Image by Andre E.X. Brown

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that Roteas receive marketing authorization for the same indications as Lixiana.

Both Roteas and Lixiana are oral factor Xa inhibitors that contain the active ingredient edoxaban.

The CHMP has recommended approving Roteas for the treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults.

In addition, the CHMP has recommended approving Roteas for the prevention of stroke and systemic embolism in adults with nonvalvular atrial fibrillation (NVAF) who have 1 or more risk factors, such as congestive heart failure, hypertension, age of 75 or older, diabetes mellitus, prior stroke, or transient ischemic attack.

The European Commission approved Lixiana for these indications in June 2015.

If the European Commission decides to approve Roteas as well, the product will be available as film-coated tablets (15 mg, 30 mg, and 60 mg).

The European Commission is expected to make a decision about Roteas within 67 days from the CHMP’s adoption of its opinion (which occurred on February 23).

The application for Roteas was an informed consent application. In this type of application, reference is made to an authorized medicine if the marketing authorization holder of the reference medicine has given consent to the use of their dossier in the application procedure.

The applicant for Roteas is Daiichi Sankyo Europe GmbH, the company that also developed Lixiana.

Lixiana was approved based on data from a pair of phase 3 trials, ENGAGE AF-TIMI 48 and Hokusai-VTE.

Hokusai-VTE

In the Hokusai-VTE trial, researchers evaluated edoxaban in 4921 patients with DVT and 3319 with PE. Patients received initial treatment with low-molecular-weight heparin and were then randomized to receive edoxaban or warfarin daily for 3 to 12 months.

Overall, edoxaban proved as effective as warfarin. Recurrent, symptomatic DVT/PE occurred in 3.2% and 3.5% of patients, respectively (P<0.001 for non-inferiority).

In addition, the incidence of clinically relevant bleeding was significantly lower in the edoxaban arm than the warfarin arm—8.5% and 10.3%, respectively (P=0.004 for superiority).

ENGAGE-AF TIMI 48

In the ENGAGE AF-TIMI 48 trial, researchers compared edoxaban and warfarin as prophylaxis for stroke or systemic embolism in patients with NVAF.

The trial included 21,105 patients who were randomized to receive warfarin (n=7036), edoxaban at 60 mg (n=7035), or edoxaban at 30 mg (n=7034).

Edoxaban was at least non-inferior to warfarin with regard to efficacy. The annual incidence of stroke or systemic embolism was 1.50% with warfarin, 1.18% with edoxaban at 60 mg (P<0.001 for non-inferiority), and 1.61% with edoxaban at 30 mg (P=0.005 for non-inferiority).

In addition, edoxaban was associated with a significantly lower rate of major and fatal bleeding. The annual incidence of major bleeding was 3.43% with warfarin, 2.75% with edoxaban at 60 mg (P<0.001), and 1.61% with edoxaban at 30 mg (P<0.001).

Fatal bleeds occurred at an annual rate of 0.38% with warfarin, 0.21% with edoxaban at 60 mg (P=0.006), and 0.13% with edoxaban at 30 mg (P<0.001).

Image by Andre E.X. Brown

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that Roteas receive marketing authorization for the same indications as Lixiana.

Both Roteas and Lixiana are oral factor Xa inhibitors that contain the active ingredient edoxaban.

The CHMP has recommended approving Roteas for the treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults.

In addition, the CHMP has recommended approving Roteas for the prevention of stroke and systemic embolism in adults with nonvalvular atrial fibrillation (NVAF) who have 1 or more risk factors, such as congestive heart failure, hypertension, age of 75 or older, diabetes mellitus, prior stroke, or transient ischemic attack.

The European Commission approved Lixiana for these indications in June 2015.

If the European Commission decides to approve Roteas as well, the product will be available as film-coated tablets (15 mg, 30 mg, and 60 mg).

The European Commission is expected to make a decision about Roteas within 67 days from the CHMP’s adoption of its opinion (which occurred on February 23).

The application for Roteas was an informed consent application. In this type of application, reference is made to an authorized medicine if the marketing authorization holder of the reference medicine has given consent to the use of their dossier in the application procedure.

The applicant for Roteas is Daiichi Sankyo Europe GmbH, the company that also developed Lixiana.

Lixiana was approved based on data from a pair of phase 3 trials, ENGAGE AF-TIMI 48 and Hokusai-VTE.

Hokusai-VTE

In the Hokusai-VTE trial, researchers evaluated edoxaban in 4921 patients with DVT and 3319 with PE. Patients received initial treatment with low-molecular-weight heparin and were then randomized to receive edoxaban or warfarin daily for 3 to 12 months.

Overall, edoxaban proved as effective as warfarin. Recurrent, symptomatic DVT/PE occurred in 3.2% and 3.5% of patients, respectively (P<0.001 for non-inferiority).

In addition, the incidence of clinically relevant bleeding was significantly lower in the edoxaban arm than the warfarin arm—8.5% and 10.3%, respectively (P=0.004 for superiority).

ENGAGE-AF TIMI 48

In the ENGAGE AF-TIMI 48 trial, researchers compared edoxaban and warfarin as prophylaxis for stroke or systemic embolism in patients with NVAF.

The trial included 21,105 patients who were randomized to receive warfarin (n=7036), edoxaban at 60 mg (n=7035), or edoxaban at 30 mg (n=7034).

Edoxaban was at least non-inferior to warfarin with regard to efficacy. The annual incidence of stroke or systemic embolism was 1.50% with warfarin, 1.18% with edoxaban at 60 mg (P<0.001 for non-inferiority), and 1.61% with edoxaban at 30 mg (P=0.005 for non-inferiority).

In addition, edoxaban was associated with a significantly lower rate of major and fatal bleeding. The annual incidence of major bleeding was 3.43% with warfarin, 2.75% with edoxaban at 60 mg (P<0.001), and 1.61% with edoxaban at 30 mg (P<0.001).

Fatal bleeds occurred at an annual rate of 0.38% with warfarin, 0.21% with edoxaban at 60 mg (P=0.006), and 0.13% with edoxaban at 30 mg (P<0.001).

Image by Andre E.X. Brown

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that Roteas receive marketing authorization for the same indications as Lixiana.

Both Roteas and Lixiana are oral factor Xa inhibitors that contain the active ingredient edoxaban.

The CHMP has recommended approving Roteas for the treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults.

In addition, the CHMP has recommended approving Roteas for the prevention of stroke and systemic embolism in adults with nonvalvular atrial fibrillation (NVAF) who have 1 or more risk factors, such as congestive heart failure, hypertension, age of 75 or older, diabetes mellitus, prior stroke, or transient ischemic attack.

The European Commission approved Lixiana for these indications in June 2015.

If the European Commission decides to approve Roteas as well, the product will be available as film-coated tablets (15 mg, 30 mg, and 60 mg).

The European Commission is expected to make a decision about Roteas within 67 days from the CHMP’s adoption of its opinion (which occurred on February 23).

The application for Roteas was an informed consent application. In this type of application, reference is made to an authorized medicine if the marketing authorization holder of the reference medicine has given consent to the use of their dossier in the application procedure.

The applicant for Roteas is Daiichi Sankyo Europe GmbH, the company that also developed Lixiana.

Lixiana was approved based on data from a pair of phase 3 trials, ENGAGE AF-TIMI 48 and Hokusai-VTE.

Hokusai-VTE

In the Hokusai-VTE trial, researchers evaluated edoxaban in 4921 patients with DVT and 3319 with PE. Patients received initial treatment with low-molecular-weight heparin and were then randomized to receive edoxaban or warfarin daily for 3 to 12 months.

Overall, edoxaban proved as effective as warfarin. Recurrent, symptomatic DVT/PE occurred in 3.2% and 3.5% of patients, respectively (P<0.001 for non-inferiority).

In addition, the incidence of clinically relevant bleeding was significantly lower in the edoxaban arm than the warfarin arm—8.5% and 10.3%, respectively (P=0.004 for superiority).

ENGAGE-AF TIMI 48

In the ENGAGE AF-TIMI 48 trial, researchers compared edoxaban and warfarin as prophylaxis for stroke or systemic embolism in patients with NVAF.

The trial included 21,105 patients who were randomized to receive warfarin (n=7036), edoxaban at 60 mg (n=7035), or edoxaban at 30 mg (n=7034).

