin nor 12 months of metformin alone halted the progressive deterioration of beta-cell function (Diabetes Care. 2018 Aug; 41[8]:1717-25).

“The uniqueness of RISE is that we employed very sophisticated techniques to measure insulin secretion and sensitivity while they were being treated with these usual drugs,” said Dr. Caprio, who was one of the study investigators. “The beta cell is unresponsive to metformin and other treatments. The question is, why?”

Despite these findings, 2018 consensus guidelines from the American Diabetes Association on the evaluation and management of youth-onset diabetes (Diabetes Care. 2018;41:2648-68) call for the administration of metformin twice daily in youth with new-onset diabetes who have a hemoglobin A_1c (HbA_1c) level of less than 8.5%. “I argue that is not the way. We need better ways to treat [these patients] because they are moving fast to having complications,” she said.

Enter the Ellipse Trial, a pivotal multicenter, randomized study that evaluated the effect of the glucagonlike peptide-1 receptor agonist liraglutide in children and adolescents with type 2 diabetes (N Engl J Med. 2019;381:637-46).

Researchers, led by William V. Tamborlane, MD, chief of Yale Medicine Pediatric Endocrinology, also in New Haven, randomized 135 patients to one of two arms: 66 to subcutaneous liraglutide (up to 1.8 mg/day) and 69 to placebo for a 26-week, double-blind period, followed by a 26-week open-label extension period. All patients received metformin during the trial. More than half of the study participants (62%) were female, the mean age was 15 years, 65% were white, the mean body mass index was 33.9 kg/m², their mean fasting glucose was 8.4 mmol/L, and their mean HbA_1c was 7.8%.

At 26 weeks, the mean glycated hemoglobin level had decreased by 0.64 percentage points with liraglutide and increased by 0.42 percentage points with placebo, for an estimated treatment difference of −1.06 percentage points (P less than .001). By 52 weeks, the difference increased to −1.30 percentage points.

“There was also a significant drop in BMI z score in patients treated with liraglutide, which is important,” Dr. Caprio said. “This medication is having an impact on weight, which is a key driver of the onset of type 2 diabetes in youth. This is a remarkable achievement because weight loss is hard to achieve in obese adolescents, as we showed in the TODAY study.”

The number of adverse events reported by patients was similar in the treatment and placebo groups (85% and 81%, respectively), but the overall rates of adverse events and gastrointestinal adverse events were higher with liraglutide.

“I use liraglutide just for weight reduction because I mainly see a lot of kids with obesity. Many kids are not responding because of the GI effects of this drug. I think the weight loss could have been better had the investigators moved to a dose of 1.8 mg, which we use in adults.”

A fasting plasma glucose of 6.1 mmol/L was the primary reason for participants remaining on a lower dose of liraglutide, she said. At the same time, liraglutide concentration data indicated a high rate of noncompliance, which was expected in this population. “That’s a big problem we face with children,” Dr. Caprio said. “Some of them are not constantly taking the medication. They skip doses a lot. But that happens with patients in this age group.”

“Finally, we have something else to help children and teenagers to delay the complications we are seeing,” Dr. Caprio said. “To me, I think this is a new era. I have hope. It will be interesting to see whether liraglutide and perhaps SGLT2 [sodium-glucose transporter 2] inhibitors can delay the onset of type 2 diabetes in children. In my view, we will be doing this with drugs. I don’t think the weight loss [concerns are] going to go away without medication, unfortunately.”

Dr. Caprio reported having no financial disclosures.

LOS ANGELES – Until the recent approval of liraglutide for the treatment of children and adolescents with type 2 diabetes, investigators like Sonia Caprio, MD, were at their wits’ end watching the beta-cell function of their patients decline on metformin treatment.

Doug Brunk/MDedge News

“The kids were not doing well. It was like they were being treated with water,” Dr. Caprio, a pediatric endocrinologist at Yale University, New Haven, Conn., said at the annual World Congress on Insulin Resistance, Diabetes and Cardiovascular Disease.

For example, in the NIH-funded TODAY (Treatment Options for Type 2 Diabetes in Adolescents and Youth) study that began enrollment in 2004, 699 patients aged between 10 and 17 years and with type 2 diabetes were treated with metformin (1,000 mg, twice daily) to attain a glycated hemoglobin level of less than 8% and were then randomly assigned to continued treatment with metformin alone or to metformin combined with rosiglitazone (4 mg, twice a day) or a lifestyle-intervention program that focused on weight loss through modifying eating and activity behaviors (N Engl J Med. 2012;366:2247-56).

Over the course of 11 months, the researchers found that 46% of the children were failing treatment. “The worst arm was the metformin arm,” said Dr. Caprio, who was involved with the study. “Kids were not responding to the drug at all. About 52% of children failed to do better using metformin – a classic drug that we all start kids on when we diagnose them with type 2 diabetes.”

Findings from a follow-up study, TODAY2, showed that these young patients were prone to serious diabetes-related events, such as heart attacks, chronic kidney disease, retinal disease, neuropathy, and complications in the offspring of pregnancies.

In addition, results from the RISE (Restoring Insulin Secretion) Pediatric Medication Study found that, in youth with impaired glucose tolerance or recently diagnosed type 2 diabetes, neither 3 months of insulin glargine followed by 9 months of metformin nor 12 months of metformin alone halted the progressive deterioration of beta-cell function (Diabetes Care. 2018 Aug; 41[8]:1717-25).

“The uniqueness of RISE is that we employed very sophisticated techniques to measure insulin secretion and sensitivity while they were being treated with these usual drugs,” said Dr. Caprio, who was one of the study investigators. “The beta cell is unresponsive to metformin and other treatments. The question is, why?”

Despite these findings, 2018 consensus guidelines from the American Diabetes Association on the evaluation and management of youth-onset diabetes (Diabetes Care. 2018;41:2648-68) call for the administration of metformin twice daily in youth with new-onset diabetes who have a hemoglobin A_1c (HbA_1c) level of less than 8.5%. “I argue that is not the way. We need better ways to treat [these patients] because they are moving fast to having complications,” she said.

Enter the Ellipse Trial, a pivotal multicenter, randomized study that evaluated the effect of the glucagonlike peptide-1 receptor agonist liraglutide in children and adolescents with type 2 diabetes (N Engl J Med. 2019;381:637-46).

Researchers, led by William V. Tamborlane, MD, chief of Yale Medicine Pediatric Endocrinology, also in New Haven, randomized 135 patients to one of two arms: 66 to subcutaneous liraglutide (up to 1.8 mg/day) and 69 to placebo for a 26-week, double-blind period, followed by a 26-week open-label extension period. All patients received metformin during the trial. More than half of the study participants (62%) were female, the mean age was 15 years, 65% were white, the mean body mass index was 33.9 kg/m², their mean fasting glucose was 8.4 mmol/L, and their mean HbA_1c was 7.8%.

At 26 weeks, the mean glycated hemoglobin level had decreased by 0.64 percentage points with liraglutide and increased by 0.42 percentage points with placebo, for an estimated treatment difference of −1.06 percentage points (P less than .001). By 52 weeks, the difference increased to −1.30 percentage points.

“There was also a significant drop in BMI z score in patients treated with liraglutide, which is important,” Dr. Caprio said. “This medication is having an impact on weight, which is a key driver of the onset of type 2 diabetes in youth. This is a remarkable achievement because weight loss is hard to achieve in obese adolescents, as we showed in the TODAY study.”

The number of adverse events reported by patients was similar in the treatment and placebo groups (85% and 81%, respectively), but the overall rates of adverse events and gastrointestinal adverse events were higher with liraglutide.

“I use liraglutide just for weight reduction because I mainly see a lot of kids with obesity. Many kids are not responding because of the GI effects of this drug. I think the weight loss could have been better had the investigators moved to a dose of 1.8 mg, which we use in adults.”

A fasting plasma glucose of 6.1 mmol/L was the primary reason for participants remaining on a lower dose of liraglutide, she said. At the same time, liraglutide concentration data indicated a high rate of noncompliance, which was expected in this population. “That’s a big problem we face with children,” Dr. Caprio said. “Some of them are not constantly taking the medication. They skip doses a lot. But that happens with patients in this age group.”

“Finally, we have something else to help children and teenagers to delay the complications we are seeing,” Dr. Caprio said. “To me, I think this is a new era. I have hope. It will be interesting to see whether liraglutide and perhaps SGLT2 [sodium-glucose transporter 2] inhibitors can delay the onset of type 2 diabetes in children. In my view, we will be doing this with drugs. I don’t think the weight loss [concerns are] going to go away without medication, unfortunately.”

Dr. Caprio reported having no financial disclosures.

LOS ANGELES – Until the recent approval of liraglutide for the treatment of children and adolescents with type 2 diabetes, investigators like Sonia Caprio, MD, were at their wits’ end watching the beta-cell function of their patients decline on metformin treatment.

Doug Brunk/MDedge News

“The kids were not doing well. It was like they were being treated with water,” Dr. Caprio, a pediatric endocrinologist at Yale University, New Haven, Conn., said at the annual World Congress on Insulin Resistance, Diabetes and Cardiovascular Disease.

For example, in the NIH-funded TODAY (Treatment Options for Type 2 Diabetes in Adolescents and Youth) study that began enrollment in 2004, 699 patients aged between 10 and 17 years and with type 2 diabetes were treated with metformin (1,000 mg, twice daily) to attain a glycated hemoglobin level of less than 8% and were then randomly assigned to continued treatment with metformin alone or to metformin combined with rosiglitazone (4 mg, twice a day) or a lifestyle-intervention program that focused on weight loss through modifying eating and activity behaviors (N Engl J Med. 2012;366:2247-56).

Over the course of 11 months, the researchers found that 46% of the children were failing treatment. “The worst arm was the metformin arm,” said Dr. Caprio, who was involved with the study. “Kids were not responding to the drug at all. About 52% of children failed to do better using metformin – a classic drug that we all start kids on when we diagnose them with type 2 diabetes.”

Findings from a follow-up study, TODAY2, showed that these young patients were prone to serious diabetes-related events, such as heart attacks, chronic kidney disease, retinal disease, neuropathy, and complications in the offspring of pregnancies.

In addition, results from the RISE (Restoring Insulin Secretion) Pediatric Medication Study found that, in youth with impaired glucose tolerance or recently diagnosed type 2 diabetes, neither 3 months of insulin glargine followed by 9 months of metformin nor 12 months of metformin alone halted the progressive deterioration of beta-cell function (Diabetes Care. 2018 Aug; 41[8]:1717-25).

“The uniqueness of RISE is that we employed very sophisticated techniques to measure insulin secretion and sensitivity while they were being treated with these usual drugs,” said Dr. Caprio, who was one of the study investigators. “The beta cell is unresponsive to metformin and other treatments. The question is, why?”

Despite these findings, 2018 consensus guidelines from the American Diabetes Association on the evaluation and management of youth-onset diabetes (Diabetes Care. 2018;41:2648-68) call for the administration of metformin twice daily in youth with new-onset diabetes who have a hemoglobin A_1c (HbA_1c) level of less than 8.5%. “I argue that is not the way. We need better ways to treat [these patients] because they are moving fast to having complications,” she said.

Enter the Ellipse Trial, a pivotal multicenter, randomized study that evaluated the effect of the glucagonlike peptide-1 receptor agonist liraglutide in children and adolescents with type 2 diabetes (N Engl J Med. 2019;381:637-46).

Researchers, led by William V. Tamborlane, MD, chief of Yale Medicine Pediatric Endocrinology, also in New Haven, randomized 135 patients to one of two arms: 66 to subcutaneous liraglutide (up to 1.8 mg/day) and 69 to placebo for a 26-week, double-blind period, followed by a 26-week open-label extension period. All patients received metformin during the trial. More than half of the study participants (62%) were female, the mean age was 15 years, 65% were white, the mean body mass index was 33.9 kg/m², their mean fasting glucose was 8.4 mmol/L, and their mean HbA_1c was 7.8%.

At 26 weeks, the mean glycated hemoglobin level had decreased by 0.64 percentage points with liraglutide and increased by 0.42 percentage points with placebo, for an estimated treatment difference of −1.06 percentage points (P less than .001). By 52 weeks, the difference increased to −1.30 percentage points.

“There was also a significant drop in BMI z score in patients treated with liraglutide, which is important,” Dr. Caprio said. “This medication is having an impact on weight, which is a key driver of the onset of type 2 diabetes in youth. This is a remarkable achievement because weight loss is hard to achieve in obese adolescents, as we showed in the TODAY study.”

The number of adverse events reported by patients was similar in the treatment and placebo groups (85% and 81%, respectively), but the overall rates of adverse events and gastrointestinal adverse events were higher with liraglutide.

“I use liraglutide just for weight reduction because I mainly see a lot of kids with obesity. Many kids are not responding because of the GI effects of this drug. I think the weight loss could have been better had the investigators moved to a dose of 1.8 mg, which we use in adults.”

A fasting plasma glucose of 6.1 mmol/L was the primary reason for participants remaining on a lower dose of liraglutide, she said. At the same time, liraglutide concentration data indicated a high rate of noncompliance, which was expected in this population. “That’s a big problem we face with children,” Dr. Caprio said. “Some of them are not constantly taking the medication. They skip doses a lot. But that happens with patients in this age group.”

“Finally, we have something else to help children and teenagers to delay the complications we are seeing,” Dr. Caprio said. “To me, I think this is a new era. I have hope. It will be interesting to see whether liraglutide and perhaps SGLT2 [sodium-glucose transporter 2] inhibitors can delay the onset of type 2 diabetes in children. In my view, we will be doing this with drugs. I don’t think the weight loss [concerns are] going to go away without medication, unfortunately.”

Dr. Caprio reported having no financial disclosures.

SAN FRANCISCO – Among patients with severe aortic stenosis at low surgical risk, both transcatheter and surgical aortic valve replacement resulted in substantial health status benefits at 1 year despite most patients having New York Heart Association class I or II symptoms at baseline.

Doug Brunk/MDedge News

However, when compared with surgical replacement, transcatheter replacement was linked with significantly improved disease-specific health status not only at 1 month, but also at 6 months and 1 year.

The findings come from an analysis of patients enrolled in the randomized PARTNER 3 trial, which showed that transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve. At 1 year post procedure, the rate of the primary composite endpoint comprising death, stroke, or cardiovascular rehospitalization was 8.5% in the TAVR group and 15.1% with surgical aortic valve replacement (SAVR), for a highly significant 46% relative risk reduction (N Engl J Med 2019 May 2;380:1695-705).

“The PARTNER 3 and Evolut Low Risk trials have demonstrated that transfemoral TAVR is both safe and effective when compared with SAVR in patients with severe aortic stenosis at low surgical risk,” Suzanne J. Baron, MD, MSc, said at the Transcatheter Cardiovascular Therapeutics annual meeting. “While prior studies have demonstrated improved early health status with transfemoral TAVR, compared with SAVR in intermediate and high-risk patients, there is little evidence of any late health status benefit with TAVR.”