Edoxaban was at least non-inferior to warfarin with regard to efficacy. The annual incidence of stroke or systemic embolism was 1.50% with warfarin, 1.18% with edoxaban at 60 mg (P<0.001 for non-inferiority), and 1.61% with edoxaban at 30 mg (P=0.005 for non-inferiority).

In addition, edoxaban was associated with a significantly lower rate of major and fatal bleeding. The annual incidence of major bleeding was 3.43% with warfarin, 2.75% with edoxaban at 60 mg (P<0.001), and 1.61% with edoxaban at 30 mg (P<0.001).

Fatal bleeds occurred at an annual rate of 0.38% with warfarin, 0.21% with edoxaban at 60 mg (P=0.006), and 0.13% with edoxaban at 30 mg (P<0.001).

SEATTLE – Bacterial vaginosis does not decrease the effectiveness of oral pre-exposure prophylaxis (PrEP) for HIV prevention, according to an investigation of 1,470 women in Africa.

Daily oral PrEP with tenofovir pills was 77% effective in protecting women with bacterial vaginosis from HIV, and 73% effective in women who did not have BV over the 3-year study. The difference was not statistically significant.

[email protected]

SEATTLE – Bacterial vaginosis does not decrease the effectiveness of oral pre-exposure prophylaxis (PrEP) for HIV prevention, according to an investigation of 1,470 women in Africa.

Daily oral PrEP with tenofovir pills was 77% effective in protecting women with bacterial vaginosis from HIV, and 73% effective in women who did not have BV over the 3-year study. The difference was not statistically significant.

[email protected]

SEATTLE – Bacterial vaginosis does not decrease the effectiveness of oral pre-exposure prophylaxis (PrEP) for HIV prevention, according to an investigation of 1,470 women in Africa.

Daily oral PrEP with tenofovir pills was 77% effective in protecting women with bacterial vaginosis from HIV, and 73% effective in women who did not have BV over the 3-year study. The difference was not statistically significant.

[email protected]

SEATTLE – Neurologic symptoms are an unreliable indicator of neurosyphilis in patients with HIV, according to University of Washington, Seattle, investigators.

After tapping 385 HIV patients with untreated syphilis and possible central nervous system involvement, “the bottom line was that [symptom] sensitivity was so low that not having [symptoms] really shouldn’t reassure you. If you are concerned that your patient could have neurosyphilis because of other factors” – such as an especially high rapid plasma reagin titer or low CD4 count – “you still need to tap them,” said lead investigator Arielle P. Davis, MD, who is in the department of neurology at the university.

[email protected]

SEATTLE – Neurologic symptoms are an unreliable indicator of neurosyphilis in patients with HIV, according to University of Washington, Seattle, investigators.

After tapping 385 HIV patients with untreated syphilis and possible central nervous system involvement, “the bottom line was that [symptom] sensitivity was so low that not having [symptoms] really shouldn’t reassure you. If you are concerned that your patient could have neurosyphilis because of other factors” – such as an especially high rapid plasma reagin titer or low CD4 count – “you still need to tap them,” said lead investigator Arielle P. Davis, MD, who is in the department of neurology at the university.

[email protected]

SEATTLE – Neurologic symptoms are an unreliable indicator of neurosyphilis in patients with HIV, according to University of Washington, Seattle, investigators.

After tapping 385 HIV patients with untreated syphilis and possible central nervous system involvement, “the bottom line was that [symptom] sensitivity was so low that not having [symptoms] really shouldn’t reassure you. If you are concerned that your patient could have neurosyphilis because of other factors” – such as an especially high rapid plasma reagin titer or low CD4 count – “you still need to tap them,” said lead investigator Arielle P. Davis, MD, who is in the department of neurology at the university.

[email protected]

SEATTLE – A behavioral intervention that takes a nontraditional approach to counseling for pre-exposure prophylaxis (PrEP) therapy boosted its adherence, according to a new study.

The New York City–based intervention program eschews the traditional approach that presents as a strategy to avoid risk. “We frame the choice of taking PrEP in terms of: Is PrEP something that’s going to help you have a safe and fulfilling sex life?” said Sarit A. Golub, PhD, MPH, a professor of psychology at Hunter College, N.Y., and the City University of New York, who presented a study examining its efficacy at a poster session at the Conference on Retroviruses & Opportunistic Infections in partnership with the International Antiviral Society.

SEATTLE – A behavioral intervention that takes a nontraditional approach to counseling for pre-exposure prophylaxis (PrEP) therapy boosted its adherence, according to a new study.

The New York City–based intervention program eschews the traditional approach that presents as a strategy to avoid risk. “We frame the choice of taking PrEP in terms of: Is PrEP something that’s going to help you have a safe and fulfilling sex life?” said Sarit A. Golub, PhD, MPH, a professor of psychology at Hunter College, N.Y., and the City University of New York, who presented a study examining its efficacy at a poster session at the Conference on Retroviruses & Opportunistic Infections in partnership with the International Antiviral Society.

SEATTLE – A behavioral intervention that takes a nontraditional approach to counseling for pre-exposure prophylaxis (PrEP) therapy boosted its adherence, according to a new study.

The New York City–based intervention program eschews the traditional approach that presents as a strategy to avoid risk. “We frame the choice of taking PrEP in terms of: Is PrEP something that’s going to help you have a safe and fulfilling sex life?” said Sarit A. Golub, PhD, MPH, a professor of psychology at Hunter College, N.Y., and the City University of New York, who presented a study examining its efficacy at a poster session at the Conference on Retroviruses & Opportunistic Infections in partnership with the International Antiviral Society.

Among adults with sickle cell disease, early mortality is associated with increasing tricuspid regurgitant jet velocity on ECG, reticulocyte count, brain natriuretic peptide levels, and patient age, and with decreasing fetal hemoglobin levels, according to a report published in Haematologica.

Although survival improved among children with sickle cell disease (SCD) following the Food and Drug Administration approval of hydroxyurea treatment in 1998, mortality remains high among adult patients. To examine the clinical and laboratory factors underlying early mortality in this patient population, researchers combined the findings from their single-center cohort study of 161 clinic patients and a meta-analysis of nine studies in the literature, for a total of 3,257 participants. This is “the largest number of SCD patients in whom risk factors for mortality have been evaluated in the hydroxyurea era,” said Poulami Maitra, PhD, of the department of biostatistics at the University of North Carolina, Chapel Hill, and her associates.

The clinic cohort had a median age of 36 years (range, 18-71 years), and there were 29 deaths during a median follow-up of 7.2 years. The median age at death was 48 years. Similarly, the median age at death ranged from 39.7 to 53 years in the meta-analysis.

In the combined cohort, patients who had a tricuspid regurgitant jet velocity of 2.5 m/s or more had three times greater risk of dying than did patients who had lower values, and the risk of dying was approximately doubled for every 1-U elevation in log(N-terminal pro-B type natriuretic peptide), which reflects increasing ventricular strain. Both links have been reported before. The findings confirm that recent clinical practice guidelines recommending periodic echocardiographic screening for these patients is warranted, the investigators said (Haematologica. 2017 Jan 19. doi: 10.3324/haematol.2016.153791).

The hazard of dying was 5% higher for every 1% increase in reticulocyte count, which suggests that hemolysis contributes to early mortality in these patients. The hazard of dying also was 3% lower for every 1% increase in fetal hemoglobin. This association with fetal hemoglobin is the basis for the development of drugs that raise that level, such as hydroxyurea.

Mortality was 30% higher for every 10-year increase in patient age, reflecting the fact that people with SCD show increasing end-organ damage over time that contributes to their mortality, Dr. Maitra and her associates said.

This work was supported by the National Institutes of Health and the North Carolina Sickle Cell Program. Dr. Maitra reported having no relevant financial disclosures; one of her associates reported serving as a consultant to Pfizer and Global Blood Therapeutics.

Among adults with sickle cell disease, early mortality is associated with increasing tricuspid regurgitant jet velocity on ECG, reticulocyte count, brain natriuretic peptide levels, and patient age, and with decreasing fetal hemoglobin levels, according to a report published in Haematologica.

Although survival improved among children with sickle cell disease (SCD) following the Food and Drug Administration approval of hydroxyurea treatment in 1998, mortality remains high among adult patients. To examine the clinical and laboratory factors underlying early mortality in this patient population, researchers combined the findings from their single-center cohort study of 161 clinic patients and a meta-analysis of nine studies in the literature, for a total of 3,257 participants. This is “the largest number of SCD patients in whom risk factors for mortality have been evaluated in the hydroxyurea era,” said Poulami Maitra, PhD, of the department of biostatistics at the University of North Carolina, Chapel Hill, and her associates.

The clinic cohort had a median age of 36 years (range, 18-71 years), and there were 29 deaths during a median follow-up of 7.2 years. The median age at death was 48 years. Similarly, the median age at death ranged from 39.7 to 53 years in the meta-analysis.

In the combined cohort, patients who had a tricuspid regurgitant jet velocity of 2.5 m/s or more had three times greater risk of dying than did patients who had lower values, and the risk of dying was approximately doubled for every 1-U elevation in log(N-terminal pro-B type natriuretic peptide), which reflects increasing ventricular strain. Both links have been reported before. The findings confirm that recent clinical practice guidelines recommending periodic echocardiographic screening for these patients is warranted, the investigators said (Haematologica. 2017 Jan 19. doi: 10.3324/haematol.2016.153791).

The hazard of dying was 5% higher for every 1% increase in reticulocyte count, which suggests that hemolysis contributes to early mortality in these patients. The hazard of dying also was 3% lower for every 1% increase in fetal hemoglobin. This association with fetal hemoglobin is the basis for the development of drugs that raise that level, such as hydroxyurea.

Mortality was 30% higher for every 10-year increase in patient age, reflecting the fact that people with SCD show increasing end-organ damage over time that contributes to their mortality, Dr. Maitra and her associates said.

This work was supported by the National Institutes of Health and the North Carolina Sickle Cell Program. Dr. Maitra reported having no relevant financial disclosures; one of her associates reported serving as a consultant to Pfizer and Global Blood Therapeutics.

Among adults with sickle cell disease, early mortality is associated with increasing tricuspid regurgitant jet velocity on ECG, reticulocyte count, brain natriuretic peptide levels, and patient age, and with decreasing fetal hemoglobin levels, according to a report published in Haematologica.

Although survival improved among children with sickle cell disease (SCD) following the Food and Drug Administration approval of hydroxyurea treatment in 1998, mortality remains high among adult patients. To examine the clinical and laboratory factors underlying early mortality in this patient population, researchers combined the findings from their single-center cohort study of 161 clinic patients and a meta-analysis of nine studies in the literature, for a total of 3,257 participants. This is “the largest number of SCD patients in whom risk factors for mortality have been evaluated in the hydroxyurea era,” said Poulami Maitra, PhD, of the department of biostatistics at the University of North Carolina, Chapel Hill, and her associates.

The clinic cohort had a median age of 36 years (range, 18-71 years), and there were 29 deaths during a median follow-up of 7.2 years. The median age at death was 48 years. Similarly, the median age at death ranged from 39.7 to 53 years in the meta-analysis.

In the combined cohort, patients who had a tricuspid regurgitant jet velocity of 2.5 m/s or more had three times greater risk of dying than did patients who had lower values, and the risk of dying was approximately doubled for every 1-U elevation in log(N-terminal pro-B type natriuretic peptide), which reflects increasing ventricular strain. Both links have been reported before. The findings confirm that recent clinical practice guidelines recommending periodic echocardiographic screening for these patients is warranted, the investigators said (Haematologica. 2017 Jan 19. doi: 10.3324/haematol.2016.153791).

The hazard of dying was 5% higher for every 1% increase in reticulocyte count, which suggests that hemolysis contributes to early mortality in these patients. The hazard of dying also was 3% lower for every 1% increase in fetal hemoglobin. This association with fetal hemoglobin is the basis for the development of drugs that raise that level, such as hydroxyurea.

Mortality was 30% higher for every 10-year increase in patient age, reflecting the fact that people with SCD show increasing end-organ damage over time that contributes to their mortality, Dr. Maitra and her associates said.

This work was supported by the National Institutes of Health and the North Carolina Sickle Cell Program. Dr. Maitra reported having no relevant financial disclosures; one of her associates reported serving as a consultant to Pfizer and Global Blood Therapeutics.

SNOWMASS, COLO. – Advances in remote telemedical management show enormous promise as a means of preventing costly heart failure hospitalizations, William T. Abraham, MD, said at the Annual Cardiovascular Conference at Snowmass.

He characterized the decades-old conventional approach to heart failure management as a reactive strategy focused on making medication adjustments based upon weight changes and worsening signs and symptoms. But these physiologic markers of acute decompensation aren’t actionable; that is, they don’t occur until it’s too late to successfully intervene to prevent hospitalization.

Finding best telemedicine options

But this high-tech patient management strategy is not quite ready for prime time use in daily clinical practice.

“We’re still sorting through this field and trying to figure out the best telemedicine options,” according to Dr. Abraham.

He cited several recent large, well-conducted randomized trials that have persuasively shown that there’s no point in applying home telemedicine in order to quickly respond to changes in a heart failure patient’s blood pressure, weight, and symptom status.

“The horse is already out of the barn at that point in time,” according to the cardiologist.

For example, the BEAT-HF (Better Effectiveness After Transition–Heart Failure) trial included 1,437 patients hospitalized for heart failure at eight California academic medical centers who were randomized to usual care or an intervention that combined health-coaching telephone calls and protocols for physician or nurse response to daily telemetric data on patient blood pressure, symptoms, heart rate, weight, and symptoms. The intervention turned out to have absolutely no effect on the 180-day rate of readmissions, which was roughly 50% in both groups (JAMA Intern Med. 2016 Mar;176[3]:310-8).

The PCDM (Patient-Centered Disease Management) trial was a multicenter Veterans Affairs study that randomized heart failure patients to usual care or a comprehensive intervention involving collaborative care by a cardiologist, psychiatrist, primary care physician, and nurse coordinator; screening and treatment for depression; and home telemonitoring of heart failure decompensation symptoms. The multifaceted intervention had no effect on the 1-year readmission rate (JAMA Intern Med. 2015 May;175[5]:725-32).

“To date, I would challenge you to find any adequately powered randomized, controlled trial in heart failure disease management that demonstrates that the way we’ve been doing things really keeps heart failure patients out of the hospital. So, it is time for a paradigm shift and some new technologies in our armamentarium,” Dr. Abraham said.
 

CardioMEMS system

Several remote telemedical management systems for heart failure, which measure early preclinical harbingers of acute decompensation, have received Food and Drug Administration approval. Many more are in development. Dr. Abraham highlighted two approved systems for which he was a coinvestigator in clinical trials.

The CardioMEMS system uses a pressure sensor the size of a small paper clip that is placed in a branch of the pulmonary artery, where it readily becomes endothelialized. Device implantation can be carried out by any cardiologist who can perform a right heart catheterization, be it an electrophysiologist, interventionalist, heart failure specialist, or general cardiologist. It takes only about an additional 7 minutes to deploy the sensor following a standard diagnostic right heart catheterization. The system doesn’t use a battery and has no moving parts.

“Now, with more than 10 years experience, we have yet to see a sensor failure. It’s a highly reliable system,” according to the cardiologist.

Once a day the patient lies down, pushes a button, and the sensor is simultaneously powered up while the data on pulmonary artery pressure waveforms and systolic and diastolic pressures is extracted using radiofrequency energy.

In the randomized, multicenter, controlled, single-blind CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients) trial, Dr. Abraham and coinvestigators demonstrated that pulmonary artery pressure-guided heart failure management reduced the rate of heart failure hospitalizations in the CardioMEMS group by 33% during the first 18 months of the trial and by 48% in the subsequent 13 months (Lancet. 2016 Jan 30;387[10017]:453-61).

“It’s important to note that the results were positive in diastolic as well as systolic heart failure. Patients with a baseline left ventricular ejection fraction of 40% or more saw a 50% reduction in the risk of heart failure hospitalizations, and those with an LVEF of 50% or more saw a 70% reduction,” Dr. Abraham said.
 

Other implantable hemodynamic monitors

Numerous other implantable pressure sensors are in development for management of heart failure, including other pulmonary artery pressure sensors as well as left atrial pressure monitors.

“You’re going to hear a lot more about this field of implantable hemodynamic monitors in the future,” the cardiologist predicted.

Dr. Abraham was also a coinvestigator in an observational study of a wearable sensor based upon radar technology developed for the military and subsequently applied to rescue searches through rubble for earthquake survivors. This remote dielectric sensing (ReDS) technology has been miniaturized, with the sensors embedded in an FDA-approved vest. The heart failure patient dons the SensiVest for 90 seconds once per day for measurement of the absolute amount of fluid in the lungs. The data is automatically transmitted to a secured site in the cloud, where the physician can review the results and adjust medications in response to early evidence of fluid buildup.