To address this gap in knowledge, Dr. Baron, director of interventional cardiology research at Lahey Hospital and Medical Center in Burlington, Mass., and associates performed a prospective study alongside the PARTNER 3 randomized trial to understand the impact of valve replacement strategy on early and late health status in aortic stenosis patients at low surgical risk. She reported results from 449 low-risk patients with severe aortic stenosis who were assigned to transfemoral TAVR using a balloon-expandable valve, and 449 who were assigned to surgery in PARTNER 3. At baseline, the mean age of patients was 73 years, 69% were male, and the average STS (Society of Thoracic Surgeons) Risk Score was 1.9%. Rates of other comorbidities were generally low.

Patients in both groups reported a mild baseline impairment in health status. The mean Kansas City Cardiomyopathy Questionnaire–Overall Summary (KCCQ-OS) score was 70, “which corresponds to only New York Heart Association Class II symptoms,” Dr. Baron said. “The SF-36 [Short Form 36] physical summary score was 44 for both groups, which is approximately half of a standard deviation below the population mean.”

As expected, patients who underwent TAVR showed substantially improved health status at 1 month based on the KCCQ-OS (mean difference,16 points; P less than .001). However, in contrast to prior studies, the researchers observed a persistent, although attenuated, benefit of TAVR over SAVR in disease-specific health status at 6 and 12 months (mean difference in KCCQ-OS of 2.6 and 1.8 points respectively; P less than .04 for both).

Dr. Baron said that a sustained benefit of TAVR over SAVR at 6 months and 1 year was observed on several KCCQ subscales, but a similar benefit was not noted on the generic health status measures such as the SF-36 physical summary score. “That’s likely reflective of the fact that, as a disease-specific measure, the KCCQ is much more sensitive in detecting meaningful differences in this population,” she explained. When change in health status was analyzed as an ordinal variable, with death as the worst outcome and large clinical improvement, which was defined as a 20-point or greater increase in the KCCQ-OS score, TAVR showed a significant benefit, compared with surgery at all time points (P less than .05).

In an effort to better understand the mechanism underlying this persistent albeit small late benefit in disease-specific health status with TAVR, the researchers generated cumulative distribution curves to display the proportion of patients who achieved a given change on the KCCQ-OS. A clear separation of the curves emerged, with 5.2% more patients in the TAVR group experiencing a change of at least 20 points, compared with the surgery group. “This suggests that the difference in late health status between the two groups is driven by this 5.2% absolute risk difference in the proportion of patients who experienced a large clinical improvement,” Dr. Baron said at the meeting, which was sponsored by the Cardiovascular Research Foundation.

Next, the researchers performed subgroup analyses to examine the interaction between the 1-year health status benefit of TAVR over surgery and prespecified baseline characteristics including age, gender, STS risk score, ejection fraction, atrial fibrillation, and New York Heart Association (NYHA) class. They observed a significant interaction between NYHA class and treatment effect such that patients who had NYHA class III or IV symptoms at baseline derived greater benefit from TAVR, compared with those who had NYHA class I or II symptoms at baseline.

“This finding suggests that it’s the patients with worse functional impairment at baseline who may be that subset of patients on the cumulative responder curves who gained better health status outcomes with TAVR, compared with surgery in the low-risk population,” Dr. Baron said.

Suzanne V. Arnold, MD, a cardiologist at Saint Luke’s Mid America Heart Institute, Kansas City, Mo., who was an invited discussant, said that it was “remarkable” that patients in the substudy were not particularly symptomatic and yet they still experienced close to a 20-point improvement in the KCCQ-OS score following TAVR, and asked whether frailty may have played a role in the 1.8-point adjusted difference in the KCCQ-OS score between TAVR and surgery at 1 year. Dr. Baron responded that she and her colleagues performed a subgroup analysis of patients who had two or more markers of frailty versus those who had one or less. Noting that there were only 20 patients in that subgroup, she said there was a significant signal that patients who were considered have two or more frail measures were considered to do much better with TAVR.

Dr. Baron concluded that the study’s overall findings, taken together with the clinical outcomes of the PARTNER 3 trial, “further support the use of TAVR in patients with severe [aortic stenosis] at low surgical risk. Longer-term follow up is needed (and ongoing) to determine whether the health status benefits of TAVR at 1 year are durable.”
The content of the study was published online at the time of presentation (J Am Coll Cardiol 2019 Sep 29. doi: 10.1016/j.jacc.2019.09.007). The PARTNER 3 quality of life substudy was funded by Edwards Lifesciences. Dr. Baron disclosed research funding and advisory board compensation from Boston Scientific Corp and consulting fees from Edwards Lifesciences.

[email protected]

SAN FRANCISCO – Among patients with severe aortic stenosis at low surgical risk, both transcatheter and surgical aortic valve replacement resulted in substantial health status benefits at 1 year despite most patients having New York Heart Association class I or II symptoms at baseline.

Doug Brunk/MDedge News

However, when compared with surgical replacement, transcatheter replacement was linked with significantly improved disease-specific health status not only at 1 month, but also at 6 months and 1 year.

The findings come from an analysis of patients enrolled in the randomized PARTNER 3 trial, which showed that transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve. At 1 year post procedure, the rate of the primary composite endpoint comprising death, stroke, or cardiovascular rehospitalization was 8.5% in the TAVR group and 15.1% with surgical aortic valve replacement (SAVR), for a highly significant 46% relative risk reduction (N Engl J Med 2019 May 2;380:1695-705).

“The PARTNER 3 and Evolut Low Risk trials have demonstrated that transfemoral TAVR is both safe and effective when compared with SAVR in patients with severe aortic stenosis at low surgical risk,” Suzanne J. Baron, MD, MSc, said at the Transcatheter Cardiovascular Therapeutics annual meeting. “While prior studies have demonstrated improved early health status with transfemoral TAVR, compared with SAVR in intermediate and high-risk patients, there is little evidence of any late health status benefit with TAVR.”

To address this gap in knowledge, Dr. Baron, director of interventional cardiology research at Lahey Hospital and Medical Center in Burlington, Mass., and associates performed a prospective study alongside the PARTNER 3 randomized trial to understand the impact of valve replacement strategy on early and late health status in aortic stenosis patients at low surgical risk. She reported results from 449 low-risk patients with severe aortic stenosis who were assigned to transfemoral TAVR using a balloon-expandable valve, and 449 who were assigned to surgery in PARTNER 3. At baseline, the mean age of patients was 73 years, 69% were male, and the average STS (Society of Thoracic Surgeons) Risk Score was 1.9%. Rates of other comorbidities were generally low.

Patients in both groups reported a mild baseline impairment in health status. The mean Kansas City Cardiomyopathy Questionnaire–Overall Summary (KCCQ-OS) score was 70, “which corresponds to only New York Heart Association Class II symptoms,” Dr. Baron said. “The SF-36 [Short Form 36] physical summary score was 44 for both groups, which is approximately half of a standard deviation below the population mean.”

As expected, patients who underwent TAVR showed substantially improved health status at 1 month based on the KCCQ-OS (mean difference,16 points; P less than .001). However, in contrast to prior studies, the researchers observed a persistent, although attenuated, benefit of TAVR over SAVR in disease-specific health status at 6 and 12 months (mean difference in KCCQ-OS of 2.6 and 1.8 points respectively; P less than .04 for both).

Dr. Baron said that a sustained benefit of TAVR over SAVR at 6 months and 1 year was observed on several KCCQ subscales, but a similar benefit was not noted on the generic health status measures such as the SF-36 physical summary score. “That’s likely reflective of the fact that, as a disease-specific measure, the KCCQ is much more sensitive in detecting meaningful differences in this population,” she explained. When change in health status was analyzed as an ordinal variable, with death as the worst outcome and large clinical improvement, which was defined as a 20-point or greater increase in the KCCQ-OS score, TAVR showed a significant benefit, compared with surgery at all time points (P less than .05).

In an effort to better understand the mechanism underlying this persistent albeit small late benefit in disease-specific health status with TAVR, the researchers generated cumulative distribution curves to display the proportion of patients who achieved a given change on the KCCQ-OS. A clear separation of the curves emerged, with 5.2% more patients in the TAVR group experiencing a change of at least 20 points, compared with the surgery group. “This suggests that the difference in late health status between the two groups is driven by this 5.2% absolute risk difference in the proportion of patients who experienced a large clinical improvement,” Dr. Baron said at the meeting, which was sponsored by the Cardiovascular Research Foundation.

Next, the researchers performed subgroup analyses to examine the interaction between the 1-year health status benefit of TAVR over surgery and prespecified baseline characteristics including age, gender, STS risk score, ejection fraction, atrial fibrillation, and New York Heart Association (NYHA) class. They observed a significant interaction between NYHA class and treatment effect such that patients who had NYHA class III or IV symptoms at baseline derived greater benefit from TAVR, compared with those who had NYHA class I or II symptoms at baseline.

“This finding suggests that it’s the patients with worse functional impairment at baseline who may be that subset of patients on the cumulative responder curves who gained better health status outcomes with TAVR, compared with surgery in the low-risk population,” Dr. Baron said.

Suzanne V. Arnold, MD, a cardiologist at Saint Luke’s Mid America Heart Institute, Kansas City, Mo., who was an invited discussant, said that it was “remarkable” that patients in the substudy were not particularly symptomatic and yet they still experienced close to a 20-point improvement in the KCCQ-OS score following TAVR, and asked whether frailty may have played a role in the 1.8-point adjusted difference in the KCCQ-OS score between TAVR and surgery at 1 year. Dr. Baron responded that she and her colleagues performed a subgroup analysis of patients who had two or more markers of frailty versus those who had one or less. Noting that there were only 20 patients in that subgroup, she said there was a significant signal that patients who were considered have two or more frail measures were considered to do much better with TAVR.

Dr. Baron concluded that the study’s overall findings, taken together with the clinical outcomes of the PARTNER 3 trial, “further support the use of TAVR in patients with severe [aortic stenosis] at low surgical risk. Longer-term follow up is needed (and ongoing) to determine whether the health status benefits of TAVR at 1 year are durable.”
The content of the study was published online at the time of presentation (J Am Coll Cardiol 2019 Sep 29. doi: 10.1016/j.jacc.2019.09.007). The PARTNER 3 quality of life substudy was funded by Edwards Lifesciences. Dr. Baron disclosed research funding and advisory board compensation from Boston Scientific Corp and consulting fees from Edwards Lifesciences.

[email protected]

SAN FRANCISCO – Among patients with severe aortic stenosis at low surgical risk, both transcatheter and surgical aortic valve replacement resulted in substantial health status benefits at 1 year despite most patients having New York Heart Association class I or II symptoms at baseline.

Doug Brunk/MDedge News

However, when compared with surgical replacement, transcatheter replacement was linked with significantly improved disease-specific health status not only at 1 month, but also at 6 months and 1 year.

The findings come from an analysis of patients enrolled in the randomized PARTNER 3 trial, which showed that transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve. At 1 year post procedure, the rate of the primary composite endpoint comprising death, stroke, or cardiovascular rehospitalization was 8.5% in the TAVR group and 15.1% with surgical aortic valve replacement (SAVR), for a highly significant 46% relative risk reduction (N Engl J Med 2019 May 2;380:1695-705).

“The PARTNER 3 and Evolut Low Risk trials have demonstrated that transfemoral TAVR is both safe and effective when compared with SAVR in patients with severe aortic stenosis at low surgical risk,” Suzanne J. Baron, MD, MSc, said at the Transcatheter Cardiovascular Therapeutics annual meeting. “While prior studies have demonstrated improved early health status with transfemoral TAVR, compared with SAVR in intermediate and high-risk patients, there is little evidence of any late health status benefit with TAVR.”

To address this gap in knowledge, Dr. Baron, director of interventional cardiology research at Lahey Hospital and Medical Center in Burlington, Mass., and associates performed a prospective study alongside the PARTNER 3 randomized trial to understand the impact of valve replacement strategy on early and late health status in aortic stenosis patients at low surgical risk. She reported results from 449 low-risk patients with severe aortic stenosis who were assigned to transfemoral TAVR using a balloon-expandable valve, and 449 who were assigned to surgery in PARTNER 3. At baseline, the mean age of patients was 73 years, 69% were male, and the average STS (Society of Thoracic Surgeons) Risk Score was 1.9%. Rates of other comorbidities were generally low.

Patients in both groups reported a mild baseline impairment in health status. The mean Kansas City Cardiomyopathy Questionnaire–Overall Summary (KCCQ-OS) score was 70, “which corresponds to only New York Heart Association Class II symptoms,” Dr. Baron said. “The SF-36 [Short Form 36] physical summary score was 44 for both groups, which is approximately half of a standard deviation below the population mean.”

As expected, patients who underwent TAVR showed substantially improved health status at 1 month based on the KCCQ-OS (mean difference,16 points; P less than .001). However, in contrast to prior studies, the researchers observed a persistent, although attenuated, benefit of TAVR over SAVR in disease-specific health status at 6 and 12 months (mean difference in KCCQ-OS of 2.6 and 1.8 points respectively; P less than .04 for both).

Dr. Baron said that a sustained benefit of TAVR over SAVR at 6 months and 1 year was observed on several KCCQ subscales, but a similar benefit was not noted on the generic health status measures such as the SF-36 physical summary score. “That’s likely reflective of the fact that, as a disease-specific measure, the KCCQ is much more sensitive in detecting meaningful differences in this population,” she explained. When change in health status was analyzed as an ordinal variable, with death as the worst outcome and large clinical improvement, which was defined as a 20-point or greater increase in the KCCQ-OS score, TAVR showed a significant benefit, compared with surgery at all time points (P less than .05).

In an effort to better understand the mechanism underlying this persistent albeit small late benefit in disease-specific health status with TAVR, the researchers generated cumulative distribution curves to display the proportion of patients who achieved a given change on the KCCQ-OS. A clear separation of the curves emerged, with 5.2% more patients in the TAVR group experiencing a change of at least 20 points, compared with the surgery group. “This suggests that the difference in late health status between the two groups is driven by this 5.2% absolute risk difference in the proportion of patients who experienced a large clinical improvement,” Dr. Baron said at the meeting, which was sponsored by the Cardiovascular Research Foundation.

Next, the researchers performed subgroup analyses to examine the interaction between the 1-year health status benefit of TAVR over surgery and prespecified baseline characteristics including age, gender, STS risk score, ejection fraction, atrial fibrillation, and New York Heart Association (NYHA) class. They observed a significant interaction between NYHA class and treatment effect such that patients who had NYHA class III or IV symptoms at baseline derived greater benefit from TAVR, compared with those who had NYHA class I or II symptoms at baseline.

“This finding suggests that it’s the patients with worse functional impairment at baseline who may be that subset of patients on the cumulative responder curves who gained better health status outcomes with TAVR, compared with surgery in the low-risk population,” Dr. Baron said.

Suzanne V. Arnold, MD, a cardiologist at Saint Luke’s Mid America Heart Institute, Kansas City, Mo., who was an invited discussant, said that it was “remarkable” that patients in the substudy were not particularly symptomatic and yet they still experienced close to a 20-point improvement in the KCCQ-OS score following TAVR, and asked whether frailty may have played a role in the 1.8-point adjusted difference in the KCCQ-OS score between TAVR and surgery at 1 year. Dr. Baron responded that she and her colleagues performed a subgroup analysis of patients who had two or more markers of frailty versus those who had one or less. Noting that there were only 20 patients in that subgroup, she said there was a significant signal that patients who were considered have two or more frail measures were considered to do much better with TAVR.

Dr. Baron concluded that the study’s overall findings, taken together with the clinical outcomes of the PARTNER 3 trial, “further support the use of TAVR in patients with severe [aortic stenosis] at low surgical risk. Longer-term follow up is needed (and ongoing) to determine whether the health status benefits of TAVR at 1 year are durable.”
The content of the study was published online at the time of presentation (J Am Coll Cardiol 2019 Sep 29. doi: 10.1016/j.jacc.2019.09.007). The PARTNER 3 quality of life substudy was funded by Edwards Lifesciences. Dr. Baron disclosed research funding and advisory board compensation from Boston Scientific Corp and consulting fees from Edwards Lifesciences.

[email protected]

Whether patients aged 50 years and older with a displaced femoral neck fracture underwent total hip arthroplasty or hemiarthroplasty had no significant influence on the risk of unplanned secondary hip procedures over 2 years of follow-up. In addition, while functional outcomes modestly favored total hip arthroplasty, the rates of mortality and serious adverse events were similar between the two treatment groups.

Those are key findings from a randomized, multicenter trial of the two procedures that was carried out in 10 countries.

“The American Academy of Orthopedic Surgeons and National Institute for Health and Care Excellence guidelines recommend total hip arthroplasty in all patients with displaced femoral neck fractures who are able to ambulate independently,” a team of investigators led by Mohit Bhandari, MD, and P.J. Devereaux, MD, both from McMaster University, Hamilton, Ont., wrote in a study published in the New England Journal of Medicine. “Our findings suggest that the advantages of total hip arthroplasty may not be compelling. The limited advantages of total hip arthroplasty, as well as the possible higher risk of complications, may be particularly important in regions of the world where total hip arthroplasty is not easily accessible or is cost prohibitive.”

In the Hip Fracture Evaluation With Alternative of Total Hip Arthroplasty Versus Hemiarthroplasty (HEALTH) trial, the researchers randomly assigned 1,495 patients aged 50 years and older who had a displaced femoral neck fracture to undergo either total hip arthroplasty or hemiarthroplasty. They were eligible for the trial only if they had been able to ambulate without the assistance of another person before the hip fracture occurred. The primary endpoint was any unplanned secondary hip procedure within 24 months after the initial surgery. Secondary endpoints included death, serious adverse events, hip-related complications, health-related quality of life, function, and overall health measures. Assessments included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score, pain score, stiffness score, and function score; the European Quality of Life–5 Dimensions utility index score and visual analogue scale; the 12-Item Short Form General Health Survey physical and mental component summary scores; and the Timed Up and Go scores.

The researchers found that the primary endpoint occurred in 7.9% of patients who had been randomly assigned to total hip arthroplasty and in 8.3% of those who had been randomly assigned to hemiarthroplasty (hazard ratio, 0.95; P = .79). As for secondary endpoints, mortality did not differ significantly between the two treatment groups (14.3% in the total hip arthroplasty group vs. 13.1% in the hemiarthroplasty group; P = .48), while serious adverse events occurred in 41.8% of patients in the total hip arthroplasty group versus 36.7% of those in the hemiarthroplasty group (HR, 1.16; P = .13).

In other findings, hip instability or dislocation occurred in 4.7% of patients who were assigned to total hip arthroplasty, compared with 2.4% of those who were assigned to hemiarthroplasty (HR, 2.00), while patients who underwent total hip arthroplasty had superior function as measured by the WOMAC total score, pain score, stiffness score, and function score. “These differences between the treatment groups fell below the threshold for a minimal clinically important difference for WOMAC,” the researchers wrote.

They acknowledged certain limitations of the study, including the fact that patients and endpoint assessors were unblinded in the assessments of function, “which left a possibility of bias.” In addition, 14.9% of patients were lost to follow-up for analysis of the primary endpoint.

In an accompanying editorial, Jan-Erik Gjertsen, MD, wrote that one implication of the HEALTH trial is that hemiarthroplasty may provide a satisfactory results for the majority of elderly patients with hip fractures. “Considering the nearly equal risk of secondary surgical procedures and the modest benefit in functional outcome, should we abandon the use of total hip arthroplasty in the treatment of hip fractures?” asked Dr. Gjertsen, of the department of orthopedic surgery at Haukeland University Hospital in Bergen, Norway (N Engl J Med. 2019 Dec 4. doi:10.1056/NEJMe1913800). “Even if the benefits seem smaller than we previously thought, patients with high physical demands and a long remaining life expectancy should probably still be considered for treatment with total hip arthroplasty. Yet the expected remaining lifetime of those patients who potentially could benefit most from a total hip arthroplasty is much longer than the 2-year follow-up period used in the HEALTH trial. However, the number of secondary procedures after hemiarthroplasty may increase with longer follow-up. Therefore, one hopes that the HEALTH investigators will be able to provide long-term results from their trial in the future.”

The HEALTH trial was supported by grants from the Canadian Institutes of Health, the National Institutes of Health, ZorgOnderzoek Nederland/Medische Wetenschappen, the Sophies Minde Foundation for Orthopedic Research, McMaster Surgical Associates, and Stryker Orthopedics. Dr. Bhandari reported receiving grant support and lecture fees from Sanofi, lecture fees from Pendopharm, and grant support from Acumed and Aphria. Dr. Devereaux reported receiving grant support from Abbott Diagnostics, Boehringer Ingelheim, Philips Healthcare, Roche Diagnostics, and Siemens.

[email protected]

SOURCE: Bhandari M et al. N Engl J Med. 2019 Dec 4. doi: 10.1056/NEJMoa1906190.

Whether patients aged 50 years and older with a displaced femoral neck fracture underwent total hip arthroplasty or hemiarthroplasty had no significant influence on the risk of unplanned secondary hip procedures over 2 years of follow-up. In addition, while functional outcomes modestly favored total hip arthroplasty, the rates of mortality and serious adverse events were similar between the two treatment groups.

Those are key findings from a randomized, multicenter trial of the two procedures that was carried out in 10 countries.

“The American Academy of Orthopedic Surgeons and National Institute for Health and Care Excellence guidelines recommend total hip arthroplasty in all patients with displaced femoral neck fractures who are able to ambulate independently,” a team of investigators led by Mohit Bhandari, MD, and P.J. Devereaux, MD, both from McMaster University, Hamilton, Ont., wrote in a study published in the New England Journal of Medicine. “Our findings suggest that the advantages of total hip arthroplasty may not be compelling. The limited advantages of total hip arthroplasty, as well as the possible higher risk of complications, may be particularly important in regions of the world where total hip arthroplasty is not easily accessible or is cost prohibitive.”

In the Hip Fracture Evaluation With Alternative of Total Hip Arthroplasty Versus Hemiarthroplasty (HEALTH) trial, the researchers randomly assigned 1,495 patients aged 50 years and older who had a displaced femoral neck fracture to undergo either total hip arthroplasty or hemiarthroplasty. They were eligible for the trial only if they had been able to ambulate without the assistance of another person before the hip fracture occurred. The primary endpoint was any unplanned secondary hip procedure within 24 months after the initial surgery. Secondary endpoints included death, serious adverse events, hip-related complications, health-related quality of life, function, and overall health measures. Assessments included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score, pain score, stiffness score, and function score; the European Quality of Life–5 Dimensions utility index score and visual analogue scale; the 12-Item Short Form General Health Survey physical and mental component summary scores; and the Timed Up and Go scores.

The researchers found that the primary endpoint occurred in 7.9% of patients who had been randomly assigned to total hip arthroplasty and in 8.3% of those who had been randomly assigned to hemiarthroplasty (hazard ratio, 0.95; P = .79). As for secondary endpoints, mortality did not differ significantly between the two treatment groups (14.3% in the total hip arthroplasty group vs. 13.1% in the hemiarthroplasty group; P = .48), while serious adverse events occurred in 41.8% of patients in the total hip arthroplasty group versus 36.7% of those in the hemiarthroplasty group (HR, 1.16; P = .13).

In other findings, hip instability or dislocation occurred in 4.7% of patients who were assigned to total hip arthroplasty, compared with 2.4% of those who were assigned to hemiarthroplasty (HR, 2.00), while patients who underwent total hip arthroplasty had superior function as measured by the WOMAC total score, pain score, stiffness score, and function score. “These differences between the treatment groups fell below the threshold for a minimal clinically important difference for WOMAC,” the researchers wrote.

They acknowledged certain limitations of the study, including the fact that patients and endpoint assessors were unblinded in the assessments of function, “which left a possibility of bias.” In addition, 14.9% of patients were lost to follow-up for analysis of the primary endpoint.

In an accompanying editorial, Jan-Erik Gjertsen, MD, wrote that one implication of the HEALTH trial is that hemiarthroplasty may provide a satisfactory results for the majority of elderly patients with hip fractures. “Considering the nearly equal risk of secondary surgical procedures and the modest benefit in functional outcome, should we abandon the use of total hip arthroplasty in the treatment of hip fractures?” asked Dr. Gjertsen, of the department of orthopedic surgery at Haukeland University Hospital in Bergen, Norway (N Engl J Med. 2019 Dec 4. doi:10.1056/NEJMe1913800). “Even if the benefits seem smaller than we previously thought, patients with high physical demands and a long remaining life expectancy should probably still be considered for treatment with total hip arthroplasty. Yet the expected remaining lifetime of those patients who potentially could benefit most from a total hip arthroplasty is much longer than the 2-year follow-up period used in the HEALTH trial. However, the number of secondary procedures after hemiarthroplasty may increase with longer follow-up. Therefore, one hopes that the HEALTH investigators will be able to provide long-term results from their trial in the future.”

The HEALTH trial was supported by grants from the Canadian Institutes of Health, the National Institutes of Health, ZorgOnderzoek Nederland/Medische Wetenschappen, the Sophies Minde Foundation for Orthopedic Research, McMaster Surgical Associates, and Stryker Orthopedics. Dr. Bhandari reported receiving grant support and lecture fees from Sanofi, lecture fees from Pendopharm, and grant support from Acumed and Aphria. Dr. Devereaux reported receiving grant support from Abbott Diagnostics, Boehringer Ingelheim, Philips Healthcare, Roche Diagnostics, and Siemens.

[email protected]

SOURCE: Bhandari M et al. N Engl J Med. 2019 Dec 4. doi: 10.1056/NEJMoa1906190.

Whether patients aged 50 years and older with a displaced femoral neck fracture underwent total hip arthroplasty or hemiarthroplasty had no significant influence on the risk of unplanned secondary hip procedures over 2 years of follow-up. In addition, while functional outcomes modestly favored total hip arthroplasty, the rates of mortality and serious adverse events were similar between the two treatment groups.

Those are key findings from a randomized, multicenter trial of the two procedures that was carried out in 10 countries.

“The American Academy of Orthopedic Surgeons and National Institute for Health and Care Excellence guidelines recommend total hip arthroplasty in all patients with displaced femoral neck fractures who are able to ambulate independently,” a team of investigators led by Mohit Bhandari, MD, and P.J. Devereaux, MD, both from McMaster University, Hamilton, Ont., wrote in a study published in the New England Journal of Medicine. “Our findings suggest that the advantages of total hip arthroplasty may not be compelling. The limited advantages of total hip arthroplasty, as well as the possible higher risk of complications, may be particularly important in regions of the world where total hip arthroplasty is not easily accessible or is cost prohibitive.”

In the Hip Fracture Evaluation With Alternative of Total Hip Arthroplasty Versus Hemiarthroplasty (HEALTH) trial, the researchers randomly assigned 1,495 patients aged 50 years and older who had a displaced femoral neck fracture to undergo either total hip arthroplasty or hemiarthroplasty. They were eligible for the trial only if they had been able to ambulate without the assistance of another person before the hip fracture occurred. The primary endpoint was any unplanned secondary hip procedure within 24 months after the initial surgery. Secondary endpoints included death, serious adverse events, hip-related complications, health-related quality of life, function, and overall health measures. Assessments included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score, pain score, stiffness score, and function score; the European Quality of Life–5 Dimensions utility index score and visual analogue scale; the 12-Item Short Form General Health Survey physical and mental component summary scores; and the Timed Up and Go scores.

The researchers found that the primary endpoint occurred in 7.9% of patients who had been randomly assigned to total hip arthroplasty and in 8.3% of those who had been randomly assigned to hemiarthroplasty (hazard ratio, 0.95; P = .79). As for secondary endpoints, mortality did not differ significantly between the two treatment groups (14.3% in the total hip arthroplasty group vs. 13.1% in the hemiarthroplasty group; P = .48), while serious adverse events occurred in 41.8% of patients in the total hip arthroplasty group versus 36.7% of those in the hemiarthroplasty group (HR, 1.16; P = .13).

In other findings, hip instability or dislocation occurred in 4.7% of patients who were assigned to total hip arthroplasty, compared with 2.4% of those who were assigned to hemiarthroplasty (HR, 2.00), while patients who underwent total hip arthroplasty had superior function as measured by the WOMAC total score, pain score, stiffness score, and function score. “These differences between the treatment groups fell below the threshold for a minimal clinically important difference for WOMAC,” the researchers wrote.

They acknowledged certain limitations of the study, including the fact that patients and endpoint assessors were unblinded in the assessments of function, “which left a possibility of bias.” In addition, 14.9% of patients were lost to follow-up for analysis of the primary endpoint.

In an accompanying editorial, Jan-Erik Gjertsen, MD, wrote that one implication of the HEALTH trial is that hemiarthroplasty may provide a satisfactory results for the majority of elderly patients with hip fractures. “Considering the nearly equal risk of secondary surgical procedures and the modest benefit in functional outcome, should we abandon the use of total hip arthroplasty in the treatment of hip fractures?” asked Dr. Gjertsen, of the department of orthopedic surgery at Haukeland University Hospital in Bergen, Norway (N Engl J Med. 2019 Dec 4. doi:10.1056/NEJMe1913800). “Even if the benefits seem smaller than we previously thought, patients with high physical demands and a long remaining life expectancy should probably still be considered for treatment with total hip arthroplasty. Yet the expected remaining lifetime of those patients who potentially could benefit most from a total hip arthroplasty is much longer than the 2-year follow-up period used in the HEALTH trial. However, the number of secondary procedures after hemiarthroplasty may increase with longer follow-up. Therefore, one hopes that the HEALTH investigators will be able to provide long-term results from their trial in the future.”

The HEALTH trial was supported by grants from the Canadian Institutes of Health, the National Institutes of Health, ZorgOnderzoek Nederland/Medische Wetenschappen, the Sophies Minde Foundation for Orthopedic Research, McMaster Surgical Associates, and Stryker Orthopedics. Dr. Bhandari reported receiving grant support and lecture fees from Sanofi, lecture fees from Pendopharm, and grant support from Acumed and Aphria. Dr. Devereaux reported receiving grant support from Abbott Diagnostics, Boehringer Ingelheim, Philips Healthcare, Roche Diagnostics, and Siemens.