“The normal lung is composed of 20%-35% fluid. So when that fluid content is elevated, patients with heart failure have wet lungs and they’re decompensating. You increase their diuretics to bring it back down into normal range,” he explained.

In the observational study, conducted in Israel, hospital readmission rates were reduced by 87% through the use of ReDS-guided patient management using the system marketed by Sensible Medical Innovations. Dr. Abraham and his coinvestigators are now seeking to confirm those results in the prospective, multicenter, randomized, controlled U.S. SMILE study.

Dr. Abraham reported serving as a consultant to Abbott Vascular, Medtronic, Novartis, and St. Jude Medical.

[email protected]

SNOWMASS, COLO. – Advances in remote telemedical management show enormous promise as a means of preventing costly heart failure hospitalizations, William T. Abraham, MD, said at the Annual Cardiovascular Conference at Snowmass.

He characterized the decades-old conventional approach to heart failure management as a reactive strategy focused on making medication adjustments based upon weight changes and worsening signs and symptoms. But these physiologic markers of acute decompensation aren’t actionable; that is, they don’t occur until it’s too late to successfully intervene to prevent hospitalization.

Finding best telemedicine options

But this high-tech patient management strategy is not quite ready for prime time use in daily clinical practice.

“We’re still sorting through this field and trying to figure out the best telemedicine options,” according to Dr. Abraham.

He cited several recent large, well-conducted randomized trials that have persuasively shown that there’s no point in applying home telemedicine in order to quickly respond to changes in a heart failure patient’s blood pressure, weight, and symptom status.

“The horse is already out of the barn at that point in time,” according to the cardiologist.

For example, the BEAT-HF (Better Effectiveness After Transition–Heart Failure) trial included 1,437 patients hospitalized for heart failure at eight California academic medical centers who were randomized to usual care or an intervention that combined health-coaching telephone calls and protocols for physician or nurse response to daily telemetric data on patient blood pressure, symptoms, heart rate, weight, and symptoms. The intervention turned out to have absolutely no effect on the 180-day rate of readmissions, which was roughly 50% in both groups (JAMA Intern Med. 2016 Mar;176[3]:310-8).

The PCDM (Patient-Centered Disease Management) trial was a multicenter Veterans Affairs study that randomized heart failure patients to usual care or a comprehensive intervention involving collaborative care by a cardiologist, psychiatrist, primary care physician, and nurse coordinator; screening and treatment for depression; and home telemonitoring of heart failure decompensation symptoms. The multifaceted intervention had no effect on the 1-year readmission rate (JAMA Intern Med. 2015 May;175[5]:725-32).

“To date, I would challenge you to find any adequately powered randomized, controlled trial in heart failure disease management that demonstrates that the way we’ve been doing things really keeps heart failure patients out of the hospital. So, it is time for a paradigm shift and some new technologies in our armamentarium,” Dr. Abraham said.
 

CardioMEMS system

Several remote telemedical management systems for heart failure, which measure early preclinical harbingers of acute decompensation, have received Food and Drug Administration approval. Many more are in development. Dr. Abraham highlighted two approved systems for which he was a coinvestigator in clinical trials.

The CardioMEMS system uses a pressure sensor the size of a small paper clip that is placed in a branch of the pulmonary artery, where it readily becomes endothelialized. Device implantation can be carried out by any cardiologist who can perform a right heart catheterization, be it an electrophysiologist, interventionalist, heart failure specialist, or general cardiologist. It takes only about an additional 7 minutes to deploy the sensor following a standard diagnostic right heart catheterization. The system doesn’t use a battery and has no moving parts.

“Now, with more than 10 years experience, we have yet to see a sensor failure. It’s a highly reliable system,” according to the cardiologist.

Once a day the patient lies down, pushes a button, and the sensor is simultaneously powered up while the data on pulmonary artery pressure waveforms and systolic and diastolic pressures is extracted using radiofrequency energy.

In the randomized, multicenter, controlled, single-blind CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients) trial, Dr. Abraham and coinvestigators demonstrated that pulmonary artery pressure-guided heart failure management reduced the rate of heart failure hospitalizations in the CardioMEMS group by 33% during the first 18 months of the trial and by 48% in the subsequent 13 months (Lancet. 2016 Jan 30;387[10017]:453-61).

“It’s important to note that the results were positive in diastolic as well as systolic heart failure. Patients with a baseline left ventricular ejection fraction of 40% or more saw a 50% reduction in the risk of heart failure hospitalizations, and those with an LVEF of 50% or more saw a 70% reduction,” Dr. Abraham said.
 

Other implantable hemodynamic monitors

Numerous other implantable pressure sensors are in development for management of heart failure, including other pulmonary artery pressure sensors as well as left atrial pressure monitors.

“You’re going to hear a lot more about this field of implantable hemodynamic monitors in the future,” the cardiologist predicted.

Dr. Abraham was also a coinvestigator in an observational study of a wearable sensor based upon radar technology developed for the military and subsequently applied to rescue searches through rubble for earthquake survivors. This remote dielectric sensing (ReDS) technology has been miniaturized, with the sensors embedded in an FDA-approved vest. The heart failure patient dons the SensiVest for 90 seconds once per day for measurement of the absolute amount of fluid in the lungs. The data is automatically transmitted to a secured site in the cloud, where the physician can review the results and adjust medications in response to early evidence of fluid buildup.

“The normal lung is composed of 20%-35% fluid. So when that fluid content is elevated, patients with heart failure have wet lungs and they’re decompensating. You increase their diuretics to bring it back down into normal range,” he explained.

In the observational study, conducted in Israel, hospital readmission rates were reduced by 87% through the use of ReDS-guided patient management using the system marketed by Sensible Medical Innovations. Dr. Abraham and his coinvestigators are now seeking to confirm those results in the prospective, multicenter, randomized, controlled U.S. SMILE study.

Dr. Abraham reported serving as a consultant to Abbott Vascular, Medtronic, Novartis, and St. Jude Medical.

[email protected]

SNOWMASS, COLO. – Advances in remote telemedical management show enormous promise as a means of preventing costly heart failure hospitalizations, William T. Abraham, MD, said at the Annual Cardiovascular Conference at Snowmass.

He characterized the decades-old conventional approach to heart failure management as a reactive strategy focused on making medication adjustments based upon weight changes and worsening signs and symptoms. But these physiologic markers of acute decompensation aren’t actionable; that is, they don’t occur until it’s too late to successfully intervene to prevent hospitalization.

Finding best telemedicine options

But this high-tech patient management strategy is not quite ready for prime time use in daily clinical practice.

“We’re still sorting through this field and trying to figure out the best telemedicine options,” according to Dr. Abraham.

He cited several recent large, well-conducted randomized trials that have persuasively shown that there’s no point in applying home telemedicine in order to quickly respond to changes in a heart failure patient’s blood pressure, weight, and symptom status.

“The horse is already out of the barn at that point in time,” according to the cardiologist.

For example, the BEAT-HF (Better Effectiveness After Transition–Heart Failure) trial included 1,437 patients hospitalized for heart failure at eight California academic medical centers who were randomized to usual care or an intervention that combined health-coaching telephone calls and protocols for physician or nurse response to daily telemetric data on patient blood pressure, symptoms, heart rate, weight, and symptoms. The intervention turned out to have absolutely no effect on the 180-day rate of readmissions, which was roughly 50% in both groups (JAMA Intern Med. 2016 Mar;176[3]:310-8).

The PCDM (Patient-Centered Disease Management) trial was a multicenter Veterans Affairs study that randomized heart failure patients to usual care or a comprehensive intervention involving collaborative care by a cardiologist, psychiatrist, primary care physician, and nurse coordinator; screening and treatment for depression; and home telemonitoring of heart failure decompensation symptoms. The multifaceted intervention had no effect on the 1-year readmission rate (JAMA Intern Med. 2015 May;175[5]:725-32).

“To date, I would challenge you to find any adequately powered randomized, controlled trial in heart failure disease management that demonstrates that the way we’ve been doing things really keeps heart failure patients out of the hospital. So, it is time for a paradigm shift and some new technologies in our armamentarium,” Dr. Abraham said.
 

CardioMEMS system

Several remote telemedical management systems for heart failure, which measure early preclinical harbingers of acute decompensation, have received Food and Drug Administration approval. Many more are in development. Dr. Abraham highlighted two approved systems for which he was a coinvestigator in clinical trials.