[email protected]

SOURCE: Bhandari M et al. N Engl J Med. 2019 Dec 4. doi: 10.1056/NEJMoa1906190.

The use of supplemental MRI screening in women with extremely dense breast tissue and normal results on mammography led to the diagnosis of significantly fewer interval cancers, compared with mammography alone during a 2-year screening period, results from a randomized trial show.

Dr. Cecil Fox/National Cancer Institute

“Women with extremely dense breast tissue have an increased risk of breast cancer, and their cancers are also less likely to be detected on mammography,” Dutch researchers led by Marije F. Bakker, PhD, of Utrecht (The Netherlands) University and colleagues wrote for the Dense Tissue and Early Breast Neoplasm Screening (DENSE) Trial Study Group in an article published in the New England Journal of Medicine.

“Such patients may benefit from a tailored breast-screening strategy, supplemented with more sensitive imaging methods. The benefit of supplemental imaging is the subject of a worldwide debate. In the United States, a federal law directs breast-density reporting, but supplemental screening is not recommended in American guidelines. Although supplemental imaging increases the rate of cancer detection in women with dense breasts, the question remains whether it improves health outcomes,” they said.

In the DENSE trial, researchers assigned 40,373 women with extremely dense breast tissue and negative results on screening mammography to a group that was invited to undergo supplemental MRI or to a group that received mammography screening only. The women were between the ages of 50 and 75 years and were enrolled between December 2011 and November 2015 as part of the Dutch population-based digital mammography screening program. The primary outcome was the between-group difference in the incidence of interval cancers during a 2-year screening period.

Dr. Bakker and associates found that the interval cancer rate was 2.5 per 1,000 screenings among 4,783 women in the MRI invitation group, compared with 5 per 1,000 among the 32,312 women in the mammography-only group, a difference of 2.5 per 1,000 screenings (P less than 0.001). Among the women who were invited to undergo MRI, 59% actually underwent the procedure. Of the 20 interval cancers diagnosed in the MRI-invitation group, 4 were diagnosed in the women who had undergone MRI, which translated to 0.8 per 1,000 screenings. The remaining 16 were diagnosed in those who had not undergone MRI, which translated into 4.9 per 1,000 screenings.

“Undergoing supplemental MRI was associated with a cancer-detection rate of 16.5 per 1,000 screenings and resulted in a false positive rate of 8.0% (79.8 per 1,000 screenings),” the researchers wrote. “Of the women who underwent a breast biopsy on the basis of an MRI indication, 26.3% had breast cancer and 73.7% did not.”

Dr. Bakker and coauthors acknowledged certain limitations of the trial, including the fact that it was not large enough to examine the effect of MRI screening on breast cancer–specific or overall mortality. “This outcome would require a much larger sample size and longer follow-up,” they wrote. “The lower rate of interval cancers that we found among participants who underwent MRI is indicative of and prerequisite for an effect on mortality. After that, a reduction in the number of advanced cancers would also be required to show a mortality benefit, which would require several years of follow-up.”

In an accompanying editorial, Dan L. Longo, MD, noted that the study provides high-quality data from a randomized trial where none existed (N Engl J Med. 2019 Nov 27. doi: 10.1056/NEJMe1912943). “It appears to show that among women with dense breasts, the risk of interval cancers is halved by following a negative mammogram with MRI screening,” wrote Dr. Longo, who is deputy editor of the New England Journal of Medicine, as well as professor of medicine at Harvard Medical School, Boston. “But is a reduction in interval cancers an appropriate surrogate for improved overall survival? It appears that most of the cancers that were detected on supplemental MRI screening were found at an early stage. Ductal carcinoma in situ was 10 times more frequent among patients undergoing MRI, and these diagnoses were likely to lead to treatments. What remains unclear is whether the tumors would never otherwise have been detected or threatened the patient’s survival.”

The trial was supported by the University Medical Center Utrecht (the Netherlands), the Netherlands Organization for Health Research and Development, the Dutch Cancer Society, the Dutch Pink Ribbon–A Sister’s Hope organization, Stichting Kankerpreventie Midden-West, and Bayer Pharmaceuticals, with an in-kind contribution from Volpara Health Technologies.

The researchers reported having no relevant financial disclosures other than the trial funding. Dr. Longo is employed by the New England Journal of Medicine as deputy editor.
 

[email protected]

SOURCE: Bakker MF et al. N Engl J Med. 2019 Nov 27. doi: 10.1056/NEJMoa1903986.

The use of supplemental MRI screening in women with extremely dense breast tissue and normal results on mammography led to the diagnosis of significantly fewer interval cancers, compared with mammography alone during a 2-year screening period, results from a randomized trial show.

Dr. Cecil Fox/National Cancer Institute

“Women with extremely dense breast tissue have an increased risk of breast cancer, and their cancers are also less likely to be detected on mammography,” Dutch researchers led by Marije F. Bakker, PhD, of Utrecht (The Netherlands) University and colleagues wrote for the Dense Tissue and Early Breast Neoplasm Screening (DENSE) Trial Study Group in an article published in the New England Journal of Medicine.

“Such patients may benefit from a tailored breast-screening strategy, supplemented with more sensitive imaging methods. The benefit of supplemental imaging is the subject of a worldwide debate. In the United States, a federal law directs breast-density reporting, but supplemental screening is not recommended in American guidelines. Although supplemental imaging increases the rate of cancer detection in women with dense breasts, the question remains whether it improves health outcomes,” they said.

In the DENSE trial, researchers assigned 40,373 women with extremely dense breast tissue and negative results on screening mammography to a group that was invited to undergo supplemental MRI or to a group that received mammography screening only. The women were between the ages of 50 and 75 years and were enrolled between December 2011 and November 2015 as part of the Dutch population-based digital mammography screening program. The primary outcome was the between-group difference in the incidence of interval cancers during a 2-year screening period.

Dr. Bakker and associates found that the interval cancer rate was 2.5 per 1,000 screenings among 4,783 women in the MRI invitation group, compared with 5 per 1,000 among the 32,312 women in the mammography-only group, a difference of 2.5 per 1,000 screenings (P less than 0.001). Among the women who were invited to undergo MRI, 59% actually underwent the procedure. Of the 20 interval cancers diagnosed in the MRI-invitation group, 4 were diagnosed in the women who had undergone MRI, which translated to 0.8 per 1,000 screenings. The remaining 16 were diagnosed in those who had not undergone MRI, which translated into 4.9 per 1,000 screenings.

“Undergoing supplemental MRI was associated with a cancer-detection rate of 16.5 per 1,000 screenings and resulted in a false positive rate of 8.0% (79.8 per 1,000 screenings),” the researchers wrote. “Of the women who underwent a breast biopsy on the basis of an MRI indication, 26.3% had breast cancer and 73.7% did not.”

Dr. Bakker and coauthors acknowledged certain limitations of the trial, including the fact that it was not large enough to examine the effect of MRI screening on breast cancer–specific or overall mortality. “This outcome would require a much larger sample size and longer follow-up,” they wrote. “The lower rate of interval cancers that we found among participants who underwent MRI is indicative of and prerequisite for an effect on mortality. After that, a reduction in the number of advanced cancers would also be required to show a mortality benefit, which would require several years of follow-up.”

In an accompanying editorial, Dan L. Longo, MD, noted that the study provides high-quality data from a randomized trial where none existed (N Engl J Med. 2019 Nov 27. doi: 10.1056/NEJMe1912943). “It appears to show that among women with dense breasts, the risk of interval cancers is halved by following a negative mammogram with MRI screening,” wrote Dr. Longo, who is deputy editor of the New England Journal of Medicine, as well as professor of medicine at Harvard Medical School, Boston. “But is a reduction in interval cancers an appropriate surrogate for improved overall survival? It appears that most of the cancers that were detected on supplemental MRI screening were found at an early stage. Ductal carcinoma in situ was 10 times more frequent among patients undergoing MRI, and these diagnoses were likely to lead to treatments. What remains unclear is whether the tumors would never otherwise have been detected or threatened the patient’s survival.”

The trial was supported by the University Medical Center Utrecht (the Netherlands), the Netherlands Organization for Health Research and Development, the Dutch Cancer Society, the Dutch Pink Ribbon–A Sister’s Hope organization, Stichting Kankerpreventie Midden-West, and Bayer Pharmaceuticals, with an in-kind contribution from Volpara Health Technologies.

The researchers reported having no relevant financial disclosures other than the trial funding. Dr. Longo is employed by the New England Journal of Medicine as deputy editor.
 

[email protected]

SOURCE: Bakker MF et al. N Engl J Med. 2019 Nov 27. doi: 10.1056/NEJMoa1903986.

The use of supplemental MRI screening in women with extremely dense breast tissue and normal results on mammography led to the diagnosis of significantly fewer interval cancers, compared with mammography alone during a 2-year screening period, results from a randomized trial show.

Dr. Cecil Fox/National Cancer Institute

“Women with extremely dense breast tissue have an increased risk of breast cancer, and their cancers are also less likely to be detected on mammography,” Dutch researchers led by Marije F. Bakker, PhD, of Utrecht (The Netherlands) University and colleagues wrote for the Dense Tissue and Early Breast Neoplasm Screening (DENSE) Trial Study Group in an article published in the New England Journal of Medicine.

“Such patients may benefit from a tailored breast-screening strategy, supplemented with more sensitive imaging methods. The benefit of supplemental imaging is the subject of a worldwide debate. In the United States, a federal law directs breast-density reporting, but supplemental screening is not recommended in American guidelines. Although supplemental imaging increases the rate of cancer detection in women with dense breasts, the question remains whether it improves health outcomes,” they said.

In the DENSE trial, researchers assigned 40,373 women with extremely dense breast tissue and negative results on screening mammography to a group that was invited to undergo supplemental MRI or to a group that received mammography screening only. The women were between the ages of 50 and 75 years and were enrolled between December 2011 and November 2015 as part of the Dutch population-based digital mammography screening program. The primary outcome was the between-group difference in the incidence of interval cancers during a 2-year screening period.

Dr. Bakker and associates found that the interval cancer rate was 2.5 per 1,000 screenings among 4,783 women in the MRI invitation group, compared with 5 per 1,000 among the 32,312 women in the mammography-only group, a difference of 2.5 per 1,000 screenings (P less than 0.001). Among the women who were invited to undergo MRI, 59% actually underwent the procedure. Of the 20 interval cancers diagnosed in the MRI-invitation group, 4 were diagnosed in the women who had undergone MRI, which translated to 0.8 per 1,000 screenings. The remaining 16 were diagnosed in those who had not undergone MRI, which translated into 4.9 per 1,000 screenings.

“Undergoing supplemental MRI was associated with a cancer-detection rate of 16.5 per 1,000 screenings and resulted in a false positive rate of 8.0% (79.8 per 1,000 screenings),” the researchers wrote. “Of the women who underwent a breast biopsy on the basis of an MRI indication, 26.3% had breast cancer and 73.7% did not.”

Dr. Bakker and coauthors acknowledged certain limitations of the trial, including the fact that it was not large enough to examine the effect of MRI screening on breast cancer–specific or overall mortality. “This outcome would require a much larger sample size and longer follow-up,” they wrote. “The lower rate of interval cancers that we found among participants who underwent MRI is indicative of and prerequisite for an effect on mortality. After that, a reduction in the number of advanced cancers would also be required to show a mortality benefit, which would require several years of follow-up.”

In an accompanying editorial, Dan L. Longo, MD, noted that the study provides high-quality data from a randomized trial where none existed (N Engl J Med. 2019 Nov 27. doi: 10.1056/NEJMe1912943). “It appears to show that among women with dense breasts, the risk of interval cancers is halved by following a negative mammogram with MRI screening,” wrote Dr. Longo, who is deputy editor of the New England Journal of Medicine, as well as professor of medicine at Harvard Medical School, Boston. “But is a reduction in interval cancers an appropriate surrogate for improved overall survival? It appears that most of the cancers that were detected on supplemental MRI screening were found at an early stage. Ductal carcinoma in situ was 10 times more frequent among patients undergoing MRI, and these diagnoses were likely to lead to treatments. What remains unclear is whether the tumors would never otherwise have been detected or threatened the patient’s survival.”

The trial was supported by the University Medical Center Utrecht (the Netherlands), the Netherlands Organization for Health Research and Development, the Dutch Cancer Society, the Dutch Pink Ribbon–A Sister’s Hope organization, Stichting Kankerpreventie Midden-West, and Bayer Pharmaceuticals, with an in-kind contribution from Volpara Health Technologies.

The researchers reported having no relevant financial disclosures other than the trial funding. Dr. Longo is employed by the New England Journal of Medicine as deputy editor.
 

[email protected]

SOURCE: Bakker MF et al. N Engl J Med. 2019 Nov 27. doi: 10.1056/NEJMoa1903986.

Initiating antiretroviral therapy within an hour after birth, rather than waiting a few weeks, lowers the reservoir of HIV virus and improves immune response, early results from an ongoing study in Botswana, Africa, showed.

Comstock/Thinkstock

Despite advances in treatment programs during pregnancy that prevent mother to child HIV transmission, 300-500 pediatric HIV infections occur each day in sub-Saharan Africa, Roger Shapiro, MD, MPH, said during a media teleconference organized by the American Association for the Advancement of Science. “Most pediatric HIV diagnosis programs currently test children at 4-6 weeks of age to identify infections that occur either in pregnancy or during delivery,” said Dr. Shapiro, associate professor of immunology and infectious diseases at the Harvard T.H. Chan School of Public Health, Boston. “However, these programs miss the opportunity to begin immediate antiretroviral treatment for children who can be identified earlier. There are benefits to starting treatment and arresting HIV replication in the first week of life. These include limiting the viral reservoir or the population of infected cells, limiting potentially harmful immune responses to the virus, and preventing the rapid decline in health that can occur in the early weeks of HIV infection in infants. Without treatment, 50% of HIV-infected children regress to death by 2 years. Starting treatment in the first weeks or months of life has been shown to improve survival.”

With these benefits in mind, he and his associates initiated the Early Infant Treatment (EIT) study in 2015 to diagnose and treat HIV infected infants in Botswana in the first week of life or as early as possible after infection. They screened more than 10,000 children and identified 40 that were HIV infected. “This low transmission rate is a testament to the fact that most HIV-positive women in Botswana receive three-drug treatment in pregnancy, which is highly successful in blocking transmission,” Dr. Shapiro said. “When we identified an HIV-infected infant, we consented mothers to allow us to start treatment right away. We used a series of regimens because there are limited options. The available options include older drugs, some of which are no longer used for adults but which were the only options for children.”

The researchers initiated three initial drugs approved for newborns: nevirapine, zidovudine, and lamivudine, and then changed the regimen slightly after a few weeks, when they used ritonavir-boosted lopinavir, plus the lamivudine and zidovudine. “We followed the children weekly at first, then at monthly refill visits, and kept close track of how they were taking the medicines and the level of virus in each child’s blood,” Dr. Shapiro said.

In a manuscript published online in Science Translational Medicine on Nov. 27, 2019, he and his associates reported results of the first 10 children enrolled in the EIT study who reached about 96 weeks on treatment. For comparison, they also enrolled a group of children as controls, who started treatment later in the first year of life, after being identified at a more standard time of 4-6 weeks. Tests performed included droplet digital polymerase chain reaction, HIV near-full-genome sequencing, whole-genome amplification, and flow cytometry.

“What we wanted to focus on are the HIV reservoir cells that are persisting in the setting of antiretroviral treatment,” study coauthor Mathias Lichterfeld, MD, PhD, explained during the teleconference. “Those are the cells that would cause viral rebound if treatment were to be interrupted. We used complex technology to look at these cells, using next-generation sequencing, which allows us to identify those cells that harbor HIV that has the ability to initiate new viral replication.”

He and his colleagues observed that the number of reservoir cells was significantly smaller than in adults who were on ART for a median of 16 years. It also was smaller than in infected infants who started ART treatment weeks after birth.

In addition, immune activation was reduced in the cohort of infants who were treated immediately after birth.

“We are seeing a distinct advantage of early treatment initiation,” said Dr. Lichterfeld of the infectious disease division at Brigham and Women’s Hospital, Boston. “By doing these assays we see both virological benefits in terms of a very-low reservoir size, and we see immune system characteristics that are also associated with better abilities for antimicrobial immune defense and a lower level of immune activation.”

Another study coauthor, Daniel R. Kuritzkes, MD, chief of the infectious disease division at Brigham and Women’s Hospital, said the findings show “how critically important” it is to extend studies of HIV cure or long-term remission to infants and children. “Very-early intervention in neonates limits the size of the reservoir and offers us the best opportunity for future interventions aimed at cure and long-term drug-free remission of HIV infection,” he said. “We don’t think the current intervention is itself curative, but it sets the stage for the capacity to offer additional innovative interventions in the future. Beyond the importance of this work for cure research per se, this very early intervention in neonates also has the potential of conferring important clinical benefits to the children who participated in this study. Finally, our study demonstrates the feasibility and importance of doing this type of research in neonates in resource-limited settings, given the appropriate infrastructure.”

EIT is supported by the National Institutes of Health. Dr. Lichterfeld disclosed having received speaking and consulting honoraria from Merck and Gilead. Dr. Kuritzkes disclosed having received consulting honoraria and/or research support from Gilead, Merck, and ViiV.

[email protected]

SOURCE: Garcia-Broncano P et al. Sci Transl Med. 2019 Nov 27. eaax7350.

Initiating antiretroviral therapy within an hour after birth, rather than waiting a few weeks, lowers the reservoir of HIV virus and improves immune response, early results from an ongoing study in Botswana, Africa, showed.

Comstock/Thinkstock

Despite advances in treatment programs during pregnancy that prevent mother to child HIV transmission, 300-500 pediatric HIV infections occur each day in sub-Saharan Africa, Roger Shapiro, MD, MPH, said during a media teleconference organized by the American Association for the Advancement of Science. “Most pediatric HIV diagnosis programs currently test children at 4-6 weeks of age to identify infections that occur either in pregnancy or during delivery,” said Dr. Shapiro, associate professor of immunology and infectious diseases at the Harvard T.H. Chan School of Public Health, Boston. “However, these programs miss the opportunity to begin immediate antiretroviral treatment for children who can be identified earlier. There are benefits to starting treatment and arresting HIV replication in the first week of life. These include limiting the viral reservoir or the population of infected cells, limiting potentially harmful immune responses to the virus, and preventing the rapid decline in health that can occur in the early weeks of HIV infection in infants. Without treatment, 50% of HIV-infected children regress to death by 2 years. Starting treatment in the first weeks or months of life has been shown to improve survival.”

With these benefits in mind, he and his associates initiated the Early Infant Treatment (EIT) study in 2015 to diagnose and treat HIV infected infants in Botswana in the first week of life or as early as possible after infection. They screened more than 10,000 children and identified 40 that were HIV infected. “This low transmission rate is a testament to the fact that most HIV-positive women in Botswana receive three-drug treatment in pregnancy, which is highly successful in blocking transmission,” Dr. Shapiro said. “When we identified an HIV-infected infant, we consented mothers to allow us to start treatment right away. We used a series of regimens because there are limited options. The available options include older drugs, some of which are no longer used for adults but which were the only options for children.”

The researchers initiated three initial drugs approved for newborns: nevirapine, zidovudine, and lamivudine, and then changed the regimen slightly after a few weeks, when they used ritonavir-boosted lopinavir, plus the lamivudine and zidovudine. “We followed the children weekly at first, then at monthly refill visits, and kept close track of how they were taking the medicines and the level of virus in each child’s blood,” Dr. Shapiro said.

In a manuscript published online in Science Translational Medicine on Nov. 27, 2019, he and his associates reported results of the first 10 children enrolled in the EIT study who reached about 96 weeks on treatment. For comparison, they also enrolled a group of children as controls, who started treatment later in the first year of life, after being identified at a more standard time of 4-6 weeks. Tests performed included droplet digital polymerase chain reaction, HIV near-full-genome sequencing, whole-genome amplification, and flow cytometry.

“What we wanted to focus on are the HIV reservoir cells that are persisting in the setting of antiretroviral treatment,” study coauthor Mathias Lichterfeld, MD, PhD, explained during the teleconference. “Those are the cells that would cause viral rebound if treatment were to be interrupted. We used complex technology to look at these cells, using next-generation sequencing, which allows us to identify those cells that harbor HIV that has the ability to initiate new viral replication.”

He and his colleagues observed that the number of reservoir cells was significantly smaller than in adults who were on ART for a median of 16 years. It also was smaller than in infected infants who started ART treatment weeks after birth.

In addition, immune activation was reduced in the cohort of infants who were treated immediately after birth.

“We are seeing a distinct advantage of early treatment initiation,” said Dr. Lichterfeld of the infectious disease division at Brigham and Women’s Hospital, Boston. “By doing these assays we see both virological benefits in terms of a very-low reservoir size, and we see immune system characteristics that are also associated with better abilities for antimicrobial immune defense and a lower level of immune activation.”

Another study coauthor, Daniel R. Kuritzkes, MD, chief of the infectious disease division at Brigham and Women’s Hospital, said the findings show “how critically important” it is to extend studies of HIV cure or long-term remission to infants and children. “Very-early intervention in neonates limits the size of the reservoir and offers us the best opportunity for future interventions aimed at cure and long-term drug-free remission of HIV infection,” he said. “We don’t think the current intervention is itself curative, but it sets the stage for the capacity to offer additional innovative interventions in the future. Beyond the importance of this work for cure research per se, this very early intervention in neonates also has the potential of conferring important clinical benefits to the children who participated in this study. Finally, our study demonstrates the feasibility and importance of doing this type of research in neonates in resource-limited settings, given the appropriate infrastructure.”

EIT is supported by the National Institutes of Health. Dr. Lichterfeld disclosed having received speaking and consulting honoraria from Merck and Gilead. Dr. Kuritzkes disclosed having received consulting honoraria and/or research support from Gilead, Merck, and ViiV.

[email protected]

SOURCE: Garcia-Broncano P et al. Sci Transl Med. 2019 Nov 27. eaax7350.

Initiating antiretroviral therapy within an hour after birth, rather than waiting a few weeks, lowers the reservoir of HIV virus and improves immune response, early results from an ongoing study in Botswana, Africa, showed.

Comstock/Thinkstock

Despite advances in treatment programs during pregnancy that prevent mother to child HIV transmission, 300-500 pediatric HIV infections occur each day in sub-Saharan Africa, Roger Shapiro, MD, MPH, said during a media teleconference organized by the American Association for the Advancement of Science. “Most pediatric HIV diagnosis programs currently test children at 4-6 weeks of age to identify infections that occur either in pregnancy or during delivery,” said Dr. Shapiro, associate professor of immunology and infectious diseases at the Harvard T.H. Chan School of Public Health, Boston. “However, these programs miss the opportunity to begin immediate antiretroviral treatment for children who can be identified earlier. There are benefits to starting treatment and arresting HIV replication in the first week of life. These include limiting the viral reservoir or the population of infected cells, limiting potentially harmful immune responses to the virus, and preventing the rapid decline in health that can occur in the early weeks of HIV infection in infants. Without treatment, 50% of HIV-infected children regress to death by 2 years. Starting treatment in the first weeks or months of life has been shown to improve survival.”

With these benefits in mind, he and his associates initiated the Early Infant Treatment (EIT) study in 2015 to diagnose and treat HIV infected infants in Botswana in the first week of life or as early as possible after infection. They screened more than 10,000 children and identified 40 that were HIV infected. “This low transmission rate is a testament to the fact that most HIV-positive women in Botswana receive three-drug treatment in pregnancy, which is highly successful in blocking transmission,” Dr. Shapiro said. “When we identified an HIV-infected infant, we consented mothers to allow us to start treatment right away. We used a series of regimens because there are limited options. The available options include older drugs, some of which are no longer used for adults but which were the only options for children.”

The researchers initiated three initial drugs approved for newborns: nevirapine, zidovudine, and lamivudine, and then changed the regimen slightly after a few weeks, when they used ritonavir-boosted lopinavir, plus the lamivudine and zidovudine. “We followed the children weekly at first, then at monthly refill visits, and kept close track of how they were taking the medicines and the level of virus in each child’s blood,” Dr. Shapiro said.

In a manuscript published online in Science Translational Medicine on Nov. 27, 2019, he and his associates reported results of the first 10 children enrolled in the EIT study who reached about 96 weeks on treatment. For comparison, they also enrolled a group of children as controls, who started treatment later in the first year of life, after being identified at a more standard time of 4-6 weeks. Tests performed included droplet digital polymerase chain reaction, HIV near-full-genome sequencing, whole-genome amplification, and flow cytometry.

“What we wanted to focus on are the HIV reservoir cells that are persisting in the setting of antiretroviral treatment,” study coauthor Mathias Lichterfeld, MD, PhD, explained during the teleconference. “Those are the cells that would cause viral rebound if treatment were to be interrupted. We used complex technology to look at these cells, using next-generation sequencing, which allows us to identify those cells that harbor HIV that has the ability to initiate new viral replication.”

He and his colleagues observed that the number of reservoir cells was significantly smaller than in adults who were on ART for a median of 16 years. It also was smaller than in infected infants who started ART treatment weeks after birth.

In addition, immune activation was reduced in the cohort of infants who were treated immediately after birth.

“We are seeing a distinct advantage of early treatment initiation,” said Dr. Lichterfeld of the infectious disease division at Brigham and Women’s Hospital, Boston. “By doing these assays we see both virological benefits in terms of a very-low reservoir size, and we see immune system characteristics that are also associated with better abilities for antimicrobial immune defense and a lower level of immune activation.”

Another study coauthor, Daniel R. Kuritzkes, MD, chief of the infectious disease division at Brigham and Women’s Hospital, said the findings show “how critically important” it is to extend studies of HIV cure or long-term remission to infants and children. “Very-early intervention in neonates limits the size of the reservoir and offers us the best opportunity for future interventions aimed at cure and long-term drug-free remission of HIV infection,” he said. “We don’t think the current intervention is itself curative, but it sets the stage for the capacity to offer additional innovative interventions in the future. Beyond the importance of this work for cure research per se, this very early intervention in neonates also has the potential of conferring important clinical benefits to the children who participated in this study. Finally, our study demonstrates the feasibility and importance of doing this type of research in neonates in resource-limited settings, given the appropriate infrastructure.”

EIT is supported by the National Institutes of Health. Dr. Lichterfeld disclosed having received speaking and consulting honoraria from Merck and Gilead. Dr. Kuritzkes disclosed having received consulting honoraria and/or research support from Gilead, Merck, and ViiV.

[email protected]

SOURCE: Garcia-Broncano P et al. Sci Transl Med. 2019 Nov 27. eaax7350.

NEW ORLEANS – When Timothy P. Brigham, MDiv, PhD, thinks about the impact of burnout and stress on the ability of physicians to practice medicine, Lewin’s equation comes to mind.

FatCamera/Getty Images

Developed by psychologist Kurt Lewin in 1936, the equation holds that behavior stems from a person’s personality and the environment that person inhabits.

“We suspect that 70%-80% of the problem with burnout and stress in medicine is environmental,” Dr. Brigham, chief of staff and chief education and organizational development officer at the Chicago-based Accreditation Council for Graduate Medical Education (ACGME), said at the annual meeting of the American Academy of Pediatrics.

“It’s a toxic mine, in some ways. What we tend to do is when we detect that physicians in general are, or a particular residency program is, too stressed out or burned out, we give them resilience training. Not that that’s unimportant, but it’s like putting a canary in a toxic mine full of poison and saying, ‘We’re going to teach you to hold your breath a little bit longer.’ Our job is to detoxify the mine.”

Troubled by the rise of suicides among physicians in recent years as well as mounting evidence about the adverse impact of burnout and stress on the practice of medicine, Dr. Brigham said that the ACGME is deepening its commitment to the well-being of faculty, residents, patients, and all members of the health care team. Since launching a “call to arms” on the topic at its annual educational conference in 2015, the ACGME has added courses on well-being to its annual meeting and remolded its Clinical Learning Environmental Review program to include all clinicians, “because everybody is affected by this: nurses, coordinators, et cetera,” he said. The ACGME also has revised Common Program Requirements, disseminated tools and resources to promote well-being and new knowledge on the topic, and partnered with the National Academy of Medicine Action Collaborative on Clinician Well-Being and Resilience – all in an effort to bring about culture change.

“But we’re well aware that the ACGME can’t do this alone,” Dr. Brigham said. “We can’t ‘requirement’ our way out of this problem. It’s going to take a culture shift. Only you physicians, in collaboration with everyone in your community of learning, can create the systemic change required to improve our culture. We have a good handle on the problem at this point, but the solutions are a little bit more difficult to get a hold of. As Martin Luther King Jr. once said, ‘You don’t have to see the whole staircase, just take the first step.’ ”

The ACGME wants to work with physicians “to collect data and do joint research, to share insights, and to share tools and resources to create a better world for practicing physicians, for other members of the health care team, and for patients. After all, clinicians who care for themselves provide better care for others. They’re less likely to make errors or leave the profession,” Dr. Brigham told attendees.

He added that clinicians can gauge their risk for burnout by asking themselves three simple questions about their work environment: Does it support self-care? Does it increase and support connection with colleagues? Does it connect people to purpose and meaningful work?

“One of the problems with our resident clinical work hours is not terrible program directors saying, ‘work longer.’ It’s residents who want to take care of families for 1 more hour,” Dr. Brigham continued. “It’s residents who want to take care of patients who are going through a difficult time. You represent the top 2% in the world in terms of your intelligence and achievement, yet that’s not what makes you special. What makes you special is that the level of self-doubt in this room exceeds that of the general population by about 10 times. You also tend to run toward what everyone else runs away from: disease, despair, people who are injured and suffering. That takes a toll.”

Courtesy AAP

He emphasized that positive social relationships with others are crucial to joy and well-being in the practice of medicine. “Burnout isn’t just about exhaustion; it’s about loneliness,” Dr. Brigham said. “There’s a surprising power in just asking people how they’re doing, and really wanting to know the answer.”