The CardioMEMS system uses a pressure sensor the size of a small paper clip that is placed in a branch of the pulmonary artery, where it readily becomes endothelialized. Device implantation can be carried out by any cardiologist who can perform a right heart catheterization, be it an electrophysiologist, interventionalist, heart failure specialist, or general cardiologist. It takes only about an additional 7 minutes to deploy the sensor following a standard diagnostic right heart catheterization. The system doesn’t use a battery and has no moving parts.

“Now, with more than 10 years experience, we have yet to see a sensor failure. It’s a highly reliable system,” according to the cardiologist.

Once a day the patient lies down, pushes a button, and the sensor is simultaneously powered up while the data on pulmonary artery pressure waveforms and systolic and diastolic pressures is extracted using radiofrequency energy.

In the randomized, multicenter, controlled, single-blind CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients) trial, Dr. Abraham and coinvestigators demonstrated that pulmonary artery pressure-guided heart failure management reduced the rate of heart failure hospitalizations in the CardioMEMS group by 33% during the first 18 months of the trial and by 48% in the subsequent 13 months (Lancet. 2016 Jan 30;387[10017]:453-61).

“It’s important to note that the results were positive in diastolic as well as systolic heart failure. Patients with a baseline left ventricular ejection fraction of 40% or more saw a 50% reduction in the risk of heart failure hospitalizations, and those with an LVEF of 50% or more saw a 70% reduction,” Dr. Abraham said.
 

Other implantable hemodynamic monitors

Numerous other implantable pressure sensors are in development for management of heart failure, including other pulmonary artery pressure sensors as well as left atrial pressure monitors.

“You’re going to hear a lot more about this field of implantable hemodynamic monitors in the future,” the cardiologist predicted.

Dr. Abraham was also a coinvestigator in an observational study of a wearable sensor based upon radar technology developed for the military and subsequently applied to rescue searches through rubble for earthquake survivors. This remote dielectric sensing (ReDS) technology has been miniaturized, with the sensors embedded in an FDA-approved vest. The heart failure patient dons the SensiVest for 90 seconds once per day for measurement of the absolute amount of fluid in the lungs. The data is automatically transmitted to a secured site in the cloud, where the physician can review the results and adjust medications in response to early evidence of fluid buildup.

“The normal lung is composed of 20%-35% fluid. So when that fluid content is elevated, patients with heart failure have wet lungs and they’re decompensating. You increase their diuretics to bring it back down into normal range,” he explained.

In the observational study, conducted in Israel, hospital readmission rates were reduced by 87% through the use of ReDS-guided patient management using the system marketed by Sensible Medical Innovations. Dr. Abraham and his coinvestigators are now seeking to confirm those results in the prospective, multicenter, randomized, controlled U.S. SMILE study.

Dr. Abraham reported serving as a consultant to Abbott Vascular, Medtronic, Novartis, and St. Jude Medical.

[email protected]

“For the first time in U.S. military history, we have the necessary policy to create and maintain a durable, enduring trauma system in times of war and peace,” said David Smith, MD, deputy assistant secretary of defense for Health Readiness Policy and Oversight, in an article for Health.mil.

Dr. Smith is talking about DoD Instruction (DoDI) 6040.47, which codifies clinical guidance for the continuum of patient care.

The move is the latest in a series of steps that began in 2003, when the Joint Trauma System (JTS) was conceived. Although medical care then was well documented in theater, critical patient information wasn’t readily available as a patient moved through multiple hospitals. Moreover, deployed medical teams relied on telephonic coordination for long-term follow-up.

“The new DoD guidelines validate all the lessons learned from the ad hoc processes used out of necessity in establishing the JTS,” said JTS Director Navy Capt Zsolt Stockinger. The DoDI provides operational commanders, clinical providers, and medical planners with the best known combat medical techniques and procedures to minimize trauma-related disability and eliminate preventable deaths after injury.

Stockinger adds, “The JTS DoDI is not meant to dictate ‘how’ and ‘what’ a trauma system should look like, because each environment and location will dictate certain aspects of a trauma system.” Rather, Stockinger says, the JTS team is a resource to help others find the best solutions as they establish and grow their own geographic trauma system.

“For the first time in U.S. military history, we have the necessary policy to create and maintain a durable, enduring trauma system in times of war and peace,” said David Smith, MD, deputy assistant secretary of defense for Health Readiness Policy and Oversight, in an article for Health.mil.

Dr. Smith is talking about DoD Instruction (DoDI) 6040.47, which codifies clinical guidance for the continuum of patient care.

The move is the latest in a series of steps that began in 2003, when the Joint Trauma System (JTS) was conceived. Although medical care then was well documented in theater, critical patient information wasn’t readily available as a patient moved through multiple hospitals. Moreover, deployed medical teams relied on telephonic coordination for long-term follow-up.

“The new DoD guidelines validate all the lessons learned from the ad hoc processes used out of necessity in establishing the JTS,” said JTS Director Navy Capt Zsolt Stockinger. The DoDI provides operational commanders, clinical providers, and medical planners with the best known combat medical techniques and procedures to minimize trauma-related disability and eliminate preventable deaths after injury.

Stockinger adds, “The JTS DoDI is not meant to dictate ‘how’ and ‘what’ a trauma system should look like, because each environment and location will dictate certain aspects of a trauma system.” Rather, Stockinger says, the JTS team is a resource to help others find the best solutions as they establish and grow their own geographic trauma system.

“For the first time in U.S. military history, we have the necessary policy to create and maintain a durable, enduring trauma system in times of war and peace,” said David Smith, MD, deputy assistant secretary of defense for Health Readiness Policy and Oversight, in an article for Health.mil.

Dr. Smith is talking about DoD Instruction (DoDI) 6040.47, which codifies clinical guidance for the continuum of patient care.

The move is the latest in a series of steps that began in 2003, when the Joint Trauma System (JTS) was conceived. Although medical care then was well documented in theater, critical patient information wasn’t readily available as a patient moved through multiple hospitals. Moreover, deployed medical teams relied on telephonic coordination for long-term follow-up.

“The new DoD guidelines validate all the lessons learned from the ad hoc processes used out of necessity in establishing the JTS,” said JTS Director Navy Capt Zsolt Stockinger. The DoDI provides operational commanders, clinical providers, and medical planners with the best known combat medical techniques and procedures to minimize trauma-related disability and eliminate preventable deaths after injury.

Stockinger adds, “The JTS DoDI is not meant to dictate ‘how’ and ‘what’ a trauma system should look like, because each environment and location will dictate certain aspects of a trauma system.” Rather, Stockinger says, the JTS team is a resource to help others find the best solutions as they establish and grow their own geographic trauma system.

Polyclonal immunoglobulin recovery 1 year after autologous stem cell transplantation (ASCT) in multiple myeloma patients may help to predict progression-free and overall survival, according to research published online Jan. 25 in Haematologica.

“Most multiple myeloma patients (85%-90%) exhibit immunoparesis at the time of diagnosis,” wrote Verónica González-Calle, MD, of the Instituto de Investigación Biomédica de Salamanca (Spain) and her coauthors. While the recovery of polyclonal immunoglobulins is expected after high doses of akylating agents like melphalan and the infusion of stem cells in the setting of ASCT, but whether the “persistence of immunoparesis after ASCT may predict worse progression or survival in patients with multiple myeloma” has not been studied.

In a retrospective cohort study, Dr. González-Calle and her colleagues evaluated 295 patients with symptomatic multiple myeloma who underwent ASCT at two referral centers in Spain.

One year after the transfer, 52% of the surviving 169 patients had experienced immunoglobulin recovery – defined as normalization of polyclonal immunoglobulin levels – and 48% had not (Haematologica. 2017 Jan 25. doi: 10.3324/haematol.2016.158345). Of the 88 patients who experienced immunoglobulin recovery, 36% had recovered by 100 days, 18% by 6 months, 17% by 9 months, and 26% by 1 year after stem cell transfer.

Immunoglobulin recovery significantly affected both progression-free survival (PFS) and overall survival. Median PFS was significantly longer in the 88 patients who experienced immunoglobulin recovery than in those who did not (60.4 vs. 27.9 months; hazard ratio, 0.45; 95% CI, 0.31-0.66; P less than .001). Similarly, median overall survival was 11.3 years in the group who experienced immunoglobulin recovery and 7.3 years in those with persistent immunoparesis from 1 year (P = .002).

There was also a significant interaction between the time to immunoglobulin recovery and the duration of PFS, with a shorter recovery time being associated with a significantly lower PFS.

“One possible explanation is that the prognostic significance of the polyclonal Ig recovery could be established only in those patients who lived enough to have experienced complete and uneventful B-cell reconstitution 1 year after ASCT,” the authors wrote. “Thus, if the polyclonal Igs have recovered by this time, our results would lead us to expect a positive outcome. By contrast, persistence of immunoparesis at this time was independently associated with shorter [progression-free survival] and worse [overall survival].”

The authors said polyclonal immunoglobulin recovery after 1 year could be considered an independent long-term marker for predicting PFS and overall survival. It is also a marker that could be easily assessed in clinical practice.

One author was supported by the Fundación AMIR and another was supported by the Fundación Española de Hematología y Hemoterapia and Janssen. No conflicts of interest were declared.

Polyclonal immunoglobulin recovery 1 year after autologous stem cell transplantation (ASCT) in multiple myeloma patients may help to predict progression-free and overall survival, according to research published online Jan. 25 in Haematologica.

“Most multiple myeloma patients (85%-90%) exhibit immunoparesis at the time of diagnosis,” wrote Verónica González-Calle, MD, of the Instituto de Investigación Biomédica de Salamanca (Spain) and her coauthors. While the recovery of polyclonal immunoglobulins is expected after high doses of akylating agents like melphalan and the infusion of stem cells in the setting of ASCT, but whether the “persistence of immunoparesis after ASCT may predict worse progression or survival in patients with multiple myeloma” has not been studied.

In a retrospective cohort study, Dr. González-Calle and her colleagues evaluated 295 patients with symptomatic multiple myeloma who underwent ASCT at two referral centers in Spain.

One year after the transfer, 52% of the surviving 169 patients had experienced immunoglobulin recovery – defined as normalization of polyclonal immunoglobulin levels – and 48% had not (Haematologica. 2017 Jan 25. doi: 10.3324/haematol.2016.158345). Of the 88 patients who experienced immunoglobulin recovery, 36% had recovered by 100 days, 18% by 6 months, 17% by 9 months, and 26% by 1 year after stem cell transfer.

Immunoglobulin recovery significantly affected both progression-free survival (PFS) and overall survival. Median PFS was significantly longer in the 88 patients who experienced immunoglobulin recovery than in those who did not (60.4 vs. 27.9 months; hazard ratio, 0.45; 95% CI, 0.31-0.66; P less than .001). Similarly, median overall survival was 11.3 years in the group who experienced immunoglobulin recovery and 7.3 years in those with persistent immunoparesis from 1 year (P = .002).

There was also a significant interaction between the time to immunoglobulin recovery and the duration of PFS, with a shorter recovery time being associated with a significantly lower PFS.

“One possible explanation is that the prognostic significance of the polyclonal Ig recovery could be established only in those patients who lived enough to have experienced complete and uneventful B-cell reconstitution 1 year after ASCT,” the authors wrote. “Thus, if the polyclonal Igs have recovered by this time, our results would lead us to expect a positive outcome. By contrast, persistence of immunoparesis at this time was independently associated with shorter [progression-free survival] and worse [overall survival].”

The authors said polyclonal immunoglobulin recovery after 1 year could be considered an independent long-term marker for predicting PFS and overall survival. It is also a marker that could be easily assessed in clinical practice.

One author was supported by the Fundación AMIR and another was supported by the Fundación Española de Hematología y Hemoterapia and Janssen. No conflicts of interest were declared.

Polyclonal immunoglobulin recovery 1 year after autologous stem cell transplantation (ASCT) in multiple myeloma patients may help to predict progression-free and overall survival, according to research published online Jan. 25 in Haematologica.

“Most multiple myeloma patients (85%-90%) exhibit immunoparesis at the time of diagnosis,” wrote Verónica González-Calle, MD, of the Instituto de Investigación Biomédica de Salamanca (Spain) and her coauthors. While the recovery of polyclonal immunoglobulins is expected after high doses of akylating agents like melphalan and the infusion of stem cells in the setting of ASCT, but whether the “persistence of immunoparesis after ASCT may predict worse progression or survival in patients with multiple myeloma” has not been studied.

In a retrospective cohort study, Dr. González-Calle and her colleagues evaluated 295 patients with symptomatic multiple myeloma who underwent ASCT at two referral centers in Spain.

One year after the transfer, 52% of the surviving 169 patients had experienced immunoglobulin recovery – defined as normalization of polyclonal immunoglobulin levels – and 48% had not (Haematologica. 2017 Jan 25. doi: 10.3324/haematol.2016.158345). Of the 88 patients who experienced immunoglobulin recovery, 36% had recovered by 100 days, 18% by 6 months, 17% by 9 months, and 26% by 1 year after stem cell transfer.

Immunoglobulin recovery significantly affected both progression-free survival (PFS) and overall survival. Median PFS was significantly longer in the 88 patients who experienced immunoglobulin recovery than in those who did not (60.4 vs. 27.9 months; hazard ratio, 0.45; 95% CI, 0.31-0.66; P less than .001). Similarly, median overall survival was 11.3 years in the group who experienced immunoglobulin recovery and 7.3 years in those with persistent immunoparesis from 1 year (P = .002).

There was also a significant interaction between the time to immunoglobulin recovery and the duration of PFS, with a shorter recovery time being associated with a significantly lower PFS.

“One possible explanation is that the prognostic significance of the polyclonal Ig recovery could be established only in those patients who lived enough to have experienced complete and uneventful B-cell reconstitution 1 year after ASCT,” the authors wrote. “Thus, if the polyclonal Igs have recovered by this time, our results would lead us to expect a positive outcome. By contrast, persistence of immunoparesis at this time was independently associated with shorter [progression-free survival] and worse [overall survival].”

The authors said polyclonal immunoglobulin recovery after 1 year could be considered an independent long-term marker for predicting PFS and overall survival. It is also a marker that could be easily assessed in clinical practice.

One author was supported by the Fundación AMIR and another was supported by the Fundación Española de Hematología y Hemoterapia and Janssen. No conflicts of interest were declared.

Flexible duty hour policies did not affect general surgery resident performance on examinations during the prospective cluster-randomized FIRST (Flexibility in Duty Hour Requirements for Surgical Trainees) trial.

However, more years under such policies may be required to observe an effect, Eddie Blay Jr., MD, of Northwestern University, Chicago, and his colleagues reported in the Journal of the American College of Surgeons.

IMAGELAGOON02/Thinkstock

Further, pass rates for the QE were 90.5% and 90.4%, and for the CE were 88.6% and 86.3%, respectively, they noted.

Residents from 117 programs participated in the FIRST trial. Those in the standard policy group had daily duty hour limits as outlined by current Accreditation Council for Graduate Medical Education requirements, with a limit of 16 hours daily for interns and 28 hours for senior residents, and with at least 8 hours between daily shifts and 14 hours off after a 24-hour call. Those in the flexible policy group were exempt from these limits by a formal waiver.

The findings suggest that flexible duty hour policies do not result in significantly different educational outcomes but are limited by concerns about the generalizability of the results, and by a focus on limited aspects of surgeon training and performance, the investigators said.

Measuring actual surgeon education and training quality is challenging and might not be possible with the ABSITE, QE, and CE, they added, noting that future FIRST trial analyses will examine the impact of multiple years of flexible duty hour policies.

The FIRST trial was funded by the American Board of Surgery, the American College of Surgeons, and the ACGME. Stipends for individual authors were supported by a National Institutes of Health grant. The authors reported having no other disclosures.

[email protected]

Flexible duty hour policies did not affect general surgery resident performance on examinations during the prospective cluster-randomized FIRST (Flexibility in Duty Hour Requirements for Surgical Trainees) trial.

However, more years under such policies may be required to observe an effect, Eddie Blay Jr., MD, of Northwestern University, Chicago, and his colleagues reported in the Journal of the American College of Surgeons.

IMAGELAGOON02/Thinkstock

Further, pass rates for the QE were 90.5% and 90.4%, and for the CE were 88.6% and 86.3%, respectively, they noted.

Residents from 117 programs participated in the FIRST trial. Those in the standard policy group had daily duty hour limits as outlined by current Accreditation Council for Graduate Medical Education requirements, with a limit of 16 hours daily for interns and 28 hours for senior residents, and with at least 8 hours between daily shifts and 14 hours off after a 24-hour call. Those in the flexible policy group were exempt from these limits by a formal waiver.