Negative social connections are highly correlated with burnout and depression, such as harassment, bullying, mistreatment, discrimination, “and using the power gradient to squash somebody who’s trying their best to be a physician,” he said.

Dr. Brigham acknowledged the tall task of bringing a spotlight to well-being as physicians continue to engage in tasks such as the burden and lack of standardization of prior authorization requirements, the burden of clinical documentation requirements, electronic health records and related work flow, and quality payment programs. “This is what we need to shift; this is what we need to take away so you can get back in touch with why you became a physician in the first place.”

Dr. Brigham reported having no financial disclosures.

[email protected]

NEW ORLEANS – When Timothy P. Brigham, MDiv, PhD, thinks about the impact of burnout and stress on the ability of physicians to practice medicine, Lewin’s equation comes to mind.

FatCamera/Getty Images

Developed by psychologist Kurt Lewin in 1936, the equation holds that behavior stems from a person’s personality and the environment that person inhabits.

“We suspect that 70%-80% of the problem with burnout and stress in medicine is environmental,” Dr. Brigham, chief of staff and chief education and organizational development officer at the Chicago-based Accreditation Council for Graduate Medical Education (ACGME), said at the annual meeting of the American Academy of Pediatrics.

“It’s a toxic mine, in some ways. What we tend to do is when we detect that physicians in general are, or a particular residency program is, too stressed out or burned out, we give them resilience training. Not that that’s unimportant, but it’s like putting a canary in a toxic mine full of poison and saying, ‘We’re going to teach you to hold your breath a little bit longer.’ Our job is to detoxify the mine.”

Troubled by the rise of suicides among physicians in recent years as well as mounting evidence about the adverse impact of burnout and stress on the practice of medicine, Dr. Brigham said that the ACGME is deepening its commitment to the well-being of faculty, residents, patients, and all members of the health care team. Since launching a “call to arms” on the topic at its annual educational conference in 2015, the ACGME has added courses on well-being to its annual meeting and remolded its Clinical Learning Environmental Review program to include all clinicians, “because everybody is affected by this: nurses, coordinators, et cetera,” he said. The ACGME also has revised Common Program Requirements, disseminated tools and resources to promote well-being and new knowledge on the topic, and partnered with the National Academy of Medicine Action Collaborative on Clinician Well-Being and Resilience – all in an effort to bring about culture change.

“But we’re well aware that the ACGME can’t do this alone,” Dr. Brigham said. “We can’t ‘requirement’ our way out of this problem. It’s going to take a culture shift. Only you physicians, in collaboration with everyone in your community of learning, can create the systemic change required to improve our culture. We have a good handle on the problem at this point, but the solutions are a little bit more difficult to get a hold of. As Martin Luther King Jr. once said, ‘You don’t have to see the whole staircase, just take the first step.’ ”

The ACGME wants to work with physicians “to collect data and do joint research, to share insights, and to share tools and resources to create a better world for practicing physicians, for other members of the health care team, and for patients. After all, clinicians who care for themselves provide better care for others. They’re less likely to make errors or leave the profession,” Dr. Brigham told attendees.

He added that clinicians can gauge their risk for burnout by asking themselves three simple questions about their work environment: Does it support self-care? Does it increase and support connection with colleagues? Does it connect people to purpose and meaningful work?

“One of the problems with our resident clinical work hours is not terrible program directors saying, ‘work longer.’ It’s residents who want to take care of families for 1 more hour,” Dr. Brigham continued. “It’s residents who want to take care of patients who are going through a difficult time. You represent the top 2% in the world in terms of your intelligence and achievement, yet that’s not what makes you special. What makes you special is that the level of self-doubt in this room exceeds that of the general population by about 10 times. You also tend to run toward what everyone else runs away from: disease, despair, people who are injured and suffering. That takes a toll.”

Courtesy AAP

He emphasized that positive social relationships with others are crucial to joy and well-being in the practice of medicine. “Burnout isn’t just about exhaustion; it’s about loneliness,” Dr. Brigham said. “There’s a surprising power in just asking people how they’re doing, and really wanting to know the answer.”

Negative social connections are highly correlated with burnout and depression, such as harassment, bullying, mistreatment, discrimination, “and using the power gradient to squash somebody who’s trying their best to be a physician,” he said.

Dr. Brigham acknowledged the tall task of bringing a spotlight to well-being as physicians continue to engage in tasks such as the burden and lack of standardization of prior authorization requirements, the burden of clinical documentation requirements, electronic health records and related work flow, and quality payment programs. “This is what we need to shift; this is what we need to take away so you can get back in touch with why you became a physician in the first place.”

Dr. Brigham reported having no financial disclosures.

[email protected]

NEW ORLEANS – When Timothy P. Brigham, MDiv, PhD, thinks about the impact of burnout and stress on the ability of physicians to practice medicine, Lewin’s equation comes to mind.

FatCamera/Getty Images

Developed by psychologist Kurt Lewin in 1936, the equation holds that behavior stems from a person’s personality and the environment that person inhabits.

“We suspect that 70%-80% of the problem with burnout and stress in medicine is environmental,” Dr. Brigham, chief of staff and chief education and organizational development officer at the Chicago-based Accreditation Council for Graduate Medical Education (ACGME), said at the annual meeting of the American Academy of Pediatrics.

“It’s a toxic mine, in some ways. What we tend to do is when we detect that physicians in general are, or a particular residency program is, too stressed out or burned out, we give them resilience training. Not that that’s unimportant, but it’s like putting a canary in a toxic mine full of poison and saying, ‘We’re going to teach you to hold your breath a little bit longer.’ Our job is to detoxify the mine.”

Troubled by the rise of suicides among physicians in recent years as well as mounting evidence about the adverse impact of burnout and stress on the practice of medicine, Dr. Brigham said that the ACGME is deepening its commitment to the well-being of faculty, residents, patients, and all members of the health care team. Since launching a “call to arms” on the topic at its annual educational conference in 2015, the ACGME has added courses on well-being to its annual meeting and remolded its Clinical Learning Environmental Review program to include all clinicians, “because everybody is affected by this: nurses, coordinators, et cetera,” he said. The ACGME also has revised Common Program Requirements, disseminated tools and resources to promote well-being and new knowledge on the topic, and partnered with the National Academy of Medicine Action Collaborative on Clinician Well-Being and Resilience – all in an effort to bring about culture change.

“But we’re well aware that the ACGME can’t do this alone,” Dr. Brigham said. “We can’t ‘requirement’ our way out of this problem. It’s going to take a culture shift. Only you physicians, in collaboration with everyone in your community of learning, can create the systemic change required to improve our culture. We have a good handle on the problem at this point, but the solutions are a little bit more difficult to get a hold of. As Martin Luther King Jr. once said, ‘You don’t have to see the whole staircase, just take the first step.’ ”

The ACGME wants to work with physicians “to collect data and do joint research, to share insights, and to share tools and resources to create a better world for practicing physicians, for other members of the health care team, and for patients. After all, clinicians who care for themselves provide better care for others. They’re less likely to make errors or leave the profession,” Dr. Brigham told attendees.

He added that clinicians can gauge their risk for burnout by asking themselves three simple questions about their work environment: Does it support self-care? Does it increase and support connection with colleagues? Does it connect people to purpose and meaningful work?

“One of the problems with our resident clinical work hours is not terrible program directors saying, ‘work longer.’ It’s residents who want to take care of families for 1 more hour,” Dr. Brigham continued. “It’s residents who want to take care of patients who are going through a difficult time. You represent the top 2% in the world in terms of your intelligence and achievement, yet that’s not what makes you special. What makes you special is that the level of self-doubt in this room exceeds that of the general population by about 10 times. You also tend to run toward what everyone else runs away from: disease, despair, people who are injured and suffering. That takes a toll.”

Courtesy AAP

He emphasized that positive social relationships with others are crucial to joy and well-being in the practice of medicine. “Burnout isn’t just about exhaustion; it’s about loneliness,” Dr. Brigham said. “There’s a surprising power in just asking people how they’re doing, and really wanting to know the answer.”

Negative social connections are highly correlated with burnout and depression, such as harassment, bullying, mistreatment, discrimination, “and using the power gradient to squash somebody who’s trying their best to be a physician,” he said.

Dr. Brigham acknowledged the tall task of bringing a spotlight to well-being as physicians continue to engage in tasks such as the burden and lack of standardization of prior authorization requirements, the burden of clinical documentation requirements, electronic health records and related work flow, and quality payment programs. “This is what we need to shift; this is what we need to take away so you can get back in touch with why you became a physician in the first place.”

Dr. Brigham reported having no financial disclosures.

[email protected]

NEW ORLEANS – Managing painful or fear-provoking procedures in children is a balance of preparation, intuition, and technical skills, Baruch S. Krauss, MD, EdM said at the annual meeting of the American Academy of Pediatrics.

Doug Brunk/MDedge News

Dr. Krauss, a pediatric emergency physician at Boston Children’s Hospital, shared tips for producing a positive experience when children present for minor procedures such as an intravenous catheter insertion or a laceration repair.
 

Control the environment

Setting the stage for a positive experience for children and their parents involves decreasing sensory stimuli by minimizing noise and bustle, the number of people in the room, and the reminder cues. “Even if you have trust with the child, there are certain things that could trigger the child to become fearful and anxious,” said Dr. Krauss, who also holds an academic post in the department of pediatrics at Harvard Medical School, Boston. “You want to make sure that medical equipment or a syringe is covered – anything that would remind the child or trigger the child to be more concerned and anxious.”

He recommends careful use of lighting, particularly in children who present with a head laceration or a facial laceration. “You may need to put a light near the wound, but that may be fearful for the child,” said Dr. Krauss, who coauthored a recent article on the topic that contains links to instructional videos (Ann Emerg Med 2019;74[1]:30-5). “Read the cues of the child,” he said. One desensitization technique he uses in such cases is to tell the child a story about the sun. He then goes on to liken the warmth of the exam light to the warmth of the sun.

Limiting the number of clinicians who speak to the child during the procedure also is key. “One person should speak to the child,” he advised. “Otherwise, it creates confusion for the child and it is hard for them to focus their attention. What you really want is to be able to control the child’s attention. You want to be able to capture their attention.”

It’s also important to keep medical equipment out of view. “I can’t tell you how many times I’ve seen consultants come in and a child needs to have a laceration repair, and they’re filling the syringe with lidocaine in front of the child,” Dr. Krauss said. “You want to avoid that. You also want to work outside of the child’s visual field if you can. Positioning is critical. I will try whatever position works for the child and the family.” This may including asking the parent to hold and swaddle an infant during the procedure, or positioning young children in the parent’s lap with their arm secured.

“Two things that upset kids during laceration repair are water dripping into their eyes during irrigation and the suture falling across their face as you’re stitching,” he added. “You want to develop your procedural skills so you can avoid that happening.”
 

Tailor the approach to the individual child

Some children will want to watch what you’re doing, but normally Dr. Krauss uses towels or blankets to cover the area being worked on. “If the child is part of your practice and you know his temperament and coping style, that makes it a lot easier; you know how to approach him,” he said. “They can trust you but they still can be quite fearful.” Sometimes, the child is relaxed but the parent becomes anxious. That anxiety can be transmitted to child. “If I see that the parents are anxious, I work directly with the child, and not the parent,” he said. “There’s not much I can tell a parent verbally that’s going to change their anxiety or fear level. But, as soon I start moving the child’s emotional state from fear to trust, the parent senses that and they relax, and that gets transmitted back to the child.”

Use age-appropriate language

When treating infants and children, Dr. Krauss often uses “parentese,” a simplified way that parents use to talk to young children. “It’s clearer, simpler, more attention-maintaining, and has longer pauses,” he said. “That can be very comforting to children.” Content and phrasing become important in older children. “You want to avoid the nocebo effect,” he continued. “If you tell a child, ‘This is really going to sting or hurt,’ you’re tipping the scales toward them having that experience.”

In an article about behavioral approaches to anxiety and pain management for pediatric venous access, Lindsey L. Cohen, PhD, devised a list of suggested phrasing to use. For example, instead of saying “You will be fine; there is nothing to worry about,” ask, “What did you do in school today?” as a form of distraction. Instead of saying, “It will feel like a bee sting,” ask, “Tell me how it feels.” And instead of saying, “Don’t cry,” say, “That was hard; I am proud of you” (Pediatrics 2008;122[suppl 3]:S134-9).

In a more recent article, Dr. Krauss and colleagues discussed current concepts of managing pain in children who present to the emergency department (Lancet 2016;387:83-92). Among distracting activities to try with infants and preschoolers are blowing bubbles, the use of a lighted wand, sound, music, or books, they noted. Distracting activities to try with preschoolers and in older children include art activities such as drawing, coloring, and the use of play dough, and computer games.

Clinicians also can ask the child to engage in a developmental task as a form of distraction. Dr. Krauss recalled a 22-month-old boy who presented to the emergency department with a forehead laceration. Mindful that the boy was developing eye-hand coordination and fine motor activity, Dr. Krauss offered him a coloring book that contained a picture of a clown, and instructed him to color the clown’s eyes red while Dr. Krauss tended to the wound. “His attention was completely fixed on that learning task,” he said.

Dr. Krauss reported having no financial disclosures.

[email protected]

NEW ORLEANS – Managing painful or fear-provoking procedures in children is a balance of preparation, intuition, and technical skills, Baruch S. Krauss, MD, EdM said at the annual meeting of the American Academy of Pediatrics.

Doug Brunk/MDedge News

Dr. Krauss, a pediatric emergency physician at Boston Children’s Hospital, shared tips for producing a positive experience when children present for minor procedures such as an intravenous catheter insertion or a laceration repair.
 

Control the environment

Setting the stage for a positive experience for children and their parents involves decreasing sensory stimuli by minimizing noise and bustle, the number of people in the room, and the reminder cues. “Even if you have trust with the child, there are certain things that could trigger the child to become fearful and anxious,” said Dr. Krauss, who also holds an academic post in the department of pediatrics at Harvard Medical School, Boston. “You want to make sure that medical equipment or a syringe is covered – anything that would remind the child or trigger the child to be more concerned and anxious.”

He recommends careful use of lighting, particularly in children who present with a head laceration or a facial laceration. “You may need to put a light near the wound, but that may be fearful for the child,” said Dr. Krauss, who coauthored a recent article on the topic that contains links to instructional videos (Ann Emerg Med 2019;74[1]:30-5). “Read the cues of the child,” he said. One desensitization technique he uses in such cases is to tell the child a story about the sun. He then goes on to liken the warmth of the exam light to the warmth of the sun.

Limiting the number of clinicians who speak to the child during the procedure also is key. “One person should speak to the child,” he advised. “Otherwise, it creates confusion for the child and it is hard for them to focus their attention. What you really want is to be able to control the child’s attention. You want to be able to capture their attention.”

It’s also important to keep medical equipment out of view. “I can’t tell you how many times I’ve seen consultants come in and a child needs to have a laceration repair, and they’re filling the syringe with lidocaine in front of the child,” Dr. Krauss said. “You want to avoid that. You also want to work outside of the child’s visual field if you can. Positioning is critical. I will try whatever position works for the child and the family.” This may including asking the parent to hold and swaddle an infant during the procedure, or positioning young children in the parent’s lap with their arm secured.