The findings suggest that flexible duty hour policies do not result in significantly different educational outcomes but are limited by concerns about the generalizability of the results, and by a focus on limited aspects of surgeon training and performance, the investigators said.

Measuring actual surgeon education and training quality is challenging and might not be possible with the ABSITE, QE, and CE, they added, noting that future FIRST trial analyses will examine the impact of multiple years of flexible duty hour policies.

The FIRST trial was funded by the American Board of Surgery, the American College of Surgeons, and the ACGME. Stipends for individual authors were supported by a National Institutes of Health grant. The authors reported having no other disclosures.

[email protected]

Flexible duty hour policies did not affect general surgery resident performance on examinations during the prospective cluster-randomized FIRST (Flexibility in Duty Hour Requirements for Surgical Trainees) trial.

However, more years under such policies may be required to observe an effect, Eddie Blay Jr., MD, of Northwestern University, Chicago, and his colleagues reported in the Journal of the American College of Surgeons.

IMAGELAGOON02/Thinkstock

Further, pass rates for the QE were 90.5% and 90.4%, and for the CE were 88.6% and 86.3%, respectively, they noted.

Residents from 117 programs participated in the FIRST trial. Those in the standard policy group had daily duty hour limits as outlined by current Accreditation Council for Graduate Medical Education requirements, with a limit of 16 hours daily for interns and 28 hours for senior residents, and with at least 8 hours between daily shifts and 14 hours off after a 24-hour call. Those in the flexible policy group were exempt from these limits by a formal waiver.

The findings suggest that flexible duty hour policies do not result in significantly different educational outcomes but are limited by concerns about the generalizability of the results, and by a focus on limited aspects of surgeon training and performance, the investigators said.

Measuring actual surgeon education and training quality is challenging and might not be possible with the ABSITE, QE, and CE, they added, noting that future FIRST trial analyses will examine the impact of multiple years of flexible duty hour policies.

The FIRST trial was funded by the American Board of Surgery, the American College of Surgeons, and the ACGME. Stipends for individual authors were supported by a National Institutes of Health grant. The authors reported having no other disclosures.

[email protected]

ORLANDO – Performing a comprehensive geriatric assessment of patients with acute myeloid leukemia (AML) does more than provide fine-tuned risk stratification; spotting areas of vulnerability and frailty can also identify targets for prehabilitation, support, and remediation as older patients face transplant.

A program at the University of Chicago termed the Transplant Optimization Program, or TOP, uses the geriatric assessment as the foundation of an interdisciplinary, customized intervention for older adults facing hematopoietic cell transplant (HCT). The team includes the transplant physician and a geriatric oncologist; however, social work, dietetics, psychology, and physical therapy professionals also are brought on board.

Courtesy University of Chicago Medicine

“High comorbidities and functional limitations influence overall survival,” Dr. Artz said. “Non-relapse mortality remains a major barrier; of course, the attendant morbidity before it is perhaps a bigger concern, and our patients’ concern.”

Dr. Artz said that he and his colleagues at the University of Chicago, where he is a professor of medicine, had adapted the geriatric assessment developed by the Cancer and Aging Group, and now administer it to all prospective transplant patients aged 50 years and older. Dr. Artz said that, at his center, they have found that 25% of patients aged 50 and older were frail according to the Fried Frailty Index. “That’s what we expect for people in the community who are aged 80 and older, so we’re painting a picture of accelerated aging for patients before they undergo allograft,” he said.

Results of the assessment are then reviewed by a multidisciplinary team, and an individualized prehabilitation and support program is developed based on those results. “Using chronologic and physiologic age in transplant can help us better risk stratify, and think about strategies to mitigate some of those risks,” Dr. Artz said.

The staging tool currently used at the University of Chicago examines seven domains and uses objective tools to deliver information in each domain. Comorbidities are assessed by the Hematopoietic Cell Transplant–Specific Comorbidity Index (HCT-CI) and the Older Americans Resources and Services (OARS) scale. “We are trying to use standardized tools such as the geriatric assessment, because our ‘eyeball test’ is quite poor,” he said.

Physical function is assessed by measuring four-meter walk speed and grip strength; by asking about falls and capacity for instrumental activities of daily living; and by administering the Karnofsky Performance Scale–MD. Patients are given the Mental Health Inventory–17 to assess psychological health.

Neurocognitive testing and the Blessed Orientation-Memory-Concentration test are used to assess cognitive function. The Medical Outcomes Study Social Activity and Social Limitations scales give an idea about social support.

Biomarkers that are tracked include C-reactive protein and ferritin, among others, Dr. Artz said. Nutritional status is assessed by measuring serum albumin as well as any weight loss.

Once the full geriatric assessment data about a patient are gathered, a plan is formulated for impairments in any given domain. For example, if significant comorbid conditions exist, the TOP team seeks subspecialty consultation for management advice in the context of transplant. “This is a consultation – not a clearance!” Dr. Artz said.

Physical and functional impairments are addressed with prehabilitation if time permits, and the home assessment is aligned with patient expectations. Sometimes, the inactivity associated with peritransplant period can worsen conditions such as osteoarthritis, so a patient who’s been functional may find themselves very stiff when going home. Caregivers can encourage early activity to help minimize this effect, Dr. Artz said.

For patients at nutritional risk, it’s vital to have a good nutrition plan for transplant and to make sure medications or social factors aren’t standing in the way of adequate nutrition, Dr. Artz said. “Don’t forget to ask about dentures,” he said, since mucositis can make dentures unbearable in the immediate posttransplant period.

It’s important to be careful when unpacking findings of cognitive impairment, Dr. Artz said, since untreated depression and anxiety can manifest as forgetfulness and perseveration. Eliminating unnecessary medication, having a good delirium protocol in place, and keeping a family member in the room with the patient can help minimize a cognitive downturn during transplant.

As patients age, it can be more common for them to have limited social support. The TOP team calls a family meeting to assess resources and appoint a “team captain” among the patient’s social circle. “We work to enlarge that circle,” by pulling in as many family members and friends as possible, Dr. Artz said. In a discussion after the talk, he said that he feels that having a family member in the hospital with the older transplant patient is important for many reasons. Not only is the patient less likely to fall, he or she may also eat better and feel better. In addition, he said he has a sense that when the caregiver has seen the patient at his or her nadir, taking that patient home isn’t as scary, since it’s easier to see that the trajectory is headed upward by the time of discharge.

Dr. Artz said that other facilities are now beginning to send patients for TOP evaluations; “the aging evaluation informs physiologic age, candidacy for transplant, and may permit optimizing outcomes,” he said. “We’re trying to ... optimize patients both before and after transplant. It’s one thing to say you’re vulnerable, but how do you take that vulnerable patient and improve their outcomes? That’s the question.” Though the proportion of older individuals receiving allogeneic transplants is growing rapidly, research is not keeping up, Dr. Artz said, calling for more prospective studies in older adults.

Dr. Artz reported that he has received research funding from Miltenyi Biotech.

[email protected]
On Twitter @karioakes

ORLANDO – Performing a comprehensive geriatric assessment of patients with acute myeloid leukemia (AML) does more than provide fine-tuned risk stratification; spotting areas of vulnerability and frailty can also identify targets for prehabilitation, support, and remediation as older patients face transplant.

A program at the University of Chicago termed the Transplant Optimization Program, or TOP, uses the geriatric assessment as the foundation of an interdisciplinary, customized intervention for older adults facing hematopoietic cell transplant (HCT). The team includes the transplant physician and a geriatric oncologist; however, social work, dietetics, psychology, and physical therapy professionals also are brought on board.

Courtesy University of Chicago Medicine

“High comorbidities and functional limitations influence overall survival,” Dr. Artz said. “Non-relapse mortality remains a major barrier; of course, the attendant morbidity before it is perhaps a bigger concern, and our patients’ concern.”

Dr. Artz said that he and his colleagues at the University of Chicago, where he is a professor of medicine, had adapted the geriatric assessment developed by the Cancer and Aging Group, and now administer it to all prospective transplant patients aged 50 years and older. Dr. Artz said that, at his center, they have found that 25% of patients aged 50 and older were frail according to the Fried Frailty Index. “That’s what we expect for people in the community who are aged 80 and older, so we’re painting a picture of accelerated aging for patients before they undergo allograft,” he said.