“Two things that upset kids during laceration repair are water dripping into their eyes during irrigation and the suture falling across their face as you’re stitching,” he added. “You want to develop your procedural skills so you can avoid that happening.”
 

Tailor the approach to the individual child

Some children will want to watch what you’re doing, but normally Dr. Krauss uses towels or blankets to cover the area being worked on. “If the child is part of your practice and you know his temperament and coping style, that makes it a lot easier; you know how to approach him,” he said. “They can trust you but they still can be quite fearful.” Sometimes, the child is relaxed but the parent becomes anxious. That anxiety can be transmitted to child. “If I see that the parents are anxious, I work directly with the child, and not the parent,” he said. “There’s not much I can tell a parent verbally that’s going to change their anxiety or fear level. But, as soon I start moving the child’s emotional state from fear to trust, the parent senses that and they relax, and that gets transmitted back to the child.”

Use age-appropriate language

When treating infants and children, Dr. Krauss often uses “parentese,” a simplified way that parents use to talk to young children. “It’s clearer, simpler, more attention-maintaining, and has longer pauses,” he said. “That can be very comforting to children.” Content and phrasing become important in older children. “You want to avoid the nocebo effect,” he continued. “If you tell a child, ‘This is really going to sting or hurt,’ you’re tipping the scales toward them having that experience.”

In an article about behavioral approaches to anxiety and pain management for pediatric venous access, Lindsey L. Cohen, PhD, devised a list of suggested phrasing to use. For example, instead of saying “You will be fine; there is nothing to worry about,” ask, “What did you do in school today?” as a form of distraction. Instead of saying, “It will feel like a bee sting,” ask, “Tell me how it feels.” And instead of saying, “Don’t cry,” say, “That was hard; I am proud of you” (Pediatrics 2008;122[suppl 3]:S134-9).

In a more recent article, Dr. Krauss and colleagues discussed current concepts of managing pain in children who present to the emergency department (Lancet 2016;387:83-92). Among distracting activities to try with infants and preschoolers are blowing bubbles, the use of a lighted wand, sound, music, or books, they noted. Distracting activities to try with preschoolers and in older children include art activities such as drawing, coloring, and the use of play dough, and computer games.

Clinicians also can ask the child to engage in a developmental task as a form of distraction. Dr. Krauss recalled a 22-month-old boy who presented to the emergency department with a forehead laceration. Mindful that the boy was developing eye-hand coordination and fine motor activity, Dr. Krauss offered him a coloring book that contained a picture of a clown, and instructed him to color the clown’s eyes red while Dr. Krauss tended to the wound. “His attention was completely fixed on that learning task,” he said.

Dr. Krauss reported having no financial disclosures.

[email protected]

NEW ORLEANS – Managing painful or fear-provoking procedures in children is a balance of preparation, intuition, and technical skills, Baruch S. Krauss, MD, EdM said at the annual meeting of the American Academy of Pediatrics.

Doug Brunk/MDedge News

Dr. Krauss, a pediatric emergency physician at Boston Children’s Hospital, shared tips for producing a positive experience when children present for minor procedures such as an intravenous catheter insertion or a laceration repair.
 

Control the environment

Setting the stage for a positive experience for children and their parents involves decreasing sensory stimuli by minimizing noise and bustle, the number of people in the room, and the reminder cues. “Even if you have trust with the child, there are certain things that could trigger the child to become fearful and anxious,” said Dr. Krauss, who also holds an academic post in the department of pediatrics at Harvard Medical School, Boston. “You want to make sure that medical equipment or a syringe is covered – anything that would remind the child or trigger the child to be more concerned and anxious.”

He recommends careful use of lighting, particularly in children who present with a head laceration or a facial laceration. “You may need to put a light near the wound, but that may be fearful for the child,” said Dr. Krauss, who coauthored a recent article on the topic that contains links to instructional videos (Ann Emerg Med 2019;74[1]:30-5). “Read the cues of the child,” he said. One desensitization technique he uses in such cases is to tell the child a story about the sun. He then goes on to liken the warmth of the exam light to the warmth of the sun.

Limiting the number of clinicians who speak to the child during the procedure also is key. “One person should speak to the child,” he advised. “Otherwise, it creates confusion for the child and it is hard for them to focus their attention. What you really want is to be able to control the child’s attention. You want to be able to capture their attention.”

It’s also important to keep medical equipment out of view. “I can’t tell you how many times I’ve seen consultants come in and a child needs to have a laceration repair, and they’re filling the syringe with lidocaine in front of the child,” Dr. Krauss said. “You want to avoid that. You also want to work outside of the child’s visual field if you can. Positioning is critical. I will try whatever position works for the child and the family.” This may including asking the parent to hold and swaddle an infant during the procedure, or positioning young children in the parent’s lap with their arm secured.

“Two things that upset kids during laceration repair are water dripping into their eyes during irrigation and the suture falling across their face as you’re stitching,” he added. “You want to develop your procedural skills so you can avoid that happening.”
 

Tailor the approach to the individual child

Some children will want to watch what you’re doing, but normally Dr. Krauss uses towels or blankets to cover the area being worked on. “If the child is part of your practice and you know his temperament and coping style, that makes it a lot easier; you know how to approach him,” he said. “They can trust you but they still can be quite fearful.” Sometimes, the child is relaxed but the parent becomes anxious. That anxiety can be transmitted to child. “If I see that the parents are anxious, I work directly with the child, and not the parent,” he said. “There’s not much I can tell a parent verbally that’s going to change their anxiety or fear level. But, as soon I start moving the child’s emotional state from fear to trust, the parent senses that and they relax, and that gets transmitted back to the child.”

Use age-appropriate language

When treating infants and children, Dr. Krauss often uses “parentese,” a simplified way that parents use to talk to young children. “It’s clearer, simpler, more attention-maintaining, and has longer pauses,” he said. “That can be very comforting to children.” Content and phrasing become important in older children. “You want to avoid the nocebo effect,” he continued. “If you tell a child, ‘This is really going to sting or hurt,’ you’re tipping the scales toward them having that experience.”

In an article about behavioral approaches to anxiety and pain management for pediatric venous access, Lindsey L. Cohen, PhD, devised a list of suggested phrasing to use. For example, instead of saying “You will be fine; there is nothing to worry about,” ask, “What did you do in school today?” as a form of distraction. Instead of saying, “It will feel like a bee sting,” ask, “Tell me how it feels.” And instead of saying, “Don’t cry,” say, “That was hard; I am proud of you” (Pediatrics 2008;122[suppl 3]:S134-9).

In a more recent article, Dr. Krauss and colleagues discussed current concepts of managing pain in children who present to the emergency department (Lancet 2016;387:83-92). Among distracting activities to try with infants and preschoolers are blowing bubbles, the use of a lighted wand, sound, music, or books, they noted. Distracting activities to try with preschoolers and in older children include art activities such as drawing, coloring, and the use of play dough, and computer games.

Clinicians also can ask the child to engage in a developmental task as a form of distraction. Dr. Krauss recalled a 22-month-old boy who presented to the emergency department with a forehead laceration. Mindful that the boy was developing eye-hand coordination and fine motor activity, Dr. Krauss offered him a coloring book that contained a picture of a clown, and instructed him to color the clown’s eyes red while Dr. Krauss tended to the wound. “His attention was completely fixed on that learning task,” he said.

Dr. Krauss reported having no financial disclosures.

[email protected]

NEW ORLEANS – The incidence of acute otitis media has decreased by 25% to 35% in the past decade, thanks largely to the widespread and near universal use of the pneumococcal conjugate vaccine, according to Ellen R. Wald, MD.

Courtesy Wikimedia Commons/Mar10029/Creative Commons License

“To a smaller degree, it is also attributable to the use of influenza vaccine, and to the use of more stringent diagnostic criteria,” Dr. Wald, who chairs the department of pediatrics at the University of Wisconsin, Madison, said at the annual meeting of the American Academy of Pediatrics. “The fact that we are decreasing the number of episodes of otitis media in children in the first year of life means that we’re going to have fewer otitis-prone children and therefore less of a need for tympanostomy tubes, either as a solution to the problem of recurrence of acute otitis media (AOM) or for the problem of persistent effusion.”

The best way to limit antimicrobial use is for clinicians to increase their ability to differentiate AOM from otitis media with effusion (OME), said Dr. Wald, pediatrician-in-chief at the American Family Children’s Hospital in Madison. She noted that OME is a nonbacterial inflammatory state that usually resolves spontaneously. It tends to occur before or after AOM, and often without ever progressing to AOM. “Its principal importance is as a cause of hearing loss and as a confounder in the diagnosis AOM,” she explained. “Because it is a nonbacterial process, antibiotics are not indicated in the management of OME. In contrast, children with AOM have a bacterial infection that will benefit from the use of antimicrobials.”*

Middle ear effusion is common to both OME and AOM, she continued. To discriminate between the two conditions, clinicians must look for signs of acute inflammation of the tympanic membrane, “which we expect to see in AOM,” she said. “The most powerful sign of inflammation of the tympanic membrane is distinct fullness or bulging of the tympanic membrane on exam.”

Dr. Wald advises clinicians to be as systematic as possible when conducting the otoscopic exam, by looking at color and classifying it as pink, gray, white, yellow, red, amber, or blue, and by documenting the position as neutral, retracted, full, or bulging. “When we gauge how light passes through the tympanic membrane, we judge it as translucent, opaque, or partially opaque, and mobility as normal, decreased, or absent,” she added. “When we find decreased or absent mobility of the tympanic membrane, it tells us that we have fluid in the middle ear, but it does not discriminate between AOM and OME.”

Advances in digital otoscopy are helping pediatricians to improve their diagnostic skills. An early device, the iPhone otoscope by CellScope, uses an iOS smartphone to capture images and videos of the external ear canal and eardrum. “The image is pretty much the same as that seen through the eye of a hand-held otoscope,” Dr. Wald said. “The problem with this particular design is that the speculum is kind of large. It does still require the removal of cerumen, and the smartphone is kind of awkward to use as a handle during an otoscopic exam.”

A new digital otoscope called Wispr was unveiled at the AAP meeting. First developed at the University of Wisconsin and now marketed by WiscMed, Wispr delivers high-resolution views of the eardrum in even small or partially obstructed ear canals with one-button image and video capture. WiscMed was founded by Jim Berbee, MD, MBA, an engineer turned emergency medicine physician.

“One of the advantages of this particular model is that it handles a lot more like a usual otoscope and can be attached to the rechargeable handles that are commercially available,” Dr. Wald said. “It has an extremely tiny speculum. Within the head, there is even a smaller camera that allows the photographs to be taken. Because the speculum is so tiny, it allows the device to sometimes avoid the presence of cerumen, or sometimes go through it and still obtain an image.”

[email protected]

*This article was updated 12/13/2019

NEW ORLEANS – The incidence of acute otitis media has decreased by 25% to 35% in the past decade, thanks largely to the widespread and near universal use of the pneumococcal conjugate vaccine, according to Ellen R. Wald, MD.

Courtesy Wikimedia Commons/Mar10029/Creative Commons License

“To a smaller degree, it is also attributable to the use of influenza vaccine, and to the use of more stringent diagnostic criteria,” Dr. Wald, who chairs the department of pediatrics at the University of Wisconsin, Madison, said at the annual meeting of the American Academy of Pediatrics. “The fact that we are decreasing the number of episodes of otitis media in children in the first year of life means that we’re going to have fewer otitis-prone children and therefore less of a need for tympanostomy tubes, either as a solution to the problem of recurrence of acute otitis media (AOM) or for the problem of persistent effusion.”

The best way to limit antimicrobial use is for clinicians to increase their ability to differentiate AOM from otitis media with effusion (OME), said Dr. Wald, pediatrician-in-chief at the American Family Children’s Hospital in Madison. She noted that OME is a nonbacterial inflammatory state that usually resolves spontaneously. It tends to occur before or after AOM, and often without ever progressing to AOM. “Its principal importance is as a cause of hearing loss and as a confounder in the diagnosis AOM,” she explained. “Because it is a nonbacterial process, antibiotics are not indicated in the management of OME. In contrast, children with AOM have a bacterial infection that will benefit from the use of antimicrobials.”*

Middle ear effusion is common to both OME and AOM, she continued. To discriminate between the two conditions, clinicians must look for signs of acute inflammation of the tympanic membrane, “which we expect to see in AOM,” she said. “The most powerful sign of inflammation of the tympanic membrane is distinct fullness or bulging of the tympanic membrane on exam.”

Dr. Wald advises clinicians to be as systematic as possible when conducting the otoscopic exam, by looking at color and classifying it as pink, gray, white, yellow, red, amber, or blue, and by documenting the position as neutral, retracted, full, or bulging. “When we gauge how light passes through the tympanic membrane, we judge it as translucent, opaque, or partially opaque, and mobility as normal, decreased, or absent,” she added. “When we find decreased or absent mobility of the tympanic membrane, it tells us that we have fluid in the middle ear, but it does not discriminate between AOM and OME.”

Advances in digital otoscopy are helping pediatricians to improve their diagnostic skills. An early device, the iPhone otoscope by CellScope, uses an iOS smartphone to capture images and videos of the external ear canal and eardrum. “The image is pretty much the same as that seen through the eye of a hand-held otoscope,” Dr. Wald said. “The problem with this particular design is that the speculum is kind of large. It does still require the removal of cerumen, and the smartphone is kind of awkward to use as a handle during an otoscopic exam.”

A new digital otoscope called Wispr was unveiled at the AAP meeting. First developed at the University of Wisconsin and now marketed by WiscMed, Wispr delivers high-resolution views of the eardrum in even small or partially obstructed ear canals with one-button image and video capture. WiscMed was founded by Jim Berbee, MD, MBA, an engineer turned emergency medicine physician.

“One of the advantages of this particular model is that it handles a lot more like a usual otoscope and can be attached to the rechargeable handles that are commercially available,” Dr. Wald said. “It has an extremely tiny speculum. Within the head, there is even a smaller camera that allows the photographs to be taken. Because the speculum is so tiny, it allows the device to sometimes avoid the presence of cerumen, or sometimes go through it and still obtain an image.”

[email protected]

*This article was updated 12/13/2019

NEW ORLEANS – The incidence of acute otitis media has decreased by 25% to 35% in the past decade, thanks largely to the widespread and near universal use of the pneumococcal conjugate vaccine, according to Ellen R. Wald, MD.

Courtesy Wikimedia Commons/Mar10029/Creative Commons License

“To a smaller degree, it is also attributable to the use of influenza vaccine, and to the use of more stringent diagnostic criteria,” Dr. Wald, who chairs the department of pediatrics at the University of Wisconsin, Madison, said at the annual meeting of the American Academy of Pediatrics. “The fact that we are decreasing the number of episodes of otitis media in children in the first year of life means that we’re going to have fewer otitis-prone children and therefore less of a need for tympanostomy tubes, either as a solution to the problem of recurrence of acute otitis media (AOM) or for the problem of persistent effusion.”