Results of the assessment are then reviewed by a multidisciplinary team, and an individualized prehabilitation and support program is developed based on those results. “Using chronologic and physiologic age in transplant can help us better risk stratify, and think about strategies to mitigate some of those risks,” Dr. Artz said.

The staging tool currently used at the University of Chicago examines seven domains and uses objective tools to deliver information in each domain. Comorbidities are assessed by the Hematopoietic Cell Transplant–Specific Comorbidity Index (HCT-CI) and the Older Americans Resources and Services (OARS) scale. “We are trying to use standardized tools such as the geriatric assessment, because our ‘eyeball test’ is quite poor,” he said.

Physical function is assessed by measuring four-meter walk speed and grip strength; by asking about falls and capacity for instrumental activities of daily living; and by administering the Karnofsky Performance Scale–MD. Patients are given the Mental Health Inventory–17 to assess psychological health.

Neurocognitive testing and the Blessed Orientation-Memory-Concentration test are used to assess cognitive function. The Medical Outcomes Study Social Activity and Social Limitations scales give an idea about social support.

Biomarkers that are tracked include C-reactive protein and ferritin, among others, Dr. Artz said. Nutritional status is assessed by measuring serum albumin as well as any weight loss.

Once the full geriatric assessment data about a patient are gathered, a plan is formulated for impairments in any given domain. For example, if significant comorbid conditions exist, the TOP team seeks subspecialty consultation for management advice in the context of transplant. “This is a consultation – not a clearance!” Dr. Artz said.

Physical and functional impairments are addressed with prehabilitation if time permits, and the home assessment is aligned with patient expectations. Sometimes, the inactivity associated with peritransplant period can worsen conditions such as osteoarthritis, so a patient who’s been functional may find themselves very stiff when going home. Caregivers can encourage early activity to help minimize this effect, Dr. Artz said.

For patients at nutritional risk, it’s vital to have a good nutrition plan for transplant and to make sure medications or social factors aren’t standing in the way of adequate nutrition, Dr. Artz said. “Don’t forget to ask about dentures,” he said, since mucositis can make dentures unbearable in the immediate posttransplant period.

It’s important to be careful when unpacking findings of cognitive impairment, Dr. Artz said, since untreated depression and anxiety can manifest as forgetfulness and perseveration. Eliminating unnecessary medication, having a good delirium protocol in place, and keeping a family member in the room with the patient can help minimize a cognitive downturn during transplant.

As patients age, it can be more common for them to have limited social support. The TOP team calls a family meeting to assess resources and appoint a “team captain” among the patient’s social circle. “We work to enlarge that circle,” by pulling in as many family members and friends as possible, Dr. Artz said. In a discussion after the talk, he said that he feels that having a family member in the hospital with the older transplant patient is important for many reasons. Not only is the patient less likely to fall, he or she may also eat better and feel better. In addition, he said he has a sense that when the caregiver has seen the patient at his or her nadir, taking that patient home isn’t as scary, since it’s easier to see that the trajectory is headed upward by the time of discharge.

Dr. Artz said that other facilities are now beginning to send patients for TOP evaluations; “the aging evaluation informs physiologic age, candidacy for transplant, and may permit optimizing outcomes,” he said. “We’re trying to ... optimize patients both before and after transplant. It’s one thing to say you’re vulnerable, but how do you take that vulnerable patient and improve their outcomes? That’s the question.” Though the proportion of older individuals receiving allogeneic transplants is growing rapidly, research is not keeping up, Dr. Artz said, calling for more prospective studies in older adults.

Dr. Artz reported that he has received research funding from Miltenyi Biotech.

[email protected]
On Twitter @karioakes

ORLANDO – Performing a comprehensive geriatric assessment of patients with acute myeloid leukemia (AML) does more than provide fine-tuned risk stratification; spotting areas of vulnerability and frailty can also identify targets for prehabilitation, support, and remediation as older patients face transplant.

A program at the University of Chicago termed the Transplant Optimization Program, or TOP, uses the geriatric assessment as the foundation of an interdisciplinary, customized intervention for older adults facing hematopoietic cell transplant (HCT). The team includes the transplant physician and a geriatric oncologist; however, social work, dietetics, psychology, and physical therapy professionals also are brought on board.

Courtesy University of Chicago Medicine

“High comorbidities and functional limitations influence overall survival,” Dr. Artz said. “Non-relapse mortality remains a major barrier; of course, the attendant morbidity before it is perhaps a bigger concern, and our patients’ concern.”

Dr. Artz said that he and his colleagues at the University of Chicago, where he is a professor of medicine, had adapted the geriatric assessment developed by the Cancer and Aging Group, and now administer it to all prospective transplant patients aged 50 years and older. Dr. Artz said that, at his center, they have found that 25% of patients aged 50 and older were frail according to the Fried Frailty Index. “That’s what we expect for people in the community who are aged 80 and older, so we’re painting a picture of accelerated aging for patients before they undergo allograft,” he said.

Results of the assessment are then reviewed by a multidisciplinary team, and an individualized prehabilitation and support program is developed based on those results. “Using chronologic and physiologic age in transplant can help us better risk stratify, and think about strategies to mitigate some of those risks,” Dr. Artz said.

The staging tool currently used at the University of Chicago examines seven domains and uses objective tools to deliver information in each domain. Comorbidities are assessed by the Hematopoietic Cell Transplant–Specific Comorbidity Index (HCT-CI) and the Older Americans Resources and Services (OARS) scale. “We are trying to use standardized tools such as the geriatric assessment, because our ‘eyeball test’ is quite poor,” he said.

Physical function is assessed by measuring four-meter walk speed and grip strength; by asking about falls and capacity for instrumental activities of daily living; and by administering the Karnofsky Performance Scale–MD. Patients are given the Mental Health Inventory–17 to assess psychological health.

Neurocognitive testing and the Blessed Orientation-Memory-Concentration test are used to assess cognitive function. The Medical Outcomes Study Social Activity and Social Limitations scales give an idea about social support.

Biomarkers that are tracked include C-reactive protein and ferritin, among others, Dr. Artz said. Nutritional status is assessed by measuring serum albumin as well as any weight loss.

Once the full geriatric assessment data about a patient are gathered, a plan is formulated for impairments in any given domain. For example, if significant comorbid conditions exist, the TOP team seeks subspecialty consultation for management advice in the context of transplant. “This is a consultation – not a clearance!” Dr. Artz said.

Physical and functional impairments are addressed with prehabilitation if time permits, and the home assessment is aligned with patient expectations. Sometimes, the inactivity associated with peritransplant period can worsen conditions such as osteoarthritis, so a patient who’s been functional may find themselves very stiff when going home. Caregivers can encourage early activity to help minimize this effect, Dr. Artz said.

For patients at nutritional risk, it’s vital to have a good nutrition plan for transplant and to make sure medications or social factors aren’t standing in the way of adequate nutrition, Dr. Artz said. “Don’t forget to ask about dentures,” he said, since mucositis can make dentures unbearable in the immediate posttransplant period.

It’s important to be careful when unpacking findings of cognitive impairment, Dr. Artz said, since untreated depression and anxiety can manifest as forgetfulness and perseveration. Eliminating unnecessary medication, having a good delirium protocol in place, and keeping a family member in the room with the patient can help minimize a cognitive downturn during transplant.

As patients age, it can be more common for them to have limited social support. The TOP team calls a family meeting to assess resources and appoint a “team captain” among the patient’s social circle. “We work to enlarge that circle,” by pulling in as many family members and friends as possible, Dr. Artz said. In a discussion after the talk, he said that he feels that having a family member in the hospital with the older transplant patient is important for many reasons. Not only is the patient less likely to fall, he or she may also eat better and feel better. In addition, he said he has a sense that when the caregiver has seen the patient at his or her nadir, taking that patient home isn’t as scary, since it’s easier to see that the trajectory is headed upward by the time of discharge.

Dr. Artz said that other facilities are now beginning to send patients for TOP evaluations; “the aging evaluation informs physiologic age, candidacy for transplant, and may permit optimizing outcomes,” he said. “We’re trying to ... optimize patients both before and after transplant. It’s one thing to say you’re vulnerable, but how do you take that vulnerable patient and improve their outcomes? That’s the question.” Though the proportion of older individuals receiving allogeneic transplants is growing rapidly, research is not keeping up, Dr. Artz said, calling for more prospective studies in older adults.

Dr. Artz reported that he has received research funding from Miltenyi Biotech.

[email protected]
On Twitter @karioakes