The best way to limit antimicrobial use is for clinicians to increase their ability to differentiate AOM from otitis media with effusion (OME), said Dr. Wald, pediatrician-in-chief at the American Family Children’s Hospital in Madison. She noted that OME is a nonbacterial inflammatory state that usually resolves spontaneously. It tends to occur before or after AOM, and often without ever progressing to AOM. “Its principal importance is as a cause of hearing loss and as a confounder in the diagnosis AOM,” she explained. “Because it is a nonbacterial process, antibiotics are not indicated in the management of OME. In contrast, children with AOM have a bacterial infection that will benefit from the use of antimicrobials.”*

Middle ear effusion is common to both OME and AOM, she continued. To discriminate between the two conditions, clinicians must look for signs of acute inflammation of the tympanic membrane, “which we expect to see in AOM,” she said. “The most powerful sign of inflammation of the tympanic membrane is distinct fullness or bulging of the tympanic membrane on exam.”

Dr. Wald advises clinicians to be as systematic as possible when conducting the otoscopic exam, by looking at color and classifying it as pink, gray, white, yellow, red, amber, or blue, and by documenting the position as neutral, retracted, full, or bulging. “When we gauge how light passes through the tympanic membrane, we judge it as translucent, opaque, or partially opaque, and mobility as normal, decreased, or absent,” she added. “When we find decreased or absent mobility of the tympanic membrane, it tells us that we have fluid in the middle ear, but it does not discriminate between AOM and OME.”

Advances in digital otoscopy are helping pediatricians to improve their diagnostic skills. An early device, the iPhone otoscope by CellScope, uses an iOS smartphone to capture images and videos of the external ear canal and eardrum. “The image is pretty much the same as that seen through the eye of a hand-held otoscope,” Dr. Wald said. “The problem with this particular design is that the speculum is kind of large. It does still require the removal of cerumen, and the smartphone is kind of awkward to use as a handle during an otoscopic exam.”

A new digital otoscope called Wispr was unveiled at the AAP meeting. First developed at the University of Wisconsin and now marketed by WiscMed, Wispr delivers high-resolution views of the eardrum in even small or partially obstructed ear canals with one-button image and video capture. WiscMed was founded by Jim Berbee, MD, MBA, an engineer turned emergency medicine physician.

“One of the advantages of this particular model is that it handles a lot more like a usual otoscope and can be attached to the rechargeable handles that are commercially available,” Dr. Wald said. “It has an extremely tiny speculum. Within the head, there is even a smaller camera that allows the photographs to be taken. Because the speculum is so tiny, it allows the device to sometimes avoid the presence of cerumen, or sometimes go through it and still obtain an image.”

[email protected]

*This article was updated 12/13/2019

NEW ORLEANS – One way to make sure your practice providing immunizations is in the black is to calculate your “carrying costs” and apply them to the cost of your vaccines.

Another is to make sure that you join an effectively managed and effective group purchasing organization.

Doug Brunk/MDedge News

Those are two tips that Chip Hart shared with attendees at the annual meeting of the American Academy of Pediatrics.

“Your practices will fail if immunizations are not paid,” said Mr. Hart, director of the Winooski, Vt.–based the Pediatric Solutions Consulting Group at the Physicians Computer Company. “Providing immunizations is the single most valuable thing that you do, by far. Yet you get ripped off by the payers all the time.”

Two documents from the AAP – “The business case for pricing vaccines” and “The business case for pricing immunization administration” – provide clear-cut guidance on the impact of vaccine delivery to your bottom line. Based on data from his company’s client base, Mr. Hart said that vaccines have grown from 13% of an average pediatric practice’s revenue in 2003 to 22% in 2018. “The AAP’s own research shows that you need to generate 17%-28% above what you paid for the vaccine in order just to break even,” he said. That’s to cover the administrative overhead required to purchase and store the product in an office-based refrigerator, and the staff time to administer it. Such “carrying costs” often are not factored into the analysis of many managing pediatricians.

“The unfortunate reality is, you are not paid for carrying costs related to the administration of vaccines, including your refrigerator, your sharps and waste management, claim denials, and especially every time you waste a vaccine,” Mr. Hart said. “None of those things are part of any fee schedule.”

How to determine your vaccine product overhead

There are two ways to go about determining your vaccine product overhead. The first is to perform an in-depth analysis of your costs, including time studies and cost accounting. For example, he said that if your hazardous waste costs are $3,500 per year and half of the material is composed of vaccine waste, that leaves $1,750. “If you divide that by the number of vaccines you did last year, it might come out to 13 cents per vaccine,” Mr. Hart said, “but these things add up.” On the administration side, he offered the example of a nurse who makes $45,000 per year and who devotes 10% of her time to vaccines in a practice that administers 13,000 vaccinations per year. In this case, $45,000 per year divided by 13,000 vaccines equals 35 cents than can be added to the cost of every vaccine.

“You can go into each one of these elements and figure out how much you need to clear in order to do all right,” he said.

Alternatively, you can use the research from the AAP to presume that you need to have a margin of 17%-28% on your product. “Use a figure like 20% or 25% – it’s likely as accurate as any analysis a busy private practice is capable of doing, and you can immediately determine if you are in the profitability ballpark,” Mr. Hart said. On the administration side of the equation, in 2009, researchers estimated that the total documented variable cost per injection, excluding vaccine cost, was $11.51 (Pediatrics. 2009 Dec;124 [Suppl 5]:S492-8). That figure is more like $14 or $15 per vaccine in today’s dollars, Mr. Hart estimated. “You can perform a time-motion study and determine all of your immunization administration costs or you can just simply pick an evidence-based figure like $14 and see how well you are doing,” he said.

On his company’s web site, he offers a free administrative analysis tool that clinicians can use to determine how they fare. The AAP also provides information about vaccine financing here.

How to make sure you are operating in the red

Mr. Hart advises practices operating in the red to review their vaccine delivery work flow “to look for leaks,” to use proper administrative codes, and to negotiate the price of vaccine product with payers. “The only payers that don’t negotiate are state Medicaid and Tricare,” he said. “Everyone else negotiates. You want to determine the methodology they use to calculate what they pay you for the vaccine product. Different payers have different rule sets.”

Another strategy to join a group purchasing organization (GPO), which can leverage volume purchasing to negotiate discounts on vaccines. “They’re like [the] Costco or Sam’s Club of vaccine purchasing, and in most cases they can save you about $10,000 per year,” Mr. Hart said. A list of GPOs from the AAP can be found here.

Implementing effective inventory management is also key. “Practices that have the discipline to maintain their inventories are inevitably the ones who are more profitable,” Mr. Hart said. “I’ve worked with too many practices where flu shots go missing. Staff take them home or bring in their friends after hours. You need inventory control, and you should be able to generate an inventory report out of your practice management system. You also should be able to generate a report out of your EHR.”

Mr. Hart reported having no relevant financial disclosures.

[email protected]

NEW ORLEANS – One way to make sure your practice providing immunizations is in the black is to calculate your “carrying costs” and apply them to the cost of your vaccines.

Another is to make sure that you join an effectively managed and effective group purchasing organization.

Doug Brunk/MDedge News

Those are two tips that Chip Hart shared with attendees at the annual meeting of the American Academy of Pediatrics.

“Your practices will fail if immunizations are not paid,” said Mr. Hart, director of the Winooski, Vt.–based the Pediatric Solutions Consulting Group at the Physicians Computer Company. “Providing immunizations is the single most valuable thing that you do, by far. Yet you get ripped off by the payers all the time.”

Two documents from the AAP – “The business case for pricing vaccines” and “The business case for pricing immunization administration” – provide clear-cut guidance on the impact of vaccine delivery to your bottom line. Based on data from his company’s client base, Mr. Hart said that vaccines have grown from 13% of an average pediatric practice’s revenue in 2003 to 22% in 2018. “The AAP’s own research shows that you need to generate 17%-28% above what you paid for the vaccine in order just to break even,” he said. That’s to cover the administrative overhead required to purchase and store the product in an office-based refrigerator, and the staff time to administer it. Such “carrying costs” often are not factored into the analysis of many managing pediatricians.

“The unfortunate reality is, you are not paid for carrying costs related to the administration of vaccines, including your refrigerator, your sharps and waste management, claim denials, and especially every time you waste a vaccine,” Mr. Hart said. “None of those things are part of any fee schedule.”

How to determine your vaccine product overhead

There are two ways to go about determining your vaccine product overhead. The first is to perform an in-depth analysis of your costs, including time studies and cost accounting. For example, he said that if your hazardous waste costs are $3,500 per year and half of the material is composed of vaccine waste, that leaves $1,750. “If you divide that by the number of vaccines you did last year, it might come out to 13 cents per vaccine,” Mr. Hart said, “but these things add up.” On the administration side, he offered the example of a nurse who makes $45,000 per year and who devotes 10% of her time to vaccines in a practice that administers 13,000 vaccinations per year. In this case, $45,000 per year divided by 13,000 vaccines equals 35 cents than can be added to the cost of every vaccine.

“You can go into each one of these elements and figure out how much you need to clear in order to do all right,” he said.

Alternatively, you can use the research from the AAP to presume that you need to have a margin of 17%-28% on your product. “Use a figure like 20% or 25% – it’s likely as accurate as any analysis a busy private practice is capable of doing, and you can immediately determine if you are in the profitability ballpark,” Mr. Hart said. On the administration side of the equation, in 2009, researchers estimated that the total documented variable cost per injection, excluding vaccine cost, was $11.51 (Pediatrics. 2009 Dec;124 [Suppl 5]:S492-8). That figure is more like $14 or $15 per vaccine in today’s dollars, Mr. Hart estimated. “You can perform a time-motion study and determine all of your immunization administration costs or you can just simply pick an evidence-based figure like $14 and see how well you are doing,” he said.

On his company’s web site, he offers a free administrative analysis tool that clinicians can use to determine how they fare. The AAP also provides information about vaccine financing here.

How to make sure you are operating in the red

Mr. Hart advises practices operating in the red to review their vaccine delivery work flow “to look for leaks,” to use proper administrative codes, and to negotiate the price of vaccine product with payers. “The only payers that don’t negotiate are state Medicaid and Tricare,” he said. “Everyone else negotiates. You want to determine the methodology they use to calculate what they pay you for the vaccine product. Different payers have different rule sets.”

Another strategy to join a group purchasing organization (GPO), which can leverage volume purchasing to negotiate discounts on vaccines. “They’re like [the] Costco or Sam’s Club of vaccine purchasing, and in most cases they can save you about $10,000 per year,” Mr. Hart said. A list of GPOs from the AAP can be found here.

Implementing effective inventory management is also key. “Practices that have the discipline to maintain their inventories are inevitably the ones who are more profitable,” Mr. Hart said. “I’ve worked with too many practices where flu shots go missing. Staff take them home or bring in their friends after hours. You need inventory control, and you should be able to generate an inventory report out of your practice management system. You also should be able to generate a report out of your EHR.”

Mr. Hart reported having no relevant financial disclosures.

[email protected]

NEW ORLEANS – One way to make sure your practice providing immunizations is in the black is to calculate your “carrying costs” and apply them to the cost of your vaccines.

Another is to make sure that you join an effectively managed and effective group purchasing organization.

Doug Brunk/MDedge News

Those are two tips that Chip Hart shared with attendees at the annual meeting of the American Academy of Pediatrics.

“Your practices will fail if immunizations are not paid,” said Mr. Hart, director of the Winooski, Vt.–based the Pediatric Solutions Consulting Group at the Physicians Computer Company. “Providing immunizations is the single most valuable thing that you do, by far. Yet you get ripped off by the payers all the time.”

Two documents from the AAP – “The business case for pricing vaccines” and “The business case for pricing immunization administration” – provide clear-cut guidance on the impact of vaccine delivery to your bottom line. Based on data from his company’s client base, Mr. Hart said that vaccines have grown from 13% of an average pediatric practice’s revenue in 2003 to 22% in 2018. “The AAP’s own research shows that you need to generate 17%-28% above what you paid for the vaccine in order just to break even,” he said. That’s to cover the administrative overhead required to purchase and store the product in an office-based refrigerator, and the staff time to administer it. Such “carrying costs” often are not factored into the analysis of many managing pediatricians.

“The unfortunate reality is, you are not paid for carrying costs related to the administration of vaccines, including your refrigerator, your sharps and waste management, claim denials, and especially every time you waste a vaccine,” Mr. Hart said. “None of those things are part of any fee schedule.”

How to determine your vaccine product overhead

There are two ways to go about determining your vaccine product overhead. The first is to perform an in-depth analysis of your costs, including time studies and cost accounting. For example, he said that if your hazardous waste costs are $3,500 per year and half of the material is composed of vaccine waste, that leaves $1,750. “If you divide that by the number of vaccines you did last year, it might come out to 13 cents per vaccine,” Mr. Hart said, “but these things add up.” On the administration side, he offered the example of a nurse who makes $45,000 per year and who devotes 10% of her time to vaccines in a practice that administers 13,000 vaccinations per year. In this case, $45,000 per year divided by 13,000 vaccines equals 35 cents than can be added to the cost of every vaccine.

“You can go into each one of these elements and figure out how much you need to clear in order to do all right,” he said.

Alternatively, you can use the research from the AAP to presume that you need to have a margin of 17%-28% on your product. “Use a figure like 20% or 25% – it’s likely as accurate as any analysis a busy private practice is capable of doing, and you can immediately determine if you are in the profitability ballpark,” Mr. Hart said. On the administration side of the equation, in 2009, researchers estimated that the total documented variable cost per injection, excluding vaccine cost, was $11.51 (Pediatrics. 2009 Dec;124 [Suppl 5]:S492-8). That figure is more like $14 or $15 per vaccine in today’s dollars, Mr. Hart estimated. “You can perform a time-motion study and determine all of your immunization administration costs or you can just simply pick an evidence-based figure like $14 and see how well you are doing,” he said.

On his company’s web site, he offers a free administrative analysis tool that clinicians can use to determine how they fare. The AAP also provides information about vaccine financing here.

How to make sure you are operating in the red

Mr. Hart advises practices operating in the red to review their vaccine delivery work flow “to look for leaks,” to use proper administrative codes, and to negotiate the price of vaccine product with payers. “The only payers that don’t negotiate are state Medicaid and Tricare,” he said. “Everyone else negotiates. You want to determine the methodology they use to calculate what they pay you for the vaccine product. Different payers have different rule sets.”

Another strategy to join a group purchasing organization (GPO), which can leverage volume purchasing to negotiate discounts on vaccines. “They’re like [the] Costco or Sam’s Club of vaccine purchasing, and in most cases they can save you about $10,000 per year,” Mr. Hart said. A list of GPOs from the AAP can be found here.

Implementing effective inventory management is also key. “Practices that have the discipline to maintain their inventories are inevitably the ones who are more profitable,” Mr. Hart said. “I’ve worked with too many practices where flu shots go missing. Staff take them home or bring in their friends after hours. You need inventory control, and you should be able to generate an inventory report out of your practice management system. You also should be able to generate a report out of your EHR.”

Mr. Hart reported having no relevant financial disclosures.

[email protected